In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

PHOENIX – During the incidental treatment of melanocytic nevi during laser hair removal, common clinical changes include regression and decreased size, while common histologic changes include mild atypia and thermal damage, according to results from a systematic review of literature on the topic. To date, no severe cases of severe dysplasia or melanoma have been reported.

“That’s reassuring,” study author Ahuva Cices, MD, said in an interview at the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. “But, with that in mind, we want to avoid treating nevi with laser hair removal to avoid changes that could be concerning. We also recommend baseline skin exams so we know what we’re looking at before we start treating with lasers, and any changes can be recognized from that baseline status. It’s important to keep an eye out for changes and always be evaluating.”

Doug Brunk/MDedge News

In December of 2022, Dr. Cices, chief dermatology resident at Mount Sinai Health System, New York, searched PubMed for articles that evaluated changes in melanocytic nevi after laser hair removal procedures. She used the search terms “nevi laser hair removal,” “nevi diode,” “nevi long pulse alexandrite,” “nevi long pulse neodymium doped yttrium aluminum garnet,” and “melanoma laser hair removal,” and limited the analysis to English language patient-based reports that discussed incidental treatment of melanocytic nevi while undergoing hair removal with a laser.

Reports excluded from the analysis were those that focused on changes following hair removal with nonlaser devices such as intense pulsed light (IPL), those evaluating nonmelanocytic nevi such as Becker’s nevus or nevus of Ota, and those evaluating the intentional ablation or removal of melanocytic lesions.

The search yielded 10 relevant studies for systematic review: seven case reports or series and three observational trials, two of which were prospective and one retrospective.

The results of the review, according to Dr. Cices, revealed that clinical and dermoscopic changes were noted to present as early as 15 days after treatment and persist to the maximum follow up time, at 3 years. Commonly reported changes included regression, decreased size, laser-induced asymmetry, bleaching, darkening, and altered pattern on dermoscopy. Histologic changes included mild atypia, thermal damage, scar formation, and regression.

“Although some of the clinical and dermoscopic alterations may be concerning for malignancy, to our knowledge, there are no documented cases of malignant transformation of nevi following treatment with laser hair removal,” she wrote in the abstract.

Dr. Cices acknowledged certain limitations of the systematic review, including the low number of relevant reports and their generally small sample size, many of which were limited to single cases.

Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, who was asked to comment on the review, characterized the findings as important because laser hair removal is such a commonly performed procedure.

While the study is limited by the small number of studies on the subject matter, “it brings up an important discussion,” Dr. Ibrahimi said in an interview. “Generally speaking, we know that most hair removal lasers do indeed target melanin pigment and can be absorbed by melanocytes. While the wavelengths used for LHR [laser hair removal] will not result in DNA damage or cause mutations that can lead to melanoma, they can sometimes alter the appearance of pigmented lesions and that may change the dermatologist’s ability to monitor them for atypia,” he noted.

“For that reason, I would recommend all patients see a dermatologist for evaluation of their nevi prior to any treatments and they consider very carefully where they get their laser treatments. If they have any atypical pigmented lesions, then that information should be disclosed with the person performing the laser hair removal procedure particularly if there are lesions that are being specifically monitored.”

Dr. Cices reported having no disclosures. Dr. Ibrahimi disclosed that he is a member of the advisory board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

PHOENIX – During the incidental treatment of melanocytic nevi during laser hair removal, common clinical changes include regression and decreased size, while common histologic changes include mild atypia and thermal damage, according to results from a systematic review of literature on the topic. To date, no severe cases of severe dysplasia or melanoma have been reported.

“That’s reassuring,” study author Ahuva Cices, MD, said in an interview at the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. “But, with that in mind, we want to avoid treating nevi with laser hair removal to avoid changes that could be concerning. We also recommend baseline skin exams so we know what we’re looking at before we start treating with lasers, and any changes can be recognized from that baseline status. It’s important to keep an eye out for changes and always be evaluating.”

Doug Brunk/MDedge News

In December of 2022, Dr. Cices, chief dermatology resident at Mount Sinai Health System, New York, searched PubMed for articles that evaluated changes in melanocytic nevi after laser hair removal procedures. She used the search terms “nevi laser hair removal,” “nevi diode,” “nevi long pulse alexandrite,” “nevi long pulse neodymium doped yttrium aluminum garnet,” and “melanoma laser hair removal,” and limited the analysis to English language patient-based reports that discussed incidental treatment of melanocytic nevi while undergoing hair removal with a laser.

Reports excluded from the analysis were those that focused on changes following hair removal with nonlaser devices such as intense pulsed light (IPL), those evaluating nonmelanocytic nevi such as Becker’s nevus or nevus of Ota, and those evaluating the intentional ablation or removal of melanocytic lesions.

The search yielded 10 relevant studies for systematic review: seven case reports or series and three observational trials, two of which were prospective and one retrospective.

The results of the review, according to Dr. Cices, revealed that clinical and dermoscopic changes were noted to present as early as 15 days after treatment and persist to the maximum follow up time, at 3 years. Commonly reported changes included regression, decreased size, laser-induced asymmetry, bleaching, darkening, and altered pattern on dermoscopy. Histologic changes included mild atypia, thermal damage, scar formation, and regression.

“Although some of the clinical and dermoscopic alterations may be concerning for malignancy, to our knowledge, there are no documented cases of malignant transformation of nevi following treatment with laser hair removal,” she wrote in the abstract.

Dr. Cices acknowledged certain limitations of the systematic review, including the low number of relevant reports and their generally small sample size, many of which were limited to single cases.

Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, who was asked to comment on the review, characterized the findings as important because laser hair removal is such a commonly performed procedure.

While the study is limited by the small number of studies on the subject matter, “it brings up an important discussion,” Dr. Ibrahimi said in an interview. “Generally speaking, we know that most hair removal lasers do indeed target melanin pigment and can be absorbed by melanocytes. While the wavelengths used for LHR [laser hair removal] will not result in DNA damage or cause mutations that can lead to melanoma, they can sometimes alter the appearance of pigmented lesions and that may change the dermatologist’s ability to monitor them for atypia,” he noted.

“For that reason, I would recommend all patients see a dermatologist for evaluation of their nevi prior to any treatments and they consider very carefully where they get their laser treatments. If they have any atypical pigmented lesions, then that information should be disclosed with the person performing the laser hair removal procedure particularly if there are lesions that are being specifically monitored.”

Dr. Cices reported having no disclosures. Dr. Ibrahimi disclosed that he is a member of the advisory board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

PHOENIX – During the incidental treatment of melanocytic nevi during laser hair removal, common clinical changes include regression and decreased size, while common histologic changes include mild atypia and thermal damage, according to results from a systematic review of literature on the topic. To date, no severe cases of severe dysplasia or melanoma have been reported.

“That’s reassuring,” study author Ahuva Cices, MD, said in an interview at the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. “But, with that in mind, we want to avoid treating nevi with laser hair removal to avoid changes that could be concerning. We also recommend baseline skin exams so we know what we’re looking at before we start treating with lasers, and any changes can be recognized from that baseline status. It’s important to keep an eye out for changes and always be evaluating.”

Doug Brunk/MDedge News

In December of 2022, Dr. Cices, chief dermatology resident at Mount Sinai Health System, New York, searched PubMed for articles that evaluated changes in melanocytic nevi after laser hair removal procedures. She used the search terms “nevi laser hair removal,” “nevi diode,” “nevi long pulse alexandrite,” “nevi long pulse neodymium doped yttrium aluminum garnet,” and “melanoma laser hair removal,” and limited the analysis to English language patient-based reports that discussed incidental treatment of melanocytic nevi while undergoing hair removal with a laser.

Reports excluded from the analysis were those that focused on changes following hair removal with nonlaser devices such as intense pulsed light (IPL), those evaluating nonmelanocytic nevi such as Becker’s nevus or nevus of Ota, and those evaluating the intentional ablation or removal of melanocytic lesions.

The search yielded 10 relevant studies for systematic review: seven case reports or series and three observational trials, two of which were prospective and one retrospective.

The results of the review, according to Dr. Cices, revealed that clinical and dermoscopic changes were noted to present as early as 15 days after treatment and persist to the maximum follow up time, at 3 years. Commonly reported changes included regression, decreased size, laser-induced asymmetry, bleaching, darkening, and altered pattern on dermoscopy. Histologic changes included mild atypia, thermal damage, scar formation, and regression.

“Although some of the clinical and dermoscopic alterations may be concerning for malignancy, to our knowledge, there are no documented cases of malignant transformation of nevi following treatment with laser hair removal,” she wrote in the abstract.

Dr. Cices acknowledged certain limitations of the systematic review, including the low number of relevant reports and their generally small sample size, many of which were limited to single cases.

Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, who was asked to comment on the review, characterized the findings as important because laser hair removal is such a commonly performed procedure.

While the study is limited by the small number of studies on the subject matter, “it brings up an important discussion,” Dr. Ibrahimi said in an interview. “Generally speaking, we know that most hair removal lasers do indeed target melanin pigment and can be absorbed by melanocytes. While the wavelengths used for LHR [laser hair removal] will not result in DNA damage or cause mutations that can lead to melanoma, they can sometimes alter the appearance of pigmented lesions and that may change the dermatologist’s ability to monitor them for atypia,” he noted.

“For that reason, I would recommend all patients see a dermatologist for evaluation of their nevi prior to any treatments and they consider very carefully where they get their laser treatments. If they have any atypical pigmented lesions, then that information should be disclosed with the person performing the laser hair removal procedure particularly if there are lesions that are being specifically monitored.”

