MDedge ObGyn

Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.

In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.

“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”

The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.

Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.

For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.

Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.

Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.

However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.

Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.

The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.

Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
 

Not asked, not told

Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.

“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.

Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.

Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.

Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.

Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.

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

Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.

In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.

“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”

The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.

Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.

For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.

Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.

Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.

However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.

Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.

The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.

Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
 

Not asked, not told

Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.

“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.

Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.

Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.

Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.

Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.

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

Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.

In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.

“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”

The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.

Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.

For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.

Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.

Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.

However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.

Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.

The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.

Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
 

Not asked, not told

Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.

“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.

Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.

Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.

Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.

Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.

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

President Joe Biden issued an executive order on June 15 banning conversion therapy and offering other LBGTQIA+ protections as part of White House efforts to advance equality during Pride Month.

“My order will use the full force of the federal government to end inhumane practices of conversion therapy,” President Biden said in a speech before signing the order. “This is the first time the federal government is making a coordinated effort against this dangerous and discredited practice.”

Conversion therapy is any emotional or physical therapy used to “cure” or “repair” a person’s attraction to the same sex, or their gender identity and expression. Providers claim these therapies can make someone heterosexual or “straight.” But there’s no evidence to support this.

Medical and mental health experts have rejected conversion therapy practices as dangerous and discriminatory for decades.

The executive order also addresses:

• The LGBTQIA+ youth mental health crisis, in part by expanding suicide prevention resources for that at-risk population.
• Discrimination within the foster care system against LGBTQIA+ children and parents.
• Discrimination, poverty and isolation challenges faced by LGBTQIA+ seniors.
• Efforts to strengthen federal data collection in this population to counter homelessness, housing insecurity and barriers to health care access.

Enforcement of executive order will rely on legal experts, including the Justice Department.

President Biden’s order comes at a time when multiple states are promoting or passing anti-LGBTQIA+ laws.

“I don’t have to tell you about the ultra-MAGA agenda attacking our freedoms. There are more than 300 discriminatory bills introduced in states across this country,” President Biden said. “In Texas, they are knocking on front doors to investigate parents who are raising transgender children, and in Florida they are going after Mickey Mouse for God’s sake.”

First Lady Jill Biden, PhD, said the order will not solve all problems. “Prejudice and discrimination still lurk. We will not let the progress we fought for slip away. Pride is a celebration of the courage it takes to stand up for what’s right.”

The American Psychiatric Association applauded President Biden’s action. This executive order will “protect the mental health of LGBTQ+ people, particularly children. APA has long condemned the practice of so-called ‘conversion therapy’ and we welcome the federal government’s efforts to raise public awareness about its harms, alongside other practices that will help to end it.”

The goal of the order is to “improve the health, wellbeing, and safety of countless families across the country,” senior White House administration officials said in a June 15 media call. “And they will send a powerful signal from the president of the United States to LGBTQIA+ kids across the country – who may be feeling scared and hopeless – that their president has their back.”

Biden also called on Congress to pass the Equality Act “to enshrine the long overdue civil rights to protect all Americans.”

The event was held in the East Room of the White House at a Pride event attended by Vice President Kamala Harris and her husband, the first lady, Transportation Secretary Pete Buttigieg, and hundreds of LGBTQIA+ leaders.
 

Guidance on starting transgender treatment

In other LGBTQIA+-related news, an international group focusing on transgender health lowered the minimum ages they recommend for starting hormone therapy or surgery for transgender youth.

The World Professional Association for Transgender Health said that hormones could be started at 14, 2 years earlier than the group’s previous advice. The association also said some surgeries can be performed at age 15 or 17, a year or so earlier than their previous recommendations.

The group acknowledged potential risks but said it is unethical and harmful to withhold early treatment, according to a report from The Associated Press.

Transgender treatment for teens has been a controversial issue, with experts disagreeing about whether teenagers can fully understand the ramifications of such life-altering decisions.

During the White House background media call, senior administration officials pointed to existing policy regarding transgender care. “We’ve already put out guidance through HHS about civil rights protections and making clear that the denial of medical care based on someone’s gender identity is discriminatory and have invited the members of the public to file complaints with the Office of Civil Rights.”

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

President Joe Biden issued an executive order on June 15 banning conversion therapy and offering other LBGTQIA+ protections as part of White House efforts to advance equality during Pride Month.

“My order will use the full force of the federal government to end inhumane practices of conversion therapy,” President Biden said in a speech before signing the order. “This is the first time the federal government is making a coordinated effort against this dangerous and discredited practice.”

Conversion therapy is any emotional or physical therapy used to “cure” or “repair” a person’s attraction to the same sex, or their gender identity and expression. Providers claim these therapies can make someone heterosexual or “straight.” But there’s no evidence to support this.

Medical and mental health experts have rejected conversion therapy practices as dangerous and discriminatory for decades.

The executive order also addresses:

• The LGBTQIA+ youth mental health crisis, in part by expanding suicide prevention resources for that at-risk population.
• Discrimination within the foster care system against LGBTQIA+ children and parents.
• Discrimination, poverty and isolation challenges faced by LGBTQIA+ seniors.
• Efforts to strengthen federal data collection in this population to counter homelessness, housing insecurity and barriers to health care access.

Enforcement of executive order will rely on legal experts, including the Justice Department.

President Biden’s order comes at a time when multiple states are promoting or passing anti-LGBTQIA+ laws.

“I don’t have to tell you about the ultra-MAGA agenda attacking our freedoms. There are more than 300 discriminatory bills introduced in states across this country,” President Biden said. “In Texas, they are knocking on front doors to investigate parents who are raising transgender children, and in Florida they are going after Mickey Mouse for God’s sake.”

First Lady Jill Biden, PhD, said the order will not solve all problems. “Prejudice and discrimination still lurk. We will not let the progress we fought for slip away. Pride is a celebration of the courage it takes to stand up for what’s right.”

The American Psychiatric Association applauded President Biden’s action. This executive order will “protect the mental health of LGBTQ+ people, particularly children. APA has long condemned the practice of so-called ‘conversion therapy’ and we welcome the federal government’s efforts to raise public awareness about its harms, alongside other practices that will help to end it.”

The goal of the order is to “improve the health, wellbeing, and safety of countless families across the country,” senior White House administration officials said in a June 15 media call. “And they will send a powerful signal from the president of the United States to LGBTQIA+ kids across the country – who may be feeling scared and hopeless – that their president has their back.”

Biden also called on Congress to pass the Equality Act “to enshrine the long overdue civil rights to protect all Americans.”

The event was held in the East Room of the White House at a Pride event attended by Vice President Kamala Harris and her husband, the first lady, Transportation Secretary Pete Buttigieg, and hundreds of LGBTQIA+ leaders.
 

Guidance on starting transgender treatment

In other LGBTQIA+-related news, an international group focusing on transgender health lowered the minimum ages they recommend for starting hormone therapy or surgery for transgender youth.

The World Professional Association for Transgender Health said that hormones could be started at 14, 2 years earlier than the group’s previous advice. The association also said some surgeries can be performed at age 15 or 17, a year or so earlier than their previous recommendations.

The group acknowledged potential risks but said it is unethical and harmful to withhold early treatment, according to a report from The Associated Press.

Transgender treatment for teens has been a controversial issue, with experts disagreeing about whether teenagers can fully understand the ramifications of such life-altering decisions.

During the White House background media call, senior administration officials pointed to existing policy regarding transgender care. “We’ve already put out guidance through HHS about civil rights protections and making clear that the denial of medical care based on someone’s gender identity is discriminatory and have invited the members of the public to file complaints with the Office of Civil Rights.”

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

President Joe Biden issued an executive order on June 15 banning conversion therapy and offering other LBGTQIA+ protections as part of White House efforts to advance equality during Pride Month.

“My order will use the full force of the federal government to end inhumane practices of conversion therapy,” President Biden said in a speech before signing the order. “This is the first time the federal government is making a coordinated effort against this dangerous and discredited practice.”

Conversion therapy is any emotional or physical therapy used to “cure” or “repair” a person’s attraction to the same sex, or their gender identity and expression. Providers claim these therapies can make someone heterosexual or “straight.” But there’s no evidence to support this.

Medical and mental health experts have rejected conversion therapy practices as dangerous and discriminatory for decades.

The executive order also addresses:

• The LGBTQIA+ youth mental health crisis, in part by expanding suicide prevention resources for that at-risk population.
• Discrimination within the foster care system against LGBTQIA+ children and parents.
• Discrimination, poverty and isolation challenges faced by LGBTQIA+ seniors.
• Efforts to strengthen federal data collection in this population to counter homelessness, housing insecurity and barriers to health care access.

Enforcement of executive order will rely on legal experts, including the Justice Department.

President Biden’s order comes at a time when multiple states are promoting or passing anti-LGBTQIA+ laws.

“I don’t have to tell you about the ultra-MAGA agenda attacking our freedoms. There are more than 300 discriminatory bills introduced in states across this country,” President Biden said. “In Texas, they are knocking on front doors to investigate parents who are raising transgender children, and in Florida they are going after Mickey Mouse for God’s sake.”

First Lady Jill Biden, PhD, said the order will not solve all problems. “Prejudice and discrimination still lurk. We will not let the progress we fought for slip away. Pride is a celebration of the courage it takes to stand up for what’s right.”

The American Psychiatric Association applauded President Biden’s action. This executive order will “protect the mental health of LGBTQ+ people, particularly children. APA has long condemned the practice of so-called ‘conversion therapy’ and we welcome the federal government’s efforts to raise public awareness about its harms, alongside other practices that will help to end it.”

The goal of the order is to “improve the health, wellbeing, and safety of countless families across the country,” senior White House administration officials said in a June 15 media call. “And they will send a powerful signal from the president of the United States to LGBTQIA+ kids across the country – who may be feeling scared and hopeless – that their president has their back.”

Biden also called on Congress to pass the Equality Act “to enshrine the long overdue civil rights to protect all Americans.”

The event was held in the East Room of the White House at a Pride event attended by Vice President Kamala Harris and her husband, the first lady, Transportation Secretary Pete Buttigieg, and hundreds of LGBTQIA+ leaders.
 

Guidance on starting transgender treatment

In other LGBTQIA+-related news, an international group focusing on transgender health lowered the minimum ages they recommend for starting hormone therapy or surgery for transgender youth.

The World Professional Association for Transgender Health said that hormones could be started at 14, 2 years earlier than the group’s previous advice. The association also said some surgeries can be performed at age 15 or 17, a year or so earlier than their previous recommendations.

The group acknowledged potential risks but said it is unethical and harmful to withhold early treatment, according to a report from The Associated Press.

Transgender treatment for teens has been a controversial issue, with experts disagreeing about whether teenagers can fully understand the ramifications of such life-altering decisions.

During the White House background media call, senior administration officials pointed to existing policy regarding transgender care. “We’ve already put out guidance through HHS about civil rights protections and making clear that the denial of medical care based on someone’s gender identity is discriminatory and have invited the members of the public to file complaints with the Office of Civil Rights.”

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

Your gut microbiome will thank you later

A healthy gut seems like the new catch-all to better overall health these days. Nutrition and diet culture has us drinking kombucha and ginger tea and coffee, but what if we told you that going to happy hour might also help?

In a recent double-blind study published in the Journal of Agricultural and Food Chemistry, 19 men were divided into two groups and asked to drink 11 ounces of alcoholic lager (5.2% by volume) or nonalcoholic lager with dinner for 4 weeks.

Beer? Yes. Beer.

Engin Akyurt/Pixabay

We humans have trillions of microorganisms running rampant through our digestive tracts. When they’re happy, we have a lower chance of developing heart disease and diabetes. You know what else has millions of happy microorganisms from fermentation? Beer. It also has polyphenols that can help the body’s tissues fight cancers, as well as heart disease and inflammation. So beer is looking a little more healthy now, isn’t it?

In the study, the researchers found that both the alcoholic- and nonalcoholic-lager groups had a boost in bacterial diversity in the gut and higher fecal alkaline phosphatase levels, which showed improved intestinal health. They acknowledged, however, that the nonalcoholic route would be safer and healthier for overall health.

So add a lager to the list of gut-healthy foods that you should be consuming. It may give the phrase “beer gut” a whole new meaning.
 

We’ve lost our minds, but at least we know how fast they’re going

The phrase “quantum consciousness” sounds like something out of a particularly cheesy episode of Star Trek: “Oh no, Captain, the quantum consciousness has invaded our computer, and the only way to drive it out is to reverse the polarity of a focused tachyon beam.”

