Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

SDI Productions/E+

The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

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

Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

SDI Productions/E+

The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

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

Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

SDI Productions/E+

The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

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

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

Individuals who consumed more ultraprocessed foods had a significantly increased risk of developing inflammatory bowel disease (IBD) than those who consumed less, according to data from more than 100,000 adults.

“Diet alters the microbiome and modifies the intestinal immune response and so could play a role in the pathogenesis of IBD,” Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues wrote. Although previous studies have investigated the impact of dietary risk factors on IBD, an association with ultraprocessed foods (defined as foods containing additives and preservatives) in particular has not been examined, they wrote.

In a study published in BMJ, the researchers examined data from 116,087 adults aged 35-70 years from 21 countries between 2003 and 2016 who were part of the large Prospective Urban Rural Epidemiology (PURE) Cohort. Participants completed baseline food frequency questionnaires and were followed at least every 3 years; the median follow-up time was 9.7 years. The primary outcome was the development of Crohn’s disease or ulcerative colitis. In this study, ultraprocessed food included all packaged and formulated foods and beverages that contained food additives, artificial flavors or colors, or other chemical ingredients.

The categories of ultraprocessed foods included processed meat, cold breakfast cereal, various sauces, soft drinks, and fruit drinks, and refined sweetened foods such as candy, chocolate, jam, jelly, and brownies.

Overall, 467 participants developed IBD, including 90 with Crohn’s disease and 377 with ulcerative colitis.

After controlling for confounding factors, the investigators found that increased consumption of ultraprocessed foods was significantly associated with an increased risk of incident IBD. Compared with individuals who consumed less than 1 serving per day of ultraprocessed foods, the hazard ratio was 1.82 for those who consumed 5 or more servings and 1.67 for those who consumed 1-4 servings daily (P = .006).

“The pattern of increased ultraprocessed food intake and higher risk of IBD persisted within each of the regions examined, and effect estimates were generally similar, with overlapping confidence intervals and no significant heterogeneity,” the researchers noted.

The risk of IBD increased among individuals who consumed 1 serving per week or more of processed meat, compared with those who consumed less than 1 serving per week, and the risk increased with the amount consumed (HR, 2.07 for 1 or more servings per day). Similarly, IBD risk was higher among individuals who consumed 100 g/day or more of refined sweetened foods compared with no intake of these foods (HR, 2.58).

Individuals who consumed at least one serving of fried foods per day had the highest risk of IBD (HR, 3.02), the researchers noted. The reason for the association is uncertain, but may occur not only because many fried foods are also processed but also because the action of frying food and the processing of oil, as well as type and quality of oil, might modify the nutrients.

In the subgroup analysis, higher consumption of salty snacks and soft drinks also was associated with higher risk for IBD. However, the researchers found no association between increased risk of IBD and consumption of white meat, unprocessed red meat, dairy, starchy foods, and fruit/vegetables/legumes.

The study findings were limited by several factors including the relatively small number of individuals with Crohn’s disease, potential lack of generalizability to those who develop IBD in childhood or young adulthood, and possible confounding from unmeasured variables. The study also did not account for dietary changes over time, the investigators reported. However, the longitudinal design allowed them “to focus on people with incident IBD and to use medical record review and central adjudication to validate a sample of the diagnoses.”

The results suggest that the way food is processed or ultraprocessed, rather than the food itself, may be what confers the risk for IBD, given the lack of association between IBD and other food categories such as unprocessed red meat and dairy, the researchers concluded.
 

Next steps: Pin down driving factors

“There is significant interest in the apparent increase in the incidence and prevalence of IBD, particularly in previously low incidence areas,” Edward L. Barnes, MD, MPH, of the University of North Carolina at Chapel Hill said in an interview.

“Many research groups and clinicians suspect that environmental exposures, including dietary exposures, may play a critical role in these trends,” said Dr. Barnes. “This study utilized a large, multinational prospective cohort design to assess the influence of diet on the risk of developing IBD,” which is particularly important considering the potential for processed foods and food additives to impact the gastrointestinal tract.

