News

A 49-year-old woman, previously recuperating from COVID-19, was found unconscious at her workplace, setting off a chain of events that would ultimately lead to an unexpected diagnosis.

This case report was published in the New England Journal of Medicine.

Noting the patient’s confusion and aphasia, emergency medical services were alerted, and she was taken to the emergency department of Massachusetts General Hospital. Initial examination revealed aphasia and coordination difficulties. However, imaging studies, including CT angiography, showed no signs of stroke or other neurological abnormalities.

The patient’s coworkers had observed that she appeared “unwell.” Her medical history included hypertension, which was managed with amlodipine, and there was no known family history of neurologic disorders.

During the examination, her vital signs were within normal ranges.

The patient’s potassium level of 2.5 mmol/L was noteworthy, indicating hypokalemia. Additionally, the patient presented with anemia and thrombocytopenia. Additional laboratory results unveiled thrombotic thrombocytopenic purpura (TTP), a rare blood disorder characterized by microangiopathic hemolytic anemia. The microscopic examination of a peripheral blood smear confirmed the extent of thrombocytopenia and was particularly notable for the increased number of schistocytes. The patient’s peripheral blood smear revealed five or six schistocytes per high-power field, constituting approximately 5% of the red cells. This significant number of schistocytes aligned with the severity of anemia and thrombocytopenia, confirming the diagnosis of microangiopathic hemolytic anemia.

Acquired TTP is an autoimmune condition driven by antibody-mediated clearance of the plasma enzyme ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin motif 13). Confirmatory laboratory testing for ADAMTS13 takes 1-3 days; therefore, therapeutic plasma exchange with glucocorticoid therapy and rituximab was initiated, which promptly improved her condition.

In this patient, the ADAMTS13 activity level was severely reduced (< 5%; reference value > 67%), and the inhibitor was present (1.4 inhibitor units; reference value ≤ 0.4).

Rectal cancer was diagnosed in this patient 2 months after the diagnosis of acquired TTP.

After undergoing four weekly infusions of rituximab and a 2-month tapering course of glucocorticoids, the patient experienced a relapse, approximately 6 months following the acquired TTP diagnosis. In response, therapeutic plasma exchange and glucocorticoid therapy were administered. There is a possibility that the underlying cancer played a role in the relapse. To minimize the risk for recurrence, the patient also received a second round of rituximab.

While establishing a clear cause is difficult, acquired TTP often appears to arise in connection with either an immune trigger, such as a viral infection, or immune dysregulation associated with another autoimmune disease or ongoing cancer. In this case, 4 weeks before the acquired TTP diagnosis, the patient had experienced COVID-19, which was likely to be the most probable trigger. However, rectal cancer was also identified in the patient, and whether these conditions are directly linked remains unclear.

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

A 49-year-old woman, previously recuperating from COVID-19, was found unconscious at her workplace, setting off a chain of events that would ultimately lead to an unexpected diagnosis.

This case report was published in the New England Journal of Medicine.

Noting the patient’s confusion and aphasia, emergency medical services were alerted, and she was taken to the emergency department of Massachusetts General Hospital. Initial examination revealed aphasia and coordination difficulties. However, imaging studies, including CT angiography, showed no signs of stroke or other neurological abnormalities.

The patient’s coworkers had observed that she appeared “unwell.” Her medical history included hypertension, which was managed with amlodipine, and there was no known family history of neurologic disorders.

During the examination, her vital signs were within normal ranges.

The patient’s potassium level of 2.5 mmol/L was noteworthy, indicating hypokalemia. Additionally, the patient presented with anemia and thrombocytopenia. Additional laboratory results unveiled thrombotic thrombocytopenic purpura (TTP), a rare blood disorder characterized by microangiopathic hemolytic anemia. The microscopic examination of a peripheral blood smear confirmed the extent of thrombocytopenia and was particularly notable for the increased number of schistocytes. The patient’s peripheral blood smear revealed five or six schistocytes per high-power field, constituting approximately 5% of the red cells. This significant number of schistocytes aligned with the severity of anemia and thrombocytopenia, confirming the diagnosis of microangiopathic hemolytic anemia.

Acquired TTP is an autoimmune condition driven by antibody-mediated clearance of the plasma enzyme ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin motif 13). Confirmatory laboratory testing for ADAMTS13 takes 1-3 days; therefore, therapeutic plasma exchange with glucocorticoid therapy and rituximab was initiated, which promptly improved her condition.

In this patient, the ADAMTS13 activity level was severely reduced (< 5%; reference value > 67%), and the inhibitor was present (1.4 inhibitor units; reference value ≤ 0.4).

Rectal cancer was diagnosed in this patient 2 months after the diagnosis of acquired TTP.

After undergoing four weekly infusions of rituximab and a 2-month tapering course of glucocorticoids, the patient experienced a relapse, approximately 6 months following the acquired TTP diagnosis. In response, therapeutic plasma exchange and glucocorticoid therapy were administered. There is a possibility that the underlying cancer played a role in the relapse. To minimize the risk for recurrence, the patient also received a second round of rituximab.

While establishing a clear cause is difficult, acquired TTP often appears to arise in connection with either an immune trigger, such as a viral infection, or immune dysregulation associated with another autoimmune disease or ongoing cancer. In this case, 4 weeks before the acquired TTP diagnosis, the patient had experienced COVID-19, which was likely to be the most probable trigger. However, rectal cancer was also identified in the patient, and whether these conditions are directly linked remains unclear.

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

A 49-year-old woman, previously recuperating from COVID-19, was found unconscious at her workplace, setting off a chain of events that would ultimately lead to an unexpected diagnosis.

This case report was published in the New England Journal of Medicine.

Noting the patient’s confusion and aphasia, emergency medical services were alerted, and she was taken to the emergency department of Massachusetts General Hospital. Initial examination revealed aphasia and coordination difficulties. However, imaging studies, including CT angiography, showed no signs of stroke or other neurological abnormalities.

The patient’s coworkers had observed that she appeared “unwell.” Her medical history included hypertension, which was managed with amlodipine, and there was no known family history of neurologic disorders.

During the examination, her vital signs were within normal ranges.

The patient’s potassium level of 2.5 mmol/L was noteworthy, indicating hypokalemia. Additionally, the patient presented with anemia and thrombocytopenia. Additional laboratory results unveiled thrombotic thrombocytopenic purpura (TTP), a rare blood disorder characterized by microangiopathic hemolytic anemia. The microscopic examination of a peripheral blood smear confirmed the extent of thrombocytopenia and was particularly notable for the increased number of schistocytes. The patient’s peripheral blood smear revealed five or six schistocytes per high-power field, constituting approximately 5% of the red cells. This significant number of schistocytes aligned with the severity of anemia and thrombocytopenia, confirming the diagnosis of microangiopathic hemolytic anemia.

Acquired TTP is an autoimmune condition driven by antibody-mediated clearance of the plasma enzyme ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin motif 13). Confirmatory laboratory testing for ADAMTS13 takes 1-3 days; therefore, therapeutic plasma exchange with glucocorticoid therapy and rituximab was initiated, which promptly improved her condition.

In this patient, the ADAMTS13 activity level was severely reduced (< 5%; reference value > 67%), and the inhibitor was present (1.4 inhibitor units; reference value ≤ 0.4).

Rectal cancer was diagnosed in this patient 2 months after the diagnosis of acquired TTP.

After undergoing four weekly infusions of rituximab and a 2-month tapering course of glucocorticoids, the patient experienced a relapse, approximately 6 months following the acquired TTP diagnosis. In response, therapeutic plasma exchange and glucocorticoid therapy were administered. There is a possibility that the underlying cancer played a role in the relapse. To minimize the risk for recurrence, the patient also received a second round of rituximab.

While establishing a clear cause is difficult, acquired TTP often appears to arise in connection with either an immune trigger, such as a viral infection, or immune dysregulation associated with another autoimmune disease or ongoing cancer. In this case, 4 weeks before the acquired TTP diagnosis, the patient had experienced COVID-19, which was likely to be the most probable trigger. However, rectal cancer was also identified in the patient, and whether these conditions are directly linked remains unclear.

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

BOSTON – Patients with metabolic-associated steatotic liver disease (MASLD, formerly NAFLD) without cirrhosis who took daily low-dose aspirin in a double-blind randomized trial demonstrated significant reductions in liver fat content over 6 months compared with similar patients who took a placebo, study results show.

“In MASLD without cirrhosis, low-dose aspirin, 81 milligrams daily, led to decreases in liver fat and improved markers of hepatic inflammation and fibrosis,” reported Robert M. Wilechansky, MD, a transplant hepatology fellow at Massachusetts General Hospital in Boston.

“It was safe and well tolerated in this study, but we would like to see larger, longer-term clinical trials to test the efficacy of aspirin for improving histology and preventing adverse outcomes in MASLD,” he said at the annual meeting of the American Association for the Study of Liver Diseases.

“We don’t have current plans, to my knowledge, to test full-dose aspirin,” he said in an interview. “I’m encouraged by the results with low-dose aspirin, and I think that, given the risk profile, using a lower dose is preferable.”
 

Reduction in inflammation

Although promising therapies for MASLD are in development, none are currently approved by the Food and Drug Administration, prompting Dr. Wilechansky and colleagues to investigate aspirin, with its anti-inflammatory properties, as a potential treatment.

In preclinical studies, aspirin has been shown to have both anti-inflammatory and antitumor effects in the liver through inhibition of cycloxygenase-2 and platelet-derived growth factor signaling, as well as through modulation of bioactive lipids, Dr. Wilechansky said.

In observational studies, use of aspirin was associated with a reduction in the prevalence of hepatic steatosis and fibrosis progression in patients with MASLD, and there was a decrease in the incidence of hepatocellular carcinoma and liver-related mortality among patients with viral hepatitis, he noted.

As for the potential mechanism of action of aspirin for patients with MASLD, Dr. Wilechansky noted that there may be some reduction in steatosis, and “if there is a reduction in inflammation, we may see some reduction in steatohepatitis.”
 

Study details

To see whether the so-called “wonder drug” could work wonders for patients with MASLD without cirrhosis, the researchers recruited 80 adults with MASLD and randomly assigned them to receive either aspirin 81 mg once daily or placebo for 6 months.

Patients with baseline cirrhosis or other liver disease, heavy drinkers, those who had used aspirin within 6 months, or those who used other antiplatelet or anticoagulant agents were excluded, as were patients with severe renal or cardiovascular disease, active cancer, pregnancy, were breastfeeding, had thrombocytopenia, or had undergone bariatric surgery within the past 2 years.

At baseline, 36.3% of all patients had F2-F3 fibrosis, as determined by vibration-controlled transient elastography (VCTE), and of 44 patients who had previously undergone liver biopsy, 37 (84.1%) were confirmed to have steatohepatitis.

At 6 months, the absolute change in hepatic fat fraction (HFF) from baseline, the primary endpoint, was a decline of 6.1% for patients taking aspirin, compared with a 4.2% increase for patients taking placebo, which translates into a 10.3% difference in favor of aspirin (P = .009).

The relative change in HFF, a secondary endpoint, for aspirin versus placebo was –59.2% (P = .003).

In addition, the use of aspirin was associated with a relative reduction in HFF of at least 30% among 16 of the 40 patients who received it.

Aspirin was significantly better than placebo for the secondary endpoints of absolute change in hepatic fat by MRI proton-density fat fraction, with –2.9% versus placebo (P = .018), and the relative change in hepatic fat by MRI-PDFF, with a difference of –24.8% versus placebo (P = .009).

Aspirin was also associated with significantly greater reductions in liver transaminase levels and liver stiffness by VCTE.

About one-third of patients in each study arm had at least one adverse event. There was only one aspirin-related adverse event (heartburn) that led to discontinuation. There were no serious bleeding events in either arm.

“We’re going to have to consider stratifying by aspirin use now in our trials,” said Mark Hartman, MD, from Eli Lilly in Indianapolis.
 

Significant weight gain in placebo group

Mary E. McCarthy Rinella, MD, FAASLD, professor of medicine at the University of Chicago, commented that the 4% increase in liver fat in the control arm “is kind of a lot for a placebo, and I’m wondering how much that accounts for the [difference] that you saw.” Dr. Rinella served as a comoderator of the session.

Dr. Wilechansky said that there were a few outliers in the placebo group who experienced significant weight gain during the study, including one patient who gained 15 kg over 6 months.

A post hoc analysis suggested that most of the increase in hepatic fat among patients who took placebo could have been among that handful of patients, he added. When those patients were removed in an adjusted analysis, the difference between the aspirin and placebo groups was smaller but remained significant.