Massimiliano De Deo, LNGS-INFN

When it comes to understanding such basic existential issues as the origin of consciousness, however, quantum mechanics wasn’t off the table. The theory of the quantum origin of consciousness dates back to the 1990s (thanks in part to noted physician Roger Penrose), and goes something like this: There are microtubules within neurons in the brain that are small enough and isolated enough from the warm, wet, and chaotic brain environment where quantum effects can briefly come into play. We’re talking miniscule fractions of a second here, but still, long enough for quantum calculations to take place in the form of system wavefunction collapse, courtesy of gravity.

To plunge even deeper into the rabbit hole of quantum mechanics, the reason Schrödinger’s cat doesn’t occur in real life is wavefunction collapse; the more massive a quantum system is, the more likely it is to collapse into one state or another (alive or dead, in the cat’s case). The quantum origin of consciousness, or Orch OR theory, holds that human consciousness arises from electrical oscillations within the neuronal microtubules caused by the computations stemming from the collapse of small quantum systems.

That is an awful lot of overly simplified explanation, especially considering the study that just came out essentially disproved it. Oops. The research, published in Physics of Life Reviews, is pretty simple. The researchers went to a lab deep underground to avoid interference from cosmic rays, and sat around for months, observing a chunk of germanium for signs of spontaneous radiation, attributable to the same sort of wavefunction collapse that is supposedly occurring in our brains. They found nothing out of the ordinary, pretty definitively disproving most of Orch OR theory.

The researchers were unwilling to completely dismiss the idea (this is quantum mechanics, after all, uncertainty kind of goes with the territory), but it does seem like we’ll have to search elsewhere for sources of human consciousness. Personally, we’re big fans of the cymbal-playing monkey.
 

Missing links: A real fish story

Dear LOTME:

Ear’s a question that’s been keeping me up at night. Is the human middle ear the result of top-secret government experiments involving alien technology, Abraham Lincoln, and the Illuminati?

Restless in Roswell

Dear Restless:

The paleoanthropologic community has been sorting through this mystery for decades, and fossils discovered in China over the past 20 years finally provide a much less conspiratorially satisfying answer.

IVPP

For some time now, experts in the field have believed that the bones of the human middle ear evolved from the spiracular gill of a fish. The spiracle is a small hole behind each eye that opens to the mouth in some fishes and was used to breathe air in the earliest, most primitive species. But how did we get from spiracle to ear?

The missing links come in the form of the cranial anatomy of Shuyu, a 438-million-year-old, fingernail-sized skull of a jawless fish, and the 419-million-year-old fossil of a completely preserved fish with gill filaments in the first branchial chamber.

“These fossils provided the first anatomical and fossil evidence for a vertebrate spiracle originating from fish gills,” senior author Gai Zhikun, PhD, of the Institute of Vertebrate Paleontology and Paleoanthropology, Beijing, said in a written statement.

In many ways, it seems, we are fish: “Many important structures of human beings can be traced back to our fish ancestors, such as our teeth, jaws, middle ears, etc,” added Zhu Min, PhD, also of the institute.

So, Restless, the next time you hear the soothing sounds of an angry mob storming the Capitol or you chew on a slab, slice, or chunk of mutant, laboratory-produced chicken in your favorite fast-food restaurant, be sure to thank Shuyu.
 

Can you lend me an ear?

If you thought locusts were only a nuisance, think again. They have their uses. If you take a locust’s ear and put it inside a robot, the robot will be able to hear and receive signals. Who knew?

850977/Pixabay

Researchers from Tel Aviv University in Israel showed the robot’s hearing abilities by giving clap signals that told the robot what to do: One clap means go forward, two claps mean move back. What do you think the robot would do if it heard the clap break from Cha Cha Slide?

“Our task was to replace the robot’s electronic microphone with a dead insect’s ear, use the ear’s ability to detect the electrical signals from the environment, in this case vibrations in the air, and, using a special chip, convert the insect input to that of the robot,” Ben M. Maoz, PhD, said in a statement from the university.

And how does a dead locust ear work in a robot? Well, Dr. Maoz explained: “My laboratory has developed a special device – Ear-on-a-Chip – that allows the ear to be kept alive throughout the experiment by supplying oxygen and food to the organ while allowing the electrical signals to be taken out of the locust’s ear and amplified and transmitted to the robot.”

The research won’t stop at hearing, he said, as the other four senses also will be taken into consideration. This could help us sense dangers in the future, such as earthquakes or diseases. We said it before and we’ll say it again: We’re rooting for you, science!

Your gut microbiome will thank you later

A healthy gut seems like the new catch-all to better overall health these days. Nutrition and diet culture has us drinking kombucha and ginger tea and coffee, but what if we told you that going to happy hour might also help?

In a recent double-blind study published in the Journal of Agricultural and Food Chemistry, 19 men were divided into two groups and asked to drink 11 ounces of alcoholic lager (5.2% by volume) or nonalcoholic lager with dinner for 4 weeks.

Beer? Yes. Beer.

Engin Akyurt/Pixabay

We humans have trillions of microorganisms running rampant through our digestive tracts. When they’re happy, we have a lower chance of developing heart disease and diabetes. You know what else has millions of happy microorganisms from fermentation? Beer. It also has polyphenols that can help the body’s tissues fight cancers, as well as heart disease and inflammation. So beer is looking a little more healthy now, isn’t it?

In the study, the researchers found that both the alcoholic- and nonalcoholic-lager groups had a boost in bacterial diversity in the gut and higher fecal alkaline phosphatase levels, which showed improved intestinal health. They acknowledged, however, that the nonalcoholic route would be safer and healthier for overall health.

So add a lager to the list of gut-healthy foods that you should be consuming. It may give the phrase “beer gut” a whole new meaning.
 

We’ve lost our minds, but at least we know how fast they’re going

The phrase “quantum consciousness” sounds like something out of a particularly cheesy episode of Star Trek: “Oh no, Captain, the quantum consciousness has invaded our computer, and the only way to drive it out is to reverse the polarity of a focused tachyon beam.”

Massimiliano De Deo, LNGS-INFN

When it comes to understanding such basic existential issues as the origin of consciousness, however, quantum mechanics wasn’t off the table. The theory of the quantum origin of consciousness dates back to the 1990s (thanks in part to noted physician Roger Penrose), and goes something like this: There are microtubules within neurons in the brain that are small enough and isolated enough from the warm, wet, and chaotic brain environment where quantum effects can briefly come into play. We’re talking miniscule fractions of a second here, but still, long enough for quantum calculations to take place in the form of system wavefunction collapse, courtesy of gravity.

To plunge even deeper into the rabbit hole of quantum mechanics, the reason Schrödinger’s cat doesn’t occur in real life is wavefunction collapse; the more massive a quantum system is, the more likely it is to collapse into one state or another (alive or dead, in the cat’s case). The quantum origin of consciousness, or Orch OR theory, holds that human consciousness arises from electrical oscillations within the neuronal microtubules caused by the computations stemming from the collapse of small quantum systems.

That is an awful lot of overly simplified explanation, especially considering the study that just came out essentially disproved it. Oops. The research, published in Physics of Life Reviews, is pretty simple. The researchers went to a lab deep underground to avoid interference from cosmic rays, and sat around for months, observing a chunk of germanium for signs of spontaneous radiation, attributable to the same sort of wavefunction collapse that is supposedly occurring in our brains. They found nothing out of the ordinary, pretty definitively disproving most of Orch OR theory.

The researchers were unwilling to completely dismiss the idea (this is quantum mechanics, after all, uncertainty kind of goes with the territory), but it does seem like we’ll have to search elsewhere for sources of human consciousness. Personally, we’re big fans of the cymbal-playing monkey.
 

Missing links: A real fish story

Dear LOTME:

Ear’s a question that’s been keeping me up at night. Is the human middle ear the result of top-secret government experiments involving alien technology, Abraham Lincoln, and the Illuminati?

Restless in Roswell

Dear Restless:

The paleoanthropologic community has been sorting through this mystery for decades, and fossils discovered in China over the past 20 years finally provide a much less conspiratorially satisfying answer.

IVPP

For some time now, experts in the field have believed that the bones of the human middle ear evolved from the spiracular gill of a fish. The spiracle is a small hole behind each eye that opens to the mouth in some fishes and was used to breathe air in the earliest, most primitive species. But how did we get from spiracle to ear?

The missing links come in the form of the cranial anatomy of Shuyu, a 438-million-year-old, fingernail-sized skull of a jawless fish, and the 419-million-year-old fossil of a completely preserved fish with gill filaments in the first branchial chamber.

“These fossils provided the first anatomical and fossil evidence for a vertebrate spiracle originating from fish gills,” senior author Gai Zhikun, PhD, of the Institute of Vertebrate Paleontology and Paleoanthropology, Beijing, said in a written statement.

In many ways, it seems, we are fish: “Many important structures of human beings can be traced back to our fish ancestors, such as our teeth, jaws, middle ears, etc,” added Zhu Min, PhD, also of the institute.

So, Restless, the next time you hear the soothing sounds of an angry mob storming the Capitol or you chew on a slab, slice, or chunk of mutant, laboratory-produced chicken in your favorite fast-food restaurant, be sure to thank Shuyu.
 

Can you lend me an ear?

If you thought locusts were only a nuisance, think again. They have their uses. If you take a locust’s ear and put it inside a robot, the robot will be able to hear and receive signals. Who knew?

850977/Pixabay

Researchers from Tel Aviv University in Israel showed the robot’s hearing abilities by giving clap signals that told the robot what to do: One clap means go forward, two claps mean move back. What do you think the robot would do if it heard the clap break from Cha Cha Slide?

“Our task was to replace the robot’s electronic microphone with a dead insect’s ear, use the ear’s ability to detect the electrical signals from the environment, in this case vibrations in the air, and, using a special chip, convert the insect input to that of the robot,” Ben M. Maoz, PhD, said in a statement from the university.

And how does a dead locust ear work in a robot? Well, Dr. Maoz explained: “My laboratory has developed a special device – Ear-on-a-Chip – that allows the ear to be kept alive throughout the experiment by supplying oxygen and food to the organ while allowing the electrical signals to be taken out of the locust’s ear and amplified and transmitted to the robot.”

The research won’t stop at hearing, he said, as the other four senses also will be taken into consideration. This could help us sense dangers in the future, such as earthquakes or diseases. We said it before and we’ll say it again: We’re rooting for you, science!

Your gut microbiome will thank you later

A healthy gut seems like the new catch-all to better overall health these days. Nutrition and diet culture has us drinking kombucha and ginger tea and coffee, but what if we told you that going to happy hour might also help?

In a recent double-blind study published in the Journal of Agricultural and Food Chemistry, 19 men were divided into two groups and asked to drink 11 ounces of alcoholic lager (5.2% by volume) or nonalcoholic lager with dinner for 4 weeks.

Beer? Yes. Beer.

Engin Akyurt/Pixabay

We humans have trillions of microorganisms running rampant through our digestive tracts. When they’re happy, we have a lower chance of developing heart disease and diabetes. You know what else has millions of happy microorganisms from fermentation? Beer. It also has polyphenols that can help the body’s tissues fight cancers, as well as heart disease and inflammation. So beer is looking a little more healthy now, isn’t it?

In the study, the researchers found that both the alcoholic- and nonalcoholic-lager groups had a boost in bacterial diversity in the gut and higher fecal alkaline phosphatase levels, which showed improved intestinal health. They acknowledged, however, that the nonalcoholic route would be safer and healthier for overall health.

So add a lager to the list of gut-healthy foods that you should be consuming. It may give the phrase “beer gut” a whole new meaning.
 

We’ve lost our minds, but at least we know how fast they’re going

The phrase “quantum consciousness” sounds like something out of a particularly cheesy episode of Star Trek: “Oh no, Captain, the quantum consciousness has invaded our computer, and the only way to drive it out is to reverse the polarity of a focused tachyon beam.”

Massimiliano De Deo, LNGS-INFN

When it comes to understanding such basic existential issues as the origin of consciousness, however, quantum mechanics wasn’t off the table. The theory of the quantum origin of consciousness dates back to the 1990s (thanks in part to noted physician Roger Penrose), and goes something like this: There are microtubules within neurons in the brain that are small enough and isolated enough from the warm, wet, and chaotic brain environment where quantum effects can briefly come into play. We’re talking miniscule fractions of a second here, but still, long enough for quantum calculations to take place in the form of system wavefunction collapse, courtesy of gravity.

