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Ovarian Cancer Red Flags: What to Know to Quicken Diagnoses
One in seven women will die within 2 months of being diagnosed with ovarian cancer, a new report from the United Kingdom states. But if diagnosed at the earliest stage, 9 in 10 women will survive. Two thirds of women are now diagnosed late, when the cancer is harder to treat.
Diagnosis is difficult for many reasons, among them that women sometimes think symptoms are a natural part of menopause and don’t acknowledge or report them. Clinicians may mistake abdominal symptoms for those of a bowel condition or bladder problem. Almost half of GPs (46%) in the UK mistakenly believe that ovarian cancer symptoms present in only the later stages of the disease.
Cervical Screening Does Not Detect Ovarian Cancer
Additionally, there are misconceptions regarding cervical cancer screening — one study found that “40% of women in the general public mistakenly believe that cervical screening detects ovarian cancer.” But there is no current screening program for ovarian cancer in the UK or United States.
During a pelvic exam, the physician feels the ovaries and uterus for size, shape, and consistency and that can be useful in finding some cancers early, but most early ovarian tumors are difficult or impossible to feel, the American Cancer Society notes.
Recognizing the Red Flags
Victoria Barber, MBBS, a general practitioner in Northamptonshire and a Primary Care Advisory Board member with the Target Ovarian Cancer program in the UK published a paper in the British Journal of Nursing (2024 Mar 7. doi: 10.12968/bjon.2024.33.5.S16) on the program’s efforts to urge clinicians to recognize ovarian cancer red flags and to “never diagnose new-onset irritable bowel syndrome or overactive bladder in women over 50 without ruling out ovarian cancer.”
She says nurses should be involved to help with earlier diagnosis of ovarian cancer as they are often involved in evaluating urine samples. Nurse practitioners, she notes, are typically included in consultations for abdominal symptoms and potential urinary tract infections.
“If the woman is recurrently presenting with urinary symptoms, sterile midstream urine samples should raise alarm,” she says. “The woman may have diabetes, an overactive bladder, or interstitial cystitis; however, urgency and frequency are some of the symptoms of ovarian cancer, and they need investigation.”
Persistent Systems Over Age 50
The paper lists ovarian cancer symptoms from the UK’s National Institute for Health and Care Excellence and notes that among red flags are having any of the following persistently/frequently (particularly more than 12 times per month and especially if the woman is 50 years or older):
- Early satiety and/or loss of appetite
- Abdominal bloating
- Pelvic or abdominal pain
- Urinary urgency/frequency
Other symptoms could include:
- Changes in bowel habits (e.g., diarrhea or constipation)
- Extreme fatigue
- Unexplained weight loss
Diagnosis Challenges Similar in US
Ernst Lengyel, MD, PhD, UChicago Medicine’s Chairman of the Department of Obstetrics and Gynecology in Chicago, Illinois, who was not involved with the paper, said the situation in the United States is similar to that described in the UK.
“The diagnosis is delayed because the symptoms are unspecific. The problem is that ovarian cancer is so rare, and primary care physicians or nurse practitioners have to consider over 100 differential diagnoses,” he says.
In the US, he says, it is likely easier to get in and see a physician because of the private insurance options and because there are more gynecologic oncologists in large urban areas. Getting imaging approved — such as ultrasound and computed tomography scans — is also easier in the US.
Still, “there is no effective way to diagnose ovarian cancer early,” he says. “No single test or combination of symptoms can be used as a screening test.”
The CA-125 blood test measures proteins that can be linked with ovarian cancer, but is not a screening test, he notes.
“Large UK and US studies have not been able to show a survival benefit with ultrasound, serial CA-125, or a combination thereof,” Dr. Lengyel said.
Weight Gain May Also be a Sign
A broad range of clinicians should be aware of the symptoms the author mentions, he says, especially primary care physicians, nurse practitioners, and obstetrician/gynecologists.
“Too often, symptoms that women report are ignored and treated as unspecific or psychosomatic,” Dr. Lengyel says. “It is easy to disregard recurrent complaints and move on instead of being vigilant and working them up. Ironically, women with ovarian cancer can initially gain weight, which is counterintuitive as most doctors believe that patients with cancer lose weight. However, if they develop abdominal fluid, a patient often gains weight.”
Dr. Barber and Dr. Lengyel report no relevant financial relationships.
One in seven women will die within 2 months of being diagnosed with ovarian cancer, a new report from the United Kingdom states. But if diagnosed at the earliest stage, 9 in 10 women will survive. Two thirds of women are now diagnosed late, when the cancer is harder to treat.
Diagnosis is difficult for many reasons, among them that women sometimes think symptoms are a natural part of menopause and don’t acknowledge or report them. Clinicians may mistake abdominal symptoms for those of a bowel condition or bladder problem. Almost half of GPs (46%) in the UK mistakenly believe that ovarian cancer symptoms present in only the later stages of the disease.
Cervical Screening Does Not Detect Ovarian Cancer
Additionally, there are misconceptions regarding cervical cancer screening — one study found that “40% of women in the general public mistakenly believe that cervical screening detects ovarian cancer.” But there is no current screening program for ovarian cancer in the UK or United States.
During a pelvic exam, the physician feels the ovaries and uterus for size, shape, and consistency and that can be useful in finding some cancers early, but most early ovarian tumors are difficult or impossible to feel, the American Cancer Society notes.
Recognizing the Red Flags
Victoria Barber, MBBS, a general practitioner in Northamptonshire and a Primary Care Advisory Board member with the Target Ovarian Cancer program in the UK published a paper in the British Journal of Nursing (2024 Mar 7. doi: 10.12968/bjon.2024.33.5.S16) on the program’s efforts to urge clinicians to recognize ovarian cancer red flags and to “never diagnose new-onset irritable bowel syndrome or overactive bladder in women over 50 without ruling out ovarian cancer.”
She says nurses should be involved to help with earlier diagnosis of ovarian cancer as they are often involved in evaluating urine samples. Nurse practitioners, she notes, are typically included in consultations for abdominal symptoms and potential urinary tract infections.
