Pediatric News

The risk of colorectal cancer (CRC) among patients with inflammatory bowel disease (IBD) does not extend to close family members, new research suggests.

In a large Swedish study, a history of IBD among first-degree relatives was not associated with an increased risk of CRC, even when considering various characteristics of IBD and CRC history.

The findings suggest that extra screening for CRC may not be needed for children, siblings, or parents of those with IBD, say the study authors, led by Kai Wang, MD, PhD, with Harvard School of Public Health, Boston. The findings strengthen the theory that it’s inflammation or atypism of the colon of people with IBD that confers the increased CRC risk.

“There is nothing in this study that changes our existing practice,” said Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who was not involved in the research. “It is already the thought that inflammation in IBD increases risk of cancer,” which would not increase CRC risk among family members.

The study appeared in the International Journal of Cancer.

Patients with IBD are known to be at increased risk for CRC. However, the association between family history of IBD and CRC risk remains less clear. Current CRC screening recommendations are the same for patients who have family members with IBD and for those who do not.

The Swedish nationwide case-control study included 69,659 individuals with CRC, of whom 1,599 (2.3%) had IBD, and 343,032 matched control persons who did not have CRC, of whom 1,477 (0.4%) had IBD.

Overall, 2.2% of CRC case patients and control patients had at least one first-degree relative who had a history of IBD.

After adjusting for family history of CRC, the authors did not find an increase in risk for CRC among first-degree relatives of people with IBD (odds ratio, 0.96; 95% confidence interval, 0.91-1.02).

The null association was consistently observed regardless of IBD subtype (Crohn’s disease or ulcerative colitis), the number of first-degree relatives with IBD, age at first IBD diagnosis, maximum location or extent of IBD, or type of relative (parent, sibling, or offspring). The null association remained for early-onset CRC diagnosed before age 50.

Overall, these findings suggest that IBD and CRC may not have substantial familial clustering or shared genetic susceptibility and provide “robust evidence that a family history of IBD did not increase the risk of CRC, supporting use of the same routine CRC screening strategy in offspring, siblings, and parents of IBD patients as in the general population,” Dr. Wang and colleagues conclude.

This “well-done” study is one of the largest to date to evaluate first-degree relatives of IBD patients and their risk of CRC, said Shannon Chang, MD, with NYU Langone Health Inflammatory Bowel Disease Center, who wasn’t involved in the research.

The findings are reassuring, as the authors assessed several factors and found that family members of patients with IBD are not at higher risk for CRC, compared with the general population, Dr. Chang added.

Support for the study was provided by the National Institutes of Health, the American Cancer Society, ALF funding, the Swedish Research Council, and the Swedish Cancer Foundation. Dr. Wang, Dr. Chang, and Dr. Ananthakrishnan have disclosed no relevant financial relationships.

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

The risk of colorectal cancer (CRC) among patients with inflammatory bowel disease (IBD) does not extend to close family members, new research suggests.

In a large Swedish study, a history of IBD among first-degree relatives was not associated with an increased risk of CRC, even when considering various characteristics of IBD and CRC history.

The findings suggest that extra screening for CRC may not be needed for children, siblings, or parents of those with IBD, say the study authors, led by Kai Wang, MD, PhD, with Harvard School of Public Health, Boston. The findings strengthen the theory that it’s inflammation or atypism of the colon of people with IBD that confers the increased CRC risk.

“There is nothing in this study that changes our existing practice,” said Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who was not involved in the research. “It is already the thought that inflammation in IBD increases risk of cancer,” which would not increase CRC risk among family members.

The study appeared in the International Journal of Cancer.

Patients with IBD are known to be at increased risk for CRC. However, the association between family history of IBD and CRC risk remains less clear. Current CRC screening recommendations are the same for patients who have family members with IBD and for those who do not.

The Swedish nationwide case-control study included 69,659 individuals with CRC, of whom 1,599 (2.3%) had IBD, and 343,032 matched control persons who did not have CRC, of whom 1,477 (0.4%) had IBD.

Overall, 2.2% of CRC case patients and control patients had at least one first-degree relative who had a history of IBD.

After adjusting for family history of CRC, the authors did not find an increase in risk for CRC among first-degree relatives of people with IBD (odds ratio, 0.96; 95% confidence interval, 0.91-1.02).

The null association was consistently observed regardless of IBD subtype (Crohn’s disease or ulcerative colitis), the number of first-degree relatives with IBD, age at first IBD diagnosis, maximum location or extent of IBD, or type of relative (parent, sibling, or offspring). The null association remained for early-onset CRC diagnosed before age 50.

Overall, these findings suggest that IBD and CRC may not have substantial familial clustering or shared genetic susceptibility and provide “robust evidence that a family history of IBD did not increase the risk of CRC, supporting use of the same routine CRC screening strategy in offspring, siblings, and parents of IBD patients as in the general population,” Dr. Wang and colleagues conclude.

This “well-done” study is one of the largest to date to evaluate first-degree relatives of IBD patients and their risk of CRC, said Shannon Chang, MD, with NYU Langone Health Inflammatory Bowel Disease Center, who wasn’t involved in the research.

The findings are reassuring, as the authors assessed several factors and found that family members of patients with IBD are not at higher risk for CRC, compared with the general population, Dr. Chang added.

Support for the study was provided by the National Institutes of Health, the American Cancer Society, ALF funding, the Swedish Research Council, and the Swedish Cancer Foundation. Dr. Wang, Dr. Chang, and Dr. Ananthakrishnan have disclosed no relevant financial relationships.

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

The risk of colorectal cancer (CRC) among patients with inflammatory bowel disease (IBD) does not extend to close family members, new research suggests.

In a large Swedish study, a history of IBD among first-degree relatives was not associated with an increased risk of CRC, even when considering various characteristics of IBD and CRC history.

The findings suggest that extra screening for CRC may not be needed for children, siblings, or parents of those with IBD, say the study authors, led by Kai Wang, MD, PhD, with Harvard School of Public Health, Boston. The findings strengthen the theory that it’s inflammation or atypism of the colon of people with IBD that confers the increased CRC risk.

“There is nothing in this study that changes our existing practice,” said Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who was not involved in the research. “It is already the thought that inflammation in IBD increases risk of cancer,” which would not increase CRC risk among family members.

The study appeared in the International Journal of Cancer.

Patients with IBD are known to be at increased risk for CRC. However, the association between family history of IBD and CRC risk remains less clear. Current CRC screening recommendations are the same for patients who have family members with IBD and for those who do not.

The Swedish nationwide case-control study included 69,659 individuals with CRC, of whom 1,599 (2.3%) had IBD, and 343,032 matched control persons who did not have CRC, of whom 1,477 (0.4%) had IBD.

Overall, 2.2% of CRC case patients and control patients had at least one first-degree relative who had a history of IBD.

After adjusting for family history of CRC, the authors did not find an increase in risk for CRC among first-degree relatives of people with IBD (odds ratio, 0.96; 95% confidence interval, 0.91-1.02).

The null association was consistently observed regardless of IBD subtype (Crohn’s disease or ulcerative colitis), the number of first-degree relatives with IBD, age at first IBD diagnosis, maximum location or extent of IBD, or type of relative (parent, sibling, or offspring). The null association remained for early-onset CRC diagnosed before age 50.

Overall, these findings suggest that IBD and CRC may not have substantial familial clustering or shared genetic susceptibility and provide “robust evidence that a family history of IBD did not increase the risk of CRC, supporting use of the same routine CRC screening strategy in offspring, siblings, and parents of IBD patients as in the general population,” Dr. Wang and colleagues conclude.

This “well-done” study is one of the largest to date to evaluate first-degree relatives of IBD patients and their risk of CRC, said Shannon Chang, MD, with NYU Langone Health Inflammatory Bowel Disease Center, who wasn’t involved in the research.

The findings are reassuring, as the authors assessed several factors and found that family members of patients with IBD are not at higher risk for CRC, compared with the general population, Dr. Chang added.

Support for the study was provided by the National Institutes of Health, the American Cancer Society, ALF funding, the Swedish Research Council, and the Swedish Cancer Foundation. Dr. Wang, Dr. Chang, and Dr. Ananthakrishnan have disclosed no relevant financial relationships.

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

Technologies that allow people to monitor blood sugar and automate the administration of insulin have radically transformed the lives of patients – and children in particular – with type 1 diabetes. But the devices often come with a cost: Insulin pumps and continuous glucose monitors can irritate the skin at the points of contact, causing some people to stop using their pumps or monitors altogether.

Regular use of lipid-rich skin creams can reduce eczema in children who use insulin pumps and continuous glucose monitors to manage type 1 diabetes, Danish researchers reported last month. The article is currently undergoing peer review at The Lancet Diabetes and Endocrinology, and the authors said they hope their approach will deter more children from abandoning diabetes technology.

“A simple thing can actually change a lot,” said Anna Korsgaard Berg, MD, a pediatrician who specializes in diabetes care at Copenhagen University Hospital’s Steno Diabetes Center in Herlev, Denmark, and a coauthor of the new study. “Not all skin reactions can be solved by the skin care program, but it can help improve the issue.”

More than 1.5 million children and adolescents worldwide live with type 1 diabetes, a condition that requires continuous insulin infusion. Insulin pumps meet this need in many wealthier countries, and are often used in combination with sensors that measure a child’s glucose level. Both the American Diabetes Association and the International Society for Adolescent and Pediatric Diabetes recommend insulin pumps and continuous glucose monitors as core treatment tools.

Dr. Berg and colleagues, who have previously shown that as many as 90% of children who use these devices experience some kind of skin reaction, want to minimize the rate of such discomfort in hopes that fewer children stop using the devices. According to a 2014 study, 18% of people with type 1 diabetes who stopped using continuous glucose monitors did so because of skin irritation.
 

Lather on that lipid-rich lotion

Dr. Berg and colleagues studied 170 children and adolescents with type 1 diabetes (average age, 11 years) who use insulin pumps, continuous glucose monitors, or both. From March 2020 to July 2021, 112 children (55 girls) employed a skin care program developed for the study, while the other 58 (34 girls) did not receive any skin care advice.

The skin care group received instructions about how to gently insert and remove their insulin pumps or glucose monitors, to minimize skin damage. They also were told to avoid disinfectants such as alcohol, which can irritate skin. The children in this group used a cream containing 70% lipids to help rehydrate their skin, applying the salve each day a device was not inserted into their skin.

Eczema can be a real problem for kids who use insulin pumps and continuous glucose monitors to manage type 1 diabetes. Researchers found that regular use of lipid-rich skin creams can reduce its incidence.

Although insulin pumps and glucose monitors are kept in place for longer periods of time than they once were, Dr. Berg and colleagues noted, users do periodically remove them when bathing or when undergoing medical tests that involve x-rays. On days when the devices were not in place for a period of time, children in the skin care group were encouraged to follow the protocol.
 

Study results

One-third of children in the skin care group developed eczema or experienced a wound, compared with almost half of the children in the control group, according to the researchers. The absolute difference in developing eczema or wounds between the two groups was 12.9 % (95% confidence interval, –28.7% to 2.9%).

Children in the skin care group were much less likely to develop wounds, the researchers found, when they focused only on wounds and not eczema (odds ratio, 0.29, 95% CI, 0.12-0.68).

Dr. Berg said she would like to explore whether other techniques, such as a combination of patches, adhesives, or other lotions, yield even better results.

“Anything that can help people use technology more consistently is better for both quality of life and diabetes outcomes,” said Priya Prahalad, MD, a specialist in pediatric endocrinology and diabetes at Stanford Medicine Children’s Health in Palo Alto and Sunnyvale, Calif. 

Dr. Prahalad, who was not involved in the Danish study, said that although the sample sizes in the trial were relatively small, the data are “headed in the right direction.”

Pediatricians already recommend using moisturizing creams at the sites where pumps or glucose monitors are inserted into the skin, she noted. But the new study simply employed an especially moisturizing cream to mitigate skin damage.

Although one reason for skin irritation may be the repeated insertion and removal of devices, Dr. Berg and Dr. Prahalad stressed that the medical devices themselves may contain allergy-causing components. Device makers are not required to disclose what’s inside the boxes.

“I do not understand why the full content of a device is not by law mandatory to declare, when declaration by law is mandatory for many other products and drugs but not for medical devices,” Dr. Berg said.

Dr. Berg reports receiving lipid cream from Teva Pharmaceuticals and research support from Medtronic. Dr. Prahalad reports no relevant financial relationships.

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

Technologies that allow people to monitor blood sugar and automate the administration of insulin have radically transformed the lives of patients – and children in particular – with type 1 diabetes. But the devices often come with a cost: Insulin pumps and continuous glucose monitors can irritate the skin at the points of contact, causing some people to stop using their pumps or monitors altogether.

Regular use of lipid-rich skin creams can reduce eczema in children who use insulin pumps and continuous glucose monitors to manage type 1 diabetes, Danish researchers reported last month. The article is currently undergoing peer review at The Lancet Diabetes and Endocrinology, and the authors said they hope their approach will deter more children from abandoning diabetes technology.

“A simple thing can actually change a lot,” said Anna Korsgaard Berg, MD, a pediatrician who specializes in diabetes care at Copenhagen University Hospital’s Steno Diabetes Center in Herlev, Denmark, and a coauthor of the new study. “Not all skin reactions can be solved by the skin care program, but it can help improve the issue.”

More than 1.5 million children and adolescents worldwide live with type 1 diabetes, a condition that requires continuous insulin infusion. Insulin pumps meet this need in many wealthier countries, and are often used in combination with sensors that measure a child’s glucose level. Both the American Diabetes Association and the International Society for Adolescent and Pediatric Diabetes recommend insulin pumps and continuous glucose monitors as core treatment tools.

Dr. Berg and colleagues, who have previously shown that as many as 90% of children who use these devices experience some kind of skin reaction, want to minimize the rate of such discomfort in hopes that fewer children stop using the devices. According to a 2014 study, 18% of people with type 1 diabetes who stopped using continuous glucose monitors did so because of skin irritation.
 

Lather on that lipid-rich lotion

Dr. Berg and colleagues studied 170 children and adolescents with type 1 diabetes (average age, 11 years) who use insulin pumps, continuous glucose monitors, or both. From March 2020 to July 2021, 112 children (55 girls) employed a skin care program developed for the study, while the other 58 (34 girls) did not receive any skin care advice.

The skin care group received instructions about how to gently insert and remove their insulin pumps or glucose monitors, to minimize skin damage. They also were told to avoid disinfectants such as alcohol, which can irritate skin. The children in this group used a cream containing 70% lipids to help rehydrate their skin, applying the salve each day a device was not inserted into their skin.

Eczema can be a real problem for kids who use insulin pumps and continuous glucose monitors to manage type 1 diabetes. Researchers found that regular use of lipid-rich skin creams can reduce its incidence.

Although insulin pumps and glucose monitors are kept in place for longer periods of time than they once were, Dr. Berg and colleagues noted, users do periodically remove them when bathing or when undergoing medical tests that involve x-rays. On days when the devices were not in place for a period of time, children in the skin care group were encouraged to follow the protocol.
 

Study results

One-third of children in the skin care group developed eczema or experienced a wound, compared with almost half of the children in the control group, according to the researchers. The absolute difference in developing eczema or wounds between the two groups was 12.9 % (95% confidence interval, –28.7% to 2.9%).

Children in the skin care group were much less likely to develop wounds, the researchers found, when they focused only on wounds and not eczema (odds ratio, 0.29, 95% CI, 0.12-0.68).

Dr. Berg said she would like to explore whether other techniques, such as a combination of patches, adhesives, or other lotions, yield even better results.

