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As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

Big Vegetable has lied to us all

Hear this, children of the world: Your parents have betrayed you. They tell you day in and day out that vegetables are necessary, that they’re healthy, that you need them, but it is not the truth. Behind their foul taste is nothing but empty lies.

Okay, before we get a full-blown child rebellion on our hands, let’s reel things in. Eating vegetables has many benefits, and will help prevent many nasty medical conditions, such as diabetes or cancer. However, cardiovascular disease is not among them.

nneem/Pixabay

For their study published in Frontiers in Nutrition, researchers analyzed the diet, lifestyle, and medical history of nearly 400,000 U.K. adults over a 5-year period, finding that 4.5% developed heart disease and that the average adult consumed about 5 tablespoons of vegetables per day. Those who consumed the most vegetables had a reduction in heart disease incidence of about 15%, compared with those who ate the least.

Hang on, you’re thinking, we just said that vegetables didn’t prevent cardiovascular disease. But the data show otherwise! Ah, but the data are unadjusted. Once the researchers took socioeconomic status, information level, and general lifestyle into account, that benefit disappeared almost completely. The benefit seems to come not from the vegetables themselves, but from being able to afford better food and medical care in general.

The researchers were quick to note the other benefits of eating vegetables, and that people should probably keep eating those five servings a day. But we’re onto you, scientists. You can’t fool us with your vegetable-based lies. Unless we’re talking about pizza. Pizza is the best vegetable.
 

The good old days of surgery?

Modern surgical instruments, techniques, and technological innovations are amazing. It’s hard to imagine what surgery was like before laparoscopes came along, or x-ray machines, or even anesthesia. But those days weren’t really that long ago. Modern anesthesia, after all, dates back to just 1846. We’ve got socks almost that old.

Petar Ubiparip/Pixabay

But suppose we go back even further … say 5,300 years. Older than the oldest sock. Scientists studying a funerary chamber in Burgos, Spain, which was built in the 4th millennium B.C., have come across what looks like “the first known radical mastoidectomy in the history of humankind,” Sonia Díaz-Navarro of the University of Valladolid (Spain) and associates wrote in Scientific Reports.

One of the skulls they uncovered shows signs of trepanation. “Despite the [evidence] of cut marks, it is difficult to conclude the type of tool used to remove the bone tissue, most likely a sharp instrument with a circular movement,” they investigators said.

What is clear, though, is that the patient survived the surgery, because there is evidence of bone regeneration at the surgical sites. Sites? “Based on the differences in bone remodelling between the two temporals, it appears that the procedure was first conducted on the right ear, due to an ear pathology sufficiently alarming to require an intervention, which this prehistoric woman survived,” they explained.

The same procedure was then performed on the left ear, “but whether this was performed shortly after the right ear, or several months or even years later can’t be concluded from the existing evidence,” IFL Science reported.

Located nearby was a small section of tree bark with some scratches on it. That, ladies and gentlemen, was the first prior authorization form.
 

I hate that song, with reason

Do you have a favorite song? You may have a million reasons for loving that song. And past research can tell you why. But it’s only in a recent study that researchers were able to tell you why you dislike a song. And you know the song we’re talking about.

MPI for Empirical Aesthetics

Dislike breaks down into three major categories of rationale: subject-related reasons (how the song makes you feel emotionally and/or physically), object-related reasons (the lyrics or composition), and social reasons (do you relate to this?). Researchers at the Max Planck Institute for Empirical Aesthetics in Frankfurt, Germany, interviewed 21 participants and asked them to come up with a prepared list of music that they disliked and why they didn’t like it. And there was a lot that they didn’t like: 277 dislikes worth, to be exact.

“The most often mentioned type of dislike was musical style, followed by artist and genre,” senior author Julia Merrill explained on Eurekalert. Just over 40% of those rationales for not liking the music just had to do with the music itself, but 85% involved the music combined with one of the other categories.

Social reasoning played a big part in dislike. If the listener didn’t feel like a part of the target in-group for the music or the music didn’t have the same social values as those of the listener, it had an impact on dislike, they said.

But our dislike of certain types of music doesn’t just separate us from people in a negative way. Looking at the dislike of certain types of music helps us define our terms of having good taste, the researchers explained. Saying that one type of music is better than another can bring us closer with like-minded people and becomes a piece of how we identify ourselves. Cue the music snobs.

So if you can blast Barry Manilow but can’t bring yourself to play the Rolling Stones, there’s a reason for that. And if you love Aretha Franklin but not Frank Sinatra, there’s a reason for that, too. It’s all very personal. Just as music is meant to be.

Big Vegetable has lied to us all

Hear this, children of the world: Your parents have betrayed you. They tell you day in and day out that vegetables are necessary, that they’re healthy, that you need them, but it is not the truth. Behind their foul taste is nothing but empty lies.

Okay, before we get a full-blown child rebellion on our hands, let’s reel things in. Eating vegetables has many benefits, and will help prevent many nasty medical conditions, such as diabetes or cancer. However, cardiovascular disease is not among them.

nneem/Pixabay

For their study published in Frontiers in Nutrition, researchers analyzed the diet, lifestyle, and medical history of nearly 400,000 U.K. adults over a 5-year period, finding that 4.5% developed heart disease and that the average adult consumed about 5 tablespoons of vegetables per day. Those who consumed the most vegetables had a reduction in heart disease incidence of about 15%, compared with those who ate the least.

Hang on, you’re thinking, we just said that vegetables didn’t prevent cardiovascular disease. But the data show otherwise! Ah, but the data are unadjusted. Once the researchers took socioeconomic status, information level, and general lifestyle into account, that benefit disappeared almost completely. The benefit seems to come not from the vegetables themselves, but from being able to afford better food and medical care in general.

The researchers were quick to note the other benefits of eating vegetables, and that people should probably keep eating those five servings a day. But we’re onto you, scientists. You can’t fool us with your vegetable-based lies. Unless we’re talking about pizza. Pizza is the best vegetable.
 

The good old days of surgery?

Modern surgical instruments, techniques, and technological innovations are amazing. It’s hard to imagine what surgery was like before laparoscopes came along, or x-ray machines, or even anesthesia. But those days weren’t really that long ago. Modern anesthesia, after all, dates back to just 1846. We’ve got socks almost that old.

