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Wed, 12/18/2024 - 09:37

CDC recommends hep B vaccination for most adults

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Wed, 04/20/2022 - 14:29

 

The Centers for Disease Control and Prevention has recommended that all adults aged 19-59 years receive a vaccination for hepatitis B.

It also added that adults aged 60 years or older without known risk factors for hepatitis B may get vaccinated.

The agency earlier recommended the vaccination for all infants and children under the age of 19 years and for adults aged 60 years or older with known risk factors.

The CDC said it wants to expand vaccinations because, after decades of progress, the number of new hepatitis B infections is increasing among adults. Acute hepatitis B infections among adults lead to chronic hepatitis B disease in an estimated 2%-6% of cases, and can result in cirrhosis, liver cancer, and death.

Among adults aged 40-49 years, the rate of cases increased from 1.9 per 100,000 people in 2011 to 2.7 per 100,000 in 2019. Among adults aged 50-59 years, the rate increased during this period from 1.1 to 1.6 per 100,000.

Most adults aren’t vaccinated. Among adults aged 19 years or older, only 30.0% reported that they’d received at least the three recommended doses of the vaccine. The rate was 40.3% for adults aged 19-49 years, and 19.1% for adults aged 50 years or older.

Hepatitis B infection rates are particularly elevated among African Americans.

Even among adults with chronic liver disease, the vaccination rate is only 33.0%. And, among travelers to countries where the virus has been endemic since 1995, only 38.9% were vaccinated.

In a 2018 survey of internal medicine and family physicians, 68% said their patients had not told them about risk factors, making it difficult to assess whether the patients needed the vaccine according to the recommendations at the time. These risk factors include injection drug use, incarceration, and multiple sex partners, experiences the patients may not have been willing to discuss.

CDC researchers calculated that universal adult hepatitis B vaccination would cost $153,000 for every quality-adjusted life-year (QALY) gained. For adults aged 19-59 years, a QALY would cost $117,000 because infections are more prevalent in that age group.

The CDC specified that it intends its new guidelines to prompt physicians to offer the vaccine to adults aged 60 years or older rather than wait for them to request it.

The Food and Drug Administration has approved both three-dose and two-dose hepatitis B vaccines, with evidence showing similar seroprotection and adverse events.

People who have already completed their vaccination or have a history of hepatitis B infection should only receive additional vaccinations in specific cases, as detailed in the CDC’s 2018 recommendations.

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

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The Centers for Disease Control and Prevention has recommended that all adults aged 19-59 years receive a vaccination for hepatitis B.

It also added that adults aged 60 years or older without known risk factors for hepatitis B may get vaccinated.

The agency earlier recommended the vaccination for all infants and children under the age of 19 years and for adults aged 60 years or older with known risk factors.

The CDC said it wants to expand vaccinations because, after decades of progress, the number of new hepatitis B infections is increasing among adults. Acute hepatitis B infections among adults lead to chronic hepatitis B disease in an estimated 2%-6% of cases, and can result in cirrhosis, liver cancer, and death.

Among adults aged 40-49 years, the rate of cases increased from 1.9 per 100,000 people in 2011 to 2.7 per 100,000 in 2019. Among adults aged 50-59 years, the rate increased during this period from 1.1 to 1.6 per 100,000.

Most adults aren’t vaccinated. Among adults aged 19 years or older, only 30.0% reported that they’d received at least the three recommended doses of the vaccine. The rate was 40.3% for adults aged 19-49 years, and 19.1% for adults aged 50 years or older.

Hepatitis B infection rates are particularly elevated among African Americans.

Even among adults with chronic liver disease, the vaccination rate is only 33.0%. And, among travelers to countries where the virus has been endemic since 1995, only 38.9% were vaccinated.

In a 2018 survey of internal medicine and family physicians, 68% said their patients had not told them about risk factors, making it difficult to assess whether the patients needed the vaccine according to the recommendations at the time. These risk factors include injection drug use, incarceration, and multiple sex partners, experiences the patients may not have been willing to discuss.

CDC researchers calculated that universal adult hepatitis B vaccination would cost $153,000 for every quality-adjusted life-year (QALY) gained. For adults aged 19-59 years, a QALY would cost $117,000 because infections are more prevalent in that age group.

The CDC specified that it intends its new guidelines to prompt physicians to offer the vaccine to adults aged 60 years or older rather than wait for them to request it.

The Food and Drug Administration has approved both three-dose and two-dose hepatitis B vaccines, with evidence showing similar seroprotection and adverse events.

People who have already completed their vaccination or have a history of hepatitis B infection should only receive additional vaccinations in specific cases, as detailed in the CDC’s 2018 recommendations.

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

 

The Centers for Disease Control and Prevention has recommended that all adults aged 19-59 years receive a vaccination for hepatitis B.

It also added that adults aged 60 years or older without known risk factors for hepatitis B may get vaccinated.

The agency earlier recommended the vaccination for all infants and children under the age of 19 years and for adults aged 60 years or older with known risk factors.

The CDC said it wants to expand vaccinations because, after decades of progress, the number of new hepatitis B infections is increasing among adults. Acute hepatitis B infections among adults lead to chronic hepatitis B disease in an estimated 2%-6% of cases, and can result in cirrhosis, liver cancer, and death.

Among adults aged 40-49 years, the rate of cases increased from 1.9 per 100,000 people in 2011 to 2.7 per 100,000 in 2019. Among adults aged 50-59 years, the rate increased during this period from 1.1 to 1.6 per 100,000.

Most adults aren’t vaccinated. Among adults aged 19 years or older, only 30.0% reported that they’d received at least the three recommended doses of the vaccine. The rate was 40.3% for adults aged 19-49 years, and 19.1% for adults aged 50 years or older.

Hepatitis B infection rates are particularly elevated among African Americans.

Even among adults with chronic liver disease, the vaccination rate is only 33.0%. And, among travelers to countries where the virus has been endemic since 1995, only 38.9% were vaccinated.

In a 2018 survey of internal medicine and family physicians, 68% said their patients had not told them about risk factors, making it difficult to assess whether the patients needed the vaccine according to the recommendations at the time. These risk factors include injection drug use, incarceration, and multiple sex partners, experiences the patients may not have been willing to discuss.

CDC researchers calculated that universal adult hepatitis B vaccination would cost $153,000 for every quality-adjusted life-year (QALY) gained. For adults aged 19-59 years, a QALY would cost $117,000 because infections are more prevalent in that age group.

The CDC specified that it intends its new guidelines to prompt physicians to offer the vaccine to adults aged 60 years or older rather than wait for them to request it.

The Food and Drug Administration has approved both three-dose and two-dose hepatitis B vaccines, with evidence showing similar seroprotection and adverse events.

People who have already completed their vaccination or have a history of hepatitis B infection should only receive additional vaccinations in specific cases, as detailed in the CDC’s 2018 recommendations.

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

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First COVID-19 human challenge study provides insights

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Mon, 04/04/2022 - 12:46

A small droplet that contains the coronavirus can infect someone with COVID-19, according to recent results from the first COVID-19 human challenge study, which were published in Nature Medicine.

Human challenge trials deliberately infect healthy volunteers to understand how an infection occurs and develops. In the first human challenge study for COVID-19, people were infected with the SARS-CoV-2 virus to better understand what has happened during the pandemic.

“Really, there’s no other type of study where you can do that, because normally, patients only come to your attention if they have developed symptoms, and so you miss all of those preceding days when the infection is brewing,” Christopher Chiu, MD, PhD, the lead study author and an infectious disease doctor and immunologist at Imperial College London, told CNN.

Starting in March 2021, Dr. Chiu and colleagues carefully selected 36 volunteers aged 18-30 years who didn’t have any risk factors for severe COVID-19, such as being overweight or having kidney, liver, heart, lung or blood problems. Participants also signed an extensive informed consent form, CNN reported.

The researchers conducted the trial in phases for safety. The first 10 participants who were infected received remdesivir, the antiviral drug, to reduce their chances of progressing to severe COVID-19. The research team also had monoclonal antibodies on hand in case any volunteers developed more severe symptoms. Ultimately, the researchers said, remdesivir was unnecessary, and they didn’t need to use the antibodies.

As part of the study, the participants had a small droplet of fluid that contained the original coronavirus strain inserted into their nose through a long tube. They stayed at London’s Royal Free Hospital for 2 weeks and were monitored by doctors 24 hours a day in rooms that had special air flow to keep the virus from spreading.

Of the 36 participants, 18 became infected, including two who never developed symptoms. The others had mild cases with symptoms such as congestion, sneezing, stuffy nose, and sore throat. Some also had headaches, muscle and joint pain, fatigue, and fever.

About 83% of participants who contracted COVID-19 lost their sense of smell to some degree, and nine people couldn’t smell at all. The symptom improved for most participants within 90 days, though one person still hadn’t fully regained their sense of smell about six months after the study ended.

