AI algorithm aids egg retrieval date during fertility treatment cycles

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Mon, 11/13/2023 - 06:39

Artificial intelligence can accurately predict the optimal retrieval date in fertility treatment cycles, according to preliminary research presented at the annual meeting of the American Society for Reproductive Medicine. According to the researchers, such an algorithm is needed due to the increased demand for fertility treatments, as well as the high day-to-day variability in lab workload.

According to the study investigators, predicting retrieval dates in advance for ongoing cycles is of major importance for both patients and clinicians.

“The population requiring fertility treatments, including genetic testing and fertility preservation, has massively increased, and this causes many more cycles and a high day-to-day variability in IVF activity, especially in the lab workload,” said Rohi Hourvitz, MBA, from FertilAI, an Israeli health care company focused on developing technologies that improve fertility treatments.

“We also need to accommodate and reschedule for non-working days, which causes a big issue with managing the workload in many clinics around the world,” added Mr. Hourvitz, who presented the research highlighting AI’s growing role in reproductive medicine.

In addition, AI has recently emerged as an effective tool for assisting in clinical decision-making in assisted reproductive technology, prompting further research in this space, he said.

The new study used a dataset of 9,550 predictable antagonist cycles (defined as having all necessary data) gathered from one lab with over 50 physicians between August 2018 and October 2022. The data were split into two subsets: one for training the AI model and the other for prospective testing. 

To train and test the AI model, data from nearly 6,000 predictable antagonist cycles were used. Key factors used for each cycle included estrogen levels, mean follicle size, primary follicle size, and various patient demographics. Other features were considered, but Mr. Hourvitz noted that primary follicle size influenced the algorithm most, “because that is what most of us use when we want to trigger.”

Mr. Hourvitz explained that these patient data were run through an algorithm that produced a graph predicting the most probable date for a cycle retrieval.

“We could accurately predict when those ‘peak days’ were going to be happening in the clinic, and we could also give a pretty good estimate on how many cycles you’re going to have every day,” Mr. Hourvitz said, explaining that this information could help clinics more efficiently allocate resources and manage patients.

According to Mr. Hourvitz, the predictions derived from this study could improve various aspects of fertility treatments and related procedures, including better staff planning and caseload management in IVF labs, as well as higher-quality eggs at retrieval. Patients would have a clearer timeline for their treatment cycles.   

Nikica Zaninovic, PhD, MS, director of the embryology lab at Weill Cornell Medical College, New York City, cautioned that the new findings are not yet ready for clinical application but emphasized the importance of more AI research focusing on the quality of oocytes, not only embryos.

“We’re so focused on the end of the process: the embryo,” Dr. Zaninovic, who was not involved in the research, said in an interview. “I think the focus should be on the beginning – the quality of eggs and sperm, not just the quantity – because that’s what the embryos will depend on.”

He noted the increasing numbers of young women in the United States undergoing egg freezing.

“Cornell is the largest academic IVF center in the United States; 20%-30% of all of the patients that we treat are actually freezing their eggs,” he said. “It’s a huge population.”

“When they come to us, they ask how many eggs they’ll need to guarantee one or two children in the future,” Dr. Zaninovic continued. “We don’t have that answer, so we always tell them [we’ll retrieve] as many as we can. That’s not the answer; we need to be more precise. We’re still lacking these tools, and I think that’s where the research will go.”

The study was funded by FertilAI. Mr. Hourvitz is a shareholder and CEO of FertilAI. Dr. Zaninovic is president of the AI Fertility Society.

A version of this article appeared on Medscape.com.

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Artificial intelligence can accurately predict the optimal retrieval date in fertility treatment cycles, according to preliminary research presented at the annual meeting of the American Society for Reproductive Medicine. According to the researchers, such an algorithm is needed due to the increased demand for fertility treatments, as well as the high day-to-day variability in lab workload.

According to the study investigators, predicting retrieval dates in advance for ongoing cycles is of major importance for both patients and clinicians.

“The population requiring fertility treatments, including genetic testing and fertility preservation, has massively increased, and this causes many more cycles and a high day-to-day variability in IVF activity, especially in the lab workload,” said Rohi Hourvitz, MBA, from FertilAI, an Israeli health care company focused on developing technologies that improve fertility treatments.

“We also need to accommodate and reschedule for non-working days, which causes a big issue with managing the workload in many clinics around the world,” added Mr. Hourvitz, who presented the research highlighting AI’s growing role in reproductive medicine.

In addition, AI has recently emerged as an effective tool for assisting in clinical decision-making in assisted reproductive technology, prompting further research in this space, he said.

The new study used a dataset of 9,550 predictable antagonist cycles (defined as having all necessary data) gathered from one lab with over 50 physicians between August 2018 and October 2022. The data were split into two subsets: one for training the AI model and the other for prospective testing. 

To train and test the AI model, data from nearly 6,000 predictable antagonist cycles were used. Key factors used for each cycle included estrogen levels, mean follicle size, primary follicle size, and various patient demographics. Other features were considered, but Mr. Hourvitz noted that primary follicle size influenced the algorithm most, “because that is what most of us use when we want to trigger.”

Mr. Hourvitz explained that these patient data were run through an algorithm that produced a graph predicting the most probable date for a cycle retrieval.

“We could accurately predict when those ‘peak days’ were going to be happening in the clinic, and we could also give a pretty good estimate on how many cycles you’re going to have every day,” Mr. Hourvitz said, explaining that this information could help clinics more efficiently allocate resources and manage patients.

According to Mr. Hourvitz, the predictions derived from this study could improve various aspects of fertility treatments and related procedures, including better staff planning and caseload management in IVF labs, as well as higher-quality eggs at retrieval. Patients would have a clearer timeline for their treatment cycles.   

Nikica Zaninovic, PhD, MS, director of the embryology lab at Weill Cornell Medical College, New York City, cautioned that the new findings are not yet ready for clinical application but emphasized the importance of more AI research focusing on the quality of oocytes, not only embryos.

“We’re so focused on the end of the process: the embryo,” Dr. Zaninovic, who was not involved in the research, said in an interview. “I think the focus should be on the beginning – the quality of eggs and sperm, not just the quantity – because that’s what the embryos will depend on.”

He noted the increasing numbers of young women in the United States undergoing egg freezing.

“Cornell is the largest academic IVF center in the United States; 20%-30% of all of the patients that we treat are actually freezing their eggs,” he said. “It’s a huge population.”

“When they come to us, they ask how many eggs they’ll need to guarantee one or two children in the future,” Dr. Zaninovic continued. “We don’t have that answer, so we always tell them [we’ll retrieve] as many as we can. That’s not the answer; we need to be more precise. We’re still lacking these tools, and I think that’s where the research will go.”

The study was funded by FertilAI. Mr. Hourvitz is a shareholder and CEO of FertilAI. Dr. Zaninovic is president of the AI Fertility Society.

A version of this article appeared on Medscape.com.

Artificial intelligence can accurately predict the optimal retrieval date in fertility treatment cycles, according to preliminary research presented at the annual meeting of the American Society for Reproductive Medicine. According to the researchers, such an algorithm is needed due to the increased demand for fertility treatments, as well as the high day-to-day variability in lab workload.

According to the study investigators, predicting retrieval dates in advance for ongoing cycles is of major importance for both patients and clinicians.

“The population requiring fertility treatments, including genetic testing and fertility preservation, has massively increased, and this causes many more cycles and a high day-to-day variability in IVF activity, especially in the lab workload,” said Rohi Hourvitz, MBA, from FertilAI, an Israeli health care company focused on developing technologies that improve fertility treatments.

“We also need to accommodate and reschedule for non-working days, which causes a big issue with managing the workload in many clinics around the world,” added Mr. Hourvitz, who presented the research highlighting AI’s growing role in reproductive medicine.

In addition, AI has recently emerged as an effective tool for assisting in clinical decision-making in assisted reproductive technology, prompting further research in this space, he said.

The new study used a dataset of 9,550 predictable antagonist cycles (defined as having all necessary data) gathered from one lab with over 50 physicians between August 2018 and October 2022. The data were split into two subsets: one for training the AI model and the other for prospective testing. 

To train and test the AI model, data from nearly 6,000 predictable antagonist cycles were used. Key factors used for each cycle included estrogen levels, mean follicle size, primary follicle size, and various patient demographics. Other features were considered, but Mr. Hourvitz noted that primary follicle size influenced the algorithm most, “because that is what most of us use when we want to trigger.”

Mr. Hourvitz explained that these patient data were run through an algorithm that produced a graph predicting the most probable date for a cycle retrieval.

“We could accurately predict when those ‘peak days’ were going to be happening in the clinic, and we could also give a pretty good estimate on how many cycles you’re going to have every day,” Mr. Hourvitz said, explaining that this information could help clinics more efficiently allocate resources and manage patients.

According to Mr. Hourvitz, the predictions derived from this study could improve various aspects of fertility treatments and related procedures, including better staff planning and caseload management in IVF labs, as well as higher-quality eggs at retrieval. Patients would have a clearer timeline for their treatment cycles.   

Nikica Zaninovic, PhD, MS, director of the embryology lab at Weill Cornell Medical College, New York City, cautioned that the new findings are not yet ready for clinical application but emphasized the importance of more AI research focusing on the quality of oocytes, not only embryos.

“We’re so focused on the end of the process: the embryo,” Dr. Zaninovic, who was not involved in the research, said in an interview. “I think the focus should be on the beginning – the quality of eggs and sperm, not just the quantity – because that’s what the embryos will depend on.”

He noted the increasing numbers of young women in the United States undergoing egg freezing.

“Cornell is the largest academic IVF center in the United States; 20%-30% of all of the patients that we treat are actually freezing their eggs,” he said. “It’s a huge population.”

“When they come to us, they ask how many eggs they’ll need to guarantee one or two children in the future,” Dr. Zaninovic continued. “We don’t have that answer, so we always tell them [we’ll retrieve] as many as we can. That’s not the answer; we need to be more precise. We’re still lacking these tools, and I think that’s where the research will go.”

The study was funded by FertilAI. Mr. Hourvitz is a shareholder and CEO of FertilAI. Dr. Zaninovic is president of the AI Fertility Society.

A version of this article appeared on Medscape.com.

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Hypertensive disorders of pregnancy and high stroke risk in Black women

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Wed, 11/08/2023 - 14:18

I’d like to talk with you about a recent report from the large-scale Black Women’s Health Study, published in the new journal NEJM Evidence.

This study looked at the association between hypertensive disorders of pregnancy, including preeclampsia and gestational hypertension, and the risk for stroke over the next 20 (median, 22) years. Previous studies have linked hypertensive disorders of pregnancy with an increased risk for stroke. However, most of these studies have been done in White women of European ancestry, and evidence in Black women has been very limited, despite a disproportionately high risk of having a hypertensive disorder of pregnancy and also of stroke.

Dr. JoAnn E. Manson

This study, in more than 40,000 U.S. women, found an increased risk for subsequent stroke among women with a prior history of hypertensive disorder of pregnancy – overall, a 66% increased risk, an 80% increased risk with gestational hypertension, and about a 50% increased risk with preeclampsia.

We know that pregnancy itself can lead to some remodeling of the vascular system, but we don’t know whether a direct causal relationship exists between preeclampsia or gestational hypertension and subsequent stroke. Another potential explanation is that these complications of pregnancy serve as a window into a woman’s future cardiometabolic health and a marker of her cardiovascular risk.

Regardless, the clinical implications are the same. First, we would want to prevent these complications of pregnancy whenever possible. Some women will be candidates for the use of aspirin if they are at high risk for preeclampsia, and certainly for monitoring blood pressure very closely during pregnancy. It will also be important to maintain blood pressure control in the postpartum period and during the subsequent years of adulthood to minimize risk for stroke, because hypertension is such a powerful risk factor for stroke.

It will also be tremendously important to intensify lifestyle modifications such as increasing physical activity and having a heart-healthy diet. These complications of pregnancy have also been linked in other studies to an increased risk for subsequent coronary heart disease events and heart failure.

This transcript has been edited for clarity.

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and chief of the division of preventive medicine, Brigham and Women’s Hospital, both in Boston, and past president, North American Menopause Society, 2011-2012. She disclosed receiving study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

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I’d like to talk with you about a recent report from the large-scale Black Women’s Health Study, published in the new journal NEJM Evidence.

This study looked at the association between hypertensive disorders of pregnancy, including preeclampsia and gestational hypertension, and the risk for stroke over the next 20 (median, 22) years. Previous studies have linked hypertensive disorders of pregnancy with an increased risk for stroke. However, most of these studies have been done in White women of European ancestry, and evidence in Black women has been very limited, despite a disproportionately high risk of having a hypertensive disorder of pregnancy and also of stroke.

Dr. JoAnn E. Manson

This study, in more than 40,000 U.S. women, found an increased risk for subsequent stroke among women with a prior history of hypertensive disorder of pregnancy – overall, a 66% increased risk, an 80% increased risk with gestational hypertension, and about a 50% increased risk with preeclampsia.

We know that pregnancy itself can lead to some remodeling of the vascular system, but we don’t know whether a direct causal relationship exists between preeclampsia or gestational hypertension and subsequent stroke. Another potential explanation is that these complications of pregnancy serve as a window into a woman’s future cardiometabolic health and a marker of her cardiovascular risk.

Regardless, the clinical implications are the same. First, we would want to prevent these complications of pregnancy whenever possible. Some women will be candidates for the use of aspirin if they are at high risk for preeclampsia, and certainly for monitoring blood pressure very closely during pregnancy. It will also be important to maintain blood pressure control in the postpartum period and during the subsequent years of adulthood to minimize risk for stroke, because hypertension is such a powerful risk factor for stroke.

It will also be tremendously important to intensify lifestyle modifications such as increasing physical activity and having a heart-healthy diet. These complications of pregnancy have also been linked in other studies to an increased risk for subsequent coronary heart disease events and heart failure.

This transcript has been edited for clarity.

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and chief of the division of preventive medicine, Brigham and Women’s Hospital, both in Boston, and past president, North American Menopause Society, 2011-2012. She disclosed receiving study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

I’d like to talk with you about a recent report from the large-scale Black Women’s Health Study, published in the new journal NEJM Evidence.

This study looked at the association between hypertensive disorders of pregnancy, including preeclampsia and gestational hypertension, and the risk for stroke over the next 20 (median, 22) years. Previous studies have linked hypertensive disorders of pregnancy with an increased risk for stroke. However, most of these studies have been done in White women of European ancestry, and evidence in Black women has been very limited, despite a disproportionately high risk of having a hypertensive disorder of pregnancy and also of stroke.

Dr. JoAnn E. Manson

This study, in more than 40,000 U.S. women, found an increased risk for subsequent stroke among women with a prior history of hypertensive disorder of pregnancy – overall, a 66% increased risk, an 80% increased risk with gestational hypertension, and about a 50% increased risk with preeclampsia.

We know that pregnancy itself can lead to some remodeling of the vascular system, but we don’t know whether a direct causal relationship exists between preeclampsia or gestational hypertension and subsequent stroke. Another potential explanation is that these complications of pregnancy serve as a window into a woman’s future cardiometabolic health and a marker of her cardiovascular risk.

Regardless, the clinical implications are the same. First, we would want to prevent these complications of pregnancy whenever possible. Some women will be candidates for the use of aspirin if they are at high risk for preeclampsia, and certainly for monitoring blood pressure very closely during pregnancy. It will also be important to maintain blood pressure control in the postpartum period and during the subsequent years of adulthood to minimize risk for stroke, because hypertension is such a powerful risk factor for stroke.