Petar Ubiparip/Pixabay

But suppose we go back even further … say 5,300 years. Older than the oldest sock. Scientists studying a funerary chamber in Burgos, Spain, which was built in the 4th millennium B.C., have come across what looks like “the first known radical mastoidectomy in the history of humankind,” Sonia Díaz-Navarro of the University of Valladolid (Spain) and associates wrote in Scientific Reports.

One of the skulls they uncovered shows signs of trepanation. “Despite the [evidence] of cut marks, it is difficult to conclude the type of tool used to remove the bone tissue, most likely a sharp instrument with a circular movement,” they investigators said.

What is clear, though, is that the patient survived the surgery, because there is evidence of bone regeneration at the surgical sites. Sites? “Based on the differences in bone remodelling between the two temporals, it appears that the procedure was first conducted on the right ear, due to an ear pathology sufficiently alarming to require an intervention, which this prehistoric woman survived,” they explained.

The same procedure was then performed on the left ear, “but whether this was performed shortly after the right ear, or several months or even years later can’t be concluded from the existing evidence,” IFL Science reported.

Located nearby was a small section of tree bark with some scratches on it. That, ladies and gentlemen, was the first prior authorization form.
 

I hate that song, with reason

Do you have a favorite song? You may have a million reasons for loving that song. And past research can tell you why. But it’s only in a recent study that researchers were able to tell you why you dislike a song. And you know the song we’re talking about.

MPI for Empirical Aesthetics

Dislike breaks down into three major categories of rationale: subject-related reasons (how the song makes you feel emotionally and/or physically), object-related reasons (the lyrics or composition), and social reasons (do you relate to this?). Researchers at the Max Planck Institute for Empirical Aesthetics in Frankfurt, Germany, interviewed 21 participants and asked them to come up with a prepared list of music that they disliked and why they didn’t like it. And there was a lot that they didn’t like: 277 dislikes worth, to be exact.

“The most often mentioned type of dislike was musical style, followed by artist and genre,” senior author Julia Merrill explained on Eurekalert. Just over 40% of those rationales for not liking the music just had to do with the music itself, but 85% involved the music combined with one of the other categories.

Social reasoning played a big part in dislike. If the listener didn’t feel like a part of the target in-group for the music or the music didn’t have the same social values as those of the listener, it had an impact on dislike, they said.

But our dislike of certain types of music doesn’t just separate us from people in a negative way. Looking at the dislike of certain types of music helps us define our terms of having good taste, the researchers explained. Saying that one type of music is better than another can bring us closer with like-minded people and becomes a piece of how we identify ourselves. Cue the music snobs.

So if you can blast Barry Manilow but can’t bring yourself to play the Rolling Stones, there’s a reason for that. And if you love Aretha Franklin but not Frank Sinatra, there’s a reason for that, too. It’s all very personal. Just as music is meant to be.

Big Vegetable has lied to us all

Hear this, children of the world: Your parents have betrayed you. They tell you day in and day out that vegetables are necessary, that they’re healthy, that you need them, but it is not the truth. Behind their foul taste is nothing but empty lies.

Okay, before we get a full-blown child rebellion on our hands, let’s reel things in. Eating vegetables has many benefits, and will help prevent many nasty medical conditions, such as diabetes or cancer. However, cardiovascular disease is not among them.

nneem/Pixabay

For their study published in Frontiers in Nutrition, researchers analyzed the diet, lifestyle, and medical history of nearly 400,000 U.K. adults over a 5-year period, finding that 4.5% developed heart disease and that the average adult consumed about 5 tablespoons of vegetables per day. Those who consumed the most vegetables had a reduction in heart disease incidence of about 15%, compared with those who ate the least.

Hang on, you’re thinking, we just said that vegetables didn’t prevent cardiovascular disease. But the data show otherwise! Ah, but the data are unadjusted. Once the researchers took socioeconomic status, information level, and general lifestyle into account, that benefit disappeared almost completely. The benefit seems to come not from the vegetables themselves, but from being able to afford better food and medical care in general.

The researchers were quick to note the other benefits of eating vegetables, and that people should probably keep eating those five servings a day. But we’re onto you, scientists. You can’t fool us with your vegetable-based lies. Unless we’re talking about pizza. Pizza is the best vegetable.
 

The good old days of surgery?

Modern surgical instruments, techniques, and technological innovations are amazing. It’s hard to imagine what surgery was like before laparoscopes came along, or x-ray machines, or even anesthesia. But those days weren’t really that long ago. Modern anesthesia, after all, dates back to just 1846. We’ve got socks almost that old.

Petar Ubiparip/Pixabay

But suppose we go back even further … say 5,300 years. Older than the oldest sock. Scientists studying a funerary chamber in Burgos, Spain, which was built in the 4th millennium B.C., have come across what looks like “the first known radical mastoidectomy in the history of humankind,” Sonia Díaz-Navarro of the University of Valladolid (Spain) and associates wrote in Scientific Reports.

One of the skulls they uncovered shows signs of trepanation. “Despite the [evidence] of cut marks, it is difficult to conclude the type of tool used to remove the bone tissue, most likely a sharp instrument with a circular movement,” they investigators said.

What is clear, though, is that the patient survived the surgery, because there is evidence of bone regeneration at the surgical sites. Sites? “Based on the differences in bone remodelling between the two temporals, it appears that the procedure was first conducted on the right ear, due to an ear pathology sufficiently alarming to require an intervention, which this prehistoric woman survived,” they explained.

The same procedure was then performed on the left ear, “but whether this was performed shortly after the right ear, or several months or even years later can’t be concluded from the existing evidence,” IFL Science reported.

Located nearby was a small section of tree bark with some scratches on it. That, ladies and gentlemen, was the first prior authorization form.
 

I hate that song, with reason

Do you have a favorite song? You may have a million reasons for loving that song. And past research can tell you why. But it’s only in a recent study that researchers were able to tell you why you dislike a song. And you know the song we’re talking about.

MPI for Empirical Aesthetics

Dislike breaks down into three major categories of rationale: subject-related reasons (how the song makes you feel emotionally and/or physically), object-related reasons (the lyrics or composition), and social reasons (do you relate to this?). Researchers at the Max Planck Institute for Empirical Aesthetics in Frankfurt, Germany, interviewed 21 participants and asked them to come up with a prepared list of music that they disliked and why they didn’t like it. And there was a lot that they didn’t like: 277 dislikes worth, to be exact.

“The most often mentioned type of dislike was musical style, followed by artist and genre,” senior author Julia Merrill explained on Eurekalert. Just over 40% of those rationales for not liking the music just had to do with the music itself, but 85% involved the music combined with one of the other categories.

