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Radiotherapy for early breast cancer: Sharp cutoff at age 70
say researchers reporting new data showing a sharp cut-off at age 70.
“In our study, one of the most significant variables in determining whether breast cancer patients who are close their 70th birthday are recommended standard-of-care radiation or de-escalated treatment is whether they show up a few months before or a few months after that 70th birthday,” commented study author Wesley J. Talcott, MD, of the department of therapeutic radiology at the Yale School of Medicine, New Haven, Conn.
The results show a trend in which radiation therapy is 50% less likely to be prescribed for patients age 70 and older with early-stage breast cancer, even when controlling for population size, patient demographics, and disease specific variables.
This suggests that oncologists are weighing the variable of age too heavily when deciding on adjuvant treatments, the authors suggest.
“In certain circumstances, breast cancer oncology providers are treating age like a binary categorical variable when selecting patients for treatments or diagnostic procedures, rather than the continuous variable that it is,” Dr. Talcott commented.
The study was published online in the International Journal of Radiation Oncology: Biology, Physics.
Approached for comment, Casey Chollet-Lipscomb, MD, radiation oncologist with Tennessee Oncology, Nashville, who was not associated with the study, agreed with its main finding.
“The study helps emphasize the importance of individualized care,” she said. “Increasing age is the most common risk factor for breast cancer, but breast cancer is an incredibly diverse disease. While you can observe trends based on age, every patient is unique, and they can’t be lumped into one bucket and prescribed treatment based on a strict age cutoff.”
The retrospective study included two cohorts of women identified in the National Cancer Data Base (2004-2017) all of whom underwent lumpectomy for early-stage breast cancer. All patients had “strong indications” for adjuvant treatment.
Patients in cohort 1 (n = 160,990) included women with estrogen-receptor negative cancer, tumor size greater than 3 cm, who were determined to be “appropriate” for radiation therapy.
Patients in cohort 2 (n = 394,946) had hormone-receptor positive cancer, tumor size greater than 5 mm, and were considered to be “appropriate” candidates for endocrine therapy.
Multivariable analysis was performed to control for comorbidity burden (measured by the Charlson-Deyo Comorbidity Index), race and ethnicity, insurance status, academic versus non-academic treatment center, median annual income of a patient’s area of residence, distance from the site of treatment, and pathology variables including number of lymph nodes sampled, histologic grade, and genomic risk score.
In cohort 1, radiation was recommended for 90%-92% of patients between the ages of 50-69; this dropped to 81% for those aged 70.
After MVA, it was determined that age difference was an independent predictor for adjuvant radiation recommendation only at age 70 versus 69 (odds ratio, 0.47; 95% confidence interval 0.39-0.57, P < .001).
For cohort 2, year-over-year age difference predicted endocrine therapy recommendation only at the juncture between age 70 versus 69 (OR, 0.86, 95% CI 0.74-0.99, P = .001).
“Our results don’t say that we should be increasing the amount of treatment for patients over the age [of] 70 or decreasing that patient treatment for patients younger than age 70. What we believe is that we need to be assessing physiologic age of our patients when treating patients,” Dr. Talcott said.
“We would do this by looking at not just how many years a patient has been on this Earth but also what their current health status is, how many good quality-of-life years they might have after treatment or without it, and what the patient wants in terms of burden of treatment. This is a much more valuable way to approach the allocation of treatments than using age alone,” he added.
Both Dr. Talcott and Dr. Chollet-Lipscomb agreed that a limitation of the study was a lack of data on how physicians decided on a specific treatment in each individual case, but they agree that even without this information the results were “significant.”
Dr. Chollet-Lipscomb also highlighted the factors other than age she would use to determine the best adjuvant treatment for a patient with early stage breast cancer, including the individual features of the tumor, how aggressive it looks under the microscope, what the receptor status is, and a patient’s overall performance status and comorbidities.
Dr. Talcott and Dr. Chollet-Lipscomb report no relevant financial relationships. The authors had no acknowledgement of research support for this study.
A version of this article first appeared on Medscape.com.
say researchers reporting new data showing a sharp cut-off at age 70.
“In our study, one of the most significant variables in determining whether breast cancer patients who are close their 70th birthday are recommended standard-of-care radiation or de-escalated treatment is whether they show up a few months before or a few months after that 70th birthday,” commented study author Wesley J. Talcott, MD, of the department of therapeutic radiology at the Yale School of Medicine, New Haven, Conn.
The results show a trend in which radiation therapy is 50% less likely to be prescribed for patients age 70 and older with early-stage breast cancer, even when controlling for population size, patient demographics, and disease specific variables.
This suggests that oncologists are weighing the variable of age too heavily when deciding on adjuvant treatments, the authors suggest.
“In certain circumstances, breast cancer oncology providers are treating age like a binary categorical variable when selecting patients for treatments or diagnostic procedures, rather than the continuous variable that it is,” Dr. Talcott commented.
The study was published online in the International Journal of Radiation Oncology: Biology, Physics.
Approached for comment, Casey Chollet-Lipscomb, MD, radiation oncologist with Tennessee Oncology, Nashville, who was not associated with the study, agreed with its main finding.
“The study helps emphasize the importance of individualized care,” she said. “Increasing age is the most common risk factor for breast cancer, but breast cancer is an incredibly diverse disease. While you can observe trends based on age, every patient is unique, and they can’t be lumped into one bucket and prescribed treatment based on a strict age cutoff.”
The retrospective study included two cohorts of women identified in the National Cancer Data Base (2004-2017) all of whom underwent lumpectomy for early-stage breast cancer. All patients had “strong indications” for adjuvant treatment.
Patients in cohort 1 (n = 160,990) included women with estrogen-receptor negative cancer, tumor size greater than 3 cm, who were determined to be “appropriate” for radiation therapy.