The trial was sponsored by Massachusetts General Hospital. Dr. Wilechansky, Dr. Rinella, and Dr. Hartman had no relevant disclosures.

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

BOSTON – Patients with metabolic-associated steatotic liver disease (MASLD, formerly NAFLD) without cirrhosis who took daily low-dose aspirin in a double-blind randomized trial demonstrated significant reductions in liver fat content over 6 months compared with similar patients who took a placebo, study results show.

“In MASLD without cirrhosis, low-dose aspirin, 81 milligrams daily, led to decreases in liver fat and improved markers of hepatic inflammation and fibrosis,” reported Robert M. Wilechansky, MD, a transplant hepatology fellow at Massachusetts General Hospital in Boston.

“It was safe and well tolerated in this study, but we would like to see larger, longer-term clinical trials to test the efficacy of aspirin for improving histology and preventing adverse outcomes in MASLD,” he said at the annual meeting of the American Association for the Study of Liver Diseases.

“We don’t have current plans, to my knowledge, to test full-dose aspirin,” he said in an interview. “I’m encouraged by the results with low-dose aspirin, and I think that, given the risk profile, using a lower dose is preferable.”
 

Reduction in inflammation

Although promising therapies for MASLD are in development, none are currently approved by the Food and Drug Administration, prompting Dr. Wilechansky and colleagues to investigate aspirin, with its anti-inflammatory properties, as a potential treatment.

In preclinical studies, aspirin has been shown to have both anti-inflammatory and antitumor effects in the liver through inhibition of cycloxygenase-2 and platelet-derived growth factor signaling, as well as through modulation of bioactive lipids, Dr. Wilechansky said.

In observational studies, use of aspirin was associated with a reduction in the prevalence of hepatic steatosis and fibrosis progression in patients with MASLD, and there was a decrease in the incidence of hepatocellular carcinoma and liver-related mortality among patients with viral hepatitis, he noted.

As for the potential mechanism of action of aspirin for patients with MASLD, Dr. Wilechansky noted that there may be some reduction in steatosis, and “if there is a reduction in inflammation, we may see some reduction in steatohepatitis.”
 

Study details

To see whether the so-called “wonder drug” could work wonders for patients with MASLD without cirrhosis, the researchers recruited 80 adults with MASLD and randomly assigned them to receive either aspirin 81 mg once daily or placebo for 6 months.

Patients with baseline cirrhosis or other liver disease, heavy drinkers, those who had used aspirin within 6 months, or those who used other antiplatelet or anticoagulant agents were excluded, as were patients with severe renal or cardiovascular disease, active cancer, pregnancy, were breastfeeding, had thrombocytopenia, or had undergone bariatric surgery within the past 2 years.

At baseline, 36.3% of all patients had F2-F3 fibrosis, as determined by vibration-controlled transient elastography (VCTE), and of 44 patients who had previously undergone liver biopsy, 37 (84.1%) were confirmed to have steatohepatitis.

At 6 months, the absolute change in hepatic fat fraction (HFF) from baseline, the primary endpoint, was a decline of 6.1% for patients taking aspirin, compared with a 4.2% increase for patients taking placebo, which translates into a 10.3% difference in favor of aspirin (P = .009).

The relative change in HFF, a secondary endpoint, for aspirin versus placebo was –59.2% (P = .003).

In addition, the use of aspirin was associated with a relative reduction in HFF of at least 30% among 16 of the 40 patients who received it.

Aspirin was significantly better than placebo for the secondary endpoints of absolute change in hepatic fat by MRI proton-density fat fraction, with –2.9% versus placebo (P = .018), and the relative change in hepatic fat by MRI-PDFF, with a difference of –24.8% versus placebo (P = .009).

Aspirin was also associated with significantly greater reductions in liver transaminase levels and liver stiffness by VCTE.

About one-third of patients in each study arm had at least one adverse event. There was only one aspirin-related adverse event (heartburn) that led to discontinuation. There were no serious bleeding events in either arm.

“We’re going to have to consider stratifying by aspirin use now in our trials,” said Mark Hartman, MD, from Eli Lilly in Indianapolis.
 

Significant weight gain in placebo group

Mary E. McCarthy Rinella, MD, FAASLD, professor of medicine at the University of Chicago, commented that the 4% increase in liver fat in the control arm “is kind of a lot for a placebo, and I’m wondering how much that accounts for the [difference] that you saw.” Dr. Rinella served as a comoderator of the session.

Dr. Wilechansky said that there were a few outliers in the placebo group who experienced significant weight gain during the study, including one patient who gained 15 kg over 6 months.

A post hoc analysis suggested that most of the increase in hepatic fat among patients who took placebo could have been among that handful of patients, he added. When those patients were removed in an adjusted analysis, the difference between the aspirin and placebo groups was smaller but remained significant.

The trial was sponsored by Massachusetts General Hospital. Dr. Wilechansky, Dr. Rinella, and Dr. Hartman had no relevant disclosures.

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

BOSTON – Patients with metabolic-associated steatotic liver disease (MASLD, formerly NAFLD) without cirrhosis who took daily low-dose aspirin in a double-blind randomized trial demonstrated significant reductions in liver fat content over 6 months compared with similar patients who took a placebo, study results show.

“In MASLD without cirrhosis, low-dose aspirin, 81 milligrams daily, led to decreases in liver fat and improved markers of hepatic inflammation and fibrosis,” reported Robert M. Wilechansky, MD, a transplant hepatology fellow at Massachusetts General Hospital in Boston.

“It was safe and well tolerated in this study, but we would like to see larger, longer-term clinical trials to test the efficacy of aspirin for improving histology and preventing adverse outcomes in MASLD,” he said at the annual meeting of the American Association for the Study of Liver Diseases.

“We don’t have current plans, to my knowledge, to test full-dose aspirin,” he said in an interview. “I’m encouraged by the results with low-dose aspirin, and I think that, given the risk profile, using a lower dose is preferable.”
 

Reduction in inflammation

Although promising therapies for MASLD are in development, none are currently approved by the Food and Drug Administration, prompting Dr. Wilechansky and colleagues to investigate aspirin, with its anti-inflammatory properties, as a potential treatment.

In preclinical studies, aspirin has been shown to have both anti-inflammatory and antitumor effects in the liver through inhibition of cycloxygenase-2 and platelet-derived growth factor signaling, as well as through modulation of bioactive lipids, Dr. Wilechansky said.

In observational studies, use of aspirin was associated with a reduction in the prevalence of hepatic steatosis and fibrosis progression in patients with MASLD, and there was a decrease in the incidence of hepatocellular carcinoma and liver-related mortality among patients with viral hepatitis, he noted.

As for the potential mechanism of action of aspirin for patients with MASLD, Dr. Wilechansky noted that there may be some reduction in steatosis, and “if there is a reduction in inflammation, we may see some reduction in steatohepatitis.”
 

Study details

To see whether the so-called “wonder drug” could work wonders for patients with MASLD without cirrhosis, the researchers recruited 80 adults with MASLD and randomly assigned them to receive either aspirin 81 mg once daily or placebo for 6 months.

Patients with baseline cirrhosis or other liver disease, heavy drinkers, those who had used aspirin within 6 months, or those who used other antiplatelet or anticoagulant agents were excluded, as were patients with severe renal or cardiovascular disease, active cancer, pregnancy, were breastfeeding, had thrombocytopenia, or had undergone bariatric surgery within the past 2 years.

At baseline, 36.3% of all patients had F2-F3 fibrosis, as determined by vibration-controlled transient elastography (VCTE), and of 44 patients who had previously undergone liver biopsy, 37 (84.1%) were confirmed to have steatohepatitis.

At 6 months, the absolute change in hepatic fat fraction (HFF) from baseline, the primary endpoint, was a decline of 6.1% for patients taking aspirin, compared with a 4.2% increase for patients taking placebo, which translates into a 10.3% difference in favor of aspirin (P = .009).

The relative change in HFF, a secondary endpoint, for aspirin versus placebo was –59.2% (P = .003).

In addition, the use of aspirin was associated with a relative reduction in HFF of at least 30% among 16 of the 40 patients who received it.

Aspirin was significantly better than placebo for the secondary endpoints of absolute change in hepatic fat by MRI proton-density fat fraction, with –2.9% versus placebo (P = .018), and the relative change in hepatic fat by MRI-PDFF, with a difference of –24.8% versus placebo (P = .009).

Aspirin was also associated with significantly greater reductions in liver transaminase levels and liver stiffness by VCTE.

About one-third of patients in each study arm had at least one adverse event. There was only one aspirin-related adverse event (heartburn) that led to discontinuation. There were no serious bleeding events in either arm.

“We’re going to have to consider stratifying by aspirin use now in our trials,” said Mark Hartman, MD, from Eli Lilly in Indianapolis.
 

Significant weight gain in placebo group

Mary E. McCarthy Rinella, MD, FAASLD, professor of medicine at the University of Chicago, commented that the 4% increase in liver fat in the control arm “is kind of a lot for a placebo, and I’m wondering how much that accounts for the [difference] that you saw.” Dr. Rinella served as a comoderator of the session.

Dr. Wilechansky said that there were a few outliers in the placebo group who experienced significant weight gain during the study, including one patient who gained 15 kg over 6 months.

A post hoc analysis suggested that most of the increase in hepatic fat among patients who took placebo could have been among that handful of patients, he added. When those patients were removed in an adjusted analysis, the difference between the aspirin and placebo groups was smaller but remained significant.

The trial was sponsored by Massachusetts General Hospital. Dr. Wilechansky, Dr. Rinella, and Dr. Hartman had no relevant disclosures.

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

More children and preteens are taking melatonin to help them sleep, a new study found, while experts cautioned parents may be unaware of some risks, particularly with long-term use. 

The investigators noted not all melatonin supplements contain what they say they do – some tested in a separate study contained two to three times the amount of melatonin on the label, and one supplement contained none at all.
 

A matter of timing?

While not completely advising against the sleep supplement, the study researchers pointed out that short-term use is likely safer. 

“We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long term,” lead study author Lauren Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado in Boulder, said in a news release.

“If, after weighing potential risks and benefits, melatonin is recommended as the appropriate treatment, [a sleep medicine specialist] can recommend a dose and timing to treat the sleep issue,” said Raj Bhui, MD, a sleep medicine specialist and American Academy of Sleep Medicine spokesperson, who was not involved in the study.
 

An increasing trend

From 2017 to 2018, only about 1.3% of parents reported their children used melatonin in national data looking at supplement use in children and teenagers. In fact, usage more than doubled in this younger population from 2017 to 2020, another study revealed. “All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin,” Dr. Hartstein said.

She and colleagues surveyed the parents of 993 children, aged 1 to less than 14, from January to April 2023. They found about 20% of these school-aged children and preteens took melatonin as a sleep aid. The findings, published in the journal JAMA Pediatrics, also suggest that some parents routinely give their preschool children melatonin.

They found nearly 6% of preschoolers aged 1-4, 18.5% of children aged 5-9, and 19.4% of kids aged 10-13 had taken melatonin in the previous month. 

The researchers also discovered that many took melatonin for longer than a few nights. Preschool children took the supplement for a median of 1 year, grade school children for a median 18 months, and preteens for 21 months. 
 

What’s in your supplement? 

In a different study published April 25 (JAMA. 2023. doi: 10.1001/jama.2023.2296), researchers looked at 25 melatonin gummy products and found that 22 of them contained different amounts of melatonin than listed on the label. In fact, one called Sleep Plus Immune contained more than three times the amount, and with a supplement called Sleep Support, researchers could not detect any melatonin. 

There is a general misconception that supplements are natural and therefore safe, Dr. Bhui said. “Multiple investigations of commercially available supplements have shown we cannot assume that what is on the label is in the pill or that what is in the pill is disclosed on the label. Formal laboratory testing has revealed some supplements to be adulterated with unapproved pharmaceutical ingredients, contaminated with microbes, or even tainted with toxins like arsenic, lead, and mercury.”

Choosing a product with the “USP Verified Mark” may give parents some comfort regarding melatonin content and consistency with labeling, Dr. Bhui said. Taking steps to safeguard the supply at home is also important in making sure children don’t take the supplements by accident. “With the increased use of melatonin, this has been a growing problem.”

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

More children and preteens are taking melatonin to help them sleep, a new study found, while experts cautioned parents may be unaware of some risks, particularly with long-term use. 

The investigators noted not all melatonin supplements contain what they say they do – some tested in a separate study contained two to three times the amount of melatonin on the label, and one supplement contained none at all.
 

A matter of timing?

While not completely advising against the sleep supplement, the study researchers pointed out that short-term use is likely safer. 

“We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long term,” lead study author Lauren Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado in Boulder, said in a news release.