“The strong associations demonstrated by the authors were impressive, particularly given that the authors performed multiple subanalyses, including evaluations by participant age and evaluations of particular food groups/types [e.g., processed meat, soft drinks, and refined sweet foods],” he noted. Dr. Barnes also found the lack of association with intake of white meat and unprocessed red meat interesting. “In my opinion, these subanalyses strengthen the overall associations demonstrated by the authors given their prospective study design and their attention to evaluating all potential associations that may be driving the relationships present in this cohort.

“At this point, the take-home message for clinicians treating patients with Crohn’s disease and ulcerative colitis should be that this association exists,” said Dr. Barnes. “One question that remains is whether the same risk factors that are present for developing disease also influence the disease course, given that the primary outcome of this study was the development of IBD. Given that much of our data with regard to the interplay between diet and IBD are still emerging, physicians treating patients with IBD can make patients aware of these associations and the potential benefit of limiting ultraprocessed foods in their diet.”

For these important results to become actionable, “further research is likely necessary to identify the factors that are driving this association,” Dr. Barnes explained. “This would likely build on prior animal models that have demonstrated an association between food additives such as emulsifiers and changes in the gastrointestinal tract that could ultimately lead to increased inflammation and the development of IBD.” Such information about specific drivers “would then allow clinicians to determine which population would benefit most from dietary changes/recommendations.”

The overall PURE study was supported by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, CIHR’s Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, and the Ontario Ministry of Health and Long-term Care. PURE also was supported in part by unrestricted grants from several pharmaceutical companies, notably AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline. The researchers had no relevant financial conflicts to disclose. Dr. Barnes disclosed serving as a consultant for AbbVie, Gilead, Pfizer, Takeda, and Target RWE.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

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

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

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

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

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

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

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

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

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

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

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

While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).

peterschreiber_media/iStock/Getty Images

They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.

Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.

Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.

They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.

The median age of the cohort was 57 years and 59% were women.

A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.

The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).

A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.

The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.

“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.

Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
 

Myocarditis cases

The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.

Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.

None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
 

Pericarditis cases

The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.

Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.

Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.

At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.

The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).

The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).

The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.

“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.

In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.  

Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.

“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.

The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.

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

While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).

peterschreiber_media/iStock/Getty Images

They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.

Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.

Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.

They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.

The median age of the cohort was 57 years and 59% were women.

A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.

The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).

A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.

The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.

“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.

Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
 

Myocarditis cases

The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.

Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.

None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
 

Pericarditis cases

The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.

Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.

Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.

At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.

The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).

The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).

The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.

“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.

In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.  

Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.

“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.

The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.

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

While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).

peterschreiber_media/iStock/Getty Images

They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.

Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.

Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.

They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.

The median age of the cohort was 57 years and 59% were women.

A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.

The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).

A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.

The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.

“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.

Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
 

Myocarditis cases

The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.

Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.

None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
 

Pericarditis cases

The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.

Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.

Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.

At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.

The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).

The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).

The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.

“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.

In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.  

Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.

“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.

The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.

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

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

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

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

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

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

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

Certain plasma biomarkers of neuronal damage and neuroinflammation are markedly elevated in hospitalized COVID-19 patients with neurologic symptoms compared with hospitalized COVID-19 patients without such symptoms, a new study shows.

These results suggest that COVID-19 may accelerate Alzheimer’s disease symptoms and pathology, said study investigator Thomas Wisniewski, MD, professor of neurology, pathology, and psychiatry at New York University.

The findings were presented here at the Alzheimer’s Association International Conference (AAIC) 2021.
 

Strong correlation

There’s a clear association between SARS-CoV-2 infection and Alzheimer’s disease-related dementia. Patients with Alzheimer’s disease are at threefold higher risk for the infection and have a twofold higher risk for death, Dr. Wisniewski told meeting delegates.

He and his colleagues conducted a prospective study of patients who had tested positive for SARS-CoV-2 and who experienced neurologic sequelae and SARS-CoV-2 patients who were without neurologic sequelae. All patients were hospitalized from March 10 to May 20, 2020. This was during a period when New York City was overwhelmed by COVID: About 35% of hospitalized patients had COVID.

Of those who experienced neurologic events, the most common “by far and away” (51%) was toxic metabolic encephalopathy (TME), said Dr. Wisniewski. Other associations included seizures, hypoxic/anoxic injury, and ischemic stroke.

The most common TMEs were septic and hypoxic ischemia. In most patients (78%), TME had more than one cause.