Social reasoning played a big part in dislike. If the listener didn’t feel like a part of the target in-group for the music or the music didn’t have the same social values as those of the listener, it had an impact on dislike, they said.

But our dislike of certain types of music doesn’t just separate us from people in a negative way. Looking at the dislike of certain types of music helps us define our terms of having good taste, the researchers explained. Saying that one type of music is better than another can bring us closer with like-minded people and becomes a piece of how we identify ourselves. Cue the music snobs.

So if you can blast Barry Manilow but can’t bring yourself to play the Rolling Stones, there’s a reason for that. And if you love Aretha Franklin but not Frank Sinatra, there’s a reason for that, too. It’s all very personal. Just as music is meant to be.

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

The birth rate for U.S. teenagers dropped 3% in counties where a federally funded sex education program was introduced, a recently published paper says.

Researchers concentrated on the effects of the Teen Pregnancy Prevention program (TPP), which was introduced during the Obama administration and administered on the county level. TPP programs provide more information on sex, contraception, and reproductive health than abstinence-only programs, the paper said.

“Sex education in the United States has been hotly debated among researchers, policy makers, and the public,” Nicholas Mark, a doctoral candidate in New York University’s department of sociology and the lead author of the paper, said in a news release. “Our analysis provides evidence that funding for more comprehensive sex education led to an overall reduction in the teen birth rate at the county level of more than 3%.”

Researchers examined teen birth rates in 55 counties from 1996 to 2009, before TTP, and from 2010 to 2016, after TTP. Next, they compared teen birth rates in the 55 counties with teen birth rates in 2,800 counties that didn’t have the funding in the years before and after TPP was introduced.

In the 55 counties, teen birth rates fell 1.5% in the first year of TTP funding and fell about 7% by the fifth year of funding, for an average drop of 3%, the news release said.

“We’ve known for some time that abstinence-only programs are ineffective at reducing teen birth rates,” said Lawrence Wu, a professor in NYU’s department of sociology and the paper’s senior author. “This work shows that more wide-reaching sex education programs – those not limited to abstinence – are successful in lowering rates of teen births.”

The paper was published in the Proceedings of the National Academy of Sciences of the United States of America.

The paper said the findings probably understate the true effect of more comprehensive sex education at the individual level.

The authors said the findings are important because U.S. women are more likely to become mothers in their teens than women in other developed nations, with many teen pregnancies reported as unintended, the authors said.

As of 2020, teen birth rates and the number of births to teen mothers had dropped steadily since 1990. Teen birth rates fell by 70% over 3 decades.

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

The birth rate for U.S. teenagers dropped 3% in counties where a federally funded sex education program was introduced, a recently published paper says.

Researchers concentrated on the effects of the Teen Pregnancy Prevention program (TPP), which was introduced during the Obama administration and administered on the county level. TPP programs provide more information on sex, contraception, and reproductive health than abstinence-only programs, the paper said.

“Sex education in the United States has been hotly debated among researchers, policy makers, and the public,” Nicholas Mark, a doctoral candidate in New York University’s department of sociology and the lead author of the paper, said in a news release. “Our analysis provides evidence that funding for more comprehensive sex education led to an overall reduction in the teen birth rate at the county level of more than 3%.”

Researchers examined teen birth rates in 55 counties from 1996 to 2009, before TTP, and from 2010 to 2016, after TTP. Next, they compared teen birth rates in the 55 counties with teen birth rates in 2,800 counties that didn’t have the funding in the years before and after TPP was introduced.

In the 55 counties, teen birth rates fell 1.5% in the first year of TTP funding and fell about 7% by the fifth year of funding, for an average drop of 3%, the news release said.

“We’ve known for some time that abstinence-only programs are ineffective at reducing teen birth rates,” said Lawrence Wu, a professor in NYU’s department of sociology and the paper’s senior author. “This work shows that more wide-reaching sex education programs – those not limited to abstinence – are successful in lowering rates of teen births.”

The paper was published in the Proceedings of the National Academy of Sciences of the United States of America.

The paper said the findings probably understate the true effect of more comprehensive sex education at the individual level.

The authors said the findings are important because U.S. women are more likely to become mothers in their teens than women in other developed nations, with many teen pregnancies reported as unintended, the authors said.

As of 2020, teen birth rates and the number of births to teen mothers had dropped steadily since 1990. Teen birth rates fell by 70% over 3 decades.

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

The birth rate for U.S. teenagers dropped 3% in counties where a federally funded sex education program was introduced, a recently published paper says.

Researchers concentrated on the effects of the Teen Pregnancy Prevention program (TPP), which was introduced during the Obama administration and administered on the county level. TPP programs provide more information on sex, contraception, and reproductive health than abstinence-only programs, the paper said.

“Sex education in the United States has been hotly debated among researchers, policy makers, and the public,” Nicholas Mark, a doctoral candidate in New York University’s department of sociology and the lead author of the paper, said in a news release. “Our analysis provides evidence that funding for more comprehensive sex education led to an overall reduction in the teen birth rate at the county level of more than 3%.”

Researchers examined teen birth rates in 55 counties from 1996 to 2009, before TTP, and from 2010 to 2016, after TTP. Next, they compared teen birth rates in the 55 counties with teen birth rates in 2,800 counties that didn’t have the funding in the years before and after TPP was introduced.

In the 55 counties, teen birth rates fell 1.5% in the first year of TTP funding and fell about 7% by the fifth year of funding, for an average drop of 3%, the news release said.

“We’ve known for some time that abstinence-only programs are ineffective at reducing teen birth rates,” said Lawrence Wu, a professor in NYU’s department of sociology and the paper’s senior author. “This work shows that more wide-reaching sex education programs – those not limited to abstinence – are successful in lowering rates of teen births.”

The paper was published in the Proceedings of the National Academy of Sciences of the United States of America.

The paper said the findings probably understate the true effect of more comprehensive sex education at the individual level.

The authors said the findings are important because U.S. women are more likely to become mothers in their teens than women in other developed nations, with many teen pregnancies reported as unintended, the authors said.

As of 2020, teen birth rates and the number of births to teen mothers had dropped steadily since 1990. Teen birth rates fell by 70% over 3 decades.