The research team reported several other findings:

  • Small amounts of the virus can make someone sick. About 10 mcm, or the amount in a single droplet that someone sneezes or coughs, can lead to infection.
  • About 40 hours after the virus was inserted into a participant’s nose, the virus could be detected in the back of the throat.
  • It took about 58 hours for the virus to appear on swabs from the nose, where the viral load eventually increased even more.
  • COVID-19 has a short incubation period. It takes about 2 days after infection for someone to begin shedding the virus to others.
  • People become contagious and shed high amounts of the virus before they show symptoms.
  • In addition, infected people can shed high levels of the virus even if they don’t develop any symptoms.
  • The study volunteers shed the virus for about 6 days on average, though some shed the virus for up to 12 days, even if they didn’t have symptoms.
  • Lateral flow tests, which are used for rapid at-home tests, work well when an infected person is contagious. These tests could diagnose infection before 70%-80% of the viable virus had been generated.
 

 

The findings emphasized the importance of contagious people covering their mouth and nose when sick to protect others, Dr. Chiu told CNN.

None of the study volunteers developed lung issues as part of their infection, CNN reported. Dr. Chiu said that’s likely because they were young, healthy and received tiny amounts of the virus. All of the participants will be followed for a year to monitor for potential long-term effects.

Throughout the study, the research team also conducted cognitive tests to check the participants’ short-term memory and reaction time. The researchers are still analyzing the data, but the results “will really be informative,” Dr. Chiu told CNN.

Now the research team will conduct another human challenge trial, which will include vaccinated people who will be infected with the Delta variant. The researchers intend to study participants’ immune responses, which could provide valuable insights about new variants and vaccines.

“While there are differences in transmissibility due to the emergence of variants, such as Delta and Omicron, fundamentally, this is the same disease and the same factors will be responsible for protecting it,” Dr. Chiu said in a statement.

The research team will also study the 18 participants who didn’t get sick in the first human challenge trial. They didn’t develop antibodies, Dr. Chiu told CNN, despite receiving the same dose of the virus as those who got sick.

Before the study, all of the participants were screened for antibodies to other viruses, such as the original SARS virus. That means the volunteers weren’t cross-protected, and other factors may play into why some people don’t contract COVID-19. Future studies could help researchers provide better advice about protection if new variants emerge or a future pandemic occurs.

“There are lots of other things that help protect us,” Dr. Chiu said. “There are barriers in the nose. There are different kinds of proteins and things which are very ancient, primordial, protective systems ... and we’re really interested in trying to understand what those are.”

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

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A small droplet that contains the coronavirus can infect someone with COVID-19, according to recent results from the first COVID-19 human challenge study, which were published in Nature Medicine.

Human challenge trials deliberately infect healthy volunteers to understand how an infection occurs and develops. In the first human challenge study for COVID-19, people were infected with the SARS-CoV-2 virus to better understand what has happened during the pandemic.

“Really, there’s no other type of study where you can do that, because normally, patients only come to your attention if they have developed symptoms, and so you miss all of those preceding days when the infection is brewing,” Christopher Chiu, MD, PhD, the lead study author and an infectious disease doctor and immunologist at Imperial College London, told CNN.

Starting in March 2021, Dr. Chiu and colleagues carefully selected 36 volunteers aged 18-30 years who didn’t have any risk factors for severe COVID-19, such as being overweight or having kidney, liver, heart, lung or blood problems. Participants also signed an extensive informed consent form, CNN reported.

The researchers conducted the trial in phases for safety. The first 10 participants who were infected received remdesivir, the antiviral drug, to reduce their chances of progressing to severe COVID-19. The research team also had monoclonal antibodies on hand in case any volunteers developed more severe symptoms. Ultimately, the researchers said, remdesivir was unnecessary, and they didn’t need to use the antibodies.

As part of the study, the participants had a small droplet of fluid that contained the original coronavirus strain inserted into their nose through a long tube. They stayed at London’s Royal Free Hospital for 2 weeks and were monitored by doctors 24 hours a day in rooms that had special air flow to keep the virus from spreading.

Of the 36 participants, 18 became infected, including two who never developed symptoms. The others had mild cases with symptoms such as congestion, sneezing, stuffy nose, and sore throat. Some also had headaches, muscle and joint pain, fatigue, and fever.

About 83% of participants who contracted COVID-19 lost their sense of smell to some degree, and nine people couldn’t smell at all. The symptom improved for most participants within 90 days, though one person still hadn’t fully regained their sense of smell about six months after the study ended.

The research team reported several other findings:

  • Small amounts of the virus can make someone sick. About 10 mcm, or the amount in a single droplet that someone sneezes or coughs, can lead to infection.
  • About 40 hours after the virus was inserted into a participant’s nose, the virus could be detected in the back of the throat.
  • It took about 58 hours for the virus to appear on swabs from the nose, where the viral load eventually increased even more.
  • COVID-19 has a short incubation period. It takes about 2 days after infection for someone to begin shedding the virus to others.
  • People become contagious and shed high amounts of the virus before they show symptoms.
  • In addition, infected people can shed high levels of the virus even if they don’t develop any symptoms.
  • The study volunteers shed the virus for about 6 days on average, though some shed the virus for up to 12 days, even if they didn’t have symptoms.
  • Lateral flow tests, which are used for rapid at-home tests, work well when an infected person is contagious. These tests could diagnose infection before 70%-80% of the viable virus had been generated.
 

 

The findings emphasized the importance of contagious people covering their mouth and nose when sick to protect others, Dr. Chiu told CNN.

None of the study volunteers developed lung issues as part of their infection, CNN reported. Dr. Chiu said that’s likely because they were young, healthy and received tiny amounts of the virus. All of the participants will be followed for a year to monitor for potential long-term effects.

Throughout the study, the research team also conducted cognitive tests to check the participants’ short-term memory and reaction time. The researchers are still analyzing the data, but the results “will really be informative,” Dr. Chiu told CNN.

Now the research team will conduct another human challenge trial, which will include vaccinated people who will be infected with the Delta variant. The researchers intend to study participants’ immune responses, which could provide valuable insights about new variants and vaccines.

“While there are differences in transmissibility due to the emergence of variants, such as Delta and Omicron, fundamentally, this is the same disease and the same factors will be responsible for protecting it,” Dr. Chiu said in a statement.

The research team will also study the 18 participants who didn’t get sick in the first human challenge trial. They didn’t develop antibodies, Dr. Chiu told CNN, despite receiving the same dose of the virus as those who got sick.

Before the study, all of the participants were screened for antibodies to other viruses, such as the original SARS virus. That means the volunteers weren’t cross-protected, and other factors may play into why some people don’t contract COVID-19. Future studies could help researchers provide better advice about protection if new variants emerge or a future pandemic occurs.

“There are lots of other things that help protect us,” Dr. Chiu said. “There are barriers in the nose. There are different kinds of proteins and things which are very ancient, primordial, protective systems ... and we’re really interested in trying to understand what those are.”

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

A small droplet that contains the coronavirus can infect someone with COVID-19, according to recent results from the first COVID-19 human challenge study, which were published in Nature Medicine.

Human challenge trials deliberately infect healthy volunteers to understand how an infection occurs and develops. In the first human challenge study for COVID-19, people were infected with the SARS-CoV-2 virus to better understand what has happened during the pandemic.

“Really, there’s no other type of study where you can do that, because normally, patients only come to your attention if they have developed symptoms, and so you miss all of those preceding days when the infection is brewing,” Christopher Chiu, MD, PhD, the lead study author and an infectious disease doctor and immunologist at Imperial College London, told CNN.

Starting in March 2021, Dr. Chiu and colleagues carefully selected 36 volunteers aged 18-30 years who didn’t have any risk factors for severe COVID-19, such as being overweight or having kidney, liver, heart, lung or blood problems. Participants also signed an extensive informed consent form, CNN reported.

The researchers conducted the trial in phases for safety. The first 10 participants who were infected received remdesivir, the antiviral drug, to reduce their chances of progressing to severe COVID-19. The research team also had monoclonal antibodies on hand in case any volunteers developed more severe symptoms. Ultimately, the researchers said, remdesivir was unnecessary, and they didn’t need to use the antibodies.

As part of the study, the participants had a small droplet of fluid that contained the original coronavirus strain inserted into their nose through a long tube. They stayed at London’s Royal Free Hospital for 2 weeks and were monitored by doctors 24 hours a day in rooms that had special air flow to keep the virus from spreading.

Of the 36 participants, 18 became infected, including two who never developed symptoms. The others had mild cases with symptoms such as congestion, sneezing, stuffy nose, and sore throat. Some also had headaches, muscle and joint pain, fatigue, and fever.

About 83% of participants who contracted COVID-19 lost their sense of smell to some degree, and nine people couldn’t smell at all. The symptom improved for most participants within 90 days, though one person still hadn’t fully regained their sense of smell about six months after the study ended.

The research team reported several other findings:

  • Small amounts of the virus can make someone sick. About 10 mcm, or the amount in a single droplet that someone sneezes or coughs, can lead to infection.
  • About 40 hours after the virus was inserted into a participant’s nose, the virus could be detected in the back of the throat.
  • It took about 58 hours for the virus to appear on swabs from the nose, where the viral load eventually increased even more.
  • COVID-19 has a short incubation period. It takes about 2 days after infection for someone to begin shedding the virus to others.
  • People become contagious and shed high amounts of the virus before they show symptoms.
  • In addition, infected people can shed high levels of the virus even if they don’t develop any symptoms.
  • The study volunteers shed the virus for about 6 days on average, though some shed the virus for up to 12 days, even if they didn’t have symptoms.
  • Lateral flow tests, which are used for rapid at-home tests, work well when an infected person is contagious. These tests could diagnose infection before 70%-80% of the viable virus had been generated.
 