“If the woman is recurrently presenting with urinary symptoms, sterile midstream urine samples should raise alarm,” she says. “The woman may have diabetes, an overactive bladder, or interstitial cystitis; however, urgency and frequency are some of the symptoms of ovarian cancer, and they need investigation.”
Persistent Systems Over Age 50
The paper lists ovarian cancer symptoms from the UK’s National Institute for Health and Care Excellence and notes that among red flags are having any of the following persistently/frequently (particularly more than 12 times per month and especially if the woman is 50 years or older):
- Early satiety and/or loss of appetite
- Abdominal bloating
- Pelvic or abdominal pain
- Urinary urgency/frequency
Other symptoms could include:
- Changes in bowel habits (e.g., diarrhea or constipation)
- Extreme fatigue
- Unexplained weight loss
Diagnosis Challenges Similar in US
Ernst Lengyel, MD, PhD, UChicago Medicine’s Chairman of the Department of Obstetrics and Gynecology in Chicago, Illinois, who was not involved with the paper, said the situation in the United States is similar to that described in the UK.
“The diagnosis is delayed because the symptoms are unspecific. The problem is that ovarian cancer is so rare, and primary care physicians or nurse practitioners have to consider over 100 differential diagnoses,” he says.
In the US, he says, it is likely easier to get in and see a physician because of the private insurance options and because there are more gynecologic oncologists in large urban areas. Getting imaging approved — such as ultrasound and computed tomography scans — is also easier in the US.
Still, “there is no effective way to diagnose ovarian cancer early,” he says. “No single test or combination of symptoms can be used as a screening test.”
The CA-125 blood test measures proteins that can be linked with ovarian cancer, but is not a screening test, he notes.
“Large UK and US studies have not been able to show a survival benefit with ultrasound, serial CA-125, or a combination thereof,” Dr. Lengyel said.
Weight Gain May Also be a Sign
A broad range of clinicians should be aware of the symptoms the author mentions, he says, especially primary care physicians, nurse practitioners, and obstetrician/gynecologists.
“Too often, symptoms that women report are ignored and treated as unspecific or psychosomatic,” Dr. Lengyel says. “It is easy to disregard recurrent complaints and move on instead of being vigilant and working them up. Ironically, women with ovarian cancer can initially gain weight, which is counterintuitive as most doctors believe that patients with cancer lose weight. However, if they develop abdominal fluid, a patient often gains weight.”
Dr. Barber and Dr. Lengyel report no relevant financial relationships.
One in seven women will die within 2 months of being diagnosed with ovarian cancer, a new report from the United Kingdom states. But if diagnosed at the earliest stage, 9 in 10 women will survive. Two thirds of women are now diagnosed late, when the cancer is harder to treat.
Diagnosis is difficult for many reasons, among them that women sometimes think symptoms are a natural part of menopause and don’t acknowledge or report them. Clinicians may mistake abdominal symptoms for those of a bowel condition or bladder problem. Almost half of GPs (46%) in the UK mistakenly believe that ovarian cancer symptoms present in only the later stages of the disease.
Cervical Screening Does Not Detect Ovarian Cancer
Additionally, there are misconceptions regarding cervical cancer screening — one study found that “40% of women in the general public mistakenly believe that cervical screening detects ovarian cancer.” But there is no current screening program for ovarian cancer in the UK or United States.
During a pelvic exam, the physician feels the ovaries and uterus for size, shape, and consistency and that can be useful in finding some cancers early, but most early ovarian tumors are difficult or impossible to feel, the American Cancer Society notes.
Recognizing the Red Flags
Victoria Barber, MBBS, a general practitioner in Northamptonshire and a Primary Care Advisory Board member with the Target Ovarian Cancer program in the UK published a paper in the British Journal of Nursing (2024 Mar 7. doi: 10.12968/bjon.2024.33.5.S16) on the program’s efforts to urge clinicians to recognize ovarian cancer red flags and to “never diagnose new-onset irritable bowel syndrome or overactive bladder in women over 50 without ruling out ovarian cancer.”
She says nurses should be involved to help with earlier diagnosis of ovarian cancer as they are often involved in evaluating urine samples. Nurse practitioners, she notes, are typically included in consultations for abdominal symptoms and potential urinary tract infections.
“If the woman is recurrently presenting with urinary symptoms, sterile midstream urine samples should raise alarm,” she says. “The woman may have diabetes, an overactive bladder, or interstitial cystitis; however, urgency and frequency are some of the symptoms of ovarian cancer, and they need investigation.”
Persistent Systems Over Age 50
The paper lists ovarian cancer symptoms from the UK’s National Institute for Health and Care Excellence and notes that among red flags are having any of the following persistently/frequently (particularly more than 12 times per month and especially if the woman is 50 years or older):
- Early satiety and/or loss of appetite
- Abdominal bloating
- Pelvic or abdominal pain
- Urinary urgency/frequency
Other symptoms could include:
- Changes in bowel habits (e.g., diarrhea or constipation)
- Extreme fatigue
- Unexplained weight loss
Diagnosis Challenges Similar in US
Ernst Lengyel, MD, PhD, UChicago Medicine’s Chairman of the Department of Obstetrics and Gynecology in Chicago, Illinois, who was not involved with the paper, said the situation in the United States is similar to that described in the UK.
“The diagnosis is delayed because the symptoms are unspecific. The problem is that ovarian cancer is so rare, and primary care physicians or nurse practitioners have to consider over 100 differential diagnoses,” he says.
In the US, he says, it is likely easier to get in and see a physician because of the private insurance options and because there are more gynecologic oncologists in large urban areas. Getting imaging approved — such as ultrasound and computed tomography scans — is also easier in the US.
Still, “there is no effective way to diagnose ovarian cancer early,” he says. “No single test or combination of symptoms can be used as a screening test.”
The CA-125 blood test measures proteins that can be linked with ovarian cancer, but is not a screening test, he notes.
“Large UK and US studies have not been able to show a survival benefit with ultrasound, serial CA-125, or a combination thereof,” Dr. Lengyel said.
Weight Gain May Also be a Sign
A broad range of clinicians should be aware of the symptoms the author mentions, he says, especially primary care physicians, nurse practitioners, and obstetrician/gynecologists.