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

Many neurocognitive disorders only present a phenotype after birth. Sukenik-Halevy et al sought to examine the ability to detect prenatal phenotypes in patients with a postnatally diagnosed neurocognitive syndrome and confirmed genetic diagnosis on ES. The team was not able to identify any specific prenatal phenotype associated with their cases of postnatally diagnosed neurocognitive syndromes. The interesting finding of this study is that, of the 122 patients studied, 35.3% (43) had no abnormal sonographic findings that could have been detected prenatally to suggest the need for ES testing. ES is typically used in a prenatal setting for fetuses with anomalies that have a normal KT and CMA. The results of this study raise the question of offering ES to all patients considering diagnostic genetic testing regardless of the indication, as it may be the only way to diagnose some cases of neurocognitive disorders prenatally.

Cell-free fetal DNA (cff DNA) testing for trisomy 21, 18, and 13 has classically be used for high-risk pregnant patients seeking aneuploidy screening. Dar et al sought to examine this type of testing in a low-risk population. They studied, prospectively, the performance of cff DNA testing for trisomy 21, 18, and 13 in both low and high-risk pregnant women with confirmation of results on diagnostic genetic testing. Negative predictive values (NPV) for both the low and high-risk groups were greater than 99.9%. Positive predictive value (PPV) was lower for the low-risk group in comparison to the high-risk group, with it important to note that PPV drops from 96.4% in the high-risk group to 81.8% in the low-risk group for trisomy 21. This means that low-risk patients with a positive result on cff DNA testing are at a higher risk for a false positive than patients at high-risk for an aneuploid fetus. This study shows the mounting evidence that cff DNA can be used in a low-risk population given the high NPV. Providers do still need to note the lower PPV with low-risk population patients and always offer diagnostic genetic testing with any abnormal cff DNA test result.

Many neurocognitive disorders only present a phenotype after birth. Sukenik-Halevy et al sought to examine the ability to detect prenatal phenotypes in patients with a postnatally diagnosed neurocognitive syndrome and confirmed genetic diagnosis on ES. The team was not able to identify any specific prenatal phenotype associated with their cases of postnatally diagnosed neurocognitive syndromes. The interesting finding of this study is that, of the 122 patients studied, 35.3% (43) had no abnormal sonographic findings that could have been detected prenatally to suggest the need for ES testing. ES is typically used in a prenatal setting for fetuses with anomalies that have a normal KT and CMA. The results of this study raise the question of offering ES to all patients considering diagnostic genetic testing regardless of the indication, as it may be the only way to diagnose some cases of neurocognitive disorders prenatally.

Cell-free fetal DNA (cff DNA) testing for trisomy 21, 18, and 13 has classically be used for high-risk pregnant patients seeking aneuploidy screening. Dar et al sought to examine this type of testing in a low-risk population. They studied, prospectively, the performance of cff DNA testing for trisomy 21, 18, and 13 in both low and high-risk pregnant women with confirmation of results on diagnostic genetic testing. Negative predictive values (NPV) for both the low and high-risk groups were greater than 99.9%. Positive predictive value (PPV) was lower for the low-risk group in comparison to the high-risk group, with it important to note that PPV drops from 96.4% in the high-risk group to 81.8% in the low-risk group for trisomy 21. This means that low-risk patients with a positive result on cff DNA testing are at a higher risk for a false positive than patients at high-risk for an aneuploid fetus. This study shows the mounting evidence that cff DNA can be used in a low-risk population given the high NPV. Providers do still need to note the lower PPV with low-risk population patients and always offer diagnostic genetic testing with any abnormal cff DNA test result.

Many neurocognitive disorders only present a phenotype after birth. Sukenik-Halevy et al sought to examine the ability to detect prenatal phenotypes in patients with a postnatally diagnosed neurocognitive syndrome and confirmed genetic diagnosis on ES. The team was not able to identify any specific prenatal phenotype associated with their cases of postnatally diagnosed neurocognitive syndromes. The interesting finding of this study is that, of the 122 patients studied, 35.3% (43) had no abnormal sonographic findings that could have been detected prenatally to suggest the need for ES testing. ES is typically used in a prenatal setting for fetuses with anomalies that have a normal KT and CMA. The results of this study raise the question of offering ES to all patients considering diagnostic genetic testing regardless of the indication, as it may be the only way to diagnose some cases of neurocognitive disorders prenatally.

Cell-free fetal DNA (cff DNA) testing for trisomy 21, 18, and 13 has classically be used for high-risk pregnant patients seeking aneuploidy screening. Dar et al sought to examine this type of testing in a low-risk population. They studied, prospectively, the performance of cff DNA testing for trisomy 21, 18, and 13 in both low and high-risk pregnant women with confirmation of results on diagnostic genetic testing. Negative predictive values (NPV) for both the low and high-risk groups were greater than 99.9%. Positive predictive value (PPV) was lower for the low-risk group in comparison to the high-risk group, with it important to note that PPV drops from 96.4% in the high-risk group to 81.8% in the low-risk group for trisomy 21. This means that low-risk patients with a positive result on cff DNA testing are at a higher risk for a false positive than patients at high-risk for an aneuploid fetus. This study shows the mounting evidence that cff DNA can be used in a low-risk population given the high NPV. Providers do still need to note the lower PPV with low-risk population patients and always offer diagnostic genetic testing with any abnormal cff DNA test result.

Hormonal therapy remains the most effective strategy for managing heavy menstrual bleeding in women with von Willebrand disease, based on data from one of three systematic reviews.

Women with von Willebrand disease (VWD) experience many obstetric and gynecologic challenges, including higher levels of von Willebrand factor (VWF) in pregnancy, Romina Brignardello-Petersen, PhD, of McMaster University, Hamilton, Ont., and colleagues wrote.

The American Society of Hematology, the International Society on Thrombosis and Haemostasis, the National Hemophilia Foundation, and the World Federation of Hemophilia convened a working group in 2017 to address updated guidelines on VWD with a focus on women, the researchers said.

In an article published in Blood Advances, the researchers described the evidence from three systematic reviews conducted to inform three recommendations for the guidelines: first-line management of heavy menstrual bleeding (HMB), treatment of women requiring or desiring neuraxial analgesia, and management of postpartum hemorrhage. The authors identified studies published through October 2019.

The first systematic review of first-line therapies for HMB included five case series, one retrospective cohort study, and one randomized controlled trial. In the randomized controlled trial of 232 patients, low-certainty evidence suggested less reduction of blood loss with desmopressin, compared with tranexamic acid (TxA), with no significant differences in side effects. Very-low-certainty evidence from an observational study also supported lower effectiveness of desmopressin versus hormonal therapy. Finally, the case series showed very-low-certainty evidence for the comparative effectiveness of hormonal therapy delivered via a levonorgestrel-releasing intrauterine system (LNG-IUS) and other therapies for HMB control.

