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CRC blood tests: A future without screening colonoscopies?
Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.
Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.
If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.
“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.
Blood tests for CRC have the potential to cause a shift in screening for colon cancer.
Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.
‘Holy grail?’
“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.
There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.
Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.
Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.
The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.
Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.
The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.
CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.
Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
A spotty track record
Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.
Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.
CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.
But CMS officials have acknowledged the strong interest in CRC blood tests.
In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:
- Receive FDA market authorization with an indication for CRC screening.
- Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.
In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.
Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.
While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.
Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.
“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
Hurdles to broad acceptance
For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.
This is the “big trifecta,” Dr. Baldo said.
In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.
The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).
The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.
If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.
Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.
“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
What the future may hold
Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.
In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.
Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.
And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.
“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.
Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.
A version of this article originally appeared on Medscape.com.
Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.
Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.
If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.
“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.
Blood tests for CRC have the potential to cause a shift in screening for colon cancer.
Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.
‘Holy grail?’
“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.
There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.
Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.
Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.
The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.
Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.
The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.
CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.
Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
A spotty track record
Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.
Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.
CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.
But CMS officials have acknowledged the strong interest in CRC blood tests.
In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:
- Receive FDA market authorization with an indication for CRC screening.
- Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.
In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.
Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.
While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.
Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.
“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
Hurdles to broad acceptance
For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.
This is the “big trifecta,” Dr. Baldo said.
In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.
The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).
The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.
If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.
Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.
“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
What the future may hold
Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.
In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.
Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.
And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.
“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.
Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.
A version of this article originally appeared on Medscape.com.
Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.
Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.
If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.
“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.
Blood tests for CRC have the potential to cause a shift in screening for colon cancer.
Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.
‘Holy grail?’
“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.
There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.
Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.
Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.
The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.
Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.
The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.
CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.
Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
A spotty track record
Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.
Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.
CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.
But CMS officials have acknowledged the strong interest in CRC blood tests.
In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:
- Receive FDA market authorization with an indication for CRC screening.
- Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.
In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.
Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.
While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.
Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.
“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
Hurdles to broad acceptance
For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.
This is the “big trifecta,” Dr. Baldo said.
In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.
The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).
The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.
If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.
Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.
“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
What the future may hold
Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.
In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.
Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.
And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.
“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.
Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.
A version of this article originally appeared on Medscape.com.
Patients with IBD express need for psychosocial support
It’s been over 2 decades since 37-year-old Joshua Denton was diagnosed with ulcerative colitis.
Controlling the physical symptoms of comorbidities, such as inflammatory bowel disease, have been possible, but he was surprised when depression and anxiety set in.
“You’re dealing with what I call the anxiety of the unknown. What does this mean?” said Mr. Denton, who serves as a patient advocate with Color of Crohn’s & Chronic Illness, a nonprofit group aimed at improving quality of life for racial-ethnic minorities. “When you understand that it’s autoimmune that is chronic and incurable, you’re wondering, ‘Am I going to have a chance to get better in terms of my quality-of-life? Is it going to get worse?’ It indirectly builds this level of anxiety.”
Mr. Denton described a level of anxiety and depression that other patients living with inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, described in a recent survey from the American Gastroenterological Association. Survey results, released in March, show how emotional and social challenges are top of mind for patients living with IBD, but not so much for gastroenterologists who said they’re more concerned about treating physical health than emotional health and believe mental health is sufficiently addressed in their patients’ IBD care.
In response,
Discussions about mental health challenges are difficult for both physician and patients. For patients, they may be unwilling to talk to their physicians out of concern of being a burden, while physicians may be reluctant to pry or intrude. “I want to dispel the myth to the patients (and tell them) that your doctor actually would love to know, but is afraid to pry. And to the doctor: Your patient wants you to know, but is afraid to be a burden,” said Laurie A. Keefer, PhD, a psychologist at Icahn School of Medicine at Mount Sinai, New York, who specializes in the psychosocial care of patients with chronic digestive diseases and serves as an adviser to the My IBD Life campaign, which was launched to support both patients living with IBD and their health care providers.
But “prying” in this way is important, Dr. Keefer said. Depression and anxiety can have wide-ranging effects on patient outcomes. Depressed patients may not follow through with medication refills or may be more accepting of disability, while anxiety can lead to worries about colonoscopies or surgeries, which can lead to avoidance. “I always tell GI providers, if you can’t figure out why someone never follows through with that test or that procedure, consider anxiety before you assume that it’s just nonadherence. Anxiety and depression really affect how somebody follows the requirements they need to manage their disease,” said Dr. Keefer.
Rates of anxiety among patients are increasing
The survey included 1,026 adults (18-59 years) with IBD and of these, 63% reported having comorbid conditions, such as anxiety (36%) and depression (35%). These rates are significantly higher than in the general population – at 19% and 8%, respectively. The rate of anxiety among patients with IBD has increased since AGA conducted a similar survey in 2017.
Patients reported that they were most concerned with the ways that IBD affects their mental health or emotional health and day-to-day life. Many said their providers were more concerned about treating them physically than emotionally and expressed a need for additional information on IBD treatment options (37%) and medications (35%). They also desired more information about the impact on emotional and mental health (25%), which has increased since the 2017 survey.
The No. 1 concern for patients was the need to consider bathroom logistics when away from home (7.03 on a scale of 1-10). The second most popular concern was mental and emotional health with a rating of 6.51 on a 1-10 scale. Thirty percent requested more information about diet and 27% asked for more information about general IBD symptoms.
Both patients and providers were less satisfied with emotional and social care than physical care for IBD. Among patients, women and those between ages 18 and 39 said they were the least satisfied with their care.
“We must always consider the mind and body together when managing a chronic disease, and IBD is no exception,” Dr. Keefer said. “We also know that failure to address emotional concerns in IBD leads to poorer disease outcomes, not just reduced quality of life.”
The surveys also highlighted different experiences among communities. For instance, people of color, particularly those in the Black community, were more likely to report that their IBD journey was impacted by their personal identity, whether by race, ethnicity, culture, sexual orientation, gender identity, or age.
In contrast, a companion survey of 117 gastroenterologists found that providers are focused on physical health over emotional health (8.34 on a scale of 1-10), but they reported having sufficiently addressed concerns their patients may have expressed about mental health issues. At the same time, many also said they feel more equipped to treat their patients physically rather than emotionally.
The provider survey showed their biggest challenge was in securing insurance authorizations for medications.
Mr. Denton encourages all patients to be as transparent as possible with their providers and family members.
“I firmly believe you cannot internalize the experience and keep it to yourself. I strongly encourage other patients with IBD to continue to push themselves to be as transparent as possible with their loved ones and health care professionals, because the more we talk about it, the more we can humanize the experience and allow people that aren’t health care professionals to have a more empathetic understanding of what we’re dealing with which in turn, hopefully, will provide better support and resources,” Mr. Denton said.
The My IBD Life website provides resources for patients to navigate a range of common scenarios, including conversations about new medications, workplace concerns, intimacy and relationships, vacations and travel, and medical procedures and surgeries. An interactive 3D graphic demonstrates how IBD affects the body, and videos of patients highlight personal experiences and ways to build emotional resilience.
The My IBD Life campaign is supported by an independent grant from Bristol Myers Squibb.
It’s been over 2 decades since 37-year-old Joshua Denton was diagnosed with ulcerative colitis.
Controlling the physical symptoms of comorbidities, such as inflammatory bowel disease, have been possible, but he was surprised when depression and anxiety set in.
“You’re dealing with what I call the anxiety of the unknown. What does this mean?” said Mr. Denton, who serves as a patient advocate with Color of Crohn’s & Chronic Illness, a nonprofit group aimed at improving quality of life for racial-ethnic minorities. “When you understand that it’s autoimmune that is chronic and incurable, you’re wondering, ‘Am I going to have a chance to get better in terms of my quality-of-life? Is it going to get worse?’ It indirectly builds this level of anxiety.”
Mr. Denton described a level of anxiety and depression that other patients living with inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, described in a recent survey from the American Gastroenterological Association. Survey results, released in March, show how emotional and social challenges are top of mind for patients living with IBD, but not so much for gastroenterologists who said they’re more concerned about treating physical health than emotional health and believe mental health is sufficiently addressed in their patients’ IBD care.
In response,
Discussions about mental health challenges are difficult for both physician and patients. For patients, they may be unwilling to talk to their physicians out of concern of being a burden, while physicians may be reluctant to pry or intrude. “I want to dispel the myth to the patients (and tell them) that your doctor actually would love to know, but is afraid to pry. And to the doctor: Your patient wants you to know, but is afraid to be a burden,” said Laurie A. Keefer, PhD, a psychologist at Icahn School of Medicine at Mount Sinai, New York, who specializes in the psychosocial care of patients with chronic digestive diseases and serves as an adviser to the My IBD Life campaign, which was launched to support both patients living with IBD and their health care providers.
But “prying” in this way is important, Dr. Keefer said. Depression and anxiety can have wide-ranging effects on patient outcomes. Depressed patients may not follow through with medication refills or may be more accepting of disability, while anxiety can lead to worries about colonoscopies or surgeries, which can lead to avoidance. “I always tell GI providers, if you can’t figure out why someone never follows through with that test or that procedure, consider anxiety before you assume that it’s just nonadherence. Anxiety and depression really affect how somebody follows the requirements they need to manage their disease,” said Dr. Keefer.
Rates of anxiety among patients are increasing
The survey included 1,026 adults (18-59 years) with IBD and of these, 63% reported having comorbid conditions, such as anxiety (36%) and depression (35%). These rates are significantly higher than in the general population – at 19% and 8%, respectively. The rate of anxiety among patients with IBD has increased since AGA conducted a similar survey in 2017.
Patients reported that they were most concerned with the ways that IBD affects their mental health or emotional health and day-to-day life. Many said their providers were more concerned about treating them physically than emotionally and expressed a need for additional information on IBD treatment options (37%) and medications (35%). They also desired more information about the impact on emotional and mental health (25%), which has increased since the 2017 survey.
The No. 1 concern for patients was the need to consider bathroom logistics when away from home (7.03 on a scale of 1-10). The second most popular concern was mental and emotional health with a rating of 6.51 on a 1-10 scale. Thirty percent requested more information about diet and 27% asked for more information about general IBD symptoms.
Both patients and providers were less satisfied with emotional and social care than physical care for IBD. Among patients, women and those between ages 18 and 39 said they were the least satisfied with their care.
“We must always consider the mind and body together when managing a chronic disease, and IBD is no exception,” Dr. Keefer said. “We also know that failure to address emotional concerns in IBD leads to poorer disease outcomes, not just reduced quality of life.”
The surveys also highlighted different experiences among communities. For instance, people of color, particularly those in the Black community, were more likely to report that their IBD journey was impacted by their personal identity, whether by race, ethnicity, culture, sexual orientation, gender identity, or age.
In contrast, a companion survey of 117 gastroenterologists found that providers are focused on physical health over emotional health (8.34 on a scale of 1-10), but they reported having sufficiently addressed concerns their patients may have expressed about mental health issues. At the same time, many also said they feel more equipped to treat their patients physically rather than emotionally.
The provider survey showed their biggest challenge was in securing insurance authorizations for medications.
Mr. Denton encourages all patients to be as transparent as possible with their providers and family members.
“I firmly believe you cannot internalize the experience and keep it to yourself. I strongly encourage other patients with IBD to continue to push themselves to be as transparent as possible with their loved ones and health care professionals, because the more we talk about it, the more we can humanize the experience and allow people that aren’t health care professionals to have a more empathetic understanding of what we’re dealing with which in turn, hopefully, will provide better support and resources,” Mr. Denton said.
The My IBD Life website provides resources for patients to navigate a range of common scenarios, including conversations about new medications, workplace concerns, intimacy and relationships, vacations and travel, and medical procedures and surgeries. An interactive 3D graphic demonstrates how IBD affects the body, and videos of patients highlight personal experiences and ways to build emotional resilience.
The My IBD Life campaign is supported by an independent grant from Bristol Myers Squibb.
It’s been over 2 decades since 37-year-old Joshua Denton was diagnosed with ulcerative colitis.
Controlling the physical symptoms of comorbidities, such as inflammatory bowel disease, have been possible, but he was surprised when depression and anxiety set in.
“You’re dealing with what I call the anxiety of the unknown. What does this mean?” said Mr. Denton, who serves as a patient advocate with Color of Crohn’s & Chronic Illness, a nonprofit group aimed at improving quality of life for racial-ethnic minorities. “When you understand that it’s autoimmune that is chronic and incurable, you’re wondering, ‘Am I going to have a chance to get better in terms of my quality-of-life? Is it going to get worse?’ It indirectly builds this level of anxiety.”