“Too often, symptoms that women report are ignored and treated as unspecific or psychosomatic,” Dr. Lengyel says. “It is easy to disregard recurrent complaints and move on instead of being vigilant and working them up. Ironically, women with ovarian cancer can initially gain weight, which is counterintuitive as most doctors believe that patients with cancer lose weight. However, if they develop abdominal fluid, a patient often gains weight.”
Dr. Barber and Dr. Lengyel report no relevant financial relationships.
FROM THE BRITISH JOURNAL OF NURSING
Debate Arises Over Ovarian Tissue Transplants to Delay Menopause
The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.
Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.
“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.
But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.
“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
The Promise and Risks of OTT
OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.
Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.
The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.
OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.
Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.
The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.
The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.
While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.
“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.
Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.
A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
Why Delay Menopause?
While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.
Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.
Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.
But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.
“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”
The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.
A version of this article appeared on Medscape.com.
The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.
Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.
“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.
But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.
“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
The Promise and Risks of OTT
OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.
Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.
The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.
OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.
Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.
The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.
The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.
While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.
“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.
Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.
A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
Why Delay Menopause?
While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.
Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.
Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.
But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.
“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”
The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.
A version of this article appeared on Medscape.com.
The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.
Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.
“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.
But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.
“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
The Promise and Risks of OTT
OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.
Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.
The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.
OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.
Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.
The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.
The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.
While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.
“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.
Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.
A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
Why Delay Menopause?
While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.
Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.
Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.
But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.
“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”
The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.
A version of this article appeared on Medscape.com.
Weight Loss in Later-Life Women: More Than Diet, Exercise
Unwanted weight gain is a common problem for women after menopause. Primary care clinicians have likely heard from patients that attempts at shedding extra pounds are not working.
according to research.
“A lot of women are in tears because they have gained 10 or 15 pounds,” said Stephanie Faubion, MD, medical director of The Menopause Society and director of the Mayo Clinic Center for Women’s Health in Jacksonville, Florida.
A shortage of obesity and menopause specialists means primary care clinicians must understand the intersection of weight management and how the body functions after menopause.
“The importance of weight management in midlife cannot be overemphasized,” Dr. Faubion said. “Excess weight around the middle increases the risk of diabetes and heart disease and that is directly related to the loss of estrogen.”
The loss of estrogen due to menopause also causes the redistribution of fat from the thighs, hips, and buttocks to the midsection, which can be more difficult to trim. And women naturally lose muscle mass as they age, in part because the hormone is important to muscle functioning, according to Maria Daniela Hurtado Andrade, MD, PhD, assistant professor of medicine at Mayo Clinic Alix School of Medicine in Jacksonville, Florida.
“Menopause compounds the changes associated with aging: It makes them worse,” Dr. Hurtado Andrade said.
Mounting evidence has linked obesity-related systemic inflammation with an increased risk for cardiovascular disease, including heart attacks and vascular damage.
Michael Knight, MD, clinical associate professor of medicine and a weight loss specialist at the George Washington University in Washington, DC, estimated that more than half of his patients are postmenopausal women.
He recommended clinicians look for adipose tissue dysfunction, which can cause localized insulin resistance and affect metabolic health. Research suggests clinicians can perform a basic metabolic panel, in addition to testing for triglyceride, low-density lipoprotein, and renal function levels. Several other recent studies have pointed to using waist circumference, insulin resistance, or presence of metabolic syndrome to diagnose adipose tissue dysfunction.
Beyond Diet and Exercise
Physicians should ask their patients about physical activity, the type of foods they are eating, and changes in day-to-day movement, Dr. Knight advised.
Pharmacotherapy or surgical options should be considered for some patients, according to Karen Adams, MD, clinical professor of obstetrics and gynecology and a lifestyle medicine specialist at Stanford Medicine in Palo Alto, California. Postmenopausal women who want to lose more than 5%-10% of their body weight likely will need another modality in addition to diet and exercise.
“What’s important is transitioning the patient from feeling like they’ve failed to a mindset of seeking help or seeking care for this condition,” she said. Dr. Adams, a certified menopause specialist, uses the idea of “good enough” with her patients and suggests they think of weight loss as a journey, which may require different tools at various points.
Glucagon-like peptide 1 receptor agonists like semaglutide or tirzepatide are some of the most effective drugs for obesity, according to Dr. Knight.
In addition to these drugs, hormone replacement therapy in combination with the weight loss drug semaglutide may improve weight loss and reduce cardiometabolic risk in postmenopausal women compared with semaglutide alone, as reported in a study Dr. Hurtado Andrade and Dr. Faubion recently coauthored. Improving vasomotor symptoms improved sleep, physical activity, and quality of life, which all can affect efforts to lose weight.
Most patients who struggle to lose weight using diet and exercise methods alone usually do not maintain a healthy weight long term, according to Knight. Physicians need a comprehensive strategy to introduce options like medications or surgery when indicated for long-term, weight management solutions.
Tips for primary care clinicians in helping postmenopausal women lose weight:
- Develop an effective solution that works for your patient’s lifestyle. If you don’t have one, make a referral to a weight loss specialist.
- Educate patients about obesity and postmenopausal weight loss challenges, to help destigmatize the condition. Explain that obesity is a chronic disease, like hypertension or diabetes.
- Exercise suggestions should consider issues like walkable neighborhoods, access and affordability of gym membership, and home broadband access.
- Strength training should be recommended to counter loss of muscle mass that comes with aging.
- Consider a patient’s culture when discussing healthier alternatives to their usual diet.
- Suggest simple changes to start, like eliminating simple carbohydrates — white bread, pasta, and white rice — as a good place to start.
Body mass index was not designed to be a clinical tool and does not fully assess weight in many populations. Risk for chronic diseases and obesity varies depending on whether a person carries weight centrally or on the hips and thighs.
But well before menopause, clinicians can educate their female patients on what body changes to expect and be more mindful about which medications to not prescribe.
People in menopause or perimenopause are frequently prescribed weight-promoting drugs like antidepressants for mood swings or gabapentin for hot flashes. Clinicians should conduct a medication review and look for alternatives to drugs that are associated with weight gain.