Researchers followed 196 patients with COVID and neurologic complications (case patients) and 186 matched control patients who had no neurologic complications over a period of 6 months.

“Unfortunately, both groups had poor outcomes,” said Dr. Wisniewski. About 50% had impaired cognition, and 56% experienced limitations in activities of daily living.

However, those patients with COVID-19 who had neurologic sequelae “fared even worse,” said Dr. Wisniewski. Compared with control patients, they had twofold worse Modified Rankin Scale scores and worse scores on activity of daily living, and they were much less likely to return to work.

Mechanisms by which COVID-19 affects longer-term cognitive dysfunction are unclear, but inflammation likely plays a role.

The research team compared a number of Alzheimer’s disease plasma biomarkers in 158 patients with COVID-19 who had neurologic symptoms and 152 COVID patients with COVID but no neurologic symptoms. They found marked elevations of neurofilament light, a marker of neuronal injury, in those with symptoms (P = .0003) as well as increased glial fibrillary acid protein, a marker of neuroinflammation (P = .0098).

Ubiquitin carboxyl-terminal hydrolase L1, another marker of neuronal injury, was also elevated in those with neurologic symptoms. Regarding Alzheimer’s disease pathology, total tau (t-tau) and phosphorylated tau “also tracked with neurological sequelae,” said Dr. Wisniewski.

There was no difference in levels of amyloid beta 40 (A beta 40) between groups. However, A beta 42 plasma levels were significantly lower in those with neurologic effects, suggesting higher levels in the brain. In addition, the ratio of t-tau to A beta 42 “clearly differentiated the two groups,” he said.

“Serum biomarkers of neuroinflammation and neuronal injury and Alzheimer’s disease correlate strongly, perhaps suggesting that folks with COVID infection and neurological sequelae may have an acceleration of Alzheimer’s disease symptoms and pathology,” he said. “That’s something that needs longer follow-up.”
 

Important differentiation

Commenting on the research, Rebecca Edelmayer, PhD, senior director of scientific engagement, Alzheimer’s Association, said the study provides important information. The inclusion of plasma biomarkers in this research is “really critical to tease out what’s the impact of COVID itself on the brain,” said Dr. Edelmayer.

“We’re in an era of biomarkers when it comes to Alzheimer’s disease and other dementias, and being able to define those changes that are happening in the brain over time is going to be really critical and aid in early detection and accurate diagnoses,” she said.

What is still to be learned is what these biomarkers reveal long term, said Dr. Edelmayer. “Do those biological markers change? Do they go back to normal? A lot of that is still unknown,” she said.

She noted that many diseases that are linked to inflammation produce similar biomarkers in the brain – for example, neurofilament light.

With other viral infections, such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), similar associations between the infection and cognition have been reported, said Dr. Edelmayer.

“But there are still a lot of questions around cause and effect. Is it really a direct effect of the virus on the brain itself? Is it an effect of having an enormous amount of inflammation going on in the body? A lot of that still needs to be teased out,” she commented.

The study was supported by the National Institutes of Health, the Alzheimer’s Association, and the State of New York. Dr. Wisniewski has consulted for Grifols, Amylon Pharmaceuticals, and Alzamed Neuro; 30 NYU patents are related to AD therapeutics.

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

Certain plasma biomarkers of neuronal damage and neuroinflammation are markedly elevated in hospitalized COVID-19 patients with neurologic symptoms compared with hospitalized COVID-19 patients without such symptoms, a new study shows.

These results suggest that COVID-19 may accelerate Alzheimer’s disease symptoms and pathology, said study investigator Thomas Wisniewski, MD, professor of neurology, pathology, and psychiatry at New York University.

The findings were presented here at the Alzheimer’s Association International Conference (AAIC) 2021.
 

Strong correlation

There’s a clear association between SARS-CoV-2 infection and Alzheimer’s disease-related dementia. Patients with Alzheimer’s disease are at threefold higher risk for the infection and have a twofold higher risk for death, Dr. Wisniewski told meeting delegates.

He and his colleagues conducted a prospective study of patients who had tested positive for SARS-CoV-2 and who experienced neurologic sequelae and SARS-CoV-2 patients who were without neurologic sequelae. All patients were hospitalized from March 10 to May 20, 2020. This was during a period when New York City was overwhelmed by COVID: About 35% of hospitalized patients had COVID.

Of those who experienced neurologic events, the most common “by far and away” (51%) was toxic metabolic encephalopathy (TME), said Dr. Wisniewski. Other associations included seizures, hypoxic/anoxic injury, and ischemic stroke.

The most common TMEs were septic and hypoxic ischemia. In most patients (78%), TME had more than one cause.

Researchers followed 196 patients with COVID and neurologic complications (case patients) and 186 matched control patients who had no neurologic complications over a period of 6 months.

“Unfortunately, both groups had poor outcomes,” said Dr. Wisniewski. About 50% had impaired cognition, and 56% experienced limitations in activities of daily living.

However, those patients with COVID-19 who had neurologic sequelae “fared even worse,” said Dr. Wisniewski. Compared with control patients, they had twofold worse Modified Rankin Scale scores and worse scores on activity of daily living, and they were much less likely to return to work.

Mechanisms by which COVID-19 affects longer-term cognitive dysfunction are unclear, but inflammation likely plays a role.

The research team compared a number of Alzheimer’s disease plasma biomarkers in 158 patients with COVID-19 who had neurologic symptoms and 152 COVID patients with COVID but no neurologic symptoms. They found marked elevations of neurofilament light, a marker of neuronal injury, in those with symptoms (P = .0003) as well as increased glial fibrillary acid protein, a marker of neuroinflammation (P = .0098).

Ubiquitin carboxyl-terminal hydrolase L1, another marker of neuronal injury, was also elevated in those with neurologic symptoms. Regarding Alzheimer’s disease pathology, total tau (t-tau) and phosphorylated tau “also tracked with neurological sequelae,” said Dr. Wisniewski.

There was no difference in levels of amyloid beta 40 (A beta 40) between groups. However, A beta 42 plasma levels were significantly lower in those with neurologic effects, suggesting higher levels in the brain. In addition, the ratio of t-tau to A beta 42 “clearly differentiated the two groups,” he said.

“Serum biomarkers of neuroinflammation and neuronal injury and Alzheimer’s disease correlate strongly, perhaps suggesting that folks with COVID infection and neurological sequelae may have an acceleration of Alzheimer’s disease symptoms and pathology,” he said. “That’s something that needs longer follow-up.”
 

Important differentiation

Commenting on the research, Rebecca Edelmayer, PhD, senior director of scientific engagement, Alzheimer’s Association, said the study provides important information. The inclusion of plasma biomarkers in this research is “really critical to tease out what’s the impact of COVID itself on the brain,” said Dr. Edelmayer.

“We’re in an era of biomarkers when it comes to Alzheimer’s disease and other dementias, and being able to define those changes that are happening in the brain over time is going to be really critical and aid in early detection and accurate diagnoses,” she said.

What is still to be learned is what these biomarkers reveal long term, said Dr. Edelmayer. “Do those biological markers change? Do they go back to normal? A lot of that is still unknown,” she said.

She noted that many diseases that are linked to inflammation produce similar biomarkers in the brain – for example, neurofilament light.

With other viral infections, such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), similar associations between the infection and cognition have been reported, said Dr. Edelmayer.

“But there are still a lot of questions around cause and effect. Is it really a direct effect of the virus on the brain itself? Is it an effect of having an enormous amount of inflammation going on in the body? A lot of that still needs to be teased out,” she commented.

The study was supported by the National Institutes of Health, the Alzheimer’s Association, and the State of New York. Dr. Wisniewski has consulted for Grifols, Amylon Pharmaceuticals, and Alzamed Neuro; 30 NYU patents are related to AD therapeutics.

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

Certain plasma biomarkers of neuronal damage and neuroinflammation are markedly elevated in hospitalized COVID-19 patients with neurologic symptoms compared with hospitalized COVID-19 patients without such symptoms, a new study shows.

These results suggest that COVID-19 may accelerate Alzheimer’s disease symptoms and pathology, said study investigator Thomas Wisniewski, MD, professor of neurology, pathology, and psychiatry at New York University.

The findings were presented here at the Alzheimer’s Association International Conference (AAIC) 2021.
 

Strong correlation

There’s a clear association between SARS-CoV-2 infection and Alzheimer’s disease-related dementia. Patients with Alzheimer’s disease are at threefold higher risk for the infection and have a twofold higher risk for death, Dr. Wisniewski told meeting delegates.