Patients in cohort 2 (n = 394,946) had hormone-receptor positive cancer, tumor size greater than 5 mm, and were considered to be “appropriate” candidates for endocrine therapy.
Multivariable analysis was performed to control for comorbidity burden (measured by the Charlson-Deyo Comorbidity Index), race and ethnicity, insurance status, academic versus non-academic treatment center, median annual income of a patient’s area of residence, distance from the site of treatment, and pathology variables including number of lymph nodes sampled, histologic grade, and genomic risk score.
In cohort 1, radiation was recommended for 90%-92% of patients between the ages of 50-69; this dropped to 81% for those aged 70.
After MVA, it was determined that age difference was an independent predictor for adjuvant radiation recommendation only at age 70 versus 69 (odds ratio, 0.47; 95% confidence interval 0.39-0.57, P < .001).
For cohort 2, year-over-year age difference predicted endocrine therapy recommendation only at the juncture between age 70 versus 69 (OR, 0.86, 95% CI 0.74-0.99, P = .001).
“Our results don’t say that we should be increasing the amount of treatment for patients over the age [of] 70 or decreasing that patient treatment for patients younger than age 70. What we believe is that we need to be assessing physiologic age of our patients when treating patients,” Dr. Talcott said.
“We would do this by looking at not just how many years a patient has been on this Earth but also what their current health status is, how many good quality-of-life years they might have after treatment or without it, and what the patient wants in terms of burden of treatment. This is a much more valuable way to approach the allocation of treatments than using age alone,” he added.
Both Dr. Talcott and Dr. Chollet-Lipscomb agreed that a limitation of the study was a lack of data on how physicians decided on a specific treatment in each individual case, but they agree that even without this information the results were “significant.”
Dr. Chollet-Lipscomb also highlighted the factors other than age she would use to determine the best adjuvant treatment for a patient with early stage breast cancer, including the individual features of the tumor, how aggressive it looks under the microscope, what the receptor status is, and a patient’s overall performance status and comorbidities.
Dr. Talcott and Dr. Chollet-Lipscomb report no relevant financial relationships. The authors had no acknowledgement of research support for this study.
A version of this article first appeared on Medscape.com.
say researchers reporting new data showing a sharp cut-off at age 70.
“In our study, one of the most significant variables in determining whether breast cancer patients who are close their 70th birthday are recommended standard-of-care radiation or de-escalated treatment is whether they show up a few months before or a few months after that 70th birthday,” commented study author Wesley J. Talcott, MD, of the department of therapeutic radiology at the Yale School of Medicine, New Haven, Conn.
The results show a trend in which radiation therapy is 50% less likely to be prescribed for patients age 70 and older with early-stage breast cancer, even when controlling for population size, patient demographics, and disease specific variables.
This suggests that oncologists are weighing the variable of age too heavily when deciding on adjuvant treatments, the authors suggest.
“In certain circumstances, breast cancer oncology providers are treating age like a binary categorical variable when selecting patients for treatments or diagnostic procedures, rather than the continuous variable that it is,” Dr. Talcott commented.
The study was published online in the International Journal of Radiation Oncology: Biology, Physics.
Approached for comment, Casey Chollet-Lipscomb, MD, radiation oncologist with Tennessee Oncology, Nashville, who was not associated with the study, agreed with its main finding.
“The study helps emphasize the importance of individualized care,” she said. “Increasing age is the most common risk factor for breast cancer, but breast cancer is an incredibly diverse disease. While you can observe trends based on age, every patient is unique, and they can’t be lumped into one bucket and prescribed treatment based on a strict age cutoff.”
The retrospective study included two cohorts of women identified in the National Cancer Data Base (2004-2017) all of whom underwent lumpectomy for early-stage breast cancer. All patients had “strong indications” for adjuvant treatment.
Patients in cohort 1 (n = 160,990) included women with estrogen-receptor negative cancer, tumor size greater than 3 cm, who were determined to be “appropriate” for radiation therapy.
Patients in cohort 2 (n = 394,946) had hormone-receptor positive cancer, tumor size greater than 5 mm, and were considered to be “appropriate” candidates for endocrine therapy.
Multivariable analysis was performed to control for comorbidity burden (measured by the Charlson-Deyo Comorbidity Index), race and ethnicity, insurance status, academic versus non-academic treatment center, median annual income of a patient’s area of residence, distance from the site of treatment, and pathology variables including number of lymph nodes sampled, histologic grade, and genomic risk score.
In cohort 1, radiation was recommended for 90%-92% of patients between the ages of 50-69; this dropped to 81% for those aged 70.
After MVA, it was determined that age difference was an independent predictor for adjuvant radiation recommendation only at age 70 versus 69 (odds ratio, 0.47; 95% confidence interval 0.39-0.57, P < .001).
For cohort 2, year-over-year age difference predicted endocrine therapy recommendation only at the juncture between age 70 versus 69 (OR, 0.86, 95% CI 0.74-0.99, P = .001).
“Our results don’t say that we should be increasing the amount of treatment for patients over the age [of] 70 or decreasing that patient treatment for patients younger than age 70. What we believe is that we need to be assessing physiologic age of our patients when treating patients,” Dr. Talcott said.
“We would do this by looking at not just how many years a patient has been on this Earth but also what their current health status is, how many good quality-of-life years they might have after treatment or without it, and what the patient wants in terms of burden of treatment. This is a much more valuable way to approach the allocation of treatments than using age alone,” he added.
Both Dr. Talcott and Dr. Chollet-Lipscomb agreed that a limitation of the study was a lack of data on how physicians decided on a specific treatment in each individual case, but they agree that even without this information the results were “significant.”