To plunge even deeper into the rabbit hole of quantum mechanics, the reason Schrödinger’s cat doesn’t occur in real life is wavefunction collapse; the more massive a quantum system is, the more likely it is to collapse into one state or another (alive or dead, in the cat’s case). The quantum origin of consciousness, or Orch OR theory, holds that human consciousness arises from electrical oscillations within the neuronal microtubules caused by the computations stemming from the collapse of small quantum systems.

That is an awful lot of overly simplified explanation, especially considering the study that just came out essentially disproved it. Oops. The research, published in Physics of Life Reviews, is pretty simple. The researchers went to a lab deep underground to avoid interference from cosmic rays, and sat around for months, observing a chunk of germanium for signs of spontaneous radiation, attributable to the same sort of wavefunction collapse that is supposedly occurring in our brains. They found nothing out of the ordinary, pretty definitively disproving most of Orch OR theory.

The researchers were unwilling to completely dismiss the idea (this is quantum mechanics, after all, uncertainty kind of goes with the territory), but it does seem like we’ll have to search elsewhere for sources of human consciousness. Personally, we’re big fans of the cymbal-playing monkey.
 

Missing links: A real fish story

Dear LOTME:

Ear’s a question that’s been keeping me up at night. Is the human middle ear the result of top-secret government experiments involving alien technology, Abraham Lincoln, and the Illuminati?

Restless in Roswell

Dear Restless:

The paleoanthropologic community has been sorting through this mystery for decades, and fossils discovered in China over the past 20 years finally provide a much less conspiratorially satisfying answer.

IVPP

For some time now, experts in the field have believed that the bones of the human middle ear evolved from the spiracular gill of a fish. The spiracle is a small hole behind each eye that opens to the mouth in some fishes and was used to breathe air in the earliest, most primitive species. But how did we get from spiracle to ear?

The missing links come in the form of the cranial anatomy of Shuyu, a 438-million-year-old, fingernail-sized skull of a jawless fish, and the 419-million-year-old fossil of a completely preserved fish with gill filaments in the first branchial chamber.

“These fossils provided the first anatomical and fossil evidence for a vertebrate spiracle originating from fish gills,” senior author Gai Zhikun, PhD, of the Institute of Vertebrate Paleontology and Paleoanthropology, Beijing, said in a written statement.

In many ways, it seems, we are fish: “Many important structures of human beings can be traced back to our fish ancestors, such as our teeth, jaws, middle ears, etc,” added Zhu Min, PhD, also of the institute.

So, Restless, the next time you hear the soothing sounds of an angry mob storming the Capitol or you chew on a slab, slice, or chunk of mutant, laboratory-produced chicken in your favorite fast-food restaurant, be sure to thank Shuyu.
 

Can you lend me an ear?

If you thought locusts were only a nuisance, think again. They have their uses. If you take a locust’s ear and put it inside a robot, the robot will be able to hear and receive signals. Who knew?

850977/Pixabay

Researchers from Tel Aviv University in Israel showed the robot’s hearing abilities by giving clap signals that told the robot what to do: One clap means go forward, two claps mean move back. What do you think the robot would do if it heard the clap break from Cha Cha Slide?

“Our task was to replace the robot’s electronic microphone with a dead insect’s ear, use the ear’s ability to detect the electrical signals from the environment, in this case vibrations in the air, and, using a special chip, convert the insect input to that of the robot,” Ben M. Maoz, PhD, said in a statement from the university.

And how does a dead locust ear work in a robot? Well, Dr. Maoz explained: “My laboratory has developed a special device – Ear-on-a-Chip – that allows the ear to be kept alive throughout the experiment by supplying oxygen and food to the organ while allowing the electrical signals to be taken out of the locust’s ear and amplified and transmitted to the robot.”

The research won’t stop at hearing, he said, as the other four senses also will be taken into consideration. This could help us sense dangers in the future, such as earthquakes or diseases. We said it before and we’ll say it again: We’re rooting for you, science!

A phase 3 trial has associated the neurokinin-3 (NK3)–receptor inhibitor fezolinetant, an oral therapy taken once daily, with substantial control over the symptoms of menopause, according to results of the randomized SKYLIGHT 2 trial.

The nonhormonal therapy has the potential to address an important unmet need, Genevieve Neal-Perry, MD, PhD, said at the annual meeting of the Endocrine Society.

The health risks of hormone therapy (HT) have “caused quite a few women to consider whether hormone replacement is right for them, and, in addition, there are other individuals who have hormone-responsive cancers or other disorders that might prohibit them [from using HT],” Dr. Neal-Perry said.

The NK3 receptor stimulates the thermoregulatory center in the hypothalamus. By blocking the NK3 receptor, vasodilation and other downstream effects are inhibited, explained Dr. Neal-Perry. She credited relatively recent advances in understanding the mechanisms of menopausal symptoms for identifying this and other potentially targetable mediators.

SKYLIGHT 2 trial: Two phases

In the double-blind multinational phase 3 SKYLIGHT 2 trial, 484 otherwise healthy symptomatic menopausal women were randomized to 30 mg of fezolinetant, 45 mg of fezolinetant, or placebo. The 120 participating centers were in North American and Europe.

In the first phase, safety and efficacy were evaluated over 12 weeks. In a second extension phase, placebo patients were rerandomized to one of the fezolinetant study doses. Those on active therapy remained in their assigned groups. All patients were then followed for an additional 40 weeks.

The coprimary endpoints were frequency and severity of moderate to severe vasomotor symptoms as reported by patients using an electronic diary. There were several secondary endpoints, including patient-reported outcomes regarding sleep quality.

As expected from other controlled trials, placebo patients achieved about a 40% reduction in moderate to severe vasomotor symptom frequency over the first 12 weeks. Relative to placebo, symptom frequency declined more quickly and steeply on fezolinetant. By week 12, both achieved reductions of about 60%. Statistical P values for the differences in the three arms were not provided, but Dr. Neal-Perry reported they were significant.

Vasomotor severity, like frequency, is reduced

The change in vasomotor severity, which subjects in the trial rated as better or worse, was also significant. The differences in the severity curves were less, but they separated in favor of the two active treatment arms by about 2 weeks, and the curves continued to show an advantage for fezolinetant over both the first 12 weeks and then the remaining 40 weeks.

Overall, the decline in vasomotor symptom frequency remained on a persistent downward slope on both doses of fezolinetant for the full 52 weeks of the study, so that the reduction at 52 weeks was on the order of 25% greater than that seen at 12 weeks.

At 52 weeks, “you can see that individuals on placebo who were crossed over to an active treatment had a significant reduction in their hot flashes and look very much like those who were randomized to fezolinetant at the beginning of the study,” said Dr. Neal-Perry, who is chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Other outcomes also favored fezolinetant over placebo. For example, a reduction in sleep disturbance observed at 12 weeks was sustained over the full 52 weeks of the study. The reduction in sleep symptoms appeared to be slightly greater on the higher dose, but the benefit at 52 weeks among patients after the crossover was similar on either active arm.

No serious side effects identified

There were no serious drug-related treatment-emergent adverse events in any treatment group. One patient in the placebo arm (< 1%), two patients in the 30-mg fezolinetant arm (1.2%), and five patients in the 45-mg arm (3%) discontinued therapy for an adverse event considered to be treatment related.

“The most common side effect associated with fezolinetant was headache. There were no other side effects that led patients to pull out of the study,” Dr. Neal-Perry reported at the meeting, which was held in Atlanta and virtually.

According to Dr. Neal-Perry the vasomotor symptoms relative to menopause, which occur in almost all women, are moderate to severe in an estimated 35%-45%. Some groups, such as those with an elevated body mass index and African Americans, appear to be at even greater risk. Study enrollment was specifically designed to include these high-risk groups, but the subgroup efficacy data have not yet been analyzed.

Other drugs with a similar mechanism of action have not been brought forward because of concern about elevated liver enzymes, but Dr. Neal-Perry said that this does not appear to be an issue for fezolinetant, which was designed with greater specificity for the NK3 target than previous treatments.

If fezolinetant is approved, Dr. Neal-Perry expects this agent to fulfill an important unmet need because of the limitations of other nonhormonal solutions for control of menopause symptoms.

HT alternatives limited

For control of many menopause symptoms, particularly hot flashes, hormone therapy (HT) is the most efficacious, but Richard J. Santen, MD, emeritus professor and an endocrinologist at the University of Virginia, Charlottesville, agreed there is a need for alternatives.

In addition to those who have contraindications for HT, Dr. Santen said in an interview that this option is not acceptable to others “for a variety of reasons.” The problem is that the alternatives are limited.

“The SSRI agents and gabapentin are alternative nonhormonal agents, but they have side effects and are not as effective,” he said. Hot flashes “can be a major disruptor of quality of life,” so he is intrigued with the positive results achieved with fezolinetant.

“A new drug such as reported at the Endocrine Society meeting would be an important new addition to the armamentarium,” he said.

Dr. Neal-Perry reports no conflicts of interest.

A phase 3 trial has associated the neurokinin-3 (NK3)–receptor inhibitor fezolinetant, an oral therapy taken once daily, with substantial control over the symptoms of menopause, according to results of the randomized SKYLIGHT 2 trial.

The nonhormonal therapy has the potential to address an important unmet need, Genevieve Neal-Perry, MD, PhD, said at the annual meeting of the Endocrine Society.

The health risks of hormone therapy (HT) have “caused quite a few women to consider whether hormone replacement is right for them, and, in addition, there are other individuals who have hormone-responsive cancers or other disorders that might prohibit them [from using HT],” Dr. Neal-Perry said.

The NK3 receptor stimulates the thermoregulatory center in the hypothalamus. By blocking the NK3 receptor, vasodilation and other downstream effects are inhibited, explained Dr. Neal-Perry. She credited relatively recent advances in understanding the mechanisms of menopausal symptoms for identifying this and other potentially targetable mediators.

SKYLIGHT 2 trial: Two phases

In the double-blind multinational phase 3 SKYLIGHT 2 trial, 484 otherwise healthy symptomatic menopausal women were randomized to 30 mg of fezolinetant, 45 mg of fezolinetant, or placebo. The 120 participating centers were in North American and Europe.

In the first phase, safety and efficacy were evaluated over 12 weeks. In a second extension phase, placebo patients were rerandomized to one of the fezolinetant study doses. Those on active therapy remained in their assigned groups. All patients were then followed for an additional 40 weeks.

The coprimary endpoints were frequency and severity of moderate to severe vasomotor symptoms as reported by patients using an electronic diary. There were several secondary endpoints, including patient-reported outcomes regarding sleep quality.

As expected from other controlled trials, placebo patients achieved about a 40% reduction in moderate to severe vasomotor symptom frequency over the first 12 weeks. Relative to placebo, symptom frequency declined more quickly and steeply on fezolinetant. By week 12, both achieved reductions of about 60%. Statistical P values for the differences in the three arms were not provided, but Dr. Neal-Perry reported they were significant.

Vasomotor severity, like frequency, is reduced

The change in vasomotor severity, which subjects in the trial rated as better or worse, was also significant. The differences in the severity curves were less, but they separated in favor of the two active treatment arms by about 2 weeks, and the curves continued to show an advantage for fezolinetant over both the first 12 weeks and then the remaining 40 weeks.

Overall, the decline in vasomotor symptom frequency remained on a persistent downward slope on both doses of fezolinetant for the full 52 weeks of the study, so that the reduction at 52 weeks was on the order of 25% greater than that seen at 12 weeks.

At 52 weeks, “you can see that individuals on placebo who were crossed over to an active treatment had a significant reduction in their hot flashes and look very much like those who were randomized to fezolinetant at the beginning of the study,” said Dr. Neal-Perry, who is chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Other outcomes also favored fezolinetant over placebo. For example, a reduction in sleep disturbance observed at 12 weeks was sustained over the full 52 weeks of the study. The reduction in sleep symptoms appeared to be slightly greater on the higher dose, but the benefit at 52 weeks among patients after the crossover was similar on either active arm.