Mr. Denton described a level of anxiety and depression that other patients living with inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, described in a recent survey from the American Gastroenterological Association. Survey results, released in March, show how emotional and social challenges are top of mind for patients living with IBD, but not so much for gastroenterologists who said they’re more concerned about treating physical health than emotional health and believe mental health is sufficiently addressed in their patients’ IBD care.
In response,
Discussions about mental health challenges are difficult for both physician and patients. For patients, they may be unwilling to talk to their physicians out of concern of being a burden, while physicians may be reluctant to pry or intrude. “I want to dispel the myth to the patients (and tell them) that your doctor actually would love to know, but is afraid to pry. And to the doctor: Your patient wants you to know, but is afraid to be a burden,” said Laurie A. Keefer, PhD, a psychologist at Icahn School of Medicine at Mount Sinai, New York, who specializes in the psychosocial care of patients with chronic digestive diseases and serves as an adviser to the My IBD Life campaign, which was launched to support both patients living with IBD and their health care providers.
But “prying” in this way is important, Dr. Keefer said. Depression and anxiety can have wide-ranging effects on patient outcomes. Depressed patients may not follow through with medication refills or may be more accepting of disability, while anxiety can lead to worries about colonoscopies or surgeries, which can lead to avoidance. “I always tell GI providers, if you can’t figure out why someone never follows through with that test or that procedure, consider anxiety before you assume that it’s just nonadherence. Anxiety and depression really affect how somebody follows the requirements they need to manage their disease,” said Dr. Keefer.
Rates of anxiety among patients are increasing
The survey included 1,026 adults (18-59 years) with IBD and of these, 63% reported having comorbid conditions, such as anxiety (36%) and depression (35%). These rates are significantly higher than in the general population – at 19% and 8%, respectively. The rate of anxiety among patients with IBD has increased since AGA conducted a similar survey in 2017.
Patients reported that they were most concerned with the ways that IBD affects their mental health or emotional health and day-to-day life. Many said their providers were more concerned about treating them physically than emotionally and expressed a need for additional information on IBD treatment options (37%) and medications (35%). They also desired more information about the impact on emotional and mental health (25%), which has increased since the 2017 survey.
The No. 1 concern for patients was the need to consider bathroom logistics when away from home (7.03 on a scale of 1-10). The second most popular concern was mental and emotional health with a rating of 6.51 on a 1-10 scale. Thirty percent requested more information about diet and 27% asked for more information about general IBD symptoms.
Both patients and providers were less satisfied with emotional and social care than physical care for IBD. Among patients, women and those between ages 18 and 39 said they were the least satisfied with their care.
“We must always consider the mind and body together when managing a chronic disease, and IBD is no exception,” Dr. Keefer said. “We also know that failure to address emotional concerns in IBD leads to poorer disease outcomes, not just reduced quality of life.”
The surveys also highlighted different experiences among communities. For instance, people of color, particularly those in the Black community, were more likely to report that their IBD journey was impacted by their personal identity, whether by race, ethnicity, culture, sexual orientation, gender identity, or age.
In contrast, a companion survey of 117 gastroenterologists found that providers are focused on physical health over emotional health (8.34 on a scale of 1-10), but they reported having sufficiently addressed concerns their patients may have expressed about mental health issues. At the same time, many also said they feel more equipped to treat their patients physically rather than emotionally.
The provider survey showed their biggest challenge was in securing insurance authorizations for medications.
Mr. Denton encourages all patients to be as transparent as possible with their providers and family members.
“I firmly believe you cannot internalize the experience and keep it to yourself. I strongly encourage other patients with IBD to continue to push themselves to be as transparent as possible with their loved ones and health care professionals, because the more we talk about it, the more we can humanize the experience and allow people that aren’t health care professionals to have a more empathetic understanding of what we’re dealing with which in turn, hopefully, will provide better support and resources,” Mr. Denton said.
The My IBD Life website provides resources for patients to navigate a range of common scenarios, including conversations about new medications, workplace concerns, intimacy and relationships, vacations and travel, and medical procedures and surgeries. An interactive 3D graphic demonstrates how IBD affects the body, and videos of patients highlight personal experiences and ways to build emotional resilience.
The My IBD Life campaign is supported by an independent grant from Bristol Myers Squibb.
High salt intake linked to atherosclerosis even with normal BP
A high salt intake is an important risk factor for atherosclerosis, even in the absence of hypertension, a large study from Sweden concludes.
The study, including more than 10,000 individuals between the ages of 50 and 64 years from the Swedish Cardiopulmonary bioImage Study, showed a significant link between dietary salt intake and the risk for atherosclerotic lesions in the coronary and carotid arteries, even in participants with normal blood pressure and without known cardiovascular disease.
The finding suggests that salt could be a damaging factor in its own right before the development of hypertension, the authors write. The results were published online in European Heart Journal Open.
It has been known for a long time that salt is linked to hypertension, but the role that salt plays in atherosclerosis has not been examined, first author Jonas Wuopio, MD, Karolinska Institutet, Huddinge, and Clinical Research Center, Falun, Uppsala University, both in Sweden, told this news organization.
“Hardly anyone looks at changes in the arteries’ calcification, the atherosclerotic plaques and the association with salt intake,” Dr. Wuopio said. “We had this exclusive data from our cohort, so we wanted to use it to close this knowledge gap.”
The analysis included 10,788 adults aged 50-64 years, (average age, 58 years; 52% women) who underwent a coronary computed tomography angiography (CCTA) scan. The estimated 24-hour sodium excretion was used to measure sodium intake.
CCTA was used to obtain 3-D images of the coronary arteries to measure the degree of coronary artery calcium as well as detect stenosis in the coronary arteries. Participants also had an ultrasound of the carotid arteries.
After adjusting for age, sex, and study site (the study was done at Uppsala and Malmö, Sweden), the researchers found that rising salt consumption was linked with increasing atherosclerosis in a linear fashion in both the coronary and carotid arteries.
Each 1,000 mg rise in sodium excretion was associated with a 9% increased occurrence of carotid plaque (odds ratio, 1.09; P < .001; confidence interval, 1.06-1.12), a higher coronary artery calcium score (OR, 1.16; P < .001; CI, 1.12-1.19), and a 17% increased occurrence of coronary artery stenosis (OR, 1.17; P < .001; CI, 1.13-1.20).
The association was abolished, though, after adjusting for blood pressure, they note. Their “interpretation is that the increase in blood pressure from sodium intake, even below the level that currently defines arterial hypertension, is an important factor that mediates the interplay between salt intake and the atherosclerotic process,” they write. “As we observed an association in individuals with normal blood pressure, one possible explanation for these findings is that the detrimental pathological processes begin already prior to the development of hypertension,” they note, although they caution that no causal relationships can be gleaned from this cross-sectional study.
They also reported no sign of a “J-curve”; participants with the lowest levels of sodium excretion had the lowest occurrence of both coronary and carotid atherosclerosis, which contradicts findings in some studies that found very low sodium linked to increased cardiovascular disease–related events.
“There have been some controversies among researchers regarding very low intake, where some say very low salt intake can increase the risk of cardiovascular disease, but we could not find this in this study,” Dr. Wuopio said.
“Our study is confirming that excess salt is not a good thing, but the fact that it is linked to atherosclerosis, even in the absence of hypertension, was a bit of a surprise,” he said.
“I will be telling my patients to follow the advice given by the World Health Organization and other medical societies, to limit your intake of salt to approximately 1 teaspoon, even if your blood pressure is normal.”
Time to scrutinize salt’s role in atherosclerosis
In an accompanying editorial, Maciej Banach, MD, Medical University of Lodz, and Stanislaw Surma, MD, Faculty of Medical Sciences in Katowice, both in Poland, write that excessive dietary salt intake is a well-documented cardiovascular risk factor, and that the association is explained in most studies by increased blood pressure.
“We should look more extensively on the role of dietary salt, as it affects many pathological mechanisms, by which, especially with the coexistence of other risk factors, atherosclerosis may progress very fast,” they write.
“The results of the study shed new light on the direct relationship between excessive dietary salt intake and the risk of ASCVD [atherosclerotic cardiovascular disease], indicating that salt intake might be a risk factor for atherosclerosis even prior to the development of hypertension,” they conclude.
Confirmatory and novel
“Nobody questions the fact that high blood pressure is a powerful risk factor for atherosclerotic disease, but not all studies have suggested that, at least at significantly higher levels of sodium intake, that high salt intake tracks with risk for atherosclerotic disease,” Alon Gitig, MD, assistant professor and director of cardiology, Mount Sinai Doctors-Westchester, Yonkers, New York, told this news organization.
Most of the studies of salt intake in the diet are based on patient self-reports via food frequency questionnaires, which can give a general idea of salt intake, but are often not totally accurate, Dr. Gitig said.
“Here, they measured sodium in the urine and estimated the 24-hour salt intake from that, which is slightly novel,” he said.
Everybody knows that high blood pressure is associated with future cardiovascular disease risk, but what many don’t realize is that that risk starts to increase slightly but significantly above a blood pressure that is already in the range of 115 mm Hg/75 mm Hg, he said.
“The lower you can get your blood pressure down, to around 115-120, the lower your risk for cardiovascular disease,” Dr. Gitig said.
It is possible for most people to lower blood pressure through attention to diet, restricting sodium, performing cardio and weight training exercises, and maintaining a healthy weight, he said.
An example of a cardiovascular health diet is the Dietary Approaches to Stop Hypertension (DASH) diet.
“The DASH diet, consisting of 9 servings of fruits and vegetables a day with few refined carbs, flour and sugar, has been shown in a randomized trial to dramatically reduce blood pressure. There are two reasons for that. One is that the fruits and vegetables have many phytonutrients that are good for arteries. The other is that a large proportion of U.S. adults have insulin resistance, which leads to high blood pressure.
“The more fruits and vegetables and healthy animal products, and less sugar and flour, the more you are going to improve your insulin resistance, so you can bring your blood pressure down that way,” Dr. Gitig said.
The study was funded by the Swedish Heart-Lung Foundation, the Knut and Alice Wallenberg Foundation, the Swedish Research Council and Vinnova (Sweden’s Innovation agency), the University of Gothenburg and Sahlgrenska University Hospital, the Karolinska Institutet and Stockholm County Council, the Linköping University and University Hospital, the Lund University and Skane University Hospital, the Umea University and University Hospital, and the Uppsala University and University Hospital. Dr. Wuopio and Dr. Gitig report no relevant financial relationships. Dr. Banach reports financial relationships with Adamed, Amgen, Daichii Sankyo, Esperion, KrKa, NewAmsterdam, Polpharma, Novartis, Pfizer, Sanofi, Teva, Viatris, and CMDO at Longevity Group (LU). Dr. Surma reports a financial relationship with Sanofi and Novartis.
A version of this article first appeared on Medscape.com.
A high salt intake is an important risk factor for atherosclerosis, even in the absence of hypertension, a large study from Sweden concludes.
The study, including more than 10,000 individuals between the ages of 50 and 64 years from the Swedish Cardiopulmonary bioImage Study, showed a significant link between dietary salt intake and the risk for atherosclerotic lesions in the coronary and carotid arteries, even in participants with normal blood pressure and without known cardiovascular disease.
The finding suggests that salt could be a damaging factor in its own right before the development of hypertension, the authors write. The results were published online in European Heart Journal Open.
It has been known for a long time that salt is linked to hypertension, but the role that salt plays in atherosclerosis has not been examined, first author Jonas Wuopio, MD, Karolinska Institutet, Huddinge, and Clinical Research Center, Falun, Uppsala University, both in Sweden, told this news organization.
“Hardly anyone looks at changes in the arteries’ calcification, the atherosclerotic plaques and the association with salt intake,” Dr. Wuopio said. “We had this exclusive data from our cohort, so we wanted to use it to close this knowledge gap.”
The analysis included 10,788 adults aged 50-64 years, (average age, 58 years; 52% women) who underwent a coronary computed tomography angiography (CCTA) scan. The estimated 24-hour sodium excretion was used to measure sodium intake.
CCTA was used to obtain 3-D images of the coronary arteries to measure the degree of coronary artery calcium as well as detect stenosis in the coronary arteries. Participants also had an ultrasound of the carotid arteries.