Dr. Chollet-Lipscomb also highlighted the factors other than age she would use to determine the best adjuvant treatment for a patient with early stage breast cancer, including the individual features of the tumor, how aggressive it looks under the microscope, what the receptor status is, and a patient’s overall performance status and comorbidities.
Dr. Talcott and Dr. Chollet-Lipscomb report no relevant financial relationships. The authors had no acknowledgement of research support for this study.
A version of this article first appeared on Medscape.com.
FROM THE INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY: BIOLOGY, PHYSICS
Scientists create ‘vagina on a chip’: What to know
For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen.
“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments.
By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow.
The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease.
Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer.
The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.
No other preclinical model exists to perform tests like that, says Dr. Ingber.
“The vagina chip is a way to help make some advances,” he says.
The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science.
“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.
Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.
That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium.
It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard.
“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.”
As such, the vagina chip could help scientists find new treatments much faster.
Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.
“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.
Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says. Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.
While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences.
“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.
To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract.
The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.
“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.”
As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.
“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.
Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health.
A version of this article first appeared on WebMD.com.
For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen.
“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments.
By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow.
The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease.
Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer.
The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.
No other preclinical model exists to perform tests like that, says Dr. Ingber.
“The vagina chip is a way to help make some advances,” he says.
The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science.
“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.
Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.
That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium.
It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard.
“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.”
As such, the vagina chip could help scientists find new treatments much faster.
Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.
“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.
Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says. Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.
While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences.
“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.
To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract.
The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.
“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.”
As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.
“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.
Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health.
A version of this article first appeared on WebMD.com.
For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen.
“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments.
By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow.
The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease.
Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer.
The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.
No other preclinical model exists to perform tests like that, says Dr. Ingber.
“The vagina chip is a way to help make some advances,” he says.
The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science.
“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.
Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.
That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium.
It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard.
“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.”
As such, the vagina chip could help scientists find new treatments much faster.
Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.
“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.
Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says. Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.
While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences.
“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.
To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract.
The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.
“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.”
As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.
“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.
Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health.
A version of this article first appeared on WebMD.com.
FROM MICROBIOME
Vacuum device for postpartum hemorrhage works well in real world
Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.
Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.
Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.
Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.
Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.
Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.
Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.
Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.
“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”
Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.
“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”
The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.
Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.
Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.
Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.
Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.
Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.
Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.
Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.
“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”
Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.
“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”
The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.
Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.
Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.
Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.
Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.
Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.
Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.
Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.
“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”
Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.
“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”
The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE PREGNANCY MEETING
More evidence suggests oxytocin can be discontinued early in labor
A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.
“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.
From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m2. All had live, singleton, full-term babies.
More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.
The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.
Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”
In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”
Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”
There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.
Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”
However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”
A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.
Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.
He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.
The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.
A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.
“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.
From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m2. All had live, singleton, full-term babies.
More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.
The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.
Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”
In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”
Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”
There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.
Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”
However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”
A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.
Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.
He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.
The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.
A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.
“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.
From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m2. All had live, singleton, full-term babies.
More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.
The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.
Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”
In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”
Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”
There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.
Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”
However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”
A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.
Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.
He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.
The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.
FROM THE PREGNANCY MEETING
USPSTF backs screening for hypertensive disorders of pregnancy
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.
All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.
“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.
In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.
“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.
The draft recommendation statement was published online .
Screening recommendation
Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.
The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.
After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”
The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.
Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.
In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.
Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.
Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.
“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
Additional considerations
The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.
Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.
Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.
The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.
“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”
The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.
No relevant financial relationships have been disclosed.
A version of this article originally appeared on Medscape.com.
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.
All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.
“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.
In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.
“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.
The draft recommendation statement was published online .
Screening recommendation
Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.
The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.
After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”
The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.
Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.
In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.
Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.
Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.
“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
Additional considerations
The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.
Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.
Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.
The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.
“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”
The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.
No relevant financial relationships have been disclosed.
A version of this article originally appeared on Medscape.com.
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.
All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.
“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.
In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.
“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.
The draft recommendation statement was published online .
Screening recommendation
Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.
The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.
After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”
The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.
Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.
In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.
Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.
Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.
“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
Additional considerations
The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.
Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.
Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.
The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.
“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”
The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.
No relevant financial relationships have been disclosed.
A version of this article originally appeared on Medscape.com.
Can a hormone shot rescue low libido?
according to results from two small randomized controlled trials.
The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.
Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.
One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
Unmet need
HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.
“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.
Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.
In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.
At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.
The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
Similar data in men, women
While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).
In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).
Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.
The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.
“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.
“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.
The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.
A version of this article first appeared on Medscape.com.
according to results from two small randomized controlled trials.
The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.
Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.
One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
Unmet need
HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.
“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.
Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.
In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.
At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.
The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
Similar data in men, women
While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).
In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).
Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.
The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.
“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.
“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.
The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.
A version of this article first appeared on Medscape.com.
according to results from two small randomized controlled trials.
The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.
Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.
One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
Unmet need
HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.
“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.
Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.
In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.
At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.
The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
Similar data in men, women
While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).
In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).
Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.
The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.
“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.
“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.
The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Maternal COVID-19 vaccine curbs infant infection
a new study shows.
Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.
In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.
Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.
Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.
The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.
The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).
Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.
The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.
The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.
The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).
Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.
Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.
The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.
Effectiveness is encouraging, but updates are needed
The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.
They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.
Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.
The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.
Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.
“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.
*This article was updated on 3/2/2023.
a new study shows.
Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.
In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.
Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.
Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.
The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.
The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).
Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.
The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.
The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.
The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).
Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.
Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.
The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.
Effectiveness is encouraging, but updates are needed
The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.
They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.
Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.
The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.
Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.
“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.
*This article was updated on 3/2/2023.
a new study shows.
Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.
In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.
Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.
Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.
The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.
The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).
Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.
The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.
The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.
The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).
Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.
Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.
The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.
Effectiveness is encouraging, but updates are needed
The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.
They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.
Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.
The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.
Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.
“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.
*This article was updated on 3/2/2023.