He and his colleagues conducted a prospective study of patients who had tested positive for SARS-CoV-2 and who experienced neurologic sequelae and SARS-CoV-2 patients who were without neurologic sequelae. All patients were hospitalized from March 10 to May 20, 2020. This was during a period when New York City was overwhelmed by COVID: About 35% of hospitalized patients had COVID.

Of those who experienced neurologic events, the most common “by far and away” (51%) was toxic metabolic encephalopathy (TME), said Dr. Wisniewski. Other associations included seizures, hypoxic/anoxic injury, and ischemic stroke.

The most common TMEs were septic and hypoxic ischemia. In most patients (78%), TME had more than one cause.

Researchers followed 196 patients with COVID and neurologic complications (case patients) and 186 matched control patients who had no neurologic complications over a period of 6 months.

“Unfortunately, both groups had poor outcomes,” said Dr. Wisniewski. About 50% had impaired cognition, and 56% experienced limitations in activities of daily living.

However, those patients with COVID-19 who had neurologic sequelae “fared even worse,” said Dr. Wisniewski. Compared with control patients, they had twofold worse Modified Rankin Scale scores and worse scores on activity of daily living, and they were much less likely to return to work.

Mechanisms by which COVID-19 affects longer-term cognitive dysfunction are unclear, but inflammation likely plays a role.

The research team compared a number of Alzheimer’s disease plasma biomarkers in 158 patients with COVID-19 who had neurologic symptoms and 152 COVID patients with COVID but no neurologic symptoms. They found marked elevations of neurofilament light, a marker of neuronal injury, in those with symptoms (P = .0003) as well as increased glial fibrillary acid protein, a marker of neuroinflammation (P = .0098).

Ubiquitin carboxyl-terminal hydrolase L1, another marker of neuronal injury, was also elevated in those with neurologic symptoms. Regarding Alzheimer’s disease pathology, total tau (t-tau) and phosphorylated tau “also tracked with neurological sequelae,” said Dr. Wisniewski.

There was no difference in levels of amyloid beta 40 (A beta 40) between groups. However, A beta 42 plasma levels were significantly lower in those with neurologic effects, suggesting higher levels in the brain. In addition, the ratio of t-tau to A beta 42 “clearly differentiated the two groups,” he said.

“Serum biomarkers of neuroinflammation and neuronal injury and Alzheimer’s disease correlate strongly, perhaps suggesting that folks with COVID infection and neurological sequelae may have an acceleration of Alzheimer’s disease symptoms and pathology,” he said. “That’s something that needs longer follow-up.”
 

Important differentiation

Commenting on the research, Rebecca Edelmayer, PhD, senior director of scientific engagement, Alzheimer’s Association, said the study provides important information. The inclusion of plasma biomarkers in this research is “really critical to tease out what’s the impact of COVID itself on the brain,” said Dr. Edelmayer.

“We’re in an era of biomarkers when it comes to Alzheimer’s disease and other dementias, and being able to define those changes that are happening in the brain over time is going to be really critical and aid in early detection and accurate diagnoses,” she said.

What is still to be learned is what these biomarkers reveal long term, said Dr. Edelmayer. “Do those biological markers change? Do they go back to normal? A lot of that is still unknown,” she said.

She noted that many diseases that are linked to inflammation produce similar biomarkers in the brain – for example, neurofilament light.

With other viral infections, such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), similar associations between the infection and cognition have been reported, said Dr. Edelmayer.

“But there are still a lot of questions around cause and effect. Is it really a direct effect of the virus on the brain itself? Is it an effect of having an enormous amount of inflammation going on in the body? A lot of that still needs to be teased out,” she commented.

The study was supported by the National Institutes of Health, the Alzheimer’s Association, and the State of New York. Dr. Wisniewski has consulted for Grifols, Amylon Pharmaceuticals, and Alzamed Neuro; 30 NYU patents are related to AD therapeutics.

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

Transgender adults are more likely to experience subjective cognitive decline (SCD) than their cisgender peers, and at an earlier age, new research shows.

Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.

‘Alarming’ finding

SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.

The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019). 

The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.

Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).

Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).

The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.

The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.

The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
 

Cause unclear

“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.

“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.

Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”

“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said. 

“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.

“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.

The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.

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

Transgender adults are more likely to experience subjective cognitive decline (SCD) than their cisgender peers, and at an earlier age, new research shows.

Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.

‘Alarming’ finding

SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.

The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019). 

The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.

Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).

Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).

The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.

The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.

The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
 

Cause unclear

“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.

“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.

Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”

“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said. 

“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.

“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.

The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.

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

Transgender adults are more likely to experience subjective cognitive decline (SCD) than their cisgender peers, and at an earlier age, new research shows.

Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.

‘Alarming’ finding

SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.

The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019). 

The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.

Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).

Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).

The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.

The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.

The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
 

Cause unclear

“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.

“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.

Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”

“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said. 

“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.

“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.

The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.

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

A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown. The women pretended to have a variety of dramatic perinatal crises that garnered them significant attention from birth support professionals.

The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.

Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.

“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.

Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.

“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.

He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.

The study was published in the May issue of the Annals of Clinical Psychiatry.
 

A warning for others

In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.

“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.

In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.

Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.

For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.

In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
 

Elaborate scenarios

The first two cases were ultimately determined to involve one person who had created elaborate scenarios.

In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.

The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.

Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.

Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.

Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.

After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
 

Child deaths

After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.

In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.

Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.

In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.

Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.

Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.

She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
 

Multiple COVID crises?

In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.

Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.

Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.

In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.

However, at least three other doulas said they had supported the same “family.”
 

Online training program

In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.

Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.

DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.

Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”

However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”

In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:

• Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in  submitting detailed posts.
• Near-fatal exacerbations of illness alternating with miraculous recoveries.
• Personal claims that are fantastic, are contradicted by later posts, or are disproved.
• Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
• Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.

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

A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown. The women pretended to have a variety of dramatic perinatal crises that garnered them significant attention from birth support professionals.

The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.

Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.

“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.

Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.

“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.

He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.

The study was published in the May issue of the Annals of Clinical Psychiatry.
 

A warning for others

In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.

“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.

In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.

Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.

For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.

In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
 

Elaborate scenarios

The first two cases were ultimately determined to involve one person who had created elaborate scenarios.

In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.

The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.

Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.

Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.

Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.

After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
 

Child deaths

After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.

In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.

Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.

In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.

Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.

Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.

She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
 

Multiple COVID crises?

In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.

Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.

Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.

In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.

However, at least three other doulas said they had supported the same “family.”
 

Online training program

In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.

Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.

DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.

Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”

However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”

In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:

• Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in  submitting detailed posts.
• Near-fatal exacerbations of illness alternating with miraculous recoveries.
• Personal claims that are fantastic, are contradicted by later posts, or are disproved.
• Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
• Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.

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

A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown. The women pretended to have a variety of dramatic perinatal crises that garnered them significant attention from birth support professionals.

The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.

Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.

“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.

Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.

“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.

He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.

The study was published in the May issue of the Annals of Clinical Psychiatry.
 

A warning for others

In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.

“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.

In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.

Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.

For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.

In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
 

Elaborate scenarios

The first two cases were ultimately determined to involve one person who had created elaborate scenarios.

In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.

The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.

Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.

Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.

Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.

After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
 

Child deaths

After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.

In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.

Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.

In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.

Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.

Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.

She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
 

Multiple COVID crises?

In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.

Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.

Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.

In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.

However, at least three other doulas said they had supported the same “family.”
 

Online training program

In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.

Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.

DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.

Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”

However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”

In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:

• Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in  submitting detailed posts.
• Near-fatal exacerbations of illness alternating with miraculous recoveries.
• Personal claims that are fantastic, are contradicted by later posts, or are disproved.
• Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
• Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.

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

In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.

“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.

Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.

“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
 

The digital dolphin treating stroke

Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.

“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”

In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.

Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
 

Reaching young patients through virtual play

Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.

“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.

Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
 

A first for therapeutic video games

In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.

Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.

EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.

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

In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.

“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.

Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.

“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
 

The digital dolphin treating stroke

Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.

“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”

In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.

Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
 

Reaching young patients through virtual play

Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.

“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.

Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
 

A first for therapeutic video games

In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.

Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.

EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.

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

In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.

“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.

Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.

“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
 

The digital dolphin treating stroke

Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.

“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”

In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.

Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
 

Reaching young patients through virtual play

Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.

“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.

Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
 

A first for therapeutic video games

In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.

Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.

EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.

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