“Anything that can help people use technology more consistently is better for both quality of life and diabetes outcomes,” said Priya Prahalad, MD, a specialist in pediatric endocrinology and diabetes at Stanford Medicine Children’s Health in Palo Alto and Sunnyvale, Calif. 

Dr. Prahalad, who was not involved in the Danish study, said that although the sample sizes in the trial were relatively small, the data are “headed in the right direction.”

Pediatricians already recommend using moisturizing creams at the sites where pumps or glucose monitors are inserted into the skin, she noted. But the new study simply employed an especially moisturizing cream to mitigate skin damage.

Although one reason for skin irritation may be the repeated insertion and removal of devices, Dr. Berg and Dr. Prahalad stressed that the medical devices themselves may contain allergy-causing components. Device makers are not required to disclose what’s inside the boxes.

“I do not understand why the full content of a device is not by law mandatory to declare, when declaration by law is mandatory for many other products and drugs but not for medical devices,” Dr. Berg said.

Dr. Berg reports receiving lipid cream from Teva Pharmaceuticals and research support from Medtronic. Dr. Prahalad reports no relevant financial relationships.

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

Technologies that allow people to monitor blood sugar and automate the administration of insulin have radically transformed the lives of patients – and children in particular – with type 1 diabetes. But the devices often come with a cost: Insulin pumps and continuous glucose monitors can irritate the skin at the points of contact, causing some people to stop using their pumps or monitors altogether.

Regular use of lipid-rich skin creams can reduce eczema in children who use insulin pumps and continuous glucose monitors to manage type 1 diabetes, Danish researchers reported last month. The article is currently undergoing peer review at The Lancet Diabetes and Endocrinology, and the authors said they hope their approach will deter more children from abandoning diabetes technology.

“A simple thing can actually change a lot,” said Anna Korsgaard Berg, MD, a pediatrician who specializes in diabetes care at Copenhagen University Hospital’s Steno Diabetes Center in Herlev, Denmark, and a coauthor of the new study. “Not all skin reactions can be solved by the skin care program, but it can help improve the issue.”

More than 1.5 million children and adolescents worldwide live with type 1 diabetes, a condition that requires continuous insulin infusion. Insulin pumps meet this need in many wealthier countries, and are often used in combination with sensors that measure a child’s glucose level. Both the American Diabetes Association and the International Society for Adolescent and Pediatric Diabetes recommend insulin pumps and continuous glucose monitors as core treatment tools.

Dr. Berg and colleagues, who have previously shown that as many as 90% of children who use these devices experience some kind of skin reaction, want to minimize the rate of such discomfort in hopes that fewer children stop using the devices. According to a 2014 study, 18% of people with type 1 diabetes who stopped using continuous glucose monitors did so because of skin irritation.
 

Lather on that lipid-rich lotion

Dr. Berg and colleagues studied 170 children and adolescents with type 1 diabetes (average age, 11 years) who use insulin pumps, continuous glucose monitors, or both. From March 2020 to July 2021, 112 children (55 girls) employed a skin care program developed for the study, while the other 58 (34 girls) did not receive any skin care advice.

The skin care group received instructions about how to gently insert and remove their insulin pumps or glucose monitors, to minimize skin damage. They also were told to avoid disinfectants such as alcohol, which can irritate skin. The children in this group used a cream containing 70% lipids to help rehydrate their skin, applying the salve each day a device was not inserted into their skin.

Eczema can be a real problem for kids who use insulin pumps and continuous glucose monitors to manage type 1 diabetes. Researchers found that regular use of lipid-rich skin creams can reduce its incidence.

Although insulin pumps and glucose monitors are kept in place for longer periods of time than they once were, Dr. Berg and colleagues noted, users do periodically remove them when bathing or when undergoing medical tests that involve x-rays. On days when the devices were not in place for a period of time, children in the skin care group were encouraged to follow the protocol.
 

Study results

One-third of children in the skin care group developed eczema or experienced a wound, compared with almost half of the children in the control group, according to the researchers. The absolute difference in developing eczema or wounds between the two groups was 12.9 % (95% confidence interval, –28.7% to 2.9%).

Children in the skin care group were much less likely to develop wounds, the researchers found, when they focused only on wounds and not eczema (odds ratio, 0.29, 95% CI, 0.12-0.68).

Dr. Berg said she would like to explore whether other techniques, such as a combination of patches, adhesives, or other lotions, yield even better results.

“Anything that can help people use technology more consistently is better for both quality of life and diabetes outcomes,” said Priya Prahalad, MD, a specialist in pediatric endocrinology and diabetes at Stanford Medicine Children’s Health in Palo Alto and Sunnyvale, Calif. 

Dr. Prahalad, who was not involved in the Danish study, said that although the sample sizes in the trial were relatively small, the data are “headed in the right direction.”

Pediatricians already recommend using moisturizing creams at the sites where pumps or glucose monitors are inserted into the skin, she noted. But the new study simply employed an especially moisturizing cream to mitigate skin damage.

Although one reason for skin irritation may be the repeated insertion and removal of devices, Dr. Berg and Dr. Prahalad stressed that the medical devices themselves may contain allergy-causing components. Device makers are not required to disclose what’s inside the boxes.

“I do not understand why the full content of a device is not by law mandatory to declare, when declaration by law is mandatory for many other products and drugs but not for medical devices,” Dr. Berg said.

Dr. Berg reports receiving lipid cream from Teva Pharmaceuticals and research support from Medtronic. Dr. Prahalad reports no relevant financial relationships.

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

The incidence of colorectal cancer (CRC) is rapidly increasing among younger individuals, and the disease is also being diagnosed at more advanced stages in all ages, according to a new report from the American Cancer Society.

Diagnoses in people younger than 55 years doubled from 11% (1 in 10) in 1995 to 20% (1 in 5) in 2019.

In addition, more advanced disease is being diagnosed; the proportion of individuals of all ages presenting with advanced-stage CRC increased from 52% in the mid-2000s to 60% in 2019.

“We know rates are increasing in young people, but it’s alarming to see how rapidly the whole patient population is shifting younger, despite shrinking numbers in the overall population,” said Rebecca Siegel, MPH, senior scientific director of surveillance research at the American Cancer Society and lead author of the report.

“The trend toward more advanced disease in people of all ages is also surprising and should motivate everyone 45 and older to get screened,” she added.

The report was published online in CA: A Cancer Journal for Clinicians.

CRC is the third most commonly diagnosed cancer and the third leading cause of cancer death of both men and women in the United States. It is estimated that there will be 153,020 new cases of CRC in the U.S. in 2023, including 106,970 tumors in the colon and 46,050 in the rectum.

Overall, in 2023, an estimated 153,020 people will be diagnosed with CRC in the U.S., and of those, 52,550 people will die from the disease.

The incidence of CRC rapidly decreased during the 2000s among people aged 50 and older, largely because of an increase in cancer screening with colonoscopy. But progress slowed during the past decade, and now the trends toward declining incidence is largely confined to those aged 65 and older.

The authors point out that more than half of all cases and deaths are associated with modifiable risk factors, including smoking, an unhealthy diet, high alcohol consumption, physical inactivity, and excess body weight. A large proportion of CRC incidence and mortality is preventable through recommended screening, surveillance, and high-quality treatment.

But it remains unclear why rates are rising among younger adults and why there is a trend toward the disase being initially diagnosed at more advanced stages.

“We have to address why the rates in young adults continue to trend in the wrong direction,” said Ahmedin Jemal, DVM, PhD, senior vice president of surveillance and health equity science at the American Cancer Society and senior author of the study. “We need to invest more in research to uncover the causes of the rising trends and to discover new treatment for advanced-stage diseases to reduce the morbidity and mortality associated with this disease in this young population, who are raising families and supporting other family members.”

For their report, Ms. Siegel and colleagues used incidence data from 1995 to 2019 from 50 states and the District of Columbia. The data came from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute and the National Program of Cancer Registries of the U.S. Centers for Disease Control and Prevention, as provided by the North American Association of Central Cancer Registries. National mortality data through 2020 were provided by the National Center for Health Statistics.

The authors note that while overall, deaths from CRC are continuing to fall, “this progress is tempered by a rapidly changing landscape of disease that foreshadows less favorable trends ahead.”

The incidence rates have increased by 2% per year among people younger than 50 years as well as among those aged 50-54 years while, for the past decade, the rates have declined among those aged 65 and older. Incidence rates have stabilized among persons aged 50-64 years.

Although the majority of diagnoses continue to occur among people aged 65 years and older, 19,550 cases (13%) will occur in those younger than age 50 years, and one-third will be diagnosed in those aged 50-64 years.

Other key findings include the following.

• Declines in incidence and mortality have slowed, from 3% to 4% per year during the 2000s to 1% per year for incidence and 2% per year for mortality during the past decade.
• The incidence rate was 33% higher among men than women from 2015 to 2019, which may reflect differences in risk factors, such as excess body weight, processed meat consumption, and a history of smoking.
• The percentage of patients who present with advanced-stage disease has increased from a low of 52% in the mid-2000s to 60% in 2019 despite an increase in the use of screening.
• Death rates from CRC have risen since around 2005 by 1% annually among those younger than 50 years and by 0.6% in people aged 50-54.
• The report also identified racial/ethnic differences in incidence and mortality: Incidence was highest among Alaska Natives (88.5 per 100,000), American Indians (46.0 per 100,000), and Black persons, compared with White persons (41.7 per 100,000 vs. 35.7 per 100,000). Mortality followed a similar pattern; the highest rates were observed among Alaska Natives (50.5 per 100,000), American Indians (17.5 per 100,000), and Black persons, compared with White persons (17.6 per 100,000 vs. 13.1 per 100,000).
• There was also a shift to left-sided tumors, despite greater efficacy of screening for preventing left-sided lesions. The proportion of CRCs occurring in the rectum has steadily risen from 27% in 1995 to 31% in 2019.

“These highly concerning data illustrate the urgent need to invest in targeted cancer research studies dedicated to understanding and preventing early-onset colorectal cancer,” said Karen E. Knudsen, MBA, PhD, and CEO of the American Cancer Society. “The shift to diagnosis of more advanced disease also underscores the importance of screening and early detection, which saves lives.”

The study was supported by the American Cancer Society.

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

The incidence of colorectal cancer (CRC) is rapidly increasing among younger individuals, and the disease is also being diagnosed at more advanced stages in all ages, according to a new report from the American Cancer Society.

Diagnoses in people younger than 55 years doubled from 11% (1 in 10) in 1995 to 20% (1 in 5) in 2019.

In addition, more advanced disease is being diagnosed; the proportion of individuals of all ages presenting with advanced-stage CRC increased from 52% in the mid-2000s to 60% in 2019.

“We know rates are increasing in young people, but it’s alarming to see how rapidly the whole patient population is shifting younger, despite shrinking numbers in the overall population,” said Rebecca Siegel, MPH, senior scientific director of surveillance research at the American Cancer Society and lead author of the report.

“The trend toward more advanced disease in people of all ages is also surprising and should motivate everyone 45 and older to get screened,” she added.

The report was published online in CA: A Cancer Journal for Clinicians.

CRC is the third most commonly diagnosed cancer and the third leading cause of cancer death of both men and women in the United States. It is estimated that there will be 153,020 new cases of CRC in the U.S. in 2023, including 106,970 tumors in the colon and 46,050 in the rectum.

Overall, in 2023, an estimated 153,020 people will be diagnosed with CRC in the U.S., and of those, 52,550 people will die from the disease.

The incidence of CRC rapidly decreased during the 2000s among people aged 50 and older, largely because of an increase in cancer screening with colonoscopy. But progress slowed during the past decade, and now the trends toward declining incidence is largely confined to those aged 65 and older.

The authors point out that more than half of all cases and deaths are associated with modifiable risk factors, including smoking, an unhealthy diet, high alcohol consumption, physical inactivity, and excess body weight. A large proportion of CRC incidence and mortality is preventable through recommended screening, surveillance, and high-quality treatment.

But it remains unclear why rates are rising among younger adults and why there is a trend toward the disase being initially diagnosed at more advanced stages.

“We have to address why the rates in young adults continue to trend in the wrong direction,” said Ahmedin Jemal, DVM, PhD, senior vice president of surveillance and health equity science at the American Cancer Society and senior author of the study. “We need to invest more in research to uncover the causes of the rising trends and to discover new treatment for advanced-stage diseases to reduce the morbidity and mortality associated with this disease in this young population, who are raising families and supporting other family members.”

For their report, Ms. Siegel and colleagues used incidence data from 1995 to 2019 from 50 states and the District of Columbia. The data came from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute and the National Program of Cancer Registries of the U.S. Centers for Disease Control and Prevention, as provided by the North American Association of Central Cancer Registries. National mortality data through 2020 were provided by the National Center for Health Statistics.

The authors note that while overall, deaths from CRC are continuing to fall, “this progress is tempered by a rapidly changing landscape of disease that foreshadows less favorable trends ahead.”

The incidence rates have increased by 2% per year among people younger than 50 years as well as among those aged 50-54 years while, for the past decade, the rates have declined among those aged 65 and older. Incidence rates have stabilized among persons aged 50-64 years.

Although the majority of diagnoses continue to occur among people aged 65 years and older, 19,550 cases (13%) will occur in those younger than age 50 years, and one-third will be diagnosed in those aged 50-64 years.

Other key findings include the following.

• Declines in incidence and mortality have slowed, from 3% to 4% per year during the 2000s to 1% per year for incidence and 2% per year for mortality during the past decade.
• The incidence rate was 33% higher among men than women from 2015 to 2019, which may reflect differences in risk factors, such as excess body weight, processed meat consumption, and a history of smoking.
• The percentage of patients who present with advanced-stage disease has increased from a low of 52% in the mid-2000s to 60% in 2019 despite an increase in the use of screening.
• Death rates from CRC have risen since around 2005 by 1% annually among those younger than 50 years and by 0.6% in people aged 50-54.
• The report also identified racial/ethnic differences in incidence and mortality: Incidence was highest among Alaska Natives (88.5 per 100,000), American Indians (46.0 per 100,000), and Black persons, compared with White persons (41.7 per 100,000 vs. 35.7 per 100,000). Mortality followed a similar pattern; the highest rates were observed among Alaska Natives (50.5 per 100,000), American Indians (17.5 per 100,000), and Black persons, compared with White persons (17.6 per 100,000 vs. 13.1 per 100,000).
• There was also a shift to left-sided tumors, despite greater efficacy of screening for preventing left-sided lesions. The proportion of CRCs occurring in the rectum has steadily risen from 27% in 1995 to 31% in 2019.

“These highly concerning data illustrate the urgent need to invest in targeted cancer research studies dedicated to understanding and preventing early-onset colorectal cancer,” said Karen E. Knudsen, MBA, PhD, and CEO of the American Cancer Society. “The shift to diagnosis of more advanced disease also underscores the importance of screening and early detection, which saves lives.”

The study was supported by the American Cancer Society.

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

The incidence of colorectal cancer (CRC) is rapidly increasing among younger individuals, and the disease is also being diagnosed at more advanced stages in all ages, according to a new report from the American Cancer Society.

Diagnoses in people younger than 55 years doubled from 11% (1 in 10) in 1995 to 20% (1 in 5) in 2019.

In addition, more advanced disease is being diagnosed; the proportion of individuals of all ages presenting with advanced-stage CRC increased from 52% in the mid-2000s to 60% in 2019.

“We know rates are increasing in young people, but it’s alarming to see how rapidly the whole patient population is shifting younger, despite shrinking numbers in the overall population,” said Rebecca Siegel, MPH, senior scientific director of surveillance research at the American Cancer Society and lead author of the report.