The best approach is to try to avoid weight gain in the first place, which can be easier than trying to lose later, Dr. Faubion said. “You can’t just exercise your way out of it,” she said.
Dr. Adams, Dr. Faubion, and Dr. Hurtado Andrade reported no disclosures. Dr. Knight is a former consultant with Novo Nordisk.
A version of this article appeared on Medscape.com.
Unwanted weight gain is a common problem for women after menopause. Primary care clinicians have likely heard from patients that attempts at shedding extra pounds are not working.
according to research.
“A lot of women are in tears because they have gained 10 or 15 pounds,” said Stephanie Faubion, MD, medical director of The Menopause Society and director of the Mayo Clinic Center for Women’s Health in Jacksonville, Florida.
A shortage of obesity and menopause specialists means primary care clinicians must understand the intersection of weight management and how the body functions after menopause.
“The importance of weight management in midlife cannot be overemphasized,” Dr. Faubion said. “Excess weight around the middle increases the risk of diabetes and heart disease and that is directly related to the loss of estrogen.”
The loss of estrogen due to menopause also causes the redistribution of fat from the thighs, hips, and buttocks to the midsection, which can be more difficult to trim. And women naturally lose muscle mass as they age, in part because the hormone is important to muscle functioning, according to Maria Daniela Hurtado Andrade, MD, PhD, assistant professor of medicine at Mayo Clinic Alix School of Medicine in Jacksonville, Florida.
“Menopause compounds the changes associated with aging: It makes them worse,” Dr. Hurtado Andrade said.
Mounting evidence has linked obesity-related systemic inflammation with an increased risk for cardiovascular disease, including heart attacks and vascular damage.
Michael Knight, MD, clinical associate professor of medicine and a weight loss specialist at the George Washington University in Washington, DC, estimated that more than half of his patients are postmenopausal women.
He recommended clinicians look for adipose tissue dysfunction, which can cause localized insulin resistance and affect metabolic health. Research suggests clinicians can perform a basic metabolic panel, in addition to testing for triglyceride, low-density lipoprotein, and renal function levels. Several other recent studies have pointed to using waist circumference, insulin resistance, or presence of metabolic syndrome to diagnose adipose tissue dysfunction.
Beyond Diet and Exercise
Physicians should ask their patients about physical activity, the type of foods they are eating, and changes in day-to-day movement, Dr. Knight advised.
Pharmacotherapy or surgical options should be considered for some patients, according to Karen Adams, MD, clinical professor of obstetrics and gynecology and a lifestyle medicine specialist at Stanford Medicine in Palo Alto, California. Postmenopausal women who want to lose more than 5%-10% of their body weight likely will need another modality in addition to diet and exercise.
“What’s important is transitioning the patient from feeling like they’ve failed to a mindset of seeking help or seeking care for this condition,” she said. Dr. Adams, a certified menopause specialist, uses the idea of “good enough” with her patients and suggests they think of weight loss as a journey, which may require different tools at various points.
Glucagon-like peptide 1 receptor agonists like semaglutide or tirzepatide are some of the most effective drugs for obesity, according to Dr. Knight.
In addition to these drugs, hormone replacement therapy in combination with the weight loss drug semaglutide may improve weight loss and reduce cardiometabolic risk in postmenopausal women compared with semaglutide alone, as reported in a study Dr. Hurtado Andrade and Dr. Faubion recently coauthored. Improving vasomotor symptoms improved sleep, physical activity, and quality of life, which all can affect efforts to lose weight.
Most patients who struggle to lose weight using diet and exercise methods alone usually do not maintain a healthy weight long term, according to Knight. Physicians need a comprehensive strategy to introduce options like medications or surgery when indicated for long-term, weight management solutions.
Tips for primary care clinicians in helping postmenopausal women lose weight:
- Develop an effective solution that works for your patient’s lifestyle. If you don’t have one, make a referral to a weight loss specialist.
- Educate patients about obesity and postmenopausal weight loss challenges, to help destigmatize the condition. Explain that obesity is a chronic disease, like hypertension or diabetes.
- Exercise suggestions should consider issues like walkable neighborhoods, access and affordability of gym membership, and home broadband access.
- Strength training should be recommended to counter loss of muscle mass that comes with aging.
- Consider a patient’s culture when discussing healthier alternatives to their usual diet.
- Suggest simple changes to start, like eliminating simple carbohydrates — white bread, pasta, and white rice — as a good place to start.
Body mass index was not designed to be a clinical tool and does not fully assess weight in many populations. Risk for chronic diseases and obesity varies depending on whether a person carries weight centrally or on the hips and thighs.
But well before menopause, clinicians can educate their female patients on what body changes to expect and be more mindful about which medications to not prescribe.
People in menopause or perimenopause are frequently prescribed weight-promoting drugs like antidepressants for mood swings or gabapentin for hot flashes. Clinicians should conduct a medication review and look for alternatives to drugs that are associated with weight gain.
The best approach is to try to avoid weight gain in the first place, which can be easier than trying to lose later, Dr. Faubion said. “You can’t just exercise your way out of it,” she said.
Dr. Adams, Dr. Faubion, and Dr. Hurtado Andrade reported no disclosures. Dr. Knight is a former consultant with Novo Nordisk.
A version of this article appeared on Medscape.com.
Unwanted weight gain is a common problem for women after menopause. Primary care clinicians have likely heard from patients that attempts at shedding extra pounds are not working.
according to research.
“A lot of women are in tears because they have gained 10 or 15 pounds,” said Stephanie Faubion, MD, medical director of The Menopause Society and director of the Mayo Clinic Center for Women’s Health in Jacksonville, Florida.
A shortage of obesity and menopause specialists means primary care clinicians must understand the intersection of weight management and how the body functions after menopause.
“The importance of weight management in midlife cannot be overemphasized,” Dr. Faubion said. “Excess weight around the middle increases the risk of diabetes and heart disease and that is directly related to the loss of estrogen.”