After adjusting for age, sex, and study site (the study was done at Uppsala and Malmö, Sweden), the researchers found that rising salt consumption was linked with increasing atherosclerosis in a linear fashion in both the coronary and carotid arteries.
Each 1,000 mg rise in sodium excretion was associated with a 9% increased occurrence of carotid plaque (odds ratio, 1.09; P < .001; confidence interval, 1.06-1.12), a higher coronary artery calcium score (OR, 1.16; P < .001; CI, 1.12-1.19), and a 17% increased occurrence of coronary artery stenosis (OR, 1.17; P < .001; CI, 1.13-1.20).
The association was abolished, though, after adjusting for blood pressure, they note. Their “interpretation is that the increase in blood pressure from sodium intake, even below the level that currently defines arterial hypertension, is an important factor that mediates the interplay between salt intake and the atherosclerotic process,” they write. “As we observed an association in individuals with normal blood pressure, one possible explanation for these findings is that the detrimental pathological processes begin already prior to the development of hypertension,” they note, although they caution that no causal relationships can be gleaned from this cross-sectional study.
They also reported no sign of a “J-curve”; participants with the lowest levels of sodium excretion had the lowest occurrence of both coronary and carotid atherosclerosis, which contradicts findings in some studies that found very low sodium linked to increased cardiovascular disease–related events.
“There have been some controversies among researchers regarding very low intake, where some say very low salt intake can increase the risk of cardiovascular disease, but we could not find this in this study,” Dr. Wuopio said.
“Our study is confirming that excess salt is not a good thing, but the fact that it is linked to atherosclerosis, even in the absence of hypertension, was a bit of a surprise,” he said.
“I will be telling my patients to follow the advice given by the World Health Organization and other medical societies, to limit your intake of salt to approximately 1 teaspoon, even if your blood pressure is normal.”
Time to scrutinize salt’s role in atherosclerosis
In an accompanying editorial, Maciej Banach, MD, Medical University of Lodz, and Stanislaw Surma, MD, Faculty of Medical Sciences in Katowice, both in Poland, write that excessive dietary salt intake is a well-documented cardiovascular risk factor, and that the association is explained in most studies by increased blood pressure.
“We should look more extensively on the role of dietary salt, as it affects many pathological mechanisms, by which, especially with the coexistence of other risk factors, atherosclerosis may progress very fast,” they write.
“The results of the study shed new light on the direct relationship between excessive dietary salt intake and the risk of ASCVD [atherosclerotic cardiovascular disease], indicating that salt intake might be a risk factor for atherosclerosis even prior to the development of hypertension,” they conclude.
Confirmatory and novel
“Nobody questions the fact that high blood pressure is a powerful risk factor for atherosclerotic disease, but not all studies have suggested that, at least at significantly higher levels of sodium intake, that high salt intake tracks with risk for atherosclerotic disease,” Alon Gitig, MD, assistant professor and director of cardiology, Mount Sinai Doctors-Westchester, Yonkers, New York, told this news organization.
Most of the studies of salt intake in the diet are based on patient self-reports via food frequency questionnaires, which can give a general idea of salt intake, but are often not totally accurate, Dr. Gitig said.
“Here, they measured sodium in the urine and estimated the 24-hour salt intake from that, which is slightly novel,” he said.
Everybody knows that high blood pressure is associated with future cardiovascular disease risk, but what many don’t realize is that that risk starts to increase slightly but significantly above a blood pressure that is already in the range of 115 mm Hg/75 mm Hg, he said.
“The lower you can get your blood pressure down, to around 115-120, the lower your risk for cardiovascular disease,” Dr. Gitig said.
It is possible for most people to lower blood pressure through attention to diet, restricting sodium, performing cardio and weight training exercises, and maintaining a healthy weight, he said.
An example of a cardiovascular health diet is the Dietary Approaches to Stop Hypertension (DASH) diet.
“The DASH diet, consisting of 9 servings of fruits and vegetables a day with few refined carbs, flour and sugar, has been shown in a randomized trial to dramatically reduce blood pressure. There are two reasons for that. One is that the fruits and vegetables have many phytonutrients that are good for arteries. The other is that a large proportion of U.S. adults have insulin resistance, which leads to high blood pressure.
“The more fruits and vegetables and healthy animal products, and less sugar and flour, the more you are going to improve your insulin resistance, so you can bring your blood pressure down that way,” Dr. Gitig said.
The study was funded by the Swedish Heart-Lung Foundation, the Knut and Alice Wallenberg Foundation, the Swedish Research Council and Vinnova (Sweden’s Innovation agency), the University of Gothenburg and Sahlgrenska University Hospital, the Karolinska Institutet and Stockholm County Council, the Linköping University and University Hospital, the Lund University and Skane University Hospital, the Umea University and University Hospital, and the Uppsala University and University Hospital. Dr. Wuopio and Dr. Gitig report no relevant financial relationships. Dr. Banach reports financial relationships with Adamed, Amgen, Daichii Sankyo, Esperion, KrKa, NewAmsterdam, Polpharma, Novartis, Pfizer, Sanofi, Teva, Viatris, and CMDO at Longevity Group (LU). Dr. Surma reports a financial relationship with Sanofi and Novartis.
A version of this article first appeared on Medscape.com.
A high salt intake is an important risk factor for atherosclerosis, even in the absence of hypertension, a large study from Sweden concludes.
The study, including more than 10,000 individuals between the ages of 50 and 64 years from the Swedish Cardiopulmonary bioImage Study, showed a significant link between dietary salt intake and the risk for atherosclerotic lesions in the coronary and carotid arteries, even in participants with normal blood pressure and without known cardiovascular disease.
The finding suggests that salt could be a damaging factor in its own right before the development of hypertension, the authors write. The results were published online in European Heart Journal Open.
It has been known for a long time that salt is linked to hypertension, but the role that salt plays in atherosclerosis has not been examined, first author Jonas Wuopio, MD, Karolinska Institutet, Huddinge, and Clinical Research Center, Falun, Uppsala University, both in Sweden, told this news organization.
“Hardly anyone looks at changes in the arteries’ calcification, the atherosclerotic plaques and the association with salt intake,” Dr. Wuopio said. “We had this exclusive data from our cohort, so we wanted to use it to close this knowledge gap.”
The analysis included 10,788 adults aged 50-64 years, (average age, 58 years; 52% women) who underwent a coronary computed tomography angiography (CCTA) scan. The estimated 24-hour sodium excretion was used to measure sodium intake.
CCTA was used to obtain 3-D images of the coronary arteries to measure the degree of coronary artery calcium as well as detect stenosis in the coronary arteries. Participants also had an ultrasound of the carotid arteries.
After adjusting for age, sex, and study site (the study was done at Uppsala and Malmö, Sweden), the researchers found that rising salt consumption was linked with increasing atherosclerosis in a linear fashion in both the coronary and carotid arteries.
Each 1,000 mg rise in sodium excretion was associated with a 9% increased occurrence of carotid plaque (odds ratio, 1.09; P < .001; confidence interval, 1.06-1.12), a higher coronary artery calcium score (OR, 1.16; P < .001; CI, 1.12-1.19), and a 17% increased occurrence of coronary artery stenosis (OR, 1.17; P < .001; CI, 1.13-1.20).
The association was abolished, though, after adjusting for blood pressure, they note. Their “interpretation is that the increase in blood pressure from sodium intake, even below the level that currently defines arterial hypertension, is an important factor that mediates the interplay between salt intake and the atherosclerotic process,” they write. “As we observed an association in individuals with normal blood pressure, one possible explanation for these findings is that the detrimental pathological processes begin already prior to the development of hypertension,” they note, although they caution that no causal relationships can be gleaned from this cross-sectional study.
They also reported no sign of a “J-curve”; participants with the lowest levels of sodium excretion had the lowest occurrence of both coronary and carotid atherosclerosis, which contradicts findings in some studies that found very low sodium linked to increased cardiovascular disease–related events.
“There have been some controversies among researchers regarding very low intake, where some say very low salt intake can increase the risk of cardiovascular disease, but we could not find this in this study,” Dr. Wuopio said.
“Our study is confirming that excess salt is not a good thing, but the fact that it is linked to atherosclerosis, even in the absence of hypertension, was a bit of a surprise,” he said.
“I will be telling my patients to follow the advice given by the World Health Organization and other medical societies, to limit your intake of salt to approximately 1 teaspoon, even if your blood pressure is normal.”
Time to scrutinize salt’s role in atherosclerosis
In an accompanying editorial, Maciej Banach, MD, Medical University of Lodz, and Stanislaw Surma, MD, Faculty of Medical Sciences in Katowice, both in Poland, write that excessive dietary salt intake is a well-documented cardiovascular risk factor, and that the association is explained in most studies by increased blood pressure.
“We should look more extensively on the role of dietary salt, as it affects many pathological mechanisms, by which, especially with the coexistence of other risk factors, atherosclerosis may progress very fast,” they write.
“The results of the study shed new light on the direct relationship between excessive dietary salt intake and the risk of ASCVD [atherosclerotic cardiovascular disease], indicating that salt intake might be a risk factor for atherosclerosis even prior to the development of hypertension,” they conclude.
Confirmatory and novel
“Nobody questions the fact that high blood pressure is a powerful risk factor for atherosclerotic disease, but not all studies have suggested that, at least at significantly higher levels of sodium intake, that high salt intake tracks with risk for atherosclerotic disease,” Alon Gitig, MD, assistant professor and director of cardiology, Mount Sinai Doctors-Westchester, Yonkers, New York, told this news organization.
Most of the studies of salt intake in the diet are based on patient self-reports via food frequency questionnaires, which can give a general idea of salt intake, but are often not totally accurate, Dr. Gitig said.
“Here, they measured sodium in the urine and estimated the 24-hour salt intake from that, which is slightly novel,” he said.
Everybody knows that high blood pressure is associated with future cardiovascular disease risk, but what many don’t realize is that that risk starts to increase slightly but significantly above a blood pressure that is already in the range of 115 mm Hg/75 mm Hg, he said.
“The lower you can get your blood pressure down, to around 115-120, the lower your risk for cardiovascular disease,” Dr. Gitig said.
It is possible for most people to lower blood pressure through attention to diet, restricting sodium, performing cardio and weight training exercises, and maintaining a healthy weight, he said.
An example of a cardiovascular health diet is the Dietary Approaches to Stop Hypertension (DASH) diet.
“The DASH diet, consisting of 9 servings of fruits and vegetables a day with few refined carbs, flour and sugar, has been shown in a randomized trial to dramatically reduce blood pressure. There are two reasons for that. One is that the fruits and vegetables have many phytonutrients that are good for arteries. The other is that a large proportion of U.S. adults have insulin resistance, which leads to high blood pressure.
“The more fruits and vegetables and healthy animal products, and less sugar and flour, the more you are going to improve your insulin resistance, so you can bring your blood pressure down that way,” Dr. Gitig said.
The study was funded by the Swedish Heart-Lung Foundation, the Knut and Alice Wallenberg Foundation, the Swedish Research Council and Vinnova (Sweden’s Innovation agency), the University of Gothenburg and Sahlgrenska University Hospital, the Karolinska Institutet and Stockholm County Council, the Linköping University and University Hospital, the Lund University and Skane University Hospital, the Umea University and University Hospital, and the Uppsala University and University Hospital. Dr. Wuopio and Dr. Gitig report no relevant financial relationships. Dr. Banach reports financial relationships with Adamed, Amgen, Daichii Sankyo, Esperion, KrKa, NewAmsterdam, Polpharma, Novartis, Pfizer, Sanofi, Teva, Viatris, and CMDO at Longevity Group (LU). Dr. Surma reports a financial relationship with Sanofi and Novartis.
A version of this article first appeared on Medscape.com.
Noisy incubators could stunt infant hearing
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies’ hearing and language development skills at risk.
Previous studies have shown that the neonatal intensive care unit is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, and colleagues.
“By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants,” and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say.
In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels to describe the sound characteristics and to identify resonance characteristics inside an incubator.
The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannequin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care.
Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency); and blood pressure measurement.
The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.
The researchers reported that the incubator tended to dampen most sounds but also that some sounds resonated inside the incubator, which raised the interior noise level by as much as 28 decibels.
Most of the measures using both A-weighted decibels (dBA) and sound pressure level decibels (dBSPL) were above the 45-decibel level for neonatal sound exposure recommended by the American Academy of Pediatrics. The measurements (dBA) versus unweighted (dBSPL) are limited in that they are designed to measure low levels of sound and therefore might underestimate proportions of high and low frequencies at stronger levels, the researchers acknowledge.
