High-Dose Psilocybin Shows Promising Results for Depression

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TOPLINE:

High-dose psilocybin is associated with greater relief from depressive symptoms than placebo or escitalopram, with no increased risk for severe adverse events, a new meta-analysis suggests.
 

METHODOLOGY:

  • Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
  • The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
  • Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
  • The primary outcome was a change in depressive symptoms from baseline.

TAKEAWAY:

  • Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
  • High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
  • High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
  • No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.

IN PRACTICE:

“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.

SOURCE:

The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ

LIMITATIONS:

The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.

DISCLOSURES:

The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

High-dose psilocybin is associated with greater relief from depressive symptoms than placebo or escitalopram, with no increased risk for severe adverse events, a new meta-analysis suggests.
 

METHODOLOGY:

  • Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
  • The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
  • Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
  • The primary outcome was a change in depressive symptoms from baseline.

TAKEAWAY:

  • Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
  • High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
  • High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
  • No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.

IN PRACTICE:

“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.

SOURCE:

The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ

LIMITATIONS:

The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.

DISCLOSURES:

The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

High-dose psilocybin is associated with greater relief from depressive symptoms than placebo or escitalopram, with no increased risk for severe adverse events, a new meta-analysis suggests.
 

METHODOLOGY:

  • Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
  • The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
  • Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
  • The primary outcome was a change in depressive symptoms from baseline.

TAKEAWAY:

  • Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
  • High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
  • High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
  • No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.

IN PRACTICE:

“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.

SOURCE:

The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ

LIMITATIONS:

The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.

DISCLOSURES:

The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Optimizing Likelihood of Treatment for Postpartum Depression: Assessment of Barriers to Care

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I have written in my first two columns of 2024 about how the obstacles for women to access perinatal mental healthcare are not well understood. This is despite an almost uniform adoption of screening practices for postpartum depression (PPD) over the last 10-15 years in the United States, the approval and off-label use of effective pharmacologic and nonpharmacologic treatments for PPD, and the growing numbers of perinatal access programs across the country in various states and hospitals.

I want to revisit this topic because I believe it is extremely important that we get to a better understanding of the obstacles postpartum patients experience so we can flatten the curve with respect to the perinatal treatment cascade. It turns out that screening is easy but accessing care for those with a positive screen with significant depressive symptoms is an entirely distinct outcome.

Recently, a group of investigators examined the barriers to identifying and treating women for PPD. In a meta-analysis that included 32 reviews, the researchers analyzed the barriers women face when they seek help, access care, and engage in treatment for mental health issues while pregnant or in the postpartum period. The researchers found women have a wide variety of barriers to seeking and accessing care related to societal, political, organizational, interpersonal, healthcare professional, and individual factors at every level of the care pathway. In total, the researchers categorized barriers into six overarching themes and 62 sub-themes, and I want to highlight a few of the biggest contributors below.

In the meta-analysis, a major contributor to deciding to consult with a healthcare professional was a lack of understanding of what constituted a perinatal mental illness. This lack of understanding led women to ignore or minimize their symptoms. Others said that the cost of travel or arranging childcare were factors that prevented them from making an appointment with a provider. Some women reported that their healthcare professionals’ normalization of their symptoms was a barrier in the early stages of the care pathway, and others were unclear about the role a healthcare professional played in involving social services and removing their child from their care, or feared being judged as a bad mom.

One of the major societal factors identified in the study is the stigma associated with PPD. It is unfortunate that for so many postpartum patients, an extraordinary stigma associated with PPD still persists despite efforts from a large number of stakeholders, including the scientific community, advocacy groups, and celebrities who have publicly come out and described their experiences with PPD. For so many postpartum patients, there is an inability to let go of the stigma, shame, humiliation, and isolation associated with the suffering that goes along with PPD.

Another factor identified in the study as being an obstacle to care was a lack of a network to help postpartum patients navigate the shifting roles associated with new parenthood, which is magnified if a patient has developed major depressive disorder. This is why a strong social support network is critical to help women navigate the novelty of being a new mom. We were aware of this as a field nearly 30 years ago when Michael W. O’Hara, PhD, published a paper in the Archives of General Psychiatry noting that social support was an important predictor for risk of PPD.

When we talk with patients in clinic, and even when we interviewed subjects for our upcoming documentary More Than Blue, which will be completed in the fall of 2024, women in the postpartum period have cited the navigation of our current healthcare system as one of the greatest obstacles to getting care. Suffering from PPD and being handed a book of potential providers, absent someone helping to navigate that referral system, is really asking a new mom to climb a very tall mountain. Additionally, moms living in rural areas likely don’t have the sort of access to perinatal mental health services that women in more urban areas do.

It becomes increasingly clear that it is not the lack of availability of effective treatments that is the problem. As I’ve mentioned in previous columns, the last 15 years has given us a much greater understanding of the effectiveness of antidepressants as well as nonpharmacologic psychotherapies for women who may not want to be on a medicine. We now have very effective psychotherapies and there’s excitement about other new treatments that may have a role in the treatment of postpartum depression, including the use of neurosteroids, ketamine or esketamine, and psychedelics or neuromodulation such as transcranial magnetic stimulation. There is also no dearth of both well-studied treatments and even new and effective treatments that, as we move toward precision reproductive psychiatry, may be useful in tailoring treatment for patients.

If we’re looking to understand the anatomy of the perinatal treatment cascade, finally systematically evaluating these barriers may lead us down a path to understand how to build the bridge to postpartum wellness for women who are suffering. While what’s on the horizon is very exciting, we still have yet to address these barriers that prevent women from accessing this expanding array of treatment options. That is, in fact, the challenge to patients, their families, advocacy groups, political organizations, and society in general. The bridging of that gap is a burden that we all share as we try to mitigate the suffering associated with such an exquisitely treatable illness while access to treatment still feels beyond reach of so many postpartum persons around us.

As we continue our research on new treatments, we should keep in mind that they will be of no value unless we understand how to facilitate access to these treatments for the greatest number of patients. This endeavor really highlights the importance of health services research and implementation science, and that we need to be partnering early and often with colleagues if we are to truly achieve this goal.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at obnews@mdedge.com

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I have written in my first two columns of 2024 about how the obstacles for women to access perinatal mental healthcare are not well understood. This is despite an almost uniform adoption of screening practices for postpartum depression (PPD) over the last 10-15 years in the United States, the approval and off-label use of effective pharmacologic and nonpharmacologic treatments for PPD, and the growing numbers of perinatal access programs across the country in various states and hospitals.

I want to revisit this topic because I believe it is extremely important that we get to a better understanding of the obstacles postpartum patients experience so we can flatten the curve with respect to the perinatal treatment cascade. It turns out that screening is easy but accessing care for those with a positive screen with significant depressive symptoms is an entirely distinct outcome.

Recently, a group of investigators examined the barriers to identifying and treating women for PPD. In a meta-analysis that included 32 reviews, the researchers analyzed the barriers women face when they seek help, access care, and engage in treatment for mental health issues while pregnant or in the postpartum period. The researchers found women have a wide variety of barriers to seeking and accessing care related to societal, political, organizational, interpersonal, healthcare professional, and individual factors at every level of the care pathway. In total, the researchers categorized barriers into six overarching themes and 62 sub-themes, and I want to highlight a few of the biggest contributors below.

In the meta-analysis, a major contributor to deciding to consult with a healthcare professional was a lack of understanding of what constituted a perinatal mental illness. This lack of understanding led women to ignore or minimize their symptoms. Others said that the cost of travel or arranging childcare were factors that prevented them from making an appointment with a provider. Some women reported that their healthcare professionals’ normalization of their symptoms was a barrier in the early stages of the care pathway, and others were unclear about the role a healthcare professional played in involving social services and removing their child from their care, or feared being judged as a bad mom.

One of the major societal factors identified in the study is the stigma associated with PPD. It is unfortunate that for so many postpartum patients, an extraordinary stigma associated with PPD still persists despite efforts from a large number of stakeholders, including the scientific community, advocacy groups, and celebrities who have publicly come out and described their experiences with PPD. For so many postpartum patients, there is an inability to let go of the stigma, shame, humiliation, and isolation associated with the suffering that goes along with PPD.

Another factor identified in the study as being an obstacle to care was a lack of a network to help postpartum patients navigate the shifting roles associated with new parenthood, which is magnified if a patient has developed major depressive disorder. This is why a strong social support network is critical to help women navigate the novelty of being a new mom. We were aware of this as a field nearly 30 years ago when Michael W. O’Hara, PhD, published a paper in the Archives of General Psychiatry noting that social support was an important predictor for risk of PPD.

When we talk with patients in clinic, and even when we interviewed subjects for our upcoming documentary More Than Blue, which will be completed in the fall of 2024, women in the postpartum period have cited the navigation of our current healthcare system as one of the greatest obstacles to getting care. Suffering from PPD and being handed a book of potential providers, absent someone helping to navigate that referral system, is really asking a new mom to climb a very tall mountain. Additionally, moms living in rural areas likely don’t have the sort of access to perinatal mental health services that women in more urban areas do.

It becomes increasingly clear that it is not the lack of availability of effective treatments that is the problem. As I’ve mentioned in previous columns, the last 15 years has given us a much greater understanding of the effectiveness of antidepressants as well as nonpharmacologic psychotherapies for women who may not want to be on a medicine. We now have very effective psychotherapies and there’s excitement about other new treatments that may have a role in the treatment of postpartum depression, including the use of neurosteroids, ketamine or esketamine, and psychedelics or neuromodulation such as transcranial magnetic stimulation. There is also no dearth of both well-studied treatments and even new and effective treatments that, as we move toward precision reproductive psychiatry, may be useful in tailoring treatment for patients.

If we’re looking to understand the anatomy of the perinatal treatment cascade, finally systematically evaluating these barriers may lead us down a path to understand how to build the bridge to postpartum wellness for women who are suffering. While what’s on the horizon is very exciting, we still have yet to address these barriers that prevent women from accessing this expanding array of treatment options. That is, in fact, the challenge to patients, their families, advocacy groups, political organizations, and society in general. The bridging of that gap is a burden that we all share as we try to mitigate the suffering associated with such an exquisitely treatable illness while access to treatment still feels beyond reach of so many postpartum persons around us.

As we continue our research on new treatments, we should keep in mind that they will be of no value unless we understand how to facilitate access to these treatments for the greatest number of patients. This endeavor really highlights the importance of health services research and implementation science, and that we need to be partnering early and often with colleagues if we are to truly achieve this goal.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at obnews@mdedge.com

I have written in my first two columns of 2024 about how the obstacles for women to access perinatal mental healthcare are not well understood. This is despite an almost uniform adoption of screening practices for postpartum depression (PPD) over the last 10-15 years in the United States, the approval and off-label use of effective pharmacologic and nonpharmacologic treatments for PPD, and the growing numbers of perinatal access programs across the country in various states and hospitals.

I want to revisit this topic because I believe it is extremely important that we get to a better understanding of the obstacles postpartum patients experience so we can flatten the curve with respect to the perinatal treatment cascade. It turns out that screening is easy but accessing care for those with a positive screen with significant depressive symptoms is an entirely distinct outcome.

Recently, a group of investigators examined the barriers to identifying and treating women for PPD. In a meta-analysis that included 32 reviews, the researchers analyzed the barriers women face when they seek help, access care, and engage in treatment for mental health issues while pregnant or in the postpartum period. The researchers found women have a wide variety of barriers to seeking and accessing care related to societal, political, organizational, interpersonal, healthcare professional, and individual factors at every level of the care pathway. In total, the researchers categorized barriers into six overarching themes and 62 sub-themes, and I want to highlight a few of the biggest contributors below.

In the meta-analysis, a major contributor to deciding to consult with a healthcare professional was a lack of understanding of what constituted a perinatal mental illness. This lack of understanding led women to ignore or minimize their symptoms. Others said that the cost of travel or arranging childcare were factors that prevented them from making an appointment with a provider. Some women reported that their healthcare professionals’ normalization of their symptoms was a barrier in the early stages of the care pathway, and others were unclear about the role a healthcare professional played in involving social services and removing their child from their care, or feared being judged as a bad mom.

One of the major societal factors identified in the study is the stigma associated with PPD. It is unfortunate that for so many postpartum patients, an extraordinary stigma associated with PPD still persists despite efforts from a large number of stakeholders, including the scientific community, advocacy groups, and celebrities who have publicly come out and described their experiences with PPD. For so many postpartum patients, there is an inability to let go of the stigma, shame, humiliation, and isolation associated with the suffering that goes along with PPD.

Another factor identified in the study as being an obstacle to care was a lack of a network to help postpartum patients navigate the shifting roles associated with new parenthood, which is magnified if a patient has developed major depressive disorder. This is why a strong social support network is critical to help women navigate the novelty of being a new mom. We were aware of this as a field nearly 30 years ago when Michael W. O’Hara, PhD, published a paper in the Archives of General Psychiatry noting that social support was an important predictor for risk of PPD.

When we talk with patients in clinic, and even when we interviewed subjects for our upcoming documentary More Than Blue, which will be completed in the fall of 2024, women in the postpartum period have cited the navigation of our current healthcare system as one of the greatest obstacles to getting care. Suffering from PPD and being handed a book of potential providers, absent someone helping to navigate that referral system, is really asking a new mom to climb a very tall mountain. Additionally, moms living in rural areas likely don’t have the sort of access to perinatal mental health services that women in more urban areas do.

It becomes increasingly clear that it is not the lack of availability of effective treatments that is the problem. As I’ve mentioned in previous columns, the last 15 years has given us a much greater understanding of the effectiveness of antidepressants as well as nonpharmacologic psychotherapies for women who may not want to be on a medicine. We now have very effective psychotherapies and there’s excitement about other new treatments that may have a role in the treatment of postpartum depression, including the use of neurosteroids, ketamine or esketamine, and psychedelics or neuromodulation such as transcranial magnetic stimulation. There is also no dearth of both well-studied treatments and even new and effective treatments that, as we move toward precision reproductive psychiatry, may be useful in tailoring treatment for patients.

If we’re looking to understand the anatomy of the perinatal treatment cascade, finally systematically evaluating these barriers may lead us down a path to understand how to build the bridge to postpartum wellness for women who are suffering. While what’s on the horizon is very exciting, we still have yet to address these barriers that prevent women from accessing this expanding array of treatment options. That is, in fact, the challenge to patients, their families, advocacy groups, political organizations, and society in general. The bridging of that gap is a burden that we all share as we try to mitigate the suffering associated with such an exquisitely treatable illness while access to treatment still feels beyond reach of so many postpartum persons around us.

As we continue our research on new treatments, we should keep in mind that they will be of no value unless we understand how to facilitate access to these treatments for the greatest number of patients. This endeavor really highlights the importance of health services research and implementation science, and that we need to be partnering early and often with colleagues if we are to truly achieve this goal.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at obnews@mdedge.com

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Signal of Suicide Ideation With GLP-1 RA Semaglutide, but Experts Urge Caution

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A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines. 

However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations. 

“Clinicians should not interpret these results as proof of causal relationship between suicidal ideation and semaglutide, as our pharmacovigilance study showed an association between the use of semaglutide and reports of suicidal ideation,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said. 

“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added. 

The study was published online on August 20 in JAMA Network Open
 

Emerging Concerns

GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe. 

Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs). 

They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozinmetformin, and orlistat as comparators. 

Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women). 

The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs. 

This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote. 

No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04). 

However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%). 
 

More Research Needed 

GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said. 

“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.

The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.

This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France. 

Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible. 

“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie. 

Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre. 

The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”

Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”

“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said. 

The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest. 
 

A version of this article appeared on Medscape.com.

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A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines. 

However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations. 

“Clinicians should not interpret these results as proof of causal relationship between suicidal ideation and semaglutide, as our pharmacovigilance study showed an association between the use of semaglutide and reports of suicidal ideation,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said. 

“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added. 

The study was published online on August 20 in JAMA Network Open
 

Emerging Concerns

GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe. 

Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs). 

They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozinmetformin, and orlistat as comparators. 

Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women). 

The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs. 

This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote. 

No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04). 

However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%). 
 

More Research Needed 

GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said. 

“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.

The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.

This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France. 

Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible. 

“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie. 

Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre. 

The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”

Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”

“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said. 

The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest. 
 

A version of this article appeared on Medscape.com.

A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines. 

However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations. 

“Clinicians should not interpret these results as proof of causal relationship between suicidal ideation and semaglutide, as our pharmacovigilance study showed an association between the use of semaglutide and reports of suicidal ideation,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said. 

“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added. 

The study was published online on August 20 in JAMA Network Open
 

Emerging Concerns

GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe. 

Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs). 

They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozinmetformin, and orlistat as comparators. 

Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women). 

The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs. 

This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote. 

No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04). 

However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%). 
 

More Research Needed 

GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said. 

“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.

The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.

This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France. 

Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible. 

“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie. 

Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre. 

The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”

Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”

“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said. 

The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest. 
 

A version of this article appeared on Medscape.com.

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Evidence Growing for Inflammation’s Role in Elevating Risk for Psychiatric Illness

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New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.

Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders. 

Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote. 

In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said. 

The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry
 

Inflammatory Phenotype

Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk. 

To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.

In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92). 

“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported. 

In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed. 

The MR analysis suggested a possible causal relationship between leukocytes and depression. 

The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.

“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote. 

A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood. 

This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
 

Support for Precision Psychiatry

This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization. 

“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said. 

“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added. 

Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”

“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.

His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices. 

Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.

This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
 

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

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New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.

Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders. 

Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote. 

In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said. 

The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry
 

Inflammatory Phenotype

Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk. 

To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.

In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92). 

“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported. 

In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed. 

The MR analysis suggested a possible causal relationship between leukocytes and depression. 

The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.

“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote. 

A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood. 

This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
 

Support for Precision Psychiatry

This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization. 

“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said. 

“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added. 

Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”

“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.

His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices. 

Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.

This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
 

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

New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.

Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders. 

Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote. 

In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said. 

The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry
 

Inflammatory Phenotype

Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk. 

To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.

In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92). 

“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported. 

In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed. 

The MR analysis suggested a possible causal relationship between leukocytes and depression. 

The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.

“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote. 

A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood. 

This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
 

Support for Precision Psychiatry

This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization. 

“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said. 

“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added. 

Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”

“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.

His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices. 

Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.

This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
 

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

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Unseen Toll: Cancer Patients’ Spouses Face Higher Suicide Risk

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TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

  • A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
  • In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
  • Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
  • A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

  • Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
  • The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
  • Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
  • Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

 

 

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

  • A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
  • In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
  • Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
  • A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

  • Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
  • The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
  • Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
  • Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

 

 

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

  • A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
  • In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
  • Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
  • A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

  • Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
  • The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
  • Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
  • Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

 

 

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Could Baseline MRIs Reshape Prostate Cancer Risk Assessment?

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Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

 

 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

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Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

 

 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

 

 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

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FROM THE JOURNAL OF UROLOGY

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Severe COVID-19 Tied to Increased Risk for Mental Illness

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New research adds to a growing body of evidence suggesting that COVID-19 infection can be hard on mental health. 

The UK study of more than 18 million adults showed an elevated rate of mental illness, including depression and serious mental illness, for up to a year following a bout of COVID-19, particularly in those with severe COVID who had not been vaccinated. 

Importantly, vaccination appeared to mitigate the adverse effects of COVID-19 on mental health, the investigators found. 

“Our results highlight the importance COVID-19 vaccination in the general population and particularly among those with mental illnesses, who may be at higher risk of both SARS-CoV-2 infection and adverse outcomes following COVID-19,” first author Venexia Walker, PhD, with University of Bristol, United Kingdom, said in a news release. 

The study was published online on August 21 in JAMA Psychiatry.
 

Novel Data

“Before this study, a number of papers had looked at associations of COVID diagnosis with mental ill health, and broadly speaking, they had reported associations of different magnitudes,” study author Jonathan A. C. Sterne, PhD, with University of Bristol, noted in a journal podcast. 

“Some studies were restricted to patients who were hospitalized with COVID-19 and some not and the duration of follow-up varied. And importantly, the nature of COVID-19 changed profoundly as vaccination became available and there was little data on the impact of vaccination on associations of COVID-19 with subsequent mental ill health,” Dr. Sterne said. 

The UK study was conducted in three cohorts — a cohort of about 18.6 million people who were diagnosed with COVID-19 before a vaccine was available, a cohort of about 14 million adults who were vaccinated, and a cohort of about 3.2 million people who were unvaccinated.

The researchers compared rates of various mental illnesses after COVID-19 with rates before or without COVID-19 and by vaccination status.

Across all cohorts, rates of most mental illnesses examined were “markedly elevated” during the first month following a COVID-19 diagnosis compared with rates before or without COVID-19.

For example, the adjusted hazard ratios for depression (the most common illness) and serious mental illness in the month after COVID-19 were 1.93 and 1.49, respectively, in the prevaccination cohort and 1.79 and 1.45, respectively, in the unvaccinated cohort compared with 1.16 and 0.91 in the vaccinated cohort.

This elevation in the rate of mental illnesses was mainly seen after severe COVID-19 that led to hospitalization and remained higher for up to a year following severe COVID-19 in unvaccinated adults.

For severe COVID-19 with hospitalization, the adjusted hazard ratio for depression in the month following admission was 16.3 in the prevaccine cohort, 15.6 in the unvaccinated cohort, and 12.9 in the vaccinated cohort.

The adjusted hazard ratios for serious mental illness in the month after COVID hospitalization was 9.71 in the prevaccine cohort, 8.75 with no vaccination, and 6.52 with vaccination. 

“Incidences of other mental illnesses were broadly similar to those of depression and serious mental illness, both overall and for COVID-19 with and without hospitalization,” the authors report in their paper.

Consistent with prior research, subgroup analyzes found the association of COVID-19 and mental illness was stronger among older adults and men, with no marked differences by ethnic group.

“We should be concerned about continuing consequences in people who experienced severe COVID-19 early in the pandemic, and they may include a continuing higher incidence of mental ill health, such as depression and serious mental illness,” Dr. Sterne said in the podcast. 

In terms of ongoing booster vaccinations, “people who are advised that they are under vaccinated or recommended for further COVID-19 vaccination, should take those invitations seriously, because by preventing severe COVID-19, which is what vaccination does, you can prevent consequences such as mental illness,” Dr. Sterne added. 

The study was supported by the COVID-19 Longitudinal Health and Wellbeing National Core Study, which is funded by the Medical Research Council and National Institute for Health and Care Research. The authors had no relevant conflicts of interest.
 

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

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New research adds to a growing body of evidence suggesting that COVID-19 infection can be hard on mental health. 

The UK study of more than 18 million adults showed an elevated rate of mental illness, including depression and serious mental illness, for up to a year following a bout of COVID-19, particularly in those with severe COVID who had not been vaccinated. 

Importantly, vaccination appeared to mitigate the adverse effects of COVID-19 on mental health, the investigators found. 

“Our results highlight the importance COVID-19 vaccination in the general population and particularly among those with mental illnesses, who may be at higher risk of both SARS-CoV-2 infection and adverse outcomes following COVID-19,” first author Venexia Walker, PhD, with University of Bristol, United Kingdom, said in a news release. 

The study was published online on August 21 in JAMA Psychiatry.
 

Novel Data

“Before this study, a number of papers had looked at associations of COVID diagnosis with mental ill health, and broadly speaking, they had reported associations of different magnitudes,” study author Jonathan A. C. Sterne, PhD, with University of Bristol, noted in a journal podcast. 

“Some studies were restricted to patients who were hospitalized with COVID-19 and some not and the duration of follow-up varied. And importantly, the nature of COVID-19 changed profoundly as vaccination became available and there was little data on the impact of vaccination on associations of COVID-19 with subsequent mental ill health,” Dr. Sterne said. 

The UK study was conducted in three cohorts — a cohort of about 18.6 million people who were diagnosed with COVID-19 before a vaccine was available, a cohort of about 14 million adults who were vaccinated, and a cohort of about 3.2 million people who were unvaccinated.

The researchers compared rates of various mental illnesses after COVID-19 with rates before or without COVID-19 and by vaccination status.

Across all cohorts, rates of most mental illnesses examined were “markedly elevated” during the first month following a COVID-19 diagnosis compared with rates before or without COVID-19.

For example, the adjusted hazard ratios for depression (the most common illness) and serious mental illness in the month after COVID-19 were 1.93 and 1.49, respectively, in the prevaccination cohort and 1.79 and 1.45, respectively, in the unvaccinated cohort compared with 1.16 and 0.91 in the vaccinated cohort.

This elevation in the rate of mental illnesses was mainly seen after severe COVID-19 that led to hospitalization and remained higher for up to a year following severe COVID-19 in unvaccinated adults.

For severe COVID-19 with hospitalization, the adjusted hazard ratio for depression in the month following admission was 16.3 in the prevaccine cohort, 15.6 in the unvaccinated cohort, and 12.9 in the vaccinated cohort.

The adjusted hazard ratios for serious mental illness in the month after COVID hospitalization was 9.71 in the prevaccine cohort, 8.75 with no vaccination, and 6.52 with vaccination. 

“Incidences of other mental illnesses were broadly similar to those of depression and serious mental illness, both overall and for COVID-19 with and without hospitalization,” the authors report in their paper.

Consistent with prior research, subgroup analyzes found the association of COVID-19 and mental illness was stronger among older adults and men, with no marked differences by ethnic group.

“We should be concerned about continuing consequences in people who experienced severe COVID-19 early in the pandemic, and they may include a continuing higher incidence of mental ill health, such as depression and serious mental illness,” Dr. Sterne said in the podcast. 

In terms of ongoing booster vaccinations, “people who are advised that they are under vaccinated or recommended for further COVID-19 vaccination, should take those invitations seriously, because by preventing severe COVID-19, which is what vaccination does, you can prevent consequences such as mental illness,” Dr. Sterne added. 

The study was supported by the COVID-19 Longitudinal Health and Wellbeing National Core Study, which is funded by the Medical Research Council and National Institute for Health and Care Research. The authors had no relevant conflicts of interest.
 

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

New research adds to a growing body of evidence suggesting that COVID-19 infection can be hard on mental health. 

The UK study of more than 18 million adults showed an elevated rate of mental illness, including depression and serious mental illness, for up to a year following a bout of COVID-19, particularly in those with severe COVID who had not been vaccinated. 

Importantly, vaccination appeared to mitigate the adverse effects of COVID-19 on mental health, the investigators found. 

“Our results highlight the importance COVID-19 vaccination in the general population and particularly among those with mental illnesses, who may be at higher risk of both SARS-CoV-2 infection and adverse outcomes following COVID-19,” first author Venexia Walker, PhD, with University of Bristol, United Kingdom, said in a news release. 

The study was published online on August 21 in JAMA Psychiatry.
 

Novel Data

“Before this study, a number of papers had looked at associations of COVID diagnosis with mental ill health, and broadly speaking, they had reported associations of different magnitudes,” study author Jonathan A. C. Sterne, PhD, with University of Bristol, noted in a journal podcast. 

“Some studies were restricted to patients who were hospitalized with COVID-19 and some not and the duration of follow-up varied. And importantly, the nature of COVID-19 changed profoundly as vaccination became available and there was little data on the impact of vaccination on associations of COVID-19 with subsequent mental ill health,” Dr. Sterne said. 

The UK study was conducted in three cohorts — a cohort of about 18.6 million people who were diagnosed with COVID-19 before a vaccine was available, a cohort of about 14 million adults who were vaccinated, and a cohort of about 3.2 million people who were unvaccinated.

The researchers compared rates of various mental illnesses after COVID-19 with rates before or without COVID-19 and by vaccination status.

Across all cohorts, rates of most mental illnesses examined were “markedly elevated” during the first month following a COVID-19 diagnosis compared with rates before or without COVID-19.

For example, the adjusted hazard ratios for depression (the most common illness) and serious mental illness in the month after COVID-19 were 1.93 and 1.49, respectively, in the prevaccination cohort and 1.79 and 1.45, respectively, in the unvaccinated cohort compared with 1.16 and 0.91 in the vaccinated cohort.

This elevation in the rate of mental illnesses was mainly seen after severe COVID-19 that led to hospitalization and remained higher for up to a year following severe COVID-19 in unvaccinated adults.

For severe COVID-19 with hospitalization, the adjusted hazard ratio for depression in the month following admission was 16.3 in the prevaccine cohort, 15.6 in the unvaccinated cohort, and 12.9 in the vaccinated cohort.

The adjusted hazard ratios for serious mental illness in the month after COVID hospitalization was 9.71 in the prevaccine cohort, 8.75 with no vaccination, and 6.52 with vaccination. 

“Incidences of other mental illnesses were broadly similar to those of depression and serious mental illness, both overall and for COVID-19 with and without hospitalization,” the authors report in their paper.

Consistent with prior research, subgroup analyzes found the association of COVID-19 and mental illness was stronger among older adults and men, with no marked differences by ethnic group.

“We should be concerned about continuing consequences in people who experienced severe COVID-19 early in the pandemic, and they may include a continuing higher incidence of mental ill health, such as depression and serious mental illness,” Dr. Sterne said in the podcast. 

In terms of ongoing booster vaccinations, “people who are advised that they are under vaccinated or recommended for further COVID-19 vaccination, should take those invitations seriously, because by preventing severe COVID-19, which is what vaccination does, you can prevent consequences such as mental illness,” Dr. Sterne added. 

The study was supported by the COVID-19 Longitudinal Health and Wellbeing National Core Study, which is funded by the Medical Research Council and National Institute for Health and Care Research. The authors had no relevant conflicts of interest.
 

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

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When Childhood Cancer Survivors Face Sexual Challenges

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Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Leaving Your Legacy Via Death Bots? Ethicist Shares Concerns

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This transcript has been edited for clarity.

I heard recently about a fascinating, important development in artificial intelligence (AI). All kinds of things are happening in AI. Clearly, it’s being used in the background to trace and keep track of medical information inside hospitals.

There are AI bots out there that are starting to talk to patients about, say, mental health issues. Plenty of people are using AI to get information about their medical condition, seeing it supplement search engines, and on and on AI goes. 

It has entered into a space where I think patients may raise questions about whether they should use it or seek opinions from doctors and nurses, particularly those involved with seriously ill people. That space is grieving, and what might be called “death bots.”

Here’s what’s going on. There’s a gentleman I read about online, who was dying of end-stage colon cancer. His wife and he were talking, knowing his death was coming, about what it would be like after his death. She said she would really miss being able to ask him questions about a variety of topics that he was expert at and that he knew very well. 

He thought about it and decided, well, maybe he could record his voice and then use AI to search information that he would record and have available, which could really address questions that his wife might put to “him” once he was gone.

It turns out that a company was formed shortly thereafter, which is now offering the service both in the US and Europe, and in fact, I think perhaps even worldwide, basically saying we’ll record a dying person’s voice. We will help people grieve by allowing people to interact with the AI version of the departed when they’re gone. 

It will be able to, if you will, search not just recorded information but anything they might have online — diaries, things they may have written, earlier videos, and information from earlier parts of their life — to generate plausible answers to questions that might be put to the artificial version of the deceased.

Obviously, this would allow not only spouses but grandchildren and people in future generations to have some way to interact with an ancestor who’s gone. It may allow people to feel comfort when they miss a loved one, to hear their voice, and not just in a prerecorded way but creatively interacting with them.

On the other hand, there are clearly many ethical issues about creating an artificial version of yourself. One obvious issue is how accurate this AI version of you will be if the death bot can create information that sounds like you, but really isn’t what you would have said, despite the effort to glean it from recordings and past information about you. Is it all right if people wander from the truth in trying to interact with someone who’s died? 

There are other ways to leave memories behind. You certainly can record messages so that you can control the content. Many people video themselves and so on. There are obviously people who would say that they have a diary or have written information they can leave behind. 

Is there a place in terms of accuracy for a kind of artificial version of ourselves to go on forever? Another interesting issue is who controls that. Can you add to it after your death? Can information be shared about you with third parties who don’t sign up for the service? Maybe the police take an interest in how you died. You can imagine many scenarios where questions might come up about wanting to access these data that the artificial agent is providing. 

Some people might say that it’s just not the way to grieve. Maybe the best way to grieve is to accept death and not try to interact with a constructed version of yourself once you’ve passed. That isn’t really accepting death. It’s a form, perhaps, of denial of death, and maybe that isn’t going to be good for the mental health of survivors who really have not come to terms with the fact that someone has passed on.

I’m not against these death bots or AI versions of trying to leave a legacy. There are all kinds of legacies that people might want to leave. While perhaps not 100% accurate, I can see how this technology has a use. 

I do think one has to go in with their eyes open. We need consent before anything like this is really purchased by or sold to surviving people. They really have to understand it may not be an accurate version of what the deceased might have said in response to questions, conversations, or interactions. 

I think we need to know who controls the information, who can erase it, and who can say, “I’m done with it, and I don’t want my husband’s AI to go on anymore.”

All that said, it’s an interesting development in a world in which I think those who are very ill might start to plan to leave a legacy that is more than just a diary or a video message. It becomes a kind of ongoing, artificial, interactive version of themselves that may provide some people with comfort.

Dr. Caplan, director of the Division of Medical Ethics at New York University Langone Medical Center, New York City, reported conflicts of interest with Johnson & Johnson and Medscape.

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

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This transcript has been edited for clarity.

I heard recently about a fascinating, important development in artificial intelligence (AI). All kinds of things are happening in AI. Clearly, it’s being used in the background to trace and keep track of medical information inside hospitals.

There are AI bots out there that are starting to talk to patients about, say, mental health issues. Plenty of people are using AI to get information about their medical condition, seeing it supplement search engines, and on and on AI goes. 

It has entered into a space where I think patients may raise questions about whether they should use it or seek opinions from doctors and nurses, particularly those involved with seriously ill people. That space is grieving, and what might be called “death bots.”

Here’s what’s going on. There’s a gentleman I read about online, who was dying of end-stage colon cancer. His wife and he were talking, knowing his death was coming, about what it would be like after his death. She said she would really miss being able to ask him questions about a variety of topics that he was expert at and that he knew very well. 

He thought about it and decided, well, maybe he could record his voice and then use AI to search information that he would record and have available, which could really address questions that his wife might put to “him” once he was gone.

It turns out that a company was formed shortly thereafter, which is now offering the service both in the US and Europe, and in fact, I think perhaps even worldwide, basically saying we’ll record a dying person’s voice. We will help people grieve by allowing people to interact with the AI version of the departed when they’re gone. 

It will be able to, if you will, search not just recorded information but anything they might have online — diaries, things they may have written, earlier videos, and information from earlier parts of their life — to generate plausible answers to questions that might be put to the artificial version of the deceased.

Obviously, this would allow not only spouses but grandchildren and people in future generations to have some way to interact with an ancestor who’s gone. It may allow people to feel comfort when they miss a loved one, to hear their voice, and not just in a prerecorded way but creatively interacting with them.

On the other hand, there are clearly many ethical issues about creating an artificial version of yourself. One obvious issue is how accurate this AI version of you will be if the death bot can create information that sounds like you, but really isn’t what you would have said, despite the effort to glean it from recordings and past information about you. Is it all right if people wander from the truth in trying to interact with someone who’s died? 

There are other ways to leave memories behind. You certainly can record messages so that you can control the content. Many people video themselves and so on. There are obviously people who would say that they have a diary or have written information they can leave behind. 

Is there a place in terms of accuracy for a kind of artificial version of ourselves to go on forever? Another interesting issue is who controls that. Can you add to it after your death? Can information be shared about you with third parties who don’t sign up for the service? Maybe the police take an interest in how you died. You can imagine many scenarios where questions might come up about wanting to access these data that the artificial agent is providing. 

Some people might say that it’s just not the way to grieve. Maybe the best way to grieve is to accept death and not try to interact with a constructed version of yourself once you’ve passed. That isn’t really accepting death. It’s a form, perhaps, of denial of death, and maybe that isn’t going to be good for the mental health of survivors who really have not come to terms with the fact that someone has passed on.

I’m not against these death bots or AI versions of trying to leave a legacy. There are all kinds of legacies that people might want to leave. While perhaps not 100% accurate, I can see how this technology has a use. 

I do think one has to go in with their eyes open. We need consent before anything like this is really purchased by or sold to surviving people. They really have to understand it may not be an accurate version of what the deceased might have said in response to questions, conversations, or interactions. 

I think we need to know who controls the information, who can erase it, and who can say, “I’m done with it, and I don’t want my husband’s AI to go on anymore.”

All that said, it’s an interesting development in a world in which I think those who are very ill might start to plan to leave a legacy that is more than just a diary or a video message. It becomes a kind of ongoing, artificial, interactive version of themselves that may provide some people with comfort.

Dr. Caplan, director of the Division of Medical Ethics at New York University Langone Medical Center, New York City, reported conflicts of interest with Johnson & Johnson and Medscape.

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

 

This transcript has been edited for clarity.

I heard recently about a fascinating, important development in artificial intelligence (AI). All kinds of things are happening in AI. Clearly, it’s being used in the background to trace and keep track of medical information inside hospitals.

There are AI bots out there that are starting to talk to patients about, say, mental health issues. Plenty of people are using AI to get information about their medical condition, seeing it supplement search engines, and on and on AI goes. 

It has entered into a space where I think patients may raise questions about whether they should use it or seek opinions from doctors and nurses, particularly those involved with seriously ill people. That space is grieving, and what might be called “death bots.”

Here’s what’s going on. There’s a gentleman I read about online, who was dying of end-stage colon cancer. His wife and he were talking, knowing his death was coming, about what it would be like after his death. She said she would really miss being able to ask him questions about a variety of topics that he was expert at and that he knew very well. 

He thought about it and decided, well, maybe he could record his voice and then use AI to search information that he would record and have available, which could really address questions that his wife might put to “him” once he was gone.

It turns out that a company was formed shortly thereafter, which is now offering the service both in the US and Europe, and in fact, I think perhaps even worldwide, basically saying we’ll record a dying person’s voice. We will help people grieve by allowing people to interact with the AI version of the departed when they’re gone. 

It will be able to, if you will, search not just recorded information but anything they might have online — diaries, things they may have written, earlier videos, and information from earlier parts of their life — to generate plausible answers to questions that might be put to the artificial version of the deceased.

Obviously, this would allow not only spouses but grandchildren and people in future generations to have some way to interact with an ancestor who’s gone. It may allow people to feel comfort when they miss a loved one, to hear their voice, and not just in a prerecorded way but creatively interacting with them.

On the other hand, there are clearly many ethical issues about creating an artificial version of yourself. One obvious issue is how accurate this AI version of you will be if the death bot can create information that sounds like you, but really isn’t what you would have said, despite the effort to glean it from recordings and past information about you. Is it all right if people wander from the truth in trying to interact with someone who’s died? 

There are other ways to leave memories behind. You certainly can record messages so that you can control the content. Many people video themselves and so on. There are obviously people who would say that they have a diary or have written information they can leave behind. 

Is there a place in terms of accuracy for a kind of artificial version of ourselves to go on forever? Another interesting issue is who controls that. Can you add to it after your death? Can information be shared about you with third parties who don’t sign up for the service? Maybe the police take an interest in how you died. You can imagine many scenarios where questions might come up about wanting to access these data that the artificial agent is providing. 

Some people might say that it’s just not the way to grieve. Maybe the best way to grieve is to accept death and not try to interact with a constructed version of yourself once you’ve passed. That isn’t really accepting death. It’s a form, perhaps, of denial of death, and maybe that isn’t going to be good for the mental health of survivors who really have not come to terms with the fact that someone has passed on.

I’m not against these death bots or AI versions of trying to leave a legacy. There are all kinds of legacies that people might want to leave. While perhaps not 100% accurate, I can see how this technology has a use. 

I do think one has to go in with their eyes open. We need consent before anything like this is really purchased by or sold to surviving people. They really have to understand it may not be an accurate version of what the deceased might have said in response to questions, conversations, or interactions. 

I think we need to know who controls the information, who can erase it, and who can say, “I’m done with it, and I don’t want my husband’s AI to go on anymore.”

All that said, it’s an interesting development in a world in which I think those who are very ill might start to plan to leave a legacy that is more than just a diary or a video message. It becomes a kind of ongoing, artificial, interactive version of themselves that may provide some people with comfort.

Dr. Caplan, director of the Division of Medical Ethics at New York University Langone Medical Center, New York City, reported conflicts of interest with Johnson & Johnson and Medscape.

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

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Hand Sanitizers and Alcohol Abuse: A Dangerous Cocktail

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Since the COVID-19 pandemic, alcoholic hand sanitizers have become widely accessible nationwide. They can pose a problem, especially for emergency departments, when alcohol-dependent patients start drinking them. One example that demonstrates the challenge of diagnosing alcohol abuse is the medical history of a young man, as reported by Mahmoud El Hussein, MD, and colleagues from Hôpital Lariboisière in Paris, France.

Presentation and History

A 26-year-old man presented with severe abdominal pain at the emergency department. Upon arrival, he was hemodynamically stable but nervous and verbally aggressive at times. The patient reported no relevant preexisting conditions and was not taking any medications.

Findings

Upon initial physical examination, the patient had a soft, diffusely tender abdomen; tachycardia; and notably poor hygiene. The patient was afebrile. An ECG confirmed the tachycardia but showed no signs of ischemia. Blood work, except for slightly elevated liver values, did not reveal any abnormalities, particularly ruling out bleeding or kidney disease.

A urease rapid test to rule out kidney stones also showed no pathologic findings. In consultation with the surgical department, a CT scan of the abdomen was performed to rule out organ perforation, volvulus, or mesenteric ischemia. Only signs of fatty liver were found.
 

A Neighbor’s Tip

During all examinations, the patient’s abdomen was repeatedly palpated to promptly detect signs of an acute abdomen. However, there was never any defense tension at any point.

Intravenous analgesics and proton pump inhibitors (ie, paracetamol, phloroglucin, and pantoprazole) did not relieve the patient’s symptoms. Morphine was administered intravenously for sedation.

Only after a frustrating diagnostic process did a neighbor of the patient inform a nurse that he suspected the patient of stealing and consuming hand sanitizer. With the patient’s consent, a blood alcohol test was performed, revealing a blood alcohol concentration of 0.2% (2 g/L). A urine test, also conducted with the patient’s consent, tested positive for tetrahydrocannabinol. Additional tests showed the following results:

  • Venous pH: 7.29 (normal, 7.32-7.38)
  • Anion gap (mEq/L): 14 (normal, 3-9)
  • Ketone bodies (mmol/L): 0.2 (normal, < 0.6)
  • Calculated serum osmolality (mOsm/kg): 292 (normal, 285-295)
  • Measured serum osmolality (mOsm/kg): 320 (normal, 285-295)
  • Osmolality gap (mOsm/kg): 2 (normal, < 10)

The patient was informed of the test results and confessed to feigning abdominal pain. He was dependent on alcohol and experiencing withdrawal symptoms. The patient had stolen seven 475-mL bottles of hand sanitizer and consumed one and a half in the past 4-6 hours. According to the authors, the sanitizer consisted of 80% ethanol, 1.45% glycerol, and 0.13% hydrogen peroxide.
 

Discussion

In Germany, alcohol consumption results in approximately €57 billion in direct economic costs annually, according to data from the Federal Ministry of Health. In 2021, about 7.9 million people aged 18-64 years consumed alcohol in a risky manner (approximately 9.6% of the German population). About 9 million people (approximately 11%) were classified as alcoholics.

The authors of the case report pointed out that those in the advanced stages of alcohol addiction often consume any alcoholic liquid they can access. This includes alcoholic hand sanitizers commonly used in hospitals. Therefore, staff in emergency departments, where potential abusers encounter a wide range of potential abuse items, should exercise caution.

Although hand sanitizers are mainly composed of ethanol, they may also contain isopropanol, methanol, or acetone. Methanol poisoning can cause abdominal pain, visual disturbances, central nervous system damage, and death. Other alcohols such as ethylene glycol, commonly found in antifreeze, can distort blood values (lactate) and complicate a correct diagnosis.

Physicians working in emergency departments should proceed with caution when suspecting alcohol abuse. Questioning the patient’s environment and determining additional laboratory parameters (such as osmolality gap in the case report) can help unmask substance abuse if it is in doubt.

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Since the COVID-19 pandemic, alcoholic hand sanitizers have become widely accessible nationwide. They can pose a problem, especially for emergency departments, when alcohol-dependent patients start drinking them. One example that demonstrates the challenge of diagnosing alcohol abuse is the medical history of a young man, as reported by Mahmoud El Hussein, MD, and colleagues from Hôpital Lariboisière in Paris, France.

Presentation and History

A 26-year-old man presented with severe abdominal pain at the emergency department. Upon arrival, he was hemodynamically stable but nervous and verbally aggressive at times. The patient reported no relevant preexisting conditions and was not taking any medications.

Findings

Upon initial physical examination, the patient had a soft, diffusely tender abdomen; tachycardia; and notably poor hygiene. The patient was afebrile. An ECG confirmed the tachycardia but showed no signs of ischemia. Blood work, except for slightly elevated liver values, did not reveal any abnormalities, particularly ruling out bleeding or kidney disease.

A urease rapid test to rule out kidney stones also showed no pathologic findings. In consultation with the surgical department, a CT scan of the abdomen was performed to rule out organ perforation