 

The findings emphasized the importance of contagious people covering their mouth and nose when sick to protect others, Dr. Chiu told CNN.

None of the study volunteers developed lung issues as part of their infection, CNN reported. Dr. Chiu said that’s likely because they were young, healthy and received tiny amounts of the virus. All of the participants will be followed for a year to monitor for potential long-term effects.

Throughout the study, the research team also conducted cognitive tests to check the participants’ short-term memory and reaction time. The researchers are still analyzing the data, but the results “will really be informative,” Dr. Chiu told CNN.

Now the research team will conduct another human challenge trial, which will include vaccinated people who will be infected with the Delta variant. The researchers intend to study participants’ immune responses, which could provide valuable insights about new variants and vaccines.

“While there are differences in transmissibility due to the emergence of variants, such as Delta and Omicron, fundamentally, this is the same disease and the same factors will be responsible for protecting it,” Dr. Chiu said in a statement.

The research team will also study the 18 participants who didn’t get sick in the first human challenge trial. They didn’t develop antibodies, Dr. Chiu told CNN, despite receiving the same dose of the virus as those who got sick.

Before the study, all of the participants were screened for antibodies to other viruses, such as the original SARS virus. That means the volunteers weren’t cross-protected, and other factors may play into why some people don’t contract COVID-19. Future studies could help researchers provide better advice about protection if new variants emerge or a future pandemic occurs.

“There are lots of other things that help protect us,” Dr. Chiu said. “There are barriers in the nose. There are different kinds of proteins and things which are very ancient, primordial, protective systems ... and we’re really interested in trying to understand what those are.”

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

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Give patients can’ts but also can do’s

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Fri, 04/01/2022 - 12:32

On his last shift in the last hockey game of the regular season, our 14-year-old grandson broke his arm. Although this was his first fracture, the rest of the nuclear family has had ample experience with orthopedic trauma over the last year, both planned and unplanned.

As I drove Peter and my daughter-in-law to his first postsetting and casting appointment I told him how sorry I was that he had been told “no contact sports for the next 3 months.” This was a tough pill for a kid eager to begin his first high school lacrosse season. Then I asked him what the doctor had told him he could do in the way of activity.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Based on personal and professional experience I was not surprised when he told me that no one had suggested things he could be doing. In fact, being a cautious and thoughtful kid, he was concerned about what he should be doing around the house let alone any athletic activities. It turns out he wasn’t even lifting his laptop computer with two hands because some nurse had told him not to lift anything over 2 pounds.

I told him “Peter, even some of the most experienced doctors focus on the ‘can’ts’ and forget to tell you the ‘cans’ and ‘shoulds.’ While you’re in the waiting room make up a mental list of what you would like to be doing that you aren’t.”

As he climbed back in the car for the ride home I asked how the visit went. The x-ray showed good alignment and the doctor was pleased. But, as I predicted, they were already on the launch pad to the receptionist to make a follow-up appointment without the physician uttering a single word about what activities he could resume. Always a very coachable kid, Peter piped up with the list he had created in the waiting room and was relieved to hear that he could do anything as long as it didn’t hurt. In fact, the doctor encouraged him to use his fingers because it might speed the healing.

Not every patient, regardless of age, is as cautious as my grandson and in some circumstances the physician must err on the side of emphasizing the “don’ts.” However, in my experience, too many physicians forget to include a generous list of “can do’s” in their visit closing discussions. This oversight is a mistake for several reasons.

First, and maybe most importantly, even a brief discussion of “can do’s” can soften the depressing message that the patient will not be able to do things he or she enjoys. I can’t quote the references but I am sure there is plenty of evidence that depression slows the healing process.

Second, and this is particularly true in older patients with orthopedic problems – failure to include a plan for return to activity can hinder recovery. I can recall more than a few patients who were seen in the emergency department and diagnosed with sprains but not given even the simplest instructions on how to begin moving the injured joint. When they finally returned to see me we had to begin the painful and unnecessary project of thawing a frozen joint.

Fortunately, we have evolved past the era when best rest was near the top of the list of our recommended remedies. However, there still remains a bias against activity in some situations. The most recent example is the evolving strategies for the management of concussion. There is some evidence that involving the patient in a return to activity plan may shorten the time to recovery. The myth about brain rest has been slow to die.

Finally, providing the patient with a personalized list of “can do’s” makes good business sense because it can head off those time-gobbling call backs that tie up you and your office staff. As an experienced physician, you have probably learned the most frequently asked “Can Jason do ... ?” questions. Make your own list and give the patient your answers. An ounce of anticipatory guidance is worth hours on the telephone or sorting through the email inbox.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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On his last shift in the last hockey game of the regular season, our 14-year-old grandson broke his arm. Although this was his first fracture, the rest of the nuclear family has had ample experience with orthopedic trauma over the last year, both planned and unplanned.

As I drove Peter and my daughter-in-law to his first postsetting and casting appointment I told him how sorry I was that he had been told “no contact sports for the next 3 months.” This was a tough pill for a kid eager to begin his first high school lacrosse season. Then I asked him what the doctor had told him he could do in the way of activity.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Based on personal and professional experience I was not surprised when he told me that no one had suggested things he could be doing. In fact, being a cautious and thoughtful kid, he was concerned about what he should be doing around the house let alone any athletic activities. It turns out he wasn’t even lifting his laptop computer with two hands because some nurse had told him not to lift anything over 2 pounds.

I told him “Peter, even some of the most experienced doctors focus on the ‘can’ts’ and forget to tell you the ‘cans’ and ‘shoulds.’ While you’re in the waiting room make up a mental list of what you would like to be doing that you aren’t.”

As he climbed back in the car for the ride home I asked how the visit went. The x-ray showed good alignment and the doctor was pleased. But, as I predicted, they were already on the launch pad to the receptionist to make a follow-up appointment without the physician uttering a single word about what activities he could resume. Always a very coachable kid, Peter piped up with the list he had created in the waiting room and was relieved to hear that he could do anything as long as it didn’t hurt. In fact, the doctor encouraged him to use his fingers because it might speed the healing.

Not every patient, regardless of age, is as cautious as my grandson and in some circumstances the physician must err on the side of emphasizing the “don’ts.” However, in my experience, too many physicians forget to include a generous list of “can do’s” in their visit closing discussions. This oversight is a mistake for several reasons.

First, and maybe most importantly, even a brief discussion of “can do’s” can soften the depressing message that the patient will not be able to do things he or she enjoys. I can’t quote the references but I am sure there is plenty of evidence that depression slows the healing process.

Second, and this is particularly true in older patients with orthopedic problems – failure to include a plan for return to activity can hinder recovery. I can recall more than a few patients who were seen in the emergency department and diagnosed with sprains but not given even the simplest instructions on how to begin moving the injured joint. When they finally returned to see me we had to begin the painful and unnecessary project of thawing a frozen joint.

Fortunately, we have evolved past the era when best rest was near the top of the list of our recommended remedies. However, there still remains a bias against activity in some situations. The most recent example is the evolving strategies for the management of concussion. There is some evidence that involving the patient in a return to activity plan may shorten the time to recovery. The myth about brain rest has been slow to die.

Finally, providing the patient with a personalized list of “can do’s” makes good business sense because it can head off those time-gobbling call backs that tie up you and your office staff. As an experienced physician, you have probably learned the most frequently asked “Can Jason do ... ?” questions. Make your own list and give the patient your answers. An ounce of anticipatory guidance is worth hours on the telephone or sorting through the email inbox.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

On his last shift in the last hockey game of the regular season, our 14-year-old grandson broke his arm. Although this was his first fracture, the rest of the nuclear family has had ample experience with orthopedic trauma over the last year, both planned and unplanned.

As I drove Peter and my daughter-in-law to his first postsetting and casting appointment I told him how sorry I was that he had been told “no contact sports for the next 3 months.” This was a tough pill for a kid eager to begin his first high school lacrosse season. Then I asked him what the doctor had told him he could do in the way of activity.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Based on personal and professional experience I was not surprised when he told me that no one had suggested things he could be doing. In fact, being a cautious and thoughtful kid, he was concerned about what he should be doing around the house let alone any athletic activities. It turns out he wasn’t even lifting his laptop computer with two hands because some nurse had told him not to lift anything over 2 pounds.

I told him “Peter, even some of the most experienced doctors focus on the ‘can’ts’ and forget to tell you the ‘cans’ and ‘shoulds.’ While you’re in the waiting room make up a mental list of what you would like to be doing that you aren’t.”

As he climbed back in the car for the ride home I asked how the visit went. The x-ray showed good alignment and the doctor was pleased. But, as I predicted, they were already on the launch pad to the receptionist to make a follow-up appointment without the physician uttering a single word about what activities he could resume. Always a very coachable kid, Peter piped up with the list he had created in the waiting room and was relieved to hear that he could do anything as long as it didn’t hurt. In fact, the doctor encouraged him to use his fingers because it might speed the healing.

Not every patient, regardless of age, is as cautious as my grandson and in some circumstances the physician must err on the side of emphasizing the “don’ts.” However, in my experience, too many physicians forget to include a generous list of “can do’s” in their visit closing discussions. This oversight is a mistake for several reasons.

First, and maybe most importantly, even a brief discussion of “can do’s” can soften the depressing message that the patient will not be able to do things he or she enjoys. I can’t quote the references but I am sure there is plenty of evidence that depression slows the healing process.

Second, and this is particularly true in older patients with orthopedic problems – failure to include a plan for return to activity can hinder recovery. I can recall more than a few patients who were seen in the emergency department and diagnosed with sprains but not given even the simplest instructions on how to begin moving the injured joint. When they finally returned to see me we had to begin the painful and unnecessary project of thawing a frozen joint.

Fortunately, we have evolved past the era when best rest was near the top of the list of our recommended remedies. However, there still remains a bias against activity in some situations. The most recent example is the evolving strategies for the management of concussion. There is some evidence that involving the patient in a return to activity plan may shorten the time to recovery. The myth about brain rest has been slow to die.

Finally, providing the patient with a personalized list of “can do’s” makes good business sense because it can head off those time-gobbling call backs that tie up you and your office staff. As an experienced physician, you have probably learned the most frequently asked “Can Jason do ... ?” questions. Make your own list and give the patient your answers. An ounce of anticipatory guidance is worth hours on the telephone or sorting through the email inbox.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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IV gentamicin improves junctional epidermolysis bullosa in children

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Fri, 04/01/2022 - 12:25

Intravenous gentamicin therapy was associated with new laminin 332 – a major component of anchoring filaments in the dermal-epidermal junction – in the skin of five pediatric patients with intermediate or severe junctional epidermolysis bullosa (JEB) caused by nonsense variants.

The newly generated structural protein persisted during the 3-month randomized clinical trial and was associated with significant wound closure – with no signs of ototoxic effects, nephrotoxic effects, or anti–laminin 332 autoantibody induction, investigators recently reported in JAMA Dermatology.

JEB is a rare, autosomal recessive disorder caused mainly by nonsense variants (i.e., mutations) in the LAMA3, LAMB3, or LAMC2 genes that encode laminin, resulting in widespread blisters and erosions of the skin. Current treatment is limited to supportive management and palliative care, and children with its severe subtype are likely to die within the first year of life.

“With data indicating a robust response to short-term gentamicin treatment and the marked stability of laminin 332, we envision that gentamicin could be delivered as a short-term pulse therapy every 2-3 months for patients with JEB caused by nonsense variants,” the researchers wrote.

Of the five patients, ages 3 months to 10 years, three received 7.5 mg/kg IV gentamicin daily for 14 days, and two received 10 mg/kg daily for 24 days at the University of Southern California, Los Angeles.

All had confirmed nonsense variants in LAMA3 or LAMB3 in one or two alleles, and all had minimal laminin 332 expression at baseline as determined by immunofluorescence. After treatment, each of the children had increased, sustained expression of laminin 332.

The researchers monitored three open wounds in each patient. By 1 month, seven of nine wounds in those receiving the lower-dose therapy and all of the wounds in those receiving the higher-dose therapy showed at least 50% closure. By 3 months, eight of nine wounds in the lower-dose group, and all wounds in the higher-dose group showed greater than 85% closure.

In an interview, senior investigators Mei Chen, PhD, professor of dermatology, and David T. Woodley, MD, professor and chair of dermatology, both at USC, emphasized laminin’s long half-life.“Once these skin structural proteins are generated at the dermal-epidermal junction, they are long-lasting structures, which means the therapy can be pulsed rather than continuously delivered, which can obviate some of the known side effects of the medication,” Dr. Woodley said.

Gentamicin, an aminoglycoside, works as a “read-through therapy,” inducing ribosomal read-through of premature termination codons (PTCs) caused by nonsense mutations. The read-through allows translation to proceed and full-length proteins to be generated.

Gentamicin read-through therapy is also being investigated for recessive dystrophic epidermolysis bullosa (RDEB) attributable to nonsense mutations. The culprit mutations in this form of EB occur in a gene that encodes collagen type VII alpha 1, which, like laminin, is responsible for dermal-epidermal adherence. A clinical trial of intravenous gentamicin for RDEB is ongoing at USC, Dr. Chen said.


 

EBS-MD case report

It may also have a role in treating epidermolysis bullosa simplex with muscular dystrophy (EBS-MD), according to investigators in Madrid. Their case report, published in JAMA Dermatology, details how two 14-day courses of infused gentamicin therapy were followed by re-expression of plectin in the skin for 4-5 months and mild improvement in symptoms in one patient, a woman in her 30s, with a homozygous nonsense variant in PLEC1.

In an editorial accompanying the two reports, Anna L. Bruckner, MD, MSCS, professor of dermatology, University of Colorado at Denver, Aurora, and colleagues expressed cautious optimism and said that additional research on the feasibility, possible cumulative toxic effects, risk of microbial resistance, and overall clinical relevance is needed.

Still, the “investigators should be applauded for taking advantage of a readily available systemic treatment to target cutaneous and extracutaneous symptoms of patients who have very limited treatment options at this time,” they wrote. While all forms of EB are considered orphan disorders, JEB and EBS-MD have received less research attention than RDEB.

The JEB study evaluated patients with clinical assessments/quality of life surveys and with a validated clinical score that considers skin and mucosae – the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). There were small positive changes in EBDASI scores, but data were incomplete and therefore difficult to interpret.

A “noteworthy” finding, the authors wrote, were improvements in emotions and functioning in two of the children who were eligible given their older ages for assessment with the Skindex-16 quality-of-life survey. The improvements suggest “potential psychosocial benefits” of the gentamicin therapy.

The JEB study was supported in part by grants from the EB Research Partnership and EB Medical Research Foundation and an award from the Congressionally Directed Medical Research Program. In addition to the grants, Dr. Woodley and Dr. Chen reported receiving personal fees from Phoenix Tissue Repair outside of the submitted work. For the EBS-MD case report, the authors reported no disclosures. Dr. Bruckner, corresponding author of the editorial, reported grants from several companies outside the submitted work.

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Intravenous gentamicin therapy was associated with new laminin 332 – a major component of anchoring filaments in the dermal-epidermal junction – in the skin of five pediatric patients with intermediate or severe junctional epidermolysis bullosa (JEB) caused by nonsense variants.

The newly generated structural protein persisted during the 3-month randomized clinical trial and was associated with significant wound closure – with no signs of ototoxic effects, nephrotoxic effects, or anti–laminin 332 autoantibody induction, investigators recently reported in JAMA Dermatology.

JEB is a rare, autosomal recessive disorder caused mainly by nonsense variants (i.e., mutations) in the LAMA3, LAMB3, or LAMC2 genes that encode laminin, resulting in widespread blisters and erosions of the skin. Current treatment is limited to supportive management and palliative care, and children with its severe subtype are likely to die within the first year of life.

“With data indicating a robust response to short-term gentamicin treatment and the marked stability of laminin 332, we envision that gentamicin could be delivered as a short-term pulse therapy every 2-3 months for patients with JEB caused by nonsense variants,” the researchers wrote.

Of the five patients, ages 3 months to 10 years, three received 7.5 mg/kg IV gentamicin daily for 14 days, and two received 10 mg/kg daily for 24 days at the University of Southern California, Los Angeles.

All had confirmed nonsense variants in LAMA3 or LAMB3 in one or two alleles, and all had minimal laminin 332 expression at baseline as determined by immunofluorescence. After treatment, each of the children had increased, sustained expression of laminin 332.

The researchers monitored three open wounds in each patient. By 1 month, seven of nine wounds in those receiving the lower-dose therapy and all of the wounds in those receiving the higher-dose therapy showed at least 50% closure. By 3 months, eight of nine wounds in the lower-dose group, and all wounds in the higher-dose group showed greater than 85% closure.

In an interview, senior investigators Mei Chen, PhD, professor of dermatology, and David T. Woodley, MD, professor and chair of dermatology, both at USC, emphasized laminin’s long half-life.“Once these skin structural proteins are generated at the dermal-epidermal junction, they are long-lasting structures, which means the therapy can be pulsed rather than continuously delivered, which can obviate some of the known side effects of the medication,” Dr. Woodley said.

Gentamicin, an aminoglycoside, works as a “read-through therapy,” inducing ribosomal read-through of premature termination codons (PTCs) caused by nonsense mutations. The read-through allows translation to proceed and full-length proteins to be generated.

Gentamicin read-through therapy is also being investigated for recessive dystrophic epidermolysis bullosa (RDEB) attributable to nonsense mutations. The culprit mutations in this form of EB occur in a gene that encodes collagen type VII alpha 1, which, like laminin, is responsible for dermal-epidermal adherence. A clinical trial of intravenous gentamicin for RDEB is ongoing at USC, Dr. Chen said.


 

EBS-MD case report

It may also have a role in treating epidermolysis bullosa simplex with muscular dystrophy (EBS-MD), according to investigators in Madrid. Their case report, published in JAMA Dermatology, details how two 14-day courses of infused gentamicin therapy were followed by re-expression of plectin in the skin for 4-5 months and mild improvement in symptoms in one patient, a woman in her 30s, with a homozygous nonsense variant in PLEC1.

In an editorial accompanying the two reports, Anna L. Bruckner, MD, MSCS, professor of dermatology, University of Colorado at Denver, Aurora, and colleagues expressed cautious optimism and said that additional research on the feasibility, possible cumulative toxic effects, risk of microbial resistance, and overall clinical relevance is needed.

Still, the “investigators should be applauded for taking advantage of a readily available systemic treatment to target cutaneous and extracutaneous symptoms of patients who have very limited treatment options at this time,” they wrote. While all forms of EB are considered orphan disorders, JEB and EBS-MD have received less research attention than RDEB.

The JEB study evaluated patients with clinical assessments/quality of life surveys and with a validated clinical score that considers skin and mucosae – the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). There were small positive changes in EBDASI scores, but data were incomplete and therefore difficult to interpret.

A “noteworthy” finding, the authors wrote, were improvements in emotions and functioning in two of the children who were eligible given their older ages for assessment with the Skindex-16 quality-of-life survey. The improvements suggest “potential psychosocial benefits” of the gentamicin therapy.

The JEB study was supported in part by grants from the EB Research Partnership and EB Medical Research Foundation and an award from the Congressionally Directed Medical Research Program. In addition to the grants, Dr. Woodley and Dr. Chen reported receiving personal fees from Phoenix Tissue Repair outside of the submitted work. For the EBS-MD case report, the authors reported no disclosures. Dr. Bruckner, corresponding author of the editorial, reported grants from several companies outside the submitted work.

Intravenous gentamicin therapy was associated with new laminin 332 – a major component of anchoring filaments in the dermal-epidermal junction – in the skin of five pediatric patients with intermediate or severe junctional epidermolysis bullosa (JEB) caused by nonsense variants.

The newly generated structural protein persisted during the 3-month randomized clinical trial and was associated with significant wound closure – with no signs of ototoxic effects, nephrotoxic effects, or anti–laminin 332 autoantibody induction, investigators recently reported in JAMA Dermatology.

JEB is a rare, autosomal recessive disorder caused mainly by nonsense variants (i.e., mutations) in the LAMA3, LAMB3, or LAMC2 genes that encode laminin, resulting in widespread blisters and erosions of the skin. Current treatment is limited to supportive management and palliative care, and children with its severe subtype are likely to die within the first year of life.

“With data indicating a robust response to short-term gentamicin treatment and the marked stability of laminin 332, we envision that gentamicin could be delivered as a short-term pulse therapy every 2-3 months for patients with JEB caused by nonsense variants,” the researchers wrote.

Of the five patients, ages 3 months to 10 years, three received 7.5 mg/kg IV gentamicin daily for 14 days, and two received 10 mg/kg daily for 24 days at the University of Southern California, Los Angeles.

All had confirmed nonsense variants in LAMA3 or LAMB3 in one or two alleles, and all had minimal laminin 332 expression at baseline as determined by immunofluorescence. After treatment, each of the children had increased, sustained expression of laminin 332.

The researchers monitored three open wounds in each patient. By 1 month, seven of nine wounds in those receiving the lower-dose therapy and all of the wounds in those receiving the higher-dose therapy showed at least 50% closure. By 3 months, eight of nine wounds in the lower-dose group, and all wounds in the higher-dose group showed greater than 85% closure.

In an interview, senior investigators Mei Chen, PhD, professor of dermatology, and David T. Woodley, MD, professor and chair of dermatology, both at USC, emphasized laminin’s long half-life.“Once these skin structural proteins are generated at the dermal-epidermal junction, they are long-lasting structures, which means the therapy can be pulsed rather than continuously delivered, which can obviate some of the known side effects of the medication,” Dr. Woodley said.

Gentamicin, an aminoglycoside, works as a “read-through therapy,” inducing ribosomal read-through of premature termination codons (PTCs) caused by nonsense mutations. The read-through allows translation to proceed and full-length proteins to be generated.

Gentamicin read-through therapy is also being investigated for recessive dystrophic epidermolysis bullosa (RDEB) attributable to nonsense mutations. The culprit mutations in this form of EB occur in a gene that encodes collagen type VII alpha 1, which, like laminin, is responsible for dermal-epidermal adherence. A clinical trial of intravenous gentamicin for RDEB is ongoing at USC, Dr. Chen said.


 

EBS-MD case report

It may also have a role in treating epidermolysis bullosa simplex with muscular dystrophy (EBS-MD), according to investigators in Madrid. Their case report, published in JAMA Dermatology, details how two 14-day courses of infused gentamicin therapy were followed by re-expression of plectin in the skin for 4-5 months and mild improvement in symptoms in one patient, a woman in her 30s, with a homozygous nonsense variant in PLEC1.

In an editorial accompanying the two reports, Anna L. Bruckner, MD, MSCS, professor of dermatology, University of Colorado at Denver, Aurora, and colleagues expressed cautious optimism and said that additional research on the feasibility, possible cumulative toxic effects, risk of microbial resistance, and overall clinical relevance is needed.

Still, the “investigators should be applauded for taking advantage of a readily available systemic treatment to target cutaneous and extracutaneous symptoms of patients who have very limited treatment options at this time,” they wrote. While all forms of EB are considered orphan disorders, JEB and EBS-MD have received less research attention than RDEB.

The JEB study evaluated patients with clinical assessments/quality of life surveys and with a validated clinical score that considers skin and mucosae – the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). There were small positive changes in EBDASI scores, but data were incomplete and therefore difficult to interpret.

A “noteworthy” finding, the authors wrote, were improvements in emotions and functioning in two of the children who were eligible given their older ages for assessment with the Skindex-16 quality-of-life survey. The improvements suggest “potential psychosocial benefits” of the gentamicin therapy.

The JEB study was supported in part by grants from the EB Research Partnership and EB Medical Research Foundation and an award from the Congressionally Directed Medical Research Program. In addition to the grants, Dr. Woodley and Dr. Chen reported receiving personal fees from Phoenix Tissue Repair outside of the submitted work. For the EBS-MD case report, the authors reported no disclosures. Dr. Bruckner, corresponding author of the editorial, reported grants from several companies outside the submitted work.

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Ivermectin doesn’t help treat COVID-19, large study finds

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Changed
Wed, 04/06/2022 - 14:44

Ivermectin, an antiparasitic drug that became popular as an alternative treatment for COVID-19, showed no signs of quelling the disease or reducing patients’ risk of hospitalization, according to results from a large clinical trial published in the New England Journal of Medicine.

The findings pretty much rule out the drug as a treatment for COVID-19, the study authors wrote.

“There’s really no sign of any benefit,” David Boulware, MD, one of the coauthors and an infectious disease specialist at the University of Minnesota, Minneapolis, told the New York Times.

The researchers shared a summary of the results in August 2021 during an online presentation hosted by the National Institutes of Health. The full data hadn’t been published until now.

“Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin toward other therapies,” Dr. Boulware said.

In the trial, the research team compared more than 1,350 people infected with the coronavirus in Brazil who received either ivermectin or a placebo as treatment.

Between March and August 2021, 679 patients received a daily dose of ivermectin over the course of 3 days. The researchers found that ivermectin didn’t reduce the risk that people with COVID-19 would be hospitalized or go to an ED within 28 days after treatment.

In addition, the researchers looked at particular groups to understand if some patients benefited for some reason, such as taking ivermectin sooner after testing positive for COVID-19. But those who took the drug during the first 3 days after a positive coronavirus test ended up doing worse than those in the placebo group. The drug also didn’t help patients recover sooner.

The researchers found “no important effects” of treatment with ivermectin on the number of days people spent in the hospital, the number of days hospitalized people needed mechanical ventilation, or the risk of death.

Ivermectin has become a controversial focal point during the pandemic.

For decades, the drug has been widely used to treat parasitic infections. At the beginning of the pandemic, researchers checked thousands of existing drugs against the coronavirus to determine if a potential treatment already existed. Laboratory experiments on cells suggested that ivermectin might work, the New York Times reported.

But some researchers noted that the experiments worked because a high concentration of ivermectin was used, a much higher dose than would be safe for people. Despite the concerns, some doctors began prescribing ivermectin to patients. After receiving reports of people who needed medical attention, particularly after using formulations intended for livestock, the Food and Drug Administration issued a warning that the drug wasn’t approved to be used for COVID-19.

Researchers around the world have done small clinical trials to understand whether ivermectin treats COVID-19, the newspaper reported. At the end of 2020, Andrew Hill, MD, a virologist at the University of Liverpool in England, reviewed the results from 23 trials and concluded that the drug could lower the risk of death from COVID-19. He published the results in July 2021, but later reports found that many of the studies were flawed, and at least one was fraudulent.

Dr. Hill retracted his original study and began another analysis, which was published in January 2022. In this review, he and his colleagues focused on studies that were least likely to be biased. They found that ivermectin was not helpful.

Recently, Dr. Hill and associates ran another analysis using the new data from the Brazil trial, and once again they saw no benefit.

Several clinical trials are still testing ivermectin as a treatment, the New York Times reported, with results expected in upcoming months. After reviewing the data from the Brazil trial, which tested ivermectin and a variety of other drugs against COVID-19, some infectious disease experts say they’ll likely see more of the same – that ivermectin doesn’t help people with COVID-19.

“I welcome the results of the other clinical trials and will view them with an open mind,” Paul Sax, MD, an infectious disease expert at Brigham and Women’s Hospital, Boston, who has been watching the data on the drug throughout the pandemic, told the New York Times.

“But at some point, it will become a waste of resources to continue studying an unpromising approach,” he said.

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

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Ivermectin, an antiparasitic drug that became popular as an alternative treatment for COVID-19, showed no signs of quelling the disease or reducing patients’ risk of hospitalization, according to results from a large clinical trial published in the New England Journal of Medicine.

The findings pretty much rule out the drug as a treatment for COVID-19, the study authors wrote.

“There’s really no sign of any benefit,” David Boulware, MD, one of the coauthors and an infectious disease specialist at the University of Minnesota, Minneapolis, told the New York Times.

The researchers shared a summary of the results in August 2021 during an online presentation hosted by the National Institutes of Health. The full data hadn’t been published until now.

“Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin toward other therapies,” Dr. Boulware said.

In the trial, the research team compared more than 1,350 people infected with the coronavirus in Brazil who received either ivermectin or a placebo as treatment.

Between March and August 2021, 679 patients received a daily dose of ivermectin over the course of 3 days. The researchers found that ivermectin didn’t reduce the risk that people with COVID-19 would be hospitalized or go to an ED within 28 days after treatment.

In addition, the researchers looked at particular groups to understand if some patients benefited for some reason, such as taking ivermectin sooner after testing positive for COVID-19. But those who took the drug during the first 3 days after a positive coronavirus test ended up doing worse than those in the placebo group. The drug also didn’t help patients recover sooner.

The researchers found “no important effects” of treatment with ivermectin on the number of days people spent in the hospital, the number of days hospitalized people needed mechanical ventilation, or the risk of death.

Ivermectin has become a controversial focal point during the pandemic.

For decades, the drug has been widely used to treat parasitic infections. At the beginning of the pandemic, researchers checked thousands of existing drugs against the coronavirus to determine if a potential treatment already existed. Laboratory experiments on cells suggested that ivermectin might work, the New York Times reported.

But some researchers noted that the experiments worked because a high concentration of ivermectin was used, a much higher dose than would be safe for people. Despite the concerns, some doctors began prescribing ivermectin to patients. After receiving reports of people who needed medical attention, particularly after using formulations intended for livestock, the Food and Drug Administration issued a warning that the drug wasn’t approved to be used for COVID-19.

Researchers around the world have done small clinical trials to understand whether ivermectin treats COVID-19, the newspaper reported. At the end of 2020, Andrew Hill, MD, a virologist at the University of Liverpool in England, reviewed the results from 23 trials and concluded that the drug could lower the risk of death from COVID-19. He published the results in July 2021, but later reports found that many of the studies were flawed, and at least one was fraudulent.

Dr. Hill retracted his original study and began another analysis, which was published in January 2022. In this review, he and his colleagues focused on studies that were least likely to be biased. They found that ivermectin was not helpful.

Recently, Dr. Hill and associates ran another analysis using the new data from the Brazil trial, and once again they saw no benefit.

Several clinical trials are still testing ivermectin as a treatment, the New York Times reported, with results expected in upcoming months. After reviewing the data from the Brazil trial, which tested ivermectin and a variety of other drugs against COVID-19, some infectious disease experts say they’ll likely see more of the same – that ivermectin doesn’t help people with COVID-19.

“I welcome the results of the other clinical trials and will view them with an open mind,” Paul Sax, MD, an infectious disease expert at Brigham and Women’s Hospital, Boston, who has been watching the data on the drug throughout the pandemic, told the New York Times.

“But at some point, it will become a waste of resources to continue studying an unpromising approach,” he said.

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

Ivermectin, an antiparasitic drug that became popular as an alternative treatment for COVID-19, showed no signs of quelling the disease or reducing patients’ risk of hospitalization, according to results from a large clinical trial published in the New England Journal of Medicine.

The findings pretty much rule out the drug as a treatment for COVID-19, the study authors wrote.

“There’s really no sign of any benefit,” David Boulware, MD, one of the coauthors and an infectious disease specialist at the University of Minnesota, Minneapolis, told the New York Times.

The researchers shared a summary of the results in August 2021 during an online presentation hosted by the National Institutes of Health. The full data hadn’t been published until now.

“Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin toward other therapies,” Dr. Boulware said.

In the trial, the research team compared more than 1,350 people infected with the coronavirus in Brazil who received either ivermectin or a placebo as treatment.

Between March and August 2021, 679 patients received a daily dose of ivermectin over the course of 3 days. The researchers found that ivermectin didn’t reduce the risk that people with COVID-19 would be hospitalized or go to an ED within 28 days after treatment.

In addition, the researchers looked at particular groups to understand if some patients benefited for some reason, such as taking ivermectin sooner after testing positive for COVID-19. But those who took the drug during the first 3 days after a positive coronavirus test ended up doing worse than those in the placebo group. The drug also didn’t help patients recover sooner.

The researchers found “no important effects” of treatment with ivermectin on the number of days people spent in the hospital, the number of days hospitalized people needed mechanical ventilation, or the risk of death.

Ivermectin has become a controversial focal point during the pandemic.

For decades, the drug has been widely used to treat parasitic infections. At the beginning of the pandemic, researchers checked thousands of existing drugs against the coronavirus to determine if a potential treatment already existed. Laboratory experiments on cells suggested that ivermectin might work, the New York Times reported.

But some researchers noted that the experiments worked because a high concentration of ivermectin was used, a much higher dose than would be safe for people. Despite the concerns, some doctors began prescribing ivermectin to patients. After receiving reports of people who needed medical attention, particularly after using formulations intended for livestock, the Food and Drug Administration issued a warning that the drug wasn’t approved to be used for COVID-19.

Researchers around the world have done small clinical trials to understand whether ivermectin treats COVID-19, the newspaper reported. At the end of 2020, Andrew Hill, MD, a virologist at the University of Liverpool in England, reviewed the results from 23 trials and concluded that the drug could lower the risk of death from COVID-19. He published the results in July 2021, but later reports found that many of the studies were flawed, and at least one was fraudulent.

Dr. Hill retracted his original study and began another analysis, which was published in January 2022. In this review, he and his colleagues focused on studies that were least likely to be biased. They found that ivermectin was not helpful.

Recently, Dr. Hill and associates ran another analysis using the new data from the Brazil trial, and once again they saw no benefit.

Several clinical trials are still testing ivermectin as a treatment, the New York Times reported, with results expected in upcoming months. After reviewing the data from the Brazil trial, which tested ivermectin and a variety of other drugs against COVID-19, some infectious disease experts say they’ll likely see more of the same – that ivermectin doesn’t help people with COVID-19.

“I welcome the results of the other clinical trials and will view them with an open mind,” Paul Sax, MD, an infectious disease expert at Brigham and Women’s Hospital, Boston, who has been watching the data on the drug throughout the pandemic, told the New York Times.

“But at some point, it will become a waste of resources to continue studying an unpromising approach,” he said.

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

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Study finds social media use negatively affects male and female adolescents at different ages

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Changed
Fri, 04/01/2022 - 14:53

A cross-sectional study in the United Kingdom has revealed an association between social media use and lower life satisfaction among children and adolescents aged 10-21 years.

“[Our] study provides evidence for age- and sex-specific windows of sensitivity to social media use in adolescence,” lead author Amy Orben, PhD, of the University of Cambridge (England), and colleagues wrote. The findings were published in Nature Communications.

The researchers analyzed cross-sectional and longitudinal data from the Understanding Society dataset and the Millennium Cohort Study. The cross-sectional data was used to investigate the existence of developmental windows of sensitivity to social media, while the longitudinal data was used to evaluate whether sex-specific windows of sensitivity to social media were present during the adolescence period.

These two datasets comprised 84,011 participants aged 10-80 years old. After applying the modeling framework, 17,409 participants aged 10-21 years were included in the analysis.

Longitudinal analyses revealed different developmental windows of sensitivity to social media during adolescence, with higher estimated social media use predicting lower life satisfaction scores 1 year later (regression coefficient [beta], −0.02; 95% confidence interval, −0.03 to −0.01; P = .004).

Among females, the researchers observed a window of sensitivity to social media between the ages of 11 and 13, with higher estimated social media use predicting lower life satisfaction ratings 1 year later (age 11: beta, −0.11; 95% CI, −0.21 to −0.02; P = .020; age 12: beta, −0.14; 95% CI, −0.22 to −0.07; P < .001; age 13: beta, −0.08; 95% CI, −0.15 to −0.01; P = .019).

Among males, a similar window was observed between the ages of 14 and 15 (age 14: beta, −0.10; 95% CI, −0.17 to −0.03; P = .005; age 15: beta, –0.18; 95% CI, −0.29 to −0.08; P = .001).

Furthermore, they showed that a later increase in sensitivity to social media, which was present at age 19 for both females and males, suggested a different underlying process was present in late adolescence (females: beta, −0.16; 95% CI, −0.25 to −0.07; P < .001; males: beta, −0.16; 95% CI, −0.26 to −0.07; P = .001).

“Speculatively, this might be related to changes in the social environment such as a move away from home and subsequent disruptions in social networks,” the researchers wrote.

Importantly, Dr. Orben and colleagues noted that these results should be interpreted with caution. Owing to the cross-sectional nature of the data, causality cannot be inferred from these findings.

“The findings reported here may enable investigation of potential mechanisms of interest, for example, in datasets with pubertal or additional social measurements,” they wrote. “One could also carry out more targeted investigations, for example, by examining the mental health measures only completed by select age ranges in the datasets.”
 

Digital literacy is important, expert says

“Digital literacy and education about social media use is warranted for all ages, starting young,” Yalda T. Uhls, MBA, PhD, of the department of psychology at the University of California, Los Angeles, said in an interview. “Attending to underlying issues for vulnerable ages, such as anxiety, as well as parental support is critical.”

“I would urge social media platforms to pay attention to what kinds of content they are making available to ensure the highest possible quality, and to embed things like suggestions for pauses and other ways to check in on someone who may be experiencing distress when on socials,” Dr. Uhls said. “We also need to increase access to mental health resources for young people and social media could help provide information for those experiencing issues.”

This study was supported by the University of Cambridge and the UK Medical Research Council. The authors reported no relevant disclosures. Dr. Uhls had no relevant disclosures.

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A cross-sectional study in the United Kingdom has revealed an association between social media use and lower life satisfaction among children and adolescents aged 10-21 years.

“[Our] study provides evidence for age- and sex-specific windows of sensitivity to social media use in adolescence,” lead author Amy Orben, PhD, of the University of Cambridge (England), and colleagues wrote. The findings were published in Nature Communications.

The researchers analyzed cross-sectional and longitudinal data from the Understanding Society dataset and the Millennium Cohort Study. The cross-sectional data was used to investigate the existence of developmental windows of sensitivity to social media, while the longitudinal data was used to evaluate whether sex-specific windows of sensitivity to social media were present during the adolescence period.

These two datasets comprised 84,011 participants aged 10-80 years old. After applying the modeling framework, 17,409 participants aged 10-21 years were included in the analysis.

Longitudinal analyses revealed different developmental windows of sensitivity to social media during adolescence, with higher estimated social media use predicting lower life satisfaction scores 1 year later (regression coefficient [beta], −0.02; 95% confidence interval, −0.03 to −0.01; P = .004).

Among females, the researchers observed a window of sensitivity to social media between the ages of 11 and 13, with higher estimated social media use predicting lower life satisfaction ratings 1 year later (age 11: beta, −0.11; 95% CI, −0.21 to −0.02; P = .020; age 12: beta, −0.14; 95% CI, −0.22 to −0.07; P < .001; age 13: beta, −0.08; 95% CI, −0.15 to −0.01; P = .019).

Among males, a similar window was observed between the ages of 14 and 15 (age 14: beta, −0.10; 95% CI, −0.17 to −0.03; P = .005; age 15: beta, –0.18; 95% CI, −0.29 to −0.08; P = .001).

Furthermore, they showed that a later increase in sensitivity to social media, which was present at age 19 for both females and males, suggested a different underlying process was present in late adolescence (females: beta, −0.16; 95% CI, −0.25 to −0.07; P < .001; males: beta, −0.16; 95% CI, −0.26 to −0.07; P = .001).

“Speculatively, this might be related to changes in the social environment such as a move away from home and subsequent disruptions in social networks,” the researchers wrote.

Importantly, Dr. Orben and colleagues noted that these results should be interpreted with caution. Owing to the cross-sectional nature of the data, causality cannot be inferred from these findings.

“The findings reported here may enable investigation of potential mechanisms of interest, for example, in datasets with pubertal or additional social measurements,” they wrote. “One could also carry out more targeted investigations, for example, by examining the mental health measures only completed by select age ranges in the datasets.”
 

Digital literacy is important, expert says

“Digital literacy and education about social media use is warranted for all ages, starting young,” Yalda T. Uhls, MBA, PhD, of the department of psychology at the University of California, Los Angeles, said in an interview. “Attending to underlying issues for vulnerable ages, such as anxiety, as well as parental support is critical.”

“I would urge social media platforms to pay attention to what kinds of content they are making available to ensure the highest possible quality, and to embed things like suggestions for pauses and other ways to check in on someone who may be experiencing distress when on socials,” Dr. Uhls said. “We also need to increase access to mental health resources for young people and social media could help provide information for those experiencing issues.”

This study was supported by the University of Cambridge and the UK Medical Research Council. The authors reported no relevant disclosures. Dr. Uhls had no relevant disclosures.

A cross-sectional study in the United Kingdom has revealed an association between social media use and lower life satisfaction among children and adolescents aged 10-21 years.

“[Our] study provides evidence for age- and sex-specific windows of sensitivity to social media use in adolescence,” lead author Amy Orben, PhD, of the University of Cambridge (England), and colleagues wrote. The findings were published in Nature Communications.

The researchers analyzed cross-sectional and longitudinal data from the Understanding Society dataset and the Millennium Cohort Study. The cross-sectional data was used to investigate the existence of developmental windows of sensitivity to social media, while the longitudinal data was used to evaluate whether sex-specific windows of sensitivity to social media were present during the adolescence period.

These two datasets comprised 84,011 participants aged 10-80 years old. After applying the modeling framework, 17,409 participants aged 10-21 years were included in the analysis.

Longitudinal analyses revealed different developmental windows of sensitivity to social media during adolescence, with higher estimated social media use predicting lower life satisfaction scores 1 year later (regression coefficient [beta], −0.02; 95% confidence interval, −0.03 to −0.01; P = .004).

Among females, the researchers observed a window of sensitivity to social media between the ages of 11 and 13, with higher estimated social media use predicting lower life satisfaction ratings 1 year later (age 11: beta, −0.11; 95% CI, −0.21 to −0.02; P = .020; age 12: beta, −0.14; 95% CI, −0.22 to −0.07; P < .001; age 13: beta, −0.08; 95% CI, −0.15 to −0.01; P = .019).

Among males, a similar window was observed between the ages of 14 and 15 (age 14: beta, −0.10; 95% CI, −0.17 to −0.03; P = .005; age 15: beta, –0.18; 95% CI, −0.29 to −0.08; P = .001).

Furthermore, they showed that a later increase in sensitivity to social media, which was present at age 19 for both females and males, suggested a different underlying process was present in late adolescence (females: beta, −0.16; 95% CI, −0.25 to −0.07; P < .001; males: beta, −0.16; 95% CI, −0.26 to −0.07; P = .001).

“Speculatively, this might be related to changes in the social environment such as a move away from home and subsequent disruptions in social networks,” the researchers wrote.

Importantly, Dr. Orben and colleagues noted that these results should be interpreted with caution. Owing to the cross-sectional nature of the data, causality cannot be inferred from these findings.

“The findings reported here may enable investigation of potential mechanisms of interest, for example, in datasets with pubertal or additional social measurements,” they wrote. “One could also carry out more targeted investigations, for example, by examining the mental health measures only completed by select age ranges in the datasets.”
 

Digital literacy is important, expert says

“Digital literacy and education about social media use is warranted for all ages, starting young,” Yalda T. Uhls, MBA, PhD, of the department of psychology at the University of California, Los Angeles, said in an interview. “Attending to underlying issues for vulnerable ages, such as anxiety, as well as parental support is critical.”

“I would urge social media platforms to pay attention to what kinds of content they are making available to ensure the highest possible quality, and to embed things like suggestions for pauses and other ways to check in on someone who may be experiencing distress when on socials,” Dr. Uhls said. “We also need to increase access to mental health resources for young people and social media could help provide information for those experiencing issues.”

This study was supported by the University of Cambridge and the UK Medical Research Council. The authors reported no relevant disclosures. Dr. Uhls had no relevant disclosures.

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Cannabis exposure in pregnancy linked with childhood obesity

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Changed
Tue, 05/03/2022 - 15:01

There is a link between cannabis exposure during pregnancy and higher fasting glucose levels and adiposity in the offspring in early childhood, a new study suggests.

Research looking at the effect of prenatal exposure to cannabis on offspring is growing. It is known to affect childhood cognition and behavior; however, there is little work to date on how it affects metabolic outcomes, said lead author Brianna F. Moore, PhD.

“Officially, the American Academy of Obstetricians and Gynecologists recommends that women do not use cannabis during pregnancy or while breastfeeding to limit the effects on offspring. There’s really a lot we don’t know, but researchers across the country are starting to look into this more, and there are signs that it isn’t great for the offspring,” Dr. Moore, assistant professor at the Colorado School of Public Health in Aurora, said in an interview.

And she noted that while some women turn to cannabis to manage the challenging symptoms of pregnancy, “Clinicians should encourage pregnant women to refrain from using cannabis; it is best for these pregnant women to talk to their physicians about alternative ways of managing these symptoms.”

The findings were published online March 31 in the Journal of Clinical Endocrinology & Metabolism.
 

Study of mother and 5-year-old child pairs

The researchers assessed 103 sets of mothers and children from the Healthy Start study. At 27 weeks of gestation, the investigators assessed 12 metabolites of cannabis/cannabinoids in urine samples. Results from these samples were used to categorize fetal exposure to cannabis as either not exposed or exposed. They found that about 15% of the mothers had traceable amounts of cannabinoids, suggesting fetal cannabis exposure.

At follow-up, the study team assessed fat-free mass and fat mass using air displacement plethysmography among the offspring around age 5. They used generalized linear models to approximate the relationship between fetal exposure to cannabis with metabolic measures such as insulin, glucose, and homeostatic model assessment of insulin resistance (HOMA-IR), and adiposity measures such as body mass index, fat-free mass, fat mass, adiposity, and BMI z-scores.

The findings showed that, compared with nonexposed offspring, exposed offspring had greater:

  • Fasting glucose (5.6 mg/dL; 95% confidence interval [CI], 0.8-10.3).
  • Fat-free mass (1.2 kg; 95% CI, 0.4-2.0).
  • Fat mass (1.0 kg; 95% CI, 0.3-1.7).
  • Adiposity (2.6%; 95% CI, 0.1-5.2).

“This finding may suggest that fetal exposure to cannabis contributes to higher fasting glucose levels via a direct effect on the pancreatic β-cells. However, we cannot draw conclusions about β-cell response to glucose because we did not perform oral glucose tolerance tests,” the study authors wrote.

Notably, however, there was no relationship between BMI z-scores, BMI, or HOMA-IR and fasting insulin, the study team found.

Study limitations include the small sample size and lack of self-report data on cannabis use to differentiate between direct use and exposure to cannabis, Dr. Moore acknowledged.

Given the small sample size, the researchers were unable to look at dose-response, which future studies will focus on, Dr. Moore noted. Future efforts will also focus on comparing the effects of tetrahydrocannabinol (THC) and cannabidiol (CBD), Dr. Moore added.

“This is a relatively new field, so there’s still work to be done. This is just one study, and we need to study this more in other cohorts to confirm our findings,” she concluded.

Dr. Moore has reported no relevant financial relationships.

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

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There is a link between cannabis exposure during pregnancy and higher fasting glucose levels and adiposity in the offspring in early childhood, a new study suggests.

Research looking at the effect of prenatal exposure to cannabis on offspring is growing. It is known to affect childhood cognition and behavior; however, there is little work to date on how it affects metabolic outcomes, said lead author Brianna F. Moore, PhD.

“Officially, the American Academy of Obstetricians and Gynecologists recommends that women do not use cannabis during pregnancy or while breastfeeding to limit the effects on offspring. There’s really a lot we don’t know, but researchers across the country are starting to look into this more, and there are signs that it isn’t great for the offspring,” Dr. Moore, assistant professor at the Colorado School of Public Health in Aurora, said in an interview.

And she noted that while some women turn to cannabis to manage the challenging symptoms of pregnancy, “Clinicians should encourage pregnant women to refrain from using cannabis; it is best for these pregnant women to talk to their physicians about alternative ways of managing these symptoms.”

The findings were published online March 31 in the Journal of Clinical Endocrinology & Metabolism.
 

Study of mother and 5-year-old child pairs

The researchers assessed 103 sets of mothers and children from the Healthy Start study. At 27 weeks of gestation, the investigators assessed 12 metabolites of cannabis/cannabinoids in urine samples. Results from these samples were used to categorize fetal exposure to cannabis as either not exposed or exposed. They found that about 15% of the mothers had traceable amounts of cannabinoids, suggesting fetal cannabis exposure.

At follow-up, the study team assessed fat-free mass and fat mass using air displacement plethysmography among the offspring around age 5. They used generalized linear models to approximate the relationship between fetal exposure to cannabis with metabolic measures such as insulin, glucose, and homeostatic model assessment of insulin resistance (HOMA-IR), and adiposity measures such as body mass index, fat-free mass, fat mass, adiposity, and BMI z-scores.

The findings showed that, compared with nonexposed offspring, exposed offspring had greater:

  • Fasting glucose (5.6 mg/dL; 95% confidence interval [CI], 0.8-10.3).
  • Fat-free mass (1.2 kg; 95% CI, 0.4-2.0).
  • Fat mass (1.0 kg; 95% CI, 0.3-1.7).
  • Adiposity (2.6%; 95% CI, 0.1-5.2).

“This finding may suggest that fetal exposure to cannabis contributes to higher fasting glucose levels via a direct effect on the pancreatic β-cells. However, we cannot draw conclusions about β-cell response to glucose because we did not perform oral glucose tolerance tests,” the study authors wrote.

Notably, however, there was no relationship between BMI z-scores, BMI, or HOMA-IR and fasting insulin, the study team found.

Study limitations include the small sample size and lack of self-report data on cannabis use to differentiate between direct use and exposure to cannabis, Dr. Moore acknowledged.

Given the small sample size, the researchers were unable to look at dose-response, which future studies will focus on, Dr. Moore noted. Future efforts will also focus on comparing the effects of tetrahydrocannabinol (THC) and cannabidiol (CBD), Dr. Moore added.

“This is a relatively new field, so there’s still work to be done. This is just one study, and we need to study this more in other cohorts to confirm our findings,” she concluded.

Dr. Moore has reported no relevant financial relationships.

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

There is a link between cannabis exposure during pregnancy and higher fasting glucose levels and adiposity in the offspring in early childhood, a new study suggests.

Research looking at the effect of prenatal exposure to cannabis on offspring is growing. It is known to affect childhood cognition and behavior; however, there is little work to date on how it affects metabolic outcomes, said lead author Brianna F. Moore, PhD.

“Officially, the American Academy of Obstetricians and Gynecologists recommends that women do not use cannabis during pregnancy or while breastfeeding to limit the effects on offspring. There’s really a lot we don’t know, but researchers across the country are starting to look into this more, and there are signs that it isn’t great for the offspring,” Dr. Moore, assistant professor at the Colorado School of Public Health in Aurora, said in an interview.

And she noted that while some women turn to cannabis to manage the challenging symptoms of pregnancy, “Clinicians should encourage pregnant women to refrain from using cannabis; it is best for these pregnant women to talk to their physicians about alternative ways of managing these symptoms.”

The findings were published online March 31 in the Journal of Clinical Endocrinology & Metabolism.
 

Study of mother and 5-year-old child pairs

The researchers assessed 103 sets of mothers and children from the Healthy Start study. At 27 weeks of gestation, the investigators assessed 12 metabolites of cannabis/cannabinoids in urine samples. Results from these samples were used to categorize fetal exposure to cannabis as either not exposed or exposed. They found that about 15% of the mothers had traceable amounts of cannabinoids, suggesting fetal cannabis exposure.

At follow-up, the study team assessed fat-free mass and fat mass using air displacement plethysmography among the offspring around age 5. They used generalized linear models to approximate the relationship between fetal exposure to cannabis with metabolic measures such as insulin, glucose, and homeostatic model assessment of insulin resistance (HOMA-IR), and adiposity measures such as body mass index, fat-free mass, fat mass, adiposity, and BMI z-scores.

The findings showed that, compared with nonexposed offspring, exposed offspring had greater:

  • Fasting glucose (5.6 mg/dL; 95% confidence interval [CI], 0.8-10.3).
  • Fat-free mass (1.2 kg; 95% CI, 0.4-2.0).
  • Fat mass (1.0 kg; 95% CI, 0.3-1.7).
  • Adiposity (2.6%; 95% CI, 0.1-5.2).

“This finding may suggest that fetal exposure to cannabis contributes to higher fasting glucose levels via a direct effect on the pancreatic β-cells. However, we cannot draw conclusions about β-cell response to glucose because we did not perform oral glucose tolerance tests,” the study authors wrote.

Notably, however, there was no relationship between BMI z-scores, BMI, or HOMA-IR and fasting insulin, the study team found.

Study limitations include the small sample size and lack of self-report data on cannabis use to differentiate between direct use and exposure to cannabis, Dr. Moore acknowledged.

Given the small sample size, the researchers were unable to look at dose-response, which future studies will focus on, Dr. Moore noted. Future efforts will also focus on comparing the effects of tetrahydrocannabinol (THC) and cannabidiol (CBD), Dr. Moore added.

“This is a relatively new field, so there’s still work to be done. This is just one study, and we need to study this more in other cohorts to confirm our findings,” she concluded.

Dr. Moore has reported no relevant financial relationships.

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

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Fingers take the fight to COVID-19

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Changed
Thu, 03/31/2022 - 12:45

 

Pointing a finger at COVID-19

The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.

Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.

PxHere

According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.

The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
 

Some emergencies need a superhero

Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.

Richard Browning/Gravity Industries

The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.

GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.

“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.

So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
 

 

 

Why we’re rejecting food as medicine

Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.

phototake/ThinkStock

First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.

Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!

To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.

So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
 

Being rude is a good thing, apparently

If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.

Piqsels

The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.

“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.

You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!

At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.

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Pointing a finger at COVID-19

The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.

Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.

PxHere

According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.

The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
 

Some emergencies need a superhero

Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.

Richard Browning/Gravity Industries

The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.

GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.

“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.

So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
 

 

 

Why we’re rejecting food as medicine

Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.

phototake/ThinkStock

First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.

Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!

To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.

So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
 

Being rude is a good thing, apparently

If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.

Piqsels

The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.

“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.

You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!

At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.

 

Pointing a finger at COVID-19

The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.

Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.

PxHere

According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.

The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
 

Some emergencies need a superhero

Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.

Richard Browning/Gravity Industries

The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.

GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.

“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.

So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
 

 

 

Why we’re rejecting food as medicine

Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.

phototake/ThinkStock

First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.

Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!

To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.

So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
 

Being rude is a good thing, apparently

If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.

Piqsels

The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.

“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.

You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!

At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.

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Does evidence support benefits of omega-3 fatty acids?

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Fri, 04/01/2022 - 08:59

 

Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

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Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

 

Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

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Late to the game: Parenting after 40

Article Type
Changed
Thu, 03/31/2022 - 09:27

 

As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

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As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

 

As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

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