Overall, most measures were clustered in the 55-75 decibel range, although some sound levels for incubator handling, while below levels previously reported in the literature, reached approximately 100 decibels.
The noise involved inside the incubator was not perceived as loud by those working with the incubator, the researchers note.
As for resonance inside the incubator, the researchers measured a low-frequency main resonance of 97 Hz, but they write that this resonance can be hard to capture in weighted measurements. However, the resonance means that “noises from the outside sound more tonal inside the incubator, booming and muffled as well as less rough or noisy,” and sounds inside the incubator are similarly affected, the researchers say.
“Most of the noise situations described in this manuscript far exceed not only the recommendation of the AAP but also international guidelines provided by the World Health Organization and the U.S. Environmental Protection Agency,” which recommend, respectively, maximum dBA levels of 35 dBA and 45 dBA for daytime and 30 dBA and 35 dBA for night, the researchers indicate.
Potential long-term implications are that babies who spend time in the NICU are at risk for hearing impairment, which could lead to delays in language acquisition, they say.
The findings were limited by several factors, including the variance among the incubators, which prevents generalizability, the researchers note. Other limitations include the use of a simulation room rather than everyday conditions, in which the environmental sounds would likely be even louder.
However, the results provide insights into the specifics of incubator and NICU noise and suggest that sound be a consideration in the development and promotion of incubators to help protect the hearing of the infants inside them, the researchers conclude.
A generalist’s take
“This is an interesting study looking at the level and character of the sound experienced by preterm infants inside an incubator and how it may compare to sounds experienced within the mother’s womb,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
In society at large, “there has been more focus lately on the general environment and its effect on health, and this study is a unique take on this concept,” he said. “Although in general the incubators work to dampen external sounds, low-frequency sounds may actually resonate more inside the incubators, and taps on the outside or inside of the incubator itself are amplified within the incubator,” he noted. “It is sad but not surprising that the decibel levels experienced by the infants in the incubators exceed the recommended levels recommended by AAP.”
As for additional research, “it would be interesting to see the results of trials looking at various short- or long-term outcomes experienced by infants exposed to a lower-level noise compared to the current levels,” Dr. Joos told this news organization.
A neonatologist’s perspective
“As the field of neonatology advances, we are caring for an ever-growing number of extremely preterm infants,” said Caitlin M. Drumm, MD, of Walter Reed National Military Medical Center, Bethesda, Md., in an interview.
“These infants will spend the first few months of their lives within an incubator in the neonatal intensive care unit, so it is important to understand the potential long-term implications of environmental effects on these vulnerable patients,” she said.
“As in prior studies, it was not surprising that essentially every environmental, handling, or respiratory intervention led to noise levels higher than the limit recommended by the American Academy of Pediatrics,” Dr. Drumm said. “What was surprising was just how high above the 45-dB recommended noise limit many environmental stimuli are. For example, the authors cite respiratory flow rates of 8 L/min or higher as risky for hearing health at 84.72 dBSPL, “ she said.
The key message for clinicians is to be aware of noise levels in the NICU, Dr. Drumm said. “Environmental stimuli as simple as putting a stethoscope on the incubator lead to noise levels well above the limit recommended by the American Academy of Pediatrics. The entire NICU care team has a role to play in minimizing environmental sound hazards for our most critically ill patients.”
Looking ahead, “future research should focus on providing more information correlating neonatal environmental sound exposure to long-term hearing and neurodevelopmental outcomes,” she said.
The study received no outside funding. The researchers report no relevant financial relationships. Dr. Joos serves on the editorial advisory board of Pediatric News. Dr. Drumm has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Clinical Practice Update: Alpha-gal syndrome often causes GI issues without anaphylaxis, skin changes
according to an American Gastroenterological Association clinical practice update.
Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.
“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.
To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.
“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”
Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.
“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.
In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.
Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.
“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.
Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.
The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.
The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.
according to an American Gastroenterological Association clinical practice update.
Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.
“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.
To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.
“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”
Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.
“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.
In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.
Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.
“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.
Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.
The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.
The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.
according to an American Gastroenterological Association clinical practice update.
Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.
“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.
To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.
“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”
Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.
“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.
In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.
Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.
“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.
Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.
The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.
The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Four PTSD blood biomarkers identified
“More accurate means of predicting or screening for PTSD could help to overcome the disorder by identifying individuals at high risk of developing PTSD and providing them with early intervention or prevention strategies,” said study investigator Stacy-Ann Miller, MS.
She also noted that the biomarkers could be used to monitor treatment for PTSD, identify subtypes of PTSD, and lead to a new understanding of the mechanisms underlying PTSD.
The findings were presented at Discover BMB, the annual meeting of the American Society for Biochemistry and Molecular Biology.
Toward better clinical assessment
The findings originated from research conducted by the Department of Defense–initiated PTSD Systems Biology Consortium. The consortium’s goals include developing a reproducible panel of blood-based biomarkers with high sensitivity and specificity for PTSD diagnosis and is made up of about 45 researchers, led by Marti Jett, PhD, Charles Marmar, MD, and Francis J. Doyle III, PhD.
The researchers analyzed blood samples from 1,000 active-duty Army personnel from the 101st Airborne at Fort Campbell, Ky. Participants were assessed before and after deployment to Afghanistan in February 2014 and are referred to as the Fort Campbell Cohort (FCC). Participants’ age ranged from 25 to 30 and approximately 6% were female.
Investigators collected blood samples from the service members and looked for four biomarkers: glycolytic ratio, arginine, serotonin, and glutamate. The team then divided the participants into four groups – those with PTSD (PTSD Checklist score above 30), those who were subthreshold for PTSD (PTSD Checklist score 15-30), those who had high resilience, and those who had low levels of resilience.
The resilience groups were determined based on answers to the Generalized Anxiety Disorder Questionnaire, Patient Health Questionnaire, Pittsburgh Sleep Quality Index, Intensive Combat Exposure (DRRI-D), the number of deployments, whether they had moderate or severe traumatic brain injury, and scores on the Alcohol Use Disorders Identification Test.
Those who scored in the high range at current or prior time points or who were PTSD/subthreshold at prior time points were placed in the low resilience group.
Ms. Miller noted that those in the PTSD group had more severe symptoms than those in the PTSD subthreshold group based on the longitudinal clinical assessment at 3-6 months, 5 years, and longer post deployment. The low resilience group had a much higher rate of PTSD post deployment than the high resilience group.
Investigators found participants with PTSD or subthreshold PTSD had significantly higher glycolic ratios and lower arginine than those with high resilience. They also found that those with PTSD had significantly lower serotonin and higher glutamate levels versus those with high resilience. These associations were independent of factors such as sex, age, body mass index, smoking, and caffeine consumption.
Ms. Miller said that the study results require further validation by the consortium’s labs and third-party labs.
“We are also interested in determining the most appropriate time to screen soldiers for PTSD, as it has been noted that the time period where we see the most psychological issues is around 2-3 months post return from deployment and when the soldier is preparing for their next assignment, perhaps a next deployment,” she said.
She added that previous studies have identified several promising biomarkers of PTSD. “However, like much of the research data, the study sample was comprised mainly of combat-exposed males. With more women serving on the front lines, the military faces new challenges in how combat affects females in the military,” including sex-specific biomarkers that will improve clinical assessment for female soldiers.
Eventually, the team would also like to be able to apply their research to the civilian population experiencing PTSD.
“Our research is anticipated to be useful in helping the medical provider select appropriate therapeutic interventions,” Ms. Miller said.
A version of this article first appeared on Medscape.com.
“More accurate means of predicting or screening for PTSD could help to overcome the disorder by identifying individuals at high risk of developing PTSD and providing them with early intervention or prevention strategies,” said study investigator Stacy-Ann Miller, MS.
She also noted that the biomarkers could be used to monitor treatment for PTSD, identify subtypes of PTSD, and lead to a new understanding of the mechanisms underlying PTSD.
The findings were presented at Discover BMB, the annual meeting of the American Society for Biochemistry and Molecular Biology.
Toward better clinical assessment
The findings originated from research conducted by the Department of Defense–initiated PTSD Systems Biology Consortium. The consortium’s goals include developing a reproducible panel of blood-based biomarkers with high sensitivity and specificity for PTSD diagnosis and is made up of about 45 researchers, led by Marti Jett, PhD, Charles Marmar, MD, and Francis J. Doyle III, PhD.
The researchers analyzed blood samples from 1,000 active-duty Army personnel from the 101st Airborne at Fort Campbell, Ky. Participants were assessed before and after deployment to Afghanistan in February 2014 and are referred to as the Fort Campbell Cohort (FCC). Participants’ age ranged from 25 to 30 and approximately 6% were female.
Investigators collected blood samples from the service members and looked for four biomarkers: glycolytic ratio, arginine, serotonin, and glutamate. The team then divided the participants into four groups – those with PTSD (PTSD Checklist score above 30), those who were subthreshold for PTSD (PTSD Checklist score 15-30), those who had high resilience, and those who had low levels of resilience.
The resilience groups were determined based on answers to the Generalized Anxiety Disorder Questionnaire, Patient Health Questionnaire, Pittsburgh Sleep Quality Index, Intensive Combat Exposure (DRRI-D), the number of deployments, whether they had moderate or severe traumatic brain injury, and scores on the Alcohol Use Disorders Identification Test.
Those who scored in the high range at current or prior time points or who were PTSD/subthreshold at prior time points were placed in the low resilience group.
Ms. Miller noted that those in the PTSD group had more severe symptoms than those in the PTSD subthreshold group based on the longitudinal clinical assessment at 3-6 months, 5 years, and longer post deployment. The low resilience group had a much higher rate of PTSD post deployment than the high resilience group.
Investigators found participants with PTSD or subthreshold PTSD had significantly higher glycolic ratios and lower arginine than those with high resilience. They also found that those with PTSD had significantly lower serotonin and higher glutamate levels versus those with high resilience. These associations were independent of factors such as sex, age, body mass index, smoking, and caffeine consumption.
Ms. Miller said that the study results require further validation by the consortium’s labs and third-party labs.
“We are also interested in determining the most appropriate time to screen soldiers for PTSD, as it has been noted that the time period where we see the most psychological issues is around 2-3 months post return from deployment and when the soldier is preparing for their next assignment, perhaps a next deployment,” she said.
She added that previous studies have identified several promising biomarkers of PTSD. “However, like much of the research data, the study sample was comprised mainly of combat-exposed males. With more women serving on the front lines, the military faces new challenges in how combat affects females in the military,” including sex-specific biomarkers that will improve clinical assessment for female soldiers.
Eventually, the team would also like to be able to apply their research to the civilian population experiencing PTSD.
“Our research is anticipated to be useful in helping the medical provider select appropriate therapeutic interventions,” Ms. Miller said.
A version of this article first appeared on Medscape.com.
“More accurate means of predicting or screening for PTSD could help to overcome the disorder by identifying individuals at high risk of developing PTSD and providing them with early intervention or prevention strategies,” said study investigator Stacy-Ann Miller, MS.
She also noted that the biomarkers could be used to monitor treatment for PTSD, identify subtypes of PTSD, and lead to a new understanding of the mechanisms underlying PTSD.
The findings were presented at Discover BMB, the annual meeting of the American Society for Biochemistry and Molecular Biology.
Toward better clinical assessment
The findings originated from research conducted by the Department of Defense–initiated PTSD Systems Biology Consortium. The consortium’s goals include developing a reproducible panel of blood-based biomarkers with high sensitivity and specificity for PTSD diagnosis and is made up of about 45 researchers, led by Marti Jett, PhD, Charles Marmar, MD, and Francis J. Doyle III, PhD.
The researchers analyzed blood samples from 1,000 active-duty Army personnel from the 101st Airborne at Fort Campbell, Ky. Participants were assessed before and after deployment to Afghanistan in February 2014 and are referred to as the Fort Campbell Cohort (FCC). Participants’ age ranged from 25 to 30 and approximately 6% were female.
Investigators collected blood samples from the service members and looked for four biomarkers: glycolytic ratio, arginine, serotonin, and glutamate. The team then divided the participants into four groups – those with PTSD (PTSD Checklist score above 30), those who were subthreshold for PTSD (PTSD Checklist score 15-30), those who had high resilience, and those who had low levels of resilience.
The resilience groups were determined based on answers to the Generalized Anxiety Disorder Questionnaire, Patient Health Questionnaire, Pittsburgh Sleep Quality Index, Intensive Combat Exposure (DRRI-D), the number of deployments, whether they had moderate or severe traumatic brain injury, and scores on the Alcohol Use Disorders Identification Test.