The second systematic review compared VWF levels in women who received neuraxial anesthesia during labor.

The review included five case series that described outcomes of women with VWF levels greater than 0.50 IU/mL; however, the studies did not describe outcomes according to VWF levels and did not cite the proportion of women with VWF levels greater than 1.50 IU/mL. Consequently, the evidence for the effects of increasing VWF levels was very low certainty, the authors said. In a meta-analysis, the proportion of anesthesia complications in these women was 6% (very low certainty). The complications included hypotension, accidental dural puncture, inadequate analgesia, bloody tap with no further complications, and failed block requiring general anesthesia.

The third systemic review included two retrospective cohort studies on the use of TxA during the postpartum period. In these studies, the authors found very-low-certainty evidence that TxA reduced the risk of severe primary postpartum hemorrhage, primary postpartum hemorrhage, and secondary postpartum hemorrhage (risk ratios, 0.36, 0.25, and 0.42, respectively). The effects of TxA on blood transfusions, vaginal hematoma, blood loss, and thrombotic complications also showed very-low-certainty evidence.

The currently available evidence for treatment options in women with VWD remains very low certainty, the researchers wrote in their discussion. “Because hormonal therapy is effective in controlling HMB (based on data from women without bleeding disorders), we believe the most effective strategy to be hormonal therapy with a LNG-IUS or combined oral contraceptives, followed by TxA and desmopressin.”

The study findings were limited by several factors including scarce evidence, the risk of bias in the observational studies, and lack of comparisons/controls in the case series, the researchers noted. Notable literature gaps included data on outcomes including major bleeding and the need for surgery or additional treatments in the first review; mortality, major bleeding, spinal hematoma, transfusion, and thrombotic events in the second review; and mortality, major bleeding, and the need for other procedures in the third review.

However, the findings were strengthened by the use of broad eligibility criteria to include any studies with potential useful advice, including case series, if these were the only available options. In developing recommendations, “the guideline panel interpreted the evidence adding their experience and knowledge of indirect evidence,” the authors noted.

The current evidence, though mainly very low certainty, “is the best available to inform decisions about management. Clinicians seeking advice on how to manage their patients with VWD should refer to the practice guidelines and assess to what extent they are applicable to their patients,” the researchers concluded.
 

Meeting the need for evidence-based guidelines

The review is important at this time because current evidence-based guidelines are limited, said coauthor Veronica Flood, MD, a pediatric hematologist at the Medical College of Wisconsin, Milwaukee, and a VWD researcher.

“While we have some guidelines that address von Willebrand disease, these were primarily based on expert opinion and not necessarily based on the best available evidence,” said Dr. Flood.

“Given how many people have von Willebrand disease, it is important that we actually base our recommendations on the data,” she emphasized. The new guidelines also incorporate patient feedback, with the inclusion of multiple panelists who are individuals living with VWD. “The final recommendations looked at not only the evidence, but the cost effectiveness, feasibility, and patient values and preferences,” she added.

“I was surprised we did not have better evidence for some of these common issues for patients with VWD,” said Dr. Flood. “I think that speaks to the need to do more high-quality research in this area.”

From a clinical standpoint, “we now have evidence-based guidelines that support the use of prophylaxis in patients with VWD and significant bleeding, as well as recommendations for surgery and bleeding issues around menstruation,” said Dr. Flood. “I do think it is also important to recognize that many of these are conditional recommendations, meaning there is room for patient preferences in implementation, which is helpful since we know that some people will have different priorities.”

Dr. Flood noted that more research is needed in many aspects of VWD. “We definitely need to better understand best options for surgical treatment, and I consider that a high priority. We are also hoping, along with the National Hemophilia Foundation, to develop some patient decision aids to help with some of these issues.”

Coauthor Nathan T. Connell, MD, an adult hematologist at the Brigham and Women’s Hospital and Harvard Medical School, both in Boston, served as the vice chair for the guideline panel. Dr. Connell agreed with the importance of the reviews and the need for additional research. “I, too, was surprised to see the lack of robust data to answer many of the basic questions about how to manage people living with VWD. Regarding the systematic reviews, I was surprised to see the power of combining the limited data in this way to come up with an evidence base for the panels to review,” he added.

The study was supported by the ASH, ISTH, NHF, and the WFH 2020 Guidelines for Management of VWD. The researchers had no financial conflicts to disclose.

Hormonal therapy remains the most effective strategy for managing heavy menstrual bleeding in women with von Willebrand disease, based on data from one of three systematic reviews.

Women with von Willebrand disease (VWD) experience many obstetric and gynecologic challenges, including higher levels of von Willebrand factor (VWF) in pregnancy, Romina Brignardello-Petersen, PhD, of McMaster University, Hamilton, Ont., and colleagues wrote.

The American Society of Hematology, the International Society on Thrombosis and Haemostasis, the National Hemophilia Foundation, and the World Federation of Hemophilia convened a working group in 2017 to address updated guidelines on VWD with a focus on women, the researchers said.

In an article published in Blood Advances, the researchers described the evidence from three systematic reviews conducted to inform three recommendations for the guidelines: first-line management of heavy menstrual bleeding (HMB), treatment of women requiring or desiring neuraxial analgesia, and management of postpartum hemorrhage. The authors identified studies published through October 2019.

The first systematic review of first-line therapies for HMB included five case series, one retrospective cohort study, and one randomized controlled trial. In the randomized controlled trial of 232 patients, low-certainty evidence suggested less reduction of blood loss with desmopressin, compared with tranexamic acid (TxA), with no significant differences in side effects. Very-low-certainty evidence from an observational study also supported lower effectiveness of desmopressin versus hormonal therapy. Finally, the case series showed very-low-certainty evidence for the comparative effectiveness of hormonal therapy delivered via a levonorgestrel-releasing intrauterine system (LNG-IUS) and other therapies for HMB control.

The second systematic review compared VWF levels in women who received neuraxial anesthesia during labor.

The review included five case series that described outcomes of women with VWF levels greater than 0.50 IU/mL; however, the studies did not describe outcomes according to VWF levels and did not cite the proportion of women with VWF levels greater than 1.50 IU/mL. Consequently, the evidence for the effects of increasing VWF levels was very low certainty, the authors said. In a meta-analysis, the proportion of anesthesia complications in these women was 6% (very low certainty). The complications included hypotension, accidental dural puncture, inadequate analgesia, bloody tap with no further complications, and failed block requiring general anesthesia.

