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Piroxicam boosts success of levonorgestrel for emergency contraception
Adding oral piroxicam to oral levonorgestrel significantly improved the efficacy of emergency contraception, based on data from 860 women.
Oral hormonal emergency contraception (EC) is the most widely used EC method worldwide, but the two currently available drugs, levonorgestrel and ulipristal acetate (UPA), are not effective when given after ovulation, wrote Raymond Hang Wun Li, MD, of the University of Hong Kong, and colleagues. Previous studies suggest that cyclo-oxygenase (COX) inhibitors may disrupt follicular rupture and prevent ovulation, but data on their use in combination with current oral ECs are lacking, the researchers said.
In a study published in The Lancet, the researchers randomized 430 women to receive a single oral dose of 1.5 mg levonorgestrel plus 40 mg of the COX-2 inhibitor piroxicam or 1.5 mg levonorgestrel plus a placebo. The study participants were women aged 18 years and older who requested EC within 72 hours of unprotected sex and who had regular menstrual cycles between 24 and 42 days long. The median age of the participants was 30 years; 97% were Chinese. The median time from intercourse to treatment was 18 hours for both groups.
The primary outcome was the percentage of pregnancies prevented, based on pregnancy status 1-2 weeks after treatment.
One pregnancy occurred in the piroxicam group, compared with seven pregnancies in the placebo group, which translated to a significant difference in the percentage of pregnancies prevented (94.7% vs. 63.4%, P < .0001).
No trend toward increased failure rates appeared based on the time elapsed between intercourse and EC use in either group, and no differences appeared in the return or delay of subsequent menstrual periods between the groups.
The most common adverse events (reported by more than 5% of participants in both groups) included fatigue or weakness, nausea, lower abdominal pain, dizziness, and headache.
The choice of piroxicam as the COX inhibitor in conjunction with levonorgestrel for the current study had several potential advantages, the researchers wrote in their discussion. These advantages include the widespread availability and long-acting characteristics of piroxicam, which is also true of levonorgestrel, they said.
The findings were limited by several factors including the generalizability to other settings and populations, the researchers noted. The efficacy of the levonorgestrel/piroxicam combination in women with a body mass index greater than 26 kg/m2 may be lower, but the current study population did not have enough women in this category to measure the potential effect, they said. The study also did not examine the effect of piroxicam in combination with ulipristal acetate.
However, the results are the first known to demonstrate the improved effectiveness of oral piroxicam coadministered with oral levonorgestrel for EC, they said.
“The strength of this recommendation and changes in clinical guidelines may be determined upon demonstration of reproducible results in further studies,” they added.
Pill combination shows potential and practicality
Oral emergency contraception on demand is an unmet need on a global level, Erica P. Cahill, MD, of the department of obstetrics and gynecology and division of family planning services at Stanford (Calif.) University, wrote in an accompanying editorial.
Dr. Cahill noted the longer half-life of piroxicam compared with other COX-2 inhibitors, which made it a practical choice. Although the study was not powered to evaluate secondary outcomes, bleeding patterns consistent with use of EC pills were observed. Documentation of these patterns is worthwhile, Dr. Cahill said, “because people using emergency contraceptive pills might also be using fertility awareness methods and need to know when they can be certain they are not pregnant.”
Overall, the study supports the addition of 40 mg piroxicam to 1.5 mg levonorgestrel as emergency contraception, said Dr. Cahill. Future studies can build on the current findings by evaluating repeat dosing of the piroxicam/levonorgestrel combination and by evaluating the combination of COX-2 inhibitors and ulipristal acetate to prevent pregnancy, she said.
The study received no outside funding. The researchers and Dr. Cahill had no financial conflicts to disclose.
Adding oral piroxicam to oral levonorgestrel significantly improved the efficacy of emergency contraception, based on data from 860 women.
Oral hormonal emergency contraception (EC) is the most widely used EC method worldwide, but the two currently available drugs, levonorgestrel and ulipristal acetate (UPA), are not effective when given after ovulation, wrote Raymond Hang Wun Li, MD, of the University of Hong Kong, and colleagues. Previous studies suggest that cyclo-oxygenase (COX) inhibitors may disrupt follicular rupture and prevent ovulation, but data on their use in combination with current oral ECs are lacking, the researchers said.