“The trend toward more advanced disease in people of all ages is also surprising and should motivate everyone 45 and older to get screened,” she added.

The report was published online in CA: A Cancer Journal for Clinicians.

CRC is the third most commonly diagnosed cancer and the third leading cause of cancer death of both men and women in the United States. It is estimated that there will be 153,020 new cases of CRC in the U.S. in 2023, including 106,970 tumors in the colon and 46,050 in the rectum.

Overall, in 2023, an estimated 153,020 people will be diagnosed with CRC in the U.S., and of those, 52,550 people will die from the disease.

The incidence of CRC rapidly decreased during the 2000s among people aged 50 and older, largely because of an increase in cancer screening with colonoscopy. But progress slowed during the past decade, and now the trends toward declining incidence is largely confined to those aged 65 and older.

The authors point out that more than half of all cases and deaths are associated with modifiable risk factors, including smoking, an unhealthy diet, high alcohol consumption, physical inactivity, and excess body weight. A large proportion of CRC incidence and mortality is preventable through recommended screening, surveillance, and high-quality treatment.

But it remains unclear why rates are rising among younger adults and why there is a trend toward the disase being initially diagnosed at more advanced stages.

“We have to address why the rates in young adults continue to trend in the wrong direction,” said Ahmedin Jemal, DVM, PhD, senior vice president of surveillance and health equity science at the American Cancer Society and senior author of the study. “We need to invest more in research to uncover the causes of the rising trends and to discover new treatment for advanced-stage diseases to reduce the morbidity and mortality associated with this disease in this young population, who are raising families and supporting other family members.”

For their report, Ms. Siegel and colleagues used incidence data from 1995 to 2019 from 50 states and the District of Columbia. The data came from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute and the National Program of Cancer Registries of the U.S. Centers for Disease Control and Prevention, as provided by the North American Association of Central Cancer Registries. National mortality data through 2020 were provided by the National Center for Health Statistics.

The authors note that while overall, deaths from CRC are continuing to fall, “this progress is tempered by a rapidly changing landscape of disease that foreshadows less favorable trends ahead.”

The incidence rates have increased by 2% per year among people younger than 50 years as well as among those aged 50-54 years while, for the past decade, the rates have declined among those aged 65 and older. Incidence rates have stabilized among persons aged 50-64 years.

Although the majority of diagnoses continue to occur among people aged 65 years and older, 19,550 cases (13%) will occur in those younger than age 50 years, and one-third will be diagnosed in those aged 50-64 years.

Other key findings include the following.

• Declines in incidence and mortality have slowed, from 3% to 4% per year during the 2000s to 1% per year for incidence and 2% per year for mortality during the past decade.
• The incidence rate was 33% higher among men than women from 2015 to 2019, which may reflect differences in risk factors, such as excess body weight, processed meat consumption, and a history of smoking.
• The percentage of patients who present with advanced-stage disease has increased from a low of 52% in the mid-2000s to 60% in 2019 despite an increase in the use of screening.
• Death rates from CRC have risen since around 2005 by 1% annually among those younger than 50 years and by 0.6% in people aged 50-54.
• The report also identified racial/ethnic differences in incidence and mortality: Incidence was highest among Alaska Natives (88.5 per 100,000), American Indians (46.0 per 100,000), and Black persons, compared with White persons (41.7 per 100,000 vs. 35.7 per 100,000). Mortality followed a similar pattern; the highest rates were observed among Alaska Natives (50.5 per 100,000), American Indians (17.5 per 100,000), and Black persons, compared with White persons (17.6 per 100,000 vs. 13.1 per 100,000).
• There was also a shift to left-sided tumors, despite greater efficacy of screening for preventing left-sided lesions. The proportion of CRCs occurring in the rectum has steadily risen from 27% in 1995 to 31% in 2019.

“These highly concerning data illustrate the urgent need to invest in targeted cancer research studies dedicated to understanding and preventing early-onset colorectal cancer,” said Karen E. Knudsen, MBA, PhD, and CEO of the American Cancer Society. “The shift to diagnosis of more advanced disease also underscores the importance of screening and early detection, which saves lives.”

The study was supported by the American Cancer Society.

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

Surgeon goes the extra half mile for his patient

Sorry medical profession, but it’s Adam Bodzin’s world now. When a donor liver got stuck in the middle of the Philadelphia Half Marathon’s 30,000 participants, Dr. Bodzin, the transplant team’s lead surgeon, took matters into his own hands. And by hands, of course, we mean feet.

Pixnio

Still wearing his hospital scrubs, Dr. Bodzin ran more than half a mile to where the van carrying the liver was stranded, according to the Philadelphia Inquirer. Fortunately, he was able to hitch a ride in a police car for the return trip and didn’t have to run back through the crowd carrying his somewhat unusual package. By package, of course, we mean human liver.

It’s been 3 months since the surgery/marathon and it’s still not clear why the driver had such trouble getting through – he had been trying for more than an hour and half by the time Dr. Bodzin reached him – but the surgery half of the big event was deemed a success and the patient has recovered.

Rick Hasz, president and chief executive officer of the Gift of Life Donor Program, which coordinates organ donation for transplants in the Philadelphia region, told the newspaper that “Dr. Bodzin’s quick action demonstrated his commitment to honoring the selfless generosity of all donors and their families and gives hope to everyone waiting for a second chance at life.”

Should Dr. Bodzin consider a step up from the transplant team to another group that’s fighting for the common good? The recipient of the liver in question seems to think so. “I guess he has a cape on under that white jacket,” 66-year-old Charles Rowe told Fox29. You already know where we’re going with this, right?

Avengers … Assemble.
 

Your spleen’s due for its 5,000-mile oil change

The human body is an incredible biological machine, capable of performing a countless array of tasks automatically and essentially without flaw, but there’s always room for improvement. After all, there are animals that can regrow entire missing limbs or live for up to 500 years. It would be nice if we could get some of that going.

Sigmund/Unsplash

Rather than any of that cool stuff, a recent survey of 2,000 average Americans revealed that our ambitions for improving the human body are a bit more mundane. The big thing that would make our lives better and easier, according to three-fourths of Americans, would be a built-in “check engine” light in our bodies. Come on guys, starfish can literally be cut in half and not only survive, but become two starfish. Mantis shrimp can punch with a force thousands of times their own weight. If we could punch like they could, we could literally break steel with our fists. Wouldn’t we rather have that?

Apparently not. Fine, we’ll stick with the check engine light.

Maybe it isn’t a huge surprise that we’d like the extra help in figuring out what our body needs. According to the survey, more than 60% of Americans struggle to identify when their body is trying to tell them something important, and only one-third actively checked in with their health every day. Considering about 40% said they feel tired for much of the day and nearly half reported not having a meal with fruits or vegetables in the past 3 days, perhaps a gentle reminder wouldn’t be the worst thing in the world.

So, if we did have a built-in check engine light, what would we use it for? A majority said they’d like to be reminded to drink a glass of water, with 45% saying they wanted to know when to take a nap. Feeling thirsty or tired isn’t quite enough, it seems.

Of course, the technology certainly exists to make the human check engine light a reality. An implanted microchip could absolutely tell us to drink a glass of water, but that would put our health in the hands of tech companies, and you just know Meta and Elon Muskrat wouldn’t pass up the chance for monetization. “Oh, sorry, we could have notified the hospital that you were about to have a heart attack, but you didn’t pay your life subscription this month.”
 

Sext offenders show more than their, well, you know

As we have become more and more attached to our phones, especially post pandemic, it’s no surprise that sexting – sending sexually explicit images and messages with those phones – has become a fairly common way for people to sexually communicate. And with dating apps just another venture in the dating landscape, regardless of age, sexting is an easy avenue to incite a mood without being physically present.

©agmit/istockphoto.com

A recent study, though, has linked sexting with anxiety, sleep issues, depression, and compulsive sexual behaviors. Yikes.

Although the researchers noted that sexting was primarily reciprocal (sending and receiving), “over 50% of adults report sending a sext, while women are up to four times more likely than men to report having received nonconsensual sexts,” said Brenda K. Wiederhold, PhD, editor-in-chief of Cyberpsychology, Behavior, and Social Networking, which published the study, in which Dr. Wiederhold was not involved.

Among the 2,160 U.S. college students who were involved, participants who had only sent sexts reported more anxiety, depression, and sleep problems than other groups (no sexting, received only, reciprocal). There was also a possible connection between sexting, marijuana use, and compulsive sexual behavior, the investigators said in a written statement.

Considering the study population, these data are perhaps not that surprising. For young adults, to receive or send an elusive nude is as common as it once was to give someone flowers. Not that the two things elicit the same reactions. “Many individuals reveal they enjoy consensual sexting and feel it empowers them and builds self-confidence,” Dr. Wiederhold added.

Receiving a nonconsensual sext, though, is definitely going to result in feeling violated and super awkward. Senders beware: Don’t be surprised if you’re ghosted after that.

Surgeon goes the extra half mile for his patient

Sorry medical profession, but it’s Adam Bodzin’s world now. When a donor liver got stuck in the middle of the Philadelphia Half Marathon’s 30,000 participants, Dr. Bodzin, the transplant team’s lead surgeon, took matters into his own hands. And by hands, of course, we mean feet.

Pixnio

Still wearing his hospital scrubs, Dr. Bodzin ran more than half a mile to where the van carrying the liver was stranded, according to the Philadelphia Inquirer. Fortunately, he was able to hitch a ride in a police car for the return trip and didn’t have to run back through the crowd carrying his somewhat unusual package. By package, of course, we mean human liver.

It’s been 3 months since the surgery/marathon and it’s still not clear why the driver had such trouble getting through – he had been trying for more than an hour and half by the time Dr. Bodzin reached him – but the surgery half of the big event was deemed a success and the patient has recovered.

Rick Hasz, president and chief executive officer of the Gift of Life Donor Program, which coordinates organ donation for transplants in the Philadelphia region, told the newspaper that “Dr. Bodzin’s quick action demonstrated his commitment to honoring the selfless generosity of all donors and their families and gives hope to everyone waiting for a second chance at life.”

Should Dr. Bodzin consider a step up from the transplant team to another group that’s fighting for the common good? The recipient of the liver in question seems to think so. “I guess he has a cape on under that white jacket,” 66-year-old Charles Rowe told Fox29. You already know where we’re going with this, right?

Avengers … Assemble.
 

Your spleen’s due for its 5,000-mile oil change

The human body is an incredible biological machine, capable of performing a countless array of tasks automatically and essentially without flaw, but there’s always room for improvement. After all, there are animals that can regrow entire missing limbs or live for up to 500 years. It would be nice if we could get some of that going.

Sigmund/Unsplash

Rather than any of that cool stuff, a recent survey of 2,000 average Americans revealed that our ambitions for improving the human body are a bit more mundane. The big thing that would make our lives better and easier, according to three-fourths of Americans, would be a built-in “check engine” light in our bodies. Come on guys, starfish can literally be cut in half and not only survive, but become two starfish. Mantis shrimp can punch with a force thousands of times their own weight. If we could punch like they could, we could literally break steel with our fists. Wouldn’t we rather have that?

Apparently not. Fine, we’ll stick with the check engine light.

Maybe it isn’t a huge surprise that we’d like the extra help in figuring out what our body needs. According to the survey, more than 60% of Americans struggle to identify when their body is trying to tell them something important, and only one-third actively checked in with their health every day. Considering about 40% said they feel tired for much of the day and nearly half reported not having a meal with fruits or vegetables in the past 3 days, perhaps a gentle reminder wouldn’t be the worst thing in the world.

So, if we did have a built-in check engine light, what would we use it for? A majority said they’d like to be reminded to drink a glass of water, with 45% saying they wanted to know when to take a nap. Feeling thirsty or tired isn’t quite enough, it seems.

Of course, the technology certainly exists to make the human check engine light a reality. An implanted microchip could absolutely tell us to drink a glass of water, but that would put our health in the hands of tech companies, and you just know Meta and Elon Muskrat wouldn’t pass up the chance for monetization. “Oh, sorry, we could have notified the hospital that you were about to have a heart attack, but you didn’t pay your life subscription this month.”
 

Sext offenders show more than their, well, you know

As we have become more and more attached to our phones, especially post pandemic, it’s no surprise that sexting – sending sexually explicit images and messages with those phones – has become a fairly common way for people to sexually communicate. And with dating apps just another venture in the dating landscape, regardless of age, sexting is an easy avenue to incite a mood without being physically present.

©agmit/istockphoto.com

A recent study, though, has linked sexting with anxiety, sleep issues, depression, and compulsive sexual behaviors. Yikes.

Although the researchers noted that sexting was primarily reciprocal (sending and receiving), “over 50% of adults report sending a sext, while women are up to four times more likely than men to report having received nonconsensual sexts,” said Brenda K. Wiederhold, PhD, editor-in-chief of Cyberpsychology, Behavior, and Social Networking, which published the study, in which Dr. Wiederhold was not involved.

Among the 2,160 U.S. college students who were involved, participants who had only sent sexts reported more anxiety, depression, and sleep problems than other groups (no sexting, received only, reciprocal). There was also a possible connection between sexting, marijuana use, and compulsive sexual behavior, the investigators said in a written statement.

Considering the study population, these data are perhaps not that surprising. For young adults, to receive or send an elusive nude is as common as it once was to give someone flowers. Not that the two things elicit the same reactions. “Many individuals reveal they enjoy consensual sexting and feel it empowers them and builds self-confidence,” Dr. Wiederhold added.

Receiving a nonconsensual sext, though, is definitely going to result in feeling violated and super awkward. Senders beware: Don’t be surprised if you’re ghosted after that.

Surgeon goes the extra half mile for his patient

Sorry medical profession, but it’s Adam Bodzin’s world now. When a donor liver got stuck in the middle of the Philadelphia Half Marathon’s 30,000 participants, Dr. Bodzin, the transplant team’s lead surgeon, took matters into his own hands. And by hands, of course, we mean feet.

Pixnio

Still wearing his hospital scrubs, Dr. Bodzin ran more than half a mile to where the van carrying the liver was stranded, according to the Philadelphia Inquirer. Fortunately, he was able to hitch a ride in a police car for the return trip and didn’t have to run back through the crowd carrying his somewhat unusual package. By package, of course, we mean human liver.

It’s been 3 months since the surgery/marathon and it’s still not clear why the driver had such trouble getting through – he had been trying for more than an hour and half by the time Dr. Bodzin reached him – but the surgery half of the big event was deemed a success and the patient has recovered.

Rick Hasz, president and chief executive officer of the Gift of Life Donor Program, which coordinates organ donation for transplants in the Philadelphia region, told the newspaper that “Dr. Bodzin’s quick action demonstrated his commitment to honoring the selfless generosity of all donors and their families and gives hope to everyone waiting for a second chance at life.”

Should Dr. Bodzin consider a step up from the transplant team to another group that’s fighting for the common good? The recipient of the liver in question seems to think so. “I guess he has a cape on under that white jacket,” 66-year-old Charles Rowe told Fox29. You already know where we’re going with this, right?

Avengers … Assemble.
 

Your spleen’s due for its 5,000-mile oil change

The human body is an incredible biological machine, capable of performing a countless array of tasks automatically and essentially without flaw, but there’s always room for improvement. After all, there are animals that can regrow entire missing limbs or live for up to 500 years. It would be nice if we could get some of that going.