“If, after weighing potential risks and benefits, melatonin is recommended as the appropriate treatment, [a sleep medicine specialist] can recommend a dose and timing to treat the sleep issue,” said Raj Bhui, MD, a sleep medicine specialist and American Academy of Sleep Medicine spokesperson, who was not involved in the study.
 

An increasing trend

From 2017 to 2018, only about 1.3% of parents reported their children used melatonin in national data looking at supplement use in children and teenagers. In fact, usage more than doubled in this younger population from 2017 to 2020, another study revealed. “All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin,” Dr. Hartstein said.

She and colleagues surveyed the parents of 993 children, aged 1 to less than 14, from January to April 2023. They found about 20% of these school-aged children and preteens took melatonin as a sleep aid. The findings, published in the journal JAMA Pediatrics, also suggest that some parents routinely give their preschool children melatonin.

They found nearly 6% of preschoolers aged 1-4, 18.5% of children aged 5-9, and 19.4% of kids aged 10-13 had taken melatonin in the previous month. 

The researchers also discovered that many took melatonin for longer than a few nights. Preschool children took the supplement for a median of 1 year, grade school children for a median 18 months, and preteens for 21 months. 
 

What’s in your supplement? 

In a different study published April 25 (JAMA. 2023. doi: 10.1001/jama.2023.2296), researchers looked at 25 melatonin gummy products and found that 22 of them contained different amounts of melatonin than listed on the label. In fact, one called Sleep Plus Immune contained more than three times the amount, and with a supplement called Sleep Support, researchers could not detect any melatonin. 

There is a general misconception that supplements are natural and therefore safe, Dr. Bhui said. “Multiple investigations of commercially available supplements have shown we cannot assume that what is on the label is in the pill or that what is in the pill is disclosed on the label. Formal laboratory testing has revealed some supplements to be adulterated with unapproved pharmaceutical ingredients, contaminated with microbes, or even tainted with toxins like arsenic, lead, and mercury.”

Choosing a product with the “USP Verified Mark” may give parents some comfort regarding melatonin content and consistency with labeling, Dr. Bhui said. Taking steps to safeguard the supply at home is also important in making sure children don’t take the supplements by accident. “With the increased use of melatonin, this has been a growing problem.”

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

More children and preteens are taking melatonin to help them sleep, a new study found, while experts cautioned parents may be unaware of some risks, particularly with long-term use. 

The investigators noted not all melatonin supplements contain what they say they do – some tested in a separate study contained two to three times the amount of melatonin on the label, and one supplement contained none at all.
 

A matter of timing?

While not completely advising against the sleep supplement, the study researchers pointed out that short-term use is likely safer. 

“We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long term,” lead study author Lauren Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado in Boulder, said in a news release.

“If, after weighing potential risks and benefits, melatonin is recommended as the appropriate treatment, [a sleep medicine specialist] can recommend a dose and timing to treat the sleep issue,” said Raj Bhui, MD, a sleep medicine specialist and American Academy of Sleep Medicine spokesperson, who was not involved in the study.
 

An increasing trend

From 2017 to 2018, only about 1.3% of parents reported their children used melatonin in national data looking at supplement use in children and teenagers. In fact, usage more than doubled in this younger population from 2017 to 2020, another study revealed. “All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin,” Dr. Hartstein said.

She and colleagues surveyed the parents of 993 children, aged 1 to less than 14, from January to April 2023. They found about 20% of these school-aged children and preteens took melatonin as a sleep aid. The findings, published in the journal JAMA Pediatrics, also suggest that some parents routinely give their preschool children melatonin.

They found nearly 6% of preschoolers aged 1-4, 18.5% of children aged 5-9, and 19.4% of kids aged 10-13 had taken melatonin in the previous month. 

The researchers also discovered that many took melatonin for longer than a few nights. Preschool children took the supplement for a median of 1 year, grade school children for a median 18 months, and preteens for 21 months. 
 

What’s in your supplement? 

In a different study published April 25 (JAMA. 2023. doi: 10.1001/jama.2023.2296), researchers looked at 25 melatonin gummy products and found that 22 of them contained different amounts of melatonin than listed on the label. In fact, one called Sleep Plus Immune contained more than three times the amount, and with a supplement called Sleep Support, researchers could not detect any melatonin. 

There is a general misconception that supplements are natural and therefore safe, Dr. Bhui said. “Multiple investigations of commercially available supplements have shown we cannot assume that what is on the label is in the pill or that what is in the pill is disclosed on the label. Formal laboratory testing has revealed some supplements to be adulterated with unapproved pharmaceutical ingredients, contaminated with microbes, or even tainted with toxins like arsenic, lead, and mercury.”

Choosing a product with the “USP Verified Mark” may give parents some comfort regarding melatonin content and consistency with labeling, Dr. Bhui said. Taking steps to safeguard the supply at home is also important in making sure children don’t take the supplements by accident. “With the increased use of melatonin, this has been a growing problem.”

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

An anesthesiologist is suing the Mayo Clinic after it allegedly ordered him to stick to “prescribed messaging” after his outspoken comments about transgender athletes and a federal agency’s sluggishness regarding a COVID-19 treatment.

Michael J. Joyner, MD, claims that the Mayo Clinic violated its own policies by muzzling him, slapping him with an unpaid 1-week suspension, and labeling his comments to the media “unprofessional.”

In his Nov. 13 lawsuit, filed in Minnesota state court, Dr. Joyner asks that a judge order Mayo Clinic to stop its “retaliation and interference” with his “communications about his research.” He that claims the retaliation stems from his 2020 report about a Mayo Clinic business partner’s “attempt to unlawfully access and use protected patient data.”

Medical institutions often refuse to comment on pending litigation. But in a pair of unusual statements, the Mayo Clinic forcefully rebutted Joyner’s claims in some detail: “Dr. Joyner’s lawsuit is yet another manifestation of his refusal to recognize or accept responsibility for his inappropriate behaviors,” it told Becker’s Hospital Review.

In a June letter to colleagues, the institution’s communications head said Dr. Joyner was not punished over his transgender athlete comments but instead because he mistreated coworkers and made “unprofessional” comments to The New York Times.

Dr. Joyner, a prominent physiologist and anesthesiologist who has worked for Mayo Clinic for 36 years, has become a cause célèbre in academic and free-speech circles over the past several months.

Two conversations with journalists appear to be at the heart of the Mayo Clinic’s complaints.

First, a 2022 New York Times article about transgender athletes quoted him about how testosterone dramatically affects performance in males: “There are social aspects to sport, but physiology and biology underpin it. Testosterone is the 800-pound gorilla.”

“The language was at best, insensitive. At worst, transphobic,” an LGBTQ advocate told a TV news station in Rochester, Minn., where the Mayo Clinic is based. The article didn’t elaborate on why the advocate believed the language could be transphobic.

Then, a CNN story in 2023 noted that Dr. Joyner has studied convalescent plasma as a treatment for COVID-19 and quoted him about how the National Institutes of Health declined to take a stand on the use of the therapy: “Joyner said he’s ‘frustrated’ with the NIH’s ‘bureaucratic rope-a-dope,’ calling the agency’s guidelines ‘a wet blanket.’ ”

It is not unusual for medical researchers to comment bluntly to the media about federal agencies.

For example, a 2020 New York Times story that unraveled the Trump Administration’s apparent mischaracterization of Dr. Joyner’s research into convalescent plasma quoted a University of Pittsburgh physician as saying, “For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy.”

In a March 5 letter, a Mayo Clinic administrator wrote to Dr. Joyner to complain that his comments regarding the NIH were an example of his “problematic” use of “idiomatic language” that “reflects poorly on Mayo Clinic’s brand and reputation.” A paragraph in the letter is redacted in the version posted by the Foundation for Individual Rights and Expression, which supports Dr. Joyner.

The letter adds that Dr. Joyner’s comments to The New York Times “were problematic in the media and the LGBTQI+ community at Mayo Clinic.” The letter, which didn’t elaborate about the blowback, also says that “concerns remain with disrespectful communications with colleagues who describe your tone as unpleasant and having a ‘bullying’ quality to it.”

Kellie Miller, one of Dr. Joyner’s attorneys, noted in a statement that “Dr. Joyner’s personnel file is free of any documentation of Mayo’s ongoing and vague allegations of bullying and unprofessionalism with colleagues.”

The letter also ordered Dr. Joyner to not be rude or criticize the work of others and repair his relationship with Mayo Clinic’s public affairs staff: “This will take individual effort on your part.” It also ordered him to “discuss approved topics only” with reporters, “stick to prescribed messaging,” and not resist if the public affairs department doesn’t let him be interviewed: “Accept ‘no’ for an answer and move forward.”

Medical institutions often monitor how their employees interact with the media in order to control “messaging.” But firm rules at academic medical institutions like the Mayo Clinic may run the risk of running afoul of the tenets of academic freedom.

The institution and its CEO then retaliated by calling his claims “unprofessional,” according to the lawsuit, which provided no further details about the situation.

In a statement, the Mayo Clinic said it “hired an outside attorney to investigate these concerns. The attorney, who is now a federal judge, found there was no retaliation and that Dr. Joyner had engaged in a pattern of asserting inflammatory allegations grounded almost entirely in speculation.”

A petition signed by dozens of professors demands that Mayo Clinic “revoke the penalties and constraints it has imposed on him.”

“Dr. Joyner, a faculty member at a medical school that avows a commitment to academic freedom and to free expression, did not exceed the limits of his expertise in any of his statements to the press that led to these sanctions,” they wrote. “At no time did he claim to be speaking for the Mayo Clinic, and his remarks were well within the mainstream of the range of scientific opinion on topics in which he is expert.”

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

An anesthesiologist is suing the Mayo Clinic after it allegedly ordered him to stick to “prescribed messaging” after his outspoken comments about transgender athletes and a federal agency’s sluggishness regarding a COVID-19 treatment.

Michael J. Joyner, MD, claims that the Mayo Clinic violated its own policies by muzzling him, slapping him with an unpaid 1-week suspension, and labeling his comments to the media “unprofessional.”

In his Nov. 13 lawsuit, filed in Minnesota state court, Dr. Joyner asks that a judge order Mayo Clinic to stop its “retaliation and interference” with his “communications about his research.” He that claims the retaliation stems from his 2020 report about a Mayo Clinic business partner’s “attempt to unlawfully access and use protected patient data.”

Medical institutions often refuse to comment on pending litigation. But in a pair of unusual statements, the Mayo Clinic forcefully rebutted Joyner’s claims in some detail: “Dr. Joyner’s lawsuit is yet another manifestation of his refusal to recognize or accept responsibility for his inappropriate behaviors,” it told Becker’s Hospital Review.

In a June letter to colleagues, the institution’s communications head said Dr. Joyner was not punished over his transgender athlete comments but instead because he mistreated coworkers and made “unprofessional” comments to The New York Times.

Dr. Joyner, a prominent physiologist and anesthesiologist who has worked for Mayo Clinic for 36 years, has become a cause célèbre in academic and free-speech circles over the past several months.

Two conversations with journalists appear to be at the heart of the Mayo Clinic’s complaints.

First, a 2022 New York Times article about transgender athletes quoted him about how testosterone dramatically affects performance in males: “There are social aspects to sport, but physiology and biology underpin it. Testosterone is the 800-pound gorilla.”

“The language was at best, insensitive. At worst, transphobic,” an LGBTQ advocate told a TV news station in Rochester, Minn., where the Mayo Clinic is based. The article didn’t elaborate on why the advocate believed the language could be transphobic.

Then, a CNN story in 2023 noted that Dr. Joyner has studied convalescent plasma as a treatment for COVID-19 and quoted him about how the National Institutes of Health declined to take a stand on the use of the therapy: “Joyner said he’s ‘frustrated’ with the NIH’s ‘bureaucratic rope-a-dope,’ calling the agency’s guidelines ‘a wet blanket.’ ”

It is not unusual for medical researchers to comment bluntly to the media about federal agencies.

For example, a 2020 New York Times story that unraveled the Trump Administration’s apparent mischaracterization of Dr. Joyner’s research into convalescent plasma quoted a University of Pittsburgh physician as saying, “For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy.”

In a March 5 letter, a Mayo Clinic administrator wrote to Dr. Joyner to complain that his comments regarding the NIH were an example of his “problematic” use of “idiomatic language” that “reflects poorly on Mayo Clinic’s brand and reputation.” A paragraph in the letter is redacted in the version posted by the Foundation for Individual Rights and Expression, which supports Dr. Joyner.