It will also be tremendously important to intensify lifestyle modifications such as increasing physical activity and having a heart-healthy diet. These complications of pregnancy have also been linked in other studies to an increased risk for subsequent coronary heart disease events and heart failure.

This transcript has been edited for clarity.

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and chief of the division of preventive medicine, Brigham and Women’s Hospital, both in Boston, and past president, North American Menopause Society, 2011-2012. She disclosed receiving study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

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Digital tool clarifies menopause symptoms

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Mon, 11/06/2023 - 11:36

– An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

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– An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

– An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

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Abdominal Pain and Fever 48 Hours After Hysterosalpingography

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Fri, 11/17/2023 - 08:43

A 37-year-old woman presented to the emergency department (ED) with 12 hours of fever and lower abdominal cramp pain. She had a history significant for hypothyroidism, infertility, and dysmenorrhea and had a hysterosalpingography (HSG) 48 hours prior for a comprehensive infertility workup.

On examination, the patient’s vital signs were a 94 bpm heart rate; 109/64 mm Hg blood pressure; 14 breaths per minute respiratory rate; 99% oxygen saturation on room air; and 101.2 °F temperature. The patient reported pain in the bilateral lower abdominal quadrants and no history of sexually transmitted infection, pelvic inflammatory disease, vaginal discharge or bleeding, dysuria, hematuria, melena, or bright red blood per rectum. A human chorionic gonadotropin urine test was negative on intake. The HSG 48 hours prior showed no concerning findings with normal uterine cavity and normal caliber fallopian tubes bilaterally.

On physical examination, the patient’s abdomen was nondistended, nonperitonitic, and without evidence of acute trauma or surgical scars. On palpation, the patient was tender in her suprapubic region and lower abdominal quadrants without evidence of guarding or rebound tenderness. At rest, the patient rated her abdominal pain 4 out of 10 and 7 out of 10 upon palpation. On pelvic examination, there was normal appearing external genitalia without evidence of discharge or bleeding. Her vaginal vault was atraumatic with a minimal amount of physiologic discharge. Her cervix was normal in appearance without evidence of cervicitis. We obtained swabs for Neisseria gonorrhoeae (N gonorrhoeae) and Chlamydia trachomatis (C trachomatis), which were negative. On bimanual pelvic examination, the patient had no cervical motion tenderness, and no adnexal masses were palpable. However, on palpation of the adnexa, she endorsed a localized dull, nonradiating 6 out of 10 right-sided pain/tenderness.

The patient’s initial laboratory tests were as follows: white blood cells, 20.1 × 103/μL (reference range, 4-11 × 103/μL); hemoglobin, 12.1 g/dL (reference range, 12.1-15.1 g/dL); hematocrit, 37.1%, (reference range, 36%-48%); alanine aminotransferase, 84 U/L (reference range, 7-56 U/L); aspartate aminotransferase, 66 U/L (reference range, 8-33 U/L); and lipase, 25 U/L (5-60 U/L). Urinalysis was notable for only 5 red blood cells and negative for white blood cells, leukocyte esterase, and nitrites. The patient’s pain and fever were controlled with 1 g IV acetaminophen.

figure

The patient’s fever, leukocytosis, and physical examination were concerning for possible intra-abdominal processes, so a computed tomography (CT) of her abdomen and pelvis with IV contrast was obtained for further evaluation. The CT showed bilateral tubular rim-enhancing fluid collections within bilateral adnexa with the right fluid collection measuring 3.7 × 3.5 × 4.0 cm and the left 4.8 × 3.5 × 3.2 cm with associated fat stranding and trace-free fluid in the abdomen (Figure).

Discussion

The patient was diagnosed with bilateral tubo-ovarian abscess (TOA) likely secondary to her HSG procedure 48 hours before. TOA is a severe infectious, inflammatory condition involving a mass of the ovaries, fallopian tubes, or adjacent tissues of the upper female genital tract.1 Traditionally, TOAs are sequelae of undiagnosed or subclinical acute or chronic pelvic inflammatory disease (PID). This is known to occur via pathogen ascension from the lower to the upper female genital tract resulting in cervicitis, endometritis, salpingitis, oophoritis, and if left untreated, peritonitis.1 About 70,000 women are diagnosed with TOAs in the US every year. These patients require hospitalization as well as IV antibiotics for gold-standard treatment; however, some cases may require percutaneous drainage based on size, severity, and location.2

 

 

Diagnostic Considerations

Clinically, patients with TOAs present with fever, chills, lower abdominal pain, vaginal discharge with cervical motion tenderness, and an adnexal mass on examination.3 When a TOA is suspected, a urine human chorionic gonadotropin test and testing for C trachomatis and N gonorrhoeae are warranted. An ED workup often reveals leukocytosis, elevated C-reactive protein, and elevated erythrocyte sedimentation rate. Imaging is recommended once a TOA is suspected. Ultrasound is the gold-standard imaging modality and boasts a sensitivity of 93% and specificity of 98% for the detection of TOAs; however, CT has also been shown to be an effective diagnostic modality.4

Despite being common, TOAs are difficult to predict, detect, and diagnose; thus the clinician must often rely on thorough history taking and physical examination to raise suspicion.5 Although most frequently associated with sexual transmission, TOAs occur in not sexually active women in adolescence and adulthood. Specifically, TOAs also can present secondary to other intra-abdominal pathologies, such as appendicitis, diverticulitis, and pyelonephritis, as well as a complication of intrauterine procedures, such as an HSG, or less commonly, following intrauterine device (IUD) insertion.5-7

table

Given that sexually transmitted infections are the most common etiology of TOAs, C trachomatis and N gonorrhoeae are the most likely microorganisms to be isolated (Table).8-12 In not sexually active populations, Escherichia coli and Gardnerella vaginalis should be considered instead. Although rare, women with IUDs have been shown to have an increased incidence of PID/TOA secondary to Actinomyces israleii relative to women without IUDs.12 In patients with TOAs secondary to intraabdominal surgery, anaerobic bacteria, such as Bacterioides and Peptostreptococcus species in addition to Escherichia coli, are likely culprits.11

In patients after HSG, infectious complications are uncommon enough that the American College of Obstetricians and Gynecologists recommends against antibiotic prophylaxis unless there are risk factors of dilated fallopian tubes or a history of PID.13 Identifying a precise percentage of TOA as a complication of HSG is rather elusive in the literature, though, it is frequently noted that infection in general is uncommon, and the risk of developing PID is about 1.4% to 3.4%.14 However, in the retrospective study most often cited, all women who developed PID following HSG had evidence of dilated fallopian tubes. Given our patient had no history of PID or dilated fallopian tubes, her risk of developing infection (PID or postprocedural abscess) would be considered very low; therefore, the index of suspicion also was low.15

Our patient’s case of bilateral TOA also is unusual because her presentation was not entirely consistent with a TOA. She had a benign pelvic examination without cervical motion tenderness or evidence of cervicitis or cervical discharge. Given the initially low clinical suspicion, transvaginal ultrasound was not ordered. However, in the setting of tenderness to palpation in the lower abdominal quadrants, suprapubic tenderness, and leukocytosis, there was still concern for an acute intra-abdominal or pelvic process, and an abdominal CT was ordered as part of the workup. It was this clinical concern that led to the identification of the patient’s bilateral TOA.

Following diagnosis, the patient was promptly admitted and treated with a course of IV ceftriaxone 1 g every 24 hours, IV doxycycline 100 mg every 12 hours, and a single dose of IV metronidazole 500 mg. Her leukocytosis, fever, and pain improved within 48 hours without the need for percutaneous drainage and the patient made a complete recovery.

 

 

Complications

TOAs can carry significant morbidity and mortality, and there are both acute and chronic complications associated. Even if properly treated, TOAs can rupture leading to severe illness, such as peritonitis and septic shock. This often requires surgical intervention and hemodynamic pressure support in the intensive care unit setting.16 One of the most feared long-term complications of TOAs is infertility secondary to structural abnormalities of the female reproductive tract.10 Adhesions, strictures, and scarring are associated with TOAs irrespective of medical or surgical management, and thus any women with a history of PID or TOA require advanced fertility workup if they are having difficulties with conception or implantation.17

Minimizing infectious transmission also is essential in the treatment of TOA/PID. All women who receive a diagnosis of PID or TOA should be evaluated for gonorrhea, chlamydia, HIV, and syphilis. Women should be instructed to abstain from sexual intercourse until therapy is complete, symptoms have resolved, and sex partners have been treated for potential chlamydial or gonococcal infections. All contraceptive methods can be continued during treatment.

Conclusions

This case presented several challenges as the bilateral TOAs developed postprocedure in a patient without risk factors. Furthermore, this case did not follow the classic presentation of ascending bacterial translocation to the ovaries over days to weeks. The diagnosis was complicated by a largely benign physical examination and a pelvic examination without evidence of abnormal vaginal discharge or cervicitis. The only indicators were fever, leukocytosis, and abdominal pain in the setting of a recent, uncomplicated HSG procedure. Vigilance is required to obtain the necessary history, and the differential of TOA must be broadened to include women without a history or symptoms of a sexually transmitted infection (contrary to the classic association). We aim to encourage heightened clinical suspicion for TOAs in patients who present with fever, leukocytosis, and abdominal pain after recent HSG or other intrauterine instrumentation procedures and therefore improve patient outcomes.

References

1. Gkrozou F, Tsonis O, Daniilidis A, Navrozoglou I, Paschopoulos M. Tubo-ovarian abscess: exploring optimal treatment options based on current evidence. J Endometr Pelvic Pain Disord. 2020;13(1):10-19. doi:10.1177/2284026520960649

2. Taylor KJ, Wasson JF, De Graaff C, Rosenfield AT, Andriole VT. Accuracy of grey-scale ultrasound diagnosis of abdominal and pelvic abscesses in 220 patients. Lancet. 1978;1(8055):83-84. doi:10.1016/s0140-6736(78)90016-8

3. Bridwell RE, Koyfman A, Long B. High risk and low prevalence diseases: tubo-ovarian abscess. Am J Emerg Med. 2022;57:70-75. doi:10.1016/j.ajem.2022.04.026

4. Lambert MJ, Villa M. Gynecologic ultrasound in emergency medicine. Emerg Med Clin North Am. 2004;22(3):683-696. doi:10.1016/j.emc.2004.04.016

5. Munro K, Gharaibeh A, Nagabushanam S, Martin C. Diagnosis and management of tubo-ovarian abscesses. Obstet Gynaecol. 2018;20(1):11-19. doi:10.1111/tog.12447

6. Fink D, Lim PPC, Desai A, Stephans AB, Wien MA. Recurrent tubo-ovarian abscess in a nonsexually active adolescent. Consultant. 2022;62(1):e26-e28. doi:10.25270/con.2021.04.00010

7. Hiller N, Fux T, Finkelstein A, Mezeh H, Simanovsky N. CT differentiation between tubo-ovarian and appendiceal origin of right lower quadrant abscess: CT, clinical, and laboratory correlation. Emerg Radiol. 2016;23:133-139. doi:10.1007/s10140-015-1372-z

8. Kairys N, Roepke C. Tubo-ovarian abscess. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 12, 2023.

9. Gao Y, Qu P, Zhou Y, Ding W. Risk factors for the development of tubo-ovarian abscesses in women with ovarian endometriosis: a retrospective matched case-control study. BMC Womens Health. 2021:21:43. doi:10.1186/s12905-021-01188-6

10. Curry A, Williams T, Penny ML. Pelvic inflammatory disease: diagnosis, management, and prevention. Am Fam Physician. 2019;100(6):357-364.

11. Landers DV, Sweet RL. Tubo-ovarian abscess: contemporary approach to management. Rev Infect Dis. 1983;5(5):876-884. doi:10.1093/clinids/5.5.876

12. Burkman R, Schlesselman S, McCaffrey L, Gupta PK, Spence M. The relationship of genital tract actinomycetes and the development of pelvic inflammatory disease. Am J Obstet Gynecol. 1982;143(5):585-589. doi:10.1016/0002-9378(82)90552-x

13. Armstrong C. ACOG releases guidelines on antibiotic prophylaxis for gynecologic procedures. Am Fam Physician. 2007;75(7):1094-1096.

14. Pittaway DE, Winfield AC, Maxson W, Daniell J, Herbert C, Wentz AC. Prevention of acute pelvic inflammatory disease after hysterosalpingography: efficacy of doxycycline prophylaxis. Am J Obstet Gynecol. 1983;147(6):623-626. doi:10.1016/0002-9378(83)90438-6

15. Committee on Practice Bulletins—Gynecology. Prevention of Infection After Gynecologic Procedures: ACOG Practice Bulletin, Number 195. Obstet Gynecol. 2018;131(6):e172-e189. doi:10.1097/AOG.0000000000002670

16. Tao X, Ge SQ, Chen L, Cai LS, Hwang MF, Wang CL. Relationships between female infertility and female genital infections and pelvic inflammatory disease: a population-based nested controlled study. Clinics (Sao Paulo). 2018;73:e364. Published 2018 Aug 9. doi:10.6061/clinics/2018/e364

17. Fouks Y, Azem F, Many A, Cohen Y, Levin I, Cohen A. Fertility outcomes in patients with tubo-ovarian abscesses after an oocyte retrieval: a longitudinal cohort analysis. Arch Gynecol Obstet. 2019;300(3):763-769. doi:10.1007/s00404-019-05230-9

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Correspondence: Andrew Evans ([email protected])

aWalter Reed National Military Medical Center, Bethesda, Maryland

bUniformed Services University of the Health Sciences, Bethesda, Maryland

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects before administering pharmacologic therapy to patients.

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Correspondence: Andrew Evans ([email protected])

aWalter Reed National Military Medical Center, Bethesda, Maryland

bUniformed Services University of the Health Sciences, Bethesda, Maryland

Author disclosures

The authors report no actual or potential conflicts of interest regarding this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects before administering pharmacologic therapy to patients.

Ethics and consent

Consent was obtained from the patient whose information is in this case report.

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CPT Andrew Evans, MD, USAa; ENS Roland Kiendrebeogo, USNb; CPT Grace Covelli, MD, USAa; CPT Christopher Russo, MD, USAFa; MAJ Caitlin Christoffel, MD, USAa

Correspondence: Andrew Evans ([email protected])

aWalter Reed National Military Medical Center, Bethesda, Maryland

bUniformed Services University of the Health Sciences, Bethesda, Maryland

Author disclosures

The authors report no actual or potential conflicts of interest regarding this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects before administering pharmacologic therapy to patients.

Ethics and consent

Consent was obtained from the patient whose information is in this case report.

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A 37-year-old woman presented to the emergency department (ED) with 12 hours of fever and lower abdominal cramp pain. She had a history significant for hypothyroidism, infertility, and dysmenorrhea and had a hysterosalpingography (HSG) 48 hours prior for a comprehensive infertility workup.

On examination, the patient’s vital signs were a 94 bpm heart rate; 109/64 mm Hg blood pressure; 14 breaths per minute respiratory rate; 99% oxygen saturation on room air; and 101.2 °F temperature. The patient reported pain in the bilateral lower abdominal quadrants and no history of sexually transmitted infection, pelvic inflammatory disease, vaginal discharge or bleeding, dysuria, hematuria, melena, or bright red blood per rectum. A human chorionic gonadotropin urine test was negative on intake. The HSG 48 hours prior showed no concerning findings with normal uterine cavity and normal caliber fallopian tubes bilaterally.