No serious side effects identified

There were no serious drug-related treatment-emergent adverse events in any treatment group. One patient in the placebo arm (< 1%), two patients in the 30-mg fezolinetant arm (1.2%), and five patients in the 45-mg arm (3%) discontinued therapy for an adverse event considered to be treatment related.

“The most common side effect associated with fezolinetant was headache. There were no other side effects that led patients to pull out of the study,” Dr. Neal-Perry reported at the meeting, which was held in Atlanta and virtually.

According to Dr. Neal-Perry the vasomotor symptoms relative to menopause, which occur in almost all women, are moderate to severe in an estimated 35%-45%. Some groups, such as those with an elevated body mass index and African Americans, appear to be at even greater risk. Study enrollment was specifically designed to include these high-risk groups, but the subgroup efficacy data have not yet been analyzed.

Other drugs with a similar mechanism of action have not been brought forward because of concern about elevated liver enzymes, but Dr. Neal-Perry said that this does not appear to be an issue for fezolinetant, which was designed with greater specificity for the NK3 target than previous treatments.

If fezolinetant is approved, Dr. Neal-Perry expects this agent to fulfill an important unmet need because of the limitations of other nonhormonal solutions for control of menopause symptoms.

HT alternatives limited

For control of many menopause symptoms, particularly hot flashes, hormone therapy (HT) is the most efficacious, but Richard J. Santen, MD, emeritus professor and an endocrinologist at the University of Virginia, Charlottesville, agreed there is a need for alternatives.

In addition to those who have contraindications for HT, Dr. Santen said in an interview that this option is not acceptable to others “for a variety of reasons.” The problem is that the alternatives are limited.

“The SSRI agents and gabapentin are alternative nonhormonal agents, but they have side effects and are not as effective,” he said. Hot flashes “can be a major disruptor of quality of life,” so he is intrigued with the positive results achieved with fezolinetant.

“A new drug such as reported at the Endocrine Society meeting would be an important new addition to the armamentarium,” he said.

Dr. Neal-Perry reports no conflicts of interest.

A phase 3 trial has associated the neurokinin-3 (NK3)–receptor inhibitor fezolinetant, an oral therapy taken once daily, with substantial control over the symptoms of menopause, according to results of the randomized SKYLIGHT 2 trial.

The nonhormonal therapy has the potential to address an important unmet need, Genevieve Neal-Perry, MD, PhD, said at the annual meeting of the Endocrine Society.

The health risks of hormone therapy (HT) have “caused quite a few women to consider whether hormone replacement is right for them, and, in addition, there are other individuals who have hormone-responsive cancers or other disorders that might prohibit them [from using HT],” Dr. Neal-Perry said.

The NK3 receptor stimulates the thermoregulatory center in the hypothalamus. By blocking the NK3 receptor, vasodilation and other downstream effects are inhibited, explained Dr. Neal-Perry. She credited relatively recent advances in understanding the mechanisms of menopausal symptoms for identifying this and other potentially targetable mediators.

SKYLIGHT 2 trial: Two phases

In the double-blind multinational phase 3 SKYLIGHT 2 trial, 484 otherwise healthy symptomatic menopausal women were randomized to 30 mg of fezolinetant, 45 mg of fezolinetant, or placebo. The 120 participating centers were in North American and Europe.

In the first phase, safety and efficacy were evaluated over 12 weeks. In a second extension phase, placebo patients were rerandomized to one of the fezolinetant study doses. Those on active therapy remained in their assigned groups. All patients were then followed for an additional 40 weeks.

The coprimary endpoints were frequency and severity of moderate to severe vasomotor symptoms as reported by patients using an electronic diary. There were several secondary endpoints, including patient-reported outcomes regarding sleep quality.

As expected from other controlled trials, placebo patients achieved about a 40% reduction in moderate to severe vasomotor symptom frequency over the first 12 weeks. Relative to placebo, symptom frequency declined more quickly and steeply on fezolinetant. By week 12, both achieved reductions of about 60%. Statistical P values for the differences in the three arms were not provided, but Dr. Neal-Perry reported they were significant.

Vasomotor severity, like frequency, is reduced

The change in vasomotor severity, which subjects in the trial rated as better or worse, was also significant. The differences in the severity curves were less, but they separated in favor of the two active treatment arms by about 2 weeks, and the curves continued to show an advantage for fezolinetant over both the first 12 weeks and then the remaining 40 weeks.

Overall, the decline in vasomotor symptom frequency remained on a persistent downward slope on both doses of fezolinetant for the full 52 weeks of the study, so that the reduction at 52 weeks was on the order of 25% greater than that seen at 12 weeks.

At 52 weeks, “you can see that individuals on placebo who were crossed over to an active treatment had a significant reduction in their hot flashes and look very much like those who were randomized to fezolinetant at the beginning of the study,” said Dr. Neal-Perry, who is chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Other outcomes also favored fezolinetant over placebo. For example, a reduction in sleep disturbance observed at 12 weeks was sustained over the full 52 weeks of the study. The reduction in sleep symptoms appeared to be slightly greater on the higher dose, but the benefit at 52 weeks among patients after the crossover was similar on either active arm.

No serious side effects identified

There were no serious drug-related treatment-emergent adverse events in any treatment group. One patient in the placebo arm (< 1%), two patients in the 30-mg fezolinetant arm (1.2%), and five patients in the 45-mg arm (3%) discontinued therapy for an adverse event considered to be treatment related.

“The most common side effect associated with fezolinetant was headache. There were no other side effects that led patients to pull out of the study,” Dr. Neal-Perry reported at the meeting, which was held in Atlanta and virtually.

According to Dr. Neal-Perry the vasomotor symptoms relative to menopause, which occur in almost all women, are moderate to severe in an estimated 35%-45%. Some groups, such as those with an elevated body mass index and African Americans, appear to be at even greater risk. Study enrollment was specifically designed to include these high-risk groups, but the subgroup efficacy data have not yet been analyzed.

Other drugs with a similar mechanism of action have not been brought forward because of concern about elevated liver enzymes, but Dr. Neal-Perry said that this does not appear to be an issue for fezolinetant, which was designed with greater specificity for the NK3 target than previous treatments.

If fezolinetant is approved, Dr. Neal-Perry expects this agent to fulfill an important unmet need because of the limitations of other nonhormonal solutions for control of menopause symptoms.

HT alternatives limited

For control of many menopause symptoms, particularly hot flashes, hormone therapy (HT) is the most efficacious, but Richard J. Santen, MD, emeritus professor and an endocrinologist at the University of Virginia, Charlottesville, agreed there is a need for alternatives.

In addition to those who have contraindications for HT, Dr. Santen said in an interview that this option is not acceptable to others “for a variety of reasons.” The problem is that the alternatives are limited.

“The SSRI agents and gabapentin are alternative nonhormonal agents, but they have side effects and are not as effective,” he said. Hot flashes “can be a major disruptor of quality of life,” so he is intrigued with the positive results achieved with fezolinetant.

“A new drug such as reported at the Endocrine Society meeting would be an important new addition to the armamentarium,” he said.

Dr. Neal-Perry reports no conflicts of interest.

The number and rate of U.S. abortions increased between 2017 and 2020 after a 30-year decline, according to a new report from the Guttmacher Institute.

More than 930,000 abortions took place in the United States in 2020, up 8% from 862,000 abortions in 2017. About one in five pregnancies ended in abortion in 2020, the report said.

The Guttmacher Institute, a research organization that supports abortion rights, said the trend shows a rising need for abortion care as the Supreme Court is poised to overturn the Roe v. Wade decision in coming weeks.

National abortion numbers reached the lowest point in 2017 since the landmark 1973 ruling that legalized the procedure. In the years following the ruling, abortion numbers rose above 1.5 million annually throughout the 1980s and then began declining in the 1990s, though they remained above 1 million annually through the early 2010s.

The latest data show that the abortion rate increased from 13.5 abortions per 1,000 women between ages 15 and 44 in 2017 to 14.4 abortions per 1,000 women in 2020, marking a 7% increase.

Similarly, the abortion ratio – or the number of abortions per 100 pregnancies – increased from 18.4% in 2017 to 20.6% in 2020, marking a 12% increase.

The increase in abortions was accompanied by a 6% decline in births between 2017 and 2020, the Guttmacher Institute said.

“Because there were many more births (3.6 million) than abortions (930,000) in 2020, these patterns mean that fewer people were getting pregnant and, among those who did, a larger proportion chose to have an abortion,” the institute wrote.

Medication-related abortions accounted for 54% of U.S. abortions in 2020, according to the report, which was the first time they made up more than half of abortions.

The number of abortions increased in every region of the country between 2017 and 2020, the report shows. The increases were largest in the West (12%) and Midwest (10%), followed by 8% in the South and 2% in the Northeast.

In some states – Illinois, Mississippi, and Oklahoma – there were substantial increases in the number of abortions, the institute said. In others – such as Missouri, Oregon, and North Dakota – there were substantially fewer abortions in 2020, compared with 2017.

The COVID-19 pandemic may have led to a decline in some states. In New York, abortions increased 5% from 2017 to 2019 and then fell 6% between 2019 and 2020. About 10% of clinics in New York paused or stopped abortion care in 2020 when the pandemic started.

New laws likely affected the numbers as well. Texas had a 7% increase between 2017 and 2019, followed by a 2% decrease between 2019 and 2020, which overlapped with restrictions that deemed abortions “nonessential” health care at the beginning of the pandemic.

In contrast, some numbers may have increased because of expanded Medicaid funding. Illinois began allowing state Medicaid funds to pay for abortions in January 2018, and abortions increased 25% between 2017 and 2020.

In Missouri, abortions decreased substantially from 4,710 in 2017 to 170 in 2020, the report shows, but the number of Missouri residents who traveled to Illinois for abortions increased to more than 6,500.

Every 3 years, the Guttmacher Institute contacts U.S. facilities that provide abortions to collect information about services, including the total number of abortions. The most recent count was completed in May, representing 1,687 health care facilities that provided abortions in 2019 or 2020. A full summary of the data will be published later this year in a peer-reviewed journal article.

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

The number and rate of U.S. abortions increased between 2017 and 2020 after a 30-year decline, according to a new report from the Guttmacher Institute.

More than 930,000 abortions took place in the United States in 2020, up 8% from 862,000 abortions in 2017. About one in five pregnancies ended in abortion in 2020, the report said.

The Guttmacher Institute, a research organization that supports abortion rights, said the trend shows a rising need for abortion care as the Supreme Court is poised to overturn the Roe v. Wade decision in coming weeks.

National abortion numbers reached the lowest point in 2017 since the landmark 1973 ruling that legalized the procedure. In the years following the ruling, abortion numbers rose above 1.5 million annually throughout the 1980s and then began declining in the 1990s, though they remained above 1 million annually through the early 2010s.

The latest data show that the abortion rate increased from 13.5 abortions per 1,000 women between ages 15 and 44 in 2017 to 14.4 abortions per 1,000 women in 2020, marking a 7% increase.

Similarly, the abortion ratio – or the number of abortions per 100 pregnancies – increased from 18.4% in 2017 to 20.6% in 2020, marking a 12% increase.

The increase in abortions was accompanied by a 6% decline in births between 2017 and 2020, the Guttmacher Institute said.

“Because there were many more births (3.6 million) than abortions (930,000) in 2020, these patterns mean that fewer people were getting pregnant and, among those who did, a larger proportion chose to have an abortion,” the institute wrote.

Medication-related abortions accounted for 54% of U.S. abortions in 2020, according to the report, which was the first time they made up more than half of abortions.

The number of abortions increased in every region of the country between 2017 and 2020, the report shows. The increases were largest in the West (12%) and Midwest (10%), followed by 8% in the South and 2% in the Northeast.

In some states – Illinois, Mississippi, and Oklahoma – there were substantial increases in the number of abortions, the institute said. In others – such as Missouri, Oregon, and North Dakota – there were substantially fewer abortions in 2020, compared with 2017.

The COVID-19 pandemic may have led to a decline in some states. In New York, abortions increased 5% from 2017 to 2019 and then fell 6% between 2019 and 2020. About 10% of clinics in New York paused or stopped abortion care in 2020 when the pandemic started.

New laws likely affected the numbers as well. Texas had a 7% increase between 2017 and 2019, followed by a 2% decrease between 2019 and 2020, which overlapped with restrictions that deemed abortions “nonessential” health care at the beginning of the pandemic.