The loss of estrogen due to menopause also causes the redistribution of fat from the thighs, hips, and buttocks to the midsection, which can be more difficult to trim. And women naturally lose muscle mass as they age, in part because the hormone is important to muscle functioning, according to Maria Daniela Hurtado Andrade, MD, PhD, assistant professor of medicine at Mayo Clinic Alix School of Medicine in Jacksonville, Florida.
“Menopause compounds the changes associated with aging: It makes them worse,” Dr. Hurtado Andrade said.
Mounting evidence has linked obesity-related systemic inflammation with an increased risk for cardiovascular disease, including heart attacks and vascular damage.
Michael Knight, MD, clinical associate professor of medicine and a weight loss specialist at the George Washington University in Washington, DC, estimated that more than half of his patients are postmenopausal women.
He recommended clinicians look for adipose tissue dysfunction, which can cause localized insulin resistance and affect metabolic health. Research suggests clinicians can perform a basic metabolic panel, in addition to testing for triglyceride, low-density lipoprotein, and renal function levels. Several other recent studies have pointed to using waist circumference, insulin resistance, or presence of metabolic syndrome to diagnose adipose tissue dysfunction.
Beyond Diet and Exercise
Physicians should ask their patients about physical activity, the type of foods they are eating, and changes in day-to-day movement, Dr. Knight advised.
Pharmacotherapy or surgical options should be considered for some patients, according to Karen Adams, MD, clinical professor of obstetrics and gynecology and a lifestyle medicine specialist at Stanford Medicine in Palo Alto, California. Postmenopausal women who want to lose more than 5%-10% of their body weight likely will need another modality in addition to diet and exercise.
“What’s important is transitioning the patient from feeling like they’ve failed to a mindset of seeking help or seeking care for this condition,” she said. Dr. Adams, a certified menopause specialist, uses the idea of “good enough” with her patients and suggests they think of weight loss as a journey, which may require different tools at various points.
Glucagon-like peptide 1 receptor agonists like semaglutide or tirzepatide are some of the most effective drugs for obesity, according to Dr. Knight.
In addition to these drugs, hormone replacement therapy in combination with the weight loss drug semaglutide may improve weight loss and reduce cardiometabolic risk in postmenopausal women compared with semaglutide alone, as reported in a study Dr. Hurtado Andrade and Dr. Faubion recently coauthored. Improving vasomotor symptoms improved sleep, physical activity, and quality of life, which all can affect efforts to lose weight.
Most patients who struggle to lose weight using diet and exercise methods alone usually do not maintain a healthy weight long term, according to Knight. Physicians need a comprehensive strategy to introduce options like medications or surgery when indicated for long-term, weight management solutions.
Tips for primary care clinicians in helping postmenopausal women lose weight:
- Develop an effective solution that works for your patient’s lifestyle. If you don’t have one, make a referral to a weight loss specialist.
- Educate patients about obesity and postmenopausal weight loss challenges, to help destigmatize the condition. Explain that obesity is a chronic disease, like hypertension or diabetes.
- Exercise suggestions should consider issues like walkable neighborhoods, access and affordability of gym membership, and home broadband access.
- Strength training should be recommended to counter loss of muscle mass that comes with aging.
- Consider a patient’s culture when discussing healthier alternatives to their usual diet.
- Suggest simple changes to start, like eliminating simple carbohydrates — white bread, pasta, and white rice — as a good place to start.
Body mass index was not designed to be a clinical tool and does not fully assess weight in many populations. Risk for chronic diseases and obesity varies depending on whether a person carries weight centrally or on the hips and thighs.
But well before menopause, clinicians can educate their female patients on what body changes to expect and be more mindful about which medications to not prescribe.
People in menopause or perimenopause are frequently prescribed weight-promoting drugs like antidepressants for mood swings or gabapentin for hot flashes. Clinicians should conduct a medication review and look for alternatives to drugs that are associated with weight gain.
The best approach is to try to avoid weight gain in the first place, which can be easier than trying to lose later, Dr. Faubion said. “You can’t just exercise your way out of it,” she said.
Dr. Adams, Dr. Faubion, and Dr. Hurtado Andrade reported no disclosures. Dr. Knight is a former consultant with Novo Nordisk.
A version of this article appeared on Medscape.com.
Cold Water Swimming Eased Menstrual, Perimenopause Symptoms
TOPLINE:
Women with menstrual or perimenopausal symptoms can relieve common physical and psychological issues through cold water swimming, a new study finds.
METHODOLOGY:
- Symptoms of menstrual cycles and perimenopause vary widely but frequently include mood swings, anxiety, depression, fatigue, hot flashes, and sleep disturbances.
- This is the first investigation of whether cold water swimming has an impact on these symptoms.
- Researchers conducted a 42-question online survey of 1114 women who were regularly swam in cold water. More than two-thirds of respondents (68.1%) were between 45 and 59 years of age.
- Some of the data included responses by women who were perimenopausal but still had menstrual symptoms.
TAKEAWAY:
- Women who swam more frequently and for longer reported more beneficial effects than women who swam less often or for less time per swim.
- Reduction of psychological and vasomotor symptoms were most often cited by cold-water swimmers.
- Perimenopausal women who swam regularly in winter and summer saw greater reduction in anxiety and hot flashes than did those who swam in the other seasons.
IN PRACTICE:
“Teaching women to swim safely and encouraging them to swim regularly may have a benefit on the debilitating symptoms associated with the perimenopause,” the authors wrote.
SOURCE:
The study was conducted by researchers from University College, London, and published online in Post Reproductive Health. The corresponding author is Joyce Harper, PhD, professor of reproductive science at EGA Institute for Women’s Health, University College London, England.
LIMITATIONS:
This was an observational study, with no control group. The underlying cause of improved psychological symptoms of perimenopause were not fully evaluated owing to unaccounted multiple variables. Use of an online survey may introduce sampling bias and not align with the population of all menstruating or perimenopausal women. Participants were primarily White and highly educated.
DISCLOSURES:
Dr. Harper disclosed giving paid talks on menopause to businesses and at conferences.
A version of this article appeared on Medscape.com.
TOPLINE:
Women with menstrual or perimenopausal symptoms can relieve common physical and psychological issues through cold water swimming, a new study finds.