On physical examination, the patient’s abdomen was nondistended, nonperitonitic, and without evidence of acute trauma or surgical scars. On palpation, the patient was tender in her suprapubic region and lower abdominal quadrants without evidence of guarding or rebound tenderness. At rest, the patient rated her abdominal pain 4 out of 10 and 7 out of 10 upon palpation. On pelvic examination, there was normal appearing external genitalia without evidence of discharge or bleeding. Her vaginal vault was atraumatic with a minimal amount of physiologic discharge. Her cervix was normal in appearance without evidence of cervicitis. We obtained swabs for Neisseria gonorrhoeae (N gonorrhoeae) and Chlamydia trachomatis (C trachomatis), which were negative. On bimanual pelvic examination, the patient had no cervical motion tenderness, and no adnexal masses were palpable. However, on palpation of the adnexa, she endorsed a localized dull, nonradiating 6 out of 10 right-sided pain/tenderness.

The patient’s initial laboratory tests were as follows: white blood cells, 20.1 × 103/μL (reference range, 4-11 × 103/μL); hemoglobin, 12.1 g/dL (reference range, 12.1-15.1 g/dL); hematocrit, 37.1%, (reference range, 36%-48%); alanine aminotransferase, 84 U/L (reference range, 7-56 U/L); aspartate aminotransferase, 66 U/L (reference range, 8-33 U/L); and lipase, 25 U/L (5-60 U/L). Urinalysis was notable for only 5 red blood cells and negative for white blood cells, leukocyte esterase, and nitrites. The patient’s pain and fever were controlled with 1 g IV acetaminophen.

figure

The patient’s fever, leukocytosis, and physical examination were concerning for possible intra-abdominal processes, so a computed tomography (CT) of her abdomen and pelvis with IV contrast was obtained for further evaluation. The CT showed bilateral tubular rim-enhancing fluid collections within bilateral adnexa with the right fluid collection measuring 3.7 × 3.5 × 4.0 cm and the left 4.8 × 3.5 × 3.2 cm with associated fat stranding and trace-free fluid in the abdomen (Figure).

Discussion

The patient was diagnosed with bilateral tubo-ovarian abscess (TOA) likely secondary to her HSG procedure 48 hours before. TOA is a severe infectious, inflammatory condition involving a mass of the ovaries, fallopian tubes, or adjacent tissues of the upper female genital tract.1 Traditionally, TOAs are sequelae of undiagnosed or subclinical acute or chronic pelvic inflammatory disease (PID). This is known to occur via pathogen ascension from the lower to the upper female genital tract resulting in cervicitis, endometritis, salpingitis, oophoritis, and if left untreated, peritonitis.1 About 70,000 women are diagnosed with TOAs in the US every year. These patients require hospitalization as well as IV antibiotics for gold-standard treatment; however, some cases may require percutaneous drainage based on size, severity, and location.2

 

 

Diagnostic Considerations

Clinically, patients with TOAs present with fever, chills, lower abdominal pain, vaginal discharge with cervical motion tenderness, and an adnexal mass on examination.3 When a TOA is suspected, a urine human chorionic gonadotropin test and testing for C trachomatis and N gonorrhoeae are warranted. An ED workup often reveals leukocytosis, elevated C-reactive protein, and elevated erythrocyte sedimentation rate. Imaging is recommended once a TOA is suspected. Ultrasound is the gold-standard imaging modality and boasts a sensitivity of 93% and specificity of 98% for the detection of TOAs; however, CT has also been shown to be an effective diagnostic modality.4

Despite being common, TOAs are difficult to predict, detect, and diagnose; thus the clinician must often rely on thorough history taking and physical examination to raise suspicion.5 Although most frequently associated with sexual transmission, TOAs occur in not sexually active women in adolescence and adulthood. Specifically, TOAs also can present secondary to other intra-abdominal pathologies, such as appendicitis, diverticulitis, and pyelonephritis, as well as a complication of intrauterine procedures, such as an HSG, or less commonly, following intrauterine device (IUD) insertion.5-7

table

Given that sexually transmitted infections are the most common etiology of TOAs, C trachomatis and N gonorrhoeae are the most likely microorganisms to be isolated (Table).8-12 In not sexually active populations, Escherichia coli and Gardnerella vaginalis should be considered instead. Although rare, women with IUDs have been shown to have an increased incidence of PID/TOA secondary to Actinomyces israleii relative to women without IUDs.12 In patients with TOAs secondary to intraabdominal surgery, anaerobic bacteria, such as Bacterioides and Peptostreptococcus species in addition to Escherichia coli, are likely culprits.11

In patients after HSG, infectious complications are uncommon enough that the American College of Obstetricians and Gynecologists recommends against antibiotic prophylaxis unless there are risk factors of dilated fallopian tubes or a history of PID.13 Identifying a precise percentage of TOA as a complication of HSG is rather elusive in the literature, though, it is frequently noted that infection in general is uncommon, and the risk of developing PID is about 1.4% to 3.4%.14 However, in the retrospective study most often cited, all women who developed PID following HSG had evidence of dilated fallopian tubes. Given our patient had no history of PID or dilated fallopian tubes, her risk of developing infection (PID or postprocedural abscess) would be considered very low; therefore, the index of suspicion also was low.15

Our patient’s case of bilateral TOA also is unusual because her presentation was not entirely consistent with a TOA. She had a benign pelvic examination without cervical motion tenderness or evidence of cervicitis or cervical discharge. Given the initially low clinical suspicion, transvaginal ultrasound was not ordered. However, in the setting of tenderness to palpation in the lower abdominal quadrants, suprapubic tenderness, and leukocytosis, there was still concern for an acute intra-abdominal or pelvic process, and an abdominal CT was ordered as part of the workup. It was this clinical concern that led to the identification of the patient’s bilateral TOA.

Following diagnosis, the patient was promptly admitted and treated with a course of IV ceftriaxone 1 g every 24 hours, IV doxycycline 100 mg every 12 hours, and a single dose of IV metronidazole 500 mg. Her leukocytosis, fever, and pain improved within 48 hours without the need for percutaneous drainage and the patient made a complete recovery.

 

 

Complications

TOAs can carry significant morbidity and mortality, and there are both acute and chronic complications associated. Even if properly treated, TOAs can rupture leading to severe illness, such as peritonitis and septic shock. This often requires surgical intervention and hemodynamic pressure support in the intensive care unit setting.16 One of the most feared long-term complications of TOAs is infertility secondary to structural abnormalities of the female reproductive tract.10 Adhesions, strictures, and scarring are associated with TOAs irrespective of medical or surgical management, and thus any women with a history of PID or TOA require advanced fertility workup if they are having difficulties with conception or implantation.17

Minimizing infectious transmission also is essential in the treatment of TOA/PID. All women who receive a diagnosis of PID or TOA should be evaluated for gonorrhea, chlamydia, HIV, and syphilis. Women should be instructed to abstain from sexual intercourse until therapy is complete, symptoms have resolved, and sex partners have been treated for potential chlamydial or gonococcal infections. All contraceptive methods can be continued during treatment.

Conclusions

This case presented several challenges as the bilateral TOAs developed postprocedure in a patient without risk factors. Furthermore, this case did not follow the classic presentation of ascending bacterial translocation to the ovaries over days to weeks. The diagnosis was complicated by a largely benign physical examination and a pelvic examination without evidence of abnormal vaginal discharge or cervicitis. The only indicators were fever, leukocytosis, and abdominal pain in the setting of a recent, uncomplicated HSG procedure. Vigilance is required to obtain the necessary history, and the differential of TOA must be broadened to include women without a history or symptoms of a sexually transmitted infection (contrary to the classic association). We aim to encourage heightened clinical suspicion for TOAs in patients who present with fever, leukocytosis, and abdominal pain after recent HSG or other intrauterine instrumentation procedures and therefore improve patient outcomes.

A 37-year-old woman presented to the emergency department (ED) with 12 hours of fever and lower abdominal cramp pain. She had a history significant for hypothyroidism, infertility, and dysmenorrhea and had a hysterosalpingography (HSG) 48 hours prior for a comprehensive infertility workup.

On examination, the patient’s vital signs were a 94 bpm heart rate; 109/64 mm Hg blood pressure; 14 breaths per minute respiratory rate; 99% oxygen saturation on room air; and 101.2 °F temperature. The patient reported pain in the bilateral lower abdominal quadrants and no history of sexually transmitted infection, pelvic inflammatory disease, vaginal discharge or bleeding, dysuria, hematuria, melena, or bright red blood per rectum. A human chorionic gonadotropin urine test was negative on intake. The HSG 48 hours prior showed no concerning findings with normal uterine cavity and normal caliber fallopian tubes bilaterally.

On physical examination, the patient’s abdomen was nondistended, nonperitonitic, and without evidence of acute trauma or surgical scars. On palpation, the patient was tender in her suprapubic region and lower abdominal quadrants without evidence of guarding or rebound tenderness. At rest, the patient rated her abdominal pain 4 out of 10 and 7 out of 10 upon palpation. On pelvic examination, there was normal appearing external genitalia without evidence of discharge or bleeding. Her vaginal vault was atraumatic with a minimal amount of physiologic discharge. Her cervix was normal in appearance without evidence of cervicitis. We obtained swabs for Neisseria gonorrhoeae (N gonorrhoeae) and Chlamydia trachomatis (C trachomatis), which were negative. On bimanual pelvic examination, the patient had no cervical motion tenderness, and no adnexal masses were palpable. However, on palpation of the adnexa, she endorsed a localized dull, nonradiating 6 out of 10 right-sided pain/tenderness.

The patient’s initial laboratory tests were as follows: white blood cells, 20.1 × 103/μL (reference range, 4-11 × 103/μL); hemoglobin, 12.1 g/dL (reference range, 12.1-15.1 g/dL); hematocrit, 37.1%, (reference range, 36%-48%); alanine aminotransferase, 84 U/L (reference range, 7-56 U/L); aspartate aminotransferase, 66 U/L (reference range, 8-33 U/L); and lipase, 25 U/L (5-60 U/L). Urinalysis was notable for only 5 red blood cells and negative for white blood cells, leukocyte esterase, and nitrites. The patient’s pain and fever were controlled with 1 g IV acetaminophen.

figure

The patient’s fever, leukocytosis, and physical examination were concerning for possible intra-abdominal processes, so a computed tomography (CT) of her abdomen and pelvis with IV contrast was obtained for further evaluation. The CT showed bilateral tubular rim-enhancing fluid collections within bilateral adnexa with the right fluid collection measuring 3.7 × 3.5 × 4.0 cm and the left 4.8 × 3.5 × 3.2 cm with associated fat stranding and trace-free fluid in the abdomen (Figure).

Discussion

The patient was diagnosed with bilateral tubo-ovarian abscess (TOA) likely secondary to her HSG procedure 48 hours before. TOA is a severe infectious, inflammatory condition involving a mass of the ovaries, fallopian tubes, or adjacent tissues of the upper female genital tract.1 Traditionally, TOAs are sequelae of undiagnosed or subclinical acute or chronic pelvic inflammatory disease (PID). This is known to occur via pathogen ascension from the lower to the upper female genital tract resulting in cervicitis, endometritis, salpingitis, oophoritis, and if left untreated, peritonitis.1 About 70,000 women are diagnosed with TOAs in the US every year. These patients require hospitalization as well as IV antibiotics for gold-standard treatment; however, some cases may require percutaneous drainage based on size, severity, and location.2

 

 

Diagnostic Considerations

Clinically, patients with TOAs present with fever, chills, lower abdominal pain, vaginal discharge with cervical motion tenderness, and an adnexal mass on examination.3 When a TOA is suspected, a urine human chorionic gonadotropin test and testing for C trachomatis and N gonorrhoeae are warranted. An ED workup often reveals leukocytosis, elevated C-reactive protein, and elevated erythrocyte sedimentation rate. Imaging is recommended once a TOA is suspected. Ultrasound is the gold-standard imaging modality and boasts a sensitivity of 93% and specificity of 98% for the detection of TOAs; however, CT has also been shown to be an effective diagnostic modality.4

Despite being common, TOAs are difficult to predict, detect, and diagnose; thus the clinician must often rely on thorough history taking and physical examination to raise suspicion.5 Although most frequently associated with sexual transmission, TOAs occur in not sexually active women in adolescence and adulthood. Specifically, TOAs also can present secondary to other intra-abdominal pathologies, such as appendicitis, diverticulitis, and pyelonephritis, as well as a complication of intrauterine procedures, such as an HSG, or less commonly, following intrauterine device (IUD) insertion.5-7

table

Given that sexually transmitted infections are the most common etiology of TOAs, C trachomatis and N gonorrhoeae are the most likely microorganisms to be isolated (Table).8-12 In not sexually active populations, Escherichia coli and Gardnerella vaginalis should be considered instead. Although rare, women with IUDs have been shown to have an increased incidence of PID/TOA secondary to Actinomyces israleii relative to women without IUDs.12 In patients with TOAs secondary to intraabdominal surgery, anaerobic bacteria, such as Bacterioides and Peptostreptococcus species in addition to Escherichia coli, are likely culprits.11

In patients after HSG, infectious complications are uncommon enough that the American College of Obstetricians and Gynecologists recommends against antibiotic prophylaxis unless there are risk factors of dilated fallopian tubes or a history of PID.13 Identifying a precise percentage of TOA as a complication of HSG is rather elusive in the literature, though, it is frequently noted that infection in general is uncommon, and the risk of developing PID is about 1.4% to 3.4%.14 However, in the retrospective study most often cited, all women who developed PID following HSG had evidence of dilated fallopian tubes. Given our patient had no history of PID or dilated fallopian tubes, her risk of developing infection (PID or postprocedural abscess) would be considered very low; therefore, the index of suspicion also was low.15

Our patient’s case of bilateral TOA also is unusual because her presentation was not entirely consistent with a TOA. She had a benign pelvic examination without cervical motion tenderness or evidence of cervicitis or cervical discharge. Given the initially low clinical suspicion, transvaginal ultrasound was not ordered. However, in the setting of tenderness to palpation in the lower abdominal quadrants, suprapubic tenderness, and leukocytosis, there was still concern for an acute intra-abdominal or pelvic process, and an abdominal CT was ordered as part of the workup. It was this clinical concern that led to the identification of the patient’s bilateral TOA.

Following diagnosis, the patient was promptly admitted and treated with a course of IV ceftriaxone 1 g every 24 hours, IV doxycycline 100 mg every 12 hours, and a single dose of IV metronidazole 500 mg. Her leukocytosis, fever, and pain improved within 48 hours without the need for percutaneous drainage and the patient made a complete recovery.

 

 

Complications

TOAs can carry significant morbidity and mortality, and there are both acute and chronic complications associated. Even if properly treated, TOAs can rupture leading to severe illness, such as peritonitis and septic shock. This often requires surgical intervention and hemodynamic pressure support in the intensive care unit setting.16 One of the most feared long-term complications of TOAs is infertility secondary to structural abnormalities of the female reproductive tract.10 Adhesions, strictures, and scarring are associated with TOAs irrespective of medical or surgical management, and thus any women with a history of PID or TOA require advanced fertility workup if they are having difficulties with conception or implantation.17

Minimizing infectious transmission also is essential in the treatment of TOA/PID. All women who receive a diagnosis of PID or TOA should be evaluated for gonorrhea, chlamydia, HIV, and syphilis. Women should be instructed to abstain from sexual intercourse until therapy is complete, symptoms have resolved, and sex partners have been treated for potential chlamydial or gonococcal infections. All contraceptive methods can be continued during treatment.

Conclusions

This case presented several challenges as the bilateral TOAs developed postprocedure in a patient without risk factors. Furthermore, this case did not follow the classic presentation of ascending bacterial translocation to the ovaries over days to weeks. The diagnosis was complicated by a largely benign physical examination and a pelvic examination without evidence of abnormal vaginal discharge or cervicitis. The only indicators were fever, leukocytosis, and abdominal pain in the setting of a recent, uncomplicated HSG procedure. Vigilance is required to obtain the necessary history, and the differential of TOA must be broadened to include women without a history or symptoms of a sexually transmitted infection (contrary to the classic association). We aim to encourage heightened clinical suspicion for TOAs in patients who present with fever, leukocytosis, and abdominal pain after recent HSG or other intrauterine instrumentation procedures and therefore improve patient outcomes.

References

1. Gkrozou F, Tsonis O, Daniilidis A, Navrozoglou I, Paschopoulos M. Tubo-ovarian abscess: exploring optimal treatment options based on current evidence. J Endometr Pelvic Pain Disord. 2020;13(1):10-19. doi:10.1177/2284026520960649

2. Taylor KJ, Wasson JF, De Graaff C, Rosenfield AT, Andriole VT. Accuracy of grey-scale ultrasound diagnosis of abdominal and pelvic abscesses in 220 patients. Lancet. 1978;1(8055):83-84. doi:10.1016/s0140-6736(78)90016-8

3. Bridwell RE, Koyfman A, Long B. High risk and low prevalence diseases: tubo-ovarian abscess. Am J Emerg Med. 2022;57:70-75. doi:10.1016/j.ajem.2022.04.026

4. Lambert MJ, Villa M. Gynecologic ultrasound in emergency medicine. Emerg Med Clin North Am. 2004;22(3):683-696. doi:10.1016/j.emc.2004.04.016

5. Munro K, Gharaibeh A, Nagabushanam S, Martin C. Diagnosis and management of tubo-ovarian abscesses. Obstet Gynaecol. 2018;20(1):11-19. doi:10.1111/tog.12447

6. Fink D, Lim PPC, Desai A, Stephans AB, Wien MA. Recurrent tubo-ovarian abscess in a nonsexually active adolescent. Consultant. 2022;62(1):e26-e28. doi:10.25270/con.2021.04.00010

7. Hiller N, Fux T, Finkelstein A, Mezeh H, Simanovsky N. CT differentiation between tubo-ovarian and appendiceal origin of right lower quadrant abscess: CT, clinical, and laboratory correlation. Emerg Radiol. 2016;23:133-139. doi:10.1007/s10140-015-1372-z

8. Kairys N, Roepke C. Tubo-ovarian abscess. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 12, 2023.

9. Gao Y, Qu P, Zhou Y, Ding W. Risk factors for the development of tubo-ovarian abscesses in women with ovarian endometriosis: a retrospective matched case-control study. BMC Womens Health. 2021:21:43. doi:10.1186/s12905-021-01188-6

10. Curry A, Williams T, Penny ML. Pelvic inflammatory disease: diagnosis, management, and prevention. Am Fam Physician. 2019;100(6):357-364.

11. Landers DV, Sweet RL. Tubo-ovarian abscess: contemporary approach to management. Rev Infect Dis. 1983;5(5):876-884. doi:10.1093/clinids/5.5.876

12. Burkman R, Schlesselman S, McCaffrey L, Gupta PK, Spence M. The relationship of genital tract actinomycetes and the development of pelvic inflammatory disease. Am J Obstet Gynecol. 1982;143(5):585-589. doi:10.1016/0002-9378(82)90552-x

13. Armstrong C. ACOG releases guidelines on antibiotic prophylaxis for gynecologic procedures. Am Fam Physician. 2007;75(7):1094-1096.

14. Pittaway DE, Winfield AC, Maxson W, Daniell J, Herbert C, Wentz AC. Prevention of acute pelvic inflammatory disease after hysterosalpingography: efficacy of doxycycline prophylaxis. Am J Obstet Gynecol. 1983;147(6):623-626. doi:10.1016/0002-9378(83)90438-6

15. Committee on Practice Bulletins—Gynecology. Prevention of Infection After Gynecologic Procedures: ACOG Practice Bulletin, Number 195. Obstet Gynecol. 2018;131(6):e172-e189. doi:10.1097/AOG.0000000000002670

16. Tao X, Ge SQ, Chen L, Cai LS, Hwang MF, Wang CL. Relationships between female infertility and female genital infections and pelvic inflammatory disease: a population-based nested controlled study. Clinics (Sao Paulo). 2018;73:e364. Published 2018 Aug 9. doi:10.6061/clinics/2018/e364

17. Fouks Y, Azem F, Many A, Cohen Y, Levin I, Cohen A. Fertility outcomes in patients with tubo-ovarian abscesses after an oocyte retrieval: a longitudinal cohort analysis. Arch Gynecol Obstet. 2019;300(3):763-769. doi:10.1007/s00404-019-05230-9

References

1. Gkrozou F, Tsonis O, Daniilidis A, Navrozoglou I, Paschopoulos M. Tubo-ovarian abscess: exploring optimal treatment options based on current evidence. J Endometr Pelvic Pain Disord. 2020;13(1):10-19. doi:10.1177/2284026520960649

2. Taylor KJ, Wasson JF, De Graaff C, Rosenfield AT, Andriole VT. Accuracy of grey-scale ultrasound diagnosis of abdominal and pelvic abscesses in 220 patients. Lancet. 1978;1(8055):83-84. doi:10.1016/s0140-6736(78)90016-8

3. Bridwell RE, Koyfman A, Long B. High risk and low prevalence diseases: tubo-ovarian abscess. Am J Emerg Med. 2022;57:70-75. doi:10.1016/j.ajem.2022.04.026

4. Lambert MJ, Villa M. Gynecologic ultrasound in emergency medicine. Emerg Med Clin North Am. 2004;22(3):683-696. doi:10.1016/j.emc.2004.04.016

5. Munro K, Gharaibeh A, Nagabushanam S, Martin C. Diagnosis and management of tubo-ovarian abscesses. Obstet Gynaecol. 2018;20(1):11-19. doi:10.1111/tog.12447

6. Fink D, Lim PPC, Desai A, Stephans AB, Wien MA. Recurrent tubo-ovarian abscess in a nonsexually active adolescent. Consultant. 2022;62(1):e26-e28. doi:10.25270/con.2021.04.00010

7. Hiller N, Fux T, Finkelstein A, Mezeh H, Simanovsky N. CT differentiation between tubo-ovarian and appendiceal origin of right lower quadrant abscess: CT, clinical, and laboratory correlation. Emerg Radiol. 2016;23:133-139. doi:10.1007/s10140-015-1372-z

8. Kairys N, Roepke C. Tubo-ovarian abscess. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 12, 2023.

9. Gao Y, Qu P, Zhou Y, Ding W. Risk factors for the development of tubo-ovarian abscesses in women with ovarian endometriosis: a retrospective matched case-control study. BMC Womens Health. 2021:21:43. doi:10.1186/s12905-021-01188-6

10. Curry A, Williams T, Penny ML. Pelvic inflammatory disease: diagnosis, management, and prevention. Am Fam Physician. 2019;100(6):357-364.

11. Landers DV, Sweet RL. Tubo-ovarian abscess: contemporary approach to management. Rev Infect Dis. 1983;5(5):876-884. doi:10.1093/clinids/5.5.876

12. Burkman R, Schlesselman S, McCaffrey L, Gupta PK, Spence M. The relationship of genital tract actinomycetes and the development of pelvic inflammatory disease. Am J Obstet Gynecol. 1982;143(5):585-589. doi:10.1016/0002-9378(82)90552-x

13. Armstrong C. ACOG releases guidelines on antibiotic prophylaxis for gynecologic procedures. Am Fam Physician. 2007;75(7):1094-1096.

14. Pittaway DE, Winfield AC, Maxson W, Daniell J, Herbert C, Wentz AC. Prevention of acute pelvic inflammatory disease after hysterosalpingography: efficacy of doxycycline prophylaxis. Am J Obstet Gynecol. 1983;147(6):623-626. doi:10.1016/0002-9378(83)90438-6

15. Committee on Practice Bulletins—Gynecology. Prevention of Infection After Gynecologic Procedures: ACOG Practice Bulletin, Number 195. Obstet Gynecol. 2018;131(6):e172-e189. doi:10.1097/AOG.0000000000002670

16. Tao X, Ge SQ, Chen L, Cai LS, Hwang MF, Wang CL. Relationships between female infertility and female genital infections and pelvic inflammatory disease: a population-based nested controlled study. Clinics (Sao Paulo). 2018;73:e364. Published 2018 Aug 9. doi:10.6061/clinics/2018/e364

17. Fouks Y, Azem F, Many A, Cohen Y, Levin I, Cohen A. Fertility outcomes in patients with tubo-ovarian abscesses after an oocyte retrieval: a longitudinal cohort analysis. Arch Gynecol Obstet. 2019;300(3):763-769. doi:10.1007/s00404-019-05230-9

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Why aren’t doctors managing pain during gynecologic procedures? 

Article Type
Changed
Fri, 11/03/2023 - 14:25

 

During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

 

 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

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During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

 

 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

 

During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

 

 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

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Perinatal depression rarely stands alone

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Changed
Thu, 11/02/2023 - 11:33

Mental health conditions are the leading cause of pregnancy-related death in Illinois (40%) and across the United States (21%).1,2There is increasing recognition in primary care that major depressive disorder (MDD) often co-occurs with other mental health conditions. Funding bodies, such as the Agency for Healthcare Research and Quality3 and the Health Resources and Service Administration,4 have spotlights on improving screening and access to care for depression and substance use disorders (SUDs). However, the needs of individuals with multiple mental health conditions still often go unrecognized and unaddressed in perinatal health settings.

The U.S. Preventive Services Task Force recommends that all adults be screened for depression, alcohol use, and drug use, and will be recommending screening for anxiety.5,6 The American College of Obstetrics and Gynecology recommends screening for perinatal mental health conditions including depression, anxiety, bipolar disorder, acute postpartum psychosis, and suicidality; however, despite these recommendations, screening and treatment for comorbid mental health disorders during pregnancy and the postpartum is not standard practice.7

Addressing perinatal mental health is critical because untreated mental health conditions during the perinatal period can cause long-term adverse psychiatric and medical outcomes for the birthing person, the baby, and the family.8 This commentary highlights the importance of recognizing and screening for perinatal mental health comorbidities, improving referral rates for mental health treatment, and raising awareness of the importance of addressing rural perinatal mental health.
 

Perinatal mental health comorbidities

Major depressive disorder is the most common mental health condition during the perinatal period9 and is often comorbid.10-12 In “Perinatal mental health in low-income urban and rural patients: The importance of screening for comorbidities,” Craemer et al.13 reported that nearly half of the perinatal patients who screened positive for MDD also screened positive for at least one other mental health condition, among them general anxiety disorder (GAD), SUD, posttraumatic stress disorder (PTSD), and suicidality.

Many (9%) of the perinatal patients with MDD had a severe comorbidity profile characterized by four diagnoses – MDD, GAD, SUD, and PTSD. In routine medical care these comorbidities often go undetected even though the risk to mothers and babies increases with more severe mental health symptoms.8

The high frequency of perinatal mental health comorbidities Craemer et al.13 found demonstrates a compelling need for comorbid mental health screening during the perinatal period, particularly for low-income Black, Hispanic, and rural birthing persons. Positive screens for perinatal mental health disorders may reflect the onset of these disorders in pregnancy or the postpartum, or preexisting disorders that have gone undetected or untreated before pregnancy.

For many patients, the perinatal period is the first time they are screened for any mental health disorder; typically, they are screened solely for depression. Screening alone can have a positive impact on perinatal mental health. In fact, the USPSTF found that programs to screen perinatal patients, with or without treatment-related support, resulted in a 2%-9% absolute reduction in depression prevalence.14 However, screening for MDD is too infrequent for many reasons, including the logistics of integrating screening into the clinic workflow and limited provider availability, time, and training in mental health.

We recommend screening perinatal patients for mental health comorbidities. This recommendation may seem impractical given the lack of screening tools for comorbid mental health conditions; however, the Computerized Adaptive Test for Mental Health (CAT-MH), the validated tool15-17 used in this study, is an ideal option. CAT-MH is uniquely capable of screening for MDD, GAD, PTSD, SUD, and suicidality in one platform and is routinely used in diverse settings including the Veterans Administration,18 foster care,19 and universities.20 The main limitation of this more comprehensive screening is that it takes about 10 minutes per patient. However, CAT-MH is self-administered and can be done in the waiting room or on a mobile device prior to a clinic visit.

CAT-MH can also be easily integrated into clinical workflow when added to the Electronic Medical Record21, and is a more comprehensive tool than existing perinatal depression tools such as the Perinatal Health Questionaire-9 (PHQ-9) and Edinburgh Perinatal Depression Scale (EPDS).22 Another limitation is cost – currently $5.00 per assessment – however, this is less than routine blood work.23 If CAT-MH is not an option, we recommend a stepped approach of screening for GAD when perinatal patients screen positive for MDD, as this is the most common comorbidity profile. The GAD-7 is a free and widely available tool.24

 

 

Barriers to care

In Craemer et al,13 nearly two-thirds (64.9%) of perinatal patients with a positive screen did not receive a referral to follow-up care or a medication prescription. These low referral rates may reflect a variety of widely recognized barriers to care, including lack of referral options, provider and/or patient reluctance to pursue referrals, barriers to insurance coverage, or inadequate behavioral health infrastructure to ensure referral and diagnostic follow-up.

Further, rural residing perinatal patients are an underserved population that need more resources and screening. Despite an on-site behavioral specialist at the rural clinic, Craemer et al13 found a stark disparity in referral rates: referrals to treatment for a positive diagnosis was over two times less at the rural clinic (23.9%), compared with the urban clinics (51.6%). The most common treatment offered at the rural clinic was a prescription for medication (17.4%), while referral to follow-up care was the most common at the urban clinics (35.5%). Rural areas not only have a shortage of health care providers, but community members seeking mental health care often encounter greater stigma, compared with urban residents.25,26

These data highlight an unmet need for referrals to treatment for patients in rural communities, particularly in Illinois where the pregnancy-related mortality ratio attributable to mental health conditions is three times greater in rural areas, compared with those residing in urban Cook County (Chicago).2 Increasing access and availability to mental health treatment and prevention resources in Illinois, especially in rural areas, is an opportunity to prevent pregnancy-related mortality attributable to mental health conditions.

Overall, there is a critical need for screening for perinatal mental health comorbidities, increased attention to low rates of referral to mental health treatment, and investing in rural perinatal mental health. Addressing perinatal mental health disorders is key to decreasing the burden of maternal mortality, particularly in Illinois.

Ms. Craemer and Ms. Sayah are senior research specialists at the Center for Research on Women & Gender, University of Illinois at Chicago. Dr. Duffecy is a professor of clinical psychiatry at the University of Illinois at Chicago. Dr. Geller is a professor of obstetrics & gynecology and director of the Center for Research on Women & Gender, University of Illinois at Chicago. Dr. Maki is a professor of psychiatry, psychology, and obstetrics & gynecology at the University of Illinois at Chicago.

References

1. Trost S et al. Pregnancy-related deaths: Data from maternal mortality review committees in 36 states, 2017-2019. Atlanta: Centers for Disease Control and Prevention, U.S. Department of Health & Human Services, 2022.

2. Illinois Department of Public Health. Illinois maternal morbidity and mortality report 2016-2017. 2021.

3. AHRQ. Funding opportunities to address opioid and other substance use disorders. Updated 2023.

4. HRSA. Screening and treatment for maternal mental health and substance use disorders.

5. U.S. Preventive Services Task Force. Recommendations for primary care practice. Accessed May 26, 2023.

6. U.S. Preventive Services Task Force. Draft recommendation statement: Anxiety in adults: Screening. 2022.

7. ACOG. Screening and diagnosis of mental health conditions during pregnancy and postpartum. Clinical Practice Guideline. Number 4. 2023 June.

8. Meltzer-Brody S and Stuebe A. The long-term psychiatric and medical prognosis of perinatal mental illness. Best Pract Res Clin Obstet Gynaecol. 2014 Jan. doi: 10.1016/j.bpobgyn.2013.08.009.

9. Van Niel MS and Payne JL. Perinatal depression: A review. Cleve Clin J Med. 2020 May. doi: 10.3949/ccjm.87a.19054.

10. Wisner KL et al. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. 2013 May. doi: 10.1001/jamapsychiatry.2013.87.

11. Falah-Hassani K et al. The prevalence of antenatal and postnatal co-morbid anxiety and depression: A meta-analysis. Psychol Med. 2017 Sep. doi: 10.1017/S0033291717000617.

12. Pentecost R et al. Scoping review of the associations between perinatal substance use and perinatal depression and anxiety. J Obstet Gynecol Neonatal Nurs. 2021 Jul. doi: 10.1016/j.jogn.2021.02.008.

13. Craemer KA et al. Perinatal mental health in low-income urban and rural patients: The importance of screening for comorbidities. Gen Hosp Psychiatry. 2023 Jul-Aug. doi: 10.1016/j.genhosppsych.2023.05.007.

14. O’Connor E et al. Primary care screening for and treatment of depression in pregnant and postpartum women: Evidence report and systematic review for the U.S. Preventive Services Task Force. JAMA. 2016 Jan 26. doi: 10.1001/jama.2015.18948.

15. Kozhimannil KB et al. Racial and ethnic disparities in postpartum depression care among low-income women. Psychiatr Serv. 2011 Jun. doi: 10.1176/ps.62.6.pss6206_0619.

16. Wenzel ES et al. Depression and anxiety symptoms across pregnancy and the postpartum in low-income Black and Latina women. Arch Womens Ment Health. 2021 Dec. doi: 10.1007/s00737-021-01139-y.

17. Gibbons RD et al. Development of a computerized adaptive substance use disorder scale for screening and measurement: The CAT‐SUD. Addiction. 2020 Jul. doi: 10.1111/add.14938.

18. Brenner LA et al. Validation of a computerized adaptive test suicide scale (CAT-SS) among united states military veterans. PloS One. 2022 Jan 21. doi: 10.1371/journal.pone.0261920.

19. The Center for State Child Welfare Data. Using technology to diagnose and report on behavioral health challenges facing foster youth. 2018.

20. Kim JJ et al. The experience of depression, anxiety, and mania among perinatal women. Arch Womens Ment Health. 2016 Oct. doi: 10.1007/s00737-016-0632-6.

21. Tepper MC et al. Toward population health: Using a learning behavioral health system and measurement-based care to improve access, care, outcomes, and disparities. Community Ment Health J. 2022 Nov. doi: 10.1007/s10597-022-00957-3.

22. Wenzel E et al. Using computerised adaptive tests to screen for perinatal depression in underserved women of colour. Evid Based Ment Health. 2022 Feb. doi: 10.1136/ebmental-2021-300262.

23. Sanger-Katz M. They want it to be secret: How a common blood test can cost $11 or almost $1,000. New York Times. 2019 Apr 19.

24. Spitzer RL et al. A brief measure for assessing generalized anxiety disorder: The GAD-7. Arch Intern Med. 2006 May 22. doi: 10.1001/archinte.166.10.1092.

25. Mollard E et al. An integrative review of postpartum depression in rural US communities. Arch Psychiatr Nurs. 2016 Jun. doi: 10.1016/j.apnu.2015.12.003.

26. Anglim AJ and Radke SM. Rural maternal health care outcomes, drivers, and patient perspectives. Clin Obstet Gynecol. 2022 Dec 1. doi: 10.1097/GRF.0000000000000753.

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Mental health conditions are the leading cause of pregnancy-related death in Illinois (40%) and across the United States (21%).1,2There is increasing recognition in primary care that major depressive disorder (MDD) often co-occurs with other mental health conditions. Funding bodies, such as the Agency for Healthcare Research and Quality3 and the Health Resources and Service Administration,4 have spotlights on improving screening and access to care for depression and substance use disorders (SUDs). However, the needs of individuals with multiple mental health conditions still often go unrecognized and unaddressed in perinatal health settings.

The U.S. Preventive Services Task Force recommends that all adults be screened for depression, alcohol use, and drug use, and will be recommending screening for anxiety.5,6 The American College of Obstetrics and Gynecology recommends screening for perinatal mental health conditions including depression, anxiety, bipolar disorder, acute postpartum psychosis, and suicidality; however, despite these recommendations, screening and treatment for comorbid mental health disorders during pregnancy and the postpartum is not standard practice.7

Addressing perinatal mental health is critical because untreated mental health conditions during the perinatal period can cause long-term adverse psychiatric and medical outcomes for the birthing person, the baby, and the family.8 This commentary highlights the importance of recognizing and screening for perinatal mental health comorbidities, improving referral rates for mental health treatment, and raising awareness of the importance of addressing rural perinatal mental health.
 

Perinatal mental health comorbidities

Major depressive disorder is the most common mental health condition during the perinatal period9 and is often comorbid.10-12 In “Perinatal mental health in low-income urban and rural patients: The importance of screening for comorbidities,” Craemer et al.13 reported that nearly half of the perinatal patients who screened positive for MDD also screened positive for at least one other mental health condition, among them general anxiety disorder (GAD), SUD, posttraumatic stress disorder (PTSD), and suicidality.

Many (9%) of the perinatal patients with MDD had a severe comorbidity profile characterized by four diagnoses – MDD, GAD, SUD, and PTSD. In routine medical care these comorbidities often go undetected even though the risk to mothers and babies increases with more severe mental health symptoms.8

The high frequency of perinatal mental health comorbidities Craemer et al.13 found demonstrates a compelling need for comorbid mental health screening during the perinatal period, particularly for low-income Black, Hispanic, and rural birthing persons. Positive screens for perinatal mental health disorders may reflect the onset of these disorders in pregnancy or the postpartum, or preexisting disorders that have gone undetected or untreated before pregnancy.

For many patients, the perinatal period is the first time they are screened for any mental health disorder; typically, they are screened solely for depression. Screening alone can have a positive impact on perinatal mental health. In fact, the USPSTF found that programs to screen perinatal patients, with or without treatment-related support, resulted in a 2%-9% absolute reduction in depression prevalence.14 However, screening for MDD is too infrequent for many reasons, including the logistics of integrating screening into the clinic workflow and limited provider availability, time, and training in mental health.

We recommend screening perinatal patients for mental health comorbidities. This recommendation may seem impractical given the lack of screening tools for comorbid mental health conditions; however, the Computerized Adaptive Test for Mental Health (CAT-MH), the validated tool15-17 used in this study, is an ideal option. CAT-MH is uniquely capable of screening for MDD, GAD, PTSD, SUD, and suicidality in one platform and is routinely used in diverse settings including the Veterans Administration,18 foster care,19 and universities.20 The main limitation of this more comprehensive screening is that it takes about 10 minutes per patient. However, CAT-MH is self-administered and can be done in the waiting room or on a mobile device prior to a clinic visit.

CAT-MH can also be easily integrated into clinical workflow when added to the Electronic Medical Record21, and is a more comprehensive tool than existing perinatal depression tools such as the Perinatal Health Questionaire-9 (PHQ-9) and Edinburgh Perinatal Depression Scale (EPDS).22 Another limitation is cost – currently $5.00 per assessment – however, this is less than routine blood work.23 If CAT-MH is not an option, we recommend a stepped approach of screening for GAD when perinatal patients screen positive for MDD, as this is the most common comorbidity profile. The GAD-7 is a free and widely available tool.24

 

 

Barriers to care

In Craemer et al,13 nearly two-thirds (64.9%) of perinatal patients with a positive screen did not receive a referral to follow-up care or a medication prescription. These low referral rates may reflect a variety of widely recognized barriers to care, including lack of referral options, provider and/or patient reluctance to pursue referrals, barriers to insurance coverage, or inadequate behavioral health infrastructure to ensure referral and diagnostic follow-up.

Further, rural residing perinatal patients are an underserved population that need more resources and screening. Despite an on-site behavioral specialist at the rural clinic, Craemer et al13 found a stark disparity in referral rates: referrals to treatment for a positive diagnosis was over two times less at the rural clinic (23.9%), compared with the urban clinics (51.6%). The most common treatment offered at the rural clinic was a prescription for medication (17.4%), while referral to follow-up care was the most common at the urban clinics (35.5%). Rural areas not only have a shortage of health care providers, but community members seeking mental health care often encounter greater stigma, compared with urban residents.25,26

These data highlight an unmet need for referrals to treatment for patients in rural communities, particularly in Illinois where the pregnancy-related mortality ratio attributable to mental health conditions is three times greater in rural areas, compared with those residing in urban Cook County (Chicago).2 Increasing access and availability to mental health treatment and prevention resources in Illinois, especially in rural areas, is an opportunity to prevent pregnancy-related mortality attributable to mental health conditions.

Overall, there is a critical need for screening for perinatal mental health comorbidities, increased attention to low rates of referral to mental health treatment, and investing in rural perinatal mental health. Addressing perinatal mental health disorders is key to decreasing the burden of maternal mortality, particularly in Illinois.

Ms. Craemer and Ms. Sayah are senior research specialists at the Center for Research on Women & Gender, University of Illinois at Chicago. Dr. Duffecy is a professor of clinical psychiatry at the University of Illinois at Chicago. Dr. Geller is a professor of obstetrics & gynecology and director of the Center for Research on Women & Gender, University of Illinois at Chicago. Dr. Maki is a professor of psychiatry, psychology, and obstetrics & gynecology at the University of Illinois at Chicago.

References

1. Trost S et al. Pregnancy-related deaths: Data from maternal mortality review committees in 36 states, 2017-2019. Atlanta: Centers for Disease Control and Prevention, U.S. Department of Health & Human Services, 2022.

2. Illinois Department of Public Health. Illinois maternal morbidity and mortality report 2016-2017. 2021.

3. AHRQ. Funding opportunities to address opioid and other substance use disorders. Updated 2023.

4. HRSA. Screening and treatment for maternal mental health and substance use disorders.

5. U.S. Preventive Services Task Force. Recommendations for primary care practice. Accessed May 26, 2023.

6. U.S. Preventive Services Task Force. Draft recommendation statement: Anxiety in adults: Screening. 2022.

7. ACOG. Screening and diagnosis of mental health conditions during pregnancy and postpartum. Clinical Practice Guideline. Number 4. 2023 June.

8. Meltzer-Brody S and Stuebe A. The long-term psychiatric and medical prognosis of perinatal mental illness. Best Pract Res Clin Obstet Gynaecol. 2014 Jan. doi: 10.1016/j.bpobgyn.2013.08.009.

9. Van Niel MS and Payne JL. Perinatal depression: A review. Cleve Clin J Med. 2020 May. doi: 10.3949/ccjm.87a.19054.

10. Wisner KL et al. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. 2013 May. doi: 10.1001/jamapsychiatry.2013.87.

11. Falah-Hassani K et al. The prevalence of antenatal and postnatal co-morbid anxiety and depression: A meta-analysis. Psychol Med. 2017 Sep. doi: 10.1017/S0033291717000617.

12. Pentecost R et al. Scoping review of the associations between perinatal substance use and perinatal depression and anxiety. J Obstet Gynecol Neonatal Nurs. 2021 Jul. doi: 10.1016/j.jogn.2021.02.008.

13. Craemer KA et al. Perinatal mental health in low-income urban and rural patients: The importance of screening for comorbidities. Gen Hosp Psychiatry. 2023 Jul-Aug. doi: 10.1016/j.genhosppsych.2023.05.007.

14. O’Connor E et al. Primary care screening for and treatment of depression in pregnant and postpartum women: Evidence report and systematic review for the U.S. Preventive Services Task Force. JAMA. 2016 Jan 26. doi: 10.1001/jama.2015.18948.

15. Kozhimannil KB et al. Racial and ethnic disparities in postpartum depression care among low-income women. Psychiatr Serv. 2011 Jun. doi: 10.1176/ps.62.6.pss6206_0619.

16. Wenzel ES et al. Depression and anxiety symptoms across pregnancy and the postpartum in low-income Black and Latina women. Arch Womens Ment Health. 2021 Dec. doi: 10.1007/s00737-021-01139-y.

17. Gibbons RD et al. Development of a computerized adaptive substance use disorder scale for screening and measurement: The CAT‐SUD. Addiction. 2020 Jul. doi: 10.1111/add.14938.

18. Brenner LA et al. Validation of a computerized adaptive test suicide scale (CAT-SS) among united states military veterans. PloS One. 2022 Jan 21. doi: 10.1371/journal.pone.0261920.

19. The Center for State Child Welfare Data. Using technology to diagnose and report on behavioral health challenges facing foster youth. 2018.

20. Kim JJ et al. The experience of depression, anxiety, and mania among perinatal women. Arch Womens Ment Health. 2016 Oct. doi: 10.1007/s00737-016-0632-6.

21. Tepper MC et al. Toward population health: Using a learning behavioral health system and measurement-based care to improve access, care, outcomes, and disparities. Community Ment Health J. 2022 Nov. doi: 10.1007/s10597-022-00957-3.

22. Wenzel E et al. Using computerised adaptive tests to screen for perinatal depression in underserved women of colour. Evid Based Ment Health. 2022 Feb. doi: 10.1136/ebmental-2021-300262.

23. Sanger-Katz M. They want it to be secret: How a common blood test can cost $11 or almost $1,000. New York Times. 2019 Apr 19.

24. Spitzer RL et al. A brief measure for assessing generalized anxiety disorder: The GAD-7. Arch Intern Med. 2006 May 22. doi: 10.1001/archinte.166.10.1092.

25. Mollard E et al. An integrative review of postpartum depression in rural US communities. Arch Psychiatr Nurs. 2016 Jun. doi: 10.1016/j.apnu.2015.12.003.

26. Anglim AJ and Radke SM. Rural maternal health care outcomes, drivers, and patient perspectives. Clin Obstet Gynecol. 2022 Dec 1. doi: 10.1097/GRF.0000000000000753.

Mental health conditions are the leading cause of pregnancy-related death in Illinois (40%) and across the United States (21%).1,2There is increasing recognition in primary care that major depressive disorder (MDD) often co-occurs with other mental health conditions. Funding bodies, such as the Agency for Healthcare Research and Quality3 and the Health Resources and Service Administration,4 have spotlights on improving screening and access to care for depression and substance use disorders (SUDs). However, the needs of individuals with multiple mental health conditions still often go unrecognized and unaddressed in perinatal health settings.

The U.S. Preventive Services Task Force recommends that all adults be screened for depression, alcohol use, and drug use, and will be recommending screening for anxiety.5,6 The American College of Obstetrics and Gynecology recommends screening for perinatal mental health conditions including depression, anxiety, bipolar disorder, acute postpartum psychosis, and suicidality; however, despite these recommendations, screening and treatment for comorbid mental health disorders during pregnancy and the postpartum is not standard practice.7

Addressing perinatal mental health is critical because untreated mental health conditions during the perinatal period can cause long-term adverse psychiatric and medical outcomes for the birthing person, the baby, and the family.8 This commentary highlights the importance of recognizing and screening for perinatal mental health comorbidities, improving referral rates for mental health treatment, and raising awareness of the importance of addressing rural perinatal mental health.
 