Dr. Cices reported having no disclosures. Dr. Ibrahimi disclosed that he is a member of the advisory board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

Vishnu Kumar/Thinkstock

“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

Vishnu Kumar/Thinkstock

“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

Vishnu Kumar/Thinkstock

“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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

Contrary to popular belief, an infant’s gut microbiome is not primarily shaped by the mother’s vaginal microbiome, results of a new study indicate. The findings suggest that practices such as vaginal seeding are ineffective.

A longitudinal, prospective cohort study of more than 600 pregnant Canadian women and their newborns showed significant differences in an infant’s stool composition by delivery mode at 10 days post partum, but the differences could not be explained by the mother’s vaginal microbiome, and they effectively disappeared by 3 months.

Henry Wells

The findings were surprising, Scott Dos Santos, a PhD candidate at the University of Saskatchewan in Saskatoon, told this news organization. “The bacteria living in the maternal vagina are the first microbes that vaginally delivered infants are exposed to. … so it sounds intuitive that different kinds of vaginal microbiomes could end up influencing the development of a baby’s gut microbiome in different ways. But the maternal vaginal microbiome didn’t seem to have any role in predicting what the infant stool microbiome looked like.”

Therefore, women should not be concerned about cesarean delivery having an adverse effect on their baby’s gut microbiome, said Mr. Dos Santos. Moreover, “vaginal seeding is not safe or advised. Professional bodies, including the Society of Obstetricians and Gynecologists of Canada and the American College of Obstetricians and Gynecologists, strongly advise against this practice.”

The study was published online in Frontiers in Cellular and Infection Microbiology.
 

Independent communities

The investigators analyzed vaginal and stool microbiome profiles from 442 mother-infant dyads. The mothers were healthy, low-risk women who delivered at term. They were recruited into the Maternal Microbiome LEGACY Project from three hospitals in British Columbia.

The mean age of the mothers at delivery was 34.6 years, which is typical of the study hospitals’ delivery populations. Participants identified themselves as White (54.7%), Asian (21.2%), South Asian (8.3%), and of other ethnicities.

A nurse, midwife, or clinician collected maternal vaginal swabs of the posterior fornix and lateral vaginal wall at first presentation to the labor and delivery area. Neonatal meconium, which was defined as the first stool specimen collected within 72 hours of birth, and two infant stool samples were collected at follow-up visits at 10 days and 3 months post partum.

A principal component analysis of infant stool microbiomes showed no significant clustering of microbiome profiles at 10 days or 3 months by maternal community state types (that is, microbial species).

Correspondence analyses also showed no coclustering of maternal and infant clusters at either time. In addition, there were no differences in the distribution of maternal vaginal microbiome clusters among infant stool microbiome clusters, regardless of delivery mode.

Vaginal microbiome clusters were distributed across infant stool clusters in proportion to their frequency in the overall maternal population, indicating that the two communities were independent of each other.

Intrapartum antibiotic administration was identified as a confounder of infant stool microbiome differences and was associated with lower abundances of Escherichia coli, Bacteroides vulgatus, Bifidobacterium longum, and Parabacteroides distasonis.

“Our findings demonstrate that maternal vaginal microbiome composition at delivery does not affect infant stool microbiome composition and development, suggesting that practices to amend infant stool microbiome composition focus on factors other than maternal vaginal microbes,” the authors conclude.
 

More evidence needed

Commenting on the study, Emily H. Adhikari, MD, assistant professor of obstetrics and gynecology at UT Southwestern Medical Center in Dallas, and medical director of perinatal infectious diseases for the Parkland Health and Hospital System, said, “These findings contribute significantly more data to an understudied area of research into factors that affect the infant gut microbiome from the earliest hours of life. Prior studies have been small and often conflicting, and the authors reference recent larger studies, which corroborate their findings.”

UT Southwestern Medical Center

The data regarding whether delivery mode or antibiotic-associated differences in infant microbiomes persist remain controversial, said Dr. Adhikari. “More evidence is needed involving a more ethnically diverse sampling of patients.” In addition, prospectively evaluating vaginal seeding in a rigorously designed clinical trial setting is “imperative to understand any potential benefit and certainly to understand the potential harms of the practice. To date, this does not exist.”

The study was funded by a Canadian Institutes of Health Research grant. Mr. Dos Santos and Dr. Adhikari have disclosed no relevant financial relationships.

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

Contrary to popular belief, an infant’s gut microbiome is not primarily shaped by the mother’s vaginal microbiome, results of a new study indicate. The findings suggest that practices such as vaginal seeding are ineffective.

A longitudinal, prospective cohort study of more than 600 pregnant Canadian women and their newborns showed significant differences in an infant’s stool composition by delivery mode at 10 days post partum, but the differences could not be explained by the mother’s vaginal microbiome, and they effectively disappeared by 3 months.

Henry Wells

The findings were surprising, Scott Dos Santos, a PhD candidate at the University of Saskatchewan in Saskatoon, told this news organization. “The bacteria living in the maternal vagina are the first microbes that vaginally delivered infants are exposed to. … so it sounds intuitive that different kinds of vaginal microbiomes could end up influencing the development of a baby’s gut microbiome in different ways. But the maternal vaginal microbiome didn’t seem to have any role in predicting what the infant stool microbiome looked like.”

Therefore, women should not be concerned about cesarean delivery having an adverse effect on their baby’s gut microbiome, said Mr. Dos Santos. Moreover, “vaginal seeding is not safe or advised. Professional bodies, including the Society of Obstetricians and Gynecologists of Canada and the American College of Obstetricians and Gynecologists, strongly advise against this practice.”

The study was published online in Frontiers in Cellular and Infection Microbiology.
 

Independent communities

The investigators analyzed vaginal and stool microbiome profiles from 442 mother-infant dyads. The mothers were healthy, low-risk women who delivered at term. They were recruited into the Maternal Microbiome LEGACY Project from three hospitals in British Columbia.

The mean age of the mothers at delivery was 34.6 years, which is typical of the study hospitals’ delivery populations. Participants identified themselves as White (54.7%), Asian (21.2%), South Asian (8.3%), and of other ethnicities.

A nurse, midwife, or clinician collected maternal vaginal swabs of the posterior fornix and lateral vaginal wall at first presentation to the labor and delivery area. Neonatal meconium, which was defined as the first stool specimen collected within 72 hours of birth, and two infant stool samples were collected at follow-up visits at 10 days and 3 months post partum.

A principal component analysis of infant stool microbiomes showed no significant clustering of microbiome profiles at 10 days or 3 months by maternal community state types (that is, microbial species).

Correspondence analyses also showed no coclustering of maternal and infant clusters at either time. In addition, there were no differences in the distribution of maternal vaginal microbiome clusters among infant stool microbiome clusters, regardless of delivery mode.

Vaginal microbiome clusters were distributed across infant stool clusters in proportion to their frequency in the overall maternal population, indicating that the two communities were independent of each other.

Intrapartum antibiotic administration was identified as a confounder of infant stool microbiome differences and was associated with lower abundances of Escherichia coli, Bacteroides vulgatus, Bifidobacterium longum, and Parabacteroides distasonis.

“Our findings demonstrate that maternal vaginal microbiome composition at delivery does not affect infant stool microbiome composition and development, suggesting that practices to amend infant stool microbiome composition focus on factors other than maternal vaginal microbes,” the authors conclude.
 

More evidence needed

Commenting on the study, Emily H. Adhikari, MD, assistant professor of obstetrics and gynecology at UT Southwestern Medical Center in Dallas, and medical director of perinatal infectious diseases for the Parkland Health and Hospital System, said, “These findings contribute significantly more data to an understudied area of research into factors that affect the infant gut microbiome from the earliest hours of life. Prior studies have been small and often conflicting, and the authors reference recent larger studies, which corroborate their findings.”

UT Southwestern Medical Center

The data regarding whether delivery mode or antibiotic-associated differences in infant microbiomes persist remain controversial, said Dr. Adhikari. “More evidence is needed involving a more ethnically diverse sampling of patients.” In addition, prospectively evaluating vaginal seeding in a rigorously designed clinical trial setting is “imperative to understand any potential benefit and certainly to understand the potential harms of the practice. To date, this does not exist.”

The study was funded by a Canadian Institutes of Health Research grant. Mr. Dos Santos and Dr. Adhikari have disclosed no relevant financial relationships.

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

Contrary to popular belief, an infant’s gut microbiome is not primarily shaped by the mother’s vaginal microbiome, results of a new study indicate. The findings suggest that practices such as vaginal seeding are ineffective.

A longitudinal, prospective cohort study of more than 600 pregnant Canadian women and their newborns showed significant differences in an infant’s stool composition by delivery mode at 10 days post partum, but the differences could not be explained by the mother’s vaginal microbiome, and they effectively disappeared by 3 months.

Henry Wells

The findings were surprising, Scott Dos Santos, a PhD candidate at the University of Saskatchewan in Saskatoon, told this news organization. “The bacteria living in the maternal vagina are the first microbes that vaginally delivered infants are exposed to. … so it sounds intuitive that different kinds of vaginal microbiomes could end up influencing the development of a baby’s gut microbiome in different ways. But the maternal vaginal microbiome didn’t seem to have any role in predicting what the infant stool microbiome looked like.”

Therefore, women should not be concerned about cesarean delivery having an adverse effect on their baby’s gut microbiome, said Mr. Dos Santos. Moreover, “vaginal seeding is not safe or advised. Professional bodies, including the Society of Obstetricians and Gynecologists of Canada and the American College of Obstetricians and Gynecologists, strongly advise against this practice.”

