Clinician Reviews

A newly published scientific statement from the American Heart Association focuses on the impact of aggressive low-density lipoprotein cholesterol (LDL-C) lowering on the risk for dementia and hemorrhagic stroke.

“The brain is the body’s most cholesterol-rich organ, and some have questioned whether aggressive LDL-C lowering induces abnormal structural and functional changes,” the writing group, led by Larry Goldstein, MD, chair, department of neurology, University of Kentucky, Lexington, points out.

The 39-page AHA scientific statement, titled “Aggressive LDL-C Lowering and the Brain: Impact on Risk for Dementia and Hemorrhagic Stroke,” was published online in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.

The objective was to evaluate contemporary evidence that either supports or refutes the conclusion that aggressive LDL-C lowering or lipid lowering exerts toxic effects on the brain, leading to cognitive impairment or dementia or hemorrhagic stroke.

The eight-member writing group used literature reviews, references to published clinical and epidemiology studies, clinical and public health guidelines, authoritative statements, and expert opinion to summarize the latest evidence and identify gaps in current knowledge.

They reached four main conclusions:

• First, the available data “consistently” show that LDL-C lowering reduces the risk of atherosclerotic cardiovascular disease-related events in high-risk groups.
• Second, although some older retrospective, case-control, and prospective longitudinal studies suggest that statins and LDL-C lowering are associated with cognitive impairment or dementia, the “preponderance” of observational studies and data from randomized trials do not support this conclusion, at least among trials with median follow-up of up to 6 years. The group says additional studies are needed to ensure cognitive safety over longer periods of time. For now, contemporary guidelines recommending the risk-stratified attainment of lipid-lowering goals are “reasonable,” they conclude.
• Third, the risk for hemorrhagic stroke associated with statin therapy in patients without a history of cerebrovascular disease is “small and consistently nonsignificant.” They found no evidence that PCSK9 inhibitors or ezetimibe (Zetia) increases bleeding risk. Further, there is “no indication” that patients or populations with lifelong low LDL-C have enhanced vulnerability to hemorrhagic stroke, and there is “little evidence” that achieving very low levels of LDL-C increases that risk. What is clear, the writing group says, is that lower LDL-C levels correlate with lower risk of overall stroke and stroke recurrence, mostly related to a reduction in ischemic stroke. “Concern about hemorrhagic stroke risk should not deter a clinician from treating LDL-C to guideline-recommended risk-stratified targets,” the writing group says.
• Fourth, the group notes that data reflecting the risk of hemorrhagic stroke with statin therapy among patients with a history of hemorrhagic stroke are not robust. PCSK9 inhibitors have not been adequately tested in patients with prior intracerebral hemorrhage. Lipid lowering in these populations requires more focused study.

The research had no commercial funding. A list of disclosures for the writing group is available with the original article.

A version of this article appeared on Medscape.com.

A newly published scientific statement from the American Heart Association focuses on the impact of aggressive low-density lipoprotein cholesterol (LDL-C) lowering on the risk for dementia and hemorrhagic stroke.

“The brain is the body’s most cholesterol-rich organ, and some have questioned whether aggressive LDL-C lowering induces abnormal structural and functional changes,” the writing group, led by Larry Goldstein, MD, chair, department of neurology, University of Kentucky, Lexington, points out.

The 39-page AHA scientific statement, titled “Aggressive LDL-C Lowering and the Brain: Impact on Risk for Dementia and Hemorrhagic Stroke,” was published online in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.

The objective was to evaluate contemporary evidence that either supports or refutes the conclusion that aggressive LDL-C lowering or lipid lowering exerts toxic effects on the brain, leading to cognitive impairment or dementia or hemorrhagic stroke.

The eight-member writing group used literature reviews, references to published clinical and epidemiology studies, clinical and public health guidelines, authoritative statements, and expert opinion to summarize the latest evidence and identify gaps in current knowledge.

They reached four main conclusions:

• First, the available data “consistently” show that LDL-C lowering reduces the risk of atherosclerotic cardiovascular disease-related events in high-risk groups.
• Second, although some older retrospective, case-control, and prospective longitudinal studies suggest that statins and LDL-C lowering are associated with cognitive impairment or dementia, the “preponderance” of observational studies and data from randomized trials do not support this conclusion, at least among trials with median follow-up of up to 6 years. The group says additional studies are needed to ensure cognitive safety over longer periods of time. For now, contemporary guidelines recommending the risk-stratified attainment of lipid-lowering goals are “reasonable,” they conclude.
• Third, the risk for hemorrhagic stroke associated with statin therapy in patients without a history of cerebrovascular disease is “small and consistently nonsignificant.” They found no evidence that PCSK9 inhibitors or ezetimibe (Zetia) increases bleeding risk. Further, there is “no indication” that patients or populations with lifelong low LDL-C have enhanced vulnerability to hemorrhagic stroke, and there is “little evidence” that achieving very low levels of LDL-C increases that risk. What is clear, the writing group says, is that lower LDL-C levels correlate with lower risk of overall stroke and stroke recurrence, mostly related to a reduction in ischemic stroke. “Concern about hemorrhagic stroke risk should not deter a clinician from treating LDL-C to guideline-recommended risk-stratified targets,” the writing group says.
• Fourth, the group notes that data reflecting the risk of hemorrhagic stroke with statin therapy among patients with a history of hemorrhagic stroke are not robust. PCSK9 inhibitors have not been adequately tested in patients with prior intracerebral hemorrhage. Lipid lowering in these populations requires more focused study.

The research had no commercial funding. A list of disclosures for the writing group is available with the original article.

A version of this article appeared on Medscape.com.

A newly published scientific statement from the American Heart Association focuses on the impact of aggressive low-density lipoprotein cholesterol (LDL-C) lowering on the risk for dementia and hemorrhagic stroke.

“The brain is the body’s most cholesterol-rich organ, and some have questioned whether aggressive LDL-C lowering induces abnormal structural and functional changes,” the writing group, led by Larry Goldstein, MD, chair, department of neurology, University of Kentucky, Lexington, points out.

The 39-page AHA scientific statement, titled “Aggressive LDL-C Lowering and the Brain: Impact on Risk for Dementia and Hemorrhagic Stroke,” was published online in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.

The objective was to evaluate contemporary evidence that either supports or refutes the conclusion that aggressive LDL-C lowering or lipid lowering exerts toxic effects on the brain, leading to cognitive impairment or dementia or hemorrhagic stroke.

The eight-member writing group used literature reviews, references to published clinical and epidemiology studies, clinical and public health guidelines, authoritative statements, and expert opinion to summarize the latest evidence and identify gaps in current knowledge.

They reached four main conclusions:

• First, the available data “consistently” show that LDL-C lowering reduces the risk of atherosclerotic cardiovascular disease-related events in high-risk groups.
• Second, although some older retrospective, case-control, and prospective longitudinal studies suggest that statins and LDL-C lowering are associated with cognitive impairment or dementia, the “preponderance” of observational studies and data from randomized trials do not support this conclusion, at least among trials with median follow-up of up to 6 years. The group says additional studies are needed to ensure cognitive safety over longer periods of time. For now, contemporary guidelines recommending the risk-stratified attainment of lipid-lowering goals are “reasonable,” they conclude.
• Third, the risk for hemorrhagic stroke associated with statin therapy in patients without a history of cerebrovascular disease is “small and consistently nonsignificant.” They found no evidence that PCSK9 inhibitors or ezetimibe (Zetia) increases bleeding risk. Further, there is “no indication” that patients or populations with lifelong low LDL-C have enhanced vulnerability to hemorrhagic stroke, and there is “little evidence” that achieving very low levels of LDL-C increases that risk. What is clear, the writing group says, is that lower LDL-C levels correlate with lower risk of overall stroke and stroke recurrence, mostly related to a reduction in ischemic stroke. “Concern about hemorrhagic stroke risk should not deter a clinician from treating LDL-C to guideline-recommended risk-stratified targets,” the writing group says.
• Fourth, the group notes that data reflecting the risk of hemorrhagic stroke with statin therapy among patients with a history of hemorrhagic stroke are not robust. PCSK9 inhibitors have not been adequately tested in patients with prior intracerebral hemorrhage. Lipid lowering in these populations requires more focused study.

The research had no commercial funding. A list of disclosures for the writing group is available with the original article.

A version of this article appeared on Medscape.com.

The American Academy of Pediatrics recommends against low-carbohydrate diets for most children and adolescents with or at risk for diabetes, according to a new clinical report.

Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.

“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”

Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.

Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.

“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”

They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”

“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”

Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.

“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.

For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
 

Lack of evidence is the problem

David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”

courtesy Boston Children's Hospital

“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”

He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.

For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.

“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”

This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.

This article was updated 9/20/23.

The American Academy of Pediatrics recommends against low-carbohydrate diets for most children and adolescents with or at risk for diabetes, according to a new clinical report.

Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.

“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”

Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.

Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.

“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”

They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”

“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”

Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.

“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.

For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
 

Lack of evidence is the problem

David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”

courtesy Boston Children's Hospital

“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”

He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.

For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.

“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”

This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.

This article was updated 9/20/23.

The American Academy of Pediatrics recommends against low-carbohydrate diets for most children and adolescents with or at risk for diabetes, according to a new clinical report.

Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.

“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”

Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.

Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.

“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”

They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”

“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”

Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.

“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.

For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
 

Lack of evidence is the problem

David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”

courtesy Boston Children's Hospital

“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”

He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.

For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.

“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”

This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.

This article was updated 9/20/23.

The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.

Version 1 appeared in late 2022.

While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
 

Practice points

• Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.

New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.

“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”

• Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.

There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.

“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.

The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).


 

Review details

Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.

It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.

Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).

Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).

“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.

In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.

The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.

Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.

Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”

Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.

The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.

Version 1 appeared in late 2022.

While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
 

Practice points

• Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.

New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.

“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”

• Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.

There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.

“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.

The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).


 

Review details

Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.

It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.

Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).

Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).

“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.

In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.

The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.

Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.

Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”

Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.

The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.

Version 1 appeared in late 2022.

While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
 

Practice points

• Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.

New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.

“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”

• Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.

There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.

“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.

The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).


 

Review details

Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.

It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.

Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).

Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).

“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.

In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.

The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.

Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.

Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”

Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.

Many labels on fish oil supplements make unsubstantiated health claims, and products contain variable daily doses of EPA plus DHA, a cross-sectional study suggests.

Overall, about 74% of more than 2,800 supplements that were examined had labels that made at least one health claim, and only 19% included a U.S. Food and Drug Administration–reviewed qualified health claim (QHC).

©Clayton Hansen/iStockphoto

‘Vague statements’

To evaluate health claims made on fish oil supplement labels in the United States and to examine doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations, the investigators analyzed labels on supplements obtained from the National Institutes of Health Dietary Supplement Label Database.

The main outcomes were the frequency and types of health claims made on the labels, including use of an FDA-reviewed QHC versus a structure/function claim and the organ system referenced, as well as the total daily doses in combined EPA and DHA supplements from leading manufacturers and retailers.

QHCs are statements regarding a supplement’s or food’s potential to treatment or prevent disease. Such claims undergo evidence review by the FDA and include qualifying language that reflects lack of scientific consensus or uncertainty.

An example: “Consuming EPA and DHA combined may reduce the risk of CHD [coronary heart disease] by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”

By contrast, structure/function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” but do not state that the supplement prevents, treats, or cures any disease. Such a claim “does not require any mitigating language regarding potential scientific uncertainty of the statement.”

Structure/function claims commonly state that the supplement “maintains,” “supports,” or “promotes” the function of certain organs. Examples are “promotes heart health” and “supports heart, mind and mood.”

Among 2,819 fish oil supplements, 2,082 (73.9%) made at least one health claim. Of these, only 399 (19.2%) used a QHC; the rest made only structure/function claims. In addition to heart-health claims, many fish oil supplements also have labels that make claims implying benefit to other organ systems, such as brain/mental health, joint health, and eye health – despite a lack of data from randomized clinical trials that support benefit.

The dose analysis of 255 fish oil supplements across 16 major brands found “substantial variability” in the daily dose of EPA (median interquartile range, 340 [135-647] mg/d), DHA (median IQR, 270 [140-500] mg/d), and total EPA+DHA (median IQR, 600 [300-1,100] mg/d).

Twenty-four (9.4%) of the supplements contained a daily dose of 2 g or more EPA+DHA.

“Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements,” the authors conclude. “Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.”

Dr. Navar added, “We now need to understand what consumers are taking away from vague statements like ‘promotes brain health’ or ‘supports joint function’ – and test what language we can use to accurately describe the state of the science around fish oil and heart health.”
 

Enthusiasm vs. evidence

“I agree with these concerns and think that the enthusiasm for these supplements outpaces the evidence from rigorous randomized clinical trials,” JoAnn E. Manson, MD, MPH, DrPH, chief of the Division of Preventive Medicine at Brigham and Women’s Hospital, Boston, said in an interview. “Results of the observational studies have tended to be much more favorable than the randomized clinical trials.

“The labels can be very misleading to the general public,” she noted. “People are confronted with a dizzying array of dietary supplements, many of which include structure/function claims that require minimal, if any, evidence of efficacy. Clinicians should emphasize with patients that a dietary supplement will never be a substitute for a heart-healthy diet and that many supplements are not helpful for people who already follow a healthy diet,” she said.

The VITAL trial, for which Dr. Manson was principal investigator, showed that supplementation with n-3 fatty acids did not lead to a lower incidence of major cardiovascular events or cancer, compared with placebo.

A subgroup analysis showed that 1 g/d conferred a 20% reduction in major events only for participants who ate less than 1.5 servings of fish per week, Dr. Manson said.

Regarding supplement labels, clinicians should recommend that patients look for a U.S. Pharmacopoeia seal or a seal from the National Science Foundation or ConsumerLab, she advised. These seals ensure that the product has been audited for purity and consistency of content and that the dose in the capsule is consistent with what is on the label.

Dr. Manson also would like to see labels explain that most of the products have not been reviewed by the FDA. “Many members of the general public are misled by these labels into thinking that they’re going to receive health benefits. They’re spending a lot of money on supplements that likely provide no benefit and may even be associated with increased risks.”

No funding for the study was reported. Dr. Navar has received grants from BMS, Esperion, Amgen, and Janssen and personal fees from AstraZeneca, Boehringer Ingelheim, Bayer, BMS, Esperion, Janssen, Eli Lilly, Merck, Silence Therapeutics, Novo Nordisk, Novartis, New Amsterdam, and Pfizer outside the submitted work and serves as deputy editor for equity, diversity, and inclusion at JAMA Cardiology.

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

Many labels on fish oil supplements make unsubstantiated health claims, and products contain variable daily doses of EPA plus DHA, a cross-sectional study suggests.

Overall, about 74% of more than 2,800 supplements that were examined had labels that made at least one health claim, and only 19% included a U.S. Food and Drug Administration–reviewed qualified health claim (QHC).

©Clayton Hansen/iStockphoto

‘Vague statements’

To evaluate health claims made on fish oil supplement labels in the United States and to examine doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations, the investigators analyzed labels on supplements obtained from the National Institutes of Health Dietary Supplement Label Database.

The main outcomes were the frequency and types of health claims made on the labels, including use of an FDA-reviewed QHC versus a structure/function claim and the organ system referenced, as well as the total daily doses in combined EPA and DHA supplements from leading manufacturers and retailers.

QHCs are statements regarding a supplement’s or food’s potential to treatment or prevent disease. Such claims undergo evidence review by the FDA and include qualifying language that reflects lack of scientific consensus or uncertainty.

An example: “Consuming EPA and DHA combined may reduce the risk of CHD [coronary heart disease] by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”

By contrast, structure/function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” but do not state that the supplement prevents, treats, or cures any disease. Such a claim “does not require any mitigating language regarding potential scientific uncertainty of the statement.”

Structure/function claims commonly state that the supplement “maintains,” “supports,” or “promotes” the function of certain organs. Examples are “promotes heart health” and “supports heart, mind and mood.”

Among 2,819 fish oil supplements, 2,082 (73.9%) made at least one health claim. Of these, only 399 (19.2%) used a QHC; the rest made only structure/function claims. In addition to heart-health claims, many fish oil supplements also have labels that make claims implying benefit to other organ systems, such as brain/mental health, joint health, and eye health – despite a lack of data from randomized clinical trials that support benefit.

The dose analysis of 255 fish oil supplements across 16 major brands found “substantial variability” in the daily dose of EPA (median interquartile range, 340 [135-647] mg/d), DHA (median IQR, 270 [140-500] mg/d), and total EPA+DHA (median IQR, 600 [300-1,100] mg/d).

Twenty-four (9.4%) of the supplements contained a daily dose of 2 g or more EPA+DHA.

“Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements,” the authors conclude. “Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.”

Dr. Navar added, “We now need to understand what consumers are taking away from vague statements like ‘promotes brain health’ or ‘supports joint function’ – and test what language we can use to accurately describe the state of the science around fish oil and heart health.”
 

Enthusiasm vs. evidence

“I agree with these concerns and think that the enthusiasm for these supplements outpaces the evidence from rigorous randomized clinical trials,” JoAnn E. Manson, MD, MPH, DrPH, chief of the Division of Preventive Medicine at Brigham and Women’s Hospital, Boston, said in an interview. “Results of the observational studies have tended to be much more favorable than the randomized clinical trials.

“The labels can be very misleading to the general public,” she noted. “People are confronted with a dizzying array of dietary supplements, many of which include structure/function claims that require minimal, if any, evidence of efficacy. Clinicians should emphasize with patients that a dietary supplement will never be a substitute for a heart-healthy diet and that many supplements are not helpful for people who already follow a healthy diet,” she said.

The VITAL trial, for which Dr. Manson was principal investigator, showed that supplementation with n-3 fatty acids did not lead to a lower incidence of major cardiovascular events or cancer, compared with placebo.

A subgroup analysis showed that 1 g/d conferred a 20% reduction in major events only for participants who ate less than 1.5 servings of fish per week, Dr. Manson said.

Regarding supplement labels, clinicians should recommend that patients look for a U.S. Pharmacopoeia seal or a seal from the National Science Foundation or ConsumerLab, she advised. These seals ensure that the product has been audited for purity and consistency of content and that the dose in the capsule is consistent with what is on the label.

Dr. Manson also would like to see labels explain that most of the products have not been reviewed by the FDA. “Many members of the general public are misled by these labels into thinking that they’re going to receive health benefits. They’re spending a lot of money on supplements that likely provide no benefit and may even be associated with increased risks.”

No funding for the study was reported. Dr. Navar has received grants from BMS, Esperion, Amgen, and Janssen and personal fees from AstraZeneca, Boehringer Ingelheim, Bayer, BMS, Esperion, Janssen, Eli Lilly, Merck, Silence Therapeutics, Novo Nordisk, Novartis, New Amsterdam, and Pfizer outside the submitted work and serves as deputy editor for equity, diversity, and inclusion at JAMA Cardiology.

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

Many labels on fish oil supplements make unsubstantiated health claims, and products contain variable daily doses of EPA plus DHA, a cross-sectional study suggests.

Overall, about 74% of more than 2,800 supplements that were examined had labels that made at least one health claim, and only 19% included a U.S. Food and Drug Administration–reviewed qualified health claim (QHC).

©Clayton Hansen/iStockphoto

‘Vague statements’

To evaluate health claims made on fish oil supplement labels in the United States and to examine doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations, the investigators analyzed labels on supplements obtained from the National Institutes of Health Dietary Supplement Label Database.

The main outcomes were the frequency and types of health claims made on the labels, including use of an FDA-reviewed QHC versus a structure/function claim and the organ system referenced, as well as the total daily doses in combined EPA and DHA supplements from leading manufacturers and retailers.

QHCs are statements regarding a supplement’s or food’s potential to treatment or prevent disease. Such claims undergo evidence review by the FDA and include qualifying language that reflects lack of scientific consensus or uncertainty.

An example: “Consuming EPA and DHA combined may reduce the risk of CHD [coronary heart disease] by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”

By contrast, structure/function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” but do not state that the supplement prevents, treats, or cures any disease. Such a claim “does not require any mitigating language regarding potential scientific uncertainty of the statement.”

Structure/function claims commonly state that the supplement “maintains,” “supports,” or “promotes” the function of certain organs. Examples are “promotes heart health” and “supports heart, mind and mood.”

Among 2,819 fish oil supplements, 2,082 (73.9%) made at least one health claim. Of these, only 399 (19.2%) used a QHC; the rest made only structure/function claims. In addition to heart-health claims, many fish oil supplements also have labels that make claims implying benefit to other organ systems, such as brain/mental health, joint health, and eye health – despite a lack of data from randomized clinical trials that support benefit.

The dose analysis of 255 fish oil supplements across 16 major brands found “substantial variability” in the daily dose of EPA (median interquartile range, 340 [135-647] mg/d), DHA (median IQR, 270 [140-500] mg/d), and total EPA+DHA (median IQR, 600 [300-1,100] mg/d).

Twenty-four (9.4%) of the supplements contained a daily dose of 2 g or more EPA+DHA.

“Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements,” the authors conclude. “Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.”

Dr. Navar added, “We now need to understand what consumers are taking away from vague statements like ‘promotes brain health’ or ‘supports joint function’ – and test what language we can use to accurately describe the state of the science around fish oil and heart health.”
 

Enthusiasm vs. evidence

“I agree with these concerns and think that the enthusiasm for these supplements outpaces the evidence from rigorous randomized clinical trials,” JoAnn E. Manson, MD, MPH, DrPH, chief of the Division of Preventive Medicine at Brigham and Women’s Hospital, Boston, said in an interview. “Results of the observational studies have tended to be much more favorable than the randomized clinical trials.

“The labels can be very misleading to the general public,” she noted. “People are confronted with a dizzying array of dietary supplements, many of which include structure/function claims that require minimal, if any, evidence of efficacy. Clinicians should emphasize with patients that a dietary supplement will never be a substitute for a heart-healthy diet and that many supplements are not helpful for people who already follow a healthy diet,” she said.

The VITAL trial, for which Dr. Manson was principal investigator, showed that supplementation with n-3 fatty acids did not lead to a lower incidence of major cardiovascular events or cancer, compared with placebo.

A subgroup analysis showed that 1 g/d conferred a 20% reduction in major events only for participants who ate less than 1.5 servings of fish per week, Dr. Manson said.

Regarding supplement labels, clinicians should recommend that patients look for a U.S. Pharmacopoeia seal or a seal from the National Science Foundation or ConsumerLab, she advised. These seals ensure that the product has been audited for purity and consistency of content and that the dose in the capsule is consistent with what is on the label.

Dr. Manson also would like to see labels explain that most of the products have not been reviewed by the FDA. “Many members of the general public are misled by these labels into thinking that they’re going to receive health benefits. They’re spending a lot of money on supplements that likely provide no benefit and may even be associated with increased risks.”

No funding for the study was reported. Dr. Navar has received grants from BMS, Esperion, Amgen, and Janssen and personal fees from AstraZeneca, Boehringer Ingelheim, Bayer, BMS, Esperion, Janssen, Eli Lilly, Merck, Silence Therapeutics, Novo Nordisk, Novartis, New Amsterdam, and Pfizer outside the submitted work and serves as deputy editor for equity, diversity, and inclusion at JAMA Cardiology.

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

Taking a patient’s blood pressure while the patient is lying down may yield more information about their cardiovascular risk than taking the reading while the patient is sitting upright, new preliminary research suggests.

An analysis of data from a long-running Atherosclerosis Risk in Communities (ARIC) study of more than 11,000 adults showed that those who had hypertension while supine were at elevated risk for cardiovascular disease (CVD) independently of their having hypertension while seated.

“If blood pressure is only measured while people are seated upright, cardiovascular disease risk may be missed if not measured also while they are lying supine on their backs,” lead investigator Duc M. Giao, a researcher and a fourth-year medical student at Harvard Medical School, Boston, said in a news release.

Mr. Giao presented the findings at the Hypertension Scientific Sessions.
 

Take seated and supine BP in clinic?

Hypertension while asleep is strongly associated with CVD and death, but whether hypertension detected in clinic while the patient is lying flat is a risk factor for CVD independently of the patient’s BP while seated remains unclear.

To investigate, Mr. Giao and colleagues reviewed health data for 11,369 adults (mean age, 54 years; 56% women; 25% Black persons) from the longitudinal ARIC study. None had a history of coronary heart disease (CHD), heart failure (HF), or stroke at baseline.

As part of the study, data on supine and seated BP were obtained during the enrollment period at ARIC visit 1, which took place between 1987 and 1989. Both seated and supine hypertension were defined as systolic BP ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg.

The data revealed that 16% of those without seated hypertension had supine hypertension, while 74% of those with seated hypertension had supine hypertension.

Despite adjusting for seated hypertension, during a median follow-up of 25-28 years, supine hypertension was associated with an increased risk for incident CHD (adjusted hazard ratio, 1.60; 95% confidence interval, 1.45-1.76), HF (aHR, 1.83; 95% CI, 1.68-2.01), stroke (aHR, 1.86; 95% CI, 1.63-2.13), fatal CHD (aHR, 2.18; 95% CI, 1.84-2.59), and all-cause mortality (aHR, 1.43; 95% CI, 1.35-1.52).

The results did not differ by antihypertensive medication use (P > .05).

For patients who had hypertension while supine but not while seated, elevations in risk were similar to those of peers who had hypertension while both seated and supine.

“Our findings suggest people with known risk factors for heart disease and stroke may benefit from having their blood pressure checked while lying flat on their backs,” Mr. Giao said in the conference news release.

“Efforts to manage blood pressure during daily life may help lower blood pressure while sleeping. Future research should compare supine blood pressure measurements in the clinic with overnight measurements,” Mr. Giao added.
 

Busy clinical practice

In a comment, Wanpen Vongpatanasin, MD, clinical chair for the conference, sponsored by the American Heart Association, said, “This finding highlights the importance of sustained control of BP in all body positions.”

She noted that many population-based studies have shown that nighttime BP independently predicts CV outcomes. “It’s unclear whether the timing of BP measurement (night vs. day) or the position (as most people sleep in supine position at night) explains this phenomenon.”

The study by Mr. Giao and colleagues suggests that “supine BP may be one explanation, as it has as much impact on long-term CV outcome as seated BP,” said Dr. Vongpatanasin, professor of internal medicine and director of the hypertension section, cardiology division, UT Southwestern Medical Center in Dallas.

However, “in busy clinical practice, it is impossible to do both seated and supine, as well as standing BP,” said Dr. Vongpatanasin.

“Additional studies are needed to determine what is considered to be the cutoff for normal supine BP and how to incorporate it in management of hypertension,” she added.

The study had no commercial funding. Mr. Giao and Dr. Vongpatanasin have disclosed no relevant financial relationships.

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

Taking a patient’s blood pressure while the patient is lying down may yield more information about their cardiovascular risk than taking the reading while the patient is sitting upright, new preliminary research suggests.

An analysis of data from a long-running Atherosclerosis Risk in Communities (ARIC) study of more than 11,000 adults showed that those who had hypertension while supine were at elevated risk for cardiovascular disease (CVD) independently of their having hypertension while seated.

“If blood pressure is only measured while people are seated upright, cardiovascular disease risk may be missed if not measured also while they are lying supine on their backs,” lead investigator Duc M. Giao, a researcher and a fourth-year medical student at Harvard Medical School, Boston, said in a news release.

Mr. Giao presented the findings at the Hypertension Scientific Sessions.
 

Take seated and supine BP in clinic?

Hypertension while asleep is strongly associated with CVD and death, but whether hypertension detected in clinic while the patient is lying flat is a risk factor for CVD independently of the patient’s BP while seated remains unclear.

To investigate, Mr. Giao and colleagues reviewed health data for 11,369 adults (mean age, 54 years; 56% women; 25% Black persons) from the longitudinal ARIC study. None had a history of coronary heart disease (CHD), heart failure (HF), or stroke at baseline.

As part of the study, data on supine and seated BP were obtained during the enrollment period at ARIC visit 1, which took place between 1987 and 1989. Both seated and supine hypertension were defined as systolic BP ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg.

The data revealed that 16% of those without seated hypertension had supine hypertension, while 74% of those with seated hypertension had supine hypertension.

Despite adjusting for seated hypertension, during a median follow-up of 25-28 years, supine hypertension was associated with an increased risk for incident CHD (adjusted hazard ratio, 1.60; 95% confidence interval, 1.45-1.76), HF (aHR, 1.83; 95% CI, 1.68-2.01), stroke (aHR, 1.86; 95% CI, 1.63-2.13), fatal CHD (aHR, 2.18; 95% CI, 1.84-2.59), and all-cause mortality (aHR, 1.43; 95% CI, 1.35-1.52).

The results did not differ by antihypertensive medication use (P > .05).

For patients who had hypertension while supine but not while seated, elevations in risk were similar to those of peers who had hypertension while both seated and supine.

“Our findings suggest people with known risk factors for heart disease and stroke may benefit from having their blood pressure checked while lying flat on their backs,” Mr. Giao said in the conference news release.

“Efforts to manage blood pressure during daily life may help lower blood pressure while sleeping. Future research should compare supine blood pressure measurements in the clinic with overnight measurements,” Mr. Giao added.
 

Busy clinical practice

In a comment, Wanpen Vongpatanasin, MD, clinical chair for the conference, sponsored by the American Heart Association, said, “This finding highlights the importance of sustained control of BP in all body positions.”

She noted that many population-based studies have shown that nighttime BP independently predicts CV outcomes. “It’s unclear whether the timing of BP measurement (night vs. day) or the position (as most people sleep in supine position at night) explains this phenomenon.”

The study by Mr. Giao and colleagues suggests that “supine BP may be one explanation, as it has as much impact on long-term CV outcome as seated BP,” said Dr. Vongpatanasin, professor of internal medicine and director of the hypertension section, cardiology division, UT Southwestern Medical Center in Dallas.

However, “in busy clinical practice, it is impossible to do both seated and supine, as well as standing BP,” said Dr. Vongpatanasin.

“Additional studies are needed to determine what is considered to be the cutoff for normal supine BP and how to incorporate it in management of hypertension,” she added.

The study had no commercial funding. Mr. Giao and Dr. Vongpatanasin have disclosed no relevant financial relationships.

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

Taking a patient’s blood pressure while the patient is lying down may yield more information about their cardiovascular risk than taking the reading while the patient is sitting upright, new preliminary research suggests.

An analysis of data from a long-running Atherosclerosis Risk in Communities (ARIC) study of more than 11,000 adults showed that those who had hypertension while supine were at elevated risk for cardiovascular disease (CVD) independently of their having hypertension while seated.

“If blood pressure is only measured while people are seated upright, cardiovascular disease risk may be missed if not measured also while they are lying supine on their backs,” lead investigator Duc M. Giao, a researcher and a fourth-year medical student at Harvard Medical School, Boston, said in a news release.

Mr. Giao presented the findings at the Hypertension Scientific Sessions.
 

Take seated and supine BP in clinic?

Hypertension while asleep is strongly associated with CVD and death, but whether hypertension detected in clinic while the patient is lying flat is a risk factor for CVD independently of the patient’s BP while seated remains unclear.

To investigate, Mr. Giao and colleagues reviewed health data for 11,369 adults (mean age, 54 years; 56% women; 25% Black persons) from the longitudinal ARIC study. None had a history of coronary heart disease (CHD), heart failure (HF), or stroke at baseline.

As part of the study, data on supine and seated BP were obtained during the enrollment period at ARIC visit 1, which took place between 1987 and 1989. Both seated and supine hypertension were defined as systolic BP ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg.

The data revealed that 16% of those without seated hypertension had supine hypertension, while 74% of those with seated hypertension had supine hypertension.

Despite adjusting for seated hypertension, during a median follow-up of 25-28 years, supine hypertension was associated with an increased risk for incident CHD (adjusted hazard ratio, 1.60; 95% confidence interval, 1.45-1.76), HF (aHR, 1.83; 95% CI, 1.68-2.01), stroke (aHR, 1.86; 95% CI, 1.63-2.13), fatal CHD (aHR, 2.18; 95% CI, 1.84-2.59), and all-cause mortality (aHR, 1.43; 95% CI, 1.35-1.52).

The results did not differ by antihypertensive medication use (P > .05).

For patients who had hypertension while supine but not while seated, elevations in risk were similar to those of peers who had hypertension while both seated and supine.

“Our findings suggest people with known risk factors for heart disease and stroke may benefit from having their blood pressure checked while lying flat on their backs,” Mr. Giao said in the conference news release.

“Efforts to manage blood pressure during daily life may help lower blood pressure while sleeping. Future research should compare supine blood pressure measurements in the clinic with overnight measurements,” Mr. Giao added.
 

Busy clinical practice

In a comment, Wanpen Vongpatanasin, MD, clinical chair for the conference, sponsored by the American Heart Association, said, “This finding highlights the importance of sustained control of BP in all body positions.”

She noted that many population-based studies have shown that nighttime BP independently predicts CV outcomes. “It’s unclear whether the timing of BP measurement (night vs. day) or the position (as most people sleep in supine position at night) explains this phenomenon.”

The study by Mr. Giao and colleagues suggests that “supine BP may be one explanation, as it has as much impact on long-term CV outcome as seated BP,” said Dr. Vongpatanasin, professor of internal medicine and director of the hypertension section, cardiology division, UT Southwestern Medical Center in Dallas.

However, “in busy clinical practice, it is impossible to do both seated and supine, as well as standing BP,” said Dr. Vongpatanasin.

“Additional studies are needed to determine what is considered to be the cutoff for normal supine BP and how to incorporate it in management of hypertension,” she added.

The study had no commercial funding. Mr. Giao and Dr. Vongpatanasin have disclosed no relevant financial relationships.

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

My young patient with type 1 diabetes (T1D) had her cell phone out to provide a share code for her Dexcom clarity app as she was checking into her visit. As my nurse was recording the code, the patient asked him, “Hey, can you add me on Snapchat?”

Her father scrolled through his own Facebook feed in the chair next to her, showing no concern that his daughter was looking to connect with an adult on a social media platform. Meanwhile, we were all grateful that the little girl, who had had a seizure due to hypoglycemia in her preschool and pre–continuous glucose monitoring (CGM) years, had access to the tools harnessed within the sparkly encased phone she held in her small hands. But did anyone in the room fully understand the potential dangers?

We are living in an exhilarating era of diabetes technology, a treatment environment that I couldn’t have dreamed of during my pediatric endocrinology fellowship. T1D is a volatile condition that changes day to day, especially in growing children. A short decade ago, the best CGM available was a bulky device on loan to patients for 3 days at a time. Information was later downloaded in-office to get a better idea of general glucose trends, if insurance would approve its use at all.

Now, we have a variety of very wearable and accurate disposable CGMs accessible to most patients. Every major insulin pump has available closed-loop capabilities. Some patients can dose from apps on their cell phones rather than juggle another device or draw attention to an insulin pump at the cafeteria table.

These developments have been game changers for children and teenagers with diabetes and for their families. When wondering whether an athlete’s dazed appearance on a soccer field was due to hypoglycemia, a parent no longer must demand that a coach pull the player – a quick glance at a smartphone app can verify the blood glucose and change rate. Children can use programs and search engines to quickly verify carbohydrate counts. Life360 and other tracking programs have increased parental feelings of security, especially with young drivers living with a chronic medical condition.

The inevitable outcome of this available technology is that children living with T1D are given cell phones far earlier than are their siblings or peers owing to “necessity.” Parents understandably want a means to stay in close contact with their children in case of a medical emergency. As a physician and mother of young children, I am thankful for the technology that keeps my patients safer and that allows them to fully participate in everything from sports to travel to an uninterrupted night’s sleep. But I am also growing more concerned that we have not completely counted the cost of early smartphone use in children.

Smartphone presence in classrooms empowers teachers, students, parents, and school nurses to be aware of glycemic trends and prevent hypoglycemic emergencies. Smartphones have also shown to be a major distraction in that setting, causing many schools to ban their use entirely. Video apps such as YouTube and TikTok can provide a wealth of support and medical information but may also open the door to misinformation and dangerous social contagion, particularly surrounding disordered eating. Informative podcasts such as The Juicebox Podcast and online forums provide incredible support for families, but the constant siren call of a phone in their pockets leads to distracted parents constantly tending to other conversations or responding to ever more demanding employers rather than focusing on face-to-face education sessions.

The Surgeon General recently released a report concerning social media use in children. This eye-opening report revealed that one-third of children admitted to using their cell phones “almost constantly.” Social media use is associated with higher rates of anxiety and depression, especially in teen girls. This is particularly concerning for children with T1D, who are more likely to suffer from these conditions.

Beyond mental health concerns, especially to developing brains, unfettered Internet use increases the risk that children are exposed to predators and harmful content. The online safety monitoring platform Bark shared data from its 2021 surveillance. Bark found that 72% of tweens and 85% of teens were involved in an online bullying situation. Sixty-nine percent of tweens and 91% of teens encountered nudity or sexual content. Ten percent of tweens and 21% of teens encountered predatory behavior.

These alarming finds mirror the prevalence suggested by conversations in my office. I hear reports of my patients sneaking out at night to meet adults they met through social media, having suicidal ideation and attempts after Internet bullying, and sharing earnest belief in bizarre conspiracy theories gleaned from online forums that lead to dangerous health care practices.

Furthermore, time is a finite resource. Teens who are spending an average of 3.5 hours daily on their devices are running out of time to play, study, and grow extracurricular interests. My friend who coaches high school baseball lamented recently the poor athleticism in his recent teams. He theorized that his players had spent their summers on tablets rather than playing catch or climbing trees. The resulting declines in exercise in young people only serve to worsen the childhood obesity epidemic.

What is a concerned parent to do? First, all phones have controls that allow parents to choose which apps are allowed and which are blocked. Caregivers must understand how various social media platforms work. Installing programs such as Bark provides an additional layer of monitoring, though these are no substitute for parental vigilance. Importantly, parents should talk to their children about their concerns regarding social media.

Sadly, I have often noticed that caregivers pity the extra hardships their children endure as the result of T1D and other chronic diseases. Being lax with rules to attempt to compensate for other suffering is far too tempting. The goal is for children and teens living with T1D to have a full and normal childhood, and unrestricted smartphone access and early social media use should not be the goal for any child. For every family, a media use plan is a smart approach. The American Academy of Pediatrics suggests several commonsense steps to use technology wisely, and parents often must address their own relationships with their devices to model healthy engagement.

As health care professionals, we owe it to our patients to discuss the ups and downs of technology with our patients. We can’t ostrich our way through this. We can point our patients and families to supportive groups such as Osprey (Old School Parents Raising Engaged Youth), founded by Ben and Erin Napier from the HGTV show Home Town along with my college friends Taylor and Dr. Catherine Sledge. Wait Until 8th provides information and motivation for parents to make wise choices regarding phone use for their children. The documentary Childhood 2.0 is another compelling resource developed by pediatric emergency physician Dr. Free Hess and her team that summarizes many of these concerns.

In another decade, many of these dangers will be far clearer. As ubiquitous as smartphone misuse is in our society, I remain hopeful that our society will change its behaviors. Just because “everyone else” allows an unhealthy relationship with technology doesn’t mean that we should for our children.

When I was a child, smoking was glamorized in movies and restaurants had dedicated smoking sections. After strong public policy efforts, many geared toward children, smoking is now almost unthinkable. My 8-year-old asked me lately whether a lady smoking a cigarette in the car next to us would have to go to jail. I chose a career in pediatrics because I am an optimist at my very core. We can’t ignore the dangers associated with the wide door opened by mobile devices. We can celebrate the benefits while clearly facing the pitfalls.

Dr. Lilley is director of the pediatric diabetes and lipid program at the Mississippi Center for Advanced Medicine, Madison. She reported no relevant conflicts of interest.

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

My young patient with type 1 diabetes (T1D) had her cell phone out to provide a share code for her Dexcom clarity app as she was checking into her visit. As my nurse was recording the code, the patient asked him, “Hey, can you add me on Snapchat?”

Her father scrolled through his own Facebook feed in the chair next to her, showing no concern that his daughter was looking to connect with an adult on a social media platform. Meanwhile, we were all grateful that the little girl, who had had a seizure due to hypoglycemia in her preschool and pre–continuous glucose monitoring (CGM) years, had access to the tools harnessed within the sparkly encased phone she held in her small hands. But did anyone in the room fully understand the potential dangers?

We are living in an exhilarating era of diabetes technology, a treatment environment that I couldn’t have dreamed of during my pediatric endocrinology fellowship. T1D is a volatile condition that changes day to day, especially in growing children. A short decade ago, the best CGM available was a bulky device on loan to patients for 3 days at a time. Information was later downloaded in-office to get a better idea of general glucose trends, if insurance would approve its use at all.

Now, we have a variety of very wearable and accurate disposable CGMs accessible to most patients. Every major insulin pump has available closed-loop capabilities. Some patients can dose from apps on their cell phones rather than juggle another device or draw attention to an insulin pump at the cafeteria table.

These developments have been game changers for children and teenagers with diabetes and for their families. When wondering whether an athlete’s dazed appearance on a soccer field was due to hypoglycemia, a parent no longer must demand that a coach pull the player – a quick glance at a smartphone app can verify the blood glucose and change rate. Children can use programs and search engines to quickly verify carbohydrate counts. Life360 and other tracking programs have increased parental feelings of security, especially with young drivers living with a chronic medical condition.

The inevitable outcome of this available technology is that children living with T1D are given cell phones far earlier than are their siblings or peers owing to “necessity.” Parents understandably want a means to stay in close contact with their children in case of a medical emergency. As a physician and mother of young children, I am thankful for the technology that keeps my patients safer and that allows them to fully participate in everything from sports to travel to an uninterrupted night’s sleep. But I am also growing more concerned that we have not completely counted the cost of early smartphone use in children.

Smartphone presence in classrooms empowers teachers, students, parents, and school nurses to be aware of glycemic trends and prevent hypoglycemic emergencies. Smartphones have also shown to be a major distraction in that setting, causing many schools to ban their use entirely. Video apps such as YouTube and TikTok can provide a wealth of support and medical information but may also open the door to misinformation and dangerous social contagion, particularly surrounding disordered eating. Informative podcasts such as The Juicebox Podcast and online forums provide incredible support for families, but the constant siren call of a phone in their pockets leads to distracted parents constantly tending to other conversations or responding to ever more demanding employers rather than focusing on face-to-face education sessions.

The Surgeon General recently released a report concerning social media use in children. This eye-opening report revealed that one-third of children admitted to using their cell phones “almost constantly.” Social media use is associated with higher rates of anxiety and depression, especially in teen girls. This is particularly concerning for children with T1D, who are more likely to suffer from these conditions.

Beyond mental health concerns, especially to developing brains, unfettered Internet use increases the risk that children are exposed to predators and harmful content. The online safety monitoring platform Bark shared data from its 2021 surveillance. Bark found that 72% of tweens and 85% of teens were involved in an online bullying situation. Sixty-nine percent of tweens and 91% of teens encountered nudity or sexual content. Ten percent of tweens and 21% of teens encountered predatory behavior.

These alarming finds mirror the prevalence suggested by conversations in my office. I hear reports of my patients sneaking out at night to meet adults they met through social media, having suicidal ideation and attempts after Internet bullying, and sharing earnest belief in bizarre conspiracy theories gleaned from online forums that lead to dangerous health care practices.

Furthermore, time is a finite resource. Teens who are spending an average of 3.5 hours daily on their devices are running out of time to play, study, and grow extracurricular interests. My friend who coaches high school baseball lamented recently the poor athleticism in his recent teams. He theorized that his players had spent their summers on tablets rather than playing catch or climbing trees. The resulting declines in exercise in young people only serve to worsen the childhood obesity epidemic.

What is a concerned parent to do? First, all phones have controls that allow parents to choose which apps are allowed and which are blocked. Caregivers must understand how various social media platforms work. Installing programs such as Bark provides an additional layer of monitoring, though these are no substitute for parental vigilance. Importantly, parents should talk to their children about their concerns regarding social media.

Sadly, I have often noticed that caregivers pity the extra hardships their children endure as the result of T1D and other chronic diseases. Being lax with rules to attempt to compensate for other suffering is far too tempting. The goal is for children and teens living with T1D to have a full and normal childhood, and unrestricted smartphone access and early social media use should not be the goal for any child. For every family, a media use plan is a smart approach. The American Academy of Pediatrics suggests several commonsense steps to use technology wisely, and parents often must address their own relationships with their devices to model healthy engagement.

As health care professionals, we owe it to our patients to discuss the ups and downs of technology with our patients. We can’t ostrich our way through this. We can point our patients and families to supportive groups such as Osprey (Old School Parents Raising Engaged Youth), founded by Ben and Erin Napier from the HGTV show Home Town along with my college friends Taylor and Dr. Catherine Sledge. Wait Until 8th provides information and motivation for parents to make wise choices regarding phone use for their children. The documentary Childhood 2.0 is another compelling resource developed by pediatric emergency physician Dr. Free Hess and her team that summarizes many of these concerns.

In another decade, many of these dangers will be far clearer. As ubiquitous as smartphone misuse is in our society, I remain hopeful that our society will change its behaviors. Just because “everyone else” allows an unhealthy relationship with technology doesn’t mean that we should for our children.

When I was a child, smoking was glamorized in movies and restaurants had dedicated smoking sections. After strong public policy efforts, many geared toward children, smoking is now almost unthinkable. My 8-year-old asked me lately whether a lady smoking a cigarette in the car next to us would have to go to jail. I chose a career in pediatrics because I am an optimist at my very core. We can’t ignore the dangers associated with the wide door opened by mobile devices. We can celebrate the benefits while clearly facing the pitfalls.

Dr. Lilley is director of the pediatric diabetes and lipid program at the Mississippi Center for Advanced Medicine, Madison. She reported no relevant conflicts of interest.

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

My young patient with type 1 diabetes (T1D) had her cell phone out to provide a share code for her Dexcom clarity app as she was checking into her visit. As my nurse was recording the code, the patient asked him, “Hey, can you add me on Snapchat?”

Her father scrolled through his own Facebook feed in the chair next to her, showing no concern that his daughter was looking to connect with an adult on a social media platform. Meanwhile, we were all grateful that the little girl, who had had a seizure due to hypoglycemia in her preschool and pre–continuous glucose monitoring (CGM) years, had access to the tools harnessed within the sparkly encased phone she held in her small hands. But did anyone in the room fully understand the potential dangers?

We are living in an exhilarating era of diabetes technology, a treatment environment that I couldn’t have dreamed of during my pediatric endocrinology fellowship. T1D is a volatile condition that changes day to day, especially in growing children. A short decade ago, the best CGM available was a bulky device on loan to patients for 3 days at a time. Information was later downloaded in-office to get a better idea of general glucose trends, if insurance would approve its use at all.

Now, we have a variety of very wearable and accurate disposable CGMs accessible to most patients. Every major insulin pump has available closed-loop capabilities. Some patients can dose from apps on their cell phones rather than juggle another device or draw attention to an insulin pump at the cafeteria table.

These developments have been game changers for children and teenagers with diabetes and for their families. When wondering whether an athlete’s dazed appearance on a soccer field was due to hypoglycemia, a parent no longer must demand that a coach pull the player – a quick glance at a smartphone app can verify the blood glucose and change rate. Children can use programs and search engines to quickly verify carbohydrate counts. Life360 and other tracking programs have increased parental feelings of security, especially with young drivers living with a chronic medical condition.

The inevitable outcome of this available technology is that children living with T1D are given cell phones far earlier than are their siblings or peers owing to “necessity.” Parents understandably want a means to stay in close contact with their children in case of a medical emergency. As a physician and mother of young children, I am thankful for the technology that keeps my patients safer and that allows them to fully participate in everything from sports to travel to an uninterrupted night’s sleep. But I am also growing more concerned that we have not completely counted the cost of early smartphone use in children.

Smartphone presence in classrooms empowers teachers, students, parents, and school nurses to be aware of glycemic trends and prevent hypoglycemic emergencies. Smartphones have also shown to be a major distraction in that setting, causing many schools to ban their use entirely. Video apps such as YouTube and TikTok can provide a wealth of support and medical information but may also open the door to misinformation and dangerous social contagion, particularly surrounding disordered eating. Informative podcasts such as The Juicebox Podcast and online forums provide incredible support for families, but the constant siren call of a phone in their pockets leads to distracted parents constantly tending to other conversations or responding to ever more demanding employers rather than focusing on face-to-face education sessions.

The Surgeon General recently released a report concerning social media use in children. This eye-opening report revealed that one-third of children admitted to using their cell phones “almost constantly.” Social media use is associated with higher rates of anxiety and depression, especially in teen girls. This is particularly concerning for children with T1D, who are more likely to suffer from these conditions.

Beyond mental health concerns, especially to developing brains, unfettered Internet use increases the risk that children are exposed to predators and harmful content. The online safety monitoring platform Bark shared data from its 2021 surveillance. Bark found that 72% of tweens and 85% of teens were involved in an online bullying situation. Sixty-nine percent of tweens and 91% of teens encountered nudity or sexual content. Ten percent of tweens and 21% of teens encountered predatory behavior.

These alarming finds mirror the prevalence suggested by conversations in my office. I hear reports of my patients sneaking out at night to meet adults they met through social media, having suicidal ideation and attempts after Internet bullying, and sharing earnest belief in bizarre conspiracy theories gleaned from online forums that lead to dangerous health care practices.

Furthermore, time is a finite resource. Teens who are spending an average of 3.5 hours daily on their devices are running out of time to play, study, and grow extracurricular interests. My friend who coaches high school baseball lamented recently the poor athleticism in his recent teams. He theorized that his players had spent their summers on tablets rather than playing catch or climbing trees. The resulting declines in exercise in young people only serve to worsen the childhood obesity epidemic.

What is a concerned parent to do? First, all phones have controls that allow parents to choose which apps are allowed and which are blocked. Caregivers must understand how various social media platforms work. Installing programs such as Bark provides an additional layer of monitoring, though these are no substitute for parental vigilance. Importantly, parents should talk to their children about their concerns regarding social media.

Sadly, I have often noticed that caregivers pity the extra hardships their children endure as the result of T1D and other chronic diseases. Being lax with rules to attempt to compensate for other suffering is far too tempting. The goal is for children and teens living with T1D to have a full and normal childhood, and unrestricted smartphone access and early social media use should not be the goal for any child. For every family, a media use plan is a smart approach. The American Academy of Pediatrics suggests several commonsense steps to use technology wisely, and parents often must address their own relationships with their devices to model healthy engagement.

As health care professionals, we owe it to our patients to discuss the ups and downs of technology with our patients. We can’t ostrich our way through this. We can point our patients and families to supportive groups such as Osprey (Old School Parents Raising Engaged Youth), founded by Ben and Erin Napier from the HGTV show Home Town along with my college friends Taylor and Dr. Catherine Sledge. Wait Until 8th provides information and motivation for parents to make wise choices regarding phone use for their children. The documentary Childhood 2.0 is another compelling resource developed by pediatric emergency physician Dr. Free Hess and her team that summarizes many of these concerns.

In another decade, many of these dangers will be far clearer. As ubiquitous as smartphone misuse is in our society, I remain hopeful that our society will change its behaviors. Just because “everyone else” allows an unhealthy relationship with technology doesn’t mean that we should for our children.

When I was a child, smoking was glamorized in movies and restaurants had dedicated smoking sections. After strong public policy efforts, many geared toward children, smoking is now almost unthinkable. My 8-year-old asked me lately whether a lady smoking a cigarette in the car next to us would have to go to jail. I chose a career in pediatrics because I am an optimist at my very core. We can’t ignore the dangers associated with the wide door opened by mobile devices. We can celebrate the benefits while clearly facing the pitfalls.

Dr. Lilley is director of the pediatric diabetes and lipid program at the Mississippi Center for Advanced Medicine, Madison. She reported no relevant conflicts of interest.

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

SAN DIEGO – Injecting a scar with intralesional steroids is a popular way to reduce its size and soften the surrounding tissue, but proper technique matters, according to Victor Ross, MD.

“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.

“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”

Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.

In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”

He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.

New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.

Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.

SAN DIEGO – Injecting a scar with intralesional steroids is a popular way to reduce its size and soften the surrounding tissue, but proper technique matters, according to Victor Ross, MD.

“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.

“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”

Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.

In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”

He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.

New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.

Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.

SAN DIEGO – Injecting a scar with intralesional steroids is a popular way to reduce its size and soften the surrounding tissue, but proper technique matters, according to Victor Ross, MD.

“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.

“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”

Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.

In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”

He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.

New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.

Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.

A recent study found a significant association between lower sexual frequency and greater all-cause mortality in young and middle-aged people with hypertension. Should primary care physicians be offering a pleasure prescription to the 6 in 10 Americans living with chronic illness? How can we help these patients access their capacity for sexual pleasure, a critical and life-affirming component of the human experience?

Ask, don’t tell

First, we need to ask routinely about sexual well-being and pleasure. Without asking patients their views, we do not know the relevance of sex for their quality of life. Unless we ask, we do not know what specific kinds of sexual play are important for a person’s pleasure, nor can we assume how they prioritize their sexual functioning in the context of their medical care. When I began asking my primary care patients about sexual well-being, many more than I expected were quietly holding on to distressing issues. Now, as a sexual medicine specialist, in each sexual function evaluation, I ask three key questions: What are your goals? What does sex mean to you? What kinds of sexual play are important for your (and your partner’s) pleasure?

Chronic disease – with physical symptoms as well as psychological, relational, and cultural components – affects both general and genital physiology. Any disease process that alters vascular, neuroendocrine, or musculoskeletal function is likely to influence sexual function, either directly through the disease process or indirectly through complications or the effect on identity and well-being. In addition, a host of iatrogenic changes to sexual function may accompany effects of treatments.

Managing the effects of chronic illness on sexuality requires resilience and flexibility. A serious injury may require a massive adjustment to sexuality, but progressive disease may require continuous accommodations to sexual changes. The life stage at which the disease occurs also matters. People facing disease early in life encounter challenges (finding willing sexual partners and limited medical guidance regarding their sexual functioning) as well as benefits (they may integrate their disease as part of their sexual life). Those who experience sexual changes related to their illness later in life may face a loss of “normal” sexual function and well-being.

Meanwhile, the partner who is not ill may have their own sexual needs, fears, and worries. Both patients and partners may experience disenfranchised grief – a sense of loss about something one is not culturally permitted to mourn (“I/my partner is alive in the face of this terrible illness; who am I to worry about our/my sexual pleasure?”).

Positive marital relationships influence health through improved survival, improved medical adherence, better quality of life for the patient, and improved life satisfaction. Sexual satisfaction is an important factor in relational satisfaction. Helping our patients with these changes therefore may improve not only sexual health but overall health.

How, then, should we address sexual pleasure in chronic illness care? Here are a few tips:

Focus on pleasure. “Performance” is foul language when it comes to sex. Full attention to sensation and enjoyment, the only sexual “skill” anyone needs, is impossible while trying to perform.

Encourage flexibility and recognize that sex encompasses a wide and varied menu of experiences that change over a lifetime. Sex is everything from kissing and cuddling to the wildest things a mind can imagine. We can help both patients and partners think about the wide variety of ways to meet sexual needs. Balancing acceptance of sexual changes with motivation for improvement also is part of our role.

Address the effects of illness on the patient’s relationship with their body. Illness may alter not only bodily function but also self-esteem and body image. A reorganization of self-concept may occur (“I am no longer a sexual person; I’m a sexually dysfunctional asthmatic/diabetic/etc. and should avoid sexual intimacy”). Examining these self-constructs allows shifts in thoughts and behaviors, leading to improved psychological and sexual well-being. Encourage patients to explore what feels good in this body now. When possible, we can help with referral for corrective surgeries or direction to resources like stoma covers, wigs, scarves, and tattoos.

We offer suggestions for “sleep hygiene”; how about pleasure hygiene?

• Encourage open communication with partner(s) and offer resources to develop communication skills.
• Consider needs for physical and emotional preparation for sexual play: adequate rest, preparing the environment for body fluids, pillows for comfort or aides for positioning, and plenty of lubricant at hand.
• Allow adequate time for sexual play and encourage the ability to adjust or stop and start over – with humor and self-compassion.
• Use sexual aides to enhance pleasure.
• Seek out sexual medicine and sex therapy colleagues when things become tricky.

All bodies, no matter their health or illness state, are capable of pleasure. Hey, pleasure might even save lives!

Dr. Kranz is an clinical assistant professor of obstetrics/gynecology and family medicine, University of Rochester (N.Y.) Medical Center. She reported no conflicts of interest.

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

A recent study found a significant association between lower sexual frequency and greater all-cause mortality in young and middle-aged people with hypertension. Should primary care physicians be offering a pleasure prescription to the 6 in 10 Americans living with chronic illness? How can we help these patients access their capacity for sexual pleasure, a critical and life-affirming component of the human experience?

Ask, don’t tell

First, we need to ask routinely about sexual well-being and pleasure. Without asking patients their views, we do not know the relevance of sex for their quality of life. Unless we ask, we do not know what specific kinds of sexual play are important for a person’s pleasure, nor can we assume how they prioritize their sexual functioning in the context of their medical care. When I began asking my primary care patients about sexual well-being, many more than I expected were quietly holding on to distressing issues. Now, as a sexual medicine specialist, in each sexual function evaluation, I ask three key questions: What are your goals? What does sex mean to you? What kinds of sexual play are important for your (and your partner’s) pleasure?

Chronic disease – with physical symptoms as well as psychological, relational, and cultural components – affects both general and genital physiology. Any disease process that alters vascular, neuroendocrine, or musculoskeletal function is likely to influence sexual function, either directly through the disease process or indirectly through complications or the effect on identity and well-being. In addition, a host of iatrogenic changes to sexual function may accompany effects of treatments.

Managing the effects of chronic illness on sexuality requires resilience and flexibility. A serious injury may require a massive adjustment to sexuality, but progressive disease may require continuous accommodations to sexual changes. The life stage at which the disease occurs also matters. People facing disease early in life encounter challenges (finding willing sexual partners and limited medical guidance regarding their sexual functioning) as well as benefits (they may integrate their disease as part of their sexual life). Those who experience sexual changes related to their illness later in life may face a loss of “normal” sexual function and well-being.

Meanwhile, the partner who is not ill may have their own sexual needs, fears, and worries. Both patients and partners may experience disenfranchised grief – a sense of loss about something one is not culturally permitted to mourn (“I/my partner is alive in the face of this terrible illness; who am I to worry about our/my sexual pleasure?”).

Positive marital relationships influence health through improved survival, improved medical adherence, better quality of life for the patient, and improved life satisfaction. Sexual satisfaction is an important factor in relational satisfaction. Helping our patients with these changes therefore may improve not only sexual health but overall health.

How, then, should we address sexual pleasure in chronic illness care? Here are a few tips:

Focus on pleasure. “Performance” is foul language when it comes to sex. Full attention to sensation and enjoyment, the only sexual “skill” anyone needs, is impossible while trying to perform.

Encourage flexibility and recognize that sex encompasses a wide and varied menu of experiences that change over a lifetime. Sex is everything from kissing and cuddling to the wildest things a mind can imagine. We can help both patients and partners think about the wide variety of ways to meet sexual needs. Balancing acceptance of sexual changes with motivation for improvement also is part of our role.

Address the effects of illness on the patient’s relationship with their body. Illness may alter not only bodily function but also self-esteem and body image. A reorganization of self-concept may occur (“I am no longer a sexual person; I’m a sexually dysfunctional asthmatic/diabetic/etc. and should avoid sexual intimacy”). Examining these self-constructs allows shifts in thoughts and behaviors, leading to improved psychological and sexual well-being. Encourage patients to explore what feels good in this body now. When possible, we can help with referral for corrective surgeries or direction to resources like stoma covers, wigs, scarves, and tattoos.

We offer suggestions for “sleep hygiene”; how about pleasure hygiene?

• Encourage open communication with partner(s) and offer resources to develop communication skills.
• Consider needs for physical and emotional preparation for sexual play: adequate rest, preparing the environment for body fluids, pillows for comfort or aides for positioning, and plenty of lubricant at hand.
• Allow adequate time for sexual play and encourage the ability to adjust or stop and start over – with humor and self-compassion.
• Use sexual aides to enhance pleasure.
• Seek out sexual medicine and sex therapy colleagues when things become tricky.

All bodies, no matter their health or illness state, are capable of pleasure. Hey, pleasure might even save lives!

Dr. Kranz is an clinical assistant professor of obstetrics/gynecology and family medicine, University of Rochester (N.Y.) Medical Center. She reported no conflicts of interest.

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

A recent study found a significant association between lower sexual frequency and greater all-cause mortality in young and middle-aged people with hypertension. Should primary care physicians be offering a pleasure prescription to the 6 in 10 Americans living with chronic illness? How can we help these patients access their capacity for sexual pleasure, a critical and life-affirming component of the human experience?

Ask, don’t tell

First, we need to ask routinely about sexual well-being and pleasure. Without asking patients their views, we do not know the relevance of sex for their quality of life. Unless we ask, we do not know what specific kinds of sexual play are important for a person’s pleasure, nor can we assume how they prioritize their sexual functioning in the context of their medical care. When I began asking my primary care patients about sexual well-being, many more than I expected were quietly holding on to distressing issues. Now, as a sexual medicine specialist, in each sexual function evaluation, I ask three key questions: What are your goals? What does sex mean to you? What kinds of sexual play are important for your (and your partner’s) pleasure?

Chronic disease – with physical symptoms as well as psychological, relational, and cultural components – affects both general and genital physiology. Any disease process that alters vascular, neuroendocrine, or musculoskeletal function is likely to influence sexual function, either directly through the disease process or indirectly through complications or the effect on identity and well-being. In addition, a host of iatrogenic changes to sexual function may accompany effects of treatments.

Managing the effects of chronic illness on sexuality requires resilience and flexibility. A serious injury may require a massive adjustment to sexuality, but progressive disease may require continuous accommodations to sexual changes. The life stage at which the disease occurs also matters. People facing disease early in life encounter challenges (finding willing sexual partners and limited medical guidance regarding their sexual functioning) as well as benefits (they may integrate their disease as part of their sexual life). Those who experience sexual changes related to their illness later in life may face a loss of “normal” sexual function and well-being.

Meanwhile, the partner who is not ill may have their own sexual needs, fears, and worries. Both patients and partners may experience disenfranchised grief – a sense of loss about something one is not culturally permitted to mourn (“I/my partner is alive in the face of this terrible illness; who am I to worry about our/my sexual pleasure?”).

Positive marital relationships influence health through improved survival, improved medical adherence, better quality of life for the patient, and improved life satisfaction. Sexual satisfaction is an important factor in relational satisfaction. Helping our patients with these changes therefore may improve not only sexual health but overall health.

How, then, should we address sexual pleasure in chronic illness care? Here are a few tips:

Focus on pleasure. “Performance” is foul language when it comes to sex. Full attention to sensation and enjoyment, the only sexual “skill” anyone needs, is impossible while trying to perform.

Encourage flexibility and recognize that sex encompasses a wide and varied menu of experiences that change over a lifetime. Sex is everything from kissing and cuddling to the wildest things a mind can imagine. We can help both patients and partners think about the wide variety of ways to meet sexual needs. Balancing acceptance of sexual changes with motivation for improvement also is part of our role.

Address the effects of illness on the patient’s relationship with their body. Illness may alter not only bodily function but also self-esteem and body image. A reorganization of self-concept may occur (“I am no longer a sexual person; I’m a sexually dysfunctional asthmatic/diabetic/etc. and should avoid sexual intimacy”). Examining these self-constructs allows shifts in thoughts and behaviors, leading to improved psychological and sexual well-being. Encourage patients to explore what feels good in this body now. When possible, we can help with referral for corrective surgeries or direction to resources like stoma covers, wigs, scarves, and tattoos.

We offer suggestions for “sleep hygiene”; how about pleasure hygiene?

• Encourage open communication with partner(s) and offer resources to develop communication skills.
• Consider needs for physical and emotional preparation for sexual play: adequate rest, preparing the environment for body fluids, pillows for comfort or aides for positioning, and plenty of lubricant at hand.
• Allow adequate time for sexual play and encourage the ability to adjust or stop and start over – with humor and self-compassion.
• Use sexual aides to enhance pleasure.
• Seek out sexual medicine and sex therapy colleagues when things become tricky.

All bodies, no matter their health or illness state, are capable of pleasure. Hey, pleasure might even save lives!

Dr. Kranz is an clinical assistant professor of obstetrics/gynecology and family medicine, University of Rochester (N.Y.) Medical Center. She reported no conflicts of interest.

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

TOPLINE:

A decision-support model for managing patients with heartburn in whom proton pump inhibitor (PPI) therapy fails suggests that endoscopy with ambulatory reflux monitoring is the optimal cost-effective approach, matching therapy to phenotype.

METHODOLOGY:

• Researchers compared the cost-effectiveness over 1 year of four strategies for managing patients in whom empirical PPI treatment failed.
• Strategies were PPI optimization without diagnostic testing; endoscopy with PPI optimization to identify erosive reflux disease; endoscopy with PPI discontinuation when no erosive reflux disease was found; and combined endoscopy/ambulatory reflux monitoring and PPI discontinuation as appropriate for the phenotype (i.e., erosive disease, nonerosive disease, or functional heartburn).
• All index testing was assumed to be done while patients were off PPI treatment.

TAKEAWAY:

• PPI optimization without testing cost insurers $3,784 a year and patients $3,128 a year owing to health care expenses and lower work productivity associated with suboptimal symptom relief, resulting in a loss of 40 healthy days over the course of the year.
• Endoscopy with PPI optimization lowered insurer costs by $1,020 a year and patient costs by $1,621 a year, compared with optimization without testing, and added 11 healthy days a year by identifying erosive reflux disease.
• Endoscopy with PPI discontinuation added 11 healthy days a year by identifying patients without erosive reflux disease who did not need PPI therapy.
• Endoscopy with ambulatory reflux monitoring and a trial of PPI discontinuation was the most effective strategy, optimizing phenotype-guided treatment, saving insurers $2,183 and patients $2,396 a year, and adding 22 healthy days a year.
• The findings support recent clinical practice guidelines from the American Gastroenterological Association and the 

IN PRACTICE:

“[A]n algorithmic approach to comprehensively stratify erosive and non-erosive reflux disease from functional heartburn combined with a trial of PPI discontinuation for patients without erosive findings provides value to patients and insurers,” the authors wrote.

SOURCE:

Eric D. Shah, MD, MBA, division of gastroenterology and hepatology, Michigan Medicine, Ann Arbor, led the study, which was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Centers may have limited capacity for routine ambulatory reflux monitoring or may not perform it at all. Single-center and older studies were used for model inputs when no other data were available.

DISCLOSURES:

The study had no specific funding. Dr. Shah is supported by a National Institutes of Health grant and disclosed that he has consulted for Salix, Mahana, Neuraxis, Phathom, Takeda, Ardelyx, Sanofi, and GI Supply. Other coauthors have consulted for pharmaceutical and/or biotech companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A decision-support model for managing patients with heartburn in whom proton pump inhibitor (PPI) therapy fails suggests that endoscopy with ambulatory reflux monitoring is the optimal cost-effective approach, matching therapy to phenotype.

METHODOLOGY:

• Researchers compared the cost-effectiveness over 1 year of four strategies for managing patients in whom empirical PPI treatment failed.
• Strategies were PPI optimization without diagnostic testing; endoscopy with PPI optimization to identify erosive reflux disease; endoscopy with PPI discontinuation when no erosive reflux disease was found; and combined endoscopy/ambulatory reflux monitoring and PPI discontinuation as appropriate for the phenotype (i.e., erosive disease, nonerosive disease, or functional heartburn).
• All index testing was assumed to be done while patients were off PPI treatment.

TAKEAWAY:

• PPI optimization without testing cost insurers $3,784 a year and patients $3,128 a year owing to health care expenses and lower work productivity associated with suboptimal symptom relief, resulting in a loss of 40 healthy days over the course of the year.
• Endoscopy with PPI optimization lowered insurer costs by $1,020 a year and patient costs by $1,621 a year, compared with optimization without testing, and added 11 healthy days a year by identifying erosive reflux disease.
• Endoscopy with PPI discontinuation added 11 healthy days a year by identifying patients without erosive reflux disease who did not need PPI therapy.
• Endoscopy with ambulatory reflux monitoring and a trial of PPI discontinuation was the most effective strategy, optimizing phenotype-guided treatment, saving insurers $2,183 and patients $2,396 a year, and adding 22 healthy days a year.
• The findings support recent clinical practice guidelines from the American Gastroenterological Association and the 

IN PRACTICE:

“[A]n algorithmic approach to comprehensively stratify erosive and non-erosive reflux disease from functional heartburn combined with a trial of PPI discontinuation for patients without erosive findings provides value to patients and insurers,” the authors wrote.

SOURCE:

Eric D. Shah, MD, MBA, division of gastroenterology and hepatology, Michigan Medicine, Ann Arbor, led the study, which was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Centers may have limited capacity for routine ambulatory reflux monitoring or may not perform it at all. Single-center and older studies were used for model inputs when no other data were available.

DISCLOSURES:

The study had no specific funding. Dr. Shah is supported by a National Institutes of Health grant and disclosed that he has consulted for Salix, Mahana, Neuraxis, Phathom, Takeda, Ardelyx, Sanofi, and GI Supply. Other coauthors have consulted for pharmaceutical and/or biotech companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A decision-support model for managing patients with heartburn in whom proton pump inhibitor (PPI) therapy fails suggests that endoscopy with ambulatory reflux monitoring is the optimal cost-effective approach, matching therapy to phenotype.

METHODOLOGY:

• Researchers compared the cost-effectiveness over 1 year of four strategies for managing patients in whom empirical PPI treatment failed.
• Strategies were PPI optimization without diagnostic testing; endoscopy with PPI optimization to identify erosive reflux disease; endoscopy with PPI discontinuation when no erosive reflux disease was found; and combined endoscopy/ambulatory reflux monitoring and PPI discontinuation as appropriate for the phenotype (i.e., erosive disease, nonerosive disease, or functional heartburn).
• All index testing was assumed to be done while patients were off PPI treatment.

TAKEAWAY:

• PPI optimization without testing cost insurers $3,784 a year and patients $3,128 a year owing to health care expenses and lower work productivity associated with suboptimal symptom relief, resulting in a loss of 40 healthy days over the course of the year.
• Endoscopy with PPI optimization lowered insurer costs by $1,020 a year and patient costs by $1,621 a year, compared with optimization without testing, and added 11 healthy days a year by identifying erosive reflux disease.
• Endoscopy with PPI discontinuation added 11 healthy days a year by identifying patients without erosive reflux disease who did not need PPI therapy.
• Endoscopy with ambulatory reflux monitoring and a trial of PPI discontinuation was the most effective strategy, optimizing phenotype-guided treatment, saving insurers $2,183 and patients $2,396 a year, and adding 22 healthy days a year.
• The findings support recent clinical practice guidelines from the American Gastroenterological Association and the 

IN PRACTICE:

“[A]n algorithmic approach to comprehensively stratify erosive and non-erosive reflux disease from functional heartburn combined with a trial of PPI discontinuation for patients without erosive findings provides value to patients and insurers,” the authors wrote.

SOURCE:

Eric D. Shah, MD, MBA, division of gastroenterology and hepatology, Michigan Medicine, Ann Arbor, led the study, which was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Centers may have limited capacity for routine ambulatory reflux monitoring or may not perform it at all. Single-center and older studies were used for model inputs when no other data were available.

DISCLOSURES:

The study had no specific funding. Dr. Shah is supported by a National Institutes of Health grant and disclosed that he has consulted for Salix, Mahana, Neuraxis, Phathom, Takeda, Ardelyx, Sanofi, and GI Supply. Other coauthors have consulted for pharmaceutical and/or biotech companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

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

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

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

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

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