METHODOLOGY:
- Symptoms of menstrual cycles and perimenopause vary widely but frequently include mood swings, anxiety, depression, fatigue, hot flashes, and sleep disturbances.
- This is the first investigation of whether cold water swimming has an impact on these symptoms.
- Researchers conducted a 42-question online survey of 1114 women who were regularly swam in cold water. More than two-thirds of respondents (68.1%) were between 45 and 59 years of age.
- Some of the data included responses by women who were perimenopausal but still had menstrual symptoms.
TAKEAWAY:
- Women who swam more frequently and for longer reported more beneficial effects than women who swam less often or for less time per swim.
- Reduction of psychological and vasomotor symptoms were most often cited by cold-water swimmers.
- Perimenopausal women who swam regularly in winter and summer saw greater reduction in anxiety and hot flashes than did those who swam in the other seasons.
IN PRACTICE:
“Teaching women to swim safely and encouraging them to swim regularly may have a benefit on the debilitating symptoms associated with the perimenopause,” the authors wrote.
SOURCE:
The study was conducted by researchers from University College, London, and published online in Post Reproductive Health. The corresponding author is Joyce Harper, PhD, professor of reproductive science at EGA Institute for Women’s Health, University College London, England.
LIMITATIONS:
This was an observational study, with no control group. The underlying cause of improved psychological symptoms of perimenopause were not fully evaluated owing to unaccounted multiple variables. Use of an online survey may introduce sampling bias and not align with the population of all menstruating or perimenopausal women. Participants were primarily White and highly educated.
DISCLOSURES:
Dr. Harper disclosed giving paid talks on menopause to businesses and at conferences.
A version of this article appeared on Medscape.com.
TOPLINE:
Women with menstrual or perimenopausal symptoms can relieve common physical and psychological issues through cold water swimming, a new study finds.
METHODOLOGY:
- Symptoms of menstrual cycles and perimenopause vary widely but frequently include mood swings, anxiety, depression, fatigue, hot flashes, and sleep disturbances.
- This is the first investigation of whether cold water swimming has an impact on these symptoms.
- Researchers conducted a 42-question online survey of 1114 women who were regularly swam in cold water. More than two-thirds of respondents (68.1%) were between 45 and 59 years of age.
- Some of the data included responses by women who were perimenopausal but still had menstrual symptoms.
TAKEAWAY:
- Women who swam more frequently and for longer reported more beneficial effects than women who swam less often or for less time per swim.
- Reduction of psychological and vasomotor symptoms were most often cited by cold-water swimmers.
- Perimenopausal women who swam regularly in winter and summer saw greater reduction in anxiety and hot flashes than did those who swam in the other seasons.
IN PRACTICE:
“Teaching women to swim safely and encouraging them to swim regularly may have a benefit on the debilitating symptoms associated with the perimenopause,” the authors wrote.
SOURCE:
The study was conducted by researchers from University College, London, and published online in Post Reproductive Health. The corresponding author is Joyce Harper, PhD, professor of reproductive science at EGA Institute for Women’s Health, University College London, England.
LIMITATIONS:
This was an observational study, with no control group. The underlying cause of improved psychological symptoms of perimenopause were not fully evaluated owing to unaccounted multiple variables. Use of an online survey may introduce sampling bias and not align with the population of all menstruating or perimenopausal women. Participants were primarily White and highly educated.
DISCLOSURES:
Dr. Harper disclosed giving paid talks on menopause to businesses and at conferences.
A version of this article appeared on Medscape.com.
Do Statins Offset Venous Thrombosis Risk With Hormone Therapy?
This transcript has been edited for clarity.
This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.
It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.
The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.
About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.
We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.
These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.
JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.
It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.
The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.
About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.
We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.
These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.
JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.
It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.
The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.
About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.
We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.
These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.
JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).
A version of this article appeared on Medscape.com.
Vegan diet may curb hot flashes by altering the gut microbiome
TOPLINE:
METHODOLOGY:
- For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
- Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
- Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.
TAKEAWAY:
- In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
- The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
- The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
- However, after correction for multiple comparisons, these associations were no longer significant.
IN PRACTICE:
“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”
SOURCE:
The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online November 8 in Complementary Therapies in Medicine.
LIMITATIONS:
The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.
DISCLOSURES:
The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
- Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
- Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.
TAKEAWAY:
- In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
- The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
- The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
- However, after correction for multiple comparisons, these associations were no longer significant.
IN PRACTICE:
“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”
SOURCE:
The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online November 8 in Complementary Therapies in Medicine.
LIMITATIONS:
The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.
DISCLOSURES:
The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
- Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
- Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.
TAKEAWAY:
- In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
- The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
- The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
- However, after correction for multiple comparisons, these associations were no longer significant.
IN PRACTICE:
“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”
SOURCE:
The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online November 8 in Complementary Therapies in Medicine.
LIMITATIONS:
The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.
DISCLOSURES:
The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.
A version of this article appeared on Medscape.com.
Procedures may ease postmenopausal pain better than drugs
a new study shows.
“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.
Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.
For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.
According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.
Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.
“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.
The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.
While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.
“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.
Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”
Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”
Dr. Yu and Dr. Wenham report no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new study shows.
“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.
Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.
For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.
According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.
Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.
“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.
The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.
While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.
“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.
Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”
Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”
Dr. Yu and Dr. Wenham report no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new study shows.
“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.
Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.
For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.
According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.
Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.
“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.
The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.
While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.
“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.
Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”
Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”
Dr. Yu and Dr. Wenham report no relevant financial relationships.
A version of this article appeared on Medscape.com.
Insufficient sleep impairs women’s insulin sensitivity
Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.
The research was published recently in Diabetes Care.
Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.
Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.
“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.
“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
Prolonged lack of sleep may accelerate diabetes progression
Dr. St-Onge added,
Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”
The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.
Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.
Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”
He continued, “There have been several studies showing the association of sleep and diabetes, but that does not necessarily mean cause and effect.”
On the other hand, Dr. Gabbay said, “randomizing people can help see sleep influences on key metabolic measures of diabetes, [which] helps to build a stronger case that sleep disturbances can cause worsening metabolic health.”