The third systemic review included two retrospective cohort studies on the use of TxA during the postpartum period. In these studies, the authors found very-low-certainty evidence that TxA reduced the risk of severe primary postpartum hemorrhage, primary postpartum hemorrhage, and secondary postpartum hemorrhage (risk ratios, 0.36, 0.25, and 0.42, respectively). The effects of TxA on blood transfusions, vaginal hematoma, blood loss, and thrombotic complications also showed very-low-certainty evidence.

The currently available evidence for treatment options in women with VWD remains very low certainty, the researchers wrote in their discussion. “Because hormonal therapy is effective in controlling HMB (based on data from women without bleeding disorders), we believe the most effective strategy to be hormonal therapy with a LNG-IUS or combined oral contraceptives, followed by TxA and desmopressin.”

The study findings were limited by several factors including scarce evidence, the risk of bias in the observational studies, and lack of comparisons/controls in the case series, the researchers noted. Notable literature gaps included data on outcomes including major bleeding and the need for surgery or additional treatments in the first review; mortality, major bleeding, spinal hematoma, transfusion, and thrombotic events in the second review; and mortality, major bleeding, and the need for other procedures in the third review.

However, the findings were strengthened by the use of broad eligibility criteria to include any studies with potential useful advice, including case series, if these were the only available options. In developing recommendations, “the guideline panel interpreted the evidence adding their experience and knowledge of indirect evidence,” the authors noted.

The current evidence, though mainly very low certainty, “is the best available to inform decisions about management. Clinicians seeking advice on how to manage their patients with VWD should refer to the practice guidelines and assess to what extent they are applicable to their patients,” the researchers concluded.
 

Meeting the need for evidence-based guidelines

The review is important at this time because current evidence-based guidelines are limited, said coauthor Veronica Flood, MD, a pediatric hematologist at the Medical College of Wisconsin, Milwaukee, and a VWD researcher.

“While we have some guidelines that address von Willebrand disease, these were primarily based on expert opinion and not necessarily based on the best available evidence,” said Dr. Flood.

“Given how many people have von Willebrand disease, it is important that we actually base our recommendations on the data,” she emphasized. The new guidelines also incorporate patient feedback, with the inclusion of multiple panelists who are individuals living with VWD. “The final recommendations looked at not only the evidence, but the cost effectiveness, feasibility, and patient values and preferences,” she added.

“I was surprised we did not have better evidence for some of these common issues for patients with VWD,” said Dr. Flood. “I think that speaks to the need to do more high-quality research in this area.”

From a clinical standpoint, “we now have evidence-based guidelines that support the use of prophylaxis in patients with VWD and significant bleeding, as well as recommendations for surgery and bleeding issues around menstruation,” said Dr. Flood. “I do think it is also important to recognize that many of these are conditional recommendations, meaning there is room for patient preferences in implementation, which is helpful since we know that some people will have different priorities.”

Dr. Flood noted that more research is needed in many aspects of VWD. “We definitely need to better understand best options for surgical treatment, and I consider that a high priority. We are also hoping, along with the National Hemophilia Foundation, to develop some patient decision aids to help with some of these issues.”

Coauthor Nathan T. Connell, MD, an adult hematologist at the Brigham and Women’s Hospital and Harvard Medical School, both in Boston, served as the vice chair for the guideline panel. Dr. Connell agreed with the importance of the reviews and the need for additional research. “I, too, was surprised to see the lack of robust data to answer many of the basic questions about how to manage people living with VWD. Regarding the systematic reviews, I was surprised to see the power of combining the limited data in this way to come up with an evidence base for the panels to review,” he added.

The study was supported by the ASH, ISTH, NHF, and the WFH 2020 Guidelines for Management of VWD. The researchers had no financial conflicts to disclose.

Hormonal therapy remains the most effective strategy for managing heavy menstrual bleeding in women with von Willebrand disease, based on data from one of three systematic reviews.

Women with von Willebrand disease (VWD) experience many obstetric and gynecologic challenges, including higher levels of von Willebrand factor (VWF) in pregnancy, Romina Brignardello-Petersen, PhD, of McMaster University, Hamilton, Ont., and colleagues wrote.

The American Society of Hematology, the International Society on Thrombosis and Haemostasis, the National Hemophilia Foundation, and the World Federation of Hemophilia convened a working group in 2017 to address updated guidelines on VWD with a focus on women, the researchers said.

In an article published in Blood Advances, the researchers described the evidence from three systematic reviews conducted to inform three recommendations for the guidelines: first-line management of heavy menstrual bleeding (HMB), treatment of women requiring or desiring neuraxial analgesia, and management of postpartum hemorrhage. The authors identified studies published through October 2019.

The first systematic review of first-line therapies for HMB included five case series, one retrospective cohort study, and one randomized controlled trial. In the randomized controlled trial of 232 patients, low-certainty evidence suggested less reduction of blood loss with desmopressin, compared with tranexamic acid (TxA), with no significant differences in side effects. Very-low-certainty evidence from an observational study also supported lower effectiveness of desmopressin versus hormonal therapy. Finally, the case series showed very-low-certainty evidence for the comparative effectiveness of hormonal therapy delivered via a levonorgestrel-releasing intrauterine system (LNG-IUS) and other therapies for HMB control.

The second systematic review compared VWF levels in women who received neuraxial anesthesia during labor.

The review included five case series that described outcomes of women with VWF levels greater than 0.50 IU/mL; however, the studies did not describe outcomes according to VWF levels and did not cite the proportion of women with VWF levels greater than 1.50 IU/mL. Consequently, the evidence for the effects of increasing VWF levels was very low certainty, the authors said. In a meta-analysis, the proportion of anesthesia complications in these women was 6% (very low certainty). The complications included hypotension, accidental dural puncture, inadequate analgesia, bloody tap with no further complications, and failed block requiring general anesthesia.

The third systemic review included two retrospective cohort studies on the use of TxA during the postpartum period. In these studies, the authors found very-low-certainty evidence that TxA reduced the risk of severe primary postpartum hemorrhage, primary postpartum hemorrhage, and secondary postpartum hemorrhage (risk ratios, 0.36, 0.25, and 0.42, respectively). The effects of TxA on blood transfusions, vaginal hematoma, blood loss, and thrombotic complications also showed very-low-certainty evidence.