Sigmund/Unsplash

Rather than any of that cool stuff, a recent survey of 2,000 average Americans revealed that our ambitions for improving the human body are a bit more mundane. The big thing that would make our lives better and easier, according to three-fourths of Americans, would be a built-in “check engine” light in our bodies. Come on guys, starfish can literally be cut in half and not only survive, but become two starfish. Mantis shrimp can punch with a force thousands of times their own weight. If we could punch like they could, we could literally break steel with our fists. Wouldn’t we rather have that?

Apparently not. Fine, we’ll stick with the check engine light.

Maybe it isn’t a huge surprise that we’d like the extra help in figuring out what our body needs. According to the survey, more than 60% of Americans struggle to identify when their body is trying to tell them something important, and only one-third actively checked in with their health every day. Considering about 40% said they feel tired for much of the day and nearly half reported not having a meal with fruits or vegetables in the past 3 days, perhaps a gentle reminder wouldn’t be the worst thing in the world.

So, if we did have a built-in check engine light, what would we use it for? A majority said they’d like to be reminded to drink a glass of water, with 45% saying they wanted to know when to take a nap. Feeling thirsty or tired isn’t quite enough, it seems.

Of course, the technology certainly exists to make the human check engine light a reality. An implanted microchip could absolutely tell us to drink a glass of water, but that would put our health in the hands of tech companies, and you just know Meta and Elon Muskrat wouldn’t pass up the chance for monetization. “Oh, sorry, we could have notified the hospital that you were about to have a heart attack, but you didn’t pay your life subscription this month.”
 

Sext offenders show more than their, well, you know

As we have become more and more attached to our phones, especially post pandemic, it’s no surprise that sexting – sending sexually explicit images and messages with those phones – has become a fairly common way for people to sexually communicate. And with dating apps just another venture in the dating landscape, regardless of age, sexting is an easy avenue to incite a mood without being physically present.

©agmit/istockphoto.com

A recent study, though, has linked sexting with anxiety, sleep issues, depression, and compulsive sexual behaviors. Yikes.

Although the researchers noted that sexting was primarily reciprocal (sending and receiving), “over 50% of adults report sending a sext, while women are up to four times more likely than men to report having received nonconsensual sexts,” said Brenda K. Wiederhold, PhD, editor-in-chief of Cyberpsychology, Behavior, and Social Networking, which published the study, in which Dr. Wiederhold was not involved.

Among the 2,160 U.S. college students who were involved, participants who had only sent sexts reported more anxiety, depression, and sleep problems than other groups (no sexting, received only, reciprocal). There was also a possible connection between sexting, marijuana use, and compulsive sexual behavior, the investigators said in a written statement.

Considering the study population, these data are perhaps not that surprising. For young adults, to receive or send an elusive nude is as common as it once was to give someone flowers. Not that the two things elicit the same reactions. “Many individuals reveal they enjoy consensual sexting and feel it empowers them and builds self-confidence,” Dr. Wiederhold added.

Receiving a nonconsensual sext, though, is definitely going to result in feeling violated and super awkward. Senders beware: Don’t be surprised if you’re ghosted after that.

Emergencies happen anywhere, anytime, and sometimes medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

In December 2017, I was a second-year urology resident at Cleveland Clinic. I’d gone to New Delhi to attend my best friend’s wedding. My flight back was New Delhi to Paris to JFK via Air France. I didn’t sleep on the first flight. So, on the second, I wanted to get some rest, because I had to go back to work the next day. I put on a movie and tried to snooze. As the saying goes in residency, you sleep when you can.

About 3 hours later, a flight attendant made an announcement in French, but I didn’t really hear it. Then they announced in English that they needed a physician. I noticed some flight attendants walking frantically around the economy cabin asking, “Is there a doctor on the plane?” Turns out there were two – the woman sitting next to me happened to be a pediatrician with Doctors Without Borders. I volunteered.

The flight attendant told me a woman was having abdominal pain. I thought it would be something straightforward. Usually, medical emergencies on planes involve chest pain or a panic attack or a vasovagal syncopal episode. Well, I was in for a ride that day.

The woman in pain was traveling from Nigeria. She told me about the abdominal pain. Then she lifted her blanket – she was pregnant. She said she was 37 or 38 weeks in. I said, “Okay, if you’re having this significant abdominal pain, then I need to examine you.” So we decided to move her to the first-class cabin, which was empty (I never did ask why – but it was good we had room to work).

Next step, I went back to my seat and asked the pediatrician if she could assist. My plan was to simply get the passenger through the flight, and as soon as we landed, she would go to the hospital.

There was room to lie down in first class. The pediatrician and I examined her, and she appeared fine. She was traveling with her 4-year-old daughter, and the flight attendants were taking care of her. Everything was okay.

The pilot came back and asked if we would need an emergency landing. I asked him how far it was to JFK – 4 hours. He said the closest place to land would be the Azores Islands, which is Portuguese territory, 2 hours away.

The problem: Even if we made it to the Azores, the hospital there was a very basic facility with no obstetric care available. And by the time the ambulance picked her up and got her there, it would still be 2 or 3 hours total. I said, “No, let’s just observe and continue our course.” Inside my head, I was hoping and praying to God that was the right decision.

Within an hour, everything changed.

The woman’s pain got worse, and she started having contractions. Then her water broke.

Things progressed quickly from there. The contractions progressively got worse and worse. The interval between them got smaller and smaller. The next time we examined her, we could see the baby’s head beginning to crown.

At that point, we had to decide – are we going to deliver? We were in the middle of the North Atlantic Ocean. There was nothing around us. We were 35,000 feet in the air, surrounded by blue.

The crew wanted us to sign a Good Samaritan agreement. So, we did that. And then I said, “Okay, let’s just go for it.”

We got the plane’s medical kit. They had IV fluids, so I started an IV. I was able to monitor the woman’s blood pressure. They had the usual drugs for doing ACLS [advanced cardiac life support], running the code, and things like that. But they didn’t have a suturing kit or a laceration kit. They didn’t have a scalpel. There was nothing else.

Honestly, there was a lot of panic going through my head. I started thinking about what could go wrong. I’d done an ob.gyn. rotation in medical school and delivered seven babies before it was over. But a plane – even the first-class cabin – is in no way, shape, or form like a delivery room. I was really scared she would hemorrhage out or something.

So, internally, I was having a meltdown. Sij, you have to keep it together right now, because there’s no one else that’s going to do this. Just give it your best shot. And that’s what I did.

I asked the pilot to go to an altitude that would minimize any turbulence, and we were very lucky that the notorious North Atlantic air wasn’t choppy.

More luck: This was the passenger’s second baby, and I was counting on second deliveries being easier. The pediatrician, the flight attendants, and I came together as a team. Two flight attendants had given birth before, so they held the patient’s hand and guided her to push. I was “downstairs” waiting to catch.

She was in some pain. At this point, usually people get an epidural. I kept thinking about what drugs were safe in pregnancy, but I wasn’t sure. I don’t know if they even had morphine or anything on the plane. We gave her some Tylenol.

It didn’t take long. After about 30 minutes, the baby’s head emerged. I was able to navigate it out, avoiding any shoulder dystocia. There’s a certain technique that you learn in medical school, which thankfully came back to me. I caught it – it was a boy born right there in a first-class seat.

I gave him to the pediatrician, and she did the Apgar score, calculating his breathing and appearance. Then my job was to make sure there were no postpartum complications.

I ended up using a piece of string in the kit to tie around the umbilical cord, and then I cut it with scissors. After that, the woman was able to deliver the placenta. She did have some vaginal bleeding, but that resolved by just holding pressure.

The baby was fine. Mom was doing great. No complications. It was a miracle. I was the right person at the right place at the right time. I just think it was something from God.

The pilot made an announcement, “We’re en route to JFK, and there’s an additional passenger on this plane now.”

When we landed, I had very little time because I had to catch my flight to Cleveland. I didn’t even process what had happened.

A few days later, I got this package from Air France with a very expensive bottle of champagne along with a travel voucher. I heard from the mom by email – she and baby were doing fine.

Eventually, the media relations people at Cleveland Clinic heard about the incident, and it became a story that went viral. That was very weird, because I’m usually someone who’s private. All through my residency, people would introduce me with, “Remember that guy who delivered a baby on a plane? That’s him.”

I’m so thankful for everyone who was on that team. It was very beautiful because it was people from different cultures, backgrounds, and faiths who came together to achieve something so miraculous. The patient was Nigerian. The flight attendants were French. The pediatrician and I were American.

That just shows you the power of teamwork and how humanity can come together. Medicine, surgery – everything, in fact – is a team sport.

Sij Hemal, MD, graduated from urology residency at the Cleveland Clinic and is currently a robotic urologic oncology and minimally invasive surgery fellow at the University of Southern California, Los Angeles.

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

Emergencies happen anywhere, anytime, and sometimes medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

In December 2017, I was a second-year urology resident at Cleveland Clinic. I’d gone to New Delhi to attend my best friend’s wedding. My flight back was New Delhi to Paris to JFK via Air France. I didn’t sleep on the first flight. So, on the second, I wanted to get some rest, because I had to go back to work the next day. I put on a movie and tried to snooze. As the saying goes in residency, you sleep when you can.

About 3 hours later, a flight attendant made an announcement in French, but I didn’t really hear it. Then they announced in English that they needed a physician. I noticed some flight attendants walking frantically around the economy cabin asking, “Is there a doctor on the plane?” Turns out there were two – the woman sitting next to me happened to be a pediatrician with Doctors Without Borders. I volunteered.

The flight attendant told me a woman was having abdominal pain. I thought it would be something straightforward. Usually, medical emergencies on planes involve chest pain or a panic attack or a vasovagal syncopal episode. Well, I was in for a ride that day.

The woman in pain was traveling from Nigeria. She told me about the abdominal pain. Then she lifted her blanket – she was pregnant. She said she was 37 or 38 weeks in. I said, “Okay, if you’re having this significant abdominal pain, then I need to examine you.” So we decided to move her to the first-class cabin, which was empty (I never did ask why – but it was good we had room to work).

Next step, I went back to my seat and asked the pediatrician if she could assist. My plan was to simply get the passenger through the flight, and as soon as we landed, she would go to the hospital.

There was room to lie down in first class. The pediatrician and I examined her, and she appeared fine. She was traveling with her 4-year-old daughter, and the flight attendants were taking care of her. Everything was okay.

The pilot came back and asked if we would need an emergency landing. I asked him how far it was to JFK – 4 hours. He said the closest place to land would be the Azores Islands, which is Portuguese territory, 2 hours away.

The problem: Even if we made it to the Azores, the hospital there was a very basic facility with no obstetric care available. And by the time the ambulance picked her up and got her there, it would still be 2 or 3 hours total. I said, “No, let’s just observe and continue our course.” Inside my head, I was hoping and praying to God that was the right decision.

Within an hour, everything changed.

The woman’s pain got worse, and she started having contractions. Then her water broke.

Things progressed quickly from there. The contractions progressively got worse and worse. The interval between them got smaller and smaller. The next time we examined her, we could see the baby’s head beginning to crown.

At that point, we had to decide – are we going to deliver? We were in the middle of the North Atlantic Ocean. There was nothing around us. We were 35,000 feet in the air, surrounded by blue.

The crew wanted us to sign a Good Samaritan agreement. So, we did that. And then I said, “Okay, let’s just go for it.”

We got the plane’s medical kit. They had IV fluids, so I started an IV. I was able to monitor the woman’s blood pressure. They had the usual drugs for doing ACLS [advanced cardiac life support], running the code, and things like that. But they didn’t have a suturing kit or a laceration kit. They didn’t have a scalpel. There was nothing else.

Honestly, there was a lot of panic going through my head. I started thinking about what could go wrong. I’d done an ob.gyn. rotation in medical school and delivered seven babies before it was over. But a plane – even the first-class cabin – is in no way, shape, or form like a delivery room. I was really scared she would hemorrhage out or something.

So, internally, I was having a meltdown. Sij, you have to keep it together right now, because there’s no one else that’s going to do this. Just give it your best shot. And that’s what I did.

I asked the pilot to go to an altitude that would minimize any turbulence, and we were very lucky that the notorious North Atlantic air wasn’t choppy.

More luck: This was the passenger’s second baby, and I was counting on second deliveries being easier. The pediatrician, the flight attendants, and I came together as a team. Two flight attendants had given birth before, so they held the patient’s hand and guided her to push. I was “downstairs” waiting to catch.

She was in some pain. At this point, usually people get an epidural. I kept thinking about what drugs were safe in pregnancy, but I wasn’t sure. I don’t know if they even had morphine or anything on the plane. We gave her some Tylenol.

It didn’t take long. After about 30 minutes, the baby’s head emerged. I was able to navigate it out, avoiding any shoulder dystocia. There’s a certain technique that you learn in medical school, which thankfully came back to me. I caught it – it was a boy born right there in a first-class seat.

I gave him to the pediatrician, and she did the Apgar score, calculating his breathing and appearance. Then my job was to make sure there were no postpartum complications.

I ended up using a piece of string in the kit to tie around the umbilical cord, and then I cut it with scissors. After that, the woman was able to deliver the placenta. She did have some vaginal bleeding, but that resolved by just holding pressure.

The baby was fine. Mom was doing great. No complications. It was a miracle. I was the right person at the right place at the right time. I just think it was something from God.

The pilot made an announcement, “We’re en route to JFK, and there’s an additional passenger on this plane now.”

When we landed, I had very little time because I had to catch my flight to Cleveland. I didn’t even process what had happened.

A few days later, I got this package from Air France with a very expensive bottle of champagne along with a travel voucher. I heard from the mom by email – she and baby were doing fine.

Eventually, the media relations people at Cleveland Clinic heard about the incident, and it became a story that went viral. That was very weird, because I’m usually someone who’s private. All through my residency, people would introduce me with, “Remember that guy who delivered a baby on a plane? That’s him.”

I’m so thankful for everyone who was on that team. It was very beautiful because it was people from different cultures, backgrounds, and faiths who came together to achieve something so miraculous. The patient was Nigerian. The flight attendants were French. The pediatrician and I were American.

That just shows you the power of teamwork and how humanity can come together. Medicine, surgery – everything, in fact – is a team sport.

Sij Hemal, MD, graduated from urology residency at the Cleveland Clinic and is currently a robotic urologic oncology and minimally invasive surgery fellow at the University of Southern California, Los Angeles.

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

Emergencies happen anywhere, anytime, and sometimes medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

In December 2017, I was a second-year urology resident at Cleveland Clinic. I’d gone to New Delhi to attend my best friend’s wedding. My flight back was New Delhi to Paris to JFK via Air France. I didn’t sleep on the first flight. So, on the second, I wanted to get some rest, because I had to go back to work the next day. I put on a movie and tried to snooze. As the saying goes in residency, you sleep when you can.

About 3 hours later, a flight attendant made an announcement in French, but I didn’t really hear it. Then they announced in English that they needed a physician. I noticed some flight attendants walking frantically around the economy cabin asking, “Is there a doctor on the plane?” Turns out there were two – the woman sitting next to me happened to be a pediatrician with Doctors Without Borders. I volunteered.

The flight attendant told me a woman was having abdominal pain. I thought it would be something straightforward. Usually, medical emergencies on planes involve chest pain or a panic attack or a vasovagal syncopal episode. Well, I was in for a ride that day.

The woman in pain was traveling from Nigeria. She told me about the abdominal pain. Then she lifted her blanket – she was pregnant. She said she was 37 or 38 weeks in. I said, “Okay, if you’re having this significant abdominal pain, then I need to examine you.” So we decided to move her to the first-class cabin, which was empty (I never did ask why – but it was good we had room to work).

Next step, I went back to my seat and asked the pediatrician if she could assist. My plan was to simply get the passenger through the flight, and as soon as we landed, she would go to the hospital.