FROM THE BMJ
Now trending on social media: Bad birth control info
Add this to the list of social media’s potential health risks: unintended pregnancy.
That’s for women who take birth control advice from influencers, particularly on YouTube, where many talk about stopping hormonal contraception and may give incomplete or inaccurate sexual health information.
In an analysis of 50 YouTube videos, University of Delaware researchers found that nearly three-quarters of influencers talked about discontinuing birth control pills or other forms hormonal birth control. And 40% were using or had used a “natural family planning” method – when women track their cycle, sometimes using an app, to identify days they might get pregnant.
“We know from previous research that these nonhormonal options, such as fertility tracking apps, are not always as accurate as hormonal birth control,” said lead study author Emily Pfender, who reported the findings in Health Communication. “They rely on so many different factors, like body temperature and cervical fluid, that vary widely.”
In fact, this “natural” approach only works when women meticulously follow guidelines like measuring basal body temperature and tracking cervical fluid daily. But many influencers left that part out. Using fertility-tracking methods without the right education and tools could raise the risk of unplanned pregnancy, as failure rates using these methods vary from 2% to 23%, according to the CDC.
Even more alarming: Of the influencers who stopped hormonal birth control, only one-third mentioned replacing it with something else, Ms. Pfender said.
“The message that some of these videos are sending is that discontinuing [hormonal birth control] is good for if you want to improve your mental health and be more natural, but it’s not important to start another form of birth control,” she said. “This places those women at an increased risk of unplanned pregnancy, and possibly sexually transmitted diseases.”
Rise of the health influencer
Taking health advice from influencers is nothing new and appears to be getting more popular.
“People have been sharing health information for decades, even before the internet, but now it is much more prevalent and easier,” said Erin Willis, PhD, an associate professor at the University of Colorado, Boulder, who studies digital media and health communication.
Peer-to-peer health information is very influential, Dr. Willis said. It makes people feel understood, especially if they have the same health condition or share similar experiences or emotions. “The social support is there,” she said. “It is almost like crowdsourcing.”
In her study, Ms. Pfender and another researcher watched 50 YouTube videos posted between December 2019 and December 2021 by influencers with between 20,000 and 2.2 million followers. The top reasons influencers gave for discontinuing birth control included the desire to be more natural and to improve mental health.
Although hormonal birth control, namely the pill, has been used for decades and is considered safe, it has been linked to side effects like depression. And people sharing their experiences with hormonal birth control online may create controversy over whether it’s safe to use.
But Ms. Pfender found that influencers didn’t always share accurate or complete information. For example, some of the influencers talked about using the cycle tracking app Daysy, touting it as highly accurate, but none mentioned that the study backing up how well it worked was retracted in 2019 due to flaws in its research methods.
Not all health influencers give bad information, Dr. Willis said. Many go through ethics and advocacy training and understand the sensitive position and influence they have. Still, people have different levels of “health literacy” – some may understand health information better than others. It’s crucial to analyze the info and sort the good from the bad.
Look for information that is not linked to a particular product, the National Institutes of Health recommends. And cross-check it against reliable websites, such as those ending in “.gov” or “.org.”
A version of this article first appeared on WebMD.com.
Add this to the list of social media’s potential health risks: unintended pregnancy.
That’s for women who take birth control advice from influencers, particularly on YouTube, where many talk about stopping hormonal contraception and may give incomplete or inaccurate sexual health information.
In an analysis of 50 YouTube videos, University of Delaware researchers found that nearly three-quarters of influencers talked about discontinuing birth control pills or other forms hormonal birth control. And 40% were using or had used a “natural family planning” method – when women track their cycle, sometimes using an app, to identify days they might get pregnant.
“We know from previous research that these nonhormonal options, such as fertility tracking apps, are not always as accurate as hormonal birth control,” said lead study author Emily Pfender, who reported the findings in Health Communication. “They rely on so many different factors, like body temperature and cervical fluid, that vary widely.”
In fact, this “natural” approach only works when women meticulously follow guidelines like measuring basal body temperature and tracking cervical fluid daily. But many influencers left that part out. Using fertility-tracking methods without the right education and tools could raise the risk of unplanned pregnancy, as failure rates using these methods vary from 2% to 23%, according to the CDC.
Even more alarming: Of the influencers who stopped hormonal birth control, only one-third mentioned replacing it with something else, Ms. Pfender said.
“The message that some of these videos are sending is that discontinuing [hormonal birth control] is good for if you want to improve your mental health and be more natural, but it’s not important to start another form of birth control,” she said. “This places those women at an increased risk of unplanned pregnancy, and possibly sexually transmitted diseases.”
Rise of the health influencer
Taking health advice from influencers is nothing new and appears to be getting more popular.
“People have been sharing health information for decades, even before the internet, but now it is much more prevalent and easier,” said Erin Willis, PhD, an associate professor at the University of Colorado, Boulder, who studies digital media and health communication.
Peer-to-peer health information is very influential, Dr. Willis said. It makes people feel understood, especially if they have the same health condition or share similar experiences or emotions. “The social support is there,” she said. “It is almost like crowdsourcing.”
In her study, Ms. Pfender and another researcher watched 50 YouTube videos posted between December 2019 and December 2021 by influencers with between 20,000 and 2.2 million followers. The top reasons influencers gave for discontinuing birth control included the desire to be more natural and to improve mental health.
Although hormonal birth control, namely the pill, has been used for decades and is considered safe, it has been linked to side effects like depression. And people sharing their experiences with hormonal birth control online may create controversy over whether it’s safe to use.
But Ms. Pfender found that influencers didn’t always share accurate or complete information. For example, some of the influencers talked about using the cycle tracking app Daysy, touting it as highly accurate, but none mentioned that the study backing up how well it worked was retracted in 2019 due to flaws in its research methods.