In contrast, some numbers may have increased because of expanded Medicaid funding. Illinois began allowing state Medicaid funds to pay for abortions in January 2018, and abortions increased 25% between 2017 and 2020.

In Missouri, abortions decreased substantially from 4,710 in 2017 to 170 in 2020, the report shows, but the number of Missouri residents who traveled to Illinois for abortions increased to more than 6,500.

Every 3 years, the Guttmacher Institute contacts U.S. facilities that provide abortions to collect information about services, including the total number of abortions. The most recent count was completed in May, representing 1,687 health care facilities that provided abortions in 2019 or 2020. A full summary of the data will be published later this year in a peer-reviewed journal article.

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

The number and rate of U.S. abortions increased between 2017 and 2020 after a 30-year decline, according to a new report from the Guttmacher Institute.

More than 930,000 abortions took place in the United States in 2020, up 8% from 862,000 abortions in 2017. About one in five pregnancies ended in abortion in 2020, the report said.

The Guttmacher Institute, a research organization that supports abortion rights, said the trend shows a rising need for abortion care as the Supreme Court is poised to overturn the Roe v. Wade decision in coming weeks.

National abortion numbers reached the lowest point in 2017 since the landmark 1973 ruling that legalized the procedure. In the years following the ruling, abortion numbers rose above 1.5 million annually throughout the 1980s and then began declining in the 1990s, though they remained above 1 million annually through the early 2010s.

The latest data show that the abortion rate increased from 13.5 abortions per 1,000 women between ages 15 and 44 in 2017 to 14.4 abortions per 1,000 women in 2020, marking a 7% increase.

Similarly, the abortion ratio – or the number of abortions per 100 pregnancies – increased from 18.4% in 2017 to 20.6% in 2020, marking a 12% increase.

The increase in abortions was accompanied by a 6% decline in births between 2017 and 2020, the Guttmacher Institute said.

“Because there were many more births (3.6 million) than abortions (930,000) in 2020, these patterns mean that fewer people were getting pregnant and, among those who did, a larger proportion chose to have an abortion,” the institute wrote.

Medication-related abortions accounted for 54% of U.S. abortions in 2020, according to the report, which was the first time they made up more than half of abortions.

The number of abortions increased in every region of the country between 2017 and 2020, the report shows. The increases were largest in the West (12%) and Midwest (10%), followed by 8% in the South and 2% in the Northeast.

In some states – Illinois, Mississippi, and Oklahoma – there were substantial increases in the number of abortions, the institute said. In others – such as Missouri, Oregon, and North Dakota – there were substantially fewer abortions in 2020, compared with 2017.

The COVID-19 pandemic may have led to a decline in some states. In New York, abortions increased 5% from 2017 to 2019 and then fell 6% between 2019 and 2020. About 10% of clinics in New York paused or stopped abortion care in 2020 when the pandemic started.

New laws likely affected the numbers as well. Texas had a 7% increase between 2017 and 2019, followed by a 2% decrease between 2019 and 2020, which overlapped with restrictions that deemed abortions “nonessential” health care at the beginning of the pandemic.

In contrast, some numbers may have increased because of expanded Medicaid funding. Illinois began allowing state Medicaid funds to pay for abortions in January 2018, and abortions increased 25% between 2017 and 2020.

In Missouri, abortions decreased substantially from 4,710 in 2017 to 170 in 2020, the report shows, but the number of Missouri residents who traveled to Illinois for abortions increased to more than 6,500.

Every 3 years, the Guttmacher Institute contacts U.S. facilities that provide abortions to collect information about services, including the total number of abortions. The most recent count was completed in May, representing 1,687 health care facilities that provided abortions in 2019 or 2020. A full summary of the data will be published later this year in a peer-reviewed journal article.

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

Following a diet rich in healthy plant-based products may lower one’s risk of breast cancer, but not if that diet happens to be high in unhealthy foods, researchers have found.

The study of more than 65,000 people showed that plant-based diets that were high in whole grains, fruits, and vegetables appear to be more protective against breast cancer than diets rich in processed plant-based products, such as juice and chips.

“Results suggest that the best plant-based diet for breast cancer prevention could be a healthy plant-based diet comprising fruit, vegetables, whole grains, nuts, and legumes,” said Sanam Shah, MBBS, FCPS, MPH, a doctoral candidate in epidemiology at Paris-Saclay University, who is the lead author of the new study. “In contrast, an unhealthy plant-based diet comprising higher intakes of primarily processed products of plant origin, such as refined grains, fruit juices, sweets, desserts, and potatoes, would be worse for breast cancer prevention.”

Dr. Shah’s group is presenting their research online at the annual meeting of the American Society for Nutrition.

Although the role of plant-based diets in cancer prevention has received extensive attention, Dr. Shah said few studies have assessed the influence of the quality of those diets on the risk of breast cancer.

Dr. Shah and colleagues conducted a prospective cohort study to investigate the link between healthy and unhealthy plant-based diets and breast cancer risk. Unlike other studies, the researchers also evaluated the effect of a gradual decrease in animal products in diets on health.

Dr. Shah’s group followed 65,574 postmenopausal women in France (mean age, 52.8 years) from 1993 to 2014. The researchers used self-reported food questionnaires to classify women into groups on the basis of adherence to a mostly plant or animal diet. Plant-based diets did not exclude meat but had more plant than animal products, Dr. Shah said. The researchers also grouped women on the basis of how healthy the plant-based diets were.

Over the 21-year study period, 3,968 women were diagnosed with breast cancer. Those who adhered to a more healthful plant-based diet had a 14% lower risk than average of developing breast cancer, while those who adhered to a less healthful plant-based diet had a 20% greater risk of developing the disease.

Nutritional quality varies greatly across plant-based foods. Quality plant-based diets should focus on variety to avoid nutritional deficiencies in iron, zinc, calcium, and vitamin B12, Dr. Shah said.

“The study by Shah and coworkers underscores the importance of considering more global aspects of the diet rather than single components when examining relationships between diet and health,” said Megan McCrory, PhD, research associate professor of nutrition at Boston University. “As the study illustrates, plant-based diets as a whole are not always healthy and may also contain less desirable nutrients and foods.”

Abstracts in the conference have been selected by a board of experts for presentation but have not yet been peer reviewed. All findings are to be regarded as preliminary until they are published in peer-reviewed articles. Dr. Shah and Dr. McCrory disclosed no relevant financial relationships.

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

Following a diet rich in healthy plant-based products may lower one’s risk of breast cancer, but not if that diet happens to be high in unhealthy foods, researchers have found.

The study of more than 65,000 people showed that plant-based diets that were high in whole grains, fruits, and vegetables appear to be more protective against breast cancer than diets rich in processed plant-based products, such as juice and chips.

“Results suggest that the best plant-based diet for breast cancer prevention could be a healthy plant-based diet comprising fruit, vegetables, whole grains, nuts, and legumes,” said Sanam Shah, MBBS, FCPS, MPH, a doctoral candidate in epidemiology at Paris-Saclay University, who is the lead author of the new study. “In contrast, an unhealthy plant-based diet comprising higher intakes of primarily processed products of plant origin, such as refined grains, fruit juices, sweets, desserts, and potatoes, would be worse for breast cancer prevention.”

Dr. Shah’s group is presenting their research online at the annual meeting of the American Society for Nutrition.

Although the role of plant-based diets in cancer prevention has received extensive attention, Dr. Shah said few studies have assessed the influence of the quality of those diets on the risk of breast cancer.

Dr. Shah and colleagues conducted a prospective cohort study to investigate the link between healthy and unhealthy plant-based diets and breast cancer risk. Unlike other studies, the researchers also evaluated the effect of a gradual decrease in animal products in diets on health.

Dr. Shah’s group followed 65,574 postmenopausal women in France (mean age, 52.8 years) from 1993 to 2014. The researchers used self-reported food questionnaires to classify women into groups on the basis of adherence to a mostly plant or animal diet. Plant-based diets did not exclude meat but had more plant than animal products, Dr. Shah said. The researchers also grouped women on the basis of how healthy the plant-based diets were.

Over the 21-year study period, 3,968 women were diagnosed with breast cancer. Those who adhered to a more healthful plant-based diet had a 14% lower risk than average of developing breast cancer, while those who adhered to a less healthful plant-based diet had a 20% greater risk of developing the disease.

Nutritional quality varies greatly across plant-based foods. Quality plant-based diets should focus on variety to avoid nutritional deficiencies in iron, zinc, calcium, and vitamin B12, Dr. Shah said.

“The study by Shah and coworkers underscores the importance of considering more global aspects of the diet rather than single components when examining relationships between diet and health,” said Megan McCrory, PhD, research associate professor of nutrition at Boston University. “As the study illustrates, plant-based diets as a whole are not always healthy and may also contain less desirable nutrients and foods.”

Abstracts in the conference have been selected by a board of experts for presentation but have not yet been peer reviewed. All findings are to be regarded as preliminary until they are published in peer-reviewed articles. Dr. Shah and Dr. McCrory disclosed no relevant financial relationships.

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

Following a diet rich in healthy plant-based products may lower one’s risk of breast cancer, but not if that diet happens to be high in unhealthy foods, researchers have found.

The study of more than 65,000 people showed that plant-based diets that were high in whole grains, fruits, and vegetables appear to be more protective against breast cancer than diets rich in processed plant-based products, such as juice and chips.

“Results suggest that the best plant-based diet for breast cancer prevention could be a healthy plant-based diet comprising fruit, vegetables, whole grains, nuts, and legumes,” said Sanam Shah, MBBS, FCPS, MPH, a doctoral candidate in epidemiology at Paris-Saclay University, who is the lead author of the new study. “In contrast, an unhealthy plant-based diet comprising higher intakes of primarily processed products of plant origin, such as refined grains, fruit juices, sweets, desserts, and potatoes, would be worse for breast cancer prevention.”

Dr. Shah’s group is presenting their research online at the annual meeting of the American Society for Nutrition.

Although the role of plant-based diets in cancer prevention has received extensive attention, Dr. Shah said few studies have assessed the influence of the quality of those diets on the risk of breast cancer.

Dr. Shah and colleagues conducted a prospective cohort study to investigate the link between healthy and unhealthy plant-based diets and breast cancer risk. Unlike other studies, the researchers also evaluated the effect of a gradual decrease in animal products in diets on health.

Dr. Shah’s group followed 65,574 postmenopausal women in France (mean age, 52.8 years) from 1993 to 2014. The researchers used self-reported food questionnaires to classify women into groups on the basis of adherence to a mostly plant or animal diet. Plant-based diets did not exclude meat but had more plant than animal products, Dr. Shah said. The researchers also grouped women on the basis of how healthy the plant-based diets were.

Over the 21-year study period, 3,968 women were diagnosed with breast cancer. Those who adhered to a more healthful plant-based diet had a 14% lower risk than average of developing breast cancer, while those who adhered to a less healthful plant-based diet had a 20% greater risk of developing the disease.

Nutritional quality varies greatly across plant-based foods. Quality plant-based diets should focus on variety to avoid nutritional deficiencies in iron, zinc, calcium, and vitamin B12, Dr. Shah said.

“The study by Shah and coworkers underscores the importance of considering more global aspects of the diet rather than single components when examining relationships between diet and health,” said Megan McCrory, PhD, research associate professor of nutrition at Boston University. “As the study illustrates, plant-based diets as a whole are not always healthy and may also contain less desirable nutrients and foods.”

Abstracts in the conference have been selected by a board of experts for presentation but have not yet been peer reviewed. All findings are to be regarded as preliminary until they are published in peer-reviewed articles. Dr. Shah and Dr. McCrory disclosed no relevant financial relationships.

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

Sleep time may be a modifiable risk factor for cancer, according to a recent study from Japan.

The findings reveal that sleeping 10-plus hours may increase a woman’s risk of getting cancer and both men and women’s risk of dying from cancer. 

The researchers say their findings may help refine sleep recommendations in Japan, which currently advise working, middle-aged adults to sleep “as long as they can.”

Based on the new findings, a sleep duration of 6-8 hours for men and 6-9 hours for women “may be the safest” regarding cancer incidence and mortality risk among Japanese adults, the authors conclude.

The findings were published online in the International Journal of Cancer. 

The literature on sleep time and cancer risk is mixed. A trio of meta-analyses conducted between 2016 and 2019 found that long sleep duration, but not short, was associated with a slightly elevated risk of all cancer mortality in Asians.