The study was published online in Frontiers in Cellular and Infection Microbiology.
 

Independent communities

The investigators analyzed vaginal and stool microbiome profiles from 442 mother-infant dyads. The mothers were healthy, low-risk women who delivered at term. They were recruited into the Maternal Microbiome LEGACY Project from three hospitals in British Columbia.

The mean age of the mothers at delivery was 34.6 years, which is typical of the study hospitals’ delivery populations. Participants identified themselves as White (54.7%), Asian (21.2%), South Asian (8.3%), and of other ethnicities.

A nurse, midwife, or clinician collected maternal vaginal swabs of the posterior fornix and lateral vaginal wall at first presentation to the labor and delivery area. Neonatal meconium, which was defined as the first stool specimen collected within 72 hours of birth, and two infant stool samples were collected at follow-up visits at 10 days and 3 months post partum.

A principal component analysis of infant stool microbiomes showed no significant clustering of microbiome profiles at 10 days or 3 months by maternal community state types (that is, microbial species).

Correspondence analyses also showed no coclustering of maternal and infant clusters at either time. In addition, there were no differences in the distribution of maternal vaginal microbiome clusters among infant stool microbiome clusters, regardless of delivery mode.

Vaginal microbiome clusters were distributed across infant stool clusters in proportion to their frequency in the overall maternal population, indicating that the two communities were independent of each other.

Intrapartum antibiotic administration was identified as a confounder of infant stool microbiome differences and was associated with lower abundances of Escherichia coli, Bacteroides vulgatus, Bifidobacterium longum, and Parabacteroides distasonis.

“Our findings demonstrate that maternal vaginal microbiome composition at delivery does not affect infant stool microbiome composition and development, suggesting that practices to amend infant stool microbiome composition focus on factors other than maternal vaginal microbes,” the authors conclude.
 

More evidence needed

Commenting on the study, Emily H. Adhikari, MD, assistant professor of obstetrics and gynecology at UT Southwestern Medical Center in Dallas, and medical director of perinatal infectious diseases for the Parkland Health and Hospital System, said, “These findings contribute significantly more data to an understudied area of research into factors that affect the infant gut microbiome from the earliest hours of life. Prior studies have been small and often conflicting, and the authors reference recent larger studies, which corroborate their findings.”

UT Southwestern Medical Center

The data regarding whether delivery mode or antibiotic-associated differences in infant microbiomes persist remain controversial, said Dr. Adhikari. “More evidence is needed involving a more ethnically diverse sampling of patients.” In addition, prospectively evaluating vaginal seeding in a rigorously designed clinical trial setting is “imperative to understand any potential benefit and certainly to understand the potential harms of the practice. To date, this does not exist.”

The study was funded by a Canadian Institutes of Health Research grant. Mr. Dos Santos and Dr. Adhikari have disclosed no relevant financial relationships.

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

Memantine, a drug typically used to treat symptoms of Alzheimer’s disease, is linked to a significant reduction in symptoms of trichotillomania and skin-picking disorder, new research shows.

Results from the double-blind, placebo-controlled trial showed that 61% of participants who received memantine were “much or very much improved,” versus 8% in the placebo group.

“Memantine was far more effective than placebo,” lead investigator Jon Grant, MD, MPH, professor of psychiatry and behavioral neuroscience at the University of Chicago, said in an interview. “However, while subjects responded favorably, that didn’t necessarily mean there were no symptoms.”

The study was published online  in the American Journal of Psychiatry.
 

Underrecognized, disabling

The investigators noted that trichotillomania and skin-picking disorder are underrecognized and are often disabling conditions. However, the researchers pointed out that with prevalence rates of 1.7% for trichotillomania and 2.1% for skin-picking disorder, they are not uncommon.

Behavioral therapy that attempts to reverse these habits is considered first-line treatment, but trained therapists are difficult to find. In addition, the investigators wrote that currently, there are no Food and Drug Administration–approved medications for either disorder, and pharmacologic clinical trials are relatively uncommon.

The existing data from double-blind, placebo-controlled studies support the use of the antipsychotic olanzapine, the tricyclic antidepressant clomipramine, and the supplement N-acetyl-L-cysteine (NAC). Dr. Grant also noted that previous drug trials involving patients with trichotillomania have been very short in duration.

Prior research has implicated the glutamate system in repetitive motor habits and the urges that drive them. Memantine, a glutamate receptor antagonist, targets excessive glutamatergic drive. To investigate whether this medication may be beneficial for patients with trichotillomania and skin-picking disorders, the investigators conducted a randomized placebo-controlled trial.

The study included 100 adults (86 women; mean age, 31.4) with trichotillomania, skin-picking disorder, or both; participants received memantine (n = 55) or placebo (n = 45) for 8 weeks; they received memantine 10 mg or placebo for the first 2 weeks, then 20 mg for the next 6 weeks.

The researchers, who were blinded to assignment, assessed participants every 2 weeks using the National Institute of Mental Health Trichotillomania Symptom Severity Scale, which was modified to include questions for skin-picking disorder.

The team also tracked symptoms and behaviors using additional scales, including the Sheehan Disability Scale and the Clinical Global Impressions severity scale.

At the study’s conclusion, 79 patients remained. Of those, 26 of the 43 participants in the memantine group were “very much” or “much” improved (61%), versus 3 of 36 (8%) in the placebo group. (P < .0001)

Six participants in the memantine group experienced complete remission of symptoms, compared with one in the placebo group. There were no differences between the study groups in terms of adverse events.

Study limitations included the relatively short length of the trial for what should be considered a chronic disease, as well as the inclusion of only mildly to moderately symptomatic participants.

Dr. Grant said that he would like to study how memantine works in combination with behavioral therapy.
 

‘Two great options’

Katharine Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, said she has been using memantine for “quite some time” to treat her patients with skin-picking disorder, adding that she uses higher doses of the drug than were tested in the study.

She noted that both NAC and memantine affect glutamate, an amino acid in the brain that is likely involved in repetitive physical or motor habits, such as hair pulling and skin picking.

“The good news is that we have two great options” for the treatment of trichotillomania and skin-picking disorder, said Dr. Phillips, and that both are easy to tolerate.

Future research should focus on longer trials of memantine and at higher doses, as well as other glutamate modulators, she said.

The study was funded by departmental research funds at the University of Chicago. Dr. Grant reported receiving research funding from Biohaven Pharmaceuticals and Janssen, as well as yearly compensation from Springer Publishing for his role as editor-in-chief of the Journal of Gambling Studies. He has also received royalties from American Psychiatric Publishing, McGraw Hill, Oxford University Press, and WW Norton. Dr. Phillips reported receiving royalties from American Psychiatric Publishing and an honorarium from the Merck Manual.

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

Memantine, a drug typically used to treat symptoms of Alzheimer’s disease, is linked to a significant reduction in symptoms of trichotillomania and skin-picking disorder, new research shows.

Results from the double-blind, placebo-controlled trial showed that 61% of participants who received memantine were “much or very much improved,” versus 8% in the placebo group.

“Memantine was far more effective than placebo,” lead investigator Jon Grant, MD, MPH, professor of psychiatry and behavioral neuroscience at the University of Chicago, said in an interview. “However, while subjects responded favorably, that didn’t necessarily mean there were no symptoms.”

The study was published online  in the American Journal of Psychiatry.
 

Underrecognized, disabling

The investigators noted that trichotillomania and skin-picking disorder are underrecognized and are often disabling conditions. However, the researchers pointed out that with prevalence rates of 1.7% for trichotillomania and 2.1% for skin-picking disorder, they are not uncommon.

Behavioral therapy that attempts to reverse these habits is considered first-line treatment, but trained therapists are difficult to find. In addition, the investigators wrote that currently, there are no Food and Drug Administration–approved medications for either disorder, and pharmacologic clinical trials are relatively uncommon.

The existing data from double-blind, placebo-controlled studies support the use of the antipsychotic olanzapine, the tricyclic antidepressant clomipramine, and the supplement N-acetyl-L-cysteine (NAC). Dr. Grant also noted that previous drug trials involving patients with trichotillomania have been very short in duration.

Prior research has implicated the glutamate system in repetitive motor habits and the urges that drive them. Memantine, a glutamate receptor antagonist, targets excessive glutamatergic drive. To investigate whether this medication may be beneficial for patients with trichotillomania and skin-picking disorders, the investigators conducted a randomized placebo-controlled trial.

The study included 100 adults (86 women; mean age, 31.4) with trichotillomania, skin-picking disorder, or both; participants received memantine (n = 55) or placebo (n = 45) for 8 weeks; they received memantine 10 mg or placebo for the first 2 weeks, then 20 mg for the next 6 weeks.

The researchers, who were blinded to assignment, assessed participants every 2 weeks using the National Institute of Mental Health Trichotillomania Symptom Severity Scale, which was modified to include questions for skin-picking disorder.

The team also tracked symptoms and behaviors using additional scales, including the Sheehan Disability Scale and the Clinical Global Impressions severity scale.

At the study’s conclusion, 79 patients remained. Of those, 26 of the 43 participants in the memantine group were “very much” or “much” improved (61%), versus 3 of 36 (8%) in the placebo group. (P < .0001)

Six participants in the memantine group experienced complete remission of symptoms, compared with one in the placebo group. There were no differences between the study groups in terms of adverse events.