Not all health influencers give bad information, Dr. Willis said. Many go through ethics and advocacy training and understand the sensitive position and influence they have. Still, people have different levels of “health literacy” – some may understand health information better than others. It’s crucial to analyze the info and sort the good from the bad.
Look for information that is not linked to a particular product, the National Institutes of Health recommends. And cross-check it against reliable websites, such as those ending in “.gov” or “.org.”
A version of this article first appeared on WebMD.com.
Add this to the list of social media’s potential health risks: unintended pregnancy.
That’s for women who take birth control advice from influencers, particularly on YouTube, where many talk about stopping hormonal contraception and may give incomplete or inaccurate sexual health information.
In an analysis of 50 YouTube videos, University of Delaware researchers found that nearly three-quarters of influencers talked about discontinuing birth control pills or other forms hormonal birth control. And 40% were using or had used a “natural family planning” method – when women track their cycle, sometimes using an app, to identify days they might get pregnant.
“We know from previous research that these nonhormonal options, such as fertility tracking apps, are not always as accurate as hormonal birth control,” said lead study author Emily Pfender, who reported the findings in Health Communication. “They rely on so many different factors, like body temperature and cervical fluid, that vary widely.”
In fact, this “natural” approach only works when women meticulously follow guidelines like measuring basal body temperature and tracking cervical fluid daily. But many influencers left that part out. Using fertility-tracking methods without the right education and tools could raise the risk of unplanned pregnancy, as failure rates using these methods vary from 2% to 23%, according to the CDC.
Even more alarming: Of the influencers who stopped hormonal birth control, only one-third mentioned replacing it with something else, Ms. Pfender said.
“The message that some of these videos are sending is that discontinuing [hormonal birth control] is good for if you want to improve your mental health and be more natural, but it’s not important to start another form of birth control,” she said. “This places those women at an increased risk of unplanned pregnancy, and possibly sexually transmitted diseases.”
Rise of the health influencer
Taking health advice from influencers is nothing new and appears to be getting more popular.
“People have been sharing health information for decades, even before the internet, but now it is much more prevalent and easier,” said Erin Willis, PhD, an associate professor at the University of Colorado, Boulder, who studies digital media and health communication.
Peer-to-peer health information is very influential, Dr. Willis said. It makes people feel understood, especially if they have the same health condition or share similar experiences or emotions. “The social support is there,” she said. “It is almost like crowdsourcing.”
In her study, Ms. Pfender and another researcher watched 50 YouTube videos posted between December 2019 and December 2021 by influencers with between 20,000 and 2.2 million followers. The top reasons influencers gave for discontinuing birth control included the desire to be more natural and to improve mental health.
Although hormonal birth control, namely the pill, has been used for decades and is considered safe, it has been linked to side effects like depression. And people sharing their experiences with hormonal birth control online may create controversy over whether it’s safe to use.
But Ms. Pfender found that influencers didn’t always share accurate or complete information. For example, some of the influencers talked about using the cycle tracking app Daysy, touting it as highly accurate, but none mentioned that the study backing up how well it worked was retracted in 2019 due to flaws in its research methods.
Not all health influencers give bad information, Dr. Willis said. Many go through ethics and advocacy training and understand the sensitive position and influence they have. Still, people have different levels of “health literacy” – some may understand health information better than others. It’s crucial to analyze the info and sort the good from the bad.
Look for information that is not linked to a particular product, the National Institutes of Health recommends. And cross-check it against reliable websites, such as those ending in “.gov” or “.org.”
A version of this article first appeared on WebMD.com.
FROM HEALTH COMMUNICATION
Little evidence to support lasers for ‘vaginal rejuvenation’
Laser devices licensed in Canada to treat genitourinary syndrome of menopause (GSM) are often marketed for vaginal rejuvenation with claims that they will tighten the vagina and improve sexual function, despite lack of evidence, a new commentary reveals.
Vaginal lasers heat the vaginal epithelium and cause thermal necrosis. This intervention induces collagen remodeling and synthesis, neovascularization, and elastin formation and may result in improved vaginal elasticity and restoration of premenopausal epithelial function, according to coauthors Blayne Welk, MD, MSc, an associate professor of urologic surgery at Western University, London, Ont., and Erin Kelly, MD, a lecturer in obstetrics and gynecology at the University of Alberta, Edmonton.
Their patients’ questions and experiences with the laser devices prompted the commentary, they told this news organization.
“A large part of my practice involves addressing GSM and urinary incontinence,” said Dr. Kelly. “Many women present to the clinic having heard of vaginal laser procedures, having had vaginal laser procedures, or having been told they need vaginal laser procedures. My impression has been that these procedures are being marketed to women … without rigorous study.”
“Many women are reluctant to have mesh slings for stress incontinence due to some of the potential risks,” and they are looking for less invasive options, said Dr. Welk. Over the past few years, he has had increasing questions from patients about the use of lasers to improve this condition.
The commentary was published online in the Canadian Medical Association Journal.
Transparency needed
The first vaginal energy device was licensed by Health Canada in 2015 to treat GSM. That meant the device was deemed to have met basic safety, effectiveness, and quality criteria. But no controlled studies are required for regulatory approval of such devices, and after licensing, some providers rebranded the device indication from GSM to vaginal rejuvenation, said Dr. Kelly and Dr. Welk.
Vaginal laser therapies are offered throughout Canada, with at least one provider of vaginal rejuvenation procedures in the 10 most populous cities. Under the current system, the number of patients who pay for these procedures and the amount that they pay cannot be tracked. Nor can the number of vaginal laser systems active in Canada be tracked. Patients can refer themselves for the service, and providers’ publicly quoted costs (on websites, for example) are thousands of dollars for treatment.