In a study published in The Lancet, the researchers randomized 430 women to receive a single oral dose of 1.5 mg levonorgestrel plus 40 mg of the COX-2 inhibitor piroxicam or 1.5 mg levonorgestrel plus a placebo. The study participants were women aged 18 years and older who requested EC within 72 hours of unprotected sex and who had regular menstrual cycles between 24 and 42 days long. The median age of the participants was 30 years; 97% were Chinese. The median time from intercourse to treatment was 18 hours for both groups.
The primary outcome was the percentage of pregnancies prevented, based on pregnancy status 1-2 weeks after treatment.
One pregnancy occurred in the piroxicam group, compared with seven pregnancies in the placebo group, which translated to a significant difference in the percentage of pregnancies prevented (94.7% vs. 63.4%, P < .0001).
No trend toward increased failure rates appeared based on the time elapsed between intercourse and EC use in either group, and no differences appeared in the return or delay of subsequent menstrual periods between the groups.
The most common adverse events (reported by more than 5% of participants in both groups) included fatigue or weakness, nausea, lower abdominal pain, dizziness, and headache.
The choice of piroxicam as the COX inhibitor in conjunction with levonorgestrel for the current study had several potential advantages, the researchers wrote in their discussion. These advantages include the widespread availability and long-acting characteristics of piroxicam, which is also true of levonorgestrel, they said.
The findings were limited by several factors including the generalizability to other settings and populations, the researchers noted. The efficacy of the levonorgestrel/piroxicam combination in women with a body mass index greater than 26 kg/m2 may be lower, but the current study population did not have enough women in this category to measure the potential effect, they said. The study also did not examine the effect of piroxicam in combination with ulipristal acetate.
However, the results are the first known to demonstrate the improved effectiveness of oral piroxicam coadministered with oral levonorgestrel for EC, they said.
“The strength of this recommendation and changes in clinical guidelines may be determined upon demonstration of reproducible results in further studies,” they added.
Pill combination shows potential and practicality
Oral emergency contraception on demand is an unmet need on a global level, Erica P. Cahill, MD, of the department of obstetrics and gynecology and division of family planning services at Stanford (Calif.) University, wrote in an accompanying editorial.
Dr. Cahill noted the longer half-life of piroxicam compared with other COX-2 inhibitors, which made it a practical choice. Although the study was not powered to evaluate secondary outcomes, bleeding patterns consistent with use of EC pills were observed. Documentation of these patterns is worthwhile, Dr. Cahill said, “because people using emergency contraceptive pills might also be using fertility awareness methods and need to know when they can be certain they are not pregnant.”
Overall, the study supports the addition of 40 mg piroxicam to 1.5 mg levonorgestrel as emergency contraception, said Dr. Cahill. Future studies can build on the current findings by evaluating repeat dosing of the piroxicam/levonorgestrel combination and by evaluating the combination of COX-2 inhibitors and ulipristal acetate to prevent pregnancy, she said.
The study received no outside funding. The researchers and Dr. Cahill had no financial conflicts to disclose.
Adding oral piroxicam to oral levonorgestrel significantly improved the efficacy of emergency contraception, based on data from 860 women.
Oral hormonal emergency contraception (EC) is the most widely used EC method worldwide, but the two currently available drugs, levonorgestrel and ulipristal acetate (UPA), are not effective when given after ovulation, wrote Raymond Hang Wun Li, MD, of the University of Hong Kong, and colleagues. Previous studies suggest that cyclo-oxygenase (COX) inhibitors may disrupt follicular rupture and prevent ovulation, but data on their use in combination with current oral ECs are lacking, the researchers said.
In a study published in The Lancet, the researchers randomized 430 women to receive a single oral dose of 1.5 mg levonorgestrel plus 40 mg of the COX-2 inhibitor piroxicam or 1.5 mg levonorgestrel plus a placebo. The study participants were women aged 18 years and older who requested EC within 72 hours of unprotected sex and who had regular menstrual cycles between 24 and 42 days long. The median age of the participants was 30 years; 97% were Chinese. The median time from intercourse to treatment was 18 hours for both groups.
The primary outcome was the percentage of pregnancies prevented, based on pregnancy status 1-2 weeks after treatment.
One pregnancy occurred in the piroxicam group, compared with seven pregnancies in the placebo group, which translated to a significant difference in the percentage of pregnancies prevented (94.7% vs. 63.4%, P < .0001).
No trend toward increased failure rates appeared based on the time elapsed between intercourse and EC use in either group, and no differences appeared in the return or delay of subsequent menstrual periods between the groups.
The most common adverse events (reported by more than 5% of participants in both groups) included fatigue or weakness, nausea, lower abdominal pain, dizziness, and headache.