Those who scored in the high range at current or prior time points or who were PTSD/subthreshold at prior time points were placed in the low resilience group.
Ms. Miller noted that those in the PTSD group had more severe symptoms than those in the PTSD subthreshold group based on the longitudinal clinical assessment at 3-6 months, 5 years, and longer post deployment. The low resilience group had a much higher rate of PTSD post deployment than the high resilience group.
Investigators found participants with PTSD or subthreshold PTSD had significantly higher glycolic ratios and lower arginine than those with high resilience. They also found that those with PTSD had significantly lower serotonin and higher glutamate levels versus those with high resilience. These associations were independent of factors such as sex, age, body mass index, smoking, and caffeine consumption.
Ms. Miller said that the study results require further validation by the consortium’s labs and third-party labs.
“We are also interested in determining the most appropriate time to screen soldiers for PTSD, as it has been noted that the time period where we see the most psychological issues is around 2-3 months post return from deployment and when the soldier is preparing for their next assignment, perhaps a next deployment,” she said.
She added that previous studies have identified several promising biomarkers of PTSD. “However, like much of the research data, the study sample was comprised mainly of combat-exposed males. With more women serving on the front lines, the military faces new challenges in how combat affects females in the military,” including sex-specific biomarkers that will improve clinical assessment for female soldiers.
Eventually, the team would also like to be able to apply their research to the civilian population experiencing PTSD.
“Our research is anticipated to be useful in helping the medical provider select appropriate therapeutic interventions,” Ms. Miller said.
A version of this article first appeared on Medscape.com.
FROM DISCOVER BMB
De-escalation still beneficial after 10 years for some HER2+ breast cancers
Lowering the intensity of chemotherapy also reduces the adverse events that are associated with it.
An open-label study of about 400 participants indicated that 12 weeks of treatment with paclitaxel (Abraxane) and trastuzumab (Herceptin), followed by 9 months of trastuzumab monotherapy, was associated with very good long-term outcomes for patients with certain HER2-positive breast cancers. Few distant recurrences were observed, and tolerability was good.
The study was conducted by a team that included researchers from the European Institute of Oncology in Milan, one of the main oncology institutes in Italy.
“HER2-positive breast cancers harbor a particularly poor prognosis, compared with HER2-negative tumors, if left untreated. However, the blockade of HER2 with trastuzumab, when added to adjuvant multiagent chemotherapy, has been shown to improve outcomes for this population,” wrote the researchers, led by Sara M. Tolaney, MD, chief of breast oncology at Dana-Farber Cancer Institute in Boston. “To our knowledge, this is the first study to report the long-term outcomes of patients with small, node-negative, HER2-positive breast cancers prospectively treated with a de-escalated adjuvant regimen.”
The study was published in the March issue of The Lancet Oncology.
Avoiding side effects
HER2-positive breast cancers, which are characterized by amplification of the HER2 gene and overexpression of the HER2 protein, account for 15% of new cases of localized breast cancer. They are more aggressive and resistant to some anticancer treatments but show sensitivity to stronger chemotherapy.
“We presented the 10-year analysis, which shows that survival for breast cancer among the 406 patients recruited in the study was 98.8% after 10 years, with only 6 recurrences,” study author Paolo Tarantino, MD, researcher at the European Institute of Oncology and clinical research fellow at Dana-Farber Cancer Institute, Boston, said in a statement. “Our data support the use of the de-escalated adjuvant paclitaxel trastuzumab regimen as an adequate standard for small HER2-positive breast cancers, which avoids the side effects of polychemotherapy.”
The researchers also focused on patient selection and identified a significant relationship between the value of HER2DX, a new diagnostic tool capable of describing multiple characteristics of HER2-positive breast cancer, and the prognosis. If future research validates these preliminary results, the biomarker may help to further customize cancer treatments in the future, according to Dr. Tarantino.
‘A valuable alternative’
“This is the 10-year update of the APT study, which is not randomized and has no control arm,” Alessandra Gennari, MD, PhD, associate professor of oncology at the University of Eastern Piedmont and head of oncology at Maggiore University Hospital in Novara, Italy, said in an interview. Dr. Gennari, who was not involved in the study, was lead author of the European Society for Medical Oncology’s 2021 guidelines on metastatic breast cancer. “This study shows, nevertheless, that in a subpopulation of HER2-positive patients with low to moderate risk of recurrence, the de-escalation of chemotherapy together with trastuzumab is a valuable alternative to more complex regimens with chemotherapy agents and is very well tolerated.”
Dr. Gennari’s comment echoes those of an editorial that accompanied the Lancet Oncology study. “This work represents a milestone in the history of breast cancer: We have definitively shown that for early HER2-positive tumors, you can do less by getting more,” coauthor Giuseppe Curigliano, MD, PhD, full professor of medical oncology at University of Milan and head of early drug development at the European Institute of Oncology, told this news organization. “It completes a pathway started by my group at the European Institute of Oncology in 2009, when we showed that HER2-positive tumors have a very good prognosis if diagnosed at a very early stage, and therefore can be treated with less aggressive and less toxic chemotherapies.” Candiolo Cancer Institute oncologists Elena Geuna, MD, and Filippo Montemurro, MD, coauthored the editorial with Dr. Curigliano.
Research on de-escalation increased after that study, and data showed that a lighter chemotherapy regimen is safe and effective and allows patients to live longer and with fewer side effects. “This finding immediately changed clinical practice, and the newly published work now adds an important piece: De-escalation maintains its benefit over the long term, beyond 10 years,” said Dr. Curigliano. “It also shows that in the future, we could identify the patients that will benefit from doing more, but also those that will benefit from doing even less, thanks to the new marker HER2DX.”
The study was funded by Genentech. Dr. Tolaney has received consulting or advisory board fees from Genentech, AstraZeneca, Eli Lilly, Merck, Novartis, Pfizer, Gilead, BMS, Eisai, Sanofi, and other pharmaceutical companies. Dr. Tarantino has received consulting or advisory board fees from AstraZeneca, Daiichi Sankyo, and Lilly, and has received payment or honoraria for educational events from AstraZeneca and Daiichi Sankyo. Dr. Curigliano and Dr. Gennari reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Lowering the intensity of chemotherapy also reduces the adverse events that are associated with it.
An open-label study of about 400 participants indicated that 12 weeks of treatment with paclitaxel (Abraxane) and trastuzumab (Herceptin), followed by 9 months of trastuzumab monotherapy, was associated with very good long-term outcomes for patients with certain HER2-positive breast cancers. Few distant recurrences were observed, and tolerability was good.
The study was conducted by a team that included researchers from the European Institute of Oncology in Milan, one of the main oncology institutes in Italy.
“HER2-positive breast cancers harbor a particularly poor prognosis, compared with HER2-negative tumors, if left untreated. However, the blockade of HER2 with trastuzumab, when added to adjuvant multiagent chemotherapy, has been shown to improve outcomes for this population,” wrote the researchers, led by Sara M. Tolaney, MD, chief of breast oncology at Dana-Farber Cancer Institute in Boston. “To our knowledge, this is the first study to report the long-term outcomes of patients with small, node-negative, HER2-positive breast cancers prospectively treated with a de-escalated adjuvant regimen.”
The study was published in the March issue of The Lancet Oncology.
Avoiding side effects
HER2-positive breast cancers, which are characterized by amplification of the HER2 gene and overexpression of the HER2 protein, account for 15% of new cases of localized breast cancer. They are more aggressive and resistant to some anticancer treatments but show sensitivity to stronger chemotherapy.
“We presented the 10-year analysis, which shows that survival for breast cancer among the 406 patients recruited in the study was 98.8% after 10 years, with only 6 recurrences,” study author Paolo Tarantino, MD, researcher at the European Institute of Oncology and clinical research fellow at Dana-Farber Cancer Institute, Boston, said in a statement. “Our data support the use of the de-escalated adjuvant paclitaxel trastuzumab regimen as an adequate standard for small HER2-positive breast cancers, which avoids the side effects of polychemotherapy.”
The researchers also focused on patient selection and identified a significant relationship between the value of HER2DX, a new diagnostic tool capable of describing multiple characteristics of HER2-positive breast cancer, and the prognosis. If future research validates these preliminary results, the biomarker may help to further customize cancer treatments in the future, according to Dr. Tarantino.
‘A valuable alternative’
“This is the 10-year update of the APT study, which is not randomized and has no control arm,” Alessandra Gennari, MD, PhD, associate professor of oncology at the University of Eastern Piedmont and head of oncology at Maggiore University Hospital in Novara, Italy, said in an interview. Dr. Gennari, who was not involved in the study, was lead author of the European Society for Medical Oncology’s 2021 guidelines on metastatic breast cancer. “This study shows, nevertheless, that in a subpopulation of HER2-positive patients with low to moderate risk of recurrence, the de-escalation of chemotherapy together with trastuzumab is a valuable alternative to more complex regimens with chemotherapy agents and is very well tolerated.”
Dr. Gennari’s comment echoes those of an editorial that accompanied the Lancet Oncology study. “This work represents a milestone in the history of breast cancer: We have definitively shown that for early HER2-positive tumors, you can do less by getting more,” coauthor Giuseppe Curigliano, MD, PhD, full professor of medical oncology at University of Milan and head of early drug development at the European Institute of Oncology, told this news organization. “It completes a pathway started by my group at the European Institute of Oncology in 2009, when we showed that HER2-positive tumors have a very good prognosis if diagnosed at a very early stage, and therefore can be treated with less aggressive and less toxic chemotherapies.” Candiolo Cancer Institute oncologists Elena Geuna, MD, and Filippo Montemurro, MD, coauthored the editorial with Dr. Curigliano.
Research on de-escalation increased after that study, and data showed that a lighter chemotherapy regimen is safe and effective and allows patients to live longer and with fewer side effects. “This finding immediately changed clinical practice, and the newly published work now adds an important piece: De-escalation maintains its benefit over the long term, beyond 10 years,” said Dr. Curigliano. “It also shows that in the future, we could identify the patients that will benefit from doing more, but also those that will benefit from doing even less, thanks to the new marker HER2DX.”
The study was funded by Genentech. Dr. Tolaney has received consulting or advisory board fees from Genentech, AstraZeneca, Eli Lilly, Merck, Novartis, Pfizer, Gilead, BMS, Eisai, Sanofi, and other pharmaceutical companies. Dr. Tarantino has received consulting or advisory board fees from AstraZeneca, Daiichi Sankyo, and Lilly, and has received payment or honoraria for educational events from AstraZeneca and Daiichi Sankyo. Dr. Curigliano and Dr. Gennari reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Lowering the intensity of chemotherapy also reduces the adverse events that are associated with it.
An open-label study of about 400 participants indicated that 12 weeks of treatment with paclitaxel (Abraxane) and trastuzumab (Herceptin), followed by 9 months of trastuzumab monotherapy, was associated with very good long-term outcomes for patients with certain HER2-positive breast cancers. Few distant recurrences were observed, and tolerability was good.
The study was conducted by a team that included researchers from the European Institute of Oncology in Milan, one of the main oncology institutes in Italy.
“HER2-positive breast cancers harbor a particularly poor prognosis, compared with HER2-negative tumors, if left untreated. However, the blockade of HER2 with trastuzumab, when added to adjuvant multiagent chemotherapy, has been shown to improve outcomes for this population,” wrote the researchers, led by Sara M. Tolaney, MD, chief of breast oncology at Dana-Farber Cancer Institute in Boston. “To our knowledge, this is the first study to report the long-term outcomes of patients with small, node-negative, HER2-positive breast cancers prospectively treated with a de-escalated adjuvant regimen.”
The study was published in the March issue of The Lancet Oncology.
Avoiding side effects
HER2-positive breast cancers, which are characterized by amplification of the HER2 gene and overexpression of the HER2 protein, account for 15% of new cases of localized breast cancer. They are more aggressive and resistant to some anticancer treatments but show sensitivity to stronger chemotherapy.
“We presented the 10-year analysis, which shows that survival for breast cancer among the 406 patients recruited in the study was 98.8% after 10 years, with only 6 recurrences,” study author Paolo Tarantino, MD, researcher at the European Institute of Oncology and clinical research fellow at Dana-Farber Cancer Institute, Boston, said in a statement. “Our data support the use of the de-escalated adjuvant paclitaxel trastuzumab regimen as an adequate standard for small HER2-positive breast cancers, which avoids the side effects of polychemotherapy.”