The rebranding for vaginal rejuvenation “represents a difference between the licensing of a medical device by Health Canada and the way that these devices are used and marketed,” according to the commentary. “A procedure with limited high-quality evidence supporting its efficacy and a potential financial conflict of interest for providers may not be serving the best interests of people in Canada, even if the risk of adverse events is low.”
Updates to Canada’s medical devices action plan, including mandatory reporting of serious incidents and the ability to compel manufacturers to provide information on safety and effectiveness, “represent important progress,” according to Dr. Kelly and Dr. Welk. However, problems persist, including lack of a requirement for peer-reviewed, controlled studies.
Furthermore, women who undergo laser treatment for GSM, urinary incontinence, or vaginal rejuvenation may not receive a proper medical evaluation and standard treatments, the authors noted.
“I would like to see more transparency and public-facing information available on approved medical devices,” said Dr. Welk. “Health Canada has an online database of approved devices, but no information around the evidence submitted during the approval process is available, nor are the indications for the various devices.”
In addition, he said, many devices in the registry are listed by a serial number rather than the name that would be familiar to the public, “making it hard to match up information.”
Dr. Kelly added the “encouraging” news that the Canadian Society for Pelvic Medicine is working with Health Canada to “improve knowledge translation when it comes to transparency regarding medical devices.”
Medicine before marketing
“The commentary provides an accurate and evidence-based assessment of the use of vaginal laser treatments,” Jason Abbott, B Med (Hons), PhD, professor of gynecology at the University of New South Wales, Sydney, told this news organization. “The marketing of this device is a case of putting the cart before the horse. It is essential that strong, scientific, and reproducible studies be available on efficacy and safety before there is a direct-to-consumer marketing approach.”
Clinicians should advise patients when the treatment effect is likely to be minimal or risky, especially when there is a financial incentive to the clinician, he said. “Governments, regulators, and medical societies have a duty of care to the public to make sure that the medicine comes before the marketing. Otherwise, we are no better than snake oil sellers.
“Given the size of studies to date, the improvement in symptoms following treatment may be less than a few percent,” he noted. “That may be acceptable to some women. We don’t know.”
Dr. Abbott’s team is conducting research to define what women would want as a minimal level of improvement, the maximum cost, and the maximum risk from the laser procedure.
“In cancer … the benefit of a new treatment may only be a few percent for survival,” he said. “That may be completely acceptable for some or even many patients. What we cannot do, however, is extrapolate those same expectations to a treatment for a benign condition where quality of life is compromised.”
Echoing Dr. Kelly and Dr. Welk, Dr. Abbott said, “It is important that there be transparency in the clinical communication. Patients should be told that the best scientific studies that are judged based on their quality show there is no benefit to laser treatment for GSM or urinary incontinence.”
Although the medical risks may be low, he added, “financial risk also needs to be discussed. Patients should be encouraged to participate in clinical trials where there is no cost to them to gain the information first, before wholesale uptake of the treatment. … Should patients still wish to undergo the procedure once the risks and an honest account of the evidence is given to them, that of course is their choice.” Dr. Kelly, Dr. Welk, and Dr. Abbott had no commercial funding or relevant financial relationships to report.
A version of this article first appeared on Medscape.com.
Laser devices licensed in Canada to treat genitourinary syndrome of menopause (GSM) are often marketed for vaginal rejuvenation with claims that they will tighten the vagina and improve sexual function, despite lack of evidence, a new commentary reveals.
Vaginal lasers heat the vaginal epithelium and cause thermal necrosis. This intervention induces collagen remodeling and synthesis, neovascularization, and elastin formation and may result in improved vaginal elasticity and restoration of premenopausal epithelial function, according to coauthors Blayne Welk, MD, MSc, an associate professor of urologic surgery at Western University, London, Ont., and Erin Kelly, MD, a lecturer in obstetrics and gynecology at the University of Alberta, Edmonton.
Their patients’ questions and experiences with the laser devices prompted the commentary, they told this news organization.
“A large part of my practice involves addressing GSM and urinary incontinence,” said Dr. Kelly. “Many women present to the clinic having heard of vaginal laser procedures, having had vaginal laser procedures, or having been told they need vaginal laser procedures. My impression has been that these procedures are being marketed to women … without rigorous study.”
“Many women are reluctant to have mesh slings for stress incontinence due to some of the potential risks,” and they are looking for less invasive options, said Dr. Welk. Over the past few years, he has had increasing questions from patients about the use of lasers to improve this condition.
The commentary was published online in the Canadian Medical Association Journal.
Transparency needed
The first vaginal energy device was licensed by Health Canada in 2015 to treat GSM. That meant the device was deemed to have met basic safety, effectiveness, and quality criteria. But no controlled studies are required for regulatory approval of such devices, and after licensing, some providers rebranded the device indication from GSM to vaginal rejuvenation, said Dr. Kelly and Dr. Welk.
Vaginal laser therapies are offered throughout Canada, with at least one provider of vaginal rejuvenation procedures in the 10 most populous cities. Under the current system, the number of patients who pay for these procedures and the amount that they pay cannot be tracked. Nor can the number of vaginal laser systems active in Canada be tracked. Patients can refer themselves for the service, and providers’ publicly quoted costs (on websites, for example) are thousands of dollars for treatment.
The rebranding for vaginal rejuvenation “represents a difference between the licensing of a medical device by Health Canada and the way that these devices are used and marketed,” according to the commentary. “A procedure with limited high-quality evidence supporting its efficacy and a potential financial conflict of interest for providers may not be serving the best interests of people in Canada, even if the risk of adverse events is low.”
Updates to Canada’s medical devices action plan, including mandatory reporting of serious incidents and the ability to compel manufacturers to provide information on safety and effectiveness, “represent important progress,” according to Dr. Kelly and Dr. Welk. However, problems persist, including lack of a requirement for peer-reviewed, controlled studies.