There was room to lie down in first class. The pediatrician and I examined her, and she appeared fine. She was traveling with her 4-year-old daughter, and the flight attendants were taking care of her. Everything was okay.

The pilot came back and asked if we would need an emergency landing. I asked him how far it was to JFK – 4 hours. He said the closest place to land would be the Azores Islands, which is Portuguese territory, 2 hours away.

The problem: Even if we made it to the Azores, the hospital there was a very basic facility with no obstetric care available. And by the time the ambulance picked her up and got her there, it would still be 2 or 3 hours total. I said, “No, let’s just observe and continue our course.” Inside my head, I was hoping and praying to God that was the right decision.

Within an hour, everything changed.

The woman’s pain got worse, and she started having contractions. Then her water broke.

Things progressed quickly from there. The contractions progressively got worse and worse. The interval between them got smaller and smaller. The next time we examined her, we could see the baby’s head beginning to crown.

At that point, we had to decide – are we going to deliver? We were in the middle of the North Atlantic Ocean. There was nothing around us. We were 35,000 feet in the air, surrounded by blue.

The crew wanted us to sign a Good Samaritan agreement. So, we did that. And then I said, “Okay, let’s just go for it.”

We got the plane’s medical kit. They had IV fluids, so I started an IV. I was able to monitor the woman’s blood pressure. They had the usual drugs for doing ACLS [advanced cardiac life support], running the code, and things like that. But they didn’t have a suturing kit or a laceration kit. They didn’t have a scalpel. There was nothing else.

Honestly, there was a lot of panic going through my head. I started thinking about what could go wrong. I’d done an ob.gyn. rotation in medical school and delivered seven babies before it was over. But a plane – even the first-class cabin – is in no way, shape, or form like a delivery room. I was really scared she would hemorrhage out or something.

So, internally, I was having a meltdown. Sij, you have to keep it together right now, because there’s no one else that’s going to do this. Just give it your best shot. And that’s what I did.

I asked the pilot to go to an altitude that would minimize any turbulence, and we were very lucky that the notorious North Atlantic air wasn’t choppy.

More luck: This was the passenger’s second baby, and I was counting on second deliveries being easier. The pediatrician, the flight attendants, and I came together as a team. Two flight attendants had given birth before, so they held the patient’s hand and guided her to push. I was “downstairs” waiting to catch.

She was in some pain. At this point, usually people get an epidural. I kept thinking about what drugs were safe in pregnancy, but I wasn’t sure. I don’t know if they even had morphine or anything on the plane. We gave her some Tylenol.

It didn’t take long. After about 30 minutes, the baby’s head emerged. I was able to navigate it out, avoiding any shoulder dystocia. There’s a certain technique that you learn in medical school, which thankfully came back to me. I caught it – it was a boy born right there in a first-class seat.

I gave him to the pediatrician, and she did the Apgar score, calculating his breathing and appearance. Then my job was to make sure there were no postpartum complications.

I ended up using a piece of string in the kit to tie around the umbilical cord, and then I cut it with scissors. After that, the woman was able to deliver the placenta. She did have some vaginal bleeding, but that resolved by just holding pressure.

The baby was fine. Mom was doing great. No complications. It was a miracle. I was the right person at the right place at the right time. I just think it was something from God.

The pilot made an announcement, “We’re en route to JFK, and there’s an additional passenger on this plane now.”

When we landed, I had very little time because I had to catch my flight to Cleveland. I didn’t even process what had happened.

A few days later, I got this package from Air France with a very expensive bottle of champagne along with a travel voucher. I heard from the mom by email – she and baby were doing fine.

Eventually, the media relations people at Cleveland Clinic heard about the incident, and it became a story that went viral. That was very weird, because I’m usually someone who’s private. All through my residency, people would introduce me with, “Remember that guy who delivered a baby on a plane? That’s him.”

I’m so thankful for everyone who was on that team. It was very beautiful because it was people from different cultures, backgrounds, and faiths who came together to achieve something so miraculous. The patient was Nigerian. The flight attendants were French. The pediatrician and I were American.

That just shows you the power of teamwork and how humanity can come together. Medicine, surgery – everything, in fact – is a team sport.

Sij Hemal, MD, graduated from urology residency at the Cleveland Clinic and is currently a robotic urologic oncology and minimally invasive surgery fellow at the University of Southern California, Los Angeles.

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

Health officials are warning that an increase in the drug-resistant form of the bacteria Shigella is a “serious public health threat.”

The CDC issued the warning Feb. 24 about the rise in the problematic infections. Most of them have been seen in men who have sex with men, but a small number have also occurred in women and in young children.

The bacteria can be spread in a variety of ways, including changing the diaper of an infected baby, touching your mouth when the bacteria are on your hands, eating or drinking contaminated food or water, or through sexual contact. It’s easily transmitted because just a tiny amount of the bacteria is enough to make someone sick.

Shigella infection causes diarrhea that can be bloody. Other symptoms are a fever, belly cramping, and the feeling that you have to poop but your bowels are already empty. Most people recover on their own with rest and fluids, and severe cases can need antibiotic treatment. But strains of the bacteria that are resistant to treatment are on the rise.

Between 2015 and 2022, cases of antibiotic-resistant Shigella infection rose from 0% to 5% of all Shigella cases in the United States. One analysis showed that 82% of cases were in men, 13% in women, and 5% in children. A small sample of affected people provided information about their sexual activity, and 88% of them reported male-to-male sexual contact.

People at increased risk of infections are young children, people who are homeless, international travelers, people who have weakened immune systems, people living with HIV, and men who have sex with men.

The CDC asked health care workers to be on the lookout for these infections and report them.

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

Health officials are warning that an increase in the drug-resistant form of the bacteria Shigella is a “serious public health threat.”

The CDC issued the warning Feb. 24 about the rise in the problematic infections. Most of them have been seen in men who have sex with men, but a small number have also occurred in women and in young children.

The bacteria can be spread in a variety of ways, including changing the diaper of an infected baby, touching your mouth when the bacteria are on your hands, eating or drinking contaminated food or water, or through sexual contact. It’s easily transmitted because just a tiny amount of the bacteria is enough to make someone sick.

Shigella infection causes diarrhea that can be bloody. Other symptoms are a fever, belly cramping, and the feeling that you have to poop but your bowels are already empty. Most people recover on their own with rest and fluids, and severe cases can need antibiotic treatment. But strains of the bacteria that are resistant to treatment are on the rise.

Between 2015 and 2022, cases of antibiotic-resistant Shigella infection rose from 0% to 5% of all Shigella cases in the United States. One analysis showed that 82% of cases were in men, 13% in women, and 5% in children. A small sample of affected people provided information about their sexual activity, and 88% of them reported male-to-male sexual contact.

People at increased risk of infections are young children, people who are homeless, international travelers, people who have weakened immune systems, people living with HIV, and men who have sex with men.

The CDC asked health care workers to be on the lookout for these infections and report them.

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

Health officials are warning that an increase in the drug-resistant form of the bacteria Shigella is a “serious public health threat.”

The CDC issued the warning Feb. 24 about the rise in the problematic infections. Most of them have been seen in men who have sex with men, but a small number have also occurred in women and in young children.

The bacteria can be spread in a variety of ways, including changing the diaper of an infected baby, touching your mouth when the bacteria are on your hands, eating or drinking contaminated food or water, or through sexual contact. It’s easily transmitted because just a tiny amount of the bacteria is enough to make someone sick.

Shigella infection causes diarrhea that can be bloody. Other symptoms are a fever, belly cramping, and the feeling that you have to poop but your bowels are already empty. Most people recover on their own with rest and fluids, and severe cases can need antibiotic treatment. But strains of the bacteria that are resistant to treatment are on the rise.

Between 2015 and 2022, cases of antibiotic-resistant Shigella infection rose from 0% to 5% of all Shigella cases in the United States. One analysis showed that 82% of cases were in men, 13% in women, and 5% in children. A small sample of affected people provided information about their sexual activity, and 88% of them reported male-to-male sexual contact.

People at increased risk of infections are young children, people who are homeless, international travelers, people who have weakened immune systems, people living with HIV, and men who have sex with men.

The CDC asked health care workers to be on the lookout for these infections and report them.

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

Considered fringe just a few years ago, oral immunotherapy (OIT) has entered mainstream conversation about treating food allergies – particularly in younger children.

The buzz surrounding OIT – which involves ingesting daily doses of the culprit food to raise the threshold that would trigger a reaction – grew with the approval, by the U.S. Food and Drug Administration of Palforzia, of the peanut OIT pill in January 2020. Yet many allergists remained wary about the treatment, a monthslong regimen that can itself trigger allergic reactions.

Now, accumulating research points to “a possible window of opportunity early in life, less than 3 years of age, for more successful disease remission,” Justin Schwartz, MD, PhD, an allergist at Cincinnati Children’s Hospital, told a crowd at the annual meeting of the American Academy of Allergy, Asthma, & Immunology.

His presentation about OIT in toddlers kicked off a 3-hour clinical practice course, one of several dozen conference offerings highlighting this emerging approach.

Several AAAAI posters add to prior studies (for example, DEVIL and IMPACT) suggesting that OIT proceeds more smoothly and faster during a child’s earliest years – a season fraught with accidental exposures and reactions.

One poster described a retrospective study of 73 children younger than 4 years who underwent OIT at the Cleveland Clinic Food Allergy Center. Sixty-four were treated for peanut allergies, and seven patients received OIT for multiple foods, including tree nuts, milk, wheat, and sesame.

Of the 80 total OIT courses, 76 (95%) reached maintenance – meaning the child tolerated a small amount (for example, 1-2 peanuts) without reacting – in a median of 104 days (~3.4 months).

That is “quite impressive,” said allergist Hugh Windom, MD, whose clinic in Sarasota, Fla., has offered OIT since 2012.

Older children typically have 80%-90% success and take longer (6-8 months) to reach maintenance because of busier schedules and reactions that slow them down, he said. In his clinic’s larger retrospective analysis of preschool-aged OIT patients, presented at the 2022 AAAAI meeting, 89% of patients with peanut allergies and 72% of children with multiple food allergies achieved maintenance.

In the Cleveland Clinic study, children with favorable lab test results after receiving the maintenance dose for 6 months were offered an oral food challenge. Of 24 patients who completed the challenge, 75% “passed with a normal serving size of the treated food (for example, two tablespoons of peanut butter),” Sarah Johnson, MD, lead author and Cleveland Clinic allergy/immunology fellow, said in an interview.

Plus, OIT seemed safer for toddlers. Although 41% of the children had reactions during clinic updosing and 48% had reactions at home, only ~3% of toddler OIT courses required epinephrine. By comparison, ~11% of treatments required epinephrine in a large OIT study of older children.

When a child reacts, “you might keep them on the dose or go a little slower,” said Johnson, who worked with allergist Jaclyn Bjelac, MD, on the study. These setbacks occurred less frequently in toddlers, allowing their OIT to “go a lot faster” than in older children. And so far, Dr. Johnson said, none of the toddlers have shown signs of eosinophilic esophagitis, a rare complication that can develop during OIT.

A smaller analysis of real-world outcomes in an academic clinical setting also found that OIT was well tolerated at very young ages. Since 2020, this ongoing study at UVA Children’s Hospital in Charlottesville has enrolled 22 peanut-allergic children (aged 6 months to 3 years) for OIT. Three patients have dropped out, four are in the buildup phrase, and 15 have reached maintenance dosing. None have reported having to use epinephrine.

Three patients have completed 1 year of maintenance therapy, and another patient accidentally consumed ~3,000 mg of peanut protein (equivalent to ~10 peanuts) after 5 months of maintenance. All four “now incorporate peanut into their diets ad lib,” according to lead author and allergist Jonathan Hemler, MD, who directs the UVA pediatric food allergy program.

These findings are “really reassuring – because even if you may not offer OIT, you’re still going to get questions about it,” said Ama Alexis, MD, an allergist/immunologist in private practice in New York and a clinical assistant professor at NYU Grossmann School of Medicine, commenting on the Cleveland Clinic study.

“It’s great that we’re hearing and seeing so much about OIT,” she added. While training as an allergy/immunology fellow 15 years ago, many saw the treatment as dangerous – “an absolute no-no,” she said.

The AAAAI still considers OIT “investigational,” yet this year’s annual meeting featured 22 posters – plus a course, workshop, seminar, and oral abstract session – on the approach.

The “thought process has shifted,” Dr. Alexis said. “It’s good to see all these numbers, these results. I think once you’re comfortable, you should embrace new therapies.”

Dr. Schwartz has consulted for Shire/Takeda and has received research funding from Knopp Biosciences. Dr. Alexis consults for AbbVie, serves on advisory boards for Jansen and Eli Lilli, and is a member of Pfizer’s advisory board and speaker’s bureau. Dr. Johnson, Dr. Windom, and Dr. Hemler report no relevant financial relationships.

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

Considered fringe just a few years ago, oral immunotherapy (OIT) has entered mainstream conversation about treating food allergies – particularly in younger children.

The buzz surrounding OIT – which involves ingesting daily doses of the culprit food to raise the threshold that would trigger a reaction – grew with the approval, by the U.S. Food and Drug Administration of Palforzia, of the peanut OIT pill in January 2020. Yet many allergists remained wary about the treatment, a monthslong regimen that can itself trigger allergic reactions.

Now, accumulating research points to “a possible window of opportunity early in life, less than 3 years of age, for more successful disease remission,” Justin Schwartz, MD, PhD, an allergist at Cincinnati Children’s Hospital, told a crowd at the annual meeting of the American Academy of Allergy, Asthma, & Immunology.

His presentation about OIT in toddlers kicked off a 3-hour clinical practice course, one of several dozen conference offerings highlighting this emerging approach.

Several AAAAI posters add to prior studies (for example, DEVIL and IMPACT) suggesting that OIT proceeds more smoothly and faster during a child’s earliest years – a season fraught with accidental exposures and reactions.

One poster described a retrospective study of 73 children younger than 4 years who underwent OIT at the Cleveland Clinic Food Allergy Center. Sixty-four were treated for peanut allergies, and seven patients received OIT for multiple foods, including tree nuts, milk, wheat, and sesame.

Of the 80 total OIT courses, 76 (95%) reached maintenance – meaning the child tolerated a small amount (for example, 1-2 peanuts) without reacting – in a median of 104 days (~3.4 months).

That is “quite impressive,” said allergist Hugh Windom, MD, whose clinic in Sarasota, Fla., has offered OIT since 2012.

Older children typically have 80%-90% success and take longer (6-8 months) to reach maintenance because of busier schedules and reactions that slow them down, he said. In his clinic’s larger retrospective analysis of preschool-aged OIT patients, presented at the 2022 AAAAI meeting, 89% of patients with peanut allergies and 72% of children with multiple food allergies achieved maintenance.

In the Cleveland Clinic study, children with favorable lab test results after receiving the maintenance dose for 6 months were offered an oral food challenge. Of 24 patients who completed the challenge, 75% “passed with a normal serving size of the treated food (for example, two tablespoons of peanut butter),” Sarah Johnson, MD, lead author and Cleveland Clinic allergy/immunology fellow, said in an interview.

Plus, OIT seemed safer for toddlers. Although 41% of the children had reactions during clinic updosing and 48% had reactions at home, only ~3% of toddler OIT courses required epinephrine. By comparison, ~11% of treatments required epinephrine in a large OIT study of older children.