The researchers also focused on patient selection and identified a significant relationship between the value of HER2DX, a new diagnostic tool capable of describing multiple characteristics of HER2-positive breast cancer, and the prognosis. If future research validates these preliminary results, the biomarker may help to further customize cancer treatments in the future, according to Dr. Tarantino.
‘A valuable alternative’
“This is the 10-year update of the APT study, which is not randomized and has no control arm,” Alessandra Gennari, MD, PhD, associate professor of oncology at the University of Eastern Piedmont and head of oncology at Maggiore University Hospital in Novara, Italy, said in an interview. Dr. Gennari, who was not involved in the study, was lead author of the European Society for Medical Oncology’s 2021 guidelines on metastatic breast cancer. “This study shows, nevertheless, that in a subpopulation of HER2-positive patients with low to moderate risk of recurrence, the de-escalation of chemotherapy together with trastuzumab is a valuable alternative to more complex regimens with chemotherapy agents and is very well tolerated.”
Dr. Gennari’s comment echoes those of an editorial that accompanied the Lancet Oncology study. “This work represents a milestone in the history of breast cancer: We have definitively shown that for early HER2-positive tumors, you can do less by getting more,” coauthor Giuseppe Curigliano, MD, PhD, full professor of medical oncology at University of Milan and head of early drug development at the European Institute of Oncology, told this news organization. “It completes a pathway started by my group at the European Institute of Oncology in 2009, when we showed that HER2-positive tumors have a very good prognosis if diagnosed at a very early stage, and therefore can be treated with less aggressive and less toxic chemotherapies.” Candiolo Cancer Institute oncologists Elena Geuna, MD, and Filippo Montemurro, MD, coauthored the editorial with Dr. Curigliano.
Research on de-escalation increased after that study, and data showed that a lighter chemotherapy regimen is safe and effective and allows patients to live longer and with fewer side effects. “This finding immediately changed clinical practice, and the newly published work now adds an important piece: De-escalation maintains its benefit over the long term, beyond 10 years,” said Dr. Curigliano. “It also shows that in the future, we could identify the patients that will benefit from doing more, but also those that will benefit from doing even less, thanks to the new marker HER2DX.”
The study was funded by Genentech. Dr. Tolaney has received consulting or advisory board fees from Genentech, AstraZeneca, Eli Lilly, Merck, Novartis, Pfizer, Gilead, BMS, Eisai, Sanofi, and other pharmaceutical companies. Dr. Tarantino has received consulting or advisory board fees from AstraZeneca, Daiichi Sankyo, and Lilly, and has received payment or honoraria for educational events from AstraZeneca and Daiichi Sankyo. Dr. Curigliano and Dr. Gennari reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM LANCET ONCOLOGY
Ultraprocessed foods and cancer: Small changes may lower risk
Processed and ultraprocessed food consumption has been shown to increase the risk for various cancers. A new analysis suggests that replacing even a small amount of such foods with an equal amount of minimally processed options may reduce that risk.
Using data from more than 450,000 participants, the dietary substitution analysis found that as well as the risk for several cancer types, including esophageal squamous cell carcinoma by 43% and hepatocellular carcinoma by 23%.
Making this substitution with ultraprocessed foods also appeared to lower cancer risk but often to a lesser degree. For instance, swapping 10% of ultraprocessed foods for minimally processed foods lowered the overall cancer risk by just 1%, the risk of hepatocellular carcinoma by 27%, and the risk of esophageal squamous cell carcinoma by 20%.
Overall, “this study suggests that the replacement of processed and ultraprocessed foods and drinks with an equal amount of minimally processed foods might reduce the risk of various cancer types,” Nathalie Kliemann, PhD, from the World Health Organization’s International Agency for Research on Cancer, Lyon, France, and colleagues concluded.
The findings were published in The Lancet Planetary Health.
Processed and ultraprocessed foods tend to have high-energy density and low nutritional value, and some epidemiological evidence indicates a possible link between consuming ultraprocessed food and cancer outcomes.
Dr. Kliemann and colleagues, for instance, recently published a study showing a link between ultraprocessed food consumption and increased risk for cancer, particularly ovarian cancer, as well as increased risk of dying from cancer. That study of nearly 200,000 middle-aged adults in the UK Biobank database showed that, for each 10 percentage point increase in the consumption of ultraprocessed foods, there was a 2% increase in the overall incidence of cancer and a 19% increase in ovarian cancer incidence.
However, conflicting reports exist, and research exploring associations between processed foods and cancer remains limited.
The researchers wanted to better understand the potential association between the degree of food processing and risk for cancer in a larger cohort of individuals.
The investigators performed a dietary substitution analysis using data from more than 450,000 participants from the European Prospective Investigation into Cancer and Nutrition (EPIC) study and looking at 25 anatomical sites. EPIC study participants, who had no cancer diagnoses prior to enrollment, were identified between March 1991 and July 2001. Of the 450,111 included in the analysis, 47,573 were diagnosed with cancer during a mean follow-up of 14.1 years. Mean age at recruitment was 51 years, and mean BMI was 25.3 kg/m2.
Food items were classified according to their level of processing using the NOVA classification system: minimally or nonprocessed foods (NOVA 1), processed culinary ingredients (NOVA 2), processed foods (NOVA 3), and ultraprocessed foods (NOVA 4). The investigators highlighted comparisons between NOVA 1 and NOVA 3 and between NOVA 1 and NOVA 4.
The analysis revealed that swapping out just 10% of processed foods with minimally processed foods significantly lowered the risk for cancer overall (hazard ratio, 0.96) as well as for esophageal squamous cell carcinoma (HR, 0.57), hepatocellular carcinoma (HR, 0.77), head and neck cancers (HR, 0.80), colon cancer (HR, 0,88), rectal cancer (HR, 0.90), and postmenopausal breast cancer (HR, 0.93)
Swapping 10% of ultraprocessed foods for minimally processed foods lowered the risk of cancer overall only slightly (HR, 0.99) as well as the risk for various cancer types, including hepatocellular carcinoma (HR, 0.73), head and neck cancers (HR, 0.80), esophageal adenocarcinoma (HR, 0.80), and colon cancer (HR, 0.93).
The authors noted several limitations to the analysis, perhaps most notably that intake of ultraprocessed foods contributed to about 32% of total daily energy intake among study participants, but today that percentage could be nearly double across European countries.
“This discrepancy might explain the fewer significant associations observed between ultraprocessed foods and cancer risk than in processed foods and cancer risk,” the authors suggested.
The findings are “broadly in line with current evidence,” but the authors also noted some inconsistencies. For example, the current study showed a positive association between processed food consumption and risk for colorectal cancer and postmenopausal breast cancer, whereas other studies have not.
Overall, though, the authors concluded that increased consumption of minimally processed and fresh foods was associated with reduced overall risk for cancer and risk for specific cancers, and increased consumption of processed and ultraprocessed foods was associated with increased cancer risks.
This study “is the largest study investigating these associations between food processing and cancer risk and therefore has greater power to detect differences in populations, potentially explaining why we found overall more significant results for different cancer sites than other cohorts,” Dr. Kliemann and colleagues wrote.
This study was funded by Cancer Research UK, the French National Cancer Institute, and World Cancer Research Fund International. The authors declared no competing interests.
A version of this article originally appeared on Medscape.com.
Processed and ultraprocessed food consumption has been shown to increase the risk for various cancers. A new analysis suggests that replacing even a small amount of such foods with an equal amount of minimally processed options may reduce that risk.
Using data from more than 450,000 participants, the dietary substitution analysis found that as well as the risk for several cancer types, including esophageal squamous cell carcinoma by 43% and hepatocellular carcinoma by 23%.
Making this substitution with ultraprocessed foods also appeared to lower cancer risk but often to a lesser degree. For instance, swapping 10% of ultraprocessed foods for minimally processed foods lowered the overall cancer risk by just 1%, the risk of hepatocellular carcinoma by 27%, and the risk of esophageal squamous cell carcinoma by 20%.
Overall, “this study suggests that the replacement of processed and ultraprocessed foods and drinks with an equal amount of minimally processed foods might reduce the risk of various cancer types,” Nathalie Kliemann, PhD, from the World Health Organization’s International Agency for Research on Cancer, Lyon, France, and colleagues concluded.
The findings were published in The Lancet Planetary Health.
Processed and ultraprocessed foods tend to have high-energy density and low nutritional value, and some epidemiological evidence indicates a possible link between consuming ultraprocessed food and cancer outcomes.
Dr. Kliemann and colleagues, for instance, recently published a study showing a link between ultraprocessed food consumption and increased risk for cancer, particularly ovarian cancer, as well as increased risk of dying from cancer. That study of nearly 200,000 middle-aged adults in the UK Biobank database showed that, for each 10 percentage point increase in the consumption of ultraprocessed foods, there was a 2% increase in the overall incidence of cancer and a 19% increase in ovarian cancer incidence.
However, conflicting reports exist, and research exploring associations between processed foods and cancer remains limited.
The researchers wanted to better understand the potential association between the degree of food processing and risk for cancer in a larger cohort of individuals.
The investigators performed a dietary substitution analysis using data from more than 450,000 participants from the European Prospective Investigation into Cancer and Nutrition (EPIC) study and looking at 25 anatomical sites. EPIC study participants, who had no cancer diagnoses prior to enrollment, were identified between March 1991 and July 2001. Of the 450,111 included in the analysis, 47,573 were diagnosed with cancer during a mean follow-up of 14.1 years. Mean age at recruitment was 51 years, and mean BMI was 25.3 kg/m2.
Food items were classified according to their level of processing using the NOVA classification system: minimally or nonprocessed foods (NOVA 1), processed culinary ingredients (NOVA 2), processed foods (NOVA 3), and ultraprocessed foods (NOVA 4). The investigators highlighted comparisons between NOVA 1 and NOVA 3 and between NOVA 1 and NOVA 4.
The analysis revealed that swapping out just 10% of processed foods with minimally processed foods significantly lowered the risk for cancer overall (hazard ratio, 0.96) as well as for esophageal squamous cell carcinoma (HR, 0.57), hepatocellular carcinoma (HR, 0.77), head and neck cancers (HR, 0.80), colon cancer (HR, 0,88), rectal cancer (HR, 0.90), and postmenopausal breast cancer (HR, 0.93)
Swapping 10% of ultraprocessed foods for minimally processed foods lowered the risk of cancer overall only slightly (HR, 0.99) as well as the risk for various cancer types, including hepatocellular carcinoma (HR, 0.73), head and neck cancers (HR, 0.80), esophageal adenocarcinoma (HR, 0.80), and colon cancer (HR, 0.93).
The authors noted several limitations to the analysis, perhaps most notably that intake of ultraprocessed foods contributed to about 32% of total daily energy intake among study participants, but today that percentage could be nearly double across European countries.
“This discrepancy might explain the fewer significant associations observed between ultraprocessed foods and cancer risk than in processed foods and cancer risk,” the authors suggested.
The findings are “broadly in line with current evidence,” but the authors also noted some inconsistencies. For example, the current study showed a positive association between processed food consumption and risk for colorectal cancer and postmenopausal breast cancer, whereas other studies have not.
Overall, though, the authors concluded that increased consumption of minimally processed and fresh foods was associated with reduced overall risk for cancer and risk for specific cancers, and increased consumption of processed and ultraprocessed foods was associated with increased cancer risks.
This study “is the largest study investigating these associations between food processing and cancer risk and therefore has greater power to detect differences in populations, potentially explaining why we found overall more significant results for different cancer sites than other cohorts,” Dr. Kliemann and colleagues wrote.
This study was funded by Cancer Research UK, the French National Cancer Institute, and World Cancer Research Fund International. The authors declared no competing interests.
A version of this article originally appeared on Medscape.com.
Processed and ultraprocessed food consumption has been shown to increase the risk for various cancers. A new analysis suggests that replacing even a small amount of such foods with an equal amount of minimally processed options may reduce that risk.
Using data from more than 450,000 participants, the dietary substitution analysis found that as well as the risk for several cancer types, including esophageal squamous cell carcinoma by 43% and hepatocellular carcinoma by 23%.
Making this substitution with ultraprocessed foods also appeared to lower cancer risk but often to a lesser degree. For instance, swapping 10% of ultraprocessed foods for minimally processed foods lowered the overall cancer risk by just 1%, the risk of hepatocellular carcinoma by 27%, and the risk of esophageal squamous cell carcinoma by 20%.