Furthermore, women who undergo laser treatment for GSM, urinary incontinence, or vaginal rejuvenation may not receive a proper medical evaluation and standard treatments, the authors noted.
“I would like to see more transparency and public-facing information available on approved medical devices,” said Dr. Welk. “Health Canada has an online database of approved devices, but no information around the evidence submitted during the approval process is available, nor are the indications for the various devices.”
In addition, he said, many devices in the registry are listed by a serial number rather than the name that would be familiar to the public, “making it hard to match up information.”
Dr. Kelly added the “encouraging” news that the Canadian Society for Pelvic Medicine is working with Health Canada to “improve knowledge translation when it comes to transparency regarding medical devices.”
Medicine before marketing
“The commentary provides an accurate and evidence-based assessment of the use of vaginal laser treatments,” Jason Abbott, B Med (Hons), PhD, professor of gynecology at the University of New South Wales, Sydney, told this news organization. “The marketing of this device is a case of putting the cart before the horse. It is essential that strong, scientific, and reproducible studies be available on efficacy and safety before there is a direct-to-consumer marketing approach.”
Clinicians should advise patients when the treatment effect is likely to be minimal or risky, especially when there is a financial incentive to the clinician, he said. “Governments, regulators, and medical societies have a duty of care to the public to make sure that the medicine comes before the marketing. Otherwise, we are no better than snake oil sellers.
“Given the size of studies to date, the improvement in symptoms following treatment may be less than a few percent,” he noted. “That may be acceptable to some women. We don’t know.”
Dr. Abbott’s team is conducting research to define what women would want as a minimal level of improvement, the maximum cost, and the maximum risk from the laser procedure.
“In cancer … the benefit of a new treatment may only be a few percent for survival,” he said. “That may be completely acceptable for some or even many patients. What we cannot do, however, is extrapolate those same expectations to a treatment for a benign condition where quality of life is compromised.”
Echoing Dr. Kelly and Dr. Welk, Dr. Abbott said, “It is important that there be transparency in the clinical communication. Patients should be told that the best scientific studies that are judged based on their quality show there is no benefit to laser treatment for GSM or urinary incontinence.”
Although the medical risks may be low, he added, “financial risk also needs to be discussed. Patients should be encouraged to participate in clinical trials where there is no cost to them to gain the information first, before wholesale uptake of the treatment. … Should patients still wish to undergo the procedure once the risks and an honest account of the evidence is given to them, that of course is their choice.” Dr. Kelly, Dr. Welk, and Dr. Abbott had no commercial funding or relevant financial relationships to report.
A version of this article first appeared on Medscape.com.
Laser devices licensed in Canada to treat genitourinary syndrome of menopause (GSM) are often marketed for vaginal rejuvenation with claims that they will tighten the vagina and improve sexual function, despite lack of evidence, a new commentary reveals.
Vaginal lasers heat the vaginal epithelium and cause thermal necrosis. This intervention induces collagen remodeling and synthesis, neovascularization, and elastin formation and may result in improved vaginal elasticity and restoration of premenopausal epithelial function, according to coauthors Blayne Welk, MD, MSc, an associate professor of urologic surgery at Western University, London, Ont., and Erin Kelly, MD, a lecturer in obstetrics and gynecology at the University of Alberta, Edmonton.
Their patients’ questions and experiences with the laser devices prompted the commentary, they told this news organization.
“A large part of my practice involves addressing GSM and urinary incontinence,” said Dr. Kelly. “Many women present to the clinic having heard of vaginal laser procedures, having had vaginal laser procedures, or having been told they need vaginal laser procedures. My impression has been that these procedures are being marketed to women … without rigorous study.”
“Many women are reluctant to have mesh slings for stress incontinence due to some of the potential risks,” and they are looking for less invasive options, said Dr. Welk. Over the past few years, he has had increasing questions from patients about the use of lasers to improve this condition.
The commentary was published online in the Canadian Medical Association Journal.
Transparency needed
The first vaginal energy device was licensed by Health Canada in 2015 to treat GSM. That meant the device was deemed to have met basic safety, effectiveness, and quality criteria. But no controlled studies are required for regulatory approval of such devices, and after licensing, some providers rebranded the device indication from GSM to vaginal rejuvenation, said Dr. Kelly and Dr. Welk.
Vaginal laser therapies are offered throughout Canada, with at least one provider of vaginal rejuvenation procedures in the 10 most populous cities. Under the current system, the number of patients who pay for these procedures and the amount that they pay cannot be tracked. Nor can the number of vaginal laser systems active in Canada be tracked. Patients can refer themselves for the service, and providers’ publicly quoted costs (on websites, for example) are thousands of dollars for treatment.
The rebranding for vaginal rejuvenation “represents a difference between the licensing of a medical device by Health Canada and the way that these devices are used and marketed,” according to the commentary. “A procedure with limited high-quality evidence supporting its efficacy and a potential financial conflict of interest for providers may not be serving the best interests of people in Canada, even if the risk of adverse events is low.”
Updates to Canada’s medical devices action plan, including mandatory reporting of serious incidents and the ability to compel manufacturers to provide information on safety and effectiveness, “represent important progress,” according to Dr. Kelly and Dr. Welk. However, problems persist, including lack of a requirement for peer-reviewed, controlled studies.
Furthermore, women who undergo laser treatment for GSM, urinary incontinence, or vaginal rejuvenation may not receive a proper medical evaluation and standard treatments, the authors noted.
“I would like to see more transparency and public-facing information available on approved medical devices,” said Dr. Welk. “Health Canada has an online database of approved devices, but no information around the evidence submitted during the approval process is available, nor are the indications for the various devices.”
In addition, he said, many devices in the registry are listed by a serial number rather than the name that would be familiar to the public, “making it hard to match up information.”