He emphasized that both the quantity and quality of sleep are “critical for optimal diabetes health” and highlighted that the ADA’s Standards of Care “recommends screening for sleep issues and counseling to improve sleep.”
“This study provides new insight into the health effects of even small sleep deficits in women across all stages of adulthood and racial and ethnic backgrounds,” commented Corinne Silva, PhD, program director in the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, which co-funded the study.
The authors note that more than one-third of adults sleep less than the recommended 7 hours per night, which is “concerning given robust associations of short sleep with cardiometabolic diseases.”
Moreover, “women report poorer sleep than men,” explained Marishka Brown, PhD, director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, which also co-funded the study.
“So understanding how sleep disturbances impact their health across the lifespan is critical, especially for postmenopausal women,” she said, particularly because previous studies have not reflected real-world sleep patterns or have focused on men.
The researchers conducted a trial to evaluate the causal impact of prolonged, mild sleep restriction on cardiometabolic risk factors in women as part of the American Heart Association Go Red for Women Strategically Focused Research Network.
They recruited metabolically healthy women aged 20-75 years who were at increased risk for cardiometabolic disease due to having either overweight or class I obesity or at least one parent with type 2 diabetes, hyperlipidemia, or cardiovascular disease.
They were also required to have a habitual total sleep time on actigraphy of 7-9 hours per night and low risk for sleep apnea. Exclusion criteria included excessive caffeine intake, a significantly advanced or delayed sleep phase, shift work, and travel across time zones.
The participants were randomly assigned to either adequate sleep, defined as 7-9 hours per night, or sleep restriction, defined as a reduction in sleep duration of 1.5 hours per night, for 6 weeks. They were then crossed over to the other sleep condition.
Assessments, including MRI and oral glucose tolerance tests, were performed at baseline and at the end of each study phase.
The researchers report on 38 women who took part in the trial, of whom 11 were postmenopausal. The mean age was 37.6 years; 31.6% self-identified as Black and 26.3% as Hispanic. The mean body mass index (BMI) was 25.5.
Postmenopausal women had a higher mean age than other women, at 56.1 years versus 30.1 years, and a higher baseline fasting blood glucose, at 5.26 mmol/L (94.68 mg/dL) versus 4.70 mmol/L (84.6 mg/dL).
The team reported that compliance with the sleep protocol was “excellent,” with women during sleep restriction having a reduction in total sleep time of 1.34 hours per night versus women in the adequate sleep arm (P < .0001).
Sleep restriction was also associated with significant increases in fasting plasma insulin versus adequate sleep, at a beta value of 0.68 pmol/L (P = .016), and significantly increased Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) values (beta = 0.30; P = .016).
The impact on HOMA-IR values was significantly more pronounced in postmenopausal than menopausal women, at beta values of 0.45 versus 0.27 (P for interaction = .042).
Sleep restriction had no significant effect on fasting plasma glucose levels, and the association between sleep duration and cardiometabolic parameters was not modified by the proportion of either total or visceral adipose tissue, or by changes in adiposity.
This clinical trial was supported by the American Heart Association, a National Institutes of Health Clinical and Translational Science Award to Columbia University, and N.Y. Nutrition Obesity Research Center. Individual authors received support from the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.
The research was published recently in Diabetes Care.
Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.
Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.
“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.
“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
Prolonged lack of sleep may accelerate diabetes progression
Dr. St-Onge added,
Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”
The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.
Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.
Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”
He continued, “There have been several studies showing the association of sleep and diabetes, but that does not necessarily mean cause and effect.”
On the other hand, Dr. Gabbay said, “randomizing people can help see sleep influences on key metabolic measures of diabetes, [which] helps to build a stronger case that sleep disturbances can cause worsening metabolic health.”
He emphasized that both the quantity and quality of sleep are “critical for optimal diabetes health” and highlighted that the ADA’s Standards of Care “recommends screening for sleep issues and counseling to improve sleep.”
“This study provides new insight into the health effects of even small sleep deficits in women across all stages of adulthood and racial and ethnic backgrounds,” commented Corinne Silva, PhD, program director in the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, which co-funded the study.
The authors note that more than one-third of adults sleep less than the recommended 7 hours per night, which is “concerning given robust associations of short sleep with cardiometabolic diseases.”
Moreover, “women report poorer sleep than men,” explained Marishka Brown, PhD, director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, which also co-funded the study.
“So understanding how sleep disturbances impact their health across the lifespan is critical, especially for postmenopausal women,” she said, particularly because previous studies have not reflected real-world sleep patterns or have focused on men.
The researchers conducted a trial to evaluate the causal impact of prolonged, mild sleep restriction on cardiometabolic risk factors in women as part of the American Heart Association Go Red for Women Strategically Focused Research Network.
They recruited metabolically healthy women aged 20-75 years who were at increased risk for cardiometabolic disease due to having either overweight or class I obesity or at least one parent with type 2 diabetes, hyperlipidemia, or cardiovascular disease.
They were also required to have a habitual total sleep time on actigraphy of 7-9 hours per night and low risk for sleep apnea. Exclusion criteria included excessive caffeine intake, a significantly advanced or delayed sleep phase, shift work, and travel across time zones.
The participants were randomly assigned to either adequate sleep, defined as 7-9 hours per night, or sleep restriction, defined as a reduction in sleep duration of 1.5 hours per night, for 6 weeks. They were then crossed over to the other sleep condition.
Assessments, including MRI and oral glucose tolerance tests, were performed at baseline and at the end of each study phase.
The researchers report on 38 women who took part in the trial, of whom 11 were postmenopausal. The mean age was 37.6 years; 31.6% self-identified as Black and 26.3% as Hispanic. The mean body mass index (BMI) was 25.5.
Postmenopausal women had a higher mean age than other women, at 56.1 years versus 30.1 years, and a higher baseline fasting blood glucose, at 5.26 mmol/L (94.68 mg/dL) versus 4.70 mmol/L (84.6 mg/dL).
The team reported that compliance with the sleep protocol was “excellent,” with women during sleep restriction having a reduction in total sleep time of 1.34 hours per night versus women in the adequate sleep arm (P < .0001).