The currently available evidence for treatment options in women with VWD remains very low certainty, the researchers wrote in their discussion. “Because hormonal therapy is effective in controlling HMB (based on data from women without bleeding disorders), we believe the most effective strategy to be hormonal therapy with a LNG-IUS or combined oral contraceptives, followed by TxA and desmopressin.”

The study findings were limited by several factors including scarce evidence, the risk of bias in the observational studies, and lack of comparisons/controls in the case series, the researchers noted. Notable literature gaps included data on outcomes including major bleeding and the need for surgery or additional treatments in the first review; mortality, major bleeding, spinal hematoma, transfusion, and thrombotic events in the second review; and mortality, major bleeding, and the need for other procedures in the third review.

However, the findings were strengthened by the use of broad eligibility criteria to include any studies with potential useful advice, including case series, if these were the only available options. In developing recommendations, “the guideline panel interpreted the evidence adding their experience and knowledge of indirect evidence,” the authors noted.

The current evidence, though mainly very low certainty, “is the best available to inform decisions about management. Clinicians seeking advice on how to manage their patients with VWD should refer to the practice guidelines and assess to what extent they are applicable to their patients,” the researchers concluded.
 

Meeting the need for evidence-based guidelines

The review is important at this time because current evidence-based guidelines are limited, said coauthor Veronica Flood, MD, a pediatric hematologist at the Medical College of Wisconsin, Milwaukee, and a VWD researcher.

“While we have some guidelines that address von Willebrand disease, these were primarily based on expert opinion and not necessarily based on the best available evidence,” said Dr. Flood.

“Given how many people have von Willebrand disease, it is important that we actually base our recommendations on the data,” she emphasized. The new guidelines also incorporate patient feedback, with the inclusion of multiple panelists who are individuals living with VWD. “The final recommendations looked at not only the evidence, but the cost effectiveness, feasibility, and patient values and preferences,” she added.

“I was surprised we did not have better evidence for some of these common issues for patients with VWD,” said Dr. Flood. “I think that speaks to the need to do more high-quality research in this area.”

From a clinical standpoint, “we now have evidence-based guidelines that support the use of prophylaxis in patients with VWD and significant bleeding, as well as recommendations for surgery and bleeding issues around menstruation,” said Dr. Flood. “I do think it is also important to recognize that many of these are conditional recommendations, meaning there is room for patient preferences in implementation, which is helpful since we know that some people will have different priorities.”

Dr. Flood noted that more research is needed in many aspects of VWD. “We definitely need to better understand best options for surgical treatment, and I consider that a high priority. We are also hoping, along with the National Hemophilia Foundation, to develop some patient decision aids to help with some of these issues.”

Coauthor Nathan T. Connell, MD, an adult hematologist at the Brigham and Women’s Hospital and Harvard Medical School, both in Boston, served as the vice chair for the guideline panel. Dr. Connell agreed with the importance of the reviews and the need for additional research. “I, too, was surprised to see the lack of robust data to answer many of the basic questions about how to manage people living with VWD. Regarding the systematic reviews, I was surprised to see the power of combining the limited data in this way to come up with an evidence base for the panels to review,” he added.

The study was supported by the ASH, ISTH, NHF, and the WFH 2020 Guidelines for Management of VWD. The researchers had no financial conflicts to disclose.

The Omicron subvariant, BA.2, is not only more transmissible than the original Omicron strain, BA.1, but may cause more severe disease, a lab study from Japan says.

“Our multiscale investigations suggest that the risk of BA.2 for global health is potentially higher than that of BA.1,” the researchers said in the study published on the preprint server bioRxiv. The study has not been peer-reviewed.

The researchers infected hamsters with BA.1 and BA.2. The hamsters infected with BA.2 got sicker, with more lung damage and loss of body weight. Results were similar when mice were infected with BA.1 and BA.2.

“Infection experiments using hamsters show that BA.2 is more pathogenic than BA.1,” the study said.

BA.1 and BA.2 both appear to evade immunity created by COVID-19 vaccines, the study said. But a booster shot makes illness after infection 74% less likely, CNN said.

What’s more, therapeutic monoclonal antibodies used to treat people infected with COVID didn’t have much effect on BA.2. 

BA.2 was “almost completely resistant” to casirivimab and imdevimab and was 35 times more resistant to sotrovimab, compared to the original B.1.1 virus, the researchers wrote. 

“In summary, our data suggest the possibility that BA.2 would be the most concerned variant to global health,” the researchers wrote. “Currently, both BA.2 and BA.1 are recognised together as Omicron and these are almost undistinguishable. Based on our findings, we propose that BA.2 should be recognised as a unique variant of concern, and this SARS-CoV-2 variant should be monitored in depth.”

If the World Health Organization recognized BA.2 as a “unique variant of concern,” it would be given its own Greek letter.

But some scientists noted that findings in the lab don’t always reflect what’s happening in the real world of people.

“I think it’s always hard to translate differences in animal and cell culture models to what’s going on with regards to human disease,” Jeremy Kamil, PhD, an associate professor of microbiology and immunology at Louisiana State University Health Shreveport, told Newsweek. “That said, the differences do look real.”

“It might be, from a human’s perspective, a worse virus than BA.1 and might be able to transmit better and cause worse disease,” Daniel Rhoads, MD, section head of microbiology at the Cleveland Clinic in Ohio, told CNN. He reviewed the Japanese study but was not involved in it.

Another scientist who reviewed the study but was not involved in the research noted that human immune systems are evolving along with the COVID variants. 

“One of the caveats that we have to think about, as we get new variants that might seem more dangerous, is the fact that there’s two sides to the story,” Deborah Fuller, PhD, a virologist at the University of Washington School of Medicine, told CNN. “Our immune system is evolving as well. And so that’s pushing back on things.”

Scientists have already established that BA.2 is more transmissible than BA.1. The Omicron subvariant has been detected in 74 countries and 47 U.S. states, according to CNN. About 4% of Americans with COVID were infected with BA.2, the outlet reported, citing the CDC, but it’s now the dominant strain in other nations.

It’s not clear yet if BA.2 causes more severe illness in people. While BA.2 spreads faster than BA.1, there’s no evidence the subvariant makes people any sicker, an official with the World Health Organization said, according to CNBC.

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

The Omicron subvariant, BA.2, is not only more transmissible than the original Omicron strain, BA.1, but may cause more severe disease, a lab study from Japan says.

“Our multiscale investigations suggest that the risk of BA.2 for global health is potentially higher than that of BA.1,” the researchers said in the study published on the preprint server bioRxiv. The study has not been peer-reviewed.