Dr. Kelly added the “encouraging” news that the Canadian Society for Pelvic Medicine is working with Health Canada to “improve knowledge translation when it comes to transparency regarding medical devices.”
Medicine before marketing
“The commentary provides an accurate and evidence-based assessment of the use of vaginal laser treatments,” Jason Abbott, B Med (Hons), PhD, professor of gynecology at the University of New South Wales, Sydney, told this news organization. “The marketing of this device is a case of putting the cart before the horse. It is essential that strong, scientific, and reproducible studies be available on efficacy and safety before there is a direct-to-consumer marketing approach.”
Clinicians should advise patients when the treatment effect is likely to be minimal or risky, especially when there is a financial incentive to the clinician, he said. “Governments, regulators, and medical societies have a duty of care to the public to make sure that the medicine comes before the marketing. Otherwise, we are no better than snake oil sellers.
“Given the size of studies to date, the improvement in symptoms following treatment may be less than a few percent,” he noted. “That may be acceptable to some women. We don’t know.”
Dr. Abbott’s team is conducting research to define what women would want as a minimal level of improvement, the maximum cost, and the maximum risk from the laser procedure.
“In cancer … the benefit of a new treatment may only be a few percent for survival,” he said. “That may be completely acceptable for some or even many patients. What we cannot do, however, is extrapolate those same expectations to a treatment for a benign condition where quality of life is compromised.”
Echoing Dr. Kelly and Dr. Welk, Dr. Abbott said, “It is important that there be transparency in the clinical communication. Patients should be told that the best scientific studies that are judged based on their quality show there is no benefit to laser treatment for GSM or urinary incontinence.”
Although the medical risks may be low, he added, “financial risk also needs to be discussed. Patients should be encouraged to participate in clinical trials where there is no cost to them to gain the information first, before wholesale uptake of the treatment. … Should patients still wish to undergo the procedure once the risks and an honest account of the evidence is given to them, that of course is their choice.” Dr. Kelly, Dr. Welk, and Dr. Abbott had no commercial funding or relevant financial relationships to report.
A version of this article first appeared on Medscape.com.
FDA OKs sacituzumab govitecan for HR+ metastatic breast cancer
for patients with unresectable, locally advanced or metastatic hormone receptor (HR)–positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.
Label expansion for the Trop-2–directed antibody-drug conjugate was based on the TROPICS-02 trial, which randomized 543 adults 1:1 to either sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of a 21-day cycle or single agent chemotherapy, most often eribulin but also vinorelbine, gemcitabine, or capecitabine.
Median progression free survival was 5.5 months with sacituzumab govitecan versus 4 months with single agent chemotherapy (hazard ratio, 0.66; P = .0003). Median overall survival was 14.4 months in the sacituzumab govitecan group versus 11.2 months with chemotherapy (HR, 0.79), according to an FDA press release announcing the approval.
In a Gilead press release, Hope Rugo, MD, a breast cancer specialist at the University of California, San Francisco, and principal investigator for TROPICS-02, said the approval “is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than 3 months with a quality-of-life benefit for these women is exceptional.”
The most common adverse events associated with sacituzumab govitecan in the trial, occurring in a quarter or more of participants, were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin.
Labeling for the agent carries a boxedwarning of severe or life-threatening neutropenia and severe diarrhea.
The recommended dose is the trial dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.
Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.
A version of this article first appeared on Medscape.com.
for patients with unresectable, locally advanced or metastatic hormone receptor (HR)–positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.
Label expansion for the Trop-2–directed antibody-drug conjugate was based on the TROPICS-02 trial, which randomized 543 adults 1:1 to either sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of a 21-day cycle or single agent chemotherapy, most often eribulin but also vinorelbine, gemcitabine, or capecitabine.
Median progression free survival was 5.5 months with sacituzumab govitecan versus 4 months with single agent chemotherapy (hazard ratio, 0.66; P = .0003). Median overall survival was 14.4 months in the sacituzumab govitecan group versus 11.2 months with chemotherapy (HR, 0.79), according to an FDA press release announcing the approval.
In a Gilead press release, Hope Rugo, MD, a breast cancer specialist at the University of California, San Francisco, and principal investigator for TROPICS-02, said the approval “is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than 3 months with a quality-of-life benefit for these women is exceptional.”
The most common adverse events associated with sacituzumab govitecan in the trial, occurring in a quarter or more of participants, were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin.
Labeling for the agent carries a boxedwarning of severe or life-threatening neutropenia and severe diarrhea.
The recommended dose is the trial dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.
Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.
A version of this article first appeared on Medscape.com.
for patients with unresectable, locally advanced or metastatic hormone receptor (HR)–positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.
Label expansion for the Trop-2–directed antibody-drug conjugate was based on the TROPICS-02 trial, which randomized 543 adults 1:1 to either sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of a 21-day cycle or single agent chemotherapy, most often eribulin but also vinorelbine, gemcitabine, or capecitabine.
Median progression free survival was 5.5 months with sacituzumab govitecan versus 4 months with single agent chemotherapy (hazard ratio, 0.66; P = .0003). Median overall survival was 14.4 months in the sacituzumab govitecan group versus 11.2 months with chemotherapy (HR, 0.79), according to an FDA press release announcing the approval.
In a Gilead press release, Hope Rugo, MD, a breast cancer specialist at the University of California, San Francisco, and principal investigator for TROPICS-02, said the approval “is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than 3 months with a quality-of-life benefit for these women is exceptional.”
The most common adverse events associated with sacituzumab govitecan in the trial, occurring in a quarter or more of participants, were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin.
Labeling for the agent carries a boxedwarning of severe or life-threatening neutropenia and severe diarrhea.
The recommended dose is the trial dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.
Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.
A version of this article first appeared on Medscape.com.