Sleep restriction was also associated with significant increases in fasting plasma insulin versus adequate sleep, at a beta value of 0.68 pmol/L (P = .016), and significantly increased Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) values (beta = 0.30; P = .016).
The impact on HOMA-IR values was significantly more pronounced in postmenopausal than menopausal women, at beta values of 0.45 versus 0.27 (P for interaction = .042).
Sleep restriction had no significant effect on fasting plasma glucose levels, and the association between sleep duration and cardiometabolic parameters was not modified by the proportion of either total or visceral adipose tissue, or by changes in adiposity.
This clinical trial was supported by the American Heart Association, a National Institutes of Health Clinical and Translational Science Award to Columbia University, and N.Y. Nutrition Obesity Research Center. Individual authors received support from the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.
The research was published recently in Diabetes Care.
Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.
Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.
“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.
“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
Prolonged lack of sleep may accelerate diabetes progression
Dr. St-Onge added,
Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”
The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.
Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.
Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”
He continued, “There have been several studies showing the association of sleep and diabetes, but that does not necessarily mean cause and effect.”
On the other hand, Dr. Gabbay said, “randomizing people can help see sleep influences on key metabolic measures of diabetes, [which] helps to build a stronger case that sleep disturbances can cause worsening metabolic health.”
He emphasized that both the quantity and quality of sleep are “critical for optimal diabetes health” and highlighted that the ADA’s Standards of Care “recommends screening for sleep issues and counseling to improve sleep.”
“This study provides new insight into the health effects of even small sleep deficits in women across all stages of adulthood and racial and ethnic backgrounds,” commented Corinne Silva, PhD, program director in the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, which co-funded the study.
The authors note that more than one-third of adults sleep less than the recommended 7 hours per night, which is “concerning given robust associations of short sleep with cardiometabolic diseases.”
Moreover, “women report poorer sleep than men,” explained Marishka Brown, PhD, director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, which also co-funded the study.
“So understanding how sleep disturbances impact their health across the lifespan is critical, especially for postmenopausal women,” she said, particularly because previous studies have not reflected real-world sleep patterns or have focused on men.
The researchers conducted a trial to evaluate the causal impact of prolonged, mild sleep restriction on cardiometabolic risk factors in women as part of the American Heart Association Go Red for Women Strategically Focused Research Network.
They recruited metabolically healthy women aged 20-75 years who were at increased risk for cardiometabolic disease due to having either overweight or class I obesity or at least one parent with type 2 diabetes, hyperlipidemia, or cardiovascular disease.
They were also required to have a habitual total sleep time on actigraphy of 7-9 hours per night and low risk for sleep apnea. Exclusion criteria included excessive caffeine intake, a significantly advanced or delayed sleep phase, shift work, and travel across time zones.
The participants were randomly assigned to either adequate sleep, defined as 7-9 hours per night, or sleep restriction, defined as a reduction in sleep duration of 1.5 hours per night, for 6 weeks. They were then crossed over to the other sleep condition.
Assessments, including MRI and oral glucose tolerance tests, were performed at baseline and at the end of each study phase.
The researchers report on 38 women who took part in the trial, of whom 11 were postmenopausal. The mean age was 37.6 years; 31.6% self-identified as Black and 26.3% as Hispanic. The mean body mass index (BMI) was 25.5.
Postmenopausal women had a higher mean age than other women, at 56.1 years versus 30.1 years, and a higher baseline fasting blood glucose, at 5.26 mmol/L (94.68 mg/dL) versus 4.70 mmol/L (84.6 mg/dL).
The team reported that compliance with the sleep protocol was “excellent,” with women during sleep restriction having a reduction in total sleep time of 1.34 hours per night versus women in the adequate sleep arm (P < .0001).
Sleep restriction was also associated with significant increases in fasting plasma insulin versus adequate sleep, at a beta value of 0.68 pmol/L (P = .016), and significantly increased Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) values (beta = 0.30; P = .016).
The impact on HOMA-IR values was significantly more pronounced in postmenopausal than menopausal women, at beta values of 0.45 versus 0.27 (P for interaction = .042).
Sleep restriction had no significant effect on fasting plasma glucose levels, and the association between sleep duration and cardiometabolic parameters was not modified by the proportion of either total or visceral adipose tissue, or by changes in adiposity.
This clinical trial was supported by the American Heart Association, a National Institutes of Health Clinical and Translational Science Award to Columbia University, and N.Y. Nutrition Obesity Research Center. Individual authors received support from the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
FROM DIABETES CARE
Digital tool clarifies menopause symptoms
GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.
“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,” said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.
For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.
“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.
The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.
Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.
One consult, too many problems
Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.”
Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”
The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.
“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.
Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”
However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”
Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.
A version of this article first appeared on Medscape.com.
GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.
“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,” said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.
For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.
“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.
The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.
Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.
One consult, too many problems
Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.”
Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”
The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.
“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.
Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”
However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”
Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.
A version of this article first appeared on Medscape.com.
GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.
“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,” said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.
For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.
“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.
The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.
Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.
One consult, too many problems
Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.”
Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”
The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.
“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.
Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”
However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”
Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.
A version of this article first appeared on Medscape.com.
AT RCGP 2023
No more hot flashes? AI device could stop menopause symptom
Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke.
Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash.
The device, which sells for $299, is already touted as a way to manage menopausal hot flashes.
But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.
That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off.
Exploring cooling therapy for hot flashes
“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.)
Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.”
Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity.
For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials.
But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change.
“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”
The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.
The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment.
But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said.
“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”
A version of this article appeared on WebMD.com.
Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke.
Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash.
The device, which sells for $299, is already touted as a way to manage menopausal hot flashes.
But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.
That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off.
Exploring cooling therapy for hot flashes
“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.)
Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.”
Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity.
For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials.
But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change.
“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”
The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.
The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment.
But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said.
“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”
A version of this article appeared on WebMD.com.
Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke.
Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash.
The device, which sells for $299, is already touted as a way to manage menopausal hot flashes.
But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.
That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off.
Exploring cooling therapy for hot flashes
“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.)
Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.”
Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity.
For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials.
But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change.
“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”
The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.
The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment.
But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said.
“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”
A version of this article appeared on WebMD.com.