The letter adds that Dr. Joyner’s comments to The New York Times “were problematic in the media and the LGBTQI+ community at Mayo Clinic.” The letter, which didn’t elaborate about the blowback, also says that “concerns remain with disrespectful communications with colleagues who describe your tone as unpleasant and having a ‘bullying’ quality to it.”

Kellie Miller, one of Dr. Joyner’s attorneys, noted in a statement that “Dr. Joyner’s personnel file is free of any documentation of Mayo’s ongoing and vague allegations of bullying and unprofessionalism with colleagues.”

The letter also ordered Dr. Joyner to not be rude or criticize the work of others and repair his relationship with Mayo Clinic’s public affairs staff: “This will take individual effort on your part.” It also ordered him to “discuss approved topics only” with reporters, “stick to prescribed messaging,” and not resist if the public affairs department doesn’t let him be interviewed: “Accept ‘no’ for an answer and move forward.”

Medical institutions often monitor how their employees interact with the media in order to control “messaging.” But firm rules at academic medical institutions like the Mayo Clinic may run the risk of running afoul of the tenets of academic freedom.

The institution and its CEO then retaliated by calling his claims “unprofessional,” according to the lawsuit, which provided no further details about the situation.

In a statement, the Mayo Clinic said it “hired an outside attorney to investigate these concerns. The attorney, who is now a federal judge, found there was no retaliation and that Dr. Joyner had engaged in a pattern of asserting inflammatory allegations grounded almost entirely in speculation.”

A petition signed by dozens of professors demands that Mayo Clinic “revoke the penalties and constraints it has imposed on him.”

“Dr. Joyner, a faculty member at a medical school that avows a commitment to academic freedom and to free expression, did not exceed the limits of his expertise in any of his statements to the press that led to these sanctions,” they wrote. “At no time did he claim to be speaking for the Mayo Clinic, and his remarks were well within the mainstream of the range of scientific opinion on topics in which he is expert.”

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

An anesthesiologist is suing the Mayo Clinic after it allegedly ordered him to stick to “prescribed messaging” after his outspoken comments about transgender athletes and a federal agency’s sluggishness regarding a COVID-19 treatment.

Michael J. Joyner, MD, claims that the Mayo Clinic violated its own policies by muzzling him, slapping him with an unpaid 1-week suspension, and labeling his comments to the media “unprofessional.”

In his Nov. 13 lawsuit, filed in Minnesota state court, Dr. Joyner asks that a judge order Mayo Clinic to stop its “retaliation and interference” with his “communications about his research.” He that claims the retaliation stems from his 2020 report about a Mayo Clinic business partner’s “attempt to unlawfully access and use protected patient data.”

Medical institutions often refuse to comment on pending litigation. But in a pair of unusual statements, the Mayo Clinic forcefully rebutted Joyner’s claims in some detail: “Dr. Joyner’s lawsuit is yet another manifestation of his refusal to recognize or accept responsibility for his inappropriate behaviors,” it told Becker’s Hospital Review.

In a June letter to colleagues, the institution’s communications head said Dr. Joyner was not punished over his transgender athlete comments but instead because he mistreated coworkers and made “unprofessional” comments to The New York Times.

Dr. Joyner, a prominent physiologist and anesthesiologist who has worked for Mayo Clinic for 36 years, has become a cause célèbre in academic and free-speech circles over the past several months.

Two conversations with journalists appear to be at the heart of the Mayo Clinic’s complaints.

First, a 2022 New York Times article about transgender athletes quoted him about how testosterone dramatically affects performance in males: “There are social aspects to sport, but physiology and biology underpin it. Testosterone is the 800-pound gorilla.”

“The language was at best, insensitive. At worst, transphobic,” an LGBTQ advocate told a TV news station in Rochester, Minn., where the Mayo Clinic is based. The article didn’t elaborate on why the advocate believed the language could be transphobic.

Then, a CNN story in 2023 noted that Dr. Joyner has studied convalescent plasma as a treatment for COVID-19 and quoted him about how the National Institutes of Health declined to take a stand on the use of the therapy: “Joyner said he’s ‘frustrated’ with the NIH’s ‘bureaucratic rope-a-dope,’ calling the agency’s guidelines ‘a wet blanket.’ ”

It is not unusual for medical researchers to comment bluntly to the media about federal agencies.

For example, a 2020 New York Times story that unraveled the Trump Administration’s apparent mischaracterization of Dr. Joyner’s research into convalescent plasma quoted a University of Pittsburgh physician as saying, “For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy.”

In a March 5 letter, a Mayo Clinic administrator wrote to Dr. Joyner to complain that his comments regarding the NIH were an example of his “problematic” use of “idiomatic language” that “reflects poorly on Mayo Clinic’s brand and reputation.” A paragraph in the letter is redacted in the version posted by the Foundation for Individual Rights and Expression, which supports Dr. Joyner.

The letter adds that Dr. Joyner’s comments to The New York Times “were problematic in the media and the LGBTQI+ community at Mayo Clinic.” The letter, which didn’t elaborate about the blowback, also says that “concerns remain with disrespectful communications with colleagues who describe your tone as unpleasant and having a ‘bullying’ quality to it.”

Kellie Miller, one of Dr. Joyner’s attorneys, noted in a statement that “Dr. Joyner’s personnel file is free of any documentation of Mayo’s ongoing and vague allegations of bullying and unprofessionalism with colleagues.”

The letter also ordered Dr. Joyner to not be rude or criticize the work of others and repair his relationship with Mayo Clinic’s public affairs staff: “This will take individual effort on your part.” It also ordered him to “discuss approved topics only” with reporters, “stick to prescribed messaging,” and not resist if the public affairs department doesn’t let him be interviewed: “Accept ‘no’ for an answer and move forward.”

Medical institutions often monitor how their employees interact with the media in order to control “messaging.” But firm rules at academic medical institutions like the Mayo Clinic may run the risk of running afoul of the tenets of academic freedom.

The institution and its CEO then retaliated by calling his claims “unprofessional,” according to the lawsuit, which provided no further details about the situation.

In a statement, the Mayo Clinic said it “hired an outside attorney to investigate these concerns. The attorney, who is now a federal judge, found there was no retaliation and that Dr. Joyner had engaged in a pattern of asserting inflammatory allegations grounded almost entirely in speculation.”

A petition signed by dozens of professors demands that Mayo Clinic “revoke the penalties and constraints it has imposed on him.”

“Dr. Joyner, a faculty member at a medical school that avows a commitment to academic freedom and to free expression, did not exceed the limits of his expertise in any of his statements to the press that led to these sanctions,” they wrote. “At no time did he claim to be speaking for the Mayo Clinic, and his remarks were well within the mainstream of the range of scientific opinion on topics in which he is expert.”

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

Sit less, move more. Or stand more. Or sleep more.

Replacing 30 minutes of sitting a day with equal time standing or even sleeping could improve obesity markers like body weight and waist circumference, according to a new cross-sectional study investigating the impact of movement behavior on cardiometabolic health. 

The findings suggest that, while higher-intensity activity may confer benefits sooner, adding more light activity or more standing, or even going to bed earlier, could improve heart health measures over time. 

“Our study highlights that replacing sedentary behavior with any other behavior can be beneficial,” said study author Joanna M. Blodgett, PhD, a researcher at University College London’s Institute of Sport, Exercise and Health, and department of targeted intervention.

The study builds on a large and growing body of evidence that movement behaviors impact cardiometabolic health. Increasing physical activity to 150 minutes a week has been shown to reduce the risk for cardiovascular disease by 17% and type 2 diabetes by 26%. Other studies suggest that even modest increases in physical activity can be beneficial. A prospective study published in October found that even short activity bouts of a few minutes a day may lower risks for heart attack, stroke, and early death. 

In the new study, researchers analyzed data from six studies and more than 15,000 participants, ranking behaviors according to their association with heart health. Moderate-to-vigorous activity was linked to the greatest benefit, followed by light activity, standing, sleeping, and finally – dead last on the list – sitting. 

A thigh-worn device tracked participants’ activity throughout the day, and six measures gauged heart health: body mass index (BMI), waist circumference, HDL cholesterol, total-cholesterol-to-HDL ratio, triglycerides, and glycated hemoglobin. 

Researchers modeled what would happen if people swapped various amounts of one activity for another every day for a week. Replacing just 4-13 minutes of sitting with moderate to vigorous activity improved heart health markers. 

The cardiovascular demands of regular intense activity like running, cycling, dancing, or playing sports – even in small bouts – strengthen the heart and improve blood flow throughout the body, Dr. Blodgett said. “This can lower cholesterol, blood pressure, and resting heart rate.”  

Even if adding moderate to vigorous activity is not an option, the findings suggest that people can still see benefits by replacing sitting with virtually any other activity – walking, standing, even sleeping.
 

Limitations

Because the study was observational, results can’t be used to infer causality.

“We cannot directly lean on the study results to guide prescriptions for particular exercise or lifestyle changes,” said Matthew Tomey, MD, a cardiologist with the Mount Sinai Health System, New York, who was not involved with the study. An interventional trial would be needed to confirm the findings.

The finding that sleep was better for participants than sitting is a good example. The benefits of replacing sitting with sleep were “clear” for adiposity measures like BMI and waist circumference, but negligible for blood markers such as cholesterol, triglycerides, and blood glucose, Dr. Blodgett said. 

One explanation: “The negative impact of sitting on these obesity measures is likely due to related unhealthy behaviors like snacking rather than the physiological benefits of sleep itself,” Dr. Blodgett said.

What’s more, study participants were relatively young, healthy, and active. The average age was 54, and they averaged nearly 8 hours of sleep, 10 hours of sitting, 3 hours of standing, 1.5 hours of light activity, and more than an hour of moderate to vigorous activity per day. So it’s difficult to draw conclusions about patients who don’t fit those metrics.
 

Impact on patient care

That said, the results could help tailor recommendations for patients, Dr. Blodgett said.

If a patient is struggling to exercise or is unable to exercise because of health or ability restrictions, you could help them find ways to add a lighter activity to their day, such as taking the stairs or walking briskly to catch the bus. Even swapping a regular desk for a standing one, or going to bed 30 minutes earlier, could be a more practical and effective suggestion. 

More than that: The research could be used to educate patients on the power of small changes. It shows that shifting daily habits even in small ways can make a difference, and people who are the least active stand to benefit the most. 

You can also remind patients that moderate or vigorous activity doesn’t need to happen at the gym. It could be lawn work, taking a walk, or moving heavy boxes. In fact, many activities can be “moderate” or even “vigorous” depending on the effort put into them. 

Share this rule of thumb: “An activity is classified as moderate intensity if you can talk but not sing while doing it, and an activity is generally considered vigorous intensity if you can’t say more than a few words without stopping to breathe,” Dr. Blodgett said.

The study also has implications for the potential of wearable activity trackers to monitor progress. Combining objective activity data with results from studies like this, and longer prospective studies, could help inform more helpful advice. 

“Ultimately, this research helps move us closer to more personalized guidance of how changing behaviors can improve your health,” Dr. Blodgett said.

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

Sit less, move more. Or stand more. Or sleep more.

Replacing 30 minutes of sitting a day with equal time standing or even sleeping could improve obesity markers like body weight and waist circumference, according to a new cross-sectional study investigating the impact of movement behavior on cardiometabolic health. 

The findings suggest that, while higher-intensity activity may confer benefits sooner, adding more light activity or more standing, or even going to bed earlier, could improve heart health measures over time. 

“Our study highlights that replacing sedentary behavior with any other behavior can be beneficial,” said study author Joanna M. Blodgett, PhD, a researcher at University College London’s Institute of Sport, Exercise and Health, and department of targeted intervention.

The study builds on a large and growing body of evidence that movement behaviors impact cardiometabolic health. Increasing physical activity to 150 minutes a week has been shown to reduce the risk for cardiovascular disease by 17% and type 2 diabetes by 26%. Other studies suggest that even modest increases in physical activity can be beneficial. A prospective study published in October found that even short activity bouts of a few minutes a day may lower risks for heart attack, stroke, and early death. 

In the new study, researchers analyzed data from six studies and more than 15,000 participants, ranking behaviors according to their association with heart health. Moderate-to-vigorous activity was linked to the greatest benefit, followed by light activity, standing, sleeping, and finally – dead last on the list – sitting. 

A thigh-worn device tracked participants’ activity throughout the day, and six measures gauged heart health: body mass index (BMI), waist circumference, HDL cholesterol, total-cholesterol-to-HDL ratio, triglycerides, and glycated hemoglobin. 

Researchers modeled what would happen if people swapped various amounts of one activity for another every day for a week. Replacing just 4-13 minutes of sitting with moderate to vigorous activity improved heart health markers. 

The cardiovascular demands of regular intense activity like running, cycling, dancing, or playing sports – even in small bouts – strengthen the heart and improve blood flow throughout the body, Dr. Blodgett said. “This can lower cholesterol, blood pressure, and resting heart rate.”  

Even if adding moderate to vigorous activity is not an option, the findings suggest that people can still see benefits by replacing sitting with virtually any other activity – walking, standing, even sleeping.
 

Limitations

Because the study was observational, results can’t be used to infer causality.

“We cannot directly lean on the study results to guide prescriptions for particular exercise or lifestyle changes,” said Matthew Tomey, MD, a cardiologist with the Mount Sinai Health System, New York, who was not involved with the study. An interventional trial would be needed to confirm the findings.

The finding that sleep was better for participants than sitting is a good example. The benefits of replacing sitting with sleep were “clear” for adiposity measures like BMI and waist circumference, but negligible for blood markers such as cholesterol, triglycerides, and blood glucose, Dr. Blodgett said. 

One explanation: “The negative impact of sitting on these obesity measures is likely due to related unhealthy behaviors like snacking rather than the physiological benefits of sleep itself,” Dr. Blodgett said.

What’s more, study participants were relatively young, healthy, and active. The average age was 54, and they averaged nearly 8 hours of sleep, 10 hours of sitting, 3 hours of standing, 1.5 hours of light activity, and more than an hour of moderate to vigorous activity per day. So it’s difficult to draw conclusions about patients who don’t fit those metrics.
 

Impact on patient care

That said, the results could help tailor recommendations for patients, Dr. Blodgett said.

If a patient is struggling to exercise or is unable to exercise because of health or ability restrictions, you could help them find ways to add a lighter activity to their day, such as taking the stairs or walking briskly to catch the bus. Even swapping a regular desk for a standing one, or going to bed 30 minutes earlier, could be a more practical and effective suggestion. 

More than that: The research could be used to educate patients on the power of small changes. It shows that shifting daily habits even in small ways can make a difference, and people who are the least active stand to benefit the most. 

You can also remind patients that moderate or vigorous activity doesn’t need to happen at the gym. It could be lawn work, taking a walk, or moving heavy boxes. In fact, many activities can be “moderate” or even “vigorous” depending on the effort put into them. 

Share this rule of thumb: “An activity is classified as moderate intensity if you can talk but not sing while doing it, and an activity is generally considered vigorous intensity if you can’t say more than a few words without stopping to breathe,” Dr. Blodgett said.

The study also has implications for the potential of wearable activity trackers to monitor progress. Combining objective activity data with results from studies like this, and longer prospective studies, could help inform more helpful advice. 

“Ultimately, this research helps move us closer to more personalized guidance of how changing behaviors can improve your health,” Dr. Blodgett said.

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

Sit less, move more. Or stand more. Or sleep more.

Replacing 30 minutes of sitting a day with equal time standing or even sleeping could improve obesity markers like body weight and waist circumference, according to a new cross-sectional study investigating the impact of movement behavior on cardiometabolic health. 

The findings suggest that, while higher-intensity activity may confer benefits sooner, adding more light activity or more standing, or even going to bed earlier, could improve heart health measures over time. 

“Our study highlights that replacing sedentary behavior with any other behavior can be beneficial,” said study author Joanna M. Blodgett, PhD, a researcher at University College London’s Institute of Sport, Exercise and Health, and department of targeted intervention.

The study builds on a large and growing body of evidence that movement behaviors impact cardiometabolic health. Increasing physical activity to 150 minutes a week has been shown to reduce the risk for cardiovascular disease by 17% and type 2 diabetes by 26%. Other studies suggest that even modest increases in physical activity can be beneficial. A prospective study published in October found that even short activity bouts of a few minutes a day may lower risks for heart attack, stroke, and early death. 

In the new study, researchers analyzed data from six studies and more than 15,000 participants, ranking behaviors according to their association with heart health. Moderate-to-vigorous activity was linked to the greatest benefit, followed by light activity, standing, sleeping, and finally – dead last on the list – sitting. 

A thigh-worn device tracked participants’ activity throughout the day, and six measures gauged heart health: body mass index (BMI), waist circumference, HDL cholesterol, total-cholesterol-to-HDL ratio, triglycerides, and glycated hemoglobin. 

Researchers modeled what would happen if people swapped various amounts of one activity for another every day for a week. Replacing just 4-13 minutes of sitting with moderate to vigorous activity improved heart health markers. 

The cardiovascular demands of regular intense activity like running, cycling, dancing, or playing sports – even in small bouts – strengthen the heart and improve blood flow throughout the body, Dr. Blodgett said. “This can lower cholesterol, blood pressure, and resting heart rate.”  

Even if adding moderate to vigorous activity is not an option, the findings suggest that people can still see benefits by replacing sitting with virtually any other activity – walking, standing, even sleeping.
 

Limitations

Because the study was observational, results can’t be used to infer causality.

“We cannot directly lean on the study results to guide prescriptions for particular exercise or lifestyle changes,” said Matthew Tomey, MD, a cardiologist with the Mount Sinai Health System, New York, who was not involved with the study. An interventional trial would be needed to confirm the findings.

The finding that sleep was better for participants than sitting is a good example. The benefits of replacing sitting with sleep were “clear” for adiposity measures like BMI and waist circumference, but negligible for blood markers such as cholesterol, triglycerides, and blood glucose, Dr. Blodgett said. 

One explanation: “The negative impact of sitting on these obesity measures is likely due to related unhealthy behaviors like snacking rather than the physiological benefits of sleep itself,” Dr. Blodgett said.

What’s more, study participants were relatively young, healthy, and active. The average age was 54, and they averaged nearly 8 hours of sleep, 10 hours of sitting, 3 hours of standing, 1.5 hours of light activity, and more than an hour of moderate to vigorous activity per day. So it’s difficult to draw conclusions about patients who don’t fit those metrics.
 

Impact on patient care

That said, the results could help tailor recommendations for patients, Dr. Blodgett said.

If a patient is struggling to exercise or is unable to exercise because of health or ability restrictions, you could help them find ways to add a lighter activity to their day, such as taking the stairs or walking briskly to catch the bus. Even swapping a regular desk for a standing one, or going to bed 30 minutes earlier, could be a more practical and effective suggestion. 

More than that: The research could be used to educate patients on the power of small changes. It shows that shifting daily habits even in small ways can make a difference, and people who are the least active stand to benefit the most. 

You can also remind patients that moderate or vigorous activity doesn’t need to happen at the gym. It could be lawn work, taking a walk, or moving heavy boxes. In fact, many activities can be “moderate” or even “vigorous” depending on the effort put into them. 

Share this rule of thumb: “An activity is classified as moderate intensity if you can talk but not sing while doing it, and an activity is generally considered vigorous intensity if you can’t say more than a few words without stopping to breathe,” Dr. Blodgett said.

The study also has implications for the potential of wearable activity trackers to monitor progress. Combining objective activity data with results from studies like this, and longer prospective studies, could help inform more helpful advice. 

“Ultimately, this research helps move us closer to more personalized guidance of how changing behaviors can improve your health,” Dr. Blodgett said.

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

PHILADELPHIA – In two studies run in parallel fashion to test different strategies, one that employed automatic referral to a pharmacist appeared to be superior to one using alerts from the electronic health record (EHR) in increasing the number of at-risk patients receiving a prescription for statins.

When outcomes were compared across these related studies, the pharmacist referrals had a greater positive impact on statin prescriptions while also increasing the proportion of patients on an appropriate statin dose, reported Alexander C. Faranoff, MD, assistant professor of cardiovascular medicine at Penn Medicine, Philadelphia.

The parallel studies were part of the SUPER LIPID program, created to generate evidence-based strategies for increasing the proportion of at-risk patients on statins. Dr. Faranoff said current data show that at least 50% of patients indicated for high-intensity statins in the United States are not taking them.

The two studies were presented together in a late breaking presentation at the American Heart Association scientific sessions.
 

EHR algorithm identifies statin candidates

The candidates for statin therapy were identified through an EHR algorithm for both studies. Both compared the impact of the intervention against a baseline period of usual care, although the study of EHR alerts also randomized physicians to provide usual care for 3 months or 6 months prior to intervention.

Dr. Faranoff described these interventions as non–visit related and visit related.

In the study of the non–visit-related strategy, referrals were generated by EHR and sent directly to the pharmacist. Upon receipt, the pharmacist verified the order was appropriate and called the patient directly to discuss starting therapy. Patients agreeing to start a statin were provided with a prescription and followed by the pharmacist.

In the study of the patient-visit approach, physicians seeing EHR-identified candidates received interruptive pop-up alerts during patient encounters. The physicians were randomized to provide usual care for 3 or 6 months before they began receiving alerts. The alerts recommended referral to a pharmacist.

During usual care in the non–visit-related study, only 15.2% of the 975 candidates for statins received a prescription. During the intervention period, the rate climbed to 31.6%. Statistically, the intervention more than doubled the odds ratio (OR) of receiving a statin prescription relative to usual care (OR 2.22; 95% confidence interval [CI] 1.47-3.37).

In addition, the proportion of patients receiving an appropriate dose of statins climbed from 7.7% in the period of usual care to 24.8% in the intervention period (OR 6.79; 95% CI 4.00-11.53).
 

Visit-based study also randomized

In the study evaluating a visit-based intervention, 16 physicians were randomized to deliver usual care for 3 or 6 months. Of physicians randomized to 3 months, 970 candidates for statins were treated during the 6-month intervention period. The physicians randomized to usual care for 6 months treated 672 candidates for statins during a 3-month intervention period,

More than 3,000 alerts were sent to both groups of physicians over the intervention period. Only 165 (4.6%) were associated with a prescription.

For the group randomized to 3 months of usual care, the proportion of candidates for statins who received a prescription rose from 14.9% during the period of usual care to 17.6% in the first 3 months of intervention and then fell slightly to 15.5% in the second 3 months.

For the group randomized to usual care for 6 months, the proportion of candidates for statins who received a prescription rose from about 11% during the period of usual care to 14.6%. Combining data from both arms, the small gain in prescriptions was significant but modest (OR 1.43; 95% CI 1.02-2.00).

In addition, the visit-based EHR notifications failed to yield a significant gain in the proportion of patients on an appropriate statin dose. During the intervention period, this proportion was only about 9% of patients treated by either of the two groups of randomized physicians,

The SUPER LIPID program involved 11 internal medicine and family medicine clinics in rural Pennsylvania. In the visit-based intervention, 16 primary care physicians (PCPs) were randomized. In the asynchronous intervention, 10 primary care practices participated. The EHR identified a total of 1,950 candidates for a statin.

Although the gain in statin prescriptions was disappointing for the visit-based intervention, the strategy of using the EHR to refer statin-eligible patients to pharmacists “could be an effective adjunct to visit-based clinical interactions in increasing statin prescribing for high-risk patients,” Dr. Faranoff maintained.
 

Overcoming clinical inertia a challenge

The greater efficacy of a pharmacist-based approach did not surprise the AHA-invited discussant, Benjamin M. Scirica, MD, associate professor of medicine at Harvard Medical School, Boston.

Pointing out that the pharmacist-based strategy of increasing statin prescriptions is more complicated and more costly, he said, “You get what you pay for.” In his opinion, simple solutions are unlikely ever to be effective due to the complex reasons for clinical inertia. Overall, he thinks a multifaceted approach to placing more patients who need statins on therapy is essential.

“Implementation science is hard,” Dr. Scirica said. Even though the referral-to-a-pharmacist approach ended up putting more patients on statins and putting them on an appropriate dose, he said even this more effective strategy “is still not getting to the majority of patients.”

This does not mean that this approach is without merit or should not be one of many strategies employed, but Dr. Scirica said “there is so much more to be done,” and that it should be employed along with other initiatives.

Faranoff reports no potential conflicts of interest. Dr. Scirica reports financial relationships with AbbVie, Aktiia, AstraZeneca, Better Therapeutics, Boehringer-Ingelheim, Eisai, GlaxoSmithKline, Hanmi, Lexicon, Merck, Novartis, Novo Nordisk, Pfizer, and Sanofi.

PHILADELPHIA – In two studies run in parallel fashion to test different strategies, one that employed automatic referral to a pharmacist appeared to be superior to one using alerts from the electronic health record (EHR) in increasing the number of at-risk patients receiving a prescription for statins.

When outcomes were compared across these related studies, the pharmacist referrals had a greater positive impact on statin prescriptions while also increasing the proportion of patients on an appropriate statin dose, reported Alexander C. Faranoff, MD, assistant professor of cardiovascular medicine at Penn Medicine, Philadelphia.