Overall, “this study suggests that the replacement of processed and ultraprocessed foods and drinks with an equal amount of minimally processed foods might reduce the risk of various cancer types,” Nathalie Kliemann, PhD, from the World Health Organization’s International Agency for Research on Cancer, Lyon, France, and colleagues concluded.
The findings were published in The Lancet Planetary Health.
Processed and ultraprocessed foods tend to have high-energy density and low nutritional value, and some epidemiological evidence indicates a possible link between consuming ultraprocessed food and cancer outcomes.
Dr. Kliemann and colleagues, for instance, recently published a study showing a link between ultraprocessed food consumption and increased risk for cancer, particularly ovarian cancer, as well as increased risk of dying from cancer. That study of nearly 200,000 middle-aged adults in the UK Biobank database showed that, for each 10 percentage point increase in the consumption of ultraprocessed foods, there was a 2% increase in the overall incidence of cancer and a 19% increase in ovarian cancer incidence.
However, conflicting reports exist, and research exploring associations between processed foods and cancer remains limited.
The researchers wanted to better understand the potential association between the degree of food processing and risk for cancer in a larger cohort of individuals.
The investigators performed a dietary substitution analysis using data from more than 450,000 participants from the European Prospective Investigation into Cancer and Nutrition (EPIC) study and looking at 25 anatomical sites. EPIC study participants, who had no cancer diagnoses prior to enrollment, were identified between March 1991 and July 2001. Of the 450,111 included in the analysis, 47,573 were diagnosed with cancer during a mean follow-up of 14.1 years. Mean age at recruitment was 51 years, and mean BMI was 25.3 kg/m2.
Food items were classified according to their level of processing using the NOVA classification system: minimally or nonprocessed foods (NOVA 1), processed culinary ingredients (NOVA 2), processed foods (NOVA 3), and ultraprocessed foods (NOVA 4). The investigators highlighted comparisons between NOVA 1 and NOVA 3 and between NOVA 1 and NOVA 4.
The analysis revealed that swapping out just 10% of processed foods with minimally processed foods significantly lowered the risk for cancer overall (hazard ratio, 0.96) as well as for esophageal squamous cell carcinoma (HR, 0.57), hepatocellular carcinoma (HR, 0.77), head and neck cancers (HR, 0.80), colon cancer (HR, 0,88), rectal cancer (HR, 0.90), and postmenopausal breast cancer (HR, 0.93)
Swapping 10% of ultraprocessed foods for minimally processed foods lowered the risk of cancer overall only slightly (HR, 0.99) as well as the risk for various cancer types, including hepatocellular carcinoma (HR, 0.73), head and neck cancers (HR, 0.80), esophageal adenocarcinoma (HR, 0.80), and colon cancer (HR, 0.93).
The authors noted several limitations to the analysis, perhaps most notably that intake of ultraprocessed foods contributed to about 32% of total daily energy intake among study participants, but today that percentage could be nearly double across European countries.
“This discrepancy might explain the fewer significant associations observed between ultraprocessed foods and cancer risk than in processed foods and cancer risk,” the authors suggested.
The findings are “broadly in line with current evidence,” but the authors also noted some inconsistencies. For example, the current study showed a positive association between processed food consumption and risk for colorectal cancer and postmenopausal breast cancer, whereas other studies have not.
Overall, though, the authors concluded that increased consumption of minimally processed and fresh foods was associated with reduced overall risk for cancer and risk for specific cancers, and increased consumption of processed and ultraprocessed foods was associated with increased cancer risks.
This study “is the largest study investigating these associations between food processing and cancer risk and therefore has greater power to detect differences in populations, potentially explaining why we found overall more significant results for different cancer sites than other cohorts,” Dr. Kliemann and colleagues wrote.
This study was funded by Cancer Research UK, the French National Cancer Institute, and World Cancer Research Fund International. The authors declared no competing interests.
A version of this article originally appeared on Medscape.com.
FROM THE LANCET PLANETARY HEALTH
Lack of food for thought: Starve a bacterium, feed an infection
A whole new, tiny level of hangry
Ever been so hungry that everything just got on your nerves? Maybe you feel a little snappy right now? Like you’ll just lash out unless you get something to eat? Been there. And so have bacteria.
New research shows that some bacteria go into a full-on Hulk smash if they’re not getting the nutrients they need by releasing toxins into the body. Sounds like a bacterial temper tantrum.
Even though two cells may be genetically identical, they don’t always behave the same in a bacterial community. Some do their job and stay in line, but some evil twins rage out and make people sick by releasing toxins into the environment, Adam Rosenthal, PhD, of the University of North Carolina and his colleagues discovered.
To figure out why some cells were all business as usual while others were not, the investigators looked at Clostridium perfringens, a bacterium found in the intestines of humans and other vertebrates. When the C. perfringens cells were fed a little acetate to munch on, the hangry cells calmed down faster than a kid with a bag of fruit snacks, reducing toxin levels. Some cells even disappeared, falling in line with their model-citizen counterparts.
So what does this really mean? More research, duh. Now that we know nutrients play a role in toxicity, it may open the door to finding a way to fight against antibiotic resistance in humans and reduce antibiotic use in the food industry.
So think to yourself. Are you bothered for no reason? Getting a little testy with your friends and coworkers? Maybe you just haven’t eaten in a while. You’re literally not alone. Even a single-cell organism can behave based on its hunger levels.
Now go have a snack. Your bacteria are getting restless.
The very hangry iguana?
Imagine yourself on a warm, sunny tropical beach. You are enjoying a piece of cake as you take in the slow beat of the waves lapping against the shore. Life is as good as it could be.
Then you feel a presence nearby. Hostility. Hunger. A set of feral, covetous eyes in the nearby jungle. A reptilian beast stalks you, and its all-encompassing sweet tooth desires your cake.
Wait, hold on, what?
As an unfortunate 3-year-old on vacation in Costa Rica found out, there’s at least one iguana in the world out there with a taste for sugar (better than a taste for blood, we suppose).
While out on the beach, the lizard darted out of nowhere, bit the girl on the back of the hand, and stole her cake. Still not the worst party guest ever. The child was taken to a local clinic, where the wound was cleaned and a 5-day antibiotic treatment (lizards carry salmonella) was provided. Things seemed fine, and the girl returned home without incident.
But of course, that’s not the end of the story. Five months later, the girl’s parents noticed a red bump at the wound site. Over the next 3 months, the surrounding skin grew red and painful. A trip to the hospital in California revealed that she had a ganglion cyst and a discharge of pus. Turns out our cake-obsessed lizard friend did give the little girl a gift: the first known human case of Mycobacterium marinum infection following an iguana bite on record.
M. marinum, which causes a disease similar to tuberculosis, typically infects fish but can infect humans if skin wounds are exposed to contaminated water. It’s also resistant to most antibiotics, which is why the first round didn’t clear up the infection. A second round of more-potent antibiotics seems to be working well.
So, to sum up, this poor child got bitten by a lizard, had her cake stolen, and contracted a rare illness in exchange. For a 3-year-old, that’s gotta be in the top-10 worst days ever. Unless, of course, we’re actually living in the Marvel universe (sorry, multiverse at this point). Then we’re totally going to see the emergence of the new superhero Iguana Girl in 15 years or so. Keep your eyes open.
No allergies? Let them give up cake
Allergy season is already here – starting earlier every year, it seems – and many people are not happy about it. So unhappy, actually, that there’s a list of things they would be willing to give up for a year to get rid of their of allergies, according to a survey conducted by OnePoll on behalf of Flonase.
Nearly 40% of 2,000 respondents with allergies would go a year without eating cake or chocolate or playing video games in exchange for allergy-free status, the survey results show. Almost as many would forgo coffee (38%) or pizza (37%) for a year, while 36% would stay off social media and 31% would take a pay cut or give up their smartphones, the Independent reported.
More than half of the allergic Americans – 54%, to be exact – who were polled this past winter – Feb. 24 to March 1, to be exact – consider allergy symptoms to be the most frustrating part of the spring. Annoying things that were less frustrating to the group included mosquitoes (41%), filing tax returns (38%), and daylight savings time (37%).
The Trump arraignment circus, of course, occurred too late to make the list, as did the big “We’re going back to the office! No wait, we’re closing the office forever!” email extravaganza and emotional roller coaster. That second one, however, did not get nearly as much media coverage.
A whole new, tiny level of hangry
Ever been so hungry that everything just got on your nerves? Maybe you feel a little snappy right now? Like you’ll just lash out unless you get something to eat? Been there. And so have bacteria.
New research shows that some bacteria go into a full-on Hulk smash if they’re not getting the nutrients they need by releasing toxins into the body. Sounds like a bacterial temper tantrum.
Even though two cells may be genetically identical, they don’t always behave the same in a bacterial community. Some do their job and stay in line, but some evil twins rage out and make people sick by releasing toxins into the environment, Adam Rosenthal, PhD, of the University of North Carolina and his colleagues discovered.
To figure out why some cells were all business as usual while others were not, the investigators looked at Clostridium perfringens, a bacterium found in the intestines of humans and other vertebrates. When the C. perfringens cells were fed a little acetate to munch on, the hangry cells calmed down faster than a kid with a bag of fruit snacks, reducing toxin levels. Some cells even disappeared, falling in line with their model-citizen counterparts.
So what does this really mean? More research, duh. Now that we know nutrients play a role in toxicity, it may open the door to finding a way to fight against antibiotic resistance in humans and reduce antibiotic use in the food industry.
So think to yourself. Are you bothered for no reason? Getting a little testy with your friends and coworkers? Maybe you just haven’t eaten in a while. You’re literally not alone. Even a single-cell organism can behave based on its hunger levels.
Now go have a snack. Your bacteria are getting restless.
The very hangry iguana?
Imagine yourself on a warm, sunny tropical beach. You are enjoying a piece of cake as you take in the slow beat of the waves lapping against the shore. Life is as good as it could be.
Then you feel a presence nearby. Hostility. Hunger. A set of feral, covetous eyes in the nearby jungle. A reptilian beast stalks you, and its all-encompassing sweet tooth desires your cake.
Wait, hold on, what?
As an unfortunate 3-year-old on vacation in Costa Rica found out, there’s at least one iguana in the world out there with a taste for sugar (better than a taste for blood, we suppose).
While out on the beach, the lizard darted out of nowhere, bit the girl on the back of the hand, and stole her cake. Still not the worst party guest ever. The child was taken to a local clinic, where the wound was cleaned and a 5-day antibiotic treatment (lizards carry salmonella) was provided. Things seemed fine, and the girl returned home without incident.
But of course, that’s not the end of the story. Five months later, the girl’s parents noticed a red bump at the wound site. Over the next 3 months, the surrounding skin grew red and painful. A trip to the hospital in California revealed that she had a ganglion cyst and a discharge of pus. Turns out our cake-obsessed lizard friend did give the little girl a gift: the first known human case of Mycobacterium marinum infection following an iguana bite on record.
M. marinum, which causes a disease similar to tuberculosis, typically infects fish but can infect humans if skin wounds are exposed to contaminated water. It’s also resistant to most antibiotics, which is why the first round didn’t clear up the infection. A second round of more-potent antibiotics seems to be working well.
So, to sum up, this poor child got bitten by a lizard, had her cake stolen, and contracted a rare illness in exchange. For a 3-year-old, that’s gotta be in the top-10 worst days ever. Unless, of course, we’re actually living in the Marvel universe (sorry, multiverse at this point). Then we’re totally going to see the emergence of the new superhero Iguana Girl in 15 years or so. Keep your eyes open.
No allergies? Let them give up cake
Allergy season is already here – starting earlier every year, it seems – and many people are not happy about it. So unhappy, actually, that there’s a list of things they would be willing to give up for a year to get rid of their of allergies, according to a survey conducted by OnePoll on behalf of Flonase.
Nearly 40% of 2,000 respondents with allergies would go a year without eating cake or chocolate or playing video games in exchange for allergy-free status, the survey results show. Almost as many would forgo coffee (38%) or pizza (37%) for a year, while 36% would stay off social media and 31% would take a pay cut or give up their smartphones, the Independent reported.
More than half of the allergic Americans – 54%, to be exact – who were polled this past winter – Feb. 24 to March 1, to be exact – consider allergy symptoms to be the most frustrating part of the spring. Annoying things that were less frustrating to the group included mosquitoes (41%), filing tax returns (38%), and daylight savings time (37%).