When a child reacts, “you might keep them on the dose or go a little slower,” said Johnson, who worked with allergist Jaclyn Bjelac, MD, on the study. These setbacks occurred less frequently in toddlers, allowing their OIT to “go a lot faster” than in older children. And so far, Dr. Johnson said, none of the toddlers have shown signs of eosinophilic esophagitis, a rare complication that can develop during OIT.

A smaller analysis of real-world outcomes in an academic clinical setting also found that OIT was well tolerated at very young ages. Since 2020, this ongoing study at UVA Children’s Hospital in Charlottesville has enrolled 22 peanut-allergic children (aged 6 months to 3 years) for OIT. Three patients have dropped out, four are in the buildup phrase, and 15 have reached maintenance dosing. None have reported having to use epinephrine.

Three patients have completed 1 year of maintenance therapy, and another patient accidentally consumed ~3,000 mg of peanut protein (equivalent to ~10 peanuts) after 5 months of maintenance. All four “now incorporate peanut into their diets ad lib,” according to lead author and allergist Jonathan Hemler, MD, who directs the UVA pediatric food allergy program.

These findings are “really reassuring – because even if you may not offer OIT, you’re still going to get questions about it,” said Ama Alexis, MD, an allergist/immunologist in private practice in New York and a clinical assistant professor at NYU Grossmann School of Medicine, commenting on the Cleveland Clinic study.

“It’s great that we’re hearing and seeing so much about OIT,” she added. While training as an allergy/immunology fellow 15 years ago, many saw the treatment as dangerous – “an absolute no-no,” she said.

The AAAAI still considers OIT “investigational,” yet this year’s annual meeting featured 22 posters – plus a course, workshop, seminar, and oral abstract session – on the approach.

The “thought process has shifted,” Dr. Alexis said. “It’s good to see all these numbers, these results. I think once you’re comfortable, you should embrace new therapies.”

Dr. Schwartz has consulted for Shire/Takeda and has received research funding from Knopp Biosciences. Dr. Alexis consults for AbbVie, serves on advisory boards for Jansen and Eli Lilli, and is a member of Pfizer’s advisory board and speaker’s bureau. Dr. Johnson, Dr. Windom, and Dr. Hemler report no relevant financial relationships.

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

Considered fringe just a few years ago, oral immunotherapy (OIT) has entered mainstream conversation about treating food allergies – particularly in younger children.

The buzz surrounding OIT – which involves ingesting daily doses of the culprit food to raise the threshold that would trigger a reaction – grew with the approval, by the U.S. Food and Drug Administration of Palforzia, of the peanut OIT pill in January 2020. Yet many allergists remained wary about the treatment, a monthslong regimen that can itself trigger allergic reactions.

Now, accumulating research points to “a possible window of opportunity early in life, less than 3 years of age, for more successful disease remission,” Justin Schwartz, MD, PhD, an allergist at Cincinnati Children’s Hospital, told a crowd at the annual meeting of the American Academy of Allergy, Asthma, & Immunology.

His presentation about OIT in toddlers kicked off a 3-hour clinical practice course, one of several dozen conference offerings highlighting this emerging approach.

Several AAAAI posters add to prior studies (for example, DEVIL and IMPACT) suggesting that OIT proceeds more smoothly and faster during a child’s earliest years – a season fraught with accidental exposures and reactions.

One poster described a retrospective study of 73 children younger than 4 years who underwent OIT at the Cleveland Clinic Food Allergy Center. Sixty-four were treated for peanut allergies, and seven patients received OIT for multiple foods, including tree nuts, milk, wheat, and sesame.

Of the 80 total OIT courses, 76 (95%) reached maintenance – meaning the child tolerated a small amount (for example, 1-2 peanuts) without reacting – in a median of 104 days (~3.4 months).

That is “quite impressive,” said allergist Hugh Windom, MD, whose clinic in Sarasota, Fla., has offered OIT since 2012.

Older children typically have 80%-90% success and take longer (6-8 months) to reach maintenance because of busier schedules and reactions that slow them down, he said. In his clinic’s larger retrospective analysis of preschool-aged OIT patients, presented at the 2022 AAAAI meeting, 89% of patients with peanut allergies and 72% of children with multiple food allergies achieved maintenance.

In the Cleveland Clinic study, children with favorable lab test results after receiving the maintenance dose for 6 months were offered an oral food challenge. Of 24 patients who completed the challenge, 75% “passed with a normal serving size of the treated food (for example, two tablespoons of peanut butter),” Sarah Johnson, MD, lead author and Cleveland Clinic allergy/immunology fellow, said in an interview.

Plus, OIT seemed safer for toddlers. Although 41% of the children had reactions during clinic updosing and 48% had reactions at home, only ~3% of toddler OIT courses required epinephrine. By comparison, ~11% of treatments required epinephrine in a large OIT study of older children.

When a child reacts, “you might keep them on the dose or go a little slower,” said Johnson, who worked with allergist Jaclyn Bjelac, MD, on the study. These setbacks occurred less frequently in toddlers, allowing their OIT to “go a lot faster” than in older children. And so far, Dr. Johnson said, none of the toddlers have shown signs of eosinophilic esophagitis, a rare complication that can develop during OIT.

A smaller analysis of real-world outcomes in an academic clinical setting also found that OIT was well tolerated at very young ages. Since 2020, this ongoing study at UVA Children’s Hospital in Charlottesville has enrolled 22 peanut-allergic children (aged 6 months to 3 years) for OIT. Three patients have dropped out, four are in the buildup phrase, and 15 have reached maintenance dosing. None have reported having to use epinephrine.

Three patients have completed 1 year of maintenance therapy, and another patient accidentally consumed ~3,000 mg of peanut protein (equivalent to ~10 peanuts) after 5 months of maintenance. All four “now incorporate peanut into their diets ad lib,” according to lead author and allergist Jonathan Hemler, MD, who directs the UVA pediatric food allergy program.

These findings are “really reassuring – because even if you may not offer OIT, you’re still going to get questions about it,” said Ama Alexis, MD, an allergist/immunologist in private practice in New York and a clinical assistant professor at NYU Grossmann School of Medicine, commenting on the Cleveland Clinic study.

“It’s great that we’re hearing and seeing so much about OIT,” she added. While training as an allergy/immunology fellow 15 years ago, many saw the treatment as dangerous – “an absolute no-no,” she said.

The AAAAI still considers OIT “investigational,” yet this year’s annual meeting featured 22 posters – plus a course, workshop, seminar, and oral abstract session – on the approach.

The “thought process has shifted,” Dr. Alexis said. “It’s good to see all these numbers, these results. I think once you’re comfortable, you should embrace new therapies.”

Dr. Schwartz has consulted for Shire/Takeda and has received research funding from Knopp Biosciences. Dr. Alexis consults for AbbVie, serves on advisory boards for Jansen and Eli Lilli, and is a member of Pfizer’s advisory board and speaker’s bureau. Dr. Johnson, Dr. Windom, and Dr. Hemler report no relevant financial relationships.

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

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

In children and adolescents with new-onset type 1 diabetes, the calcium channel blocker verapamil slowed the destruction of insulin-producing pancreatic beta cells for up to a year, new data show.

Use of daily verapamil within a month of diagnosis resulted in a 30% increase in C-peptide secretion (a measure of preserved beta-cell function), compared with placebo at 52 weeks, without serious adverse events.

To put it another way, verapamil delayed the expected decline in C-peptide production from 3 months after diagnosis of type 1 diabetes to 6 months after diagnosis.

“We think this is a really, really exciting finding that’s hopefully going to impact the care for children with type 1 diabetes in the new-onset period,” lead author Gregory P. Forlenza, MD, said during his presentation of the data on Feb. 24 at the annual Advanced Technologies & Treatments for Diabetes (ATTD) meeting in Berlin.

“In view of the favorable safety profile, particularly compared with immune-suppressive agents, once-a-day oral administration, and low cost, initiation of verapamil should be a consideration for newly diagnosed patients with type 1 diabetes,” added Dr. Forlenza, a pediatric endocrinologist at the Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora.

The data were also simultaneously published in JAMA, as part of the CLVer (Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes) trial.

The randomized, double-blind, six-center trial involved 113 participants, aged 7-17 years, with newly diagnosed type 1 diabetes. They were randomized to the most advanced commercially available automated insulin delivery systems available or standard care to test the effects of intensive glucose control on C-peptide levels for 52 weeks during the COVID-19 pandemic (July 2020 to September 2022). Eighty-eight patients who weighed 30 kg (66 lb) or more were further randomized (1:1) to daily extended-release verapamil or placebo for the same duration. 

The positive findings for verapamil, published in one paper, contrasted with the negative ones for the automated insulin delivery (AID) system. The latter did not prevent the expected decline in C-peptide, putting to rest a long-held hypothesis that reducing glucotoxicity might preserve beta-cell function in newly diagnosed individuals with type 1 diabetes, noted Dr. Forlenza.
 

Could combination therapy work?

In recent years, immune-modulating agents have increasingly been shown to preserve beta-cell function in both new-onset and preclinical type 1 diabetes. One such agent, teplizumab (Tzield, Provention Bio), was approved by the U.S. Food and Drug Administration in November 2022 to delay type 1 diabetes onset in those at high risk.

Calcium channel blockers such as verapamil – used for years to treat hypertension and cardiac arrhythmias – may accomplish the same goal as teplizumab but in a different way, by reducing the protein overexpression that induces beta-cell apoptosis and death.

Dr. Forlenza showed a slide comparing the preservation of C-peptide, which was much lower with verapamil, at 30%, than with teplizumab, at 75%.

Asked to comment, session moderator Torben Biester, MD, a pediatric diabetologist at Auf der Bult-Zentrum Diabetes-Center for Children and Adolescents, Hanover, Germany, said: “[Verapamil] is a very cheap [daily] pill. [Teplizumab] is a very high-priced ... immune therapy in the United States ... an infusion twice for 10 days, so it’s a lot more burden for the patients and a lot more risk of side effects.”

“The future might be combination therapy,” added Dr. Biester.

And in an editorial published in JAMA and accompanying the two CLVer papers, Jennifer Couper, MD, of the University of Adelaide, agrees: “A well-tolerated, inexpensive, oral treatment such as verapamil with modest benefits on C-peptide production is relevant to practice.”

The new work “supports investigation of verapamil in combination with other effective agents during the earlier stages of type 1 diabetes before insulin dependence develops,” she noted.
 

Verapamil results ‘brilliant’ but more work needed

In the verapamil part of the CLVer trial, by 52 weeks, verapamil doses in the youth who received it ranged from 120-360 mg/day based on weight and tolerance.

The primary outcome, C-peptide area under the curve, stayed stable, from 0.66 pmol/mL at baseline to 0.65 pmol/mL at 52 weeks in the verapamil group, compared with a drop from 0.60 pmol/mL down to 0.44 pmol/mL with placebo, a significant difference of 0.14 pmol/mL (P = .04), representing a 30% higher C-peptide level in the verapamil group.

“For us, this is a phenomenally exciting result,” Dr. Forlenza commented during his presentation.

At 52 weeks, A1c was 6.6% in the verapamil group versus 6.9% with placebo, which was not significantly different. Daily insulin dose was 0.65 versus 0.74 units/kg per day, respectively, also not significantly different.

One severe hypoglycemic event occurred in each group, and one diabetic ketoacidosis event occurred in the placebo group. In the verapamil group, three participants experienced “nonserious” electrocardiogram abnormalities and one had hypertension.

Dr. Biester said he isn’t “that concerned” about the small number of mild ECG abnormalities seen in the study with verapamil, as this is a known side effect. But overall, he said, “I would think that for a recommendation for routine use it’s too early after one study, even though the results are brilliant.”

He noted that he is involved in a similar ongoing study of verapamil in adults with new-onset type 1 diabetes, called Ver-A-T1D.
 

No C-peptide effect of tight glycemic control: ‘A tough pill’

In the AID part of the study, the 113 participants were randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact (a median of 35 times) by study staff, or standard management using a continuous glucose monitor (CGM) with an insulin pump or multiple daily injections.

At 52 weeks, A1c was 6.5% for the intensive group versus 7.1% with standard care, a significant difference. Time in blood glucose range of 70-180 mg/dL was significantly longer with intensive management, at 78%, compared with standard care, at 64%.

Nonetheless, the change in C-peptide area under the curve did not differ between the two groups, decreasing from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks with the AID system, compared with a decrease from 0.60 pmol/L down to 0.50 pmol/L with standard care (P = .89).

Dr. Forlenza commented that the hypothesis that tight glycemic control would delay the decline in C-peptide secretion “is something I think a lot of endocrinologists assumed to be true and something I’ve heard lots of colleagues over the years talk about.”

Consequently, he said these findings are “a tough pill for us to swallow ... but it’s important for us in the field to understand.”

“Even with frequent contacts that are well above the level we’d be able to do in standard clinical care, and even with use of the most advanced AID systems we have ... we saw absolutely no difference in stimulated C-peptide levels at any of the timepoints throughout the first year or at 52 weeks.”

“So, in our opinion, this,” combined with a prior study from 2022, “should put this hypothesis to rest,” he said.

“Excellent glycemic control has a benefit in and of itself, but it was not a successful intervention for beta-cell preservation.”

Dr. Forlenza has reported serving as a consultant, speaker, or advisory board member for Medtronic, Dexcom, Abbott, Tandem Diabetes Care, Insulet, Lilly, and Beta Bionics, and his institution has also received funding on his behalf for research grants from these companies. Dr. Biester has reported receiving speaker’s fees from DexCom, Medtronic, Novo Nordisk, F. Hoffmann–La Roche, Sanofi, and Ypsomed Holding; serving on advisory boards for Ascensia Diabetes Care Holdings, AstraZeneca, DexCom, and Medtronic; and receiving personal fees from SYNLAB; and is a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes. Dr. Couper has reported no relevant financial relationships.

The rationale for the companion CLVer analysis of the effect of reducing glucose toxicity via tight glycemic control on C-peptide progression dates back to an inpatient study published in 1989 involving 26 adolescents using an early artificial pancreas prototype called a Biostator, in which beta-cell preservation was achieved. However, two more recent studies of this approach, including one published in late 2022, did not show a difference. The CLVer analysis involved 113 participants randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact by study staff, or standard management using a CGM with a pump or multiple daily injections.

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

In children and adolescents with new-onset type 1 diabetes, the calcium channel blocker verapamil slowed the destruction of insulin-producing pancreatic beta cells for up to a year, new data show.

Use of daily verapamil within a month of diagnosis resulted in a 30% increase in C-peptide secretion (a measure of preserved beta-cell function), compared with placebo at 52 weeks, without serious adverse events.

To put it another way, verapamil delayed the expected decline in C-peptide production from 3 months after diagnosis of type 1 diabetes to 6 months after diagnosis.

“We think this is a really, really exciting finding that’s hopefully going to impact the care for children with type 1 diabetes in the new-onset period,” lead author Gregory P. Forlenza, MD, said during his presentation of the data on Feb. 24 at the annual Advanced Technologies & Treatments for Diabetes (ATTD) meeting in Berlin.

“In view of the favorable safety profile, particularly compared with immune-suppressive agents, once-a-day oral administration, and low cost, initiation of verapamil should be a consideration for newly diagnosed patients with type 1 diabetes,” added Dr. Forlenza, a pediatric endocrinologist at the Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora.

The data were also simultaneously published in JAMA, as part of the CLVer (Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes) trial.

The randomized, double-blind, six-center trial involved 113 participants, aged 7-17 years, with newly diagnosed type 1 diabetes. They were randomized to the most advanced commercially available automated insulin delivery systems available or standard care to test the effects of intensive glucose control on C-peptide levels for 52 weeks during the COVID-19 pandemic (July 2020 to September 2022). Eighty-eight patients who weighed 30 kg (66 lb) or more were further randomized (1:1) to daily extended-release verapamil or placebo for the same duration. 