The parallel studies were part of the SUPER LIPID program, created to generate evidence-based strategies for increasing the proportion of at-risk patients on statins. Dr. Faranoff said current data show that at least 50% of patients indicated for high-intensity statins in the United States are not taking them.

The two studies were presented together in a late breaking presentation at the American Heart Association scientific sessions.
 

EHR algorithm identifies statin candidates

The candidates for statin therapy were identified through an EHR algorithm for both studies. Both compared the impact of the intervention against a baseline period of usual care, although the study of EHR alerts also randomized physicians to provide usual care for 3 months or 6 months prior to intervention.

Dr. Faranoff described these interventions as non–visit related and visit related.

In the study of the non–visit-related strategy, referrals were generated by EHR and sent directly to the pharmacist. Upon receipt, the pharmacist verified the order was appropriate and called the patient directly to discuss starting therapy. Patients agreeing to start a statin were provided with a prescription and followed by the pharmacist.

In the study of the patient-visit approach, physicians seeing EHR-identified candidates received interruptive pop-up alerts during patient encounters. The physicians were randomized to provide usual care for 3 or 6 months before they began receiving alerts. The alerts recommended referral to a pharmacist.

During usual care in the non–visit-related study, only 15.2% of the 975 candidates for statins received a prescription. During the intervention period, the rate climbed to 31.6%. Statistically, the intervention more than doubled the odds ratio (OR) of receiving a statin prescription relative to usual care (OR 2.22; 95% confidence interval [CI] 1.47-3.37).

In addition, the proportion of patients receiving an appropriate dose of statins climbed from 7.7% in the period of usual care to 24.8% in the intervention period (OR 6.79; 95% CI 4.00-11.53).
 

Visit-based study also randomized

In the study evaluating a visit-based intervention, 16 physicians were randomized to deliver usual care for 3 or 6 months. Of physicians randomized to 3 months, 970 candidates for statins were treated during the 6-month intervention period. The physicians randomized to usual care for 6 months treated 672 candidates for statins during a 3-month intervention period,

More than 3,000 alerts were sent to both groups of physicians over the intervention period. Only 165 (4.6%) were associated with a prescription.

For the group randomized to 3 months of usual care, the proportion of candidates for statins who received a prescription rose from 14.9% during the period of usual care to 17.6% in the first 3 months of intervention and then fell slightly to 15.5% in the second 3 months.

For the group randomized to usual care for 6 months, the proportion of candidates for statins who received a prescription rose from about 11% during the period of usual care to 14.6%. Combining data from both arms, the small gain in prescriptions was significant but modest (OR 1.43; 95% CI 1.02-2.00).

In addition, the visit-based EHR notifications failed to yield a significant gain in the proportion of patients on an appropriate statin dose. During the intervention period, this proportion was only about 9% of patients treated by either of the two groups of randomized physicians,

The SUPER LIPID program involved 11 internal medicine and family medicine clinics in rural Pennsylvania. In the visit-based intervention, 16 primary care physicians (PCPs) were randomized. In the asynchronous intervention, 10 primary care practices participated. The EHR identified a total of 1,950 candidates for a statin.

Although the gain in statin prescriptions was disappointing for the visit-based intervention, the strategy of using the EHR to refer statin-eligible patients to pharmacists “could be an effective adjunct to visit-based clinical interactions in increasing statin prescribing for high-risk patients,” Dr. Faranoff maintained.
 

Overcoming clinical inertia a challenge

The greater efficacy of a pharmacist-based approach did not surprise the AHA-invited discussant, Benjamin M. Scirica, MD, associate professor of medicine at Harvard Medical School, Boston.

Pointing out that the pharmacist-based strategy of increasing statin prescriptions is more complicated and more costly, he said, “You get what you pay for.” In his opinion, simple solutions are unlikely ever to be effective due to the complex reasons for clinical inertia. Overall, he thinks a multifaceted approach to placing more patients who need statins on therapy is essential.

“Implementation science is hard,” Dr. Scirica said. Even though the referral-to-a-pharmacist approach ended up putting more patients on statins and putting them on an appropriate dose, he said even this more effective strategy “is still not getting to the majority of patients.”

This does not mean that this approach is without merit or should not be one of many strategies employed, but Dr. Scirica said “there is so much more to be done,” and that it should be employed along with other initiatives.

Faranoff reports no potential conflicts of interest. Dr. Scirica reports financial relationships with AbbVie, Aktiia, AstraZeneca, Better Therapeutics, Boehringer-Ingelheim, Eisai, GlaxoSmithKline, Hanmi, Lexicon, Merck, Novartis, Novo Nordisk, Pfizer, and Sanofi.

PHILADELPHIA – In two studies run in parallel fashion to test different strategies, one that employed automatic referral to a pharmacist appeared to be superior to one using alerts from the electronic health record (EHR) in increasing the number of at-risk patients receiving a prescription for statins.

When outcomes were compared across these related studies, the pharmacist referrals had a greater positive impact on statin prescriptions while also increasing the proportion of patients on an appropriate statin dose, reported Alexander C. Faranoff, MD, assistant professor of cardiovascular medicine at Penn Medicine, Philadelphia.

The parallel studies were part of the SUPER LIPID program, created to generate evidence-based strategies for increasing the proportion of at-risk patients on statins. Dr. Faranoff said current data show that at least 50% of patients indicated for high-intensity statins in the United States are not taking them.

The two studies were presented together in a late breaking presentation at the American Heart Association scientific sessions.
 

EHR algorithm identifies statin candidates

The candidates for statin therapy were identified through an EHR algorithm for both studies. Both compared the impact of the intervention against a baseline period of usual care, although the study of EHR alerts also randomized physicians to provide usual care for 3 months or 6 months prior to intervention.

Dr. Faranoff described these interventions as non–visit related and visit related.

In the study of the non–visit-related strategy, referrals were generated by EHR and sent directly to the pharmacist. Upon receipt, the pharmacist verified the order was appropriate and called the patient directly to discuss starting therapy. Patients agreeing to start a statin were provided with a prescription and followed by the pharmacist.

In the study of the patient-visit approach, physicians seeing EHR-identified candidates received interruptive pop-up alerts during patient encounters. The physicians were randomized to provide usual care for 3 or 6 months before they began receiving alerts. The alerts recommended referral to a pharmacist.

During usual care in the non–visit-related study, only 15.2% of the 975 candidates for statins received a prescription. During the intervention period, the rate climbed to 31.6%. Statistically, the intervention more than doubled the odds ratio (OR) of receiving a statin prescription relative to usual care (OR 2.22; 95% confidence interval [CI] 1.47-3.37).

In addition, the proportion of patients receiving an appropriate dose of statins climbed from 7.7% in the period of usual care to 24.8% in the intervention period (OR 6.79; 95% CI 4.00-11.53).
 

Visit-based study also randomized

In the study evaluating a visit-based intervention, 16 physicians were randomized to deliver usual care for 3 or 6 months. Of physicians randomized to 3 months, 970 candidates for statins were treated during the 6-month intervention period. The physicians randomized to usual care for 6 months treated 672 candidates for statins during a 3-month intervention period,

More than 3,000 alerts were sent to both groups of physicians over the intervention period. Only 165 (4.6%) were associated with a prescription.

For the group randomized to 3 months of usual care, the proportion of candidates for statins who received a prescription rose from 14.9% during the period of usual care to 17.6% in the first 3 months of intervention and then fell slightly to 15.5% in the second 3 months.

For the group randomized to usual care for 6 months, the proportion of candidates for statins who received a prescription rose from about 11% during the period of usual care to 14.6%. Combining data from both arms, the small gain in prescriptions was significant but modest (OR 1.43; 95% CI 1.02-2.00).

In addition, the visit-based EHR notifications failed to yield a significant gain in the proportion of patients on an appropriate statin dose. During the intervention period, this proportion was only about 9% of patients treated by either of the two groups of randomized physicians,

The SUPER LIPID program involved 11 internal medicine and family medicine clinics in rural Pennsylvania. In the visit-based intervention, 16 primary care physicians (PCPs) were randomized. In the asynchronous intervention, 10 primary care practices participated. The EHR identified a total of 1,950 candidates for a statin.

Although the gain in statin prescriptions was disappointing for the visit-based intervention, the strategy of using the EHR to refer statin-eligible patients to pharmacists “could be an effective adjunct to visit-based clinical interactions in increasing statin prescribing for high-risk patients,” Dr. Faranoff maintained.
 

Overcoming clinical inertia a challenge

The greater efficacy of a pharmacist-based approach did not surprise the AHA-invited discussant, Benjamin M. Scirica, MD, associate professor of medicine at Harvard Medical School, Boston.

Pointing out that the pharmacist-based strategy of increasing statin prescriptions is more complicated and more costly, he said, “You get what you pay for.” In his opinion, simple solutions are unlikely ever to be effective due to the complex reasons for clinical inertia. Overall, he thinks a multifaceted approach to placing more patients who need statins on therapy is essential.

“Implementation science is hard,” Dr. Scirica said. Even though the referral-to-a-pharmacist approach ended up putting more patients on statins and putting them on an appropriate dose, he said even this more effective strategy “is still not getting to the majority of patients.”

This does not mean that this approach is without merit or should not be one of many strategies employed, but Dr. Scirica said “there is so much more to be done,” and that it should be employed along with other initiatives.

Faranoff reports no potential conflicts of interest. Dr. Scirica reports financial relationships with AbbVie, Aktiia, AstraZeneca, Better Therapeutics, Boehringer-Ingelheim, Eisai, GlaxoSmithKline, Hanmi, Lexicon, Merck, Novartis, Novo Nordisk, Pfizer, and Sanofi.

False-positive mammography results are common, but a large population-based cohort study conducted in Sweden found an elevated incidence of developing and dying of breast cancer up to 20 years after a false-positive result.

Women with a false-positive mammography result had 61% greater risk of developing breast cancer and an 84% greater risk of dying of breast cancer, compared with those who did not have a false-positive result.

However, the investigators also found that the risk for breast cancer varied by individual characteristics such as age and breast density.

The analysis provides clues about which patients with false-positive mammography results will go on to develop breast cancer and “can be used to develop individualized risk-based breast cancer screening,” said the investigators, led by Xinhe Mao, MSc, of Karolinska Institute, Stockholm.

The findings were published online in JAMA Oncology.

About 11% of women in the United States and 2.5% in Europe will receive a false-positive result after a single mammography screening, and previous research shows that these women have a higher risk of developing breast cancer, compared with women without false-positive results. Still, whether this risk for breast cancer varies by individual characteristics and whether an association between a false-positive mammography result and mortality exists remain unclear.

To assess long-term outcomes after a false-positive result, the study investigators compared 45,213 women who had a false-positive mammography result between 1991 and 2017 with 452,130 controls matched for age, calendar year of mammography, and screening history. These data came from the Stockholm Mammography Screening program and Swedish nationwide registers. The analysis also included 1,113 women with a false-positive result and 11,130 matched controls with information on mammographic breast density from the Karolinska Mammography Project for Risk Prediction of Breast Cancer study. 

Among women with a false-positive result, the 20-year cumulative breast cancer incidence was 11.3% compared with 7.3% among those without a false-positive (adjusted hazard ratio, 1.61).

Breast cancer risk was higher in older women – those aged 60-75 years (HR, 2.02) – vs younger women aged 40-49 years (HR, 1.38). Breast cancer risk was also higher among women with less dense breasts (HR, 4.65) vs more dense breasts (HR, 1.60) and those who underwent a biopsy during recall (HR, 1.77) vs those who did not (HR, 1.51).

After a false-positive result, cancers were more likely to occur on the ipsilateral side to the false-positive result (HR, 1.92) versus the contralateral (HR, 1.28) and were more common during the first 4 years of follow-up (HR, 2.57 in the first 2 years and 1.93 between 2 and 4 years). No statistical differences were observed based on tumor characteristics, aside from tumor size (HR, 1.78 for tumors ≥ 20 mm vs. 1.47 for smaller tumors).

The prognosis of patients with breast cancer did not differ on the basis of whether they had false-positive results before diagnosis (HR, 1.05 for a false-positive result versus no false-positive result; 95% CI, 0.89-1.25).

This study is the first to show that “women with a false-positive result are at increased risk of death from breast cancer,” Ms. Mao and colleagues concluded. This finding is “most probably associated with the increased breast cancer incidence,” given that the prognosis of patients with breast cancer was similar among those who had a false-positive result versus those who did not.

The authors noted that the increased risk for breast cancer after a false-positive result could suggest that false positives indicate the presence of small tumors that were missed or generally indicate a higher risk for breast cancer. Other factors, such as hormones or genetics, may be at play as well, but would need to be investigated in further studies, Ms. Mao and colleagues noted.