Study limitations included the relatively short length of the trial for what should be considered a chronic disease, as well as the inclusion of only mildly to moderately symptomatic participants.

Dr. Grant said that he would like to study how memantine works in combination with behavioral therapy.
 

‘Two great options’

Katharine Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, said she has been using memantine for “quite some time” to treat her patients with skin-picking disorder, adding that she uses higher doses of the drug than were tested in the study.

She noted that both NAC and memantine affect glutamate, an amino acid in the brain that is likely involved in repetitive physical or motor habits, such as hair pulling and skin picking.

“The good news is that we have two great options” for the treatment of trichotillomania and skin-picking disorder, said Dr. Phillips, and that both are easy to tolerate.

Future research should focus on longer trials of memantine and at higher doses, as well as other glutamate modulators, she said.

The study was funded by departmental research funds at the University of Chicago. Dr. Grant reported receiving research funding from Biohaven Pharmaceuticals and Janssen, as well as yearly compensation from Springer Publishing for his role as editor-in-chief of the Journal of Gambling Studies. He has also received royalties from American Psychiatric Publishing, McGraw Hill, Oxford University Press, and WW Norton. Dr. Phillips reported receiving royalties from American Psychiatric Publishing and an honorarium from the Merck Manual.

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

Memantine, a drug typically used to treat symptoms of Alzheimer’s disease, is linked to a significant reduction in symptoms of trichotillomania and skin-picking disorder, new research shows.

Results from the double-blind, placebo-controlled trial showed that 61% of participants who received memantine were “much or very much improved,” versus 8% in the placebo group.

“Memantine was far more effective than placebo,” lead investigator Jon Grant, MD, MPH, professor of psychiatry and behavioral neuroscience at the University of Chicago, said in an interview. “However, while subjects responded favorably, that didn’t necessarily mean there were no symptoms.”

The study was published online  in the American Journal of Psychiatry.
 

Underrecognized, disabling

The investigators noted that trichotillomania and skin-picking disorder are underrecognized and are often disabling conditions. However, the researchers pointed out that with prevalence rates of 1.7% for trichotillomania and 2.1% for skin-picking disorder, they are not uncommon.

Behavioral therapy that attempts to reverse these habits is considered first-line treatment, but trained therapists are difficult to find. In addition, the investigators wrote that currently, there are no Food and Drug Administration–approved medications for either disorder, and pharmacologic clinical trials are relatively uncommon.

The existing data from double-blind, placebo-controlled studies support the use of the antipsychotic olanzapine, the tricyclic antidepressant clomipramine, and the supplement N-acetyl-L-cysteine (NAC). Dr. Grant also noted that previous drug trials involving patients with trichotillomania have been very short in duration.

Prior research has implicated the glutamate system in repetitive motor habits and the urges that drive them. Memantine, a glutamate receptor antagonist, targets excessive glutamatergic drive. To investigate whether this medication may be beneficial for patients with trichotillomania and skin-picking disorders, the investigators conducted a randomized placebo-controlled trial.

The study included 100 adults (86 women; mean age, 31.4) with trichotillomania, skin-picking disorder, or both; participants received memantine (n = 55) or placebo (n = 45) for 8 weeks; they received memantine 10 mg or placebo for the first 2 weeks, then 20 mg for the next 6 weeks.

The researchers, who were blinded to assignment, assessed participants every 2 weeks using the National Institute of Mental Health Trichotillomania Symptom Severity Scale, which was modified to include questions for skin-picking disorder.

The team also tracked symptoms and behaviors using additional scales, including the Sheehan Disability Scale and the Clinical Global Impressions severity scale.

At the study’s conclusion, 79 patients remained. Of those, 26 of the 43 participants in the memantine group were “very much” or “much” improved (61%), versus 3 of 36 (8%) in the placebo group. (P < .0001)

Six participants in the memantine group experienced complete remission of symptoms, compared with one in the placebo group. There were no differences between the study groups in terms of adverse events.

Study limitations included the relatively short length of the trial for what should be considered a chronic disease, as well as the inclusion of only mildly to moderately symptomatic participants.

Dr. Grant said that he would like to study how memantine works in combination with behavioral therapy.
 

‘Two great options’

Katharine Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, said she has been using memantine for “quite some time” to treat her patients with skin-picking disorder, adding that she uses higher doses of the drug than were tested in the study.

She noted that both NAC and memantine affect glutamate, an amino acid in the brain that is likely involved in repetitive physical or motor habits, such as hair pulling and skin picking.

“The good news is that we have two great options” for the treatment of trichotillomania and skin-picking disorder, said Dr. Phillips, and that both are easy to tolerate.

Future research should focus on longer trials of memantine and at higher doses, as well as other glutamate modulators, she said.

The study was funded by departmental research funds at the University of Chicago. Dr. Grant reported receiving research funding from Biohaven Pharmaceuticals and Janssen, as well as yearly compensation from Springer Publishing for his role as editor-in-chief of the Journal of Gambling Studies. He has also received royalties from American Psychiatric Publishing, McGraw Hill, Oxford University Press, and WW Norton. Dr. Phillips reported receiving royalties from American Psychiatric Publishing and an honorarium from the Merck Manual.

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

Integrating buprenorphine and harm eduction tools into primary care may improve clinical outcomes, increase costs only modestly, and be cost effective in health systems, authors conclude in an original investigation in JAMA Network Open.

A team led by Raagini Jawa, MD, MPH, with the Center for Research on Healthcare, University of Pittsburgh, set out to analyze costs of the interventions versus increased benefit in extending life expectancy.

Their analysis found that, compared with the status quo, integrating buprenorphine and harm reduction kits (syringes, wound care supplies, etc.) reduced drug use–related deaths by 33% and was cost effective.

“Our results suggest that integrated addiction care in primary care has the potential to save lives and increase nonemergency health care use, which is consistent with prior literature,” the authors write. “Colocated addiction services within primary care is pragmatic and effective and has comparable quality to specialty care. We found that onsite BUP [buprenorphine prescribing] plus HR [harm reduction] provides better outcomes than BUP alone at a lower cost.”
 

Three strategies compared

Using a microsimulation model of 2.25 million people in the United States who inject opioids, with an average age of 44 (69% of them male), the researchers tested three strategies:

• Status quo. PCP refers to addiction care.
• BUP. PCP services plus onsite buprenorphine prescribing with referral to off-site harm reduction kits.
• BUP plus HR. PCP services plus on-site buprenorphine prescribing and harm reduction kits.

The model is the Reducing Infections Related to Drug Use Cost-Effectiveness (REDUCE) microsimulation model, which tracks serious injection-related infections, overdose, hospitalization, and death.

The status quo (referral for treatment) resulted in 1,162 overdose deaths per 10,000 people (95% credible interval, 1,144-2,303), whereas both BUP and BUP plus HR resulted in about 160 fewer deaths per 10,000 people (95% Crl for BUP, 802-1718; 95% CrI for BUP plus HR, 692-1,810).

Compared with the status quo strategy, life expectancy was lengthened with the BUP strategy by 2.65 years and BUP plus HR by 2.71 years.

Researchers found the average discounted lifetime cost per person of both the BUP strategy and the BUP plus HR strategy were higher than the average status quo.

“The dominating strategy was BUP plus HR,” the authors write. “Compared with status quo, BUP plus HR was cost effective (incremental cost-effectiveness ratio [ICER], $34,400 per life year).”
 

Cost for primary care practices

Comparatively, over a 5-year period, BUP plus HR was found to cost an individual PCP practice approximately $13,000.

That cost includes direct costs for resources and opportunity costs, the authors write. These costs could be offset by health care system savings.

“These costs included those for X-waiver training, which has been eliminated; thus, we expect this to cost less. Put another way, our findings inform ways to reinvest health care dollars as financial incentives for PCPs to adopt this new paradigm. Public health departments could provide grants or harm reduction kit supplies directly to PCPs to offset these costs as they do in some places with syringe service programs and/or increase Medicaid reimbursements for providing addiction care in primary care,” they write.
 

Data help make the case

Dinah Applewhite, MD, a primary care physician and addiction medicine specialist at Massachusetts General Hospital in Boston, who was not part of the study, said clinicians there have seen the benefits of integrating various aspects of addiction medicine into primary care but these data on outcomes and cost-effectiveness can help make the case to hospital leaders, legislators, and grant providers.

The primary care setting also provides a chance to engage patients around their injection practice and explore ways to minimize risk, she said.

“By offering them these kits, it lets them know your priority is their safety and well-being,” Dr. Applewhite said.

She noted that the linkage to primary care was low for patients who inject drugs, which speaks to the need for models in addition to this one, such as bringing primary care clinicians into syringe service programs.

“The medical establishment has a lot to learn from these programs,” she said.
 

Practices need support

She said it’s important to note that primary care practices need support from administrative leaders, philanthropists, and grant providers to help cover the costs.

“It’s one of the barriers to doing this,” she said. “There isn’t a mechanism to pay for this.”

Sarah Bagley, MD, a primary care physician at Boston Medical Center and medical director of BMC’s Center for Addiction Treatment for Adolescents/Young Adults Who Use Substances told this publication she was excited to see that the addition of harm reduction kits to buprenorphine seemed to have the optimal effect in improving outcomes. People with substance abuse disorders should feel they are welcome in primary care even if they are not yet ready to stop drug use, she said.

She said she was also glad to see increased life expectancy with these interventions. The news of overdose deaths contributing to a decrease in life expectancy can be overwhelming, she said.