The positive findings for verapamil, published in one paper, contrasted with the negative ones for the automated insulin delivery (AID) system. The latter did not prevent the expected decline in C-peptide, putting to rest a long-held hypothesis that reducing glucotoxicity might preserve beta-cell function in newly diagnosed individuals with type 1 diabetes, noted Dr. Forlenza.
 

Could combination therapy work?

In recent years, immune-modulating agents have increasingly been shown to preserve beta-cell function in both new-onset and preclinical type 1 diabetes. One such agent, teplizumab (Tzield, Provention Bio), was approved by the U.S. Food and Drug Administration in November 2022 to delay type 1 diabetes onset in those at high risk.

Calcium channel blockers such as verapamil – used for years to treat hypertension and cardiac arrhythmias – may accomplish the same goal as teplizumab but in a different way, by reducing the protein overexpression that induces beta-cell apoptosis and death.

Dr. Forlenza showed a slide comparing the preservation of C-peptide, which was much lower with verapamil, at 30%, than with teplizumab, at 75%.

Asked to comment, session moderator Torben Biester, MD, a pediatric diabetologist at Auf der Bult-Zentrum Diabetes-Center for Children and Adolescents, Hanover, Germany, said: “[Verapamil] is a very cheap [daily] pill. [Teplizumab] is a very high-priced ... immune therapy in the United States ... an infusion twice for 10 days, so it’s a lot more burden for the patients and a lot more risk of side effects.”

“The future might be combination therapy,” added Dr. Biester.

And in an editorial published in JAMA and accompanying the two CLVer papers, Jennifer Couper, MD, of the University of Adelaide, agrees: “A well-tolerated, inexpensive, oral treatment such as verapamil with modest benefits on C-peptide production is relevant to practice.”

The new work “supports investigation of verapamil in combination with other effective agents during the earlier stages of type 1 diabetes before insulin dependence develops,” she noted.
 

Verapamil results ‘brilliant’ but more work needed

In the verapamil part of the CLVer trial, by 52 weeks, verapamil doses in the youth who received it ranged from 120-360 mg/day based on weight and tolerance.

The primary outcome, C-peptide area under the curve, stayed stable, from 0.66 pmol/mL at baseline to 0.65 pmol/mL at 52 weeks in the verapamil group, compared with a drop from 0.60 pmol/mL down to 0.44 pmol/mL with placebo, a significant difference of 0.14 pmol/mL (P = .04), representing a 30% higher C-peptide level in the verapamil group.

“For us, this is a phenomenally exciting result,” Dr. Forlenza commented during his presentation.

At 52 weeks, A1c was 6.6% in the verapamil group versus 6.9% with placebo, which was not significantly different. Daily insulin dose was 0.65 versus 0.74 units/kg per day, respectively, also not significantly different.

One severe hypoglycemic event occurred in each group, and one diabetic ketoacidosis event occurred in the placebo group. In the verapamil group, three participants experienced “nonserious” electrocardiogram abnormalities and one had hypertension.

Dr. Biester said he isn’t “that concerned” about the small number of mild ECG abnormalities seen in the study with verapamil, as this is a known side effect. But overall, he said, “I would think that for a recommendation for routine use it’s too early after one study, even though the results are brilliant.”

He noted that he is involved in a similar ongoing study of verapamil in adults with new-onset type 1 diabetes, called Ver-A-T1D.
 

No C-peptide effect of tight glycemic control: ‘A tough pill’

In the AID part of the study, the 113 participants were randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact (a median of 35 times) by study staff, or standard management using a continuous glucose monitor (CGM) with an insulin pump or multiple daily injections.

At 52 weeks, A1c was 6.5% for the intensive group versus 7.1% with standard care, a significant difference. Time in blood glucose range of 70-180 mg/dL was significantly longer with intensive management, at 78%, compared with standard care, at 64%.

Nonetheless, the change in C-peptide area under the curve did not differ between the two groups, decreasing from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks with the AID system, compared with a decrease from 0.60 pmol/L down to 0.50 pmol/L with standard care (P = .89).

Dr. Forlenza commented that the hypothesis that tight glycemic control would delay the decline in C-peptide secretion “is something I think a lot of endocrinologists assumed to be true and something I’ve heard lots of colleagues over the years talk about.”

Consequently, he said these findings are “a tough pill for us to swallow ... but it’s important for us in the field to understand.”

“Even with frequent contacts that are well above the level we’d be able to do in standard clinical care, and even with use of the most advanced AID systems we have ... we saw absolutely no difference in stimulated C-peptide levels at any of the timepoints throughout the first year or at 52 weeks.”

“So, in our opinion, this,” combined with a prior study from 2022, “should put this hypothesis to rest,” he said.

“Excellent glycemic control has a benefit in and of itself, but it was not a successful intervention for beta-cell preservation.”

Dr. Forlenza has reported serving as a consultant, speaker, or advisory board member for Medtronic, Dexcom, Abbott, Tandem Diabetes Care, Insulet, Lilly, and Beta Bionics, and his institution has also received funding on his behalf for research grants from these companies. Dr. Biester has reported receiving speaker’s fees from DexCom, Medtronic, Novo Nordisk, F. Hoffmann–La Roche, Sanofi, and Ypsomed Holding; serving on advisory boards for Ascensia Diabetes Care Holdings, AstraZeneca, DexCom, and Medtronic; and receiving personal fees from SYNLAB; and is a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes. Dr. Couper has reported no relevant financial relationships.

The rationale for the companion CLVer analysis of the effect of reducing glucose toxicity via tight glycemic control on C-peptide progression dates back to an inpatient study published in 1989 involving 26 adolescents using an early artificial pancreas prototype called a Biostator, in which beta-cell preservation was achieved. However, two more recent studies of this approach, including one published in late 2022, did not show a difference. The CLVer analysis involved 113 participants randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact by study staff, or standard management using a CGM with a pump or multiple daily injections.

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

In children and adolescents with new-onset type 1 diabetes, the calcium channel blocker verapamil slowed the destruction of insulin-producing pancreatic beta cells for up to a year, new data show.

Use of daily verapamil within a month of diagnosis resulted in a 30% increase in C-peptide secretion (a measure of preserved beta-cell function), compared with placebo at 52 weeks, without serious adverse events.

To put it another way, verapamil delayed the expected decline in C-peptide production from 3 months after diagnosis of type 1 diabetes to 6 months after diagnosis.

“We think this is a really, really exciting finding that’s hopefully going to impact the care for children with type 1 diabetes in the new-onset period,” lead author Gregory P. Forlenza, MD, said during his presentation of the data on Feb. 24 at the annual Advanced Technologies & Treatments for Diabetes (ATTD) meeting in Berlin.

“In view of the favorable safety profile, particularly compared with immune-suppressive agents, once-a-day oral administration, and low cost, initiation of verapamil should be a consideration for newly diagnosed patients with type 1 diabetes,” added Dr. Forlenza, a pediatric endocrinologist at the Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora.

The data were also simultaneously published in JAMA, as part of the CLVer (Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes) trial.

The randomized, double-blind, six-center trial involved 113 participants, aged 7-17 years, with newly diagnosed type 1 diabetes. They were randomized to the most advanced commercially available automated insulin delivery systems available or standard care to test the effects of intensive glucose control on C-peptide levels for 52 weeks during the COVID-19 pandemic (July 2020 to September 2022). Eighty-eight patients who weighed 30 kg (66 lb) or more were further randomized (1:1) to daily extended-release verapamil or placebo for the same duration. 

The positive findings for verapamil, published in one paper, contrasted with the negative ones for the automated insulin delivery (AID) system. The latter did not prevent the expected decline in C-peptide, putting to rest a long-held hypothesis that reducing glucotoxicity might preserve beta-cell function in newly diagnosed individuals with type 1 diabetes, noted Dr. Forlenza.
 

Could combination therapy work?

In recent years, immune-modulating agents have increasingly been shown to preserve beta-cell function in both new-onset and preclinical type 1 diabetes. One such agent, teplizumab (Tzield, Provention Bio), was approved by the U.S. Food and Drug Administration in November 2022 to delay type 1 diabetes onset in those at high risk.

Calcium channel blockers such as verapamil – used for years to treat hypertension and cardiac arrhythmias – may accomplish the same goal as teplizumab but in a different way, by reducing the protein overexpression that induces beta-cell apoptosis and death.

Dr. Forlenza showed a slide comparing the preservation of C-peptide, which was much lower with verapamil, at 30%, than with teplizumab, at 75%.

Asked to comment, session moderator Torben Biester, MD, a pediatric diabetologist at Auf der Bult-Zentrum Diabetes-Center for Children and Adolescents, Hanover, Germany, said: “[Verapamil] is a very cheap [daily] pill. [Teplizumab] is a very high-priced ... immune therapy in the United States ... an infusion twice for 10 days, so it’s a lot more burden for the patients and a lot more risk of side effects.”

“The future might be combination therapy,” added Dr. Biester.

And in an editorial published in JAMA and accompanying the two CLVer papers, Jennifer Couper, MD, of the University of Adelaide, agrees: “A well-tolerated, inexpensive, oral treatment such as verapamil with modest benefits on C-peptide production is relevant to practice.”

The new work “supports investigation of verapamil in combination with other effective agents during the earlier stages of type 1 diabetes before insulin dependence develops,” she noted.
 

Verapamil results ‘brilliant’ but more work needed

In the verapamil part of the CLVer trial, by 52 weeks, verapamil doses in the youth who received it ranged from 120-360 mg/day based on weight and tolerance.

The primary outcome, C-peptide area under the curve, stayed stable, from 0.66 pmol/mL at baseline to 0.65 pmol/mL at 52 weeks in the verapamil group, compared with a drop from 0.60 pmol/mL down to 0.44 pmol/mL with placebo, a significant difference of 0.14 pmol/mL (P = .04), representing a 30% higher C-peptide level in the verapamil group.

“For us, this is a phenomenally exciting result,” Dr. Forlenza commented during his presentation.

At 52 weeks, A1c was 6.6% in the verapamil group versus 6.9% with placebo, which was not significantly different. Daily insulin dose was 0.65 versus 0.74 units/kg per day, respectively, also not significantly different.

One severe hypoglycemic event occurred in each group, and one diabetic ketoacidosis event occurred in the placebo group. In the verapamil group, three participants experienced “nonserious” electrocardiogram abnormalities and one had hypertension.

Dr. Biester said he isn’t “that concerned” about the small number of mild ECG abnormalities seen in the study with verapamil, as this is a known side effect. But overall, he said, “I would think that for a recommendation for routine use it’s too early after one study, even though the results are brilliant.”

He noted that he is involved in a similar ongoing study of verapamil in adults with new-onset type 1 diabetes, called Ver-A-T1D.
 

No C-peptide effect of tight glycemic control: ‘A tough pill’

In the AID part of the study, the 113 participants were randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact (a median of 35 times) by study staff, or standard management using a continuous glucose monitor (CGM) with an insulin pump or multiple daily injections.

At 52 weeks, A1c was 6.5% for the intensive group versus 7.1% with standard care, a significant difference. Time in blood glucose range of 70-180 mg/dL was significantly longer with intensive management, at 78%, compared with standard care, at 64%.

Nonetheless, the change in C-peptide area under the curve did not differ between the two groups, decreasing from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks with the AID system, compared with a decrease from 0.60 pmol/L down to 0.50 pmol/L with standard care (P = .89).

Dr. Forlenza commented that the hypothesis that tight glycemic control would delay the decline in C-peptide secretion “is something I think a lot of endocrinologists assumed to be true and something I’ve heard lots of colleagues over the years talk about.”

Consequently, he said these findings are “a tough pill for us to swallow ... but it’s important for us in the field to understand.”

“Even with frequent contacts that are well above the level we’d be able to do in standard clinical care, and even with use of the most advanced AID systems we have ... we saw absolutely no difference in stimulated C-peptide levels at any of the timepoints throughout the first year or at 52 weeks.”

“So, in our opinion, this,” combined with a prior study from 2022, “should put this hypothesis to rest,” he said.

“Excellent glycemic control has a benefit in and of itself, but it was not a successful intervention for beta-cell preservation.”

Dr. Forlenza has reported serving as a consultant, speaker, or advisory board member for Medtronic, Dexcom, Abbott, Tandem Diabetes Care, Insulet, Lilly, and Beta Bionics, and his institution has also received funding on his behalf for research grants from these companies. Dr. Biester has reported receiving speaker’s fees from DexCom, Medtronic, Novo Nordisk, F. Hoffmann–La Roche, Sanofi, and Ypsomed Holding; serving on advisory boards for Ascensia Diabetes Care Holdings, AstraZeneca, DexCom, and Medtronic; and receiving personal fees from SYNLAB; and is a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes. Dr. Couper has reported no relevant financial relationships.

The rationale for the companion CLVer analysis of the effect of reducing glucose toxicity via tight glycemic control on C-peptide progression dates back to an inpatient study published in 1989 involving 26 adolescents using an early artificial pancreas prototype called a Biostator, in which beta-cell preservation was achieved. However, two more recent studies of this approach, including one published in late 2022, did not show a difference. The CLVer analysis involved 113 participants randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact by study staff, or standard management using a CGM with a pump or multiple daily injections.

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

A multipart study reports that erythritol – a sugar alcohol (polyol) increasingly used as an artificial sweetener that is also made in the body – is associated with risk of major adverse cardiovascular events (MACE) and promotes clotting (thrombosis).

Erythritol is one of the most widely used artificial sweeteners with rapidly increasing prevalence in processed and “keto-related” foods. Artificial sweeteners are “generally recognized as safe” (GRAS) by the U.S. Food and Drug Administration, so there is no requirement for long-term safety studies, and little is known about the long-term health effects.

The current research, published online in Nature Medicine by Marco Witkowski, MD, of the Lerner Research Institute at Cleveland Clinic and colleagues, had multiple parts.

First, in a group of patients undergoing cardiac risk assessment, the researchers found that high levels of polyols, especially erythritol, were associated with increased 3-year risk of MACE, defined as cardiovascular death or nonfatal myocardial infarction or stroke. 

Next, the association of erythritol with this outcome was reproduced in two large U.S. and European groups of stable patients undergoing elective cardiac evaluation.

Next, adding erythritol to whole blood or platelets led to clot activation. And lastly, in eight healthy volunteers, ingesting 30 g of an erythritol-sweetened drink – comparable to a single can of commercially available beverage or a pint of keto ice cream – induced marked and sustained (> 2 day) increases in levels of plasma erythritol.

“Our study shows that when participants consumed an artificially sweetened beverage with an amount of erythritol found in many processed foods, markedly elevated levels in the blood are observed for days – levels well above those observed to enhance clotting risks,” said senior author Stanley L. Hazen, MD, PhD.  

“It is important that further safety studies are conducted to examine the long-term effects of artificial sweeteners in general, and erythritol specifically, on risks for heart attack and stroke, particularly in people at higher risk for cardiovascular disease,” Dr. Hazen, co–section head of preventive cardiology at Cleveland Clinic, said in a press release from his institution.

“Sweeteners like erythritol have rapidly increased in popularity in recent years, but there needs to be more in-depth research into their long-term effects. Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors,” Dr. Hazen urged.

The topic remains controversial.

Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University, Birmingham, England, told the U.K. Science Media Centre: “This paper effectively shows multiple pieces of a jigsaw exploring the effects of erythritol – although it claims to show an associated risk with the use of erythritol as an artificial sweetener and cardiovascular disease, I believe it fails to do so, as ultimately, erythritol can be made inside our bodies and the intake in most people’s diet is much lower than the amount given in this study.” 

Dr. Hazen countered that data from the 2013-2014 National Health and Nutrition Examination Survey (NHANES) in the United States show that, in some individuals, daily intake of erythritol is estimated to reach 30 g/day. 

“Many try and reduce sugar intake by taking many teaspoons of erythritol in their tea, coffee, etc., instead of sugar,” Dr. Hazen added. “Or they eat keto processed foods that have significant quantities of erythritol within it.”

“These studies are a warning for how our processed food (keto and zero sugar, especially) may inadvertently be causing risk/harm. … in the very subset of subjects who are most vulnerable,” according to Dr. Hazen.
 

Erythritol marketed as ‘zero calorie’, ‘non-nutritive’, or ‘natural’

Patients with type 2 diabetes and obesity are often advised to replace sugar with artificial sweeteners for better glucose control and weight loss, but growing epidemiologic evidence links artificial sweetener consumption with weight gain, insulin resistance, type 2 diabetes, and cardiovascular disease, the researchers write.

Erythritol is naturally present in low amounts in fruits and vegetables; the artificial sweetener erythritol that is produced from corn is only 70% as sweet as sugar.

Upon ingestion it is poorly metabolized, and most is excreted in the urine, so it is characterized as a “zero-calorie,” “non-nutritive,” or “natural sweetener.” It is predicted to double in marketshare in the sweetener sector in the next 5 years.
 

Multipart study

In the first part of their study, in a discovery cohort in 1,157 patients undergoing cardiovascular assessment with 3-year outcomes, the researchers identified polyols that were associated with MACE, and erythritol was among the top MACE-associated molecules.

Next, in a U.S. validation cohort of 2,149 patients, over a 3-year follow-up, patients with plasma levels of erythritol in the highest quartile had a 1.8-fold higher risk of MACE than patients in the lowest quartile (P = .007), after adjusting for cardiovascular risk factors.

In a European validation cohort of 833 patients, over a 3-year follow-up, patients with plasma levels of erythritol in the highest quartile had a 2.21-fold higher risk of MACE than patients in the lowest quartile (P = .010, after adjustment).

At physiologic levels, erythritol enhanced platelet reactivity in vitro and thrombosis formation in vivo.

Finally, in a prospective pilot intervention study, erythritol ingestion in healthy volunteers induced marked and sustained increases in plasma erythritol levels well above thresholds associated with heightened platelet reactivity and thrombosis potential in in vitro and in vivo studies.
 

Others weigh in

“While I think the finding certainly warrants further investigation, don’t throw out your sweeteners just yet,” commented Oliver Jones, PhD, professor of chemistry at the Royal Melbourne Institute of Technology.

“This study only looks at erythritol, and artificial sweeteners are generally considered safe. Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” he said.

Dr. Hazen responded: “True enough. Erythritol is but one of many artificial sweeteners. That is why it is important to read labels. This study can make patients be informed about how to potentially avoid something that might cause them inadvertent harm.”

“The key findings of this study are that high blood levels of erythritol are strongly associated with cardiovascular outcomes in high-risk patients, which has been replicated in separate validation studies,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London.

“Diabetes UK currently advises diabetes patients not to use polyols,” he added.

Dr. Hazen noted that “About three-quarters of the participants had coronary disease, high blood pressure, and about a fifth had diabetes.”

The researchers acknowledge, however, that the observational studies cannot show cause and effect.

The study was supported by the Office of Dietary Supplements at the National Institutes of Health, the Leducq Foundation, and the German Research Foundation (Deutsche Forschungsgemeinschaft). Dr. Mellor, Dr. Jones, and Dr. Sanders have reported no relevant financial relationships.

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

A multipart study reports that erythritol – a sugar alcohol (polyol) increasingly used as an artificial sweetener that is also made in the body – is associated with risk of major adverse cardiovascular events (MACE) and promotes clotting (thrombosis).

Erythritol is one of the most widely used artificial sweeteners with rapidly increasing prevalence in processed and “keto-related” foods. Artificial sweeteners are “generally recognized as safe” (GRAS) by the U.S. Food and Drug Administration, so there is no requirement for long-term safety studies, and little is known about the long-term health effects.

The current research, published online in Nature Medicine by Marco Witkowski, MD, of the Lerner Research Institute at Cleveland Clinic and colleagues, had multiple parts.

First, in a group of patients undergoing cardiac risk assessment, the researchers found that high levels of polyols, especially erythritol, were associated with increased 3-year risk of MACE, defined as cardiovascular death or nonfatal myocardial infarction or stroke. 

Next, the association of erythritol with this outcome was reproduced in two large U.S. and European groups of stable patients undergoing elective cardiac evaluation.

Next, adding erythritol to whole blood or platelets led to clot activation. And lastly, in eight healthy volunteers, ingesting 30 g of an erythritol-sweetened drink – comparable to a single can of commercially available beverage or a pint of keto ice cream – induced marked and sustained (> 2 day) increases in levels of plasma erythritol.

“Our study shows that when participants consumed an artificially sweetened beverage with an amount of erythritol found in many processed foods, markedly elevated levels in the blood are observed for days – levels well above those observed to enhance clotting risks,” said senior author Stanley L. Hazen, MD, PhD.  

“It is important that further safety studies are conducted to examine the long-term effects of artificial sweeteners in general, and erythritol specifically, on risks for heart attack and stroke, particularly in people at higher risk for cardiovascular disease,” Dr. Hazen, co–section head of preventive cardiology at Cleveland Clinic, said in a press release from his institution.

“Sweeteners like erythritol have rapidly increased in popularity in recent years, but there needs to be more in-depth research into their long-term effects. Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors,” Dr. Hazen urged.

The topic remains controversial.

Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University, Birmingham, England, told the U.K. Science Media Centre: “This paper effectively shows multiple pieces of a jigsaw exploring the effects of erythritol – although it claims to show an associated risk with the use of erythritol as an artificial sweetener and cardiovascular disease, I believe it fails to do so, as ultimately, erythritol can be made inside our bodies and the intake in most people’s diet is much lower than the amount given in this study.” 

Dr. Hazen countered that data from the 2013-2014 National Health and Nutrition Examination Survey (NHANES) in the United States show that, in some individuals, daily intake of erythritol is estimated to reach 30 g/day. 

“Many try and reduce sugar intake by taking many teaspoons of erythritol in their tea, coffee, etc., instead of sugar,” Dr. Hazen added. “Or they eat keto processed foods that have significant quantities of erythritol within it.”

“These studies are a warning for how our processed food (keto and zero sugar, especially) may inadvertently be causing risk/harm. … in the very subset of subjects who are most vulnerable,” according to Dr. Hazen.
 

Erythritol marketed as ‘zero calorie’, ‘non-nutritive’, or ‘natural’

Patients with type 2 diabetes and obesity are often advised to replace sugar with artificial sweeteners for better glucose control and weight loss, but growing epidemiologic evidence links artificial sweetener consumption with weight gain, insulin resistance, type 2 diabetes, and cardiovascular disease, the researchers write.

Erythritol is naturally present in low amounts in fruits and vegetables; the artificial sweetener erythritol that is produced from corn is only 70% as sweet as sugar.

Upon ingestion it is poorly metabolized, and most is excreted in the urine, so it is characterized as a “zero-calorie,” “non-nutritive,” or “natural sweetener.” It is predicted to double in marketshare in the sweetener sector in the next 5 years.
 

Multipart study

In the first part of their study, in a discovery cohort in 1,157 patients undergoing cardiovascular assessment with 3-year outcomes, the researchers identified polyols that were associated with MACE, and erythritol was among the top MACE-associated molecules.

Next, in a U.S. validation cohort of 2,149 patients, over a 3-year follow-up, patients with plasma levels of erythritol in the highest quartile had a 1.8-fold higher risk of MACE than patients in the lowest quartile (P = .007), after adjusting for cardiovascular risk factors.

In a European validation cohort of 833 patients, over a 3-year follow-up, patients with plasma levels of erythritol in the highest quartile had a 2.21-fold higher risk of MACE than patients in the lowest quartile (P = .010, after adjustment).

At physiologic levels, erythritol enhanced platelet reactivity in vitro and thrombosis formation in vivo.

Finally, in a prospective pilot intervention study, erythritol ingestion in healthy volunteers induced marked and sustained increases in plasma erythritol levels well above thresholds associated with heightened platelet reactivity and thrombosis potential in in vitro and in vivo studies.
 

Others weigh in

“While I think the finding certainly warrants further investigation, don’t throw out your sweeteners just yet,” commented Oliver Jones, PhD, professor of chemistry at the Royal Melbourne Institute of Technology.

“This study only looks at erythritol, and artificial sweeteners are generally considered safe. Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” he said.

Dr. Hazen responded: “True enough. Erythritol is but one of many artificial sweeteners. That is why it is important to read labels. This study can make patients be informed about how to potentially avoid something that might cause them inadvertent harm.”

“The key findings of this study are that high blood levels of erythritol are strongly associated with cardiovascular outcomes in high-risk patients, which has been replicated in separate validation studies,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London.

“Diabetes UK currently advises diabetes patients not to use polyols,” he added.

Dr. Hazen noted that “About three-quarters of the participants had coronary disease, high blood pressure, and about a fifth had diabetes.”

The researchers acknowledge, however, that the observational studies cannot show cause and effect.

The study was supported by the Office of Dietary Supplements at the National Institutes of Health, the Leducq Foundation, and the German Research Foundation (Deutsche Forschungsgemeinschaft). Dr. Mellor, Dr. Jones, and Dr. Sanders have reported no relevant financial relationships.

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

A multipart study reports that erythritol – a sugar alcohol (polyol) increasingly used as an artificial sweetener that is also made in the body – is associated with risk of major adverse cardiovascular events (MACE) and promotes clotting (thrombosis).

Erythritol is one of the most widely used artificial sweeteners with rapidly increasing prevalence in processed and “keto-related” foods. Artificial sweeteners are “generally recognized as safe” (GRAS) by the U.S. Food and Drug Administration, so there is no requirement for long-term safety studies, and little is known about the long-term health effects.

The current research, published online in Nature Medicine by Marco Witkowski, MD, of the Lerner Research Institute at Cleveland Clinic and colleagues, had multiple parts.

First, in a group of patients undergoing cardiac risk assessment, the researchers found that high levels of polyols, especially erythritol, were associated with increased 3-year risk of MACE, defined as cardiovascular death or nonfatal myocardial infarction or stroke. 

Next, the association of erythritol with this outcome was reproduced in two large U.S. and European groups of stable patients undergoing elective cardiac evaluation.

Next, adding erythritol to whole blood or platelets led to clot activation. And lastly, in eight healthy volunteers, ingesting 30 g of an erythritol-sweetened drink – comparable to a single can of commercially available beverage or a pint of keto ice cream – induced marked and sustained (> 2 day) increases in levels of plasma erythritol.

“Our study shows that when participants consumed an artificially sweetened beverage with an amount of erythritol found in many processed foods, markedly elevated levels in the blood are observed for days – levels well above those observed to enhance clotting risks,” said senior author Stanley L. Hazen, MD, PhD.  

“It is important that further safety studies are conducted to examine the long-term effects of artificial sweeteners in general, and erythritol specifically, on risks for heart attack and stroke, particularly in people at higher risk for cardiovascular disease,” Dr. Hazen, co–section head of preventive cardiology at Cleveland Clinic, said in a press release from his institution.

“Sweeteners like erythritol have rapidly increased in popularity in recent years, but there needs to be more in-depth research into their long-term effects. Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors,” Dr. Hazen urged.

The topic remains controversial.

Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University, Birmingham, England, told the U.K. Science Media Centre: “This paper effectively shows multiple pieces of a jigsaw exploring the effects of erythritol – although it claims to show an associated risk with the use of erythritol as an artificial sweetener and cardiovascular disease, I believe it fails to do so, as ultimately, erythritol can be made inside our bodies and the intake in most people’s diet is much lower than the amount given in this study.” 

Dr. Hazen countered that data from the 2013-2014 National Health and Nutrition Examination Survey (NHANES) in the United States show that, in some individuals, daily intake of erythritol is estimated to reach 30 g/day. 

“Many try and reduce sugar intake by taking many teaspoons of erythritol in their tea, coffee, etc., instead of sugar,” Dr. Hazen added. “Or they eat keto processed foods that have significant quantities of erythritol within it.”

“These studies are a warning for how our processed food (keto and zero sugar, especially) may inadvertently be causing risk/harm. … in the very subset of subjects who are most vulnerable,” according to Dr. Hazen.
 

Erythritol marketed as ‘zero calorie’, ‘non-nutritive’, or ‘natural’

Patients with type 2 diabetes and obesity are often advised to replace sugar with artificial sweeteners for better glucose control and weight loss, but growing epidemiologic evidence links artificial sweetener consumption with weight gain, insulin resistance, type 2 diabetes, and cardiovascular disease, the researchers write.

Erythritol is naturally present in low amounts in fruits and vegetables; the artificial sweetener erythritol that is produced from corn is only 70% as sweet as sugar.

Upon ingestion it is poorly metabolized, and most is excreted in the urine, so it is characterized as a “zero-calorie,” “non-nutritive,” or “natural sweetener.” It is predicted to double in marketshare in the sweetener sector in the next 5 years.
 

Multipart study

In the first part of their study, in a discovery cohort in 1,157 patients undergoing cardiovascular assessment with 3-year outcomes, the researchers identified polyols that were associated with MACE, and erythritol was among the top MACE-associated molecules.

Next, in a U.S. validation cohort of 2,149 patients, over a 3-year follow-up, patients with plasma levels of erythritol in the highest quartile had a 1.8-fold higher risk of MACE than patients in the lowest quartile (P = .007), after adjusting for cardiovascular risk factors.

In a European validation cohort of 833 patients, over a 3-year follow-up, patients with plasma levels of erythritol in the highest quartile had a 2.21-fold higher risk of MACE than patients in the lowest quartile (P = .010, after adjustment).

At physiologic levels, erythritol enhanced platelet reactivity in vitro and thrombosis formation in vivo.

Finally, in a prospective pilot intervention study, erythritol ingestion in healthy volunteers induced marked and sustained increases in plasma erythritol levels well above thresholds associated with heightened platelet reactivity and thrombosis potential in in vitro and in vivo studies.
 

Others weigh in

“While I think the finding certainly warrants further investigation, don’t throw out your sweeteners just yet,” commented Oliver Jones, PhD, professor of chemistry at the Royal Melbourne Institute of Technology.

“This study only looks at erythritol, and artificial sweeteners are generally considered safe. Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” he said.

Dr. Hazen responded: “True enough. Erythritol is but one of many artificial sweeteners. That is why it is important to read labels. This study can make patients be informed about how to potentially avoid something that might cause them inadvertent harm.”

“The key findings of this study are that high blood levels of erythritol are strongly associated with cardiovascular outcomes in high-risk patients, which has been replicated in separate validation studies,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London.

“Diabetes UK currently advises diabetes patients not to use polyols,” he added.

Dr. Hazen noted that “About three-quarters of the participants had coronary disease, high blood pressure, and about a fifth had diabetes.”

The researchers acknowledge, however, that the observational studies cannot show cause and effect.

The study was supported by the Office of Dietary Supplements at the National Institutes of Health, the Leducq Foundation, and the German Research Foundation (Deutsche Forschungsgemeinschaft). Dr. Mellor, Dr. Jones, and Dr. Sanders have reported no relevant financial relationships.

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