The researchers infected hamsters with BA.1 and BA.2. The hamsters infected with BA.2 got sicker, with more lung damage and loss of body weight. Results were similar when mice were infected with BA.1 and BA.2.

“Infection experiments using hamsters show that BA.2 is more pathogenic than BA.1,” the study said.

BA.1 and BA.2 both appear to evade immunity created by COVID-19 vaccines, the study said. But a booster shot makes illness after infection 74% less likely, CNN said.

What’s more, therapeutic monoclonal antibodies used to treat people infected with COVID didn’t have much effect on BA.2. 

BA.2 was “almost completely resistant” to casirivimab and imdevimab and was 35 times more resistant to sotrovimab, compared to the original B.1.1 virus, the researchers wrote. 

“In summary, our data suggest the possibility that BA.2 would be the most concerned variant to global health,” the researchers wrote. “Currently, both BA.2 and BA.1 are recognised together as Omicron and these are almost undistinguishable. Based on our findings, we propose that BA.2 should be recognised as a unique variant of concern, and this SARS-CoV-2 variant should be monitored in depth.”

If the World Health Organization recognized BA.2 as a “unique variant of concern,” it would be given its own Greek letter.

But some scientists noted that findings in the lab don’t always reflect what’s happening in the real world of people.

“I think it’s always hard to translate differences in animal and cell culture models to what’s going on with regards to human disease,” Jeremy Kamil, PhD, an associate professor of microbiology and immunology at Louisiana State University Health Shreveport, told Newsweek. “That said, the differences do look real.”

“It might be, from a human’s perspective, a worse virus than BA.1 and might be able to transmit better and cause worse disease,” Daniel Rhoads, MD, section head of microbiology at the Cleveland Clinic in Ohio, told CNN. He reviewed the Japanese study but was not involved in it.

Another scientist who reviewed the study but was not involved in the research noted that human immune systems are evolving along with the COVID variants. 

“One of the caveats that we have to think about, as we get new variants that might seem more dangerous, is the fact that there’s two sides to the story,” Deborah Fuller, PhD, a virologist at the University of Washington School of Medicine, told CNN. “Our immune system is evolving as well. And so that’s pushing back on things.”

Scientists have already established that BA.2 is more transmissible than BA.1. The Omicron subvariant has been detected in 74 countries and 47 U.S. states, according to CNN. About 4% of Americans with COVID were infected with BA.2, the outlet reported, citing the CDC, but it’s now the dominant strain in other nations.

It’s not clear yet if BA.2 causes more severe illness in people. While BA.2 spreads faster than BA.1, there’s no evidence the subvariant makes people any sicker, an official with the World Health Organization said, according to CNBC.

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

The Omicron subvariant, BA.2, is not only more transmissible than the original Omicron strain, BA.1, but may cause more severe disease, a lab study from Japan says.

“Our multiscale investigations suggest that the risk of BA.2 for global health is potentially higher than that of BA.1,” the researchers said in the study published on the preprint server bioRxiv. The study has not been peer-reviewed.

The researchers infected hamsters with BA.1 and BA.2. The hamsters infected with BA.2 got sicker, with more lung damage and loss of body weight. Results were similar when mice were infected with BA.1 and BA.2.

“Infection experiments using hamsters show that BA.2 is more pathogenic than BA.1,” the study said.

BA.1 and BA.2 both appear to evade immunity created by COVID-19 vaccines, the study said. But a booster shot makes illness after infection 74% less likely, CNN said.

What’s more, therapeutic monoclonal antibodies used to treat people infected with COVID didn’t have much effect on BA.2. 

BA.2 was “almost completely resistant” to casirivimab and imdevimab and was 35 times more resistant to sotrovimab, compared to the original B.1.1 virus, the researchers wrote. 

“In summary, our data suggest the possibility that BA.2 would be the most concerned variant to global health,” the researchers wrote. “Currently, both BA.2 and BA.1 are recognised together as Omicron and these are almost undistinguishable. Based on our findings, we propose that BA.2 should be recognised as a unique variant of concern, and this SARS-CoV-2 variant should be monitored in depth.”

If the World Health Organization recognized BA.2 as a “unique variant of concern,” it would be given its own Greek letter.

But some scientists noted that findings in the lab don’t always reflect what’s happening in the real world of people.

“I think it’s always hard to translate differences in animal and cell culture models to what’s going on with regards to human disease,” Jeremy Kamil, PhD, an associate professor of microbiology and immunology at Louisiana State University Health Shreveport, told Newsweek. “That said, the differences do look real.”

“It might be, from a human’s perspective, a worse virus than BA.1 and might be able to transmit better and cause worse disease,” Daniel Rhoads, MD, section head of microbiology at the Cleveland Clinic in Ohio, told CNN. He reviewed the Japanese study but was not involved in it.

Another scientist who reviewed the study but was not involved in the research noted that human immune systems are evolving along with the COVID variants. 

“One of the caveats that we have to think about, as we get new variants that might seem more dangerous, is the fact that there’s two sides to the story,” Deborah Fuller, PhD, a virologist at the University of Washington School of Medicine, told CNN. “Our immune system is evolving as well. And so that’s pushing back on things.”

Scientists have already established that BA.2 is more transmissible than BA.1. The Omicron subvariant has been detected in 74 countries and 47 U.S. states, according to CNN. About 4% of Americans with COVID were infected with BA.2, the outlet reported, citing the CDC, but it’s now the dominant strain in other nations.

It’s not clear yet if BA.2 causes more severe illness in people. While BA.2 spreads faster than BA.1, there’s no evidence the subvariant makes people any sicker, an official with the World Health Organization said, according to CNBC.

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

Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.

“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.

The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.

Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.

Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
 

Secondary outcomes

Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.

In all the secondary outcomes, there were no significant differences between groups.

Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).

The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
 

No difference by vaccine status

The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”

Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).

Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.

The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”

Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.

Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.

In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.

Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.

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

Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.

“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.

The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.

Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.

Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
 

Secondary outcomes

Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.

In all the secondary outcomes, there were no significant differences between groups.

Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).

The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
 

No difference by vaccine status

The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”

Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).

Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.

The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”

Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.

Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.

In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.

Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.

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

Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.

“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.

The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.

Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.

Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
 

Secondary outcomes

Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.

In all the secondary outcomes, there were no significant differences between groups.

Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).

The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
 

No difference by vaccine status

The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”

Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).

Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.

The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”

Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.

Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.

In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.

Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.

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