The Trump arraignment circus, of course, occurred too late to make the list, as did the big “We’re going back to the office! No wait, we’re closing the office forever!” email extravaganza and emotional roller coaster. That second one, however, did not get nearly as much media coverage.
A whole new, tiny level of hangry
Ever been so hungry that everything just got on your nerves? Maybe you feel a little snappy right now? Like you’ll just lash out unless you get something to eat? Been there. And so have bacteria.
New research shows that some bacteria go into a full-on Hulk smash if they’re not getting the nutrients they need by releasing toxins into the body. Sounds like a bacterial temper tantrum.
Even though two cells may be genetically identical, they don’t always behave the same in a bacterial community. Some do their job and stay in line, but some evil twins rage out and make people sick by releasing toxins into the environment, Adam Rosenthal, PhD, of the University of North Carolina and his colleagues discovered.
To figure out why some cells were all business as usual while others were not, the investigators looked at Clostridium perfringens, a bacterium found in the intestines of humans and other vertebrates. When the C. perfringens cells were fed a little acetate to munch on, the hangry cells calmed down faster than a kid with a bag of fruit snacks, reducing toxin levels. Some cells even disappeared, falling in line with their model-citizen counterparts.
So what does this really mean? More research, duh. Now that we know nutrients play a role in toxicity, it may open the door to finding a way to fight against antibiotic resistance in humans and reduce antibiotic use in the food industry.
So think to yourself. Are you bothered for no reason? Getting a little testy with your friends and coworkers? Maybe you just haven’t eaten in a while. You’re literally not alone. Even a single-cell organism can behave based on its hunger levels.
Now go have a snack. Your bacteria are getting restless.
The very hangry iguana?
Imagine yourself on a warm, sunny tropical beach. You are enjoying a piece of cake as you take in the slow beat of the waves lapping against the shore. Life is as good as it could be.
Then you feel a presence nearby. Hostility. Hunger. A set of feral, covetous eyes in the nearby jungle. A reptilian beast stalks you, and its all-encompassing sweet tooth desires your cake.
Wait, hold on, what?
As an unfortunate 3-year-old on vacation in Costa Rica found out, there’s at least one iguana in the world out there with a taste for sugar (better than a taste for blood, we suppose).
While out on the beach, the lizard darted out of nowhere, bit the girl on the back of the hand, and stole her cake. Still not the worst party guest ever. The child was taken to a local clinic, where the wound was cleaned and a 5-day antibiotic treatment (lizards carry salmonella) was provided. Things seemed fine, and the girl returned home without incident.
But of course, that’s not the end of the story. Five months later, the girl’s parents noticed a red bump at the wound site. Over the next 3 months, the surrounding skin grew red and painful. A trip to the hospital in California revealed that she had a ganglion cyst and a discharge of pus. Turns out our cake-obsessed lizard friend did give the little girl a gift: the first known human case of Mycobacterium marinum infection following an iguana bite on record.
M. marinum, which causes a disease similar to tuberculosis, typically infects fish but can infect humans if skin wounds are exposed to contaminated water. It’s also resistant to most antibiotics, which is why the first round didn’t clear up the infection. A second round of more-potent antibiotics seems to be working well.
So, to sum up, this poor child got bitten by a lizard, had her cake stolen, and contracted a rare illness in exchange. For a 3-year-old, that’s gotta be in the top-10 worst days ever. Unless, of course, we’re actually living in the Marvel universe (sorry, multiverse at this point). Then we’re totally going to see the emergence of the new superhero Iguana Girl in 15 years or so. Keep your eyes open.
No allergies? Let them give up cake
Allergy season is already here – starting earlier every year, it seems – and many people are not happy about it. So unhappy, actually, that there’s a list of things they would be willing to give up for a year to get rid of their of allergies, according to a survey conducted by OnePoll on behalf of Flonase.
Nearly 40% of 2,000 respondents with allergies would go a year without eating cake or chocolate or playing video games in exchange for allergy-free status, the survey results show. Almost as many would forgo coffee (38%) or pizza (37%) for a year, while 36% would stay off social media and 31% would take a pay cut or give up their smartphones, the Independent reported.
More than half of the allergic Americans – 54%, to be exact – who were polled this past winter – Feb. 24 to March 1, to be exact – consider allergy symptoms to be the most frustrating part of the spring. Annoying things that were less frustrating to the group included mosquitoes (41%), filing tax returns (38%), and daylight savings time (37%).
The Trump arraignment circus, of course, occurred too late to make the list, as did the big “We’re going back to the office! No wait, we’re closing the office forever!” email extravaganza and emotional roller coaster. That second one, however, did not get nearly as much media coverage.
AGA clinical practice update addresses role of endoscopic ultrasound–guided gallbladder drainage in acute cholecystitis
according to a recent clinical practice update by the American Gastroenterological Association.
The update, written by Shayan S. Irani, MD, of Virginia Mason Medical Center, Seattle, and colleagues, also covers techniques and outcomes of EUS-GBD and provides suggestions for training and patient selection.
“In this clinical practice update, we comment on the role of EUS-GBD (compared with ET-GBD [endoscopic treatment via transpapillary gallbladder drainage] and PT [percutaneous transhepatic]-GBD) in the management of acute cholecystitis, and describe its indications, contraindications, procedural considerations, and associated adverse events,” the authors wrote in Clinical Gastroenterology and Hepatology.
Dr. Irani and colleagues noted that EUS-GBD is a valuable alternative to PT-GBD, which can have a significant morbidity, and ET-GBD has been associated with relatively lower technical and clinical success rates in the presence of obstructing pathology of the cystic duct. Advances in lumen-apposing metal stents have further improved outcomes in EUS-GBD, as demonstrated by multiple case series and comparative trials.
According to the update, EUS-GBD is suggested in three scenarios: for draining the gallbladder in patients with acute cholecystitis who are at high risk for surgery, for removing percutaneous cholecystostomy drains in patients who cannot undergo cholecystectomy, and for draining malignant biliary obstruction in patients who have not responded to other treatments. EUS-GBD is contraindicated in patients with significant coagulopathy, large-volume uncontrolled ascites, or gallbladder perforation.
Dr. Irani and colleagues also noted that, between the three main techniques mentioned above, EUS-GBD has the lowest risk of recurrent cholecystitis, whereas ET-GBD and PT-GBD present slightly lower mortality rates.
While the update provides technical guidance on performing EUS-GBD, Dr. Irani and colleagues make clear that EUS-GBD is a highly specialized procedure that requires sufficient training to optimal results.
“Performing the procedure has an associated learning curve and requires advanced EUS training,” they wrote. “Two recent publications have suggested that the minimum number of procedures to gain competency should be approximately 19-25 procedures.”
Addressing unmet needs, Dr. Irani and colleagues suggested that more research is needed to standardize patient selection, procedure technique, and stent follow-up evaluation.
Ongoing studies aim to address whether endoscopic management of cholecystitis and symptomatic gallstones could become a mainstream treatment in the future, they wrote, but “we are still a long way from abandoning standard of care with cholecystectomy.”
This clinical practice update was commissioned by the AGA. Dr. Irani is a consultant for Boston Scientific, ConMed, and GORE; one coauthor received research support from Boston Scientific and Olympus and is a consultant and speaker for Boston Scientific, Cook, Medtronic, Olympus and ConMed. The remaining coauthor disclosed no conflicts.
according to a recent clinical practice update by the American Gastroenterological Association.
The update, written by Shayan S. Irani, MD, of Virginia Mason Medical Center, Seattle, and colleagues, also covers techniques and outcomes of EUS-GBD and provides suggestions for training and patient selection.
“In this clinical practice update, we comment on the role of EUS-GBD (compared with ET-GBD [endoscopic treatment via transpapillary gallbladder drainage] and PT [percutaneous transhepatic]-GBD) in the management of acute cholecystitis, and describe its indications, contraindications, procedural considerations, and associated adverse events,” the authors wrote in Clinical Gastroenterology and Hepatology.
Dr. Irani and colleagues noted that EUS-GBD is a valuable alternative to PT-GBD, which can have a significant morbidity, and ET-GBD has been associated with relatively lower technical and clinical success rates in the presence of obstructing pathology of the cystic duct. Advances in lumen-apposing metal stents have further improved outcomes in EUS-GBD, as demonstrated by multiple case series and comparative trials.
According to the update, EUS-GBD is suggested in three scenarios: for draining the gallbladder in patients with acute cholecystitis who are at high risk for surgery, for removing percutaneous cholecystostomy drains in patients who cannot undergo cholecystectomy, and for draining malignant biliary obstruction in patients who have not responded to other treatments. EUS-GBD is contraindicated in patients with significant coagulopathy, large-volume uncontrolled ascites, or gallbladder perforation.
Dr. Irani and colleagues also noted that, between the three main techniques mentioned above, EUS-GBD has the lowest risk of recurrent cholecystitis, whereas ET-GBD and PT-GBD present slightly lower mortality rates.
While the update provides technical guidance on performing EUS-GBD, Dr. Irani and colleagues make clear that EUS-GBD is a highly specialized procedure that requires sufficient training to optimal results.
“Performing the procedure has an associated learning curve and requires advanced EUS training,” they wrote. “Two recent publications have suggested that the minimum number of procedures to gain competency should be approximately 19-25 procedures.”
Addressing unmet needs, Dr. Irani and colleagues suggested that more research is needed to standardize patient selection, procedure technique, and stent follow-up evaluation.
Ongoing studies aim to address whether endoscopic management of cholecystitis and symptomatic gallstones could become a mainstream treatment in the future, they wrote, but “we are still a long way from abandoning standard of care with cholecystectomy.”
This clinical practice update was commissioned by the AGA. Dr. Irani is a consultant for Boston Scientific, ConMed, and GORE; one coauthor received research support from Boston Scientific and Olympus and is a consultant and speaker for Boston Scientific, Cook, Medtronic, Olympus and ConMed. The remaining coauthor disclosed no conflicts.
according to a recent clinical practice update by the American Gastroenterological Association.
The update, written by Shayan S. Irani, MD, of Virginia Mason Medical Center, Seattle, and colleagues, also covers techniques and outcomes of EUS-GBD and provides suggestions for training and patient selection.
“In this clinical practice update, we comment on the role of EUS-GBD (compared with ET-GBD [endoscopic treatment via transpapillary gallbladder drainage] and PT [percutaneous transhepatic]-GBD) in the management of acute cholecystitis, and describe its indications, contraindications, procedural considerations, and associated adverse events,” the authors wrote in Clinical Gastroenterology and Hepatology.
Dr. Irani and colleagues noted that EUS-GBD is a valuable alternative to PT-GBD, which can have a significant morbidity, and ET-GBD has been associated with relatively lower technical and clinical success rates in the presence of obstructing pathology of the cystic duct. Advances in lumen-apposing metal stents have further improved outcomes in EUS-GBD, as demonstrated by multiple case series and comparative trials.
According to the update, EUS-GBD is suggested in three scenarios: for draining the gallbladder in patients with acute cholecystitis who are at high risk for surgery, for removing percutaneous cholecystostomy drains in patients who cannot undergo cholecystectomy, and for draining malignant biliary obstruction in patients who have not responded to other treatments. EUS-GBD is contraindicated in patients with significant coagulopathy, large-volume uncontrolled ascites, or gallbladder perforation.
Dr. Irani and colleagues also noted that, between the three main techniques mentioned above, EUS-GBD has the lowest risk of recurrent cholecystitis, whereas ET-GBD and PT-GBD present slightly lower mortality rates.
While the update provides technical guidance on performing EUS-GBD, Dr. Irani and colleagues make clear that EUS-GBD is a highly specialized procedure that requires sufficient training to optimal results.
“Performing the procedure has an associated learning curve and requires advanced EUS training,” they wrote. “Two recent publications have suggested that the minimum number of procedures to gain competency should be approximately 19-25 procedures.”
Addressing unmet needs, Dr. Irani and colleagues suggested that more research is needed to standardize patient selection, procedure technique, and stent follow-up evaluation.
Ongoing studies aim to address whether endoscopic management of cholecystitis and symptomatic gallstones could become a mainstream treatment in the future, they wrote, but “we are still a long way from abandoning standard of care with cholecystectomy.”
This clinical practice update was commissioned by the AGA. Dr. Irani is a consultant for Boston Scientific, ConMed, and GORE; one coauthor received research support from Boston Scientific and Olympus and is a consultant and speaker for Boston Scientific, Cook, Medtronic, Olympus and ConMed. The remaining coauthor disclosed no conflicts.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY