Ob.Gyn. News

Although drugstore shelves might suggest otherwise, affordable dietary supplements that provide critical nutrients in appropriate doses for pregnant women are virtually nonexistent, researchers have found.

In a new study published in the American Journal of Clinical Nutrition, investigators observed what many physicians have long suspected: Most prenatal vitamins and other supplements do not adequately make up the difference of what food-based intake of nutrients leave lacking. Despite patients believing they are getting everything they need with their product purchase, they fall short of guideline-recommended requirements.

“There is no magic pill,” said Katherine A. Sauder, PhD, an associate professor of pediatrics at the University of Colorado Anschutz Medical Campus, Aurora, and lead author of the study. “There is no easy answer here.”

Getty Images

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

Although drugstore shelves might suggest otherwise, affordable dietary supplements that provide critical nutrients in appropriate doses for pregnant women are virtually nonexistent, researchers have found.

In a new study published in the American Journal of Clinical Nutrition, investigators observed what many physicians have long suspected: Most prenatal vitamins and other supplements do not adequately make up the difference of what food-based intake of nutrients leave lacking. Despite patients believing they are getting everything they need with their product purchase, they fall short of guideline-recommended requirements.

“There is no magic pill,” said Katherine A. Sauder, PhD, an associate professor of pediatrics at the University of Colorado Anschutz Medical Campus, Aurora, and lead author of the study. “There is no easy answer here.”

Getty Images

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

Although drugstore shelves might suggest otherwise, affordable dietary supplements that provide critical nutrients in appropriate doses for pregnant women are virtually nonexistent, researchers have found.

In a new study published in the American Journal of Clinical Nutrition, investigators observed what many physicians have long suspected: Most prenatal vitamins and other supplements do not adequately make up the difference of what food-based intake of nutrients leave lacking. Despite patients believing they are getting everything they need with their product purchase, they fall short of guideline-recommended requirements.

“There is no magic pill,” said Katherine A. Sauder, PhD, an associate professor of pediatrics at the University of Colorado Anschutz Medical Campus, Aurora, and lead author of the study. “There is no easy answer here.”

Getty Images

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

Use of oophorectomy for adnexal torsion has remained at approximately 70% despite guidelines advising ovarian conservation, based on data from more than 1,700 individuals.

Prompt surgical management is essential in cases of ovarian torsion in order to salvage ovarian function, and recent studies have shown that conservative management with detorsion does not increase postoperative complications, compared with oophorectomy, wrote Hannah Ryles, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

The American College of Obstetricians and Gynecologists issued practice guidelines in November 2016 that recommended ovarian conservation rather than oophorectomy to manage adnexal torsion in women wishing to preserve fertility. However, the impact of this guideline on clinical practice and surgical patterns remains unclear, the researchers said.

In a study published in Obstetrics and Gynecology, the researchers reviewed data from 402 patients who underwent surgeries before the updated ACOG guidelines (2008-2016) and 1,389 who underwent surgeries after the guidelines (2017-2020). Surgery data came from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. The study population included women aged 18-50 years who underwent adnexal torsion surgery and were identified as having either oophorectomy or ovarian conservation surgery.

A total of 1,791 surgeries performed for adnexal torsion were included in the study; 542 (30.3%) involved ovarian conservation and 1,249 (69.7%) involved oophorectomy.

The proportion of oophorectomies was similar during the periods before and after the guidelines (71.9% vs. 69.1%; P = .16). However, the proportion of oophorectomies changed significantly across the entire study period, by approximately –1.6% each year.

Factors significantly associated with oophorectomy compared with ovarian conservation included older age (35 years vs. 28 years), higher body mass index (29.2 kg/m² vs. 27.5 kg/m²), anemia (12.2% vs. 7.2%), hypertension (10.4% vs. 3.1%), and higher American Society of Anesthesiologists classification.

“There remains no defined acceptable rate of oophorectomy; this decision involves multiple factors, such as fertility and other patient desires after a risk and benefit discussion, menopausal status, concern for malignancy, and safety and feasibility of conservative procedures,” the researchers wrote in their discussion. However, in emergency situations, it may be difficult to determine a patient’s preferences, and a lack of desire for future fertility may be presumed, which may contribute to the relatively high oophorectomy rates over time, they said.

The findings were limited by several factors including the retrospective design and lack of data on surgical history, histopathology, and intraoperative appearance of the ovary, as well as lack of clinical data including the time from presentation to diagnosis or surgery, the researchers noted. “Although we were also unable to determine obstetric history and fertility desires, our median age of 32 years reflects a young cohort that was limited to women of reproductive age,” they added.

However, the results reflect studies suggesting that clinical practice often lags behind updated guidelines, and the findings were strengthened by the use of the NSQIP database and reflect a need for greater efforts to promote ovarian conservation in accordance with the current guidelines, the researchers concluded.
 

Consider unilateral oophorectomy

The current study highlights the discrepancy between the ACOG guidelines and clinical practice, with “disappointingly low” rates of ovarian preservation in the adult population, wrote Riley J. Young, MD, and Kimberly A. Kho, MD, both of the University of Texas Southwestern Medical Center, Dallas, in an accompanying editorial. The reasons for the discrepancy include clinical concerns for conserving a torsed ovary and the difficulty of assessing fertility desires in an emergency situation, they said.

However, consideration of unilateral oophorectomy as an option should be part of clinical decision-making, according to the editorialists. Previous studies suggest that retention of a single ovarian may still allow for a successful pregnancy, and the effects of unilateral oophorectomy have been studied in infertility and assisted reproductive technology settings.

Women with a single ovary have fewer eggs and require higher amounts of gonadotropins, but pregnancy is possible, the editorialists said. However, the long-term effects of unilateral oophorectomy are uncertain, and potential detrimental outcomes include increased mortality and cognitive impairment; therefore “we aim for premenopausal ovaries simply to be conserved, whether fertility is the stated goal or not,” they noted. This may include consideration of unilateral oophorectomy. “Each ovary conserved at midnight moves us closer to a more acceptable ovarian conservation rate,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kho disclosed funding to her institution from Hologic for being on an investigator-initiated study, Dr. Young had no financial conflicts to disclose.

Use of oophorectomy for adnexal torsion has remained at approximately 70% despite guidelines advising ovarian conservation, based on data from more than 1,700 individuals.

Prompt surgical management is essential in cases of ovarian torsion in order to salvage ovarian function, and recent studies have shown that conservative management with detorsion does not increase postoperative complications, compared with oophorectomy, wrote Hannah Ryles, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

The American College of Obstetricians and Gynecologists issued practice guidelines in November 2016 that recommended ovarian conservation rather than oophorectomy to manage adnexal torsion in women wishing to preserve fertility. However, the impact of this guideline on clinical practice and surgical patterns remains unclear, the researchers said.

In a study published in Obstetrics and Gynecology, the researchers reviewed data from 402 patients who underwent surgeries before the updated ACOG guidelines (2008-2016) and 1,389 who underwent surgeries after the guidelines (2017-2020). Surgery data came from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. The study population included women aged 18-50 years who underwent adnexal torsion surgery and were identified as having either oophorectomy or ovarian conservation surgery.

A total of 1,791 surgeries performed for adnexal torsion were included in the study; 542 (30.3%) involved ovarian conservation and 1,249 (69.7%) involved oophorectomy.

The proportion of oophorectomies was similar during the periods before and after the guidelines (71.9% vs. 69.1%; P = .16). However, the proportion of oophorectomies changed significantly across the entire study period, by approximately –1.6% each year.

Factors significantly associated with oophorectomy compared with ovarian conservation included older age (35 years vs. 28 years), higher body mass index (29.2 kg/m² vs. 27.5 kg/m²), anemia (12.2% vs. 7.2%), hypertension (10.4% vs. 3.1%), and higher American Society of Anesthesiologists classification.

“There remains no defined acceptable rate of oophorectomy; this decision involves multiple factors, such as fertility and other patient desires after a risk and benefit discussion, menopausal status, concern for malignancy, and safety and feasibility of conservative procedures,” the researchers wrote in their discussion. However, in emergency situations, it may be difficult to determine a patient’s preferences, and a lack of desire for future fertility may be presumed, which may contribute to the relatively high oophorectomy rates over time, they said.

The findings were limited by several factors including the retrospective design and lack of data on surgical history, histopathology, and intraoperative appearance of the ovary, as well as lack of clinical data including the time from presentation to diagnosis or surgery, the researchers noted. “Although we were also unable to determine obstetric history and fertility desires, our median age of 32 years reflects a young cohort that was limited to women of reproductive age,” they added.

However, the results reflect studies suggesting that clinical practice often lags behind updated guidelines, and the findings were strengthened by the use of the NSQIP database and reflect a need for greater efforts to promote ovarian conservation in accordance with the current guidelines, the researchers concluded.
 

Consider unilateral oophorectomy

The current study highlights the discrepancy between the ACOG guidelines and clinical practice, with “disappointingly low” rates of ovarian preservation in the adult population, wrote Riley J. Young, MD, and Kimberly A. Kho, MD, both of the University of Texas Southwestern Medical Center, Dallas, in an accompanying editorial. The reasons for the discrepancy include clinical concerns for conserving a torsed ovary and the difficulty of assessing fertility desires in an emergency situation, they said.

However, consideration of unilateral oophorectomy as an option should be part of clinical decision-making, according to the editorialists. Previous studies suggest that retention of a single ovarian may still allow for a successful pregnancy, and the effects of unilateral oophorectomy have been studied in infertility and assisted reproductive technology settings.

Women with a single ovary have fewer eggs and require higher amounts of gonadotropins, but pregnancy is possible, the editorialists said. However, the long-term effects of unilateral oophorectomy are uncertain, and potential detrimental outcomes include increased mortality and cognitive impairment; therefore “we aim for premenopausal ovaries simply to be conserved, whether fertility is the stated goal or not,” they noted. This may include consideration of unilateral oophorectomy. “Each ovary conserved at midnight moves us closer to a more acceptable ovarian conservation rate,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kho disclosed funding to her institution from Hologic for being on an investigator-initiated study, Dr. Young had no financial conflicts to disclose.

Use of oophorectomy for adnexal torsion has remained at approximately 70% despite guidelines advising ovarian conservation, based on data from more than 1,700 individuals.

Prompt surgical management is essential in cases of ovarian torsion in order to salvage ovarian function, and recent studies have shown that conservative management with detorsion does not increase postoperative complications, compared with oophorectomy, wrote Hannah Ryles, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

The American College of Obstetricians and Gynecologists issued practice guidelines in November 2016 that recommended ovarian conservation rather than oophorectomy to manage adnexal torsion in women wishing to preserve fertility. However, the impact of this guideline on clinical practice and surgical patterns remains unclear, the researchers said.

In a study published in Obstetrics and Gynecology, the researchers reviewed data from 402 patients who underwent surgeries before the updated ACOG guidelines (2008-2016) and 1,389 who underwent surgeries after the guidelines (2017-2020). Surgery data came from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. The study population included women aged 18-50 years who underwent adnexal torsion surgery and were identified as having either oophorectomy or ovarian conservation surgery.

A total of 1,791 surgeries performed for adnexal torsion were included in the study; 542 (30.3%) involved ovarian conservation and 1,249 (69.7%) involved oophorectomy.

The proportion of oophorectomies was similar during the periods before and after the guidelines (71.9% vs. 69.1%; P = .16). However, the proportion of oophorectomies changed significantly across the entire study period, by approximately –1.6% each year.

Factors significantly associated with oophorectomy compared with ovarian conservation included older age (35 years vs. 28 years), higher body mass index (29.2 kg/m² vs. 27.5 kg/m²), anemia (12.2% vs. 7.2%), hypertension (10.4% vs. 3.1%), and higher American Society of Anesthesiologists classification.

“There remains no defined acceptable rate of oophorectomy; this decision involves multiple factors, such as fertility and other patient desires after a risk and benefit discussion, menopausal status, concern for malignancy, and safety and feasibility of conservative procedures,” the researchers wrote in their discussion. However, in emergency situations, it may be difficult to determine a patient’s preferences, and a lack of desire for future fertility may be presumed, which may contribute to the relatively high oophorectomy rates over time, they said.

The findings were limited by several factors including the retrospective design and lack of data on surgical history, histopathology, and intraoperative appearance of the ovary, as well as lack of clinical data including the time from presentation to diagnosis or surgery, the researchers noted. “Although we were also unable to determine obstetric history and fertility desires, our median age of 32 years reflects a young cohort that was limited to women of reproductive age,” they added.

However, the results reflect studies suggesting that clinical practice often lags behind updated guidelines, and the findings were strengthened by the use of the NSQIP database and reflect a need for greater efforts to promote ovarian conservation in accordance with the current guidelines, the researchers concluded.
 

Consider unilateral oophorectomy

The current study highlights the discrepancy between the ACOG guidelines and clinical practice, with “disappointingly low” rates of ovarian preservation in the adult population, wrote Riley J. Young, MD, and Kimberly A. Kho, MD, both of the University of Texas Southwestern Medical Center, Dallas, in an accompanying editorial. The reasons for the discrepancy include clinical concerns for conserving a torsed ovary and the difficulty of assessing fertility desires in an emergency situation, they said.

However, consideration of unilateral oophorectomy as an option should be part of clinical decision-making, according to the editorialists. Previous studies suggest that retention of a single ovarian may still allow for a successful pregnancy, and the effects of unilateral oophorectomy have been studied in infertility and assisted reproductive technology settings.

Women with a single ovary have fewer eggs and require higher amounts of gonadotropins, but pregnancy is possible, the editorialists said. However, the long-term effects of unilateral oophorectomy are uncertain, and potential detrimental outcomes include increased mortality and cognitive impairment; therefore “we aim for premenopausal ovaries simply to be conserved, whether fertility is the stated goal or not,” they noted. This may include consideration of unilateral oophorectomy. “Each ovary conserved at midnight moves us closer to a more acceptable ovarian conservation rate,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kho disclosed funding to her institution from Hologic for being on an investigator-initiated study, Dr. Young had no financial conflicts to disclose.

A new federal rule seeks to reduce Medicare Advantage insurance plans’ prior authorization burdens on physicians while also ensuring that enrollees have the same access to necessary care that they would receive under traditional fee-for-service Medicare.

The prior authorization changes, announced this week, are part of the Centers for Medicare & Medicaid Services’ 2024 update of policy changes for Medicare Advantage and Part D pharmacy plans

Medicare Advantage plans’ business practices have raised significant concerns in recent years. More than 28 million Americans were enrolled in a Medicare Advantage plan in 2022, which is nearly half of all Medicare enrollees, according to the Kaiser Family Foundation.

Medicare pays a fixed amount per enrollee per year to these privately run managed care plans, in contrast to traditional fee-for-service Medicare. Medicare Advantage plans have been criticized for aggressive marketing, for overbilling the federal government for care, and for using prior authorization to inappropriately deny needed care to patients.

About 13% of prior authorization requests that are denied by Medicare Advantage plans actually met Medicare coverage rules and should have been approved, the Office of the Inspector General at the U.S. Department of Health & Human Services reported in 2022.

The newly finalized rule now requires Medicare Advantage plans to do the following.

• Ensure that a prior authorization approval, once granted, remains valid for as long as medically necessary to avoid disruptions in care.
• Conduct an annual review of utilization management policies.
• Ensure that coverage denials based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued.

Physician groups welcomed the changes. In a statement, the American Medical Association said that an initial reading of the rule suggested CMS had “taken important steps toward right-sizing the prior authorization process.”

The Medical Group Management Association praised CMS in a statement for having limited “dangerous disruptions and delays to necessary patient care” resulting from the cumbersome processes of prior approval. With the new rules, CMS will provide greater consistency across Advantage plans as well as traditional Medicare, said Anders Gilberg, MGMA’s senior vice president of government affairs, in a statement.
 

Peer consideration

The final rule did disappoint physician groups in one key way. CMS rebuffed requests to have CMS require Advantage plans to use reviewers of the same specialty as treating physicians in handling disputes about prior authorization. CMS said it expects plans to exercise judgment in finding reviewers with “sufficient expertise to make an informed and supportable decision.”

“In some instances, we expect that plans will use a physician or other health care professional of the same specialty or subspecialty as the treating physician,” CMS said. “In other instances, we expect that plans will utilize a reviewer with specialized training, certification, or clinical experience in the applicable field of medicine.”
 

Medicare Advantage marketing ‘sowing confusion’

With this final rule, CMS also sought to protect consumers from “potentially misleading marketing practices” used in promoting Medicare Advantage and Part D prescription drug plans.

The agency said it had received complaints about people who have received official-looking promotional materials for Medicare that directed them not to government sources of information but to Medicare Advantage and Part D plans or their agents and brokers.

Ads now must mention a specific plan name, and they cannot use the Medicare name, CMS logo, Medicare card, or other government information in a misleading way, CMS said.

“CMS can see no value or purpose in a non-governmental entity’s use of the Medicare logo or HHS logo except for the express purpose of sowing confusion and misrepresenting itself as the government,” the agency said.

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

A new federal rule seeks to reduce Medicare Advantage insurance plans’ prior authorization burdens on physicians while also ensuring that enrollees have the same access to necessary care that they would receive under traditional fee-for-service Medicare.

The prior authorization changes, announced this week, are part of the Centers for Medicare & Medicaid Services’ 2024 update of policy changes for Medicare Advantage and Part D pharmacy plans

Medicare Advantage plans’ business practices have raised significant concerns in recent years. More than 28 million Americans were enrolled in a Medicare Advantage plan in 2022, which is nearly half of all Medicare enrollees, according to the Kaiser Family Foundation.

Medicare pays a fixed amount per enrollee per year to these privately run managed care plans, in contrast to traditional fee-for-service Medicare. Medicare Advantage plans have been criticized for aggressive marketing, for overbilling the federal government for care, and for using prior authorization to inappropriately deny needed care to patients.

About 13% of prior authorization requests that are denied by Medicare Advantage plans actually met Medicare coverage rules and should have been approved, the Office of the Inspector General at the U.S. Department of Health & Human Services reported in 2022.

The newly finalized rule now requires Medicare Advantage plans to do the following.

• Ensure that a prior authorization approval, once granted, remains valid for as long as medically necessary to avoid disruptions in care.
• Conduct an annual review of utilization management policies.
• Ensure that coverage denials based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued.

Physician groups welcomed the changes. In a statement, the American Medical Association said that an initial reading of the rule suggested CMS had “taken important steps toward right-sizing the prior authorization process.”

The Medical Group Management Association praised CMS in a statement for having limited “dangerous disruptions and delays to necessary patient care” resulting from the cumbersome processes of prior approval. With the new rules, CMS will provide greater consistency across Advantage plans as well as traditional Medicare, said Anders Gilberg, MGMA’s senior vice president of government affairs, in a statement.
 

Peer consideration

The final rule did disappoint physician groups in one key way. CMS rebuffed requests to have CMS require Advantage plans to use reviewers of the same specialty as treating physicians in handling disputes about prior authorization. CMS said it expects plans to exercise judgment in finding reviewers with “sufficient expertise to make an informed and supportable decision.”

“In some instances, we expect that plans will use a physician or other health care professional of the same specialty or subspecialty as the treating physician,” CMS said. “In other instances, we expect that plans will utilize a reviewer with specialized training, certification, or clinical experience in the applicable field of medicine.”
 

Medicare Advantage marketing ‘sowing confusion’

With this final rule, CMS also sought to protect consumers from “potentially misleading marketing practices” used in promoting Medicare Advantage and Part D prescription drug plans.

The agency said it had received complaints about people who have received official-looking promotional materials for Medicare that directed them not to government sources of information but to Medicare Advantage and Part D plans or their agents and brokers.

Ads now must mention a specific plan name, and they cannot use the Medicare name, CMS logo, Medicare card, or other government information in a misleading way, CMS said.

“CMS can see no value or purpose in a non-governmental entity’s use of the Medicare logo or HHS logo except for the express purpose of sowing confusion and misrepresenting itself as the government,” the agency said.

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

A new federal rule seeks to reduce Medicare Advantage insurance plans’ prior authorization burdens on physicians while also ensuring that enrollees have the same access to necessary care that they would receive under traditional fee-for-service Medicare.

The prior authorization changes, announced this week, are part of the Centers for Medicare & Medicaid Services’ 2024 update of policy changes for Medicare Advantage and Part D pharmacy plans

Medicare Advantage plans’ business practices have raised significant concerns in recent years. More than 28 million Americans were enrolled in a Medicare Advantage plan in 2022, which is nearly half of all Medicare enrollees, according to the Kaiser Family Foundation.

Medicare pays a fixed amount per enrollee per year to these privately run managed care plans, in contrast to traditional fee-for-service Medicare. Medicare Advantage plans have been criticized for aggressive marketing, for overbilling the federal government for care, and for using prior authorization to inappropriately deny needed care to patients.

About 13% of prior authorization requests that are denied by Medicare Advantage plans actually met Medicare coverage rules and should have been approved, the Office of the Inspector General at the U.S. Department of Health & Human Services reported in 2022.

The newly finalized rule now requires Medicare Advantage plans to do the following.

• Ensure that a prior authorization approval, once granted, remains valid for as long as medically necessary to avoid disruptions in care.
• Conduct an annual review of utilization management policies.
• Ensure that coverage denials based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued.

Physician groups welcomed the changes. In a statement, the American Medical Association said that an initial reading of the rule suggested CMS had “taken important steps toward right-sizing the prior authorization process.”

The Medical Group Management Association praised CMS in a statement for having limited “dangerous disruptions and delays to necessary patient care” resulting from the cumbersome processes of prior approval. With the new rules, CMS will provide greater consistency across Advantage plans as well as traditional Medicare, said Anders Gilberg, MGMA’s senior vice president of government affairs, in a statement.
 

Peer consideration

The final rule did disappoint physician groups in one key way. CMS rebuffed requests to have CMS require Advantage plans to use reviewers of the same specialty as treating physicians in handling disputes about prior authorization. CMS said it expects plans to exercise judgment in finding reviewers with “sufficient expertise to make an informed and supportable decision.”

“In some instances, we expect that plans will use a physician or other health care professional of the same specialty or subspecialty as the treating physician,” CMS said. “In other instances, we expect that plans will utilize a reviewer with specialized training, certification, or clinical experience in the applicable field of medicine.”
 

Medicare Advantage marketing ‘sowing confusion’

With this final rule, CMS also sought to protect consumers from “potentially misleading marketing practices” used in promoting Medicare Advantage and Part D prescription drug plans.

The agency said it had received complaints about people who have received official-looking promotional materials for Medicare that directed them not to government sources of information but to Medicare Advantage and Part D plans or their agents and brokers.

Ads now must mention a specific plan name, and they cannot use the Medicare name, CMS logo, Medicare card, or other government information in a misleading way, CMS said.

“CMS can see no value or purpose in a non-governmental entity’s use of the Medicare logo or HHS logo except for the express purpose of sowing confusion and misrepresenting itself as the government,” the agency said.

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

With more than 306 million views, #hormonebalance and #hormonebalancing are among the latest hacks to take over the social media platform TikTok, on which users post short videos. Influencers offer advice such as eating raw carrots for “happy hormones,” eating protein followed by fat for breakfast to regulate blood glucose, or taking vitamin B2 supplements for thyroid health.

Have you ever wondered if you were asleep during the lecture on “hormone balancing” in medical school? No, you weren’t. It was never a class for good reason, and you didn’t fail to read any such breakthrough studies in The New England Journal of Medicine either.

Although the sound bites no doubt garner attention among TikTok users, “hormone balancing” is a fictional term that is practically meaningless.

There are over 50 different hormones produced by humans and animals, regulating sleep, growth, metabolism and reproduction, among many other biological processes, so there is certainly no one-size-fits-all solution to ensure these are all working in perfect harmony.

When someone mentions “hormone balancing,” my mind wanders to the last time I took my car to have my tires rotated and balanced. If only it were as simple to balance hormones in real life. The best we can hope for is to get a specific hormone within the ideal physiologic range for that person’s age.

The term “hormone” can mean many things to different people. When a woman comes in with a hormone question, for example, it is often related to estrogen, followed by thyroid hormones. A wealth of misinformation exists in popular literature regarding these hormones alone.

Estrogen can be replaced, but not everyone needs it replaced. It depends on variables including age, underlying medical conditions, the time of day a test was drawn, and concomitant medications. Having low levels of a given hormone does not necessarily call for replacement either.

Insulin is another example of a hormone that can never completely be replaced in people with diabetes in a way that exactly mimics the normal physiologic release.

There are many lesser-known hormones that are measurable and replaceable but are also more difficult to reset to original manufacturer specifications.

A Google search for “hormone balancing” often sends you to “naturopaths” or “integrative medicine” practitioners, who often propose similar solutions to the TikTok influencers. Users are told that their hormones are out of whack and that restoring this “balance” can be achieved by purchasing whatever “natural products” or concoction they are selling.

These TikTok videos and online “experts” are the home-brewed versions of the strip-mall hormone specialists. TikTok videos claiming to help “balance hormones” typically don’t name a specific hormone either, or the end organs that each would have an impact on. Rather, they lump all hormones into a monolithic entity, implying that there is a single solution for all health problems. And personal testimonials extolling the benefits of a TikTok intervention don’t constitute proof of efficacy no matter how many “likes” they get. These influencers assume that viewers can “sense” their hormones are out of tune and no lab tests can convince them otherwise.

In these inflationary times, the cost of seeking medical care from conventional channels is increasingly prohibitive. It’s easy to understand the appeal of getting free advice from TikTok or some other Internet site. At best, following the advice will not have much impact; at worst, it could be harmful.
 

Don’t try this at home

There are some things that should never be tried at home, and do-it-yourself hormone replacement or remediation both fall under this umbrella.

Generally, the body does a good job of balancing its own hormones. Most patients don’t need to be worried if they’re in good health. If they’re in doubt, they should seek advice from a doctor, ideally an endocrinologist, but an ob.gyn. or general practitioner are also good options.

One of the first questions to ask a patient is “Which hormone are you worried about?” or “What health issue is it specifically that is bothering you?” Narrowing the focus to a single thing, if possible, will lead to a more efficient evaluation.

Often, patients arrive with multiple concerns written on little pieces of paper. These ubiquitous pieces of paper are the red flag for the flood of questions to follow.

Ordering the appropriate tests for the conditions they are concerned about can help put their minds at ease. If there are any specific deficiencies, or excesses in any hormones, then appropriate solutions can be discussed.

TikTok hormone-balancing solutions are simply the 21st-century version of the snake oil sold on late-night cable TV in the 1990s.

Needless to say, you should gently encourage your patients to stay away from these non–FDA-approved products, without making them feel stupid. Off-label use of hormones when these are not indicated is also to be avoided, unless a medical practitioner feels it is warranted.

Dr. de la Rosa is an endocrinologist in Englewood, Fla. He disclosed no conflicts of interest.

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

With more than 306 million views, #hormonebalance and #hormonebalancing are among the latest hacks to take over the social media platform TikTok, on which users post short videos. Influencers offer advice such as eating raw carrots for “happy hormones,” eating protein followed by fat for breakfast to regulate blood glucose, or taking vitamin B2 supplements for thyroid health.

Have you ever wondered if you were asleep during the lecture on “hormone balancing” in medical school? No, you weren’t. It was never a class for good reason, and you didn’t fail to read any such breakthrough studies in The New England Journal of Medicine either.

Although the sound bites no doubt garner attention among TikTok users, “hormone balancing” is a fictional term that is practically meaningless.

There are over 50 different hormones produced by humans and animals, regulating sleep, growth, metabolism and reproduction, among many other biological processes, so there is certainly no one-size-fits-all solution to ensure these are all working in perfect harmony.

When someone mentions “hormone balancing,” my mind wanders to the last time I took my car to have my tires rotated and balanced. If only it were as simple to balance hormones in real life. The best we can hope for is to get a specific hormone within the ideal physiologic range for that person’s age.

The term “hormone” can mean many things to different people. When a woman comes in with a hormone question, for example, it is often related to estrogen, followed by thyroid hormones. A wealth of misinformation exists in popular literature regarding these hormones alone.

Estrogen can be replaced, but not everyone needs it replaced. It depends on variables including age, underlying medical conditions, the time of day a test was drawn, and concomitant medications. Having low levels of a given hormone does not necessarily call for replacement either.

Insulin is another example of a hormone that can never completely be replaced in people with diabetes in a way that exactly mimics the normal physiologic release.

There are many lesser-known hormones that are measurable and replaceable but are also more difficult to reset to original manufacturer specifications.

A Google search for “hormone balancing” often sends you to “naturopaths” or “integrative medicine” practitioners, who often propose similar solutions to the TikTok influencers. Users are told that their hormones are out of whack and that restoring this “balance” can be achieved by purchasing whatever “natural products” or concoction they are selling.

These TikTok videos and online “experts” are the home-brewed versions of the strip-mall hormone specialists. TikTok videos claiming to help “balance hormones” typically don’t name a specific hormone either, or the end organs that each would have an impact on. Rather, they lump all hormones into a monolithic entity, implying that there is a single solution for all health problems. And personal testimonials extolling the benefits of a TikTok intervention don’t constitute proof of efficacy no matter how many “likes” they get. These influencers assume that viewers can “sense” their hormones are out of tune and no lab tests can convince them otherwise.

In these inflationary times, the cost of seeking medical care from conventional channels is increasingly prohibitive. It’s easy to understand the appeal of getting free advice from TikTok or some other Internet site. At best, following the advice will not have much impact; at worst, it could be harmful.
 

Don’t try this at home

There are some things that should never be tried at home, and do-it-yourself hormone replacement or remediation both fall under this umbrella.

Generally, the body does a good job of balancing its own hormones. Most patients don’t need to be worried if they’re in good health. If they’re in doubt, they should seek advice from a doctor, ideally an endocrinologist, but an ob.gyn. or general practitioner are also good options.

One of the first questions to ask a patient is “Which hormone are you worried about?” or “What health issue is it specifically that is bothering you?” Narrowing the focus to a single thing, if possible, will lead to a more efficient evaluation.

Often, patients arrive with multiple concerns written on little pieces of paper. These ubiquitous pieces of paper are the red flag for the flood of questions to follow.

Ordering the appropriate tests for the conditions they are concerned about can help put their minds at ease. If there are any specific deficiencies, or excesses in any hormones, then appropriate solutions can be discussed.

TikTok hormone-balancing solutions are simply the 21st-century version of the snake oil sold on late-night cable TV in the 1990s.

Needless to say, you should gently encourage your patients to stay away from these non–FDA-approved products, without making them feel stupid. Off-label use of hormones when these are not indicated is also to be avoided, unless a medical practitioner feels it is warranted.

Dr. de la Rosa is an endocrinologist in Englewood, Fla. He disclosed no conflicts of interest.

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

With more than 306 million views, #hormonebalance and #hormonebalancing are among the latest hacks to take over the social media platform TikTok, on which users post short videos. Influencers offer advice such as eating raw carrots for “happy hormones,” eating protein followed by fat for breakfast to regulate blood glucose, or taking vitamin B2 supplements for thyroid health.

Have you ever wondered if you were asleep during the lecture on “hormone balancing” in medical school? No, you weren’t. It was never a class for good reason, and you didn’t fail to read any such breakthrough studies in The New England Journal of Medicine either.

Although the sound bites no doubt garner attention among TikTok users, “hormone balancing” is a fictional term that is practically meaningless.

There are over 50 different hormones produced by humans and animals, regulating sleep, growth, metabolism and reproduction, among many other biological processes, so there is certainly no one-size-fits-all solution to ensure these are all working in perfect harmony.

When someone mentions “hormone balancing,” my mind wanders to the last time I took my car to have my tires rotated and balanced. If only it were as simple to balance hormones in real life. The best we can hope for is to get a specific hormone within the ideal physiologic range for that person’s age.

The term “hormone” can mean many things to different people. When a woman comes in with a hormone question, for example, it is often related to estrogen, followed by thyroid hormones. A wealth of misinformation exists in popular literature regarding these hormones alone.

Estrogen can be replaced, but not everyone needs it replaced. It depends on variables including age, underlying medical conditions, the time of day a test was drawn, and concomitant medications. Having low levels of a given hormone does not necessarily call for replacement either.

Insulin is another example of a hormone that can never completely be replaced in people with diabetes in a way that exactly mimics the normal physiologic release.

There are many lesser-known hormones that are measurable and replaceable but are also more difficult to reset to original manufacturer specifications.

A Google search for “hormone balancing” often sends you to “naturopaths” or “integrative medicine” practitioners, who often propose similar solutions to the TikTok influencers. Users are told that their hormones are out of whack and that restoring this “balance” can be achieved by purchasing whatever “natural products” or concoction they are selling.

These TikTok videos and online “experts” are the home-brewed versions of the strip-mall hormone specialists. TikTok videos claiming to help “balance hormones” typically don’t name a specific hormone either, or the end organs that each would have an impact on. Rather, they lump all hormones into a monolithic entity, implying that there is a single solution for all health problems. And personal testimonials extolling the benefits of a TikTok intervention don’t constitute proof of efficacy no matter how many “likes” they get. These influencers assume that viewers can “sense” their hormones are out of tune and no lab tests can convince them otherwise.

In these inflationary times, the cost of seeking medical care from conventional channels is increasingly prohibitive. It’s easy to understand the appeal of getting free advice from TikTok or some other Internet site. At best, following the advice will not have much impact; at worst, it could be harmful.
 

Don’t try this at home

There are some things that should never be tried at home, and do-it-yourself hormone replacement or remediation both fall under this umbrella.

Generally, the body does a good job of balancing its own hormones. Most patients don’t need to be worried if they’re in good health. If they’re in doubt, they should seek advice from a doctor, ideally an endocrinologist, but an ob.gyn. or general practitioner are also good options.

One of the first questions to ask a patient is “Which hormone are you worried about?” or “What health issue is it specifically that is bothering you?” Narrowing the focus to a single thing, if possible, will lead to a more efficient evaluation.

Often, patients arrive with multiple concerns written on little pieces of paper. These ubiquitous pieces of paper are the red flag for the flood of questions to follow.

Ordering the appropriate tests for the conditions they are concerned about can help put their minds at ease. If there are any specific deficiencies, or excesses in any hormones, then appropriate solutions can be discussed.

TikTok hormone-balancing solutions are simply the 21st-century version of the snake oil sold on late-night cable TV in the 1990s.

Needless to say, you should gently encourage your patients to stay away from these non–FDA-approved products, without making them feel stupid. Off-label use of hormones when these are not indicated is also to be avoided, unless a medical practitioner feels it is warranted.

Dr. de la Rosa is an endocrinologist in Englewood, Fla. He disclosed no conflicts of interest.

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

Approximately 10,000 suicide deaths are recorded in Brazil every year. The suicide risk is highest among patients with depressive disorders, particularly women (> 18% vs. 11% for men).

There are countless people who work to prevent suicide, and the challenges they face are many. But now, on the horizon, there are new tools that could prove invaluable to their efforts – tools such as biomarkers. In a study recently published in the journal Frontiers in Psychiatry, researchers from the Catholic University of Pelotas (UCPel), Brazil, reported an association of glutathione (GSH) with the degree of suicide risk in women at 18 months postpartum. Specifically, they found that reduced serum GSH levels were significantly lower for those with moderate to high suicide risk than for those without suicide risk. Their findings suggest that GSH may be a potential biomarker or etiologic factor among women at risk for suicide, with therapeutic implications.

This was a case-control study nested within a cohort study. From this cohort, 45 women were selected at 18 months postpartum. Thirty of them had mood disorders, such as major depression and bipolar disorder. The other 15 participants, none of whom had a mood disorder, made up the control group.

Depression and the risk for suicide were assessed using the Mini International Neuropsychiatric Interview Plus (MINI-Plus 5.0.0 Brazilian version), module A and module C, respectively. Blood samples were collected to evaluate serum levels of the following oxidative stress biomarkers: reactive oxygen species, superoxide dismutase, and GSH.

The prevalence of suicide risk observed in the women at 18 months postpartum was 24.4%. The prevalence of suicide risk in the mood disorder group was 36.7%.

In addition, the statistical analysis found that women with moderate to high suicide risk had cerebral redox imbalance, resulting in a decrease in blood GSH levels.

The study team was led by neuroscientist Adriano Martimbianco de Assis, PhD, the coordinator of UCPel’s postgraduate program in health and behavior. He said that the correlation identified between GSH serum levels and suicide risk gives rise to two possible applications: using GSH as a biomarker for suicide risk and using GSH therapeutically.

Regarding the former application, Dr. Martimbianco de Assis explained that additional studies are needed to take a step forward. “Although we believe that most of the GSH came from the brain – given that it’s the brain’s main antioxidant – as we analyze blood samples, we’re not yet able to rule out the possibility that it came from other organs,” he said in an interview. So, confirming that hypothesis will require studies that involve imaging brain tissue. According to Dr. Martimbianco de Assis, once there is confirmation, it will be possible to move to using the antioxidant as a biomarker for suicide risk.

He also shared his views about the second application: using GSH therapeutically. “We already know that there are very simple alternatives that can influence GSH levels, [and they] mostly have to do with exercise and [improving the quality of] the food one eats. But there are also drugs: for example, N-acetyl cysteine, which is a precursor of GSH.” Adopting strategies to increase the levels of this antioxidant in the body should reverse the imbalance identified in the study and, as a result, may lead to lowering the risk for suicide. But, he reiterated, “getting to a place where GSH [can be used] in clinical practice hinges on getting that confirmation that it did, in fact, come from the brain. Recall that our study found lower levels of GSH in women at risk for suicide.”

Even though the study evaluated postpartum women, it’s possible that the results can be extrapolated to other populations, said Dr. Martimbianco de Assis. This is because when the data were collected, 18 months had already passed since giving birth. The participants’ physiological condition at that point was more similar to the one prior to becoming pregnant.

The UCPel researchers continue to follow the cohort. “We intend to continue monitoring GSH levels at other times. Forty-eight months have now passed since the women gave birth, and the idea is to continue studying [the patients involved in the study],” said Dr. Martimbianco de Assis, adding that the team also intends to analyze brain tissue from in vitro studies using cell cultures.

This article was translated from the Medscape Portuguese Edition and a version appeared on Medscape.com.

Approximately 10,000 suicide deaths are recorded in Brazil every year. The suicide risk is highest among patients with depressive disorders, particularly women (> 18% vs. 11% for men).

There are countless people who work to prevent suicide, and the challenges they face are many. But now, on the horizon, there are new tools that could prove invaluable to their efforts – tools such as biomarkers. In a study recently published in the journal Frontiers in Psychiatry, researchers from the Catholic University of Pelotas (UCPel), Brazil, reported an association of glutathione (GSH) with the degree of suicide risk in women at 18 months postpartum. Specifically, they found that reduced serum GSH levels were significantly lower for those with moderate to high suicide risk than for those without suicide risk. Their findings suggest that GSH may be a potential biomarker or etiologic factor among women at risk for suicide, with therapeutic implications.

This was a case-control study nested within a cohort study. From this cohort, 45 women were selected at 18 months postpartum. Thirty of them had mood disorders, such as major depression and bipolar disorder. The other 15 participants, none of whom had a mood disorder, made up the control group.

Depression and the risk for suicide were assessed using the Mini International Neuropsychiatric Interview Plus (MINI-Plus 5.0.0 Brazilian version), module A and module C, respectively. Blood samples were collected to evaluate serum levels of the following oxidative stress biomarkers: reactive oxygen species, superoxide dismutase, and GSH.

The prevalence of suicide risk observed in the women at 18 months postpartum was 24.4%. The prevalence of suicide risk in the mood disorder group was 36.7%.

In addition, the statistical analysis found that women with moderate to high suicide risk had cerebral redox imbalance, resulting in a decrease in blood GSH levels.

The study team was led by neuroscientist Adriano Martimbianco de Assis, PhD, the coordinator of UCPel’s postgraduate program in health and behavior. He said that the correlation identified between GSH serum levels and suicide risk gives rise to two possible applications: using GSH as a biomarker for suicide risk and using GSH therapeutically.

Regarding the former application, Dr. Martimbianco de Assis explained that additional studies are needed to take a step forward. “Although we believe that most of the GSH came from the brain – given that it’s the brain’s main antioxidant – as we analyze blood samples, we’re not yet able to rule out the possibility that it came from other organs,” he said in an interview. So, confirming that hypothesis will require studies that involve imaging brain tissue. According to Dr. Martimbianco de Assis, once there is confirmation, it will be possible to move to using the antioxidant as a biomarker for suicide risk.

He also shared his views about the second application: using GSH therapeutically. “We already know that there are very simple alternatives that can influence GSH levels, [and they] mostly have to do with exercise and [improving the quality of] the food one eats. But there are also drugs: for example, N-acetyl cysteine, which is a precursor of GSH.” Adopting strategies to increase the levels of this antioxidant in the body should reverse the imbalance identified in the study and, as a result, may lead to lowering the risk for suicide. But, he reiterated, “getting to a place where GSH [can be used] in clinical practice hinges on getting that confirmation that it did, in fact, come from the brain. Recall that our study found lower levels of GSH in women at risk for suicide.”

Even though the study evaluated postpartum women, it’s possible that the results can be extrapolated to other populations, said Dr. Martimbianco de Assis. This is because when the data were collected, 18 months had already passed since giving birth. The participants’ physiological condition at that point was more similar to the one prior to becoming pregnant.

The UCPel researchers continue to follow the cohort. “We intend to continue monitoring GSH levels at other times. Forty-eight months have now passed since the women gave birth, and the idea is to continue studying [the patients involved in the study],” said Dr. Martimbianco de Assis, adding that the team also intends to analyze brain tissue from in vitro studies using cell cultures.

This article was translated from the Medscape Portuguese Edition and a version appeared on Medscape.com.

Approximately 10,000 suicide deaths are recorded in Brazil every year. The suicide risk is highest among patients with depressive disorders, particularly women (> 18% vs. 11% for men).

There are countless people who work to prevent suicide, and the challenges they face are many. But now, on the horizon, there are new tools that could prove invaluable to their efforts – tools such as biomarkers. In a study recently published in the journal Frontiers in Psychiatry, researchers from the Catholic University of Pelotas (UCPel), Brazil, reported an association of glutathione (GSH) with the degree of suicide risk in women at 18 months postpartum. Specifically, they found that reduced serum GSH levels were significantly lower for those with moderate to high suicide risk than for those without suicide risk. Their findings suggest that GSH may be a potential biomarker or etiologic factor among women at risk for suicide, with therapeutic implications.

This was a case-control study nested within a cohort study. From this cohort, 45 women were selected at 18 months postpartum. Thirty of them had mood disorders, such as major depression and bipolar disorder. The other 15 participants, none of whom had a mood disorder, made up the control group.

Depression and the risk for suicide were assessed using the Mini International Neuropsychiatric Interview Plus (MINI-Plus 5.0.0 Brazilian version), module A and module C, respectively. Blood samples were collected to evaluate serum levels of the following oxidative stress biomarkers: reactive oxygen species, superoxide dismutase, and GSH.

The prevalence of suicide risk observed in the women at 18 months postpartum was 24.4%. The prevalence of suicide risk in the mood disorder group was 36.7%.

In addition, the statistical analysis found that women with moderate to high suicide risk had cerebral redox imbalance, resulting in a decrease in blood GSH levels.

The study team was led by neuroscientist Adriano Martimbianco de Assis, PhD, the coordinator of UCPel’s postgraduate program in health and behavior. He said that the correlation identified between GSH serum levels and suicide risk gives rise to two possible applications: using GSH as a biomarker for suicide risk and using GSH therapeutically.

Regarding the former application, Dr. Martimbianco de Assis explained that additional studies are needed to take a step forward. “Although we believe that most of the GSH came from the brain – given that it’s the brain’s main antioxidant – as we analyze blood samples, we’re not yet able to rule out the possibility that it came from other organs,” he said in an interview. So, confirming that hypothesis will require studies that involve imaging brain tissue. According to Dr. Martimbianco de Assis, once there is confirmation, it will be possible to move to using the antioxidant as a biomarker for suicide risk.

He also shared his views about the second application: using GSH therapeutically. “We already know that there are very simple alternatives that can influence GSH levels, [and they] mostly have to do with exercise and [improving the quality of] the food one eats. But there are also drugs: for example, N-acetyl cysteine, which is a precursor of GSH.” Adopting strategies to increase the levels of this antioxidant in the body should reverse the imbalance identified in the study and, as a result, may lead to lowering the risk for suicide. But, he reiterated, “getting to a place where GSH [can be used] in clinical practice hinges on getting that confirmation that it did, in fact, come from the brain. Recall that our study found lower levels of GSH in women at risk for suicide.”

Even though the study evaluated postpartum women, it’s possible that the results can be extrapolated to other populations, said Dr. Martimbianco de Assis. This is because when the data were collected, 18 months had already passed since giving birth. The participants’ physiological condition at that point was more similar to the one prior to becoming pregnant.

The UCPel researchers continue to follow the cohort. “We intend to continue monitoring GSH levels at other times. Forty-eight months have now passed since the women gave birth, and the idea is to continue studying [the patients involved in the study],” said Dr. Martimbianco de Assis, adding that the team also intends to analyze brain tissue from in vitro studies using cell cultures.

This article was translated from the Medscape Portuguese Edition and a version appeared on Medscape.com.

For women with excessive menstrual blood loss, the contraceptive levonorgestrel 52 mg delivered via an intrauterine device (IUD) reduced monthly blood loss by more than 90% over six monthly cycles, a multicenter open-label study reports.

Median blood loss decreased by more than 90% in the first three cycles. Overall, treatment was successful in 81.8% of 99 patients (95% confidence interval, 74.2%-89.4%), according to findings published in Obstetrics & Gynecology.

Racially diverse cohort

Conducted at 29 U.S. sites prior to seeking FDA registration for this new use, the phase 3 open-label trial of the 52 mg progestin-releasing IUD enrolled 105 participants with a mean age of 35.4 years. Unlike previous trials, this one included obese or severely obese women (44.8%), with 42 participants having a body mass index (BMI) of more than 35 kg/m², and also 28 nulliparous women (27.6%).

Those with abnormalities such as fibroids or coagulopathies were excluded. Although most of the cohort was White (n = 68), the study included Black (n = 25), Asian (n = 4), and Hispanic (n = 10) women, plus 7 from other minorities, suggesting the results would be widely applicable.

Mean baseline blood loss in the cohort ranged from 73 mL to 520 mL (median, 143 mL). Of 89 treated women with follow-up, participants had a median absolute blood-loss decreases of 93.3% (86.1%-97.8%) at cycle three and 97.6% (90.4%-100%) at cycle six. Median bleeding reductions at cycle six were similar between women with and without obesity at 97.6% and 97.5%, respectively, and between nulliparous and parous women at 97.0% and 98.1%, respectively (P = .43). The study, however, was not sufficiently powered to fully analyze these subgroups, the authors acknowledged.

Although results were overall comparable with those of a previous study on a different IUD, the expulsion rate was somewhat higher, at 9%, than the 6% reported in the earlier study.

Brigham and Women’s Hospital

“Although this strategy for reducing blood loss is not new, this study is notable because it looked at high-BMI women and nulliparous women,” said Kathryn J. Gray, MD, PhD, an attending physician in the department of obstetrics and gynecology at Brigham and Women’s Hospital in Boston, who was not involved in the research.“No prior trials have included patients with BMIs exceeding 35 kg/m² or nulliparous patients, while this study enrolled a full array of patients, which allowed exploratory analyses of these subpopulations,” Dr. Creinin confirmed.

According to Dr. Gray, the IUD approach has advantages over systemic treatment with oral medication. “First, treatment is not user-dependent so the user doesn’t have to remember to take it. In addition, because the medication is locally targeted in the uterus, it is more effective and there is less fluctuation and variability in drug levels than when taken orally.”

As to treatment durability, Dr. Creinin said, “Long-term studies in a population being treated for heavy menstrual bleeding would be helpful to have an idea of how long this effect lasts. Still, there is no reason to expect that the effect will not last for many years.”

And with this treatment, he added, both patient and clinician can readily detect its effect. “If bleeding begins to increase, they will know!”

Would there be a lingering residual effect even after removal of the IUD? “That is an excellent question that remains to be answered,” Dr. Creinin said. “There are no data on when the heavy bleeding returns, but it would be expected to do so.”

This study was funded, designed, and supervised by Medicines360, which also provided the study treatment. Dr. Creinin disclosed financial relationships with various private-sector companies, including Medicines360, Organon, Fuji Pharma, GlaxoSmithKline, and Merck & Co. Multiple study coauthors disclosed similar financial ties to industry partners, including Medicines360. Dr. Gray had no potential conflicts of interest with regard to her comments.

For women with excessive menstrual blood loss, the contraceptive levonorgestrel 52 mg delivered via an intrauterine device (IUD) reduced monthly blood loss by more than 90% over six monthly cycles, a multicenter open-label study reports.

Median blood loss decreased by more than 90% in the first three cycles. Overall, treatment was successful in 81.8% of 99 patients (95% confidence interval, 74.2%-89.4%), according to findings published in Obstetrics & Gynecology.

Racially diverse cohort

Conducted at 29 U.S. sites prior to seeking FDA registration for this new use, the phase 3 open-label trial of the 52 mg progestin-releasing IUD enrolled 105 participants with a mean age of 35.4 years. Unlike previous trials, this one included obese or severely obese women (44.8%), with 42 participants having a body mass index (BMI) of more than 35 kg/m², and also 28 nulliparous women (27.6%).

Those with abnormalities such as fibroids or coagulopathies were excluded. Although most of the cohort was White (n = 68), the study included Black (n = 25), Asian (n = 4), and Hispanic (n = 10) women, plus 7 from other minorities, suggesting the results would be widely applicable.

Mean baseline blood loss in the cohort ranged from 73 mL to 520 mL (median, 143 mL). Of 89 treated women with follow-up, participants had a median absolute blood-loss decreases of 93.3% (86.1%-97.8%) at cycle three and 97.6% (90.4%-100%) at cycle six. Median bleeding reductions at cycle six were similar between women with and without obesity at 97.6% and 97.5%, respectively, and between nulliparous and parous women at 97.0% and 98.1%, respectively (P = .43). The study, however, was not sufficiently powered to fully analyze these subgroups, the authors acknowledged.

Although results were overall comparable with those of a previous study on a different IUD, the expulsion rate was somewhat higher, at 9%, than the 6% reported in the earlier study.

Brigham and Women’s Hospital

“Although this strategy for reducing blood loss is not new, this study is notable because it looked at high-BMI women and nulliparous women,” said Kathryn J. Gray, MD, PhD, an attending physician in the department of obstetrics and gynecology at Brigham and Women’s Hospital in Boston, who was not involved in the research.“No prior trials have included patients with BMIs exceeding 35 kg/m² or nulliparous patients, while this study enrolled a full array of patients, which allowed exploratory analyses of these subpopulations,” Dr. Creinin confirmed.

According to Dr. Gray, the IUD approach has advantages over systemic treatment with oral medication. “First, treatment is not user-dependent so the user doesn’t have to remember to take it. In addition, because the medication is locally targeted in the uterus, it is more effective and there is less fluctuation and variability in drug levels than when taken orally.”

As to treatment durability, Dr. Creinin said, “Long-term studies in a population being treated for heavy menstrual bleeding would be helpful to have an idea of how long this effect lasts. Still, there is no reason to expect that the effect will not last for many years.”

And with this treatment, he added, both patient and clinician can readily detect its effect. “If bleeding begins to increase, they will know!”

Would there be a lingering residual effect even after removal of the IUD? “That is an excellent question that remains to be answered,” Dr. Creinin said. “There are no data on when the heavy bleeding returns, but it would be expected to do so.”

This study was funded, designed, and supervised by Medicines360, which also provided the study treatment. Dr. Creinin disclosed financial relationships with various private-sector companies, including Medicines360, Organon, Fuji Pharma, GlaxoSmithKline, and Merck & Co. Multiple study coauthors disclosed similar financial ties to industry partners, including Medicines360. Dr. Gray had no potential conflicts of interest with regard to her comments.

For women with excessive menstrual blood loss, the contraceptive levonorgestrel 52 mg delivered via an intrauterine device (IUD) reduced monthly blood loss by more than 90% over six monthly cycles, a multicenter open-label study reports.

Median blood loss decreased by more than 90% in the first three cycles. Overall, treatment was successful in 81.8% of 99 patients (95% confidence interval, 74.2%-89.4%), according to findings published in Obstetrics & Gynecology.

Racially diverse cohort

Conducted at 29 U.S. sites prior to seeking FDA registration for this new use, the phase 3 open-label trial of the 52 mg progestin-releasing IUD enrolled 105 participants with a mean age of 35.4 years. Unlike previous trials, this one included obese or severely obese women (44.8%), with 42 participants having a body mass index (BMI) of more than 35 kg/m², and also 28 nulliparous women (27.6%).

Those with abnormalities such as fibroids or coagulopathies were excluded. Although most of the cohort was White (n = 68), the study included Black (n = 25), Asian (n = 4), and Hispanic (n = 10) women, plus 7 from other minorities, suggesting the results would be widely applicable.

Mean baseline blood loss in the cohort ranged from 73 mL to 520 mL (median, 143 mL). Of 89 treated women with follow-up, participants had a median absolute blood-loss decreases of 93.3% (86.1%-97.8%) at cycle three and 97.6% (90.4%-100%) at cycle six. Median bleeding reductions at cycle six were similar between women with and without obesity at 97.6% and 97.5%, respectively, and between nulliparous and parous women at 97.0% and 98.1%, respectively (P = .43). The study, however, was not sufficiently powered to fully analyze these subgroups, the authors acknowledged.

Although results were overall comparable with those of a previous study on a different IUD, the expulsion rate was somewhat higher, at 9%, than the 6% reported in the earlier study.

Brigham and Women’s Hospital

“Although this strategy for reducing blood loss is not new, this study is notable because it looked at high-BMI women and nulliparous women,” said Kathryn J. Gray, MD, PhD, an attending physician in the department of obstetrics and gynecology at Brigham and Women’s Hospital in Boston, who was not involved in the research.“No prior trials have included patients with BMIs exceeding 35 kg/m² or nulliparous patients, while this study enrolled a full array of patients, which allowed exploratory analyses of these subpopulations,” Dr. Creinin confirmed.

According to Dr. Gray, the IUD approach has advantages over systemic treatment with oral medication. “First, treatment is not user-dependent so the user doesn’t have to remember to take it. In addition, because the medication is locally targeted in the uterus, it is more effective and there is less fluctuation and variability in drug levels than when taken orally.”

As to treatment durability, Dr. Creinin said, “Long-term studies in a population being treated for heavy menstrual bleeding would be helpful to have an idea of how long this effect lasts. Still, there is no reason to expect that the effect will not last for many years.”

And with this treatment, he added, both patient and clinician can readily detect its effect. “If bleeding begins to increase, they will know!”

Would there be a lingering residual effect even after removal of the IUD? “That is an excellent question that remains to be answered,” Dr. Creinin said. “There are no data on when the heavy bleeding returns, but it would be expected to do so.”

This study was funded, designed, and supervised by Medicines360, which also provided the study treatment. Dr. Creinin disclosed financial relationships with various private-sector companies, including Medicines360, Organon, Fuji Pharma, GlaxoSmithKline, and Merck & Co. Multiple study coauthors disclosed similar financial ties to industry partners, including Medicines360. Dr. Gray had no potential conflicts of interest with regard to her comments.

Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.

For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.

“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”

The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.

“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”

High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.

“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.

In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.

The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.

“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.

A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.

“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”

“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”

Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”

Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”

Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.

The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.

Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.

For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.

“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”

The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.

“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”

High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.

“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.

In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.

The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.

“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.

A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.

“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”

“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”

Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”

Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”

Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.

The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.

Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.

For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.

“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”

The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.

“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”

High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.

“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.

In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.

The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.

“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.

A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.

“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”

“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”

Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”

Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”

Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.

The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.

Implementing universal ultrasound during the third trimester of pregnancy significantly reduced the number of undiagnosed breech presentations, according to a study published in PLOS Medicine. The effects held if sonographers used a traditional ultrasound machine or if midwives used a handheld ultrasound tool to perform what is known as a point-of-care ultrasound (POCUS) procedure.

“Giving pregnant women a third-trimester scan reduces the rate of undetected breech in labor by over two-thirds, which reduces the chances of harm to the baby,” said Asma Khalil, MBBCh, MD, professor of obstetrics and maternal-fetal medicine at the University of London’s St. George’s Hospital, and a coauthor of the new study.

Routine ultrasounds typically are performed from the 10th to the 13th week of pregnancy, not during the third trimester, when the risk for a breech birth would be most apparent. Breech births occur in 3%-4% of pregnancies, raising the risk that babies will experience broken bones or hemorrhage. Knowing that breech is possible before birth enables physicians to discuss options with the pregnant woman in advance, Dr. Khalil said. These steps include rotating the baby in the uterus or conducting a cesarean delivery. Such counseling is not possible if breech is undetected until spontaneous or induced labor. 

“Breech presentation at term is not very common, but diagnosing it prior to the onset of labor or induction of labor offers patients much more flexibility in terms of options and planning,” said Cecilia B. Leggett, MD, a resident in obstetrics and gynecology at Cedars-Sinai in Los Angeles. Dr. Leggett, who was not involved in the study, has shown that handheld devices are as accurate at assessing fetal weight as are standard ultrasound machines.
 

Two tools, same result

Dr. Khalil and her colleagues compared the rates of undiagnosed breech presentations before and after implementing universal third-semester ultrasound at two hospitals in the United Kingdom. The requirement began in 2020; the study compared the rate of undiagnosed breeches from the period of 2016-2020 with that of 2020-2021.

St. George’s Hospital in London used a traditional ultrasound machine that is read by a sonographer, whereas the Norfolk and Norwich University Hospitals, in Norwich, England, employed midwives to use a handheld ultrasound device.

The rate of undiagnosed breech cases declined from 14.2% at St. George’s before the universal ultrasound requirement (82 missed cases of 578 breech births) to 2.8% after the requirement began (7 missed cases of 251 breech births). The story was similar at Norfolk and Norwich, where 16.2% missed breech cases occurred before the requirement (27 of 167) and 3.5% missed cases were reported after it (5 of 142).

The increased accuracy of breech diagnosis before labor probably led to fewer cases of impaired blood flow to a baby’s brain at birth, Dr. Khalil’s group reported, as well as a probable reduction in the number of stillborn babies or those who die extremely young.

Traditional ultrasound scans read by sonographers are expensive, Dr. Khalil noted, whereas the portable handheld devices are much cheaper and could be used widely to improve detection of breech births. That step would require robust training about how to properly use these devices, Dr. Leggett said.

“As we see more and more studies come out about technology for POCUS, I think it’s important to keep in mind that we need the education about the tools to be as accessible as the tools themselves,” she said.

Dr. Leggett had no relevant financial relationships. Dr. Khalil is a vice president of the Royal College of Obstetricians and Gynaecologists, is a trustee and the treasurer of the International Society of Ultrasound in Obstetrics and Gynecology, and has lectured at and consulted in several ultrasound-based projects, webinars, and educational events.
 

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

Implementing universal ultrasound during the third trimester of pregnancy significantly reduced the number of undiagnosed breech presentations, according to a study published in PLOS Medicine. The effects held if sonographers used a traditional ultrasound machine or if midwives used a handheld ultrasound tool to perform what is known as a point-of-care ultrasound (POCUS) procedure.

“Giving pregnant women a third-trimester scan reduces the rate of undetected breech in labor by over two-thirds, which reduces the chances of harm to the baby,” said Asma Khalil, MBBCh, MD, professor of obstetrics and maternal-fetal medicine at the University of London’s St. George’s Hospital, and a coauthor of the new study.

Routine ultrasounds typically are performed from the 10th to the 13th week of pregnancy, not during the third trimester, when the risk for a breech birth would be most apparent. Breech births occur in 3%-4% of pregnancies, raising the risk that babies will experience broken bones or hemorrhage. Knowing that breech is possible before birth enables physicians to discuss options with the pregnant woman in advance, Dr. Khalil said. These steps include rotating the baby in the uterus or conducting a cesarean delivery. Such counseling is not possible if breech is undetected until spontaneous or induced labor. 

“Breech presentation at term is not very common, but diagnosing it prior to the onset of labor or induction of labor offers patients much more flexibility in terms of options and planning,” said Cecilia B. Leggett, MD, a resident in obstetrics and gynecology at Cedars-Sinai in Los Angeles. Dr. Leggett, who was not involved in the study, has shown that handheld devices are as accurate at assessing fetal weight as are standard ultrasound machines.
 

Two tools, same result

Dr. Khalil and her colleagues compared the rates of undiagnosed breech presentations before and after implementing universal third-semester ultrasound at two hospitals in the United Kingdom. The requirement began in 2020; the study compared the rate of undiagnosed breeches from the period of 2016-2020 with that of 2020-2021.

St. George’s Hospital in London used a traditional ultrasound machine that is read by a sonographer, whereas the Norfolk and Norwich University Hospitals, in Norwich, England, employed midwives to use a handheld ultrasound device.

The rate of undiagnosed breech cases declined from 14.2% at St. George’s before the universal ultrasound requirement (82 missed cases of 578 breech births) to 2.8% after the requirement began (7 missed cases of 251 breech births). The story was similar at Norfolk and Norwich, where 16.2% missed breech cases occurred before the requirement (27 of 167) and 3.5% missed cases were reported after it (5 of 142).

The increased accuracy of breech diagnosis before labor probably led to fewer cases of impaired blood flow to a baby’s brain at birth, Dr. Khalil’s group reported, as well as a probable reduction in the number of stillborn babies or those who die extremely young.

Traditional ultrasound scans read by sonographers are expensive, Dr. Khalil noted, whereas the portable handheld devices are much cheaper and could be used widely to improve detection of breech births. That step would require robust training about how to properly use these devices, Dr. Leggett said.

“As we see more and more studies come out about technology for POCUS, I think it’s important to keep in mind that we need the education about the tools to be as accessible as the tools themselves,” she said.

Dr. Leggett had no relevant financial relationships. Dr. Khalil is a vice president of the Royal College of Obstetricians and Gynaecologists, is a trustee and the treasurer of the International Society of Ultrasound in Obstetrics and Gynecology, and has lectured at and consulted in several ultrasound-based projects, webinars, and educational events.
 

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

Implementing universal ultrasound during the third trimester of pregnancy significantly reduced the number of undiagnosed breech presentations, according to a study published in PLOS Medicine. The effects held if sonographers used a traditional ultrasound machine or if midwives used a handheld ultrasound tool to perform what is known as a point-of-care ultrasound (POCUS) procedure.

“Giving pregnant women a third-trimester scan reduces the rate of undetected breech in labor by over two-thirds, which reduces the chances of harm to the baby,” said Asma Khalil, MBBCh, MD, professor of obstetrics and maternal-fetal medicine at the University of London’s St. George’s Hospital, and a coauthor of the new study.

Routine ultrasounds typically are performed from the 10th to the 13th week of pregnancy, not during the third trimester, when the risk for a breech birth would be most apparent. Breech births occur in 3%-4% of pregnancies, raising the risk that babies will experience broken bones or hemorrhage. Knowing that breech is possible before birth enables physicians to discuss options with the pregnant woman in advance, Dr. Khalil said. These steps include rotating the baby in the uterus or conducting a cesarean delivery. Such counseling is not possible if breech is undetected until spontaneous or induced labor. 

“Breech presentation at term is not very common, but diagnosing it prior to the onset of labor or induction of labor offers patients much more flexibility in terms of options and planning,” said Cecilia B. Leggett, MD, a resident in obstetrics and gynecology at Cedars-Sinai in Los Angeles. Dr. Leggett, who was not involved in the study, has shown that handheld devices are as accurate at assessing fetal weight as are standard ultrasound machines.
 

Two tools, same result

Dr. Khalil and her colleagues compared the rates of undiagnosed breech presentations before and after implementing universal third-semester ultrasound at two hospitals in the United Kingdom. The requirement began in 2020; the study compared the rate of undiagnosed breeches from the period of 2016-2020 with that of 2020-2021.

St. George’s Hospital in London used a traditional ultrasound machine that is read by a sonographer, whereas the Norfolk and Norwich University Hospitals, in Norwich, England, employed midwives to use a handheld ultrasound device.

The rate of undiagnosed breech cases declined from 14.2% at St. George’s before the universal ultrasound requirement (82 missed cases of 578 breech births) to 2.8% after the requirement began (7 missed cases of 251 breech births). The story was similar at Norfolk and Norwich, where 16.2% missed breech cases occurred before the requirement (27 of 167) and 3.5% missed cases were reported after it (5 of 142).

The increased accuracy of breech diagnosis before labor probably led to fewer cases of impaired blood flow to a baby’s brain at birth, Dr. Khalil’s group reported, as well as a probable reduction in the number of stillborn babies or those who die extremely young.

Traditional ultrasound scans read by sonographers are expensive, Dr. Khalil noted, whereas the portable handheld devices are much cheaper and could be used widely to improve detection of breech births. That step would require robust training about how to properly use these devices, Dr. Leggett said.

“As we see more and more studies come out about technology for POCUS, I think it’s important to keep in mind that we need the education about the tools to be as accessible as the tools themselves,” she said.

Dr. Leggett had no relevant financial relationships. Dr. Khalil is a vice president of the Royal College of Obstetricians and Gynaecologists, is a trustee and the treasurer of the International Society of Ultrasound in Obstetrics and Gynecology, and has lectured at and consulted in several ultrasound-based projects, webinars, and educational events.
 

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

New clinical practice guidelines for cannabis in chronic pain management have been released.

Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.

“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.

University of Toronto

Examining the evidence

A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.

Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.

Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.

When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.

In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.

The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.

Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.

An effective alternative

Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.

“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”

Dr. Wallace said he found the guidelines’ dosing recommendations helpful.

“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”

While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.

Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.

Brigham and Women's Hospital

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

New clinical practice guidelines for cannabis in chronic pain management have been released.

Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.

“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.

University of Toronto

Examining the evidence

A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.

Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.

Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.

When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.

In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.

The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.

Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.

An effective alternative

Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.

“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”

Dr. Wallace said he found the guidelines’ dosing recommendations helpful.

“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”

While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.

Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.

Brigham and Women's Hospital

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

New clinical practice guidelines for cannabis in chronic pain management have been released.

Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.

“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.

University of Toronto

Examining the evidence

A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.

Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.

Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.

When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.

In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.

The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.

Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.

An effective alternative

Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.

“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”

Dr. Wallace said he found the guidelines’ dosing recommendations helpful.

“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”

While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.

Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.

Brigham and Women's Hospital

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

Results of a study recently published in Nature Communications suggests that radiation from ultraviolet nail polish dryers could induce cell death and trigger molecular changes linked to cancer in human cells. According to two experts, these findings raise concerns regarding the safety of frequent use of these nail dryers.

In the study, human and mouse cells were exposed to radiation from UV nail dryers. Exposing human and mice skin cells to UVA light for 20 minutes resulted in the death of 20%-30% of cells; three consecutive 20-minute sessions resulted in the death of 65%-70% of cells. Additionally, surviving cells suffered oxidative damage to their DNA and mitochondria, with mutational patterns similar to those seen in skin cancer, study investigator Maria Zhivagui, PhD, of the University of California, San Diego, and associates reported.  

“This study showed that irradiation of human and mouse cell lines using UV nail polish dryers resulted in DNA damage and genome mutations,” Shari Lipner, MD, PhD, director of the nail division at New York–Presbyterian Hospital/Weill Cornell Medicine, New York, said in an interview. The study “ties together exposure to UV light from nail polish dryers and genetic mutations that are associated with skin cancers,” added Dr. Lipner, who was not involved with the study.

UV nail lamps are commonly used to dry and harden gel nail polish formulas. Often referred to as “mini tanning beds,” these devices emit UVA radiation, classified as a Group 1 Carcinogen by the International Agency for Research on Cancer.

“Both UVA and UVB are main drivers of both melanoma and keratinocyte carcinomas (basal cell carcinoma and squamous cell carcinoma),” said Anthony Rossi, MD, a dermatologic surgeon at Memorial Sloan Kettering Cancer Center, New York, who was also not a study investigator. UV irradiance “produces DNA mutations that are specific to forming types of skin cancer,” he said in an interview.

UVA wavelengths commonly used in nail dryers can penetrate all layers of the epidermis, the top layer of the skin, potentially affecting stem cells in the skin, according to the study.

Dr. Lipner noted that “there have been several case reports of patients with histories of gel manicures using UV nail polish dryers who later developed squamous cell carcinomas on the dorsal hands, fingers, and nails, and articles describing high UV emissions from nail polish dryers, but the direct connection between UV dryers and skin cancer development was tenuous.” The first of its kind, the new study investigated the impact of UV nail drying devices at a cellular level.

The results of this study, in combination with previous case reports suggesting the development of skin cancers following UVA dryer use, raise concern regarding the safety of these commonly used devices. The study, the authors wrote, “does not provide direct evidence for an increased cancer risk in human beings,” but their findings and “prior evidence strongly suggest that radiation emitted by UV nail polish dryers may cause cancers of the hand and that UV nail polish dryers, similar to tanning beds, may increase the risk of early onset skin cancer.”

Courtesy MSKCC

Dr. Rossi said that, “while this study shows that the UV exposure does affect human cells and causes mutations, the study was not done in vivo in human beings, so further studies are needed to know at what dose and frequency gel manicures would be needed to cause detrimental effects.” However, for people who regularly receive gel manicures involving UV nail dryers, both Dr. Lipner and Dr. Rossi recommend applying a broad-spectrum sunscreen to protect the dorsal hands, fingertips, and skin surrounding the nails, or wearing UV-protective gloves.

The study was supported by an Alfred B. Sloan Research Fellowship to one of the authors and grants from the National Institutes of Health to two authors. One author reported being a compensated consultant and having an equity interest in io9. Dr. Lipner and Dr. Rossi reported no relevant financial relationships.

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

Results of a study recently published in Nature Communications suggests that radiation from ultraviolet nail polish dryers could induce cell death and trigger molecular changes linked to cancer in human cells. According to two experts, these findings raise concerns regarding the safety of frequent use of these nail dryers.

In the study, human and mouse cells were exposed to radiation from UV nail dryers. Exposing human and mice skin cells to UVA light for 20 minutes resulted in the death of 20%-30% of cells; three consecutive 20-minute sessions resulted in the death of 65%-70% of cells. Additionally, surviving cells suffered oxidative damage to their DNA and mitochondria, with mutational patterns similar to those seen in skin cancer, study investigator Maria Zhivagui, PhD, of the University of California, San Diego, and associates reported.  

“This study showed that irradiation of human and mouse cell lines using UV nail polish dryers resulted in DNA damage and genome mutations,” Shari Lipner, MD, PhD, director of the nail division at New York–Presbyterian Hospital/Weill Cornell Medicine, New York, said in an interview. The study “ties together exposure to UV light from nail polish dryers and genetic mutations that are associated with skin cancers,” added Dr. Lipner, who was not involved with the study.

UV nail lamps are commonly used to dry and harden gel nail polish formulas. Often referred to as “mini tanning beds,” these devices emit UVA radiation, classified as a Group 1 Carcinogen by the International Agency for Research on Cancer.

“Both UVA and UVB are main drivers of both melanoma and keratinocyte carcinomas (basal cell carcinoma and squamous cell carcinoma),” said Anthony Rossi, MD, a dermatologic surgeon at Memorial Sloan Kettering Cancer Center, New York, who was also not a study investigator. UV irradiance “produces DNA mutations that are specific to forming types of skin cancer,” he said in an interview.

UVA wavelengths commonly used in nail dryers can penetrate all layers of the epidermis, the top layer of the skin, potentially affecting stem cells in the skin, according to the study.

Dr. Lipner noted that “there have been several case reports of patients with histories of gel manicures using UV nail polish dryers who later developed squamous cell carcinomas on the dorsal hands, fingers, and nails, and articles describing high UV emissions from nail polish dryers, but the direct connection between UV dryers and skin cancer development was tenuous.” The first of its kind, the new study investigated the impact of UV nail drying devices at a cellular level.

The results of this study, in combination with previous case reports suggesting the development of skin cancers following UVA dryer use, raise concern regarding the safety of these commonly used devices. The study, the authors wrote, “does not provide direct evidence for an increased cancer risk in human beings,” but their findings and “prior evidence strongly suggest that radiation emitted by UV nail polish dryers may cause cancers of the hand and that UV nail polish dryers, similar to tanning beds, may increase the risk of early onset skin cancer.”

Courtesy MSKCC

Dr. Rossi said that, “while this study shows that the UV exposure does affect human cells and causes mutations, the study was not done in vivo in human beings, so further studies are needed to know at what dose and frequency gel manicures would be needed to cause detrimental effects.” However, for people who regularly receive gel manicures involving UV nail dryers, both Dr. Lipner and Dr. Rossi recommend applying a broad-spectrum sunscreen to protect the dorsal hands, fingertips, and skin surrounding the nails, or wearing UV-protective gloves.

The study was supported by an Alfred B. Sloan Research Fellowship to one of the authors and grants from the National Institutes of Health to two authors. One author reported being a compensated consultant and having an equity interest in io9. Dr. Lipner and Dr. Rossi reported no relevant financial relationships.

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

Results of a study recently published in Nature Communications suggests that radiation from ultraviolet nail polish dryers could induce cell death and trigger molecular changes linked to cancer in human cells. According to two experts, these findings raise concerns regarding the safety of frequent use of these nail dryers.

In the study, human and mouse cells were exposed to radiation from UV nail dryers. Exposing human and mice skin cells to UVA light for 20 minutes resulted in the death of 20%-30% of cells; three consecutive 20-minute sessions resulted in the death of 65%-70% of cells. Additionally, surviving cells suffered oxidative damage to their DNA and mitochondria, with mutational patterns similar to those seen in skin cancer, study investigator Maria Zhivagui, PhD, of the University of California, San Diego, and associates reported.  

“This study showed that irradiation of human and mouse cell lines using UV nail polish dryers resulted in DNA damage and genome mutations,” Shari Lipner, MD, PhD, director of the nail division at New York–Presbyterian Hospital/Weill Cornell Medicine, New York, said in an interview. The study “ties together exposure to UV light from nail polish dryers and genetic mutations that are associated with skin cancers,” added Dr. Lipner, who was not involved with the study.

UV nail lamps are commonly used to dry and harden gel nail polish formulas. Often referred to as “mini tanning beds,” these devices emit UVA radiation, classified as a Group 1 Carcinogen by the International Agency for Research on Cancer.

“Both UVA and UVB are main drivers of both melanoma and keratinocyte carcinomas (basal cell carcinoma and squamous cell carcinoma),” said Anthony Rossi, MD, a dermatologic surgeon at Memorial Sloan Kettering Cancer Center, New York, who was also not a study investigator. UV irradiance “produces DNA mutations that are specific to forming types of skin cancer,” he said in an interview.

UVA wavelengths commonly used in nail dryers can penetrate all layers of the epidermis, the top layer of the skin, potentially affecting stem cells in the skin, according to the study.

Dr. Lipner noted that “there have been several case reports of patients with histories of gel manicures using UV nail polish dryers who later developed squamous cell carcinomas on the dorsal hands, fingers, and nails, and articles describing high UV emissions from nail polish dryers, but the direct connection between UV dryers and skin cancer development was tenuous.” The first of its kind, the new study investigated the impact of UV nail drying devices at a cellular level.

The results of this study, in combination with previous case reports suggesting the development of skin cancers following UVA dryer use, raise concern regarding the safety of these commonly used devices. The study, the authors wrote, “does not provide direct evidence for an increased cancer risk in human beings,” but their findings and “prior evidence strongly suggest that radiation emitted by UV nail polish dryers may cause cancers of the hand and that UV nail polish dryers, similar to tanning beds, may increase the risk of early onset skin cancer.”

Courtesy MSKCC

Dr. Rossi said that, “while this study shows that the UV exposure does affect human cells and causes mutations, the study was not done in vivo in human beings, so further studies are needed to know at what dose and frequency gel manicures would be needed to cause detrimental effects.” However, for people who regularly receive gel manicures involving UV nail dryers, both Dr. Lipner and Dr. Rossi recommend applying a broad-spectrum sunscreen to protect the dorsal hands, fingertips, and skin surrounding the nails, or wearing UV-protective gloves.

The study was supported by an Alfred B. Sloan Research Fellowship to one of the authors and grants from the National Institutes of Health to two authors. One author reported being a compensated consultant and having an equity interest in io9. Dr. Lipner and Dr. Rossi reported no relevant financial relationships.

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