The choice of piroxicam as the COX inhibitor in conjunction with levonorgestrel for the current study had several potential advantages, the researchers wrote in their discussion. These advantages include the widespread availability and long-acting characteristics of piroxicam, which is also true of levonorgestrel, they said.
The findings were limited by several factors including the generalizability to other settings and populations, the researchers noted. The efficacy of the levonorgestrel/piroxicam combination in women with a body mass index greater than 26 kg/m2 may be lower, but the current study population did not have enough women in this category to measure the potential effect, they said. The study also did not examine the effect of piroxicam in combination with ulipristal acetate.
However, the results are the first known to demonstrate the improved effectiveness of oral piroxicam coadministered with oral levonorgestrel for EC, they said.
“The strength of this recommendation and changes in clinical guidelines may be determined upon demonstration of reproducible results in further studies,” they added.
Pill combination shows potential and practicality
Oral emergency contraception on demand is an unmet need on a global level, Erica P. Cahill, MD, of the department of obstetrics and gynecology and division of family planning services at Stanford (Calif.) University, wrote in an accompanying editorial.
Dr. Cahill noted the longer half-life of piroxicam compared with other COX-2 inhibitors, which made it a practical choice. Although the study was not powered to evaluate secondary outcomes, bleeding patterns consistent with use of EC pills were observed. Documentation of these patterns is worthwhile, Dr. Cahill said, “because people using emergency contraceptive pills might also be using fertility awareness methods and need to know when they can be certain they are not pregnant.”
Overall, the study supports the addition of 40 mg piroxicam to 1.5 mg levonorgestrel as emergency contraception, said Dr. Cahill. Future studies can build on the current findings by evaluating repeat dosing of the piroxicam/levonorgestrel combination and by evaluating the combination of COX-2 inhibitors and ulipristal acetate to prevent pregnancy, she said.
The study received no outside funding. The researchers and Dr. Cahill had no financial conflicts to disclose.
FROM THE LANCET
Ob.gyn. organizations opt for new residency application platform
In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
Efficiencies and lower costs
Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.
“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”
A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
Holistic review
According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.
“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.
So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.
For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”
An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.
Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.
“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.
“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”
Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.
According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.
“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
AAMC strikes back
Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.
“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”
Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
Evolution of specialty application
In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.
Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.
While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.
“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
Financial impact
Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.
But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.
“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”
Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.
In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
Efficiencies and lower costs
Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.
“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”
A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
Holistic review
According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.
“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.
So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.
For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”
An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.
Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.
“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.
“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”
Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.
According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.
“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
AAMC strikes back
Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.
“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”
Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
Evolution of specialty application
In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.
Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.
While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.
“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
Financial impact
Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.
But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.
“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”
Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.
In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
Efficiencies and lower costs
Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.
“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”
A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
Holistic review
According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.
“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.
So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.
For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”
An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.
Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.
“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.
“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”
Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.
According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.
“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
AAMC strikes back
Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.
“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”
Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
Evolution of specialty application
In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.
Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.
While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.
“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
Financial impact
Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.
But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.
“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”
Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.
New studies inform best practices for pelvic organ prolapse
“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.
“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.
In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.
The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.
After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).
Overall, anatomic recurrence was the most common outcome associated with surgical failure.
However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.
The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
Unexpected results
“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”
This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”
The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections.
Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
Manchester technique surpasses sacrospinous hysteropexy
In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.
“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.
“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.
In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.
The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.
The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.
Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.
Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.
However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.
The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.
As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
Studies challenge current prolapse protocols
The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.
The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”
The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.
Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”
The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.
“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.
“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.
In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.
The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.
After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).
Overall, anatomic recurrence was the most common outcome associated with surgical failure.
However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.
The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
Unexpected results
“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”
This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”
The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections.
Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
Manchester technique surpasses sacrospinous hysteropexy
In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.
“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.
“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.
In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.
The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.
The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.
Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.
Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.
However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.
The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.
As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
Studies challenge current prolapse protocols
The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.
The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”
The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.
Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”
The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.
“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.
“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.
In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.
The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.
After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).
Overall, anatomic recurrence was the most common outcome associated with surgical failure.
However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.
The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
Unexpected results
“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”
This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”
The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections.
Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
Manchester technique surpasses sacrospinous hysteropexy
In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.
“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.
“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.
In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.
The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.
The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.
Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.
Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.
However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.
The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.
As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
Studies challenge current prolapse protocols
The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.
The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”
The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.
Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”
The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.