When individualizing surveillance after a false-positive result, age and breast density should be considered, the authors explained. Clinicians may also want to provide more intensive surveillance in the years after a false-positive result as well as education to patients about the risks associated with a false-positive result.

Overall, the findings indicate that clinicians “ should stress the importance of continued screening in women with false-positive results, given their higher risk of cancer, especially within the first 5 or so years after a false-positive result,” Diana L. Miglioretti, PhD, professor and division chief of biostatistics at the University of California, Davis, said in an interview.

Dr. Miglioretti, who has led research on false-positive mammography results and approaches to reduce false positives, noted that “this is a very important study confirming prior work by the Breast Cancer Surveillance Consortium showing individuals with false-positive screening mammography results are at increased risk of developing breast cancer in the future.”

The new evidence demonstrated an increased risk for death from breast cancer in patients who have a false-positive result is particularly worrisome because some studies suggest that women with false-positive results are less likely to return for screening, perhaps because of their negative experience, Dr. Miglioretti said.

However, her own research has shown that providing immediate screening mammography interpretation and same-day diagnostic workup to individuals who have not had a mammogram in the past 5 years and to younger women could prevent 40% of people from needing to return for diagnostic workup later and potentially reduce time to diagnosis for those with cancer.

It is “important that radiology facilities find ways to reduce false-positive results and the anxiety associated with these results,” Dr. Miglioretti said.

This study was supported by grants from the Swedish Research Council, the Swedish Cancer Society, the Stockholm County Council, and FORTE. Ms. Mao is supported by a grant from the China Scholarship Council. Dr. Miglioretti received funding from PCORI and NCI and royalties from Elsevier.

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

False-positive mammography results are common, but a large population-based cohort study conducted in Sweden found an elevated incidence of developing and dying of breast cancer up to 20 years after a false-positive result.

Women with a false-positive mammography result had 61% greater risk of developing breast cancer and an 84% greater risk of dying of breast cancer, compared with those who did not have a false-positive result.

However, the investigators also found that the risk for breast cancer varied by individual characteristics such as age and breast density.

The analysis provides clues about which patients with false-positive mammography results will go on to develop breast cancer and “can be used to develop individualized risk-based breast cancer screening,” said the investigators, led by Xinhe Mao, MSc, of Karolinska Institute, Stockholm.

The findings were published online in JAMA Oncology.

About 11% of women in the United States and 2.5% in Europe will receive a false-positive result after a single mammography screening, and previous research shows that these women have a higher risk of developing breast cancer, compared with women without false-positive results. Still, whether this risk for breast cancer varies by individual characteristics and whether an association between a false-positive mammography result and mortality exists remain unclear.

To assess long-term outcomes after a false-positive result, the study investigators compared 45,213 women who had a false-positive mammography result between 1991 and 2017 with 452,130 controls matched for age, calendar year of mammography, and screening history. These data came from the Stockholm Mammography Screening program and Swedish nationwide registers. The analysis also included 1,113 women with a false-positive result and 11,130 matched controls with information on mammographic breast density from the Karolinska Mammography Project for Risk Prediction of Breast Cancer study. 

Among women with a false-positive result, the 20-year cumulative breast cancer incidence was 11.3% compared with 7.3% among those without a false-positive (adjusted hazard ratio, 1.61).

Breast cancer risk was higher in older women – those aged 60-75 years (HR, 2.02) – vs younger women aged 40-49 years (HR, 1.38). Breast cancer risk was also higher among women with less dense breasts (HR, 4.65) vs more dense breasts (HR, 1.60) and those who underwent a biopsy during recall (HR, 1.77) vs those who did not (HR, 1.51).

After a false-positive result, cancers were more likely to occur on the ipsilateral side to the false-positive result (HR, 1.92) versus the contralateral (HR, 1.28) and were more common during the first 4 years of follow-up (HR, 2.57 in the first 2 years and 1.93 between 2 and 4 years). No statistical differences were observed based on tumor characteristics, aside from tumor size (HR, 1.78 for tumors ≥ 20 mm vs. 1.47 for smaller tumors).

The prognosis of patients with breast cancer did not differ on the basis of whether they had false-positive results before diagnosis (HR, 1.05 for a false-positive result versus no false-positive result; 95% CI, 0.89-1.25).

This study is the first to show that “women with a false-positive result are at increased risk of death from breast cancer,” Ms. Mao and colleagues concluded. This finding is “most probably associated with the increased breast cancer incidence,” given that the prognosis of patients with breast cancer was similar among those who had a false-positive result versus those who did not.

The authors noted that the increased risk for breast cancer after a false-positive result could suggest that false positives indicate the presence of small tumors that were missed or generally indicate a higher risk for breast cancer. Other factors, such as hormones or genetics, may be at play as well, but would need to be investigated in further studies, Ms. Mao and colleagues noted.

When individualizing surveillance after a false-positive result, age and breast density should be considered, the authors explained. Clinicians may also want to provide more intensive surveillance in the years after a false-positive result as well as education to patients about the risks associated with a false-positive result.

Overall, the findings indicate that clinicians “ should stress the importance of continued screening in women with false-positive results, given their higher risk of cancer, especially within the first 5 or so years after a false-positive result,” Diana L. Miglioretti, PhD, professor and division chief of biostatistics at the University of California, Davis, said in an interview.

Dr. Miglioretti, who has led research on false-positive mammography results and approaches to reduce false positives, noted that “this is a very important study confirming prior work by the Breast Cancer Surveillance Consortium showing individuals with false-positive screening mammography results are at increased risk of developing breast cancer in the future.”

The new evidence demonstrated an increased risk for death from breast cancer in patients who have a false-positive result is particularly worrisome because some studies suggest that women with false-positive results are less likely to return for screening, perhaps because of their negative experience, Dr. Miglioretti said.

However, her own research has shown that providing immediate screening mammography interpretation and same-day diagnostic workup to individuals who have not had a mammogram in the past 5 years and to younger women could prevent 40% of people from needing to return for diagnostic workup later and potentially reduce time to diagnosis for those with cancer.

It is “important that radiology facilities find ways to reduce false-positive results and the anxiety associated with these results,” Dr. Miglioretti said.

This study was supported by grants from the Swedish Research Council, the Swedish Cancer Society, the Stockholm County Council, and FORTE. Ms. Mao is supported by a grant from the China Scholarship Council. Dr. Miglioretti received funding from PCORI and NCI and royalties from Elsevier.

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

False-positive mammography results are common, but a large population-based cohort study conducted in Sweden found an elevated incidence of developing and dying of breast cancer up to 20 years after a false-positive result.

Women with a false-positive mammography result had 61% greater risk of developing breast cancer and an 84% greater risk of dying of breast cancer, compared with those who did not have a false-positive result.

However, the investigators also found that the risk for breast cancer varied by individual characteristics such as age and breast density.

The analysis provides clues about which patients with false-positive mammography results will go on to develop breast cancer and “can be used to develop individualized risk-based breast cancer screening,” said the investigators, led by Xinhe Mao, MSc, of Karolinska Institute, Stockholm.

The findings were published online in JAMA Oncology.

About 11% of women in the United States and 2.5% in Europe will receive a false-positive result after a single mammography screening, and previous research shows that these women have a higher risk of developing breast cancer, compared with women without false-positive results. Still, whether this risk for breast cancer varies by individual characteristics and whether an association between a false-positive mammography result and mortality exists remain unclear.

To assess long-term outcomes after a false-positive result, the study investigators compared 45,213 women who had a false-positive mammography result between 1991 and 2017 with 452,130 controls matched for age, calendar year of mammography, and screening history. These data came from the Stockholm Mammography Screening program and Swedish nationwide registers. The analysis also included 1,113 women with a false-positive result and 11,130 matched controls with information on mammographic breast density from the Karolinska Mammography Project for Risk Prediction of Breast Cancer study. 

Among women with a false-positive result, the 20-year cumulative breast cancer incidence was 11.3% compared with 7.3% among those without a false-positive (adjusted hazard ratio, 1.61).

Breast cancer risk was higher in older women – those aged 60-75 years (HR, 2.02) – vs younger women aged 40-49 years (HR, 1.38). Breast cancer risk was also higher among women with less dense breasts (HR, 4.65) vs more dense breasts (HR, 1.60) and those who underwent a biopsy during recall (HR, 1.77) vs those who did not (HR, 1.51).

After a false-positive result, cancers were more likely to occur on the ipsilateral side to the false-positive result (HR, 1.92) versus the contralateral (HR, 1.28) and were more common during the first 4 years of follow-up (HR, 2.57 in the first 2 years and 1.93 between 2 and 4 years). No statistical differences were observed based on tumor characteristics, aside from tumor size (HR, 1.78 for tumors ≥ 20 mm vs. 1.47 for smaller tumors).

The prognosis of patients with breast cancer did not differ on the basis of whether they had false-positive results before diagnosis (HR, 1.05 for a false-positive result versus no false-positive result; 95% CI, 0.89-1.25).

This study is the first to show that “women with a false-positive result are at increased risk of death from breast cancer,” Ms. Mao and colleagues concluded. This finding is “most probably associated with the increased breast cancer incidence,” given that the prognosis of patients with breast cancer was similar among those who had a false-positive result versus those who did not.

The authors noted that the increased risk for breast cancer after a false-positive result could suggest that false positives indicate the presence of small tumors that were missed or generally indicate a higher risk for breast cancer. Other factors, such as hormones or genetics, may be at play as well, but would need to be investigated in further studies, Ms. Mao and colleagues noted.

When individualizing surveillance after a false-positive result, age and breast density should be considered, the authors explained. Clinicians may also want to provide more intensive surveillance in the years after a false-positive result as well as education to patients about the risks associated with a false-positive result.

Overall, the findings indicate that clinicians “ should stress the importance of continued screening in women with false-positive results, given their higher risk of cancer, especially within the first 5 or so years after a false-positive result,” Diana L. Miglioretti, PhD, professor and division chief of biostatistics at the University of California, Davis, said in an interview.

Dr. Miglioretti, who has led research on false-positive mammography results and approaches to reduce false positives, noted that “this is a very important study confirming prior work by the Breast Cancer Surveillance Consortium showing individuals with false-positive screening mammography results are at increased risk of developing breast cancer in the future.”

The new evidence demonstrated an increased risk for death from breast cancer in patients who have a false-positive result is particularly worrisome because some studies suggest that women with false-positive results are less likely to return for screening, perhaps because of their negative experience, Dr. Miglioretti said.

However, her own research has shown that providing immediate screening mammography interpretation and same-day diagnostic workup to individuals who have not had a mammogram in the past 5 years and to younger women could prevent 40% of people from needing to return for diagnostic workup later and potentially reduce time to diagnosis for those with cancer.

It is “important that radiology facilities find ways to reduce false-positive results and the anxiety associated with these results,” Dr. Miglioretti said.

This study was supported by grants from the Swedish Research Council, the Swedish Cancer Society, the Stockholm County Council, and FORTE. Ms. Mao is supported by a grant from the China Scholarship Council. Dr. Miglioretti received funding from PCORI and NCI and royalties from Elsevier.

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

People with diabetes had a 47% increased risk of getting colorectal cancer, compared with people without diabetes, according to results of a large new study. Getting a colonoscopy dramatically reduced the risk, the results showed.

The findings, published in JAMA Network Open, suggest that colonoscopies are particularly important for people with diabetes. People diagnosed with diabetes within the past 5 years have the greatest colorectal cancer risk, the study found, suggesting screening should be part of a person’s health care after they’re diagnosed with diabetes.

Researchers analyzed data for 54,597 people who contributed at least 2 years of health data as part of a study that recruited people from 12 Southeastern states between 2002 and 2009. The people self-reported their diabetes status, and although researchers tried to only include people with type 2 diabetes, it’s possible that some people in the study had type 1 diabetes. The average age of those in the study was 51 years old; 64% were women; more than half of them had an income of less than $15,000 per year; and 66% of them were African American. 

Among the people in the study who had diabetes, the risk of having colorectal cancer was not strongly impacted by their race or ethnicity, gender, weight, or income level, the study showed.

While race didn’t predict whether people with diabetes would get colorectal cancer, the findings are particularly important because most of the people in the study were African American. Diabetes and colorectal cancer disproportionately affect African American people, the authors noted. Medical research studies often struggle to recruit people of color, resulting in a lack of data to help guide health care priorities and decision-making.

The study also provided important guidance for people newly diagnosed with diabetes. People who were diagnosed with diabetes within the past 5 years were at a particularly increased risk of getting colorectal cancer, compared to people who had been diagnosed for 5-10 years.