But this study, she says, offers a road map for addressing the overdose crisis “by including harm reduction in the substance abuse care we provide.”

She pointed out that the study showed that costs increase per patient with both interventions, compared with the status quo. The study found that health care costs per person during a lifetime increased, compared with the status quo, by 69.1% for BUP and 74.3% for BUP plus HR.

But it’s important to understand the reason for that, she said: “The cost was higher because people were staying alive.”

She said it may help to compare giving optimal care to people who have substance abuse disorders with giving optimal care to people with other chronic conditions, such as diabetes, who may not always adhere to recommended diets or treatment regimens.

“We still invite those patients in and work with them based on where they are,” she said.

Growing epidemic

The researchers point to the urgent need for solutions given the U.S. opioid epidemic, which has led to increasing numbers of overdoses and injection drug use–related infections, such as infective endocarditis, and severe skin and soft tissue infections.

They point out that primary care providers are the largest clinical workforce in the United States, but few of their practices offer comprehensive addiction care onsite.

“Primary care practices are a practical place to integrate addiction services, where PCPs can prescribe buprenorphine and deliver harm reduction kits,” they write.

Coauthor Dr. Kimmel reports personal fees from Massachusetts Department of Public Health, Bureau of Substance Addiction Services Overdose Education and Prevention Program, and American Academy of Addiction Psychiatry, Opioid Response Network for harm reduction education outside the submitted work and previous consulting with Abt Associates on a Massachusetts Department of Public Health–funded project to improve access to medications for opioid use disorder treatment. Dr. Applewhite and Dr. Bagley report no relevant financial relationships.

Integrating buprenorphine and harm eduction tools into primary care may improve clinical outcomes, increase costs only modestly, and be cost effective in health systems, authors conclude in an original investigation in JAMA Network Open.

A team led by Raagini Jawa, MD, MPH, with the Center for Research on Healthcare, University of Pittsburgh, set out to analyze costs of the interventions versus increased benefit in extending life expectancy.

Their analysis found that, compared with the status quo, integrating buprenorphine and harm reduction kits (syringes, wound care supplies, etc.) reduced drug use–related deaths by 33% and was cost effective.

“Our results suggest that integrated addiction care in primary care has the potential to save lives and increase nonemergency health care use, which is consistent with prior literature,” the authors write. “Colocated addiction services within primary care is pragmatic and effective and has comparable quality to specialty care. We found that onsite BUP [buprenorphine prescribing] plus HR [harm reduction] provides better outcomes than BUP alone at a lower cost.”
 

Three strategies compared

Using a microsimulation model of 2.25 million people in the United States who inject opioids, with an average age of 44 (69% of them male), the researchers tested three strategies:

• Status quo. PCP refers to addiction care.
• BUP. PCP services plus onsite buprenorphine prescribing with referral to off-site harm reduction kits.
• BUP plus HR. PCP services plus on-site buprenorphine prescribing and harm reduction kits.

The model is the Reducing Infections Related to Drug Use Cost-Effectiveness (REDUCE) microsimulation model, which tracks serious injection-related infections, overdose, hospitalization, and death.

The status quo (referral for treatment) resulted in 1,162 overdose deaths per 10,000 people (95% credible interval, 1,144-2,303), whereas both BUP and BUP plus HR resulted in about 160 fewer deaths per 10,000 people (95% Crl for BUP, 802-1718; 95% CrI for BUP plus HR, 692-1,810).

Compared with the status quo strategy, life expectancy was lengthened with the BUP strategy by 2.65 years and BUP plus HR by 2.71 years.

Researchers found the average discounted lifetime cost per person of both the BUP strategy and the BUP plus HR strategy were higher than the average status quo.

“The dominating strategy was BUP plus HR,” the authors write. “Compared with status quo, BUP plus HR was cost effective (incremental cost-effectiveness ratio [ICER], $34,400 per life year).”
 

Cost for primary care practices

Comparatively, over a 5-year period, BUP plus HR was found to cost an individual PCP practice approximately $13,000.

That cost includes direct costs for resources and opportunity costs, the authors write. These costs could be offset by health care system savings.

“These costs included those for X-waiver training, which has been eliminated; thus, we expect this to cost less. Put another way, our findings inform ways to reinvest health care dollars as financial incentives for PCPs to adopt this new paradigm. Public health departments could provide grants or harm reduction kit supplies directly to PCPs to offset these costs as they do in some places with syringe service programs and/or increase Medicaid reimbursements for providing addiction care in primary care,” they write.
 

Data help make the case

Dinah Applewhite, MD, a primary care physician and addiction medicine specialist at Massachusetts General Hospital in Boston, who was not part of the study, said clinicians there have seen the benefits of integrating various aspects of addiction medicine into primary care but these data on outcomes and cost-effectiveness can help make the case to hospital leaders, legislators, and grant providers.

The primary care setting also provides a chance to engage patients around their injection practice and explore ways to minimize risk, she said.

“By offering them these kits, it lets them know your priority is their safety and well-being,” Dr. Applewhite said.

She noted that the linkage to primary care was low for patients who inject drugs, which speaks to the need for models in addition to this one, such as bringing primary care clinicians into syringe service programs.

“The medical establishment has a lot to learn from these programs,” she said.
 

Practices need support

She said it’s important to note that primary care practices need support from administrative leaders, philanthropists, and grant providers to help cover the costs.

“It’s one of the barriers to doing this,” she said. “There isn’t a mechanism to pay for this.”

Sarah Bagley, MD, a primary care physician at Boston Medical Center and medical director of BMC’s Center for Addiction Treatment for Adolescents/Young Adults Who Use Substances told this publication she was excited to see that the addition of harm reduction kits to buprenorphine seemed to have the optimal effect in improving outcomes. People with substance abuse disorders should feel they are welcome in primary care even if they are not yet ready to stop drug use, she said.

She said she was also glad to see increased life expectancy with these interventions. The news of overdose deaths contributing to a decrease in life expectancy can be overwhelming, she said.

But this study, she says, offers a road map for addressing the overdose crisis “by including harm reduction in the substance abuse care we provide.”

She pointed out that the study showed that costs increase per patient with both interventions, compared with the status quo. The study found that health care costs per person during a lifetime increased, compared with the status quo, by 69.1% for BUP and 74.3% for BUP plus HR.

But it’s important to understand the reason for that, she said: “The cost was higher because people were staying alive.”

She said it may help to compare giving optimal care to people who have substance abuse disorders with giving optimal care to people with other chronic conditions, such as diabetes, who may not always adhere to recommended diets or treatment regimens.

“We still invite those patients in and work with them based on where they are,” she said.

Growing epidemic

The researchers point to the urgent need for solutions given the U.S. opioid epidemic, which has led to increasing numbers of overdoses and injection drug use–related infections, such as infective endocarditis, and severe skin and soft tissue infections.

They point out that primary care providers are the largest clinical workforce in the United States, but few of their practices offer comprehensive addiction care onsite.

“Primary care practices are a practical place to integrate addiction services, where PCPs can prescribe buprenorphine and deliver harm reduction kits,” they write.

Coauthor Dr. Kimmel reports personal fees from Massachusetts Department of Public Health, Bureau of Substance Addiction Services Overdose Education and Prevention Program, and American Academy of Addiction Psychiatry, Opioid Response Network for harm reduction education outside the submitted work and previous consulting with Abt Associates on a Massachusetts Department of Public Health–funded project to improve access to medications for opioid use disorder treatment. Dr. Applewhite and Dr. Bagley report no relevant financial relationships.

Integrating buprenorphine and harm eduction tools into primary care may improve clinical outcomes, increase costs only modestly, and be cost effective in health systems, authors conclude in an original investigation in JAMA Network Open.

A team led by Raagini Jawa, MD, MPH, with the Center for Research on Healthcare, University of Pittsburgh, set out to analyze costs of the interventions versus increased benefit in extending life expectancy.

Their analysis found that, compared with the status quo, integrating buprenorphine and harm reduction kits (syringes, wound care supplies, etc.) reduced drug use–related deaths by 33% and was cost effective.

“Our results suggest that integrated addiction care in primary care has the potential to save lives and increase nonemergency health care use, which is consistent with prior literature,” the authors write. “Colocated addiction services within primary care is pragmatic and effective and has comparable quality to specialty care. We found that onsite BUP [buprenorphine prescribing] plus HR [harm reduction] provides better outcomes than BUP alone at a lower cost.”
 

Three strategies compared

Using a microsimulation model of 2.25 million people in the United States who inject opioids, with an average age of 44 (69% of them male), the researchers tested three strategies:

• Status quo. PCP refers to addiction care.
• BUP. PCP services plus onsite buprenorphine prescribing with referral to off-site harm reduction kits.
• BUP plus HR. PCP services plus on-site buprenorphine prescribing and harm reduction kits.

The model is the Reducing Infections Related to Drug Use Cost-Effectiveness (REDUCE) microsimulation model, which tracks serious injection-related infections, overdose, hospitalization, and death.

The status quo (referral for treatment) resulted in 1,162 overdose deaths per 10,000 people (95% credible interval, 1,144-2,303), whereas both BUP and BUP plus HR resulted in about 160 fewer deaths per 10,000 people (95% Crl for BUP, 802-1718; 95% CrI for BUP plus HR, 692-1,810).

Compared with the status quo strategy, life expectancy was lengthened with the BUP strategy by 2.65 years and BUP plus HR by 2.71 years.

Researchers found the average discounted lifetime cost per person of both the BUP strategy and the BUP plus HR strategy were higher than the average status quo.

“The dominating strategy was BUP plus HR,” the authors write. “Compared with status quo, BUP plus HR was cost effective (incremental cost-effectiveness ratio [ICER], $34,400 per life year).”
 

Cost for primary care practices

Comparatively, over a 5-year period, BUP plus HR was found to cost an individual PCP practice approximately $13,000.

That cost includes direct costs for resources and opportunity costs, the authors write. These costs could be offset by health care system savings.

“These costs included those for X-waiver training, which has been eliminated; thus, we expect this to cost less. Put another way, our findings inform ways to reinvest health care dollars as financial incentives for PCPs to adopt this new paradigm. Public health departments could provide grants or harm reduction kit supplies directly to PCPs to offset these costs as they do in some places with syringe service programs and/or increase Medicaid reimbursements for providing addiction care in primary care,” they write.
 

Data help make the case

Dinah Applewhite, MD, a primary care physician and addiction medicine specialist at Massachusetts General Hospital in Boston, who was not part of the study, said clinicians there have seen the benefits of integrating various aspects of addiction medicine into primary care but these data on outcomes and cost-effectiveness can help make the case to hospital leaders, legislators, and grant providers.

The primary care setting also provides a chance to engage patients around their injection practice and explore ways to minimize risk, she said.

“By offering them these kits, it lets them know your priority is their safety and well-being,” Dr. Applewhite said.

She noted that the linkage to primary care was low for patients who inject drugs, which speaks to the need for models in addition to this one, such as bringing primary care clinicians into syringe service programs.

“The medical establishment has a lot to learn from these programs,” she said.
 

Practices need support

She said it’s important to note that primary care practices need support from administrative leaders, philanthropists, and grant providers to help cover the costs.

“It’s one of the barriers to doing this,” she said. “There isn’t a mechanism to pay for this.”

Sarah Bagley, MD, a primary care physician at Boston Medical Center and medical director of BMC’s Center for Addiction Treatment for Adolescents/Young Adults Who Use Substances told this publication she was excited to see that the addition of harm reduction kits to buprenorphine seemed to have the optimal effect in improving outcomes. People with substance abuse disorders should feel they are welcome in primary care even if they are not yet ready to stop drug use, she said.

She said she was also glad to see increased life expectancy with these interventions. The news of overdose deaths contributing to a decrease in life expectancy can be overwhelming, she said.

But this study, she says, offers a road map for addressing the overdose crisis “by including harm reduction in the substance abuse care we provide.”

She pointed out that the study showed that costs increase per patient with both interventions, compared with the status quo. The study found that health care costs per person during a lifetime increased, compared with the status quo, by 69.1% for BUP and 74.3% for BUP plus HR.

But it’s important to understand the reason for that, she said: “The cost was higher because people were staying alive.”

She said it may help to compare giving optimal care to people who have substance abuse disorders with giving optimal care to people with other chronic conditions, such as diabetes, who may not always adhere to recommended diets or treatment regimens.

“We still invite those patients in and work with them based on where they are,” she said.

Growing epidemic

The researchers point to the urgent need for solutions given the U.S. opioid epidemic, which has led to increasing numbers of overdoses and injection drug use–related infections, such as infective endocarditis, and severe skin and soft tissue infections.

They point out that primary care providers are the largest clinical workforce in the United States, but few of their practices offer comprehensive addiction care onsite.

“Primary care practices are a practical place to integrate addiction services, where PCPs can prescribe buprenorphine and deliver harm reduction kits,” they write.

Coauthor Dr. Kimmel reports personal fees from Massachusetts Department of Public Health, Bureau of Substance Addiction Services Overdose Education and Prevention Program, and American Academy of Addiction Psychiatry, Opioid Response Network for harm reduction education outside the submitted work and previous consulting with Abt Associates on a Massachusetts Department of Public Health–funded project to improve access to medications for opioid use disorder treatment. Dr. Applewhite and Dr. Bagley report no relevant financial relationships.

Early detection and management of sleep disorders could reduce asthma incidence, according to a large-scale prospective study that included nearly half a million participants. The study was published in BMJ Open Respiratory Research.

The population-attributable risk analysis indicated that 19% of asthma cases could be prevented through improving sleep traits. The investigators took into consideration polygenic risk scores (PRSs) for asthma and comprehensive sleep scores encompassing five sleep traits.

Sleep quality is generally recognized as a nongenetic driver of asthma. Poor sleep quality and obstructive sleep apnea have been reported particularly among those with severe disease. In addition, asthma is known to adversely affect sleep duration, sleep quality, napping, and daytime sleepiness.

The researchers suggest that the relationship between sleep and asthma is bidirectional, given that sleep disorders (sleep of short duration, insomnia, evening chronotype [“night owl”], snoring, excessive daytime sleepiness) are associated with specific chronic inflammatory reactions. It has remained unclear, however, whether poor sleep reflects a higher risk of early asthma progression.

Genetic factors also contribute to asthma risk, but highly variable heritability suggests that the nongenetic exposures play an important role. “However, whether healthy nongenetic exposure could decrease the risk of asthma and mitigate the adverse effect of genetic risk remains largely unknown,” the authors state. They hypothesize that healthier sleep could decrease future asthma risk and mitigate the hazards of genetic effects.

Using data from the UK Biobank, a national large, prospective cohort drawn from 22 U.K. assessment centers, they investigated the independent and combined effects of sleep pattern and PRSs on asthma incidence.

In the UK Biobank cohort (455,405 adults aged 38-73 years, who were enrolled from 2006 to 2010), 17,836 were diagnosed with asthma over 10 years of follow-up. PRSs were constructed for each participant on the basis of their having any of 17 single-nucleotide polymorphisms that are significantly associated with asthma. Participants were stratified into three groups: those at high genetic risk, those at intermediate genetic risk, and those at low genetic risk. Around 1 in 3 participants were classified as being at high genetic risk (150,429), and another third (151,970) were classified as being at intermediate risk. The remainder were classified as being at low risk. Some 7,105 people at high genetic risk and 5,748 at intermediate genetic risk were diagnosed with asthma during the monitoring period.

Comprehensive sleep scores, which ranged from 0 to 5, were constructed on the basis of self-reported sleep traits. Higher scores represented healthier sleep patterns. A healthy sleep pattern was defined as early chronotype; getting from 7 to 9 hours of sleep every night; never or rare insomnia; no snoring; and no frequent daytime sleepiness. On the basis of their responses, 73,223 people met the criteria for a healthy sleep pattern; 284,267, an intermediate sleep pattern; and 97,915, a poor sleep pattern.

“Compared with non-cases, asthma cases were more likely to have lower education levels, unhealthy sleep traits and patterns, obesity, higher PRS, more smoking, more alcohol consumption, hypertension, diabetes, depression, gastroesophageal reflux. and more air pollution exposure,” the authors report. All five healthy sleep traits were independently associated with lower risk for asthma. Never/rare insomnia and sleep duration of 7-9 hours a night were seemingly the most influential; they were associated with risk reductions of 25% and 20%, respectively.

Analysis showed that, compared with the low-risk group, the hazard ratios and 95% confidence intervals for the highest PRS group and the poor sleep pattern group were 1.47 (95% CI, 1.41-1.52) and 1.55 (95% CI, 1.45-1.65), respectively.

Risk was twofold higher in the presence of a combination of poor sleep and high genetic susceptibility (HR, 2.22; 95% CI, 1.97-2.49; P < .001). Conversely, a healthy sleep pattern was associated with a lower risk of asthma in the low (HR, 0.56; 95% CI, 0.50-0.64), intermediate (HR, 0.59; 95% CI, 0.53-0.67), and high genetic susceptibility groups (HR, 0.63; 95% CI, 0.57-0.70). A population-attributable risk analysis indicated that improving these sleep traits would prevent 19% of asthma cases. Also, a subset analysis suggested that a healthy sleep pattern might reduce the risk of asthma among those at high genetic risk by 37%.

The study findings suggest that analysis of sleep patterns is warranted for all asthma patients, said coauthor Qing Wang, PhD, Cheeloo College of Medicine, Shandong University, Jinan, China, in an interview. “In our results, the effects of sleep and genetics were independent. Therefore, what we learned about the effects of sleep on asthma could be applied to all the patients, including those with a high or low genetic predisposition. In addition, we believe that intervening among those with high genetic predisposition could be more beneficial since they are more likely to have asthma. However, because this study is observational, a large clinical trial is absolutely needed to provide causal evidence, especially before guidelines modifications can be considered.”
 

Complex and multifactorial

“Addressing relevant asthma comorbid conditions continues to be an integral part of asthma care,” commented Diego J. Maselli, MD, associate professor of medicine and interim chief, division of pulmonary diseases and critical care, UT Health, San Antonio, in an interview. “There is mounting evidence that sleep patterns and obstructive sleep apnea may influence asthma control. This association is complex and multifactorial. It is important to remember that obstructive sleep apnea may coexist with other conditions, such as obesity and gastroesophageal reflux disease, that in turn can also worsen asthma control and influence clinical outcomes.

CHEST

“Yet, even after controlling for these factors, sleep disturbances have been associated with poor asthma outcomes. It is reasonable, particularly in patients with uncontrolled and/or severe asthma, to screen for sleep disturbances. There are multiple questionnaires and clinical tools that can be employed to screen for coexisting sleep apnea and other conditions. Although genetic testing has shown some promise in identifying individuals at risk, these assays are not widely available and are not ready yet for routine clinical practice. Therefore, sleep studies should be reserved for patients that have symptoms and test positive for screening questionnaires and other tools.

“The study by Xiang and colleagues adds to the field of study, but further evidence is required to change practice guidelines at this time. Fortunately, sleep studies are readily available now with more widespread use of home testing, so patients can be easily tested. The majority third-party payers have identified that diagnosing these disorders is cost-effective and are able to reimburse sleep studies,” Dr. Maselli concluded.

The research was funded by the Future Program for Young Scholars and National Key Research and Development Program. The study authors and Dr. Maselli have disclosed no relevant financial relationships.
 

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

Early detection and management of sleep disorders could reduce asthma incidence, according to a large-scale prospective study that included nearly half a million participants. The study was published in BMJ Open Respiratory Research.

The population-attributable risk analysis indicated that 19% of asthma cases could be prevented through improving sleep traits. The investigators took into consideration polygenic risk scores (PRSs) for asthma and comprehensive sleep scores encompassing five sleep traits.

Sleep quality is generally recognized as a nongenetic driver of asthma. Poor sleep quality and obstructive sleep apnea have been reported particularly among those with severe disease. In addition, asthma is known to adversely affect sleep duration, sleep quality, napping, and daytime sleepiness.

The researchers suggest that the relationship between sleep and asthma is bidirectional, given that sleep disorders (sleep of short duration, insomnia, evening chronotype [“night owl”], snoring, excessive daytime sleepiness) are associated with specific chronic inflammatory reactions. It has remained unclear, however, whether poor sleep reflects a higher risk of early asthma progression.

Genetic factors also contribute to asthma risk, but highly variable heritability suggests that the nongenetic exposures play an important role. “However, whether healthy nongenetic exposure could decrease the risk of asthma and mitigate the adverse effect of genetic risk remains largely unknown,” the authors state. They hypothesize that healthier sleep could decrease future asthma risk and mitigate the hazards of genetic effects.

Using data from the UK Biobank, a national large, prospective cohort drawn from 22 U.K. assessment centers, they investigated the independent and combined effects of sleep pattern and PRSs on asthma incidence.

In the UK Biobank cohort (455,405 adults aged 38-73 years, who were enrolled from 2006 to 2010), 17,836 were diagnosed with asthma over 10 years of follow-up. PRSs were constructed for each participant on the basis of their having any of 17 single-nucleotide polymorphisms that are significantly associated with asthma. Participants were stratified into three groups: those at high genetic risk, those at intermediate genetic risk, and those at low genetic risk. Around 1 in 3 participants were classified as being at high genetic risk (150,429), and another third (151,970) were classified as being at intermediate risk. The remainder were classified as being at low risk. Some 7,105 people at high genetic risk and 5,748 at intermediate genetic risk were diagnosed with asthma during the monitoring period.

Comprehensive sleep scores, which ranged from 0 to 5, were constructed on the basis of self-reported sleep traits. Higher scores represented healthier sleep patterns. A healthy sleep pattern was defined as early chronotype; getting from 7 to 9 hours of sleep every night; never or rare insomnia; no snoring; and no frequent daytime sleepiness. On the basis of their responses, 73,223 people met the criteria for a healthy sleep pattern; 284,267, an intermediate sleep pattern; and 97,915, a poor sleep pattern.

“Compared with non-cases, asthma cases were more likely to have lower education levels, unhealthy sleep traits and patterns, obesity, higher PRS, more smoking, more alcohol consumption, hypertension, diabetes, depression, gastroesophageal reflux. and more air pollution exposure,” the authors report. All five healthy sleep traits were independently associated with lower risk for asthma. Never/rare insomnia and sleep duration of 7-9 hours a night were seemingly the most influential; they were associated with risk reductions of 25% and 20%, respectively.

Analysis showed that, compared with the low-risk group, the hazard ratios and 95% confidence intervals for the highest PRS group and the poor sleep pattern group were 1.47 (95% CI, 1.41-1.52) and 1.55 (95% CI, 1.45-1.65), respectively.

Risk was twofold higher in the presence of a combination of poor sleep and high genetic susceptibility (HR, 2.22; 95% CI, 1.97-2.49; P < .001). Conversely, a healthy sleep pattern was associated with a lower risk of asthma in the low (HR, 0.56; 95% CI, 0.50-0.64), intermediate (HR, 0.59; 95% CI, 0.53-0.67), and high genetic susceptibility groups (HR, 0.63; 95% CI, 0.57-0.70). A population-attributable risk analysis indicated that improving these sleep traits would prevent 19% of asthma cases. Also, a subset analysis suggested that a healthy sleep pattern might reduce the risk of asthma among those at high genetic risk by 37%.

The study findings suggest that analysis of sleep patterns is warranted for all asthma patients, said coauthor Qing Wang, PhD, Cheeloo College of Medicine, Shandong University, Jinan, China, in an interview. “In our results, the effects of sleep and genetics were independent. Therefore, what we learned about the effects of sleep on asthma could be applied to all the patients, including those with a high or low genetic predisposition. In addition, we believe that intervening among those with high genetic predisposition could be more beneficial since they are more likely to have asthma. However, because this study is observational, a large clinical trial is absolutely needed to provide causal evidence, especially before guidelines modifications can be considered.”
 

Complex and multifactorial

“Addressing relevant asthma comorbid conditions continues to be an integral part of asthma care,” commented Diego J. Maselli, MD, associate professor of medicine and interim chief, division of pulmonary diseases and critical care, UT Health, San Antonio, in an interview. “There is mounting evidence that sleep patterns and obstructive sleep apnea may influence asthma control. This association is complex and multifactorial. It is important to remember that obstructive sleep apnea may coexist with other conditions, such as obesity and gastroesophageal reflux disease, that in turn can also worsen asthma control and influence clinical outcomes.

CHEST

“Yet, even after controlling for these factors, sleep disturbances have been associated with poor asthma outcomes. It is reasonable, particularly in patients with uncontrolled and/or severe asthma, to screen for sleep disturbances. There are multiple questionnaires and clinical tools that can be employed to screen for coexisting sleep apnea and other conditions. Although genetic testing has shown some promise in identifying individuals at risk, these assays are not widely available and are not ready yet for routine clinical practice. Therefore, sleep studies should be reserved for patients that have symptoms and test positive for screening questionnaires and other tools.

“The study by Xiang and colleagues adds to the field of study, but further evidence is required to change practice guidelines at this time. Fortunately, sleep studies are readily available now with more widespread use of home testing, so patients can be easily tested. The majority third-party payers have identified that diagnosing these disorders is cost-effective and are able to reimburse sleep studies,” Dr. Maselli concluded.

The research was funded by the Future Program for Young Scholars and National Key Research and Development Program. The study authors and Dr. Maselli have disclosed no relevant financial relationships.
 

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

Early detection and management of sleep disorders could reduce asthma incidence, according to a large-scale prospective study that included nearly half a million participants. The study was published in BMJ Open Respiratory Research.

The population-attributable risk analysis indicated that 19% of asthma cases could be prevented through improving sleep traits. The investigators took into consideration polygenic risk scores (PRSs) for asthma and comprehensive sleep scores encompassing five sleep traits.

Sleep quality is generally recognized as a nongenetic driver of asthma. Poor sleep quality and obstructive sleep apnea have been reported particularly among those with severe disease. In addition, asthma is known to adversely affect sleep duration, sleep quality, napping, and daytime sleepiness.

The researchers suggest that the relationship between sleep and asthma is bidirectional, given that sleep disorders (sleep of short duration, insomnia, evening chronotype [“night owl”], snoring, excessive daytime sleepiness) are associated with specific chronic inflammatory reactions. It has remained unclear, however, whether poor sleep reflects a higher risk of early asthma progression.

Genetic factors also contribute to asthma risk, but highly variable heritability suggests that the nongenetic exposures play an important role. “However, whether healthy nongenetic exposure could decrease the risk of asthma and mitigate the adverse effect of genetic risk remains largely unknown,” the authors state. They hypothesize that healthier sleep could decrease future asthma risk and mitigate the hazards of genetic effects.

Using data from the UK Biobank, a national large, prospective cohort drawn from 22 U.K. assessment centers, they investigated the independent and combined effects of sleep pattern and PRSs on asthma incidence.

In the UK Biobank cohort (455,405 adults aged 38-73 years, who were enrolled from 2006 to 2010), 17,836 were diagnosed with asthma over 10 years of follow-up. PRSs were constructed for each participant on the basis of their having any of 17 single-nucleotide polymorphisms that are significantly associated with asthma. Participants were stratified into three groups: those at high genetic risk, those at intermediate genetic risk, and those at low genetic risk. Around 1 in 3 participants were classified as being at high genetic risk (150,429), and another third (151,970) were classified as being at intermediate risk. The remainder were classified as being at low risk. Some 7,105 people at high genetic risk and 5,748 at intermediate genetic risk were diagnosed with asthma during the monitoring period.

Comprehensive sleep scores, which ranged from 0 to 5, were constructed on the basis of self-reported sleep traits. Higher scores represented healthier sleep patterns. A healthy sleep pattern was defined as early chronotype; getting from 7 to 9 hours of sleep every night; never or rare insomnia; no snoring; and no frequent daytime sleepiness. On the basis of their responses, 73,223 people met the criteria for a healthy sleep pattern; 284,267, an intermediate sleep pattern; and 97,915, a poor sleep pattern.