Perinatal mental health comorbidities

Major depressive disorder is the most common mental health condition during the perinatal period9 and is often comorbid.10-12 In “Perinatal mental health in low-income urban and rural patients: The importance of screening for comorbidities,” Craemer et al.13 reported that nearly half of the perinatal patients who screened positive for MDD also screened positive for at least one other mental health condition, among them general anxiety disorder (GAD), SUD, posttraumatic stress disorder (PTSD), and suicidality.

Many (9%) of the perinatal patients with MDD had a severe comorbidity profile characterized by four diagnoses – MDD, GAD, SUD, and PTSD. In routine medical care these comorbidities often go undetected even though the risk to mothers and babies increases with more severe mental health symptoms.8

The high frequency of perinatal mental health comorbidities Craemer et al.13 found demonstrates a compelling need for comorbid mental health screening during the perinatal period, particularly for low-income Black, Hispanic, and rural birthing persons. Positive screens for perinatal mental health disorders may reflect the onset of these disorders in pregnancy or the postpartum, or preexisting disorders that have gone undetected or untreated before pregnancy.

For many patients, the perinatal period is the first time they are screened for any mental health disorder; typically, they are screened solely for depression. Screening alone can have a positive impact on perinatal mental health. In fact, the USPSTF found that programs to screen perinatal patients, with or without treatment-related support, resulted in a 2%-9% absolute reduction in depression prevalence.14 However, screening for MDD is too infrequent for many reasons, including the logistics of integrating screening into the clinic workflow and limited provider availability, time, and training in mental health.

We recommend screening perinatal patients for mental health comorbidities. This recommendation may seem impractical given the lack of screening tools for comorbid mental health conditions; however, the Computerized Adaptive Test for Mental Health (CAT-MH), the validated tool15-17 used in this study, is an ideal option. CAT-MH is uniquely capable of screening for MDD, GAD, PTSD, SUD, and suicidality in one platform and is routinely used in diverse settings including the Veterans Administration,18 foster care,19 and universities.20 The main limitation of this more comprehensive screening is that it takes about 10 minutes per patient. However, CAT-MH is self-administered and can be done in the waiting room or on a mobile device prior to a clinic visit.

CAT-MH can also be easily integrated into clinical workflow when added to the Electronic Medical Record21, and is a more comprehensive tool than existing perinatal depression tools such as the Perinatal Health Questionaire-9 (PHQ-9) and Edinburgh Perinatal Depression Scale (EPDS).22 Another limitation is cost – currently $5.00 per assessment – however, this is less than routine blood work.23 If CAT-MH is not an option, we recommend a stepped approach of screening for GAD when perinatal patients screen positive for MDD, as this is the most common comorbidity profile. The GAD-7 is a free and widely available tool.24

 

 

Barriers to care

In Craemer et al,13 nearly two-thirds (64.9%) of perinatal patients with a positive screen did not receive a referral to follow-up care or a medication prescription. These low referral rates may reflect a variety of widely recognized barriers to care, including lack of referral options, provider and/or patient reluctance to pursue referrals, barriers to insurance coverage, or inadequate behavioral health infrastructure to ensure referral and diagnostic follow-up.

Further, rural residing perinatal patients are an underserved population that need more resources and screening. Despite an on-site behavioral specialist at the rural clinic, Craemer et al13 found a stark disparity in referral rates: referrals to treatment for a positive diagnosis was over two times less at the rural clinic (23.9%), compared with the urban clinics (51.6%). The most common treatment offered at the rural clinic was a prescription for medication (17.4%), while referral to follow-up care was the most common at the urban clinics (35.5%). Rural areas not only have a shortage of health care providers, but community members seeking mental health care often encounter greater stigma, compared with urban residents.25,26

These data highlight an unmet need for referrals to treatment for patients in rural communities, particularly in Illinois where the pregnancy-related mortality ratio attributable to mental health conditions is three times greater in rural areas, compared with those residing in urban Cook County (Chicago).2 Increasing access and availability to mental health treatment and prevention resources in Illinois, especially in rural areas, is an opportunity to prevent pregnancy-related mortality attributable to mental health conditions.

Overall, there is a critical need for screening for perinatal mental health comorbidities, increased attention to low rates of referral to mental health treatment, and investing in rural perinatal mental health. Addressing perinatal mental health disorders is key to decreasing the burden of maternal mortality, particularly in Illinois.

Ms. Craemer and Ms. Sayah are senior research specialists at the Center for Research on Women & Gender, University of Illinois at Chicago. Dr. Duffecy is a professor of clinical psychiatry at the University of Illinois at Chicago. Dr. Geller is a professor of obstetrics & gynecology and director of the Center for Research on Women & Gender, University of Illinois at Chicago. Dr. Maki is a professor of psychiatry, psychology, and obstetrics & gynecology at the University of Illinois at Chicago.

References

1. Trost S et al. Pregnancy-related deaths: Data from maternal mortality review committees in 36 states, 2017-2019. Atlanta: Centers for Disease Control and Prevention, U.S. Department of Health & Human Services, 2022.

2. Illinois Department of Public Health. Illinois maternal morbidity and mortality report 2016-2017. 2021.

3. AHRQ. Funding opportunities to address opioid and other substance use disorders. Updated 2023.

4. HRSA. Screening and treatment for maternal mental health and substance use disorders.

5. U.S. Preventive Services Task Force. Recommendations for primary care practice. Accessed May 26, 2023.

6. U.S. Preventive Services Task Force. Draft recommendation statement: Anxiety in adults: Screening. 2022.

7. ACOG. Screening and diagnosis of mental health conditions during pregnancy and postpartum. Clinical Practice Guideline. Number 4. 2023 June.

8. Meltzer-Brody S and Stuebe A. The long-term psychiatric and medical prognosis of perinatal mental illness. Best Pract Res Clin Obstet Gynaecol. 2014 Jan. doi: 10.1016/j.bpobgyn.2013.08.009.

9. Van Niel MS and Payne JL. Perinatal depression: A review. Cleve Clin J Med. 2020 May. doi: 10.3949/ccjm.87a.19054.

10. Wisner KL et al. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. 2013 May. doi: 10.1001/jamapsychiatry.2013.87.

11. Falah-Hassani K et al. The prevalence of antenatal and postnatal co-morbid anxiety and depression: A meta-analysis. Psychol Med. 2017 Sep. doi: 10.1017/S0033291717000617.

12. Pentecost R et al. Scoping review of the associations between perinatal substance use and perinatal depression and anxiety. J Obstet Gynecol Neonatal Nurs. 2021 Jul. doi: 10.1016/j.jogn.2021.02.008.

13. Craemer KA et al. Perinatal mental health in low-income urban and rural patients: The importance of screening for comorbidities. Gen Hosp Psychiatry. 2023 Jul-Aug. doi: 10.1016/j.genhosppsych.2023.05.007.

14. O’Connor E et al. Primary care screening for and treatment of depression in pregnant and postpartum women: Evidence report and systematic review for the U.S. Preventive Services Task Force. JAMA. 2016 Jan 26. doi: 10.1001/jama.2015.18948.

15. Kozhimannil KB et al. Racial and ethnic disparities in postpartum depression care among low-income women. Psychiatr Serv. 2011 Jun. doi: 10.1176/ps.62.6.pss6206_0619.

16. Wenzel ES et al. Depression and anxiety symptoms across pregnancy and the postpartum in low-income Black and Latina women. Arch Womens Ment Health. 2021 Dec. doi: 10.1007/s00737-021-01139-y.

17. Gibbons RD et al. Development of a computerized adaptive substance use disorder scale for screening and measurement: The CAT‐SUD. Addiction. 2020 Jul. doi: 10.1111/add.14938.

18. Brenner LA et al. Validation of a computerized adaptive test suicide scale (CAT-SS) among united states military veterans. PloS One. 2022 Jan 21. doi: 10.1371/journal.pone.0261920.

19. The Center for State Child Welfare Data. Using technology to diagnose and report on behavioral health challenges facing foster youth. 2018.

20. Kim JJ et al. The experience of depression, anxiety, and mania among perinatal women. Arch Womens Ment Health. 2016 Oct. doi: 10.1007/s00737-016-0632-6.

21. Tepper MC et al. Toward population health: Using a learning behavioral health system and measurement-based care to improve access, care, outcomes, and disparities. Community Ment Health J. 2022 Nov. doi: 10.1007/s10597-022-00957-3.

22. Wenzel E et al. Using computerised adaptive tests to screen for perinatal depression in underserved women of colour. Evid Based Ment Health. 2022 Feb. doi: 10.1136/ebmental-2021-300262.

23. Sanger-Katz M. They want it to be secret: How a common blood test can cost $11 or almost $1,000. New York Times. 2019 Apr 19.

24. Spitzer RL et al. A brief measure for assessing generalized anxiety disorder: The GAD-7. Arch Intern Med. 2006 May 22. doi: 10.1001/archinte.166.10.1092.

25. Mollard E et al. An integrative review of postpartum depression in rural US communities. Arch Psychiatr Nurs. 2016 Jun. doi: 10.1016/j.apnu.2015.12.003.

26. Anglim AJ and Radke SM. Rural maternal health care outcomes, drivers, and patient perspectives. Clin Obstet Gynecol. 2022 Dec 1. doi: 10.1097/GRF.0000000000000753.

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No more hot flashes? AI device could stop menopause symptom

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Changed
Wed, 11/01/2023 - 14:20

Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke. 

Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash. 

Their idea is to combine this algorithm with a product called Embr Wave, a watch-like wearable that can emit coolness (or warmth) to the sensitive skin on the inside of the wrist, providing whole-body relief. The device, which sells for $299, is already touted as a way to manage menopausal hot flashes. 

But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.

That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off. 
 

Exploring cooling therapy for hot flashes

“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.) 

Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.” 

Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity

For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials. 

But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change. 

“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”

The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.

The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment. 

But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said. 

“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”

A version of this article appeared on WebMD.com.

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Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke. 

Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash. 

Their idea is to combine this algorithm with a product called Embr Wave, a watch-like wearable that can emit coolness (or warmth) to the sensitive skin on the inside of the wrist, providing whole-body relief. The device, which sells for $299, is already touted as a way to manage menopausal hot flashes. 

But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.

That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off. 
 

Exploring cooling therapy for hot flashes

“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.) 

Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.” 

Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity

For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials. 

But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change. 

“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”

The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.

The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment. 

But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said. 

“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”

A version of this article appeared on WebMD.com.

Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke. 

Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash. 

Their idea is to combine this algorithm with a product called Embr Wave, a watch-like wearable that can emit coolness (or warmth) to the sensitive skin on the inside of the wrist, providing whole-body relief. The device, which sells for $299, is already touted as a way to manage menopausal hot flashes. 

But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.

That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off. 
 

Exploring cooling therapy for hot flashes

“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.) 

Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.” 

Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity

For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials. 

But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change. 

“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”

The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.

The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment. 

But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said. 

“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”

A version of this article appeared on WebMD.com.

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Air pollution tied to postpartum depression

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Tue, 10/31/2023 - 11:05

 

TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

  • Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
  • Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM2.5), PM ≤ 10 mcm (PM10), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
  • Constituents of PM2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
  • Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

  • A total of 25,674 women had PPD (7.5%).
  • Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM10 (aOR, 1.02), and PM2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
  • Among PM2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
  • Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

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

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TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

  • Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
  • Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM2.5), PM ≤ 10 mcm (PM10), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
  • Constituents of PM2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
  • Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

  • A total of 25,674 women had PPD (7.5%).
  • Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM10 (aOR, 1.02), and PM2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
  • Among PM2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
  • Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

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

 

TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

  • Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
  • Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM2.5), PM ≤ 10 mcm (PM10), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
  • Constituents of PM2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
  • Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

  • A total of 25,674 women had PPD (7.5%).
  • Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM10 (aOR, 1.02), and PM2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
  • Among PM2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
  • Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

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

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GI symptoms during menopause deserve attention

Article Type
Changed
Mon, 10/30/2023 - 13:38

 

This transcript has been edited for clarity.

Welcome back to another GI Common Concerns.

Today, I want to highlight some information about menopause.

Approximately 1.5 million women in the United States per year enter into menopause. Hysterectomy is also one of the most common surgeries for women worldwide, with an estimated 20%-40% undergoing this procedure by the age of 60.

Therefore, whether it’s because of biologic onset with age or surgical induction, menopause is a very common condition, and it’s important that we understand its symptoms and the latest information around it.
 

Impact on GI motility

One of the clearest functional symptoms to be aware of with menopause relates to alterations in hormonal balance. This has an impact on gastrointestinal (GI) motility by increasing abdominal muscle stimulation related to different patterns of secretion and can result in a number of symptomatic changes.

One such change that can occur is food intolerance. It is believed that menopause-associated food intolerance has multiple possible causes and may be related more to alterations to the microbiome, which can be contributed to by diet, activity, sleep cycle, and other factors.

When food intolerances are triggered in the perimenopausal or menopausal patient, it may lead you to recommend the well-established FODMAP diet, which is known to reduce symptoms. But the answer for every patient is not simply placing them on a FODMAP diet and telling them they have irritable bowel syndrome.

Other approaches can be considered for addressing food intolerance in these patients. The data are quite strong that adjunctive use of a dietitian is tremendously helpful in this particular population.

When it comes to menopausal patients, however, we need to consider other changes in their activity or adverse contributors to their mental health, such as stress or anxiety. These all contribute to more of a multifactorial composite in this population, for which irritable bowel syndrome serves as a similar example.

This means that we may need to expand our horizons rather than to focus on solely on antispasmodic or diet-related interventions.

Instead, we can start to consider more of a multidimensional treatment approach consisting of education, relaxation, cognitive-behavioral therapy, and physical activity. Certainly, there are now behavioral interventions using Internet-based digital formats to increase the acceptability and sustainability among patients.

Choosing such a multidisciplinary approach can be quite helpful.
 

The metabolic consequences of altering hormonal balance

Recent data from a rat model study investigated the metabolic impact of changing hormonal balance.

Investigators looked at ovariectomized rats and found that there was a biologic change in the diversity of the general GI biome. There were also noteworthy associations with weight fluctuations and dramatic changes in the spatial memory and cognitive performance characteristics of these rats, which was subsequently improved by supplemental estrogen.

This indicates that we may be able to remediate these effects with the similar use of supplemental hormone replacement treatments.

Another recent study looked at nonalcoholic fatty liver disease, which is very common in the general population and has a > 20% worldwide prevalence in postmenopausal women. Albeit small in numbers, this was a very interesting study.

Investigators looked at the delivery method for menopausal hormone therapy, which was transdermal for 75 patients and oral for 293 patients. Then, they looked at ultrasound definition of nonalcoholic fatty liver disease after 1 year as the endpoint. They found an approximate 7% reduction in the patients who received the transdermal administration compared with a 4% increase in the patients who received it orally.

Again, we have to remember this is a relatively small study, but the results indicate that the route of estrogen administration may be an important consideration in nonalcoholic fatty liver disease.
 

 

 

Sleep disturbances: fragmentation, duration, and quality

Sleep is something that’s near and dear to my heart and is the focus of a lot of our research.

Sleep disturbances are really part and parcel of menopause and are observed with hormonal imbalances and temperature intolerances. Disturbances such as sleep fragmentation, shorter sleep duration, and poorer sleep quality have a dramatic effect not only on the biome but also on sensory thresholds.

Therefore, as we start to look at mitigating strategies here, we need to focus on sleep and ask the right questions.

In my own practice, I try not to just ask, “How did you sleep last night?” That’s because sleep can be somewhat amnestic. You may have a cognitive awakening or a noncognitive awakening but still have experienced fragmentation.

As a result, my focus is on next-day function. I ask my patients, “When you get up in the morning, are you refreshed? Do you have the ability to perform daytime activities? Do you experience early fatigue or cognitive changes that occur?”

These questions can provide good insights into the sleep efficiency of the previous night.
 

The effect of the microbiome on osteoporosis

One final topic I found very interesting pertains to the effects of menopause on osteoporosis.

We certainly know that postmenopausal women have a very high prevalence of osteopenia, and that osteoporosis is a progression of that, as well as that increased bone-related disease affects fractures and related morbidity and mortality.

However, there’s accumulating evidence on the osteoporotic effects of biomarker changes in menopause, which shows that the biome regulates the pathophysiologic process of at least a large degree of osteoporosis.

This starts to make sense when you look at the pro-inflammatory factors that increase with changes in biome diversity, in particular tumor necrosis factor alpha (which is something we also see in inflammatory bowel disease), interleukin-1, and increased activated osteoclasts.

Therefore, when it comes to decreasing bone loss among patients who are perimenopausal or postmenopausal, we don’t yet have a clear answer. Hormone therapy, diet, activity, vitamin D supplementation, and other things may positively change the biome. They are worthy topics for patients to bring up with their ob.gyns. or primary care doctors.

Although it may be a little bit outside the scope of gastroenterology, in my opinion there are a number of new findings relating to menopause that we as a field need to be more proactive in addressing.

Ask the right questions when these people come in to you, irrespective of why they’re there. Start to ask about the quality of their sleep. What are their other functional symptoms? What are their other potential osteoporosis-related risks?

We must do a better job about individualizing care. Rather than treating patients as disease states, we must start to do specific patient-focused care.

I hope this gives you some provocative thoughts when you have your next session with a patient in the perimenopausal or menopausal state. There are lots of things that we continue to learn.
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Va., and a past president of the American College of Gastroenterology. He serves as an adviser to ISOThrive and Johnson & Johnson.

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

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This transcript has been edited for clarity.

Welcome back to another GI Common Concerns.

Today, I want to highlight some information about menopause.

Approximately 1.5 million women in the United States per year enter into menopause. Hysterectomy is also one of the most common surgeries for women worldwide, with an estimated 20%-40% undergoing this procedure by the age of 60.

Therefore, whether it’s because of biologic onset with age or surgical induction, menopause is a very common condition, and it’s important that we understand its symptoms and the latest information around it.
 

Impact on GI motility

One of the clearest functional symptoms to be aware of with menopause relates to alterations in hormonal balance. This has an impact on gastrointestinal (GI) motility by increasing abdominal muscle stimulation related to different patterns of secretion and can result in a number of symptomatic changes.

One such change that can occur is food intolerance. It is believed that menopause-associated food intolerance has multiple possible causes and may be related more to alterations to the microbiome, which can be contributed to by diet, activity, sleep cycle, and other factors.

When food intolerances are triggered in the perimenopausal or menopausal patient, it may lead you to recommend the well-established FODMAP diet, which is known to reduce symptoms. But the answer for every patient is not simply placing them on a FODMAP diet and telling them they have irritable bowel syndrome.

Other approaches can be considered for addressing food intolerance in these patients. The data are quite strong that adjunctive use of a dietitian is tremendously helpful in this particular population.

When it comes to menopausal patients, however, we need to consider other changes in their activity or adverse contributors to their mental health, such as stress or anxiety. These all contribute to more of a multifactorial composite in this population, for which irritable bowel syndrome serves as a similar example.

This means that we may need to expand our horizons rather than to focus on solely on antispasmodic or diet-related interventions.

Instead, we can start to consider more of a multidimensional treatment approach consisting of education, relaxation, cognitive-behavioral therapy, and physical activity. Certainly, there are now behavioral interventions using Internet-based digital formats to increase the acceptability and sustainability among patients.

Choosing such a multidisciplinary approach can be quite helpful.
 

The metabolic consequences of altering hormonal balance

Recent data from a rat model study investigated the metabolic impact of changing hormonal balance.

Investigators looked at ovariectomized rats and found that there was a biologic change in the diversity of the general GI biome. There were also noteworthy associations with weight fluctuations and dramatic changes in the spatial memory and cognitive performance characteristics of these rats, which was subsequently improved by supplemental estrogen.

This indicates that we may be able to remediate these effects with the similar use of supplemental hormone replacement treatments.

Another recent study looked at nonalcoholic fatty liver disease, which is very common in the general population and has a > 20% worldwide prevalence in postmenopausal women. Albeit small in numbers, this was a very interesting study.

Investigators looked at the delivery method for menopausal hormone therapy, which was transdermal for 75 patients and oral for 293 patients. Then, they looked at ultrasound definition of nonalcoholic fatty liver disease after 1 year as the endpoint. They found an approximate 7% reduction in the patients who received the transdermal administration compared with a 4% increase in the patients who received it orally.

Again, we have to remember this is a relatively small study, but the results indicate that the route of estrogen administration may be an important consideration in nonalcoholic fatty liver disease.
 

 

 

Sleep disturbances: fragmentation, duration, and quality

Sleep is something that’s near and dear to my heart and is the focus of a lot of our research.

Sleep disturbances are really part and parcel of menopause and are observed with hormonal imbalances and temperature intolerances. Disturbances such as sleep fragmentation, shorter sleep duration, and poorer sleep quality have a dramatic effect not only on the biome but also on sensory thresholds.

Therefore, as we start to look at mitigating strategies here, we need to focus on sleep and ask the right questions.

In my own practice, I try not to just ask, “How did you sleep last night?” That’s because sleep can be somewhat amnestic. You may have a cognitive awakening or a noncognitive awakening but still have experienced fragmentation.

As a result, my focus is on next-day function. I ask my patients, “When you get up in the morning, are you refreshed? Do you have the ability to perform daytime activities? Do you experience early fatigue or cognitive changes that occur?”

These questions can provide good insights into the sleep efficiency of the previous night.
 

The effect of the microbiome on osteoporosis

One final topic I found very interesting pertains to the effects of menopause on osteoporosis.

We certainly know that postmenopausal women have a very high prevalence of osteopenia, and that osteoporosis is a progression of that, as well as that increased bone-related disease affects fractures and related morbidity and mortality.

However, there’s accumulating evidence on the osteoporotic effects of biomarker changes in menopause, which shows that the biome regulates the pathophysiologic process of at least a large degree of osteoporosis.

This starts to make sense when you look at the pro-inflammatory factors that increase with changes in biome diversity, in particular tumor necrosis factor alpha (which is something we also see in inflammatory bowel disease), interleukin-1, and increased activated osteoclasts.

Therefore, when it comes to decreasing bone loss among patients who are perimenopausal or postmenopausal, we don’t yet have a clear answer. Hormone therapy, diet, activity, vitamin D supplementation, and other things may positively change the biome. They are worthy topics for patients to bring up with their ob.gyns. or primary care doctors.

Although it may be a little bit outside the scope of gastroenterology, in my opinion there are a number of new findings relating to menopause that we as a field need to be more proactive in addressing.

Ask the right questions when these people come in to you, irrespective of why they’re there. Start to ask about the quality of their sleep. What are their other functional symptoms? What are their other potential osteoporosis-related risks?

We must do a better job about individualizing care. Rather than treating patients as disease states, we must start to do specific patient-focused care.

I hope this gives you some provocative thoughts when you have your next session with a patient in the perimenopausal or menopausal state. There are lots of things that we continue to learn.
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Va., and a past president of the American College of Gastroenterology. He serves as an adviser to ISOThrive and Johnson & Johnson.

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

 

This transcript has been edited for clarity.

Welcome back to another GI Common Concerns.

Today, I want to highlight some information about menopause.

Approximately 1.5 million women in the United States per year enter into menopause. Hysterectomy is also one of the most common surgeries for women worldwide, with an estimated 20%-40% undergoing this procedure by the age of 60.

Therefore, whether it’s because of biologic onset with age or surgical induction, menopause is a very common condition, and it’s important that we understand its symptoms and the latest information around it.
 

Impact on GI motility

One of the clearest functional symptoms to be aware of with menopause relates to alterations in hormonal balance. This has an impact on gastrointestinal (GI) motility by increasing abdominal muscle stimulation related to different patterns of secretion and can result in a number of symptomatic changes.

One such change that can occur is food intolerance. It is believed that menopause-associated food intolerance has multiple possible causes and may be related more to alterations to the microbiome, which can be contributed to by diet, activity, sleep cycle, and other factors.

When food intolerances are triggered in the perimenopausal or menopausal patient, it may lead you to recommend the well-established FODMAP diet, which is known to reduce symptoms. But the answer for every patient is not simply placing them on a FODMAP diet and telling them they have irritable bowel syndrome.

Other approaches can be considered for addressing food intolerance in these patients. The data are quite strong that adjunctive use of a dietitian is tremendously helpful in this particular population.

When it comes to menopausal patients, however, we need to consider other changes in their activity or adverse contributors to their mental health, such as stress or anxiety. These all contribute to more of a multifactorial composite in this population, for which irritable bowel syndrome serves as a similar example.

This means that we may need to expand our horizons rather than to focus on solely on antispasmodic or diet-related interventions.

Instead, we can start to consider more of a multidimensional treatment approach consisting of education, relaxation, cognitive-behavioral therapy, and physical activity. Certainly, there are now behavioral interventions using Internet-based digital formats to increase the acceptability and sustainability among patients.

Choosing such a multidisciplinary approach can be quite helpful.
 

The metabolic consequences of altering hormonal balance

Recent data from a rat model study investigated the metabolic impact of changing hormonal balance.

Investigators looked at ovariectomized rats and found that there was a biologic change in the diversity of the general GI biome. There were also noteworthy associations with weight fluctuations and dramatic changes in the spatial memory and cognitive performance characteristics of these rats, which was subsequently improved by supplemental estrogen.

This indicates that we may be able to remediate these effects with the similar use of supplemental hormone replacement treatments.

Another recent study looked at nonalcoholic fatty liver disease, which is very common in the general population and has a > 20% worldwide prevalence in postmenopausal women. Albeit small in numbers, this was a very interesting study.

Investigators looked at the delivery method for menopausal hormone therapy, which was transdermal for 75 patients and oral for 293 patients. Then, they looked at ultrasound definition of nonalcoholic fatty liver disease after 1 year as the endpoint. They found an approximate 7% reduction in the patients who received the transdermal administration compared with a 4% increase in the patients who received it orally.

Again, we have to remember this is a relatively small study, but the results indicate that the route of estrogen administration may be an important consideration in nonalcoholic fatty liver disease.
 

 

 

Sleep disturbances: fragmentation, duration, and quality

Sleep is something that’s near and dear to my heart and is the focus of a lot of our research.

Sleep disturbances are really part and parcel of menopause and are observed with hormonal imbalances and temperature intolerances. Disturbances such as sleep fragmentation, shorter sleep duration, and poorer sleep quality have a dramatic effect not only on the biome but also on sensory thresholds.

Therefore, as we start to look at mitigating strategies here, we need to focus on sleep and ask the right questions.

In my own practice, I try not to just ask, “How did you sleep last night?” That’s because sleep can be somewhat amnestic. You may have a cognitive awakening or a noncognitive awakening but still have experienced fragmentation.

As a result, my focus is on next-day function. I ask my patients, “When you get up in the morning, are you refreshed? Do you have the ability to perform daytime activities? Do you experience early fatigue or cognitive changes that occur?”

These questions can provide good insights into the sleep efficiency of the previous night.
 

The effect of the microbiome on osteoporosis

One final topic I found very interesting pertains to the effects of menopause on osteoporosis.

We certainly know that postmenopausal women have a very high prevalence of osteopenia, and that osteoporosis is a progression of that, as well as that increased bone-related disease affects fractures and related morbidity and mortality.

However, there’s accumulating evidence on the osteoporotic effects of biomarker changes in menopause, which shows that the biome regulates the pathophysiologic process of at least a large degree of osteoporosis.

This starts to make sense when you look at the pro-inflammatory factors that increase with changes in biome diversity, in particular tumor necrosis factor alpha (which is something we also see in inflammatory bowel disease), interleukin-1, and increased activated osteoclasts.

Therefore, when it comes to decreasing bone loss among patients who are perimenopausal or postmenopausal, we don’t yet have a clear answer. Hormone therapy, diet, activity, vitamin D supplementation, and other things may positively change the biome. They are worthy topics for patients to bring up with their ob.gyns. or primary care doctors.

Although it may be a little bit outside the scope of gastroenterology, in my opinion there are a number of new findings relating to menopause that we as a field need to be more proactive in addressing.

Ask the right questions when these people come in to you, irrespective of why they’re there. Start to ask about the quality of their sleep. What are their other functional symptoms? What are their other potential osteoporosis-related risks?

We must do a better job about individualizing care. Rather than treating patients as disease states, we must start to do specific patient-focused care.

I hope this gives you some provocative thoughts when you have your next session with a patient in the perimenopausal or menopausal state. There are lots of things that we continue to learn.
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Va., and a past president of the American College of Gastroenterology. He serves as an adviser to ISOThrive and Johnson & Johnson.

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

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Postmenopausal testosterone for low libido only, doctors say

Article Type
Changed
Mon, 10/30/2023 - 11:32

Your patients may see ads claiming that testosterone replacement therapy (TRT) offers postmenopausal women health benefits beyond restored sex drive: that TRT can improve their mood, energy, and thinking and give them stronger bones and bigger muscles.

How accurate are these claims? According to six experts who talked with this news organization, not very.

“Right now in this country and around the world, testosterone’s only use in postmenopausal women is for libido,” said Adrian Sandra Dobs, MD, MHS, professor of medicine and director of the Johns Hopkins Clinical Research Network at Johns Hopkins Medicine, Baltimore.

“Treating postmenopausal women with testosterone is a rarity. Some physicians and some wellness centers make their money out of prescribing estrogen and testosterone to women in patches, gels, creams, capsules, pellets, and other forms. But when you look at the scientific data, outside of libido, it’s difficult to recommend testosterone therapy,” she added by phone.

“One has to be very careful about using testosterone in women,” Dr. Dobs cautioned. “There’s a lot of hype out there.”

Low testosterone in women has not been well studied, and no testosterone treatments for this condition have been approved by the U.S. Food and Drug Administration. Providers need to adjust male treatment data to their female patients, who require significantly lower doses than males. Contraindications and long-term side effects are poorly understood, said Mary Rosser, MD, PhD, assistant professor of women’s health and director of integrated women’s health at Columbia University Irving Medical Center, New York.

“Despite this preponderance of scientific evidence and recommendations, the myths about testosterone die hard, including that it improves women’s muscle function, endurance, and well-being,” Dr. Rosser said.

“Websites that use compounded products or pellets are not FDA-regulated; therefore, they have no responsibility to prove their claims. They can entice women into using this stuff with all kinds of promises about ‘hormone balancing’ and other meaningless terms. The Endocrine Society statement reviewed the clinical studies on testosterone for various indications surrounding physical endurance, well-being, and mental health – and the studies do not support its use,” Dr. Rosser added.

According to the Australasian Menopause Society, women’s blood testosterone levels tend to peak in their 20s, slowly decline to around 25% of peak levels at menopause, then rise again in later years.

Susan Davis, PhD, and her colleagues at Monash University, Melbourne, found in a study that TRT in postmenopausal women may improve sexual well-being and that side effects include acne and increased hair growth. But they found no benefits for cognition, bone mineral density, body composition, muscle strength, or psychological well-being, and they note that more data are needed on long-term safety.
 

Postmenopausal testosterone recommended for libido only

“Hypoactive sexual desire disorder (HSDD) is really the only indication for postmenopausal testosterone use,” Nanette F. Santoro, MD, professor and chair of obstetrics and gynecology at the University of Colorado School of Medicine, Aurora, noted by email. “In clinical studies using androgen gel containing testosterone, testosterone treatment has resulted in a mean of one more satisfying sexual encounter per month. Consensus statements issued by the Endocrine SocietyThe International Menopause Society, and the North American Menopause Society have come to similar conclusions: The only indication for androgen therapy for women is HSDD,” added Santoro, an author of the Endocrine Society statement.

“Sexual health and the sense of well-being are very much related,” Sandra Ann Carson, MD, professor of obstetrics and gynecology at Yale Medicine, New Haven, Conn., said by phone. “So we give testosterone to increase sexual desire. Testosterone is not a treatment for decreased sense of well-being alone. Women who lose their sense of well-being due to depression or other factors need to have a mental health evaluation, not testosterone.”

“Because no female product is presently approved by a national regulatory body, male formulations can be judiciously used in female doses and blood testosterone concentrations must be monitored regularly,” Dr. Rosser said. “The recommendation is for considering use of compounded testosterone for hypoactive sexual desire only; it is against use for overall health and wellness.”

“The real mischief occurs when women are exposed to doses that are supraphysiologic,” Dr. Rosser cautioned. “At high doses that approach and sometimes exceed men’s levels of testosterone, women can have deepening of the voice, adverse changes in cholesterol, and even breast atrophy. This can occur with bioidentical compounded testosterone and with testosterone pellets. The National Academies of Science, Engineering, and Medicine recommend unequivocally that such preparations not be used.”

Not all postmenopausal women should take TRT, said Meredith McClure, MD, assistant professor in the department of obstetrics and gynecology of UT Southwestern Medical School, Dallas, because it has only been shown in trials to help with HSDD.

She advised clinicians to avoid prescribing testosterone to patients who “can’t take estrogen, including if [they] have hormone-sensitive cancer, blood clot risk, liver disease, heart attack, stroke, or undiagnosed genital bleeding.”
 

TRT for non-libido issues may sometimes be appropriate

“Perhaps women with hip fracture or cancer cachexia could benefit from testosterone to build muscle mass,” said Dr. Dobbs, who is involved in an ongoing study of testosterone treatment in women with hip fracture. “But as yet, we have no proof that testosterone helps.”

In rare cases, Stanley G. Korenman, MD, a reproductive endocrinologist and associate dean for ethics at UCLA Health, treats postmenopausal patients with TRT for reasons other than low libido. “I have a very specialized practice in reproductive endocrinology and internal medicine and am one of very few people in the country who do this kind of management,” he said in an interview. “If my postmenopausal patients have low testosterone and lack energy, I’m willing to give them low doses. If they feel more energetic, we continue, but if they don’t, we stop. I don’t think there’s any risk whatsoever at the low level I prescribe.

“I prescribe standard gel that comes in a squirt bottle, and I suggest they take half a squirt every other day – about one-eighth of a male dose – on the sole of the foot, where hair does not grow.

“I would not prescribe testosterone for bone health. We have bisphosphonates and other much better treatments for that. And I would not prescribe it to someone who is seriously emotionally disturbed or seriously depressed. This is not a treatment for depression.”

“Postmenopausal testosterone is not ‘the latest greatest thing,’ but being very low risk, it’s worth trying once in a while, in the appropriate patient, at the right dose,” Dr. Korenman advised. He cautioned people to “avoid the longevity salespeople who sell all sorts of things in all sorts of doses to try to keep us alive forever.”

All contributors report no relevant financial relationships.

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

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Your patients may see ads claiming that testosterone replacement therapy (TRT) offers postmenopausal women health benefits beyond restored sex drive: that TRT can improve their mood, energy, and thinking and give them stronger bones and bigger muscles.

How accurate are these claims? According to six experts who talked with this news organization, not very.

“Right now in this country and around the world, testosterone’s only use in postmenopausal women is for libido,” said Adrian Sandra Dobs, MD, MHS, professor of medicine and director of the Johns Hopkins Clinical Research Network at Johns Hopkins Medicine, Baltimore.

“Treating postmenopausal women with testosterone is a rarity. Some physicians and some wellness centers make their money out of prescribing estrogen and testosterone to women in patches, gels, creams, capsules, pellets, and other forms. But when you look at the scientific data, outside of libido, it’s difficult to recommend testosterone therapy,” she added by phone.

“One has to be very careful about using testosterone in women,” Dr. Dobs cautioned. “There’s a lot of hype out there.”

Low testosterone in women has not been well studied, and no testosterone treatments for this condition have been approved by the U.S. Food and Drug Administration. Providers need to adjust male treatment data to their female patients, who require significantly lower doses than males. Contraindications and long-term side effects are poorly understood, said Mary Rosser, MD, PhD, assistant professor of women’s health and director of integrated women’s health at Columbia University Irving Medical Center, New York.

“Despite this preponderance of scientific evidence and recommendations, the myths about testosterone die hard, including that it improves women’s muscle function, endurance, and well-being,” Dr. Rosser said.

“Websites that use compounded products or pellets are not FDA-regulated; therefore, they have no responsibility to prove their claims. They can entice women into using this stuff with all kinds of promises about ‘hormone balancing’ and other meaningless terms. The Endocrine Society statement reviewed the clinical studies on testosterone for various indications surrounding physical endurance, well-being, and mental health – and the studies do not support its use,” Dr. Rosser added.

According to the Australasian Menopause Society, women’s blood testosterone levels tend to peak in their 20s, slowly decline to around 25% of peak levels at menopause, then rise again in later years.

Susan Davis, PhD, and her colleagues at Monash University, Melbourne, found in a study that TRT in postmenopausal women may improve sexual well-being and that side effects include acne and increased hair growth. But they found no benefits for cognition, bone mineral density, body composition, muscle strength, or psychological well-being, and they note that more data are needed on long-term safety.
 

Postmenopausal testosterone recommended for libido only

“Hypoactive sexual desire disorder (HSDD) is really the only indication for postmenopausal testosterone use,” Nanette F. Santoro, MD, professor and chair of obstetrics and gynecology at the University of Colorado School of Medicine, Aurora, noted by email. “In clinical studies using androgen gel containing testosterone, testosterone treatment has resulted in a mean of one more satisfying sexual encounter per month. Consensus statements issued by the Endocrine SocietyThe International Menopause Society, and the North American Menopause Society have come to similar conclusions: The only indication for androgen therapy for women is HSDD,” added Santoro, an author of the Endocrine Society statement.

“Sexual health and the sense of well-being are very much related,” Sandra Ann Carson, MD, professor of obstetrics and gynecology at Yale Medicine, New Haven, Conn., said by phone. “So we give testosterone to increase sexual desire. Testosterone is not a treatment for decreased sense of well-being alone. Women who lose their sense of well-being due to depression or other factors need to have a mental health evaluation, not testosterone.”

“Because no female product is presently approved by a national regulatory body, male formulations can be judiciously used in female doses and blood testosterone concentrations must be monitored regularly,” Dr. Rosser said. “The recommendation is for considering use of compounded testosterone for hypoactive sexual desire only; it is against use for overall health and wellness.”

“The real mischief occurs when women are exposed to doses that are supraphysiologic,” Dr. Rosser cautioned. “At high doses that approach and sometimes exceed men’s levels of testosterone, women can have deepening of the voice, adverse changes in cholesterol, and even breast atrophy. This can occur with bioidentical compounded testosterone and with testosterone pellets. The National Academies of Science, Engineering, and Medicine recommend unequivocally that such preparations not be used.”

Not all postmenopausal women should take TRT, said Meredith McClure, MD, assistant professor in the department of obstetrics and gynecology of UT Southwestern Medical School, Dallas, because it has only been shown in trials to help with HSDD.

She advised clinicians to avoid prescribing testosterone to patients who “can’t take estrogen, including if [they] have hormone-sensitive cancer, blood clot risk, liver disease, heart attack, stroke, or undiagnosed genital bleeding.”
 

TRT for non-libido issues may sometimes be appropriate

“Perhaps women with hip fracture or cancer cachexia could benefit from testosterone to build muscle mass,” said Dr. Dobbs, who is involved in an ongoing study of testosterone treatment in women with hip fracture. “But as yet, we have no proof that testosterone helps.”

In rare cases, Stanley G. Korenman, MD, a reproductive endocrinologist and associate dean for ethics at UCLA Health, treats postmenopausal patients with TRT for reasons other than low libido. “I have a very specialized practice in reproductive endocrinology and internal medicine and am one of very few people in the country who do this kind of management,” he said in an interview. “If my postmenopausal patients have low testosterone and lack energy, I’m willing to give them low doses. If they feel more energetic, we continue, but if they don’t, we stop. I don’t think there’s any risk whatsoever at the low level I prescribe.

“I prescribe standard gel that comes in a squirt bottle, and I suggest they take half a squirt every other day – about one-eighth of a male dose – on the sole of the foot, where hair does not grow.

“I would not prescribe testosterone for bone health. We have bisphosphonates and other much better treatments for that. And I would not prescribe it to someone who is seriously emotionally disturbed or seriously depressed. This is not a treatment for depression.”

“Postmenopausal testosterone is not ‘the latest greatest thing,’ but being very low risk, it’s worth trying once in a while, in the appropriate patient, at the right dose,” Dr. Korenman advised. He cautioned people to “avoid the longevity salespeople who sell all sorts of things in all sorts of doses to try to keep us alive forever.”

All contributors report no relevant financial relationships.

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

Your patients may see ads claiming that testosterone replacement therapy (TRT) offers postmenopausal women health benefits beyond restored sex drive: that TRT can improve their mood, energy, and thinking and give them stronger bones and bigger muscles.

How accurate are these claims? According to six experts who talked with this news organization, not very.

“Right now in this country and around the world, testosterone’s only use in postmenopausal women is for libido,” said Adrian Sandra Dobs, MD, MHS, professor of medicine and director of the Johns Hopkins Clinical Research Network at Johns Hopkins Medicine, Baltimore.

“Treating postmenopausal women with testosterone is a rarity. Some physicians and some wellness centers make their money out of prescribing estrogen and testosterone to women in patches, gels, creams, capsules, pellets, and other forms. But when you look at the scientific data, outside of libido, it’s difficult to recommend testosterone therapy,” she added by phone.

“One has to be very careful about using testosterone in women,” Dr. Dobs cautioned. “There’s a lot of hype out there.”

Low testosterone in women has not been well studied, and no testosterone treatments for this condition have been approved by the U.S. Food and Drug Administration. Providers need to adjust male treatment data to their female patients, who require significantly lower doses than males. Contraindications and long-term side effects are poorly understood, said Mary Rosser, MD, PhD, assistant professor of women’s health and director of integrated women’s health at Columbia University Irving Medical Center, New York.

“Despite this preponderance of scientific evidence and recommendations, the myths about testosterone die hard, including that it improves women’s muscle function, endurance, and well-being,” Dr. Rosser said.

“Websites that use compounded products or pellets are not FDA-regulated; therefore, they have no responsibility to prove their claims. They can entice women into using this stuff with all kinds of promises about ‘hormone balancing’ and other meaningless terms. The Endocrine Society statement reviewed the clinical studies on testosterone for various indications surrounding physical endurance, well-being, and mental health – and the studies do not support its use,” Dr. Rosser added.

According to the Australasian Menopause Society, women’s blood testosterone levels tend to peak in their 20s, slowly decline to around 25% of peak levels at menopause, then rise again in later years.

Susan Davis, PhD, and her colleagues at Monash University, Melbourne, found in a study that TRT in postmenopausal women may improve sexual well-being and that side effects include acne and increased hair growth. But they found no benefits for cognition, bone mineral density, body composition, muscle strength, or psychological well-being, and they note that more data are needed on long-term safety.
 

Postmenopausal testosterone recommended for libido only

“Hypoactive sexual desire disorder (HSDD) is really the only indication for postmenopausal testosterone use,” Nanette F. Santoro, MD, professor and chair of obstetrics and gynecology at the University of Colorado School of Medicine, Aurora, noted by email. “In clinical studies using androgen gel containing testosterone, testosterone treatment has resulted in a mean of one more satisfying sexual encounter per month. Consensus statements issued by the Endocrine SocietyThe International Menopause Society, and the North American Menopause Society have come to similar conclusions: The only indication for androgen therapy for women is HSDD,” added Santoro, an author of the Endocrine Society statement.

“Sexual health and the sense of well-being are very much related,” Sandra Ann Carson, MD, professor of obstetrics and gynecology at Yale Medicine, New Haven, Conn., said by phone. “So we give testosterone to increase sexual desire. Testosterone is not a treatment for decreased sense of well-being alone. Women who lose their sense of well-being due to depression or other factors need to have a mental health evaluation, not testosterone.”

“Because no female product is presently approved by a national regulatory body, male formulations can be judiciously used in female doses and blood testosterone concentrations must be monitored regularly,” Dr. Rosser said. “The recommendation is for considering use of compounded testosterone for hypoactive sexual desire only; it is against use for overall health and wellness.”

“The real mischief occurs when women are exposed to doses that are supraphysiologic,” Dr. Rosser cautioned. “At high doses that approach and sometimes exceed men’s levels of testosterone, women can have deepening of the voice, adverse changes in cholesterol, and even breast atrophy. This can occur with bioidentical compounded testosterone and with testosterone pellets. The National Academies of Science, Engineering, and Medicine recommend unequivocally that such preparations not be used.”

Not all postmenopausal women should take TRT, said Meredith McClure, MD, assistant professor in the department of obstetrics and gynecology of UT Southwestern Medical School, Dallas, because it has only been shown in trials to help with HSDD.

She advised clinicians to avoid prescribing testosterone to patients who “can’t take estrogen, including if [they] have hormone-sensitive cancer, blood clot risk, liver disease, heart attack, stroke, or undiagnosed genital bleeding.”
 

TRT for non-libido issues may sometimes be appropriate

“Perhaps women with hip fracture or cancer cachexia could benefit from testosterone to build muscle mass,” said Dr. Dobbs, who is involved in an ongoing study of testosterone treatment in women with hip fracture. “But as yet, we have no proof that testosterone helps.”

In rare cases, Stanley G. Korenman, MD, a reproductive endocrinologist and associate dean for ethics at UCLA Health, treats postmenopausal patients with TRT for reasons other than low libido. “I have a very specialized practice in reproductive endocrinology and internal medicine and am one of very few people in the country who do this kind of management,” he said in an interview. “If my postmenopausal patients have low testosterone and lack energy, I’m willing to give them low doses. If they feel more energetic, we continue, but if they don’t, we stop. I don’t think there’s any risk whatsoever at the low level I prescribe.

“I prescribe standard gel that comes in a squirt bottle, and I suggest they take half a squirt every other day – about one-eighth of a male dose – on the sole of the foot, where hair does not grow.

“I would not prescribe testosterone for bone health. We have bisphosphonates and other much better treatments for that. And I would not prescribe it to someone who is seriously emotionally disturbed or seriously depressed. This is not a treatment for depression.”

“Postmenopausal testosterone is not ‘the latest greatest thing,’ but being very low risk, it’s worth trying once in a while, in the appropriate patient, at the right dose,” Dr. Korenman advised. He cautioned people to “avoid the longevity salespeople who sell all sorts of things in all sorts of doses to try to keep us alive forever.”

All contributors report no relevant financial relationships.

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

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