A separate meta-analysis conducted in 2018 found that both short and long sleep durations were not related to cancer incidence. But in the stratified analysis, shorter sleep time was associated with 36% increased cancer risk among Asians.

To investigate further, the researchers pooled data from six population-based cohorts that included 271,694 adults – 126,930 men and 144,764 women – with 40,751 total incident cancer cases and 18,323 total cancer deaths during a follow-up lasting about 5.9 million person-years.

In the multivariable analysis, longer sleep duration was not associated with total cancer incidence in men. In women, however, sleeping 10 or more hours vs. 7 was associated with a 19% increased risk of cancer.

In addition, sleeping 10 or more hours was associated with an increased risk of dying from cancer in women (hazard ratio, 1.44) and men (HR, 1.18).

Sleeping for 5 hours or fewer, compared with 7, was not associated with cancer incidence and mortality. However, among postmenopausal women, shorter sleep durations did increase the risk of dying from cancer (HR, 1.15).

The authors highlight several strengths of the analysis, including a large sample size as well as stratification of the results by body mass index and menopause status, which has rarely been done in previous studies.

Limitations include self-reported sleep durations and lack of data on sleep quality. The researchers note that the mechanism by which sleep time may influence cancer incidence and mortality is unclear but likely to be complex and cancer site specific.

It’s also possible that reverse causation could explain associations between sleep duration and cancer occurrence and mortality – with pain from cancer, for instance, impairing sleep duration and quality. However, the sensitivity analysis found no evidence of reverse causality or other confounding factors.

Based on these findings, the researchers say sleep duration “may be an important variable to include in cancer incidence and mortality risk prediction models.”

The study had no specific funding. The authors declared no relevant conflicts of interest.

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

Sleep time may be a modifiable risk factor for cancer, according to a recent study from Japan.

The findings reveal that sleeping 10-plus hours may increase a woman’s risk of getting cancer and both men and women’s risk of dying from cancer. 

The researchers say their findings may help refine sleep recommendations in Japan, which currently advise working, middle-aged adults to sleep “as long as they can.”

Based on the new findings, a sleep duration of 6-8 hours for men and 6-9 hours for women “may be the safest” regarding cancer incidence and mortality risk among Japanese adults, the authors conclude.

The findings were published online in the International Journal of Cancer. 

The literature on sleep time and cancer risk is mixed. A trio of meta-analyses conducted between 2016 and 2019 found that long sleep duration, but not short, was associated with a slightly elevated risk of all cancer mortality in Asians.

A separate meta-analysis conducted in 2018 found that both short and long sleep durations were not related to cancer incidence. But in the stratified analysis, shorter sleep time was associated with 36% increased cancer risk among Asians.

To investigate further, the researchers pooled data from six population-based cohorts that included 271,694 adults – 126,930 men and 144,764 women – with 40,751 total incident cancer cases and 18,323 total cancer deaths during a follow-up lasting about 5.9 million person-years.

In the multivariable analysis, longer sleep duration was not associated with total cancer incidence in men. In women, however, sleeping 10 or more hours vs. 7 was associated with a 19% increased risk of cancer.

In addition, sleeping 10 or more hours was associated with an increased risk of dying from cancer in women (hazard ratio, 1.44) and men (HR, 1.18).

Sleeping for 5 hours or fewer, compared with 7, was not associated with cancer incidence and mortality. However, among postmenopausal women, shorter sleep durations did increase the risk of dying from cancer (HR, 1.15).

The authors highlight several strengths of the analysis, including a large sample size as well as stratification of the results by body mass index and menopause status, which has rarely been done in previous studies.

Limitations include self-reported sleep durations and lack of data on sleep quality. The researchers note that the mechanism by which sleep time may influence cancer incidence and mortality is unclear but likely to be complex and cancer site specific.

It’s also possible that reverse causation could explain associations between sleep duration and cancer occurrence and mortality – with pain from cancer, for instance, impairing sleep duration and quality. However, the sensitivity analysis found no evidence of reverse causality or other confounding factors.

Based on these findings, the researchers say sleep duration “may be an important variable to include in cancer incidence and mortality risk prediction models.”

The study had no specific funding. The authors declared no relevant conflicts of interest.

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

Sleep time may be a modifiable risk factor for cancer, according to a recent study from Japan.

The findings reveal that sleeping 10-plus hours may increase a woman’s risk of getting cancer and both men and women’s risk of dying from cancer. 

The researchers say their findings may help refine sleep recommendations in Japan, which currently advise working, middle-aged adults to sleep “as long as they can.”

Based on the new findings, a sleep duration of 6-8 hours for men and 6-9 hours for women “may be the safest” regarding cancer incidence and mortality risk among Japanese adults, the authors conclude.

The findings were published online in the International Journal of Cancer. 

The literature on sleep time and cancer risk is mixed. A trio of meta-analyses conducted between 2016 and 2019 found that long sleep duration, but not short, was associated with a slightly elevated risk of all cancer mortality in Asians.

A separate meta-analysis conducted in 2018 found that both short and long sleep durations were not related to cancer incidence. But in the stratified analysis, shorter sleep time was associated with 36% increased cancer risk among Asians.

To investigate further, the researchers pooled data from six population-based cohorts that included 271,694 adults – 126,930 men and 144,764 women – with 40,751 total incident cancer cases and 18,323 total cancer deaths during a follow-up lasting about 5.9 million person-years.

In the multivariable analysis, longer sleep duration was not associated with total cancer incidence in men. In women, however, sleeping 10 or more hours vs. 7 was associated with a 19% increased risk of cancer.

In addition, sleeping 10 or more hours was associated with an increased risk of dying from cancer in women (hazard ratio, 1.44) and men (HR, 1.18).

Sleeping for 5 hours or fewer, compared with 7, was not associated with cancer incidence and mortality. However, among postmenopausal women, shorter sleep durations did increase the risk of dying from cancer (HR, 1.15).

The authors highlight several strengths of the analysis, including a large sample size as well as stratification of the results by body mass index and menopause status, which has rarely been done in previous studies.

Limitations include self-reported sleep durations and lack of data on sleep quality. The researchers note that the mechanism by which sleep time may influence cancer incidence and mortality is unclear but likely to be complex and cancer site specific.

It’s also possible that reverse causation could explain associations between sleep duration and cancer occurrence and mortality – with pain from cancer, for instance, impairing sleep duration and quality. However, the sensitivity analysis found no evidence of reverse causality or other confounding factors.

Based on these findings, the researchers say sleep duration “may be an important variable to include in cancer incidence and mortality risk prediction models.”

The study had no specific funding. The authors declared no relevant conflicts of interest.

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

Exposure to per- and polyfluoroalkyl substances (PFAS) – a class of widely used synthetic chemicals dubbed “forever chemicals” – may be a modifiable risk factor for the development of hypertension.

In a large, prospective study, researchers found an association between higher blood levels of PFAS and increased risk of hypertension in middle-aged women. Women in the highest tertile of overall PFAS concentrations had a 71% increased risk of developing hypertension.

“Our findings suggest that long-term cumulative exposure, even before midlife, may increase the risk of high blood pressure, and therefore, the benefit of reducing the population exposure to PFAS and potential prevention of high blood pressure and other health conditions would be enormous,” Sung Kyun Park, ScD, MPH, University of Michigan School of Public Health, Ann Arbor, said in an interview.

The study was published online  in Hypertension.
 

Everywhere and forever

“PFAS are forever chemicals as well as everywhere chemicals,” Dr. Park noted.

Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and drinking water. They have been detected in the blood of most people and have been linked to a variety of health concerns.

“A few studies showed an association between PFAS and hypertension, but those were cross-sectional and examined prevalence of hypertension. It was unclear whether PFAS are associated with the development (incidence) of hypertension,” Dr. Park explained.

For their study, the researchers examined the association between serum concentrations of PFAS and risks of incident hypertension in 1,058 initially normotensive women participating in the Study of Women’s Health Across the Nation-Multi-Pollutant Study (SWAN-MPS). They were followed annually between 1999 and 2017.

During 11,722 person-years of follow-up, 470 of the women developed hypertension, at a rate of 40.1 cases per 1,000 person-years. Hypertension was defined as blood pressure of at least 140 mm Hg systolic or at least 90 mm Hg diastolic or receiving antihypertensive treatment.

Women in the highest tertile of baseline serum concentration of perfluorooctane sulfonate (PFOS) had a 42% higher risk of developing hypertension, compared with peers in the lowest tertile (adjusted hazard ratio, 1.42; 95% confidence interval, 1.19-1.68; P trend = .01).

Similar results were found for perfluorooctanoate (PFOA) and 2-N-ethyl-perfluorooctane sulfonamido acetate (EtFOSAA), with 47% (aHR, 1.47; 95% CI, 1.24-1.75; P trend = .01) and 42% (aHR, 1.42; 95% CI, 1.19-1.70; P trend = .01) higher risks of incident hypertension, comparing the highest to the lowest tertiles.

The risks persisted after adjusting for various factors, including race, study site, education, financial strain, smoking status, alcohol use, total calorie intake, and menopausal status.

In the PFAS “mixture” analysis, women in the highest tertile of overall PFAS concentrations were 71% more likely to develop hypertension during follow-up, compared with women in the lowest tertile (aHR, 1.71; 95% CI, 1.15-2.54; P trend = .008).

“These findings suggest that PFAS might be an underappreciated contributing factor to women’s cardiovascular disease risk,” the researchers write.

They caution that the study only included middle-aged women and that it is unclear whether the findings hold for middle-aged men.

“This is an important question, but the answer is that we do not know,” Dr. Park told this news organization.

“Women become more susceptible to metabolic changes and hypertension risk during the menopausal transition. Our findings suggest that PFAS may play a role in the development of hypertension in women during this critical life stage,” Dr. Park said.

The researchers say more research is needed to confirm and expand the findings and to find ways to reduce PFAS exposure.

“If confirmed in future studies, these findings suggest that understanding human exposure to PFAS and developing effective strategies to reduce PFAS exposure may help prevent the development of hypertension and thereby reduce the global burden of CVD,” the researchers write.
 

‘The more we learn, the worse it gets’

This is an “interesting” study and shows that “the more we learn about PFAS, the worse it seems to get,” Ankur Shah, MD, division of kidney disease and hypertension, Warren Alpert Medical School of Brown University, Providence, R.I., said in an interview.

“This multisite, multiracial and multiethnic, community-based longitudinal study establishes an association between PFAS and hypertension,” said Dr. Shah, who wasn’t involved in the study.

“This adds to a growing literature base of associations of PFAS with illnesses, including malignancy, thyroid disorders, diabetes, ulcerative colitis, hyperlipidemia, and pregnancy-induced hypertension,” he noted.

Dr. Shah also noted that the authors adjusted for race and ethnicity, study site, education, financial strain, smoking status, environmental tobacco smoke, alcohol consumption, total calorie intake, and menopausal status “and still found a strong association.”

“Still to be determined are both whether PFAS are the causative agent or if there is an unmeasured/unadjusted for entity which has resulted in both increased PFAS exposure and hypertension, as well as if PFAS are causative, if reduction in PFAS exposure would be result in blood pressure reduction,” Dr. Shah added.

The study had no sources of funding. Dr. Park and Dr. Shah have disclosed no relevant financial relationships.

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

Exposure to per- and polyfluoroalkyl substances (PFAS) – a class of widely used synthetic chemicals dubbed “forever chemicals” – may be a modifiable risk factor for the development of hypertension.

In a large, prospective study, researchers found an association between higher blood levels of PFAS and increased risk of hypertension in middle-aged women. Women in the highest tertile of overall PFAS concentrations had a 71% increased risk of developing hypertension.

“Our findings suggest that long-term cumulative exposure, even before midlife, may increase the risk of high blood pressure, and therefore, the benefit of reducing the population exposure to PFAS and potential prevention of high blood pressure and other health conditions would be enormous,” Sung Kyun Park, ScD, MPH, University of Michigan School of Public Health, Ann Arbor, said in an interview.

The study was published online  in Hypertension.
 

Everywhere and forever

“PFAS are forever chemicals as well as everywhere chemicals,” Dr. Park noted.

Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and drinking water. They have been detected in the blood of most people and have been linked to a variety of health concerns.

“A few studies showed an association between PFAS and hypertension, but those were cross-sectional and examined prevalence of hypertension. It was unclear whether PFAS are associated with the development (incidence) of hypertension,” Dr. Park explained.

For their study, the researchers examined the association between serum concentrations of PFAS and risks of incident hypertension in 1,058 initially normotensive women participating in the Study of Women’s Health Across the Nation-Multi-Pollutant Study (SWAN-MPS). They were followed annually between 1999 and 2017.

During 11,722 person-years of follow-up, 470 of the women developed hypertension, at a rate of 40.1 cases per 1,000 person-years. Hypertension was defined as blood pressure of at least 140 mm Hg systolic or at least 90 mm Hg diastolic or receiving antihypertensive treatment.

Women in the highest tertile of baseline serum concentration of perfluorooctane sulfonate (PFOS) had a 42% higher risk of developing hypertension, compared with peers in the lowest tertile (adjusted hazard ratio, 1.42; 95% confidence interval, 1.19-1.68; P trend = .01).

Similar results were found for perfluorooctanoate (PFOA) and 2-N-ethyl-perfluorooctane sulfonamido acetate (EtFOSAA), with 47% (aHR, 1.47; 95% CI, 1.24-1.75; P trend = .01) and 42% (aHR, 1.42; 95% CI, 1.19-1.70; P trend = .01) higher risks of incident hypertension, comparing the highest to the lowest tertiles.

The risks persisted after adjusting for various factors, including race, study site, education, financial strain, smoking status, alcohol use, total calorie intake, and menopausal status.

In the PFAS “mixture” analysis, women in the highest tertile of overall PFAS concentrations were 71% more likely to develop hypertension during follow-up, compared with women in the lowest tertile (aHR, 1.71; 95% CI, 1.15-2.54; P trend = .008).

“These findings suggest that PFAS might be an underappreciated contributing factor to women’s cardiovascular disease risk,” the researchers write.

They caution that the study only included middle-aged women and that it is unclear whether the findings hold for middle-aged men.

“This is an important question, but the answer is that we do not know,” Dr. Park told this news organization.

“Women become more susceptible to metabolic changes and hypertension risk during the menopausal transition. Our findings suggest that PFAS may play a role in the development of hypertension in women during this critical life stage,” Dr. Park said.

The researchers say more research is needed to confirm and expand the findings and to find ways to reduce PFAS exposure.

“If confirmed in future studies, these findings suggest that understanding human exposure to PFAS and developing effective strategies to reduce PFAS exposure may help prevent the development of hypertension and thereby reduce the global burden of CVD,” the researchers write.
 

‘The more we learn, the worse it gets’

This is an “interesting” study and shows that “the more we learn about PFAS, the worse it seems to get,” Ankur Shah, MD, division of kidney disease and hypertension, Warren Alpert Medical School of Brown University, Providence, R.I., said in an interview.

“This multisite, multiracial and multiethnic, community-based longitudinal study establishes an association between PFAS and hypertension,” said Dr. Shah, who wasn’t involved in the study.

“This adds to a growing literature base of associations of PFAS with illnesses, including malignancy, thyroid disorders, diabetes, ulcerative colitis, hyperlipidemia, and pregnancy-induced hypertension,” he noted.

Dr. Shah also noted that the authors adjusted for race and ethnicity, study site, education, financial strain, smoking status, environmental tobacco smoke, alcohol consumption, total calorie intake, and menopausal status “and still found a strong association.”

“Still to be determined are both whether PFAS are the causative agent or if there is an unmeasured/unadjusted for entity which has resulted in both increased PFAS exposure and hypertension, as well as if PFAS are causative, if reduction in PFAS exposure would be result in blood pressure reduction,” Dr. Shah added.

The study had no sources of funding. Dr. Park and Dr. Shah have disclosed no relevant financial relationships.

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

Exposure to per- and polyfluoroalkyl substances (PFAS) – a class of widely used synthetic chemicals dubbed “forever chemicals” – may be a modifiable risk factor for the development of hypertension.

In a large, prospective study, researchers found an association between higher blood levels of PFAS and increased risk of hypertension in middle-aged women. Women in the highest tertile of overall PFAS concentrations had a 71% increased risk of developing hypertension.

“Our findings suggest that long-term cumulative exposure, even before midlife, may increase the risk of high blood pressure, and therefore, the benefit of reducing the population exposure to PFAS and potential prevention of high blood pressure and other health conditions would be enormous,” Sung Kyun Park, ScD, MPH, University of Michigan School of Public Health, Ann Arbor, said in an interview.

The study was published online  in Hypertension.
 

Everywhere and forever

“PFAS are forever chemicals as well as everywhere chemicals,” Dr. Park noted.

Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and drinking water. They have been detected in the blood of most people and have been linked to a variety of health concerns.

“A few studies showed an association between PFAS and hypertension, but those were cross-sectional and examined prevalence of hypertension. It was unclear whether PFAS are associated with the development (incidence) of hypertension,” Dr. Park explained.

For their study, the researchers examined the association between serum concentrations of PFAS and risks of incident hypertension in 1,058 initially normotensive women participating in the Study of Women’s Health Across the Nation-Multi-Pollutant Study (SWAN-MPS). They were followed annually between 1999 and 2017.

During 11,722 person-years of follow-up, 470 of the women developed hypertension, at a rate of 40.1 cases per 1,000 person-years. Hypertension was defined as blood pressure of at least 140 mm Hg systolic or at least 90 mm Hg diastolic or receiving antihypertensive treatment.

Women in the highest tertile of baseline serum concentration of perfluorooctane sulfonate (PFOS) had a 42% higher risk of developing hypertension, compared with peers in the lowest tertile (adjusted hazard ratio, 1.42; 95% confidence interval, 1.19-1.68; P trend = .01).

Similar results were found for perfluorooctanoate (PFOA) and 2-N-ethyl-perfluorooctane sulfonamido acetate (EtFOSAA), with 47% (aHR, 1.47; 95% CI, 1.24-1.75; P trend = .01) and 42% (aHR, 1.42; 95% CI, 1.19-1.70; P trend = .01) higher risks of incident hypertension, comparing the highest to the lowest tertiles.

The risks persisted after adjusting for various factors, including race, study site, education, financial strain, smoking status, alcohol use, total calorie intake, and menopausal status.

In the PFAS “mixture” analysis, women in the highest tertile of overall PFAS concentrations were 71% more likely to develop hypertension during follow-up, compared with women in the lowest tertile (aHR, 1.71; 95% CI, 1.15-2.54; P trend = .008).

“These findings suggest that PFAS might be an underappreciated contributing factor to women’s cardiovascular disease risk,” the researchers write.

They caution that the study only included middle-aged women and that it is unclear whether the findings hold for middle-aged men.

“This is an important question, but the answer is that we do not know,” Dr. Park told this news organization.

“Women become more susceptible to metabolic changes and hypertension risk during the menopausal transition. Our findings suggest that PFAS may play a role in the development of hypertension in women during this critical life stage,” Dr. Park said.

The researchers say more research is needed to confirm and expand the findings and to find ways to reduce PFAS exposure.

“If confirmed in future studies, these findings suggest that understanding human exposure to PFAS and developing effective strategies to reduce PFAS exposure may help prevent the development of hypertension and thereby reduce the global burden of CVD,” the researchers write.
 

‘The more we learn, the worse it gets’

This is an “interesting” study and shows that “the more we learn about PFAS, the worse it seems to get,” Ankur Shah, MD, division of kidney disease and hypertension, Warren Alpert Medical School of Brown University, Providence, R.I., said in an interview.

“This multisite, multiracial and multiethnic, community-based longitudinal study establishes an association between PFAS and hypertension,” said Dr. Shah, who wasn’t involved in the study.

“This adds to a growing literature base of associations of PFAS with illnesses, including malignancy, thyroid disorders, diabetes, ulcerative colitis, hyperlipidemia, and pregnancy-induced hypertension,” he noted.

Dr. Shah also noted that the authors adjusted for race and ethnicity, study site, education, financial strain, smoking status, environmental tobacco smoke, alcohol consumption, total calorie intake, and menopausal status “and still found a strong association.”

“Still to be determined are both whether PFAS are the causative agent or if there is an unmeasured/unadjusted for entity which has resulted in both increased PFAS exposure and hypertension, as well as if PFAS are causative, if reduction in PFAS exposure would be result in blood pressure reduction,” Dr. Shah added.

The study had no sources of funding. Dr. Park and Dr. Shah have disclosed no relevant financial relationships.

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

Tampons may be harder to find because of supply chain challenges and inflation hikes that are causing higher prices.

Social media users have posted about bare shelves and higher costs for months, marking the latest products to face stress under global supply chain concerns after baby formula, cars, and appliances.

Other menstrual products have increased in price as well because of inflation, according to Bloomberg News. The average price for a package of menstrual pads has increased about 8% this year, and the price of a box of tampons has increased about 10%.

Andre Schulten, the chief financial officer for Procter & Gamble, which makes and sells 4.5 billion boxes of Tampax each year, said on a recent earnings call that it has been “costly and highly volatile” to acquire the raw materials needed for production.

Raw materials such as cotton, rayon, and plastic, for instance, have been used to produce personal protective gear during the pandemic, which has led to shortages. The cost of transportation for consumer goods has also nearly tripled, and pandemic policies at ports have led to shipping delays.

Edgewell Personal Care, which makes the brands Playtex and o.b., has had a severe staff shortage at its Delaware facility where tampons are made, according to Time. The FDA has classified tampons as class II medical devices, which require certain quality-control regulations and qualified workers on the assembly line, the news outlet reported.

Representatives for CVS and Walgreens confirmed that they’ve had shortages in recent weeks, according to The Washington Post. Procter & Gamble said it is working with retail partners to make feminine care products more available.

“We understand it is frustrating for consumers when they can’t find what they need,” the company told the newspaper. “We can assure you this is a temporary situation.”

Kimberly-Clark, which makes U by Kotex tampons, told the Post that it “has not experienced a product or supply shortage” in the United States, saying it is “working closely with our retail partners to keep shelves stocked.”

But the shortage may grow worse as the year goes on and the peak season for shipping approaches, the newspaper reported.

“Capacity is only going to get tighter as we move toward the end of the year,” Vaughn Moore, chief executive of AIT Worldwide Logistics, told the Post.

While the situation is being straightened out, gynecologists have recommended against extending supply at home by wearing tampons for longer stretches of time, according to The New York Times. Toxic shock syndrome is a rare but potentially fatal condition that can occur when tampons are worn for more than 8 hours.

There are other options, such as reusable menstrual pads, period underwear, and menstrual cups and discs, the Times reported. But some of these may be less appealing to use, or they may cost too much.

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

Tampons may be harder to find because of supply chain challenges and inflation hikes that are causing higher prices.

Social media users have posted about bare shelves and higher costs for months, marking the latest products to face stress under global supply chain concerns after baby formula, cars, and appliances.

Other menstrual products have increased in price as well because of inflation, according to Bloomberg News. The average price for a package of menstrual pads has increased about 8% this year, and the price of a box of tampons has increased about 10%.

Andre Schulten, the chief financial officer for Procter & Gamble, which makes and sells 4.5 billion boxes of Tampax each year, said on a recent earnings call that it has been “costly and highly volatile” to acquire the raw materials needed for production.

Raw materials such as cotton, rayon, and plastic, for instance, have been used to produce personal protective gear during the pandemic, which has led to shortages. The cost of transportation for consumer goods has also nearly tripled, and pandemic policies at ports have led to shipping delays.

Edgewell Personal Care, which makes the brands Playtex and o.b., has had a severe staff shortage at its Delaware facility where tampons are made, according to Time. The FDA has classified tampons as class II medical devices, which require certain quality-control regulations and qualified workers on the assembly line, the news outlet reported.

Representatives for CVS and Walgreens confirmed that they’ve had shortages in recent weeks, according to The Washington Post. Procter & Gamble said it is working with retail partners to make feminine care products more available.

“We understand it is frustrating for consumers when they can’t find what they need,” the company told the newspaper. “We can assure you this is a temporary situation.”

Kimberly-Clark, which makes U by Kotex tampons, told the Post that it “has not experienced a product or supply shortage” in the United States, saying it is “working closely with our retail partners to keep shelves stocked.”

But the shortage may grow worse as the year goes on and the peak season for shipping approaches, the newspaper reported.

“Capacity is only going to get tighter as we move toward the end of the year,” Vaughn Moore, chief executive of AIT Worldwide Logistics, told the Post.

While the situation is being straightened out, gynecologists have recommended against extending supply at home by wearing tampons for longer stretches of time, according to The New York Times. Toxic shock syndrome is a rare but potentially fatal condition that can occur when tampons are worn for more than 8 hours.

There are other options, such as reusable menstrual pads, period underwear, and menstrual cups and discs, the Times reported. But some of these may be less appealing to use, or they may cost too much.

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

Tampons may be harder to find because of supply chain challenges and inflation hikes that are causing higher prices.

Social media users have posted about bare shelves and higher costs for months, marking the latest products to face stress under global supply chain concerns after baby formula, cars, and appliances.

Other menstrual products have increased in price as well because of inflation, according to Bloomberg News. The average price for a package of menstrual pads has increased about 8% this year, and the price of a box of tampons has increased about 10%.

Andre Schulten, the chief financial officer for Procter & Gamble, which makes and sells 4.5 billion boxes of Tampax each year, said on a recent earnings call that it has been “costly and highly volatile” to acquire the raw materials needed for production.

Raw materials such as cotton, rayon, and plastic, for instance, have been used to produce personal protective gear during the pandemic, which has led to shortages. The cost of transportation for consumer goods has also nearly tripled, and pandemic policies at ports have led to shipping delays.

Edgewell Personal Care, which makes the brands Playtex and o.b., has had a severe staff shortage at its Delaware facility where tampons are made, according to Time. The FDA has classified tampons as class II medical devices, which require certain quality-control regulations and qualified workers on the assembly line, the news outlet reported.

Representatives for CVS and Walgreens confirmed that they’ve had shortages in recent weeks, according to The Washington Post. Procter & Gamble said it is working with retail partners to make feminine care products more available.

“We understand it is frustrating for consumers when they can’t find what they need,” the company told the newspaper. “We can assure you this is a temporary situation.”

Kimberly-Clark, which makes U by Kotex tampons, told the Post that it “has not experienced a product or supply shortage” in the United States, saying it is “working closely with our retail partners to keep shelves stocked.”

But the shortage may grow worse as the year goes on and the peak season for shipping approaches, the newspaper reported.

“Capacity is only going to get tighter as we move toward the end of the year,” Vaughn Moore, chief executive of AIT Worldwide Logistics, told the Post.

While the situation is being straightened out, gynecologists have recommended against extending supply at home by wearing tampons for longer stretches of time, according to The New York Times. Toxic shock syndrome is a rare but potentially fatal condition that can occur when tampons are worn for more than 8 hours.

There are other options, such as reusable menstrual pads, period underwear, and menstrual cups and discs, the Times reported. But some of these may be less appealing to use, or they may cost too much.

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

CHICAGO – Comorbid autoimmune disease is associated with a greater chance of survival among women with stage IV breast cancer, according to a retrospective study presented at the annual meeting of the American Society of Clinical Oncology.

“It’s counterintuitive that, if you have two diseases instead of one, that you live longer, so then we had to scratch our heads a little bit and think about why these people are living longer,” said lead author Demitrios Dedousis, MD, University Hospitals, Case Medical Center, Cleveland.

Dr. Dedousis and colleagues conducted a retrospective analysis of patients from Surveillance, Epidemiology, and End Results–Medicare databases between 2007 and 2014 with breast cancer. The study included data from 137,324 patients diagnosed between 2007 and 2012, before the widespread use of immunotherapy. 27% of patients had an autoimmune disease, most commonly rheumatoid arthritis (23%), psoriasis (2.4%), and systemic lupus erythematosus (1.1%).

When all patients were included in the analysis, those with autoimmune disorders had slightly longer survival times, but these weren’t clinically significant. A subanalysis found a greater difference in survival.

The association appears more pronounced in metastatic cancer. Patients with stage 4 breast cancer and autoimmune disease had a longer mean overall survival (36 months vs. 30 months; hazard ratio, 1.46; P < .0001. Cancer-specific survival: HR, 1.39; P < .0001). Patients with autoimmune disease and stage 1-3 breast cancer had lower overall survival (P < .0001, P < 0.0001, and P = 0.026 respectively), compared with patients without autoimmune disease.

“What we thought was happening is that the lack of increased survival in stages 1 through 3 was hiding the increase in survival among the stage IV patients when looking at the overall cohort,” Dr. Dedousis said.

The retrospective nature of the study makes it impossible to draw any firm conclusions about causation. It could be that patients who have already been diagnosed with an autoimmune disease are more vigilant about going to health checkups. “There are other possible explanations, but the one that’s most interesting to us is that their immune system is involved in fighting the cancer. Our study certainly didn’t prove that, but it’s suggesting that’s a possibility,” Dr. Dedousis said.

He and his coauthors anticipate conducting similar studies in other cancers to see if there are similar relationships. Some preliminary work has already suggested something similar in lung cancer. “I think demonstrating this in a few kinds of cancer goes part of the way towards showing that this is a real biological phenomenon,” he said.

Another research avenue is to examine the immune systems and pathology specimens in patients with both an autoimmune disease and cancer to see if there is a greater immune response within the tumor. If so, that could suggest new immunotherapy strategies.

Another possibility is to look at the specific immune pathways within “protective” autoimmune conditions. “For the sake of argument, if we find a particular autoimmune condition is improving survival across multiple kinds of cancers, we could look at those pathways that are specifically involved in that autoimmune condition. It might help us identify a target for drug development,” Dr. Dedousis said.

Asked why a potential benefit might be more apparent in late-stage disease, he suggested that, in early-stage breast cancer, surgery and other treatments may be so effective that the immune system’s role only rarely makes a difference. It could play a larger role in late-stage disease when there are less effective therapies. It could also be that the immune system doesn’t recognize the cancer until it has spread beyond the regional lymph nodes on its way to metastasizing.

According to the National Cancer Institute, 10%-30% of people with cancer also have an autoimmune disease.

Dr. Dedousis has no relevant financial disclosures.

CHICAGO – Comorbid autoimmune disease is associated with a greater chance of survival among women with stage IV breast cancer, according to a retrospective study presented at the annual meeting of the American Society of Clinical Oncology.

“It’s counterintuitive that, if you have two diseases instead of one, that you live longer, so then we had to scratch our heads a little bit and think about why these people are living longer,” said lead author Demitrios Dedousis, MD, University Hospitals, Case Medical Center, Cleveland.

Dr. Dedousis and colleagues conducted a retrospective analysis of patients from Surveillance, Epidemiology, and End Results–Medicare databases between 2007 and 2014 with breast cancer. The study included data from 137,324 patients diagnosed between 2007 and 2012, before the widespread use of immunotherapy. 27% of patients had an autoimmune disease, most commonly rheumatoid arthritis (23%), psoriasis (2.4%), and systemic lupus erythematosus (1.1%).

When all patients were included in the analysis, those with autoimmune disorders had slightly longer survival times, but these weren’t clinically significant. A subanalysis found a greater difference in survival.

The association appears more pronounced in metastatic cancer. Patients with stage 4 breast cancer and autoimmune disease had a longer mean overall survival (36 months vs. 30 months; hazard ratio, 1.46; P < .0001. Cancer-specific survival: HR, 1.39; P < .0001). Patients with autoimmune disease and stage 1-3 breast cancer had lower overall survival (P < .0001, P < 0.0001, and P = 0.026 respectively), compared with patients without autoimmune disease.

“What we thought was happening is that the lack of increased survival in stages 1 through 3 was hiding the increase in survival among the stage IV patients when looking at the overall cohort,” Dr. Dedousis said.

The retrospective nature of the study makes it impossible to draw any firm conclusions about causation. It could be that patients who have already been diagnosed with an autoimmune disease are more vigilant about going to health checkups. “There are other possible explanations, but the one that’s most interesting to us is that their immune system is involved in fighting the cancer. Our study certainly didn’t prove that, but it’s suggesting that’s a possibility,” Dr. Dedousis said.

He and his coauthors anticipate conducting similar studies in other cancers to see if there are similar relationships. Some preliminary work has already suggested something similar in lung cancer. “I think demonstrating this in a few kinds of cancer goes part of the way towards showing that this is a real biological phenomenon,” he said.

Another research avenue is to examine the immune systems and pathology specimens in patients with both an autoimmune disease and cancer to see if there is a greater immune response within the tumor. If so, that could suggest new immunotherapy strategies.

Another possibility is to look at the specific immune pathways within “protective” autoimmune conditions. “For the sake of argument, if we find a particular autoimmune condition is improving survival across multiple kinds of cancers, we could look at those pathways that are specifically involved in that autoimmune condition. It might help us identify a target for drug development,” Dr. Dedousis said.

Asked why a potential benefit might be more apparent in late-stage disease, he suggested that, in early-stage breast cancer, surgery and other treatments may be so effective that the immune system’s role only rarely makes a difference. It could play a larger role in late-stage disease when there are less effective therapies. It could also be that the immune system doesn’t recognize the cancer until it has spread beyond the regional lymph nodes on its way to metastasizing.

According to the National Cancer Institute, 10%-30% of people with cancer also have an autoimmune disease.

Dr. Dedousis has no relevant financial disclosures.

CHICAGO – Comorbid autoimmune disease is associated with a greater chance of survival among women with stage IV breast cancer, according to a retrospective study presented at the annual meeting of the American Society of Clinical Oncology.

“It’s counterintuitive that, if you have two diseases instead of one, that you live longer, so then we had to scratch our heads a little bit and think about why these people are living longer,” said lead author Demitrios Dedousis, MD, University Hospitals, Case Medical Center, Cleveland.

Dr. Dedousis and colleagues conducted a retrospective analysis of patients from Surveillance, Epidemiology, and End Results–Medicare databases between 2007 and 2014 with breast cancer. The study included data from 137,324 patients diagnosed between 2007 and 2012, before the widespread use of immunotherapy. 27% of patients had an autoimmune disease, most commonly rheumatoid arthritis (23%), psoriasis (2.4%), and systemic lupus erythematosus (1.1%).

When all patients were included in the analysis, those with autoimmune disorders had slightly longer survival times, but these weren’t clinically significant. A subanalysis found a greater difference in survival.

The association appears more pronounced in metastatic cancer. Patients with stage 4 breast cancer and autoimmune disease had a longer mean overall survival (36 months vs. 30 months; hazard ratio, 1.46; P < .0001. Cancer-specific survival: HR, 1.39; P < .0001). Patients with autoimmune disease and stage 1-3 breast cancer had lower overall survival (P < .0001, P < 0.0001, and P = 0.026 respectively), compared with patients without autoimmune disease.

“What we thought was happening is that the lack of increased survival in stages 1 through 3 was hiding the increase in survival among the stage IV patients when looking at the overall cohort,” Dr. Dedousis said.

The retrospective nature of the study makes it impossible to draw any firm conclusions about causation. It could be that patients who have already been diagnosed with an autoimmune disease are more vigilant about going to health checkups. “There are other possible explanations, but the one that’s most interesting to us is that their immune system is involved in fighting the cancer. Our study certainly didn’t prove that, but it’s suggesting that’s a possibility,” Dr. Dedousis said.

He and his coauthors anticipate conducting similar studies in other cancers to see if there are similar relationships. Some preliminary work has already suggested something similar in lung cancer. “I think demonstrating this in a few kinds of cancer goes part of the way towards showing that this is a real biological phenomenon,” he said.

Another research avenue is to examine the immune systems and pathology specimens in patients with both an autoimmune disease and cancer to see if there is a greater immune response within the tumor. If so, that could suggest new immunotherapy strategies.

Another possibility is to look at the specific immune pathways within “protective” autoimmune conditions. “For the sake of argument, if we find a particular autoimmune condition is improving survival across multiple kinds of cancers, we could look at those pathways that are specifically involved in that autoimmune condition. It might help us identify a target for drug development,” Dr. Dedousis said.

Asked why a potential benefit might be more apparent in late-stage disease, he suggested that, in early-stage breast cancer, surgery and other treatments may be so effective that the immune system’s role only rarely makes a difference. It could play a larger role in late-stage disease when there are less effective therapies. It could also be that the immune system doesn’t recognize the cancer until it has spread beyond the regional lymph nodes on its way to metastasizing.

According to the National Cancer Institute, 10%-30% of people with cancer also have an autoimmune disease.

Dr. Dedousis has no relevant financial disclosures.