FROM JAMA
Zuranolone: A novel postpartum depression treatment, with lingering questions
Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that , along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that , along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that , along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Postpartum depression risk increased among sexual minority women
However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
FROM JAMA PSYCHIATRY
My favorite iron pearls
A 45-year-old women presents for evaluation of fatigue. She has been tired for the past 6 months. She has had no problems with sleep and no other new symptoms. Her physical exam is unremarkable. Her Patient Health Questionnaire–9 score is 4. Lab results are as follows: hemoglobin, 13 g/dL; hematocrit, 39%; mean corpuscular volume, 90 fL; blood urea nitrogen, 10 mg/dL; Cr, 1.0 mg/dL; AST, 20 IU/L; ALT, 15 IU/L; ferritin, 35 mcg/mL; thyroid-stimulating hormone, 3.5 mIU/L.
What would you recommend?
A. Sertraline
B. Sleep study
C. Iron supplementation
I would treat this patient with iron. Verdon and colleagues conducted a randomized, double-blind placebo-controlled trial of iron treatment in nonanemic women.1 The women who received iron had a much greater reduction in fatigue score, compared with the women who did not (P < .004). Only women with ferritin levels less than 50 mcg/L benefited. Houston and colleagues performed a systematic review of the literature of iron supplementation for fatigue and concluded that iron should be considered for treatment of fatigue in nonanemic women.2 The key number for benefit was a ferritin level less than 50 mcg/L.
Hair thinning is a common concern for many women. Does iron deficiency have a possible role in this problem? A number of studies have correlated low ferritin levels with hair loss.3 There is less clear evidence of iron treatment being effective. Hard studied 140 women with diffuse hair loss, and found 19% had iron deficiency without anemia.4 All patients with iron deficiency were treated with oral iron and in all patients hair loss ceased, and hair regrowth occurred. The target ferritin goal for treatment is greater than 40 mcg/L.5
Iron deficiency is an important trigger for restless leg syndrome (RLS). All patients who present with RLS should have ferritin checked, and appropriate evaluation for the cause of iron deficiency if ferritin levels are low. Allen and colleagues published clinical practice guidelines for iron treatment of RLS.6 The guidelines conclude that ferric carboxymaltose (1,000 mg) is effective for treating moderate to severe RLS in those with serum ferritin less than 300 mcg/L and could be used as first-line therapy for RLS in adults, with oral iron (65 mg) possibly effective in patients with ferritin levels less than 75 mcg/L.
Pearl: Think of iron as therapy for fatigue in nonanemic women with a ferritin level less than 50 mcg/L, consider a trial of iron for thinning hair in women with ferritin levels less than 50 mcg/L, and a trial of iron in those with RLS with ferritin levels less than 75 mcg/L.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Verdon F et al. BMJ. 2003 May 24;326(7399):1124. .
2. Houston BL et al. BMJ Open. 2018 Apr 5;8(4):e019240.
3. Almohanna HM et al. Dermatol Ther (Heidelb). 2019 Mar;9(1):51-70. .
4. Hard S. Acta Derm Venereol. 1963;43:562-9.
5. Kantor J et al. J Invest Dermatol. 2003 Nov;121(5):985-8. .
6. Allen RP et al. Sleep Med. 2018 Jan;41:27-44. .
A 45-year-old women presents for evaluation of fatigue. She has been tired for the past 6 months. She has had no problems with sleep and no other new symptoms. Her physical exam is unremarkable. Her Patient Health Questionnaire–9 score is 4. Lab results are as follows: hemoglobin, 13 g/dL; hematocrit, 39%; mean corpuscular volume, 90 fL; blood urea nitrogen, 10 mg/dL; Cr, 1.0 mg/dL; AST, 20 IU/L; ALT, 15 IU/L; ferritin, 35 mcg/mL; thyroid-stimulating hormone, 3.5 mIU/L.
What would you recommend?
A. Sertraline
B. Sleep study
C. Iron supplementation
I would treat this patient with iron. Verdon and colleagues conducted a randomized, double-blind placebo-controlled trial of iron treatment in nonanemic women.1 The women who received iron had a much greater reduction in fatigue score, compared with the women who did not (P < .004). Only women with ferritin levels less than 50 mcg/L benefited. Houston and colleagues performed a systematic review of the literature of iron supplementation for fatigue and concluded that iron should be considered for treatment of fatigue in nonanemic women.2 The key number for benefit was a ferritin level less than 50 mcg/L.
Hair thinning is a common concern for many women. Does iron deficiency have a possible role in this problem? A number of studies have correlated low ferritin levels with hair loss.3 There is less clear evidence of iron treatment being effective. Hard studied 140 women with diffuse hair loss, and found 19% had iron deficiency without anemia.4 All patients with iron deficiency were treated with oral iron and in all patients hair loss ceased, and hair regrowth occurred. The target ferritin goal for treatment is greater than 40 mcg/L.5
Iron deficiency is an important trigger for restless leg syndrome (RLS). All patients who present with RLS should have ferritin checked, and appropriate evaluation for the cause of iron deficiency if ferritin levels are low. Allen and colleagues published clinical practice guidelines for iron treatment of RLS.6 The guidelines conclude that ferric carboxymaltose (1,000 mg) is effective for treating moderate to severe RLS in those with serum ferritin less than 300 mcg/L and could be used as first-line therapy for RLS in adults, with oral iron (65 mg) possibly effective in patients with ferritin levels less than 75 mcg/L.
Pearl: Think of iron as therapy for fatigue in nonanemic women with a ferritin level less than 50 mcg/L, consider a trial of iron for thinning hair in women with ferritin levels less than 50 mcg/L, and a trial of iron in those with RLS with ferritin levels less than 75 mcg/L.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Verdon F et al. BMJ. 2003 May 24;326(7399):1124. .
2. Houston BL et al. BMJ Open. 2018 Apr 5;8(4):e019240.
3. Almohanna HM et al. Dermatol Ther (Heidelb). 2019 Mar;9(1):51-70. .
4. Hard S. Acta Derm Venereol. 1963;43:562-9.
5. Kantor J et al. J Invest Dermatol. 2003 Nov;121(5):985-8. .
6. Allen RP et al. Sleep Med. 2018 Jan;41:27-44. .
A 45-year-old women presents for evaluation of fatigue. She has been tired for the past 6 months. She has had no problems with sleep and no other new symptoms. Her physical exam is unremarkable. Her Patient Health Questionnaire–9 score is 4. Lab results are as follows: hemoglobin, 13 g/dL; hematocrit, 39%; mean corpuscular volume, 90 fL; blood urea nitrogen, 10 mg/dL; Cr, 1.0 mg/dL; AST, 20 IU/L; ALT, 15 IU/L; ferritin, 35 mcg/mL; thyroid-stimulating hormone, 3.5 mIU/L.
What would you recommend?
A. Sertraline
B. Sleep study
C. Iron supplementation
I would treat this patient with iron. Verdon and colleagues conducted a randomized, double-blind placebo-controlled trial of iron treatment in nonanemic women.1 The women who received iron had a much greater reduction in fatigue score, compared with the women who did not (P < .004). Only women with ferritin levels less than 50 mcg/L benefited. Houston and colleagues performed a systematic review of the literature of iron supplementation for fatigue and concluded that iron should be considered for treatment of fatigue in nonanemic women.2 The key number for benefit was a ferritin level less than 50 mcg/L.
Hair thinning is a common concern for many women. Does iron deficiency have a possible role in this problem? A number of studies have correlated low ferritin levels with hair loss.3 There is less clear evidence of iron treatment being effective. Hard studied 140 women with diffuse hair loss, and found 19% had iron deficiency without anemia.4 All patients with iron deficiency were treated with oral iron and in all patients hair loss ceased, and hair regrowth occurred. The target ferritin goal for treatment is greater than 40 mcg/L.5
Iron deficiency is an important trigger for restless leg syndrome (RLS). All patients who present with RLS should have ferritin checked, and appropriate evaluation for the cause of iron deficiency if ferritin levels are low. Allen and colleagues published clinical practice guidelines for iron treatment of RLS.6 The guidelines conclude that ferric carboxymaltose (1,000 mg) is effective for treating moderate to severe RLS in those with serum ferritin less than 300 mcg/L and could be used as first-line therapy for RLS in adults, with oral iron (65 mg) possibly effective in patients with ferritin levels less than 75 mcg/L.
Pearl: Think of iron as therapy for fatigue in nonanemic women with a ferritin level less than 50 mcg/L, consider a trial of iron for thinning hair in women with ferritin levels less than 50 mcg/L, and a trial of iron in those with RLS with ferritin levels less than 75 mcg/L.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Verdon F et al. BMJ. 2003 May 24;326(7399):1124. .
2. Houston BL et al. BMJ Open. 2018 Apr 5;8(4):e019240.
3. Almohanna HM et al. Dermatol Ther (Heidelb). 2019 Mar;9(1):51-70. .
4. Hard S. Acta Derm Venereol. 1963;43:562-9.
5. Kantor J et al. J Invest Dermatol. 2003 Nov;121(5):985-8. .
6. Allen RP et al. Sleep Med. 2018 Jan;41:27-44. .
Don’t skip contraception talk for women with complex health conditions
.
In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.
“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”
The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.
“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
Start the conversation
Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.
Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.
Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
Clinical considerations and contraindications
Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.
When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.
The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.
The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
Risks, benefits, and balance
“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.
The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.
“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.
As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
Contraceptive counseling is everyone’s specialty
In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.
“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.
As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.
Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.
The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.
.
In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.
“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”
The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.
“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
Start the conversation
Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.
Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.
Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
Clinical considerations and contraindications
Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.
When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.
The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.
The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
Risks, benefits, and balance
“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.
The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.
“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.
As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
Contraceptive counseling is everyone’s specialty
In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.
“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.
As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.
Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.
The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.
.
In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.
“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”
The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.
“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
Start the conversation
Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.
Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.
Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
Clinical considerations and contraindications
Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.
When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.
The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.
The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
Risks, benefits, and balance
“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.
The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.
“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.
As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
Contraceptive counseling is everyone’s specialty
In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.
“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.
As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.
Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.
The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.
FROM THE ANNALS OF INTERNAL MEDICINE
Experts highlight benefits and offer caveats for first postpartum depression pill
For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.
for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
A fast-acting option
“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.
Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).
“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.
Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.
The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.
Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.
Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.
“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).
ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.
The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
Beyond ‘baby blues’
The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”
No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.
Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
Can be a medical emergency
Severe postpartum depression requires immediate attention and treatment.
“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.
“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.
“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
The science that led to approval
The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”
The antidepressant effect lasted at least 4 weeks after stopping the medication.
Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
The start of more help for mothers?
Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.
Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”
Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.
for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
A fast-acting option
“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.
Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).
“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.
Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.
The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.
Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.
Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.
“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).
ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.
The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
Beyond ‘baby blues’
The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”
No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.
Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
Can be a medical emergency
Severe postpartum depression requires immediate attention and treatment.
“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.
“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.
“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
The science that led to approval
The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”
The antidepressant effect lasted at least 4 weeks after stopping the medication.
Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
The start of more help for mothers?
Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.
Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”
Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.
for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
A fast-acting option
“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.
Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).
“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.
Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.
The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.
Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.
Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.
“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).
ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.
The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
Beyond ‘baby blues’
The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”
No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.
Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
Can be a medical emergency
Severe postpartum depression requires immediate attention and treatment.
“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.
“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.
“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
The science that led to approval
The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”
The antidepressant effect lasted at least 4 weeks after stopping the medication.
Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
The start of more help for mothers?
Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.
Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”
Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Older women risk overdiagnosis with mammograms: Study
Women who continued breast cancer screenings when they reached age 70 had no lower chance of dying from the disease, and just getting a mammogram could instead set them on a path toward unnecessary risks, according to a new study from Yale University.
The findings, published in Annals of Internal Medicine, suggest that , meaning that the cancer found during the screening would not have caused symptoms in a person’s lifetime. (For context, the average life expectancy of a woman in the U.S. is 79 years, according to the Centers for Disease Control and Prevention.)
Overdiagnosis can be harmful because it carries the risks of complications from overtreatment, plus financial and emotional hardships and unnecessary use of limited resources.
For the study, researchers analyzed data for 54,635 women aged 70 and older and compared the rate of breast cancer diagnosis and death among women who did and did not have mammograms during a 15-year follow-up period.
The rate of breast cancer in the study among women aged 70-74 was 6% for women who were screened and 4% for women who were not screened. The researchers estimated that 31% of the cases were potentially overdiagnosed. Among women aged 75-84, breast cancer was found in 5% of women who were screened, compared to less than 3% of unscreened women. Their estimated overdiagnosis rate was 47%. Finally, 3% of women aged 85 and older who were screened had breast cancer detected, compared with 1% of women in the unscreened group. For the older group, the overdiagnosis rate was 54%.
“While our study focused on overdiagnosis, it is important to acknowledge that overdiagnosis is just one of many considerations when deciding whether to continue screening,” researcher and Yale assistant professor of medicine Ilana Richman, MD, said in a statement. “A patient’s preferences and values, personal risk factors, and the overall balance of risks and benefits from screening are also important to take into account when making screening decisions.”
A version of this article first appeared on WebMD.com.
Women who continued breast cancer screenings when they reached age 70 had no lower chance of dying from the disease, and just getting a mammogram could instead set them on a path toward unnecessary risks, according to a new study from Yale University.
The findings, published in Annals of Internal Medicine, suggest that , meaning that the cancer found during the screening would not have caused symptoms in a person’s lifetime. (For context, the average life expectancy of a woman in the U.S. is 79 years, according to the Centers for Disease Control and Prevention.)
Overdiagnosis can be harmful because it carries the risks of complications from overtreatment, plus financial and emotional hardships and unnecessary use of limited resources.
For the study, researchers analyzed data for 54,635 women aged 70 and older and compared the rate of breast cancer diagnosis and death among women who did and did not have mammograms during a 15-year follow-up period.
The rate of breast cancer in the study among women aged 70-74 was 6% for women who were screened and 4% for women who were not screened. The researchers estimated that 31% of the cases were potentially overdiagnosed. Among women aged 75-84, breast cancer was found in 5% of women who were screened, compared to less than 3% of unscreened women. Their estimated overdiagnosis rate was 47%. Finally, 3% of women aged 85 and older who were screened had breast cancer detected, compared with 1% of women in the unscreened group. For the older group, the overdiagnosis rate was 54%.
“While our study focused on overdiagnosis, it is important to acknowledge that overdiagnosis is just one of many considerations when deciding whether to continue screening,” researcher and Yale assistant professor of medicine Ilana Richman, MD, said in a statement. “A patient’s preferences and values, personal risk factors, and the overall balance of risks and benefits from screening are also important to take into account when making screening decisions.”
A version of this article first appeared on WebMD.com.
Women who continued breast cancer screenings when they reached age 70 had no lower chance of dying from the disease, and just getting a mammogram could instead set them on a path toward unnecessary risks, according to a new study from Yale University.
The findings, published in Annals of Internal Medicine, suggest that , meaning that the cancer found during the screening would not have caused symptoms in a person’s lifetime. (For context, the average life expectancy of a woman in the U.S. is 79 years, according to the Centers for Disease Control and Prevention.)
Overdiagnosis can be harmful because it carries the risks of complications from overtreatment, plus financial and emotional hardships and unnecessary use of limited resources.
For the study, researchers analyzed data for 54,635 women aged 70 and older and compared the rate of breast cancer diagnosis and death among women who did and did not have mammograms during a 15-year follow-up period.
The rate of breast cancer in the study among women aged 70-74 was 6% for women who were screened and 4% for women who were not screened. The researchers estimated that 31% of the cases were potentially overdiagnosed. Among women aged 75-84, breast cancer was found in 5% of women who were screened, compared to less than 3% of unscreened women. Their estimated overdiagnosis rate was 47%. Finally, 3% of women aged 85 and older who were screened had breast cancer detected, compared with 1% of women in the unscreened group. For the older group, the overdiagnosis rate was 54%.
“While our study focused on overdiagnosis, it is important to acknowledge that overdiagnosis is just one of many considerations when deciding whether to continue screening,” researcher and Yale assistant professor of medicine Ilana Richman, MD, said in a statement. “A patient’s preferences and values, personal risk factors, and the overall balance of risks and benefits from screening are also important to take into account when making screening decisions.”
A version of this article first appeared on WebMD.com.
FROM ANNALS OF INTERNAL MEDICINE
FDA approves first pill for postpartum depression
a condition that affects an estimated one in seven mothers in the United States.
The pill, zuranolone (Zurzuvae), is a neuroactive steroid that acts on GABAA receptors in the brain responsible for regulating mood, arousal, behavior, and cognition, according to Biogen, which, along with Sage Therapeutics, developed the product. The recommended dose for Zurzuvae is 50 mg taken once daily for 14 days, in the evening with a fatty meal, according to the FDA.
Postpartum depression often goes undiagnosed and untreated. Many mothers are hesitant to reveal their symptoms to family and clinicians, fearing they’ll be judged on their parenting. A 2017 study found that suicide accounted for roughly 5% of perinatal deaths among women in Canada, with most of those deaths occurring in the first 3 months in the year after giving birth.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, said in a statement about the approval. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
The other approved therapy for postpartum depression is the intravenous agent brexanolone (Zulresso; Sage). But the product requires prolonged infusions in hospital settings and costs $34,000.
FDA approval of Zurzuvae was based in part on data reported in a 2023 study in the American Journal of Psychiatry, which showed that the drug led to significantly greater improvement in depressive symptoms at 15 days compared with the placebo group. Improvements were observed on day 3, the earliest assessment, and were sustained at all subsequent visits during the treatment and follow-up period (through day 42).