The authors concluded that increased referrals for colonoscopies among people with diabetes, particularly among those newly diagnosed, could greatly reduce the impact of colorectal cancer. Current guidelines suggest most people should begin colorectal cancer screenings at age 45, according to the Centers for Disease Control and Prevention.

The study was supported by the National Cancer Institute and the University of Wisconsin, Madison. The study authors reported no relevant conflicts of interest.

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

People with diabetes had a 47% increased risk of getting colorectal cancer, compared with people without diabetes, according to results of a large new study. Getting a colonoscopy dramatically reduced the risk, the results showed.

The findings, published in JAMA Network Open, suggest that colonoscopies are particularly important for people with diabetes. People diagnosed with diabetes within the past 5 years have the greatest colorectal cancer risk, the study found, suggesting screening should be part of a person’s health care after they’re diagnosed with diabetes.

Researchers analyzed data for 54,597 people who contributed at least 2 years of health data as part of a study that recruited people from 12 Southeastern states between 2002 and 2009. The people self-reported their diabetes status, and although researchers tried to only include people with type 2 diabetes, it’s possible that some people in the study had type 1 diabetes. The average age of those in the study was 51 years old; 64% were women; more than half of them had an income of less than $15,000 per year; and 66% of them were African American. 

Among the people in the study who had diabetes, the risk of having colorectal cancer was not strongly impacted by their race or ethnicity, gender, weight, or income level, the study showed.

While race didn’t predict whether people with diabetes would get colorectal cancer, the findings are particularly important because most of the people in the study were African American. Diabetes and colorectal cancer disproportionately affect African American people, the authors noted. Medical research studies often struggle to recruit people of color, resulting in a lack of data to help guide health care priorities and decision-making.

The study also provided important guidance for people newly diagnosed with diabetes. People who were diagnosed with diabetes within the past 5 years were at a particularly increased risk of getting colorectal cancer, compared to people who had been diagnosed for 5-10 years.

The authors concluded that increased referrals for colonoscopies among people with diabetes, particularly among those newly diagnosed, could greatly reduce the impact of colorectal cancer. Current guidelines suggest most people should begin colorectal cancer screenings at age 45, according to the Centers for Disease Control and Prevention.

The study was supported by the National Cancer Institute and the University of Wisconsin, Madison. The study authors reported no relevant conflicts of interest.

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

People with diabetes had a 47% increased risk of getting colorectal cancer, compared with people without diabetes, according to results of a large new study. Getting a colonoscopy dramatically reduced the risk, the results showed.

The findings, published in JAMA Network Open, suggest that colonoscopies are particularly important for people with diabetes. People diagnosed with diabetes within the past 5 years have the greatest colorectal cancer risk, the study found, suggesting screening should be part of a person’s health care after they’re diagnosed with diabetes.

Researchers analyzed data for 54,597 people who contributed at least 2 years of health data as part of a study that recruited people from 12 Southeastern states between 2002 and 2009. The people self-reported their diabetes status, and although researchers tried to only include people with type 2 diabetes, it’s possible that some people in the study had type 1 diabetes. The average age of those in the study was 51 years old; 64% were women; more than half of them had an income of less than $15,000 per year; and 66% of them were African American. 

Among the people in the study who had diabetes, the risk of having colorectal cancer was not strongly impacted by their race or ethnicity, gender, weight, or income level, the study showed.

While race didn’t predict whether people with diabetes would get colorectal cancer, the findings are particularly important because most of the people in the study were African American. Diabetes and colorectal cancer disproportionately affect African American people, the authors noted. Medical research studies often struggle to recruit people of color, resulting in a lack of data to help guide health care priorities and decision-making.

The study also provided important guidance for people newly diagnosed with diabetes. People who were diagnosed with diabetes within the past 5 years were at a particularly increased risk of getting colorectal cancer, compared to people who had been diagnosed for 5-10 years.

The authors concluded that increased referrals for colonoscopies among people with diabetes, particularly among those newly diagnosed, could greatly reduce the impact of colorectal cancer. Current guidelines suggest most people should begin colorectal cancer screenings at age 45, according to the Centers for Disease Control and Prevention.

The study was supported by the National Cancer Institute and the University of Wisconsin, Madison. The study authors reported no relevant conflicts of interest.

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

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

New research strengthens the body of evidence demonstrating an increased risk of blood cancer from exposure to low doses of radiation from CT scans. The results suggest that, for every 10,000 children examined with an average low dose of 8 mGy, 1-2 will likely develop a hematologic malignancy related to radiation exposure over the next 12 years.

The findings, published online in Nature Medicine, are based on more than 1.3 million CT scans in nearly 900,000 people younger than 22 years old when scanned.

This study makes a “significant contribution to the understanding of the effects of ionizing radiation, specifically x-rays, on the human body at the levels of radiation exposure encountered in diagnostic CT procedures,” Peter Marsden, PhD, and Jim Thurston, radiation protection experts at Dorset County (England) Hospital, NHS Foundation Trust, said in a press release from the U.K. nonprofit Science Media Centre.

These findings highlight levels of risk that “align with those currently estimated and do not suggest that the use of CT carries a greater risk than previously thought,” Dr. Marsden and Thurston said.

Exposure to moderate- (≥ 100 mGy) to high-dose (≥ 1 Gy) ionizing radiation is a well-established risk factor for leukemia in both children and adults. However, the risk associated with low-dose exposure (< 100 mGy) typically associated with diagnostic CT exams in children and teens remains unclear.

The current study, coordinated by the International Agency for Research on Cancer, aimed to improve direct estimates of cancer risk from low-dose radiation exposure from CT scans performed in childhood and adolescence. The researchers estimated radiation doses to the active bone marrow based on body part scanned, patient characteristics, time period, and inferred CT technical parameters.

A total of 790 hematologic malignancies, including lymphoid and myeloid malignancies, were identified during follow-up. More than half (51%) of the cases were diagnosed in people under age 20 and 88.5% were diagnosed in people under age 30 years.

Overall, the observational study found a nearly twofold excess risk of all hematologic malignancies per 100 mGy in children, adolescents, and young adults, with similar risk estimates observed for lymphoid and myeloid cancers. The excess relative risk for hematologic malignancies increased as the number of CT exams increased – with risk rising by 43% per exam.

The results of this study “strengthen the findings from previous low-dose studies of a consistent and robust dose-related increased risk of radiation-induced hematological malignancies” and highlight the importance of optimizing doses in this patient population, study author Elisabeth Cardis, PhD, with the Barcelona Institute for Global Health, and colleagues concluded.

Sarah McQuaid, PhD, chair of the nuclear medicine special interest group, Institute of Physics and Engineering in Medicine, York, England, agreed.

“This publication indicates that there could be a small cancer risk from CT scans in young people, but it is important for this to be viewed in the context of the substantial benefit these scans bring, due to the important diagnostic information they provide,” Dr. McQuaid said in the press release. Overall, “the number of patients whose medical care will have been improved from these CT scans will have been very high, and lives undoubtedly saved as a result.”

The study had no commercial funding. The authors and outside experts reported no relevant financial relationships.

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

New research strengthens the body of evidence demonstrating an increased risk of blood cancer from exposure to low doses of radiation from CT scans. The results suggest that, for every 10,000 children examined with an average low dose of 8 mGy, 1-2 will likely develop a hematologic malignancy related to radiation exposure over the next 12 years.

The findings, published online in Nature Medicine, are based on more than 1.3 million CT scans in nearly 900,000 people younger than 22 years old when scanned.

This study makes a “significant contribution to the understanding of the effects of ionizing radiation, specifically x-rays, on the human body at the levels of radiation exposure encountered in diagnostic CT procedures,” Peter Marsden, PhD, and Jim Thurston, radiation protection experts at Dorset County (England) Hospital, NHS Foundation Trust, said in a press release from the U.K. nonprofit Science Media Centre.

These findings highlight levels of risk that “align with those currently estimated and do not suggest that the use of CT carries a greater risk than previously thought,” Dr. Marsden and Thurston said.

Exposure to moderate- (≥ 100 mGy) to high-dose (≥ 1 Gy) ionizing radiation is a well-established risk factor for leukemia in both children and adults. However, the risk associated with low-dose exposure (< 100 mGy) typically associated with diagnostic CT exams in children and teens remains unclear.

The current study, coordinated by the International Agency for Research on Cancer, aimed to improve direct estimates of cancer risk from low-dose radiation exposure from CT scans performed in childhood and adolescence. The researchers estimated radiation doses to the active bone marrow based on body part scanned, patient characteristics, time period, and inferred CT technical parameters.

A total of 790 hematologic malignancies, including lymphoid and myeloid malignancies, were identified during follow-up. More than half (51%) of the cases were diagnosed in people under age 20 and 88.5% were diagnosed in people under age 30 years.

Overall, the observational study found a nearly twofold excess risk of all hematologic malignancies per 100 mGy in children, adolescents, and young adults, with similar risk estimates observed for lymphoid and myeloid cancers. The excess relative risk for hematologic malignancies increased as the number of CT exams increased – with risk rising by 43% per exam.

The results of this study “strengthen the findings from previous low-dose studies of a consistent and robust dose-related increased risk of radiation-induced hematological malignancies” and highlight the importance of optimizing doses in this patient population, study author Elisabeth Cardis, PhD, with the Barcelona Institute for Global Health, and colleagues concluded.

Sarah McQuaid, PhD, chair of the nuclear medicine special interest group, Institute of Physics and Engineering in Medicine, York, England, agreed.

“This publication indicates that there could be a small cancer risk from CT scans in young people, but it is important for this to be viewed in the context of the substantial benefit these scans bring, due to the important diagnostic information they provide,” Dr. McQuaid said in the press release. Overall, “the number of patients whose medical care will have been improved from these CT scans will have been very high, and lives undoubtedly saved as a result.”

The study had no commercial funding. The authors and outside experts reported no relevant financial relationships.

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

New research strengthens the body of evidence demonstrating an increased risk of blood cancer from exposure to low doses of radiation from CT scans. The results suggest that, for every 10,000 children examined with an average low dose of 8 mGy, 1-2 will likely develop a hematologic malignancy related to radiation exposure over the next 12 years.

The findings, published online in Nature Medicine, are based on more than 1.3 million CT scans in nearly 900,000 people younger than 22 years old when scanned.

This study makes a “significant contribution to the understanding of the effects of ionizing radiation, specifically x-rays, on the human body at the levels of radiation exposure encountered in diagnostic CT procedures,” Peter Marsden, PhD, and Jim Thurston, radiation protection experts at Dorset County (England) Hospital, NHS Foundation Trust, said in a press release from the U.K. nonprofit Science Media Centre.

These findings highlight levels of risk that “align with those currently estimated and do not suggest that the use of CT carries a greater risk than previously thought,” Dr. Marsden and Thurston said.

Exposure to moderate- (≥ 100 mGy) to high-dose (≥ 1 Gy) ionizing radiation is a well-established risk factor for leukemia in both children and adults. However, the risk associated with low-dose exposure (< 100 mGy) typically associated with diagnostic CT exams in children and teens remains unclear.

The current study, coordinated by the International Agency for Research on Cancer, aimed to improve direct estimates of cancer risk from low-dose radiation exposure from CT scans performed in childhood and adolescence. The researchers estimated radiation doses to the active bone marrow based on body part scanned, patient characteristics, time period, and inferred CT technical parameters.

A total of 790 hematologic malignancies, including lymphoid and myeloid malignancies, were identified during follow-up. More than half (51%) of the cases were diagnosed in people under age 20 and 88.5% were diagnosed in people under age 30 years.

Overall, the observational study found a nearly twofold excess risk of all hematologic malignancies per 100 mGy in children, adolescents, and young adults, with similar risk estimates observed for lymphoid and myeloid cancers. The excess relative risk for hematologic malignancies increased as the number of CT exams increased – with risk rising by 43% per exam.

The results of this study “strengthen the findings from previous low-dose studies of a consistent and robust dose-related increased risk of radiation-induced hematological malignancies” and highlight the importance of optimizing doses in this patient population, study author Elisabeth Cardis, PhD, with the Barcelona Institute for Global Health, and colleagues concluded.

Sarah McQuaid, PhD, chair of the nuclear medicine special interest group, Institute of Physics and Engineering in Medicine, York, England, agreed.

“This publication indicates that there could be a small cancer risk from CT scans in young people, but it is important for this to be viewed in the context of the substantial benefit these scans bring, due to the important diagnostic information they provide,” Dr. McQuaid said in the press release. Overall, “the number of patients whose medical care will have been improved from these CT scans will have been very high, and lives undoubtedly saved as a result.”

The study had no commercial funding. The authors and outside experts reported no relevant financial relationships.

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