“Compared with non-cases, asthma cases were more likely to have lower education levels, unhealthy sleep traits and patterns, obesity, higher PRS, more smoking, more alcohol consumption, hypertension, diabetes, depression, gastroesophageal reflux. and more air pollution exposure,” the authors report. All five healthy sleep traits were independently associated with lower risk for asthma. Never/rare insomnia and sleep duration of 7-9 hours a night were seemingly the most influential; they were associated with risk reductions of 25% and 20%, respectively.

Analysis showed that, compared with the low-risk group, the hazard ratios and 95% confidence intervals for the highest PRS group and the poor sleep pattern group were 1.47 (95% CI, 1.41-1.52) and 1.55 (95% CI, 1.45-1.65), respectively.

Risk was twofold higher in the presence of a combination of poor sleep and high genetic susceptibility (HR, 2.22; 95% CI, 1.97-2.49; P < .001). Conversely, a healthy sleep pattern was associated with a lower risk of asthma in the low (HR, 0.56; 95% CI, 0.50-0.64), intermediate (HR, 0.59; 95% CI, 0.53-0.67), and high genetic susceptibility groups (HR, 0.63; 95% CI, 0.57-0.70). A population-attributable risk analysis indicated that improving these sleep traits would prevent 19% of asthma cases. Also, a subset analysis suggested that a healthy sleep pattern might reduce the risk of asthma among those at high genetic risk by 37%.

The study findings suggest that analysis of sleep patterns is warranted for all asthma patients, said coauthor Qing Wang, PhD, Cheeloo College of Medicine, Shandong University, Jinan, China, in an interview. “In our results, the effects of sleep and genetics were independent. Therefore, what we learned about the effects of sleep on asthma could be applied to all the patients, including those with a high or low genetic predisposition. In addition, we believe that intervening among those with high genetic predisposition could be more beneficial since they are more likely to have asthma. However, because this study is observational, a large clinical trial is absolutely needed to provide causal evidence, especially before guidelines modifications can be considered.”
 

Complex and multifactorial

“Addressing relevant asthma comorbid conditions continues to be an integral part of asthma care,” commented Diego J. Maselli, MD, associate professor of medicine and interim chief, division of pulmonary diseases and critical care, UT Health, San Antonio, in an interview. “There is mounting evidence that sleep patterns and obstructive sleep apnea may influence asthma control. This association is complex and multifactorial. It is important to remember that obstructive sleep apnea may coexist with other conditions, such as obesity and gastroesophageal reflux disease, that in turn can also worsen asthma control and influence clinical outcomes.

CHEST

“Yet, even after controlling for these factors, sleep disturbances have been associated with poor asthma outcomes. It is reasonable, particularly in patients with uncontrolled and/or severe asthma, to screen for sleep disturbances. There are multiple questionnaires and clinical tools that can be employed to screen for coexisting sleep apnea and other conditions. Although genetic testing has shown some promise in identifying individuals at risk, these assays are not widely available and are not ready yet for routine clinical practice. Therefore, sleep studies should be reserved for patients that have symptoms and test positive for screening questionnaires and other tools.

“The study by Xiang and colleagues adds to the field of study, but further evidence is required to change practice guidelines at this time. Fortunately, sleep studies are readily available now with more widespread use of home testing, so patients can be easily tested. The majority third-party payers have identified that diagnosing these disorders is cost-effective and are able to reimburse sleep studies,” Dr. Maselli concluded.

The research was funded by the Future Program for Young Scholars and National Key Research and Development Program. The study authors and Dr. Maselli have disclosed no relevant financial relationships.
 

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

As you may have seen in the February issue, in my year serving as President of the American College of Chest Physicians, I will be periodically contributing to CHEST Physician with the latest updates and to serve as a touchpoint for what we are currently working on.

For this contribution, I want to share and reflect upon the recent Nurse Work Environment study published by the American Association of Critical-Care Nurses (AACN). Deployed in 2021, the now-published study concluded that there is serious need for “bold, intentional, and relentless” efforts to create and sustain healthy work environments that foster excellence in patient care and optimal outcomes for patients, nurses, and other members of the health care team.

CHEST

To achieve this, AACN recommends adhering to the Healthy Work Environments (HWE) Standards created in 2005 but that are more pertinent than ever in 2023.

As close partners of the AACN through the Critical Care Societies Collaborative, the CHEST organization applauds and vehemently supports the need for increased efforts to support nurses and other members of the care team.

In a previous article for CHEST Physician, I spoke about my goals for 2023 and one of those goals was to focus on increasing the membership of a variety of providers who help care for patients, including advanced practice providers, respiratory therapists, registered nurses, and others. CHEST is already an inclusive organization to a variety of health care providers, but we can do more, and this is a great time to reemphasize the importance of the care team by showing our support of the AACN and the working conditions of nurses.

Beyond supporting other organizations, the CHEST Board of Regents will focus on new ways to make the organization a valuable resource to every member at every level of their career and with every designation.

The (HWE) Standards that I encourage all CHEST members to support include:

• Skilled communication and true collaboration between doctors, nurses and other clinicians.
• Effective decision-making that includes nurses in the process for input and expertise.
• Appropriate staffing that ensures an effective match between patient needs and the skills of the nurse.
• Meaningful recognition by rewarding and appreciating the value that everyone brings to the team.
• Authentic leadership that embraces a healthy work environment and is supportive of every member of the care team.

Let’s all make a dedicated effort to be intentional in our support of our care team colleagues to improve the working environment and overall patient care.

Think of one thing you can do at your own institution or in your practice to improve the work environment for all those on your team. And then make it happen!

Please reach out with ideas or questions.

As you may have seen in the February issue, in my year serving as President of the American College of Chest Physicians, I will be periodically contributing to CHEST Physician with the latest updates and to serve as a touchpoint for what we are currently working on.

For this contribution, I want to share and reflect upon the recent Nurse Work Environment study published by the American Association of Critical-Care Nurses (AACN). Deployed in 2021, the now-published study concluded that there is serious need for “bold, intentional, and relentless” efforts to create and sustain healthy work environments that foster excellence in patient care and optimal outcomes for patients, nurses, and other members of the health care team.

CHEST

To achieve this, AACN recommends adhering to the Healthy Work Environments (HWE) Standards created in 2005 but that are more pertinent than ever in 2023.

As close partners of the AACN through the Critical Care Societies Collaborative, the CHEST organization applauds and vehemently supports the need for increased efforts to support nurses and other members of the care team.

In a previous article for CHEST Physician, I spoke about my goals for 2023 and one of those goals was to focus on increasing the membership of a variety of providers who help care for patients, including advanced practice providers, respiratory therapists, registered nurses, and others. CHEST is already an inclusive organization to a variety of health care providers, but we can do more, and this is a great time to reemphasize the importance of the care team by showing our support of the AACN and the working conditions of nurses.

Beyond supporting other organizations, the CHEST Board of Regents will focus on new ways to make the organization a valuable resource to every member at every level of their career and with every designation.

The (HWE) Standards that I encourage all CHEST members to support include:

• Skilled communication and true collaboration between doctors, nurses and other clinicians.
• Effective decision-making that includes nurses in the process for input and expertise.
• Appropriate staffing that ensures an effective match between patient needs and the skills of the nurse.
• Meaningful recognition by rewarding and appreciating the value that everyone brings to the team.
• Authentic leadership that embraces a healthy work environment and is supportive of every member of the care team.

Let’s all make a dedicated effort to be intentional in our support of our care team colleagues to improve the working environment and overall patient care.

Think of one thing you can do at your own institution or in your practice to improve the work environment for all those on your team. And then make it happen!

Please reach out with ideas or questions.

As you may have seen in the February issue, in my year serving as President of the American College of Chest Physicians, I will be periodically contributing to CHEST Physician with the latest updates and to serve as a touchpoint for what we are currently working on.

For this contribution, I want to share and reflect upon the recent Nurse Work Environment study published by the American Association of Critical-Care Nurses (AACN). Deployed in 2021, the now-published study concluded that there is serious need for “bold, intentional, and relentless” efforts to create and sustain healthy work environments that foster excellence in patient care and optimal outcomes for patients, nurses, and other members of the health care team.

CHEST

To achieve this, AACN recommends adhering to the Healthy Work Environments (HWE) Standards created in 2005 but that are more pertinent than ever in 2023.

As close partners of the AACN through the Critical Care Societies Collaborative, the CHEST organization applauds and vehemently supports the need for increased efforts to support nurses and other members of the care team.

In a previous article for CHEST Physician, I spoke about my goals for 2023 and one of those goals was to focus on increasing the membership of a variety of providers who help care for patients, including advanced practice providers, respiratory therapists, registered nurses, and others. CHEST is already an inclusive organization to a variety of health care providers, but we can do more, and this is a great time to reemphasize the importance of the care team by showing our support of the AACN and the working conditions of nurses.

Beyond supporting other organizations, the CHEST Board of Regents will focus on new ways to make the organization a valuable resource to every member at every level of their career and with every designation.

The (HWE) Standards that I encourage all CHEST members to support include:

• Skilled communication and true collaboration between doctors, nurses and other clinicians.
• Effective decision-making that includes nurses in the process for input and expertise.
• Appropriate staffing that ensures an effective match between patient needs and the skills of the nurse.
• Meaningful recognition by rewarding and appreciating the value that everyone brings to the team.
• Authentic leadership that embraces a healthy work environment and is supportive of every member of the care team.

Let’s all make a dedicated effort to be intentional in our support of our care team colleagues to improve the working environment and overall patient care.

Think of one thing you can do at your own institution or in your practice to improve the work environment for all those on your team. And then make it happen!

Please reach out with ideas or questions.