Patients with anxiety who received the active drug experienced improvement in related symptoms compared with the patients who received a placebo.
The most common adverse events reported in the trial were somnolence and headaches. Weight gain, sexual dysfunction, withdrawal symptoms, and increased suicidal ideation or behavior were not observed.
The packaging for Zurzuvae will include a boxed warning noting that the drug can affect a user’s ability to drive and perform other potentially hazardous activities, possibly without their knowledge of the impairment, the FDA said. As a result, people who use Zurzuvae should not drive or operate heavy machinery for at least 12 hours after taking the pill.
A version of this article first appeared on Medscape.com.
a condition that affects an estimated one in seven mothers in the United States.
The pill, zuranolone (Zurzuvae), is a neuroactive steroid that acts on GABAA receptors in the brain responsible for regulating mood, arousal, behavior, and cognition, according to Biogen, which, along with Sage Therapeutics, developed the product. The recommended dose for Zurzuvae is 50 mg taken once daily for 14 days, in the evening with a fatty meal, according to the FDA.
Postpartum depression often goes undiagnosed and untreated. Many mothers are hesitant to reveal their symptoms to family and clinicians, fearing they’ll be judged on their parenting. A 2017 study found that suicide accounted for roughly 5% of perinatal deaths among women in Canada, with most of those deaths occurring in the first 3 months in the year after giving birth.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, said in a statement about the approval. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
The other approved therapy for postpartum depression is the intravenous agent brexanolone (Zulresso; Sage). But the product requires prolonged infusions in hospital settings and costs $34,000.
FDA approval of Zurzuvae was based in part on data reported in a 2023 study in the American Journal of Psychiatry, which showed that the drug led to significantly greater improvement in depressive symptoms at 15 days compared with the placebo group. Improvements were observed on day 3, the earliest assessment, and were sustained at all subsequent visits during the treatment and follow-up period (through day 42).
Patients with anxiety who received the active drug experienced improvement in related symptoms compared with the patients who received a placebo.
The most common adverse events reported in the trial were somnolence and headaches. Weight gain, sexual dysfunction, withdrawal symptoms, and increased suicidal ideation or behavior were not observed.
The packaging for Zurzuvae will include a boxed warning noting that the drug can affect a user’s ability to drive and perform other potentially hazardous activities, possibly without their knowledge of the impairment, the FDA said. As a result, people who use Zurzuvae should not drive or operate heavy machinery for at least 12 hours after taking the pill.
A version of this article first appeared on Medscape.com.
a condition that affects an estimated one in seven mothers in the United States.
The pill, zuranolone (Zurzuvae), is a neuroactive steroid that acts on GABAA receptors in the brain responsible for regulating mood, arousal, behavior, and cognition, according to Biogen, which, along with Sage Therapeutics, developed the product. The recommended dose for Zurzuvae is 50 mg taken once daily for 14 days, in the evening with a fatty meal, according to the FDA.
Postpartum depression often goes undiagnosed and untreated. Many mothers are hesitant to reveal their symptoms to family and clinicians, fearing they’ll be judged on their parenting. A 2017 study found that suicide accounted for roughly 5% of perinatal deaths among women in Canada, with most of those deaths occurring in the first 3 months in the year after giving birth.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, said in a statement about the approval. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
The other approved therapy for postpartum depression is the intravenous agent brexanolone (Zulresso; Sage). But the product requires prolonged infusions in hospital settings and costs $34,000.
FDA approval of Zurzuvae was based in part on data reported in a 2023 study in the American Journal of Psychiatry, which showed that the drug led to significantly greater improvement in depressive symptoms at 15 days compared with the placebo group. Improvements were observed on day 3, the earliest assessment, and were sustained at all subsequent visits during the treatment and follow-up period (through day 42).
Patients with anxiety who received the active drug experienced improvement in related symptoms compared with the patients who received a placebo.
The most common adverse events reported in the trial were somnolence and headaches. Weight gain, sexual dysfunction, withdrawal symptoms, and increased suicidal ideation or behavior were not observed.
The packaging for Zurzuvae will include a boxed warning noting that the drug can affect a user’s ability to drive and perform other potentially hazardous activities, possibly without their knowledge of the impairment, the FDA said. As a result, people who use Zurzuvae should not drive or operate heavy machinery for at least 12 hours after taking the pill.
A version of this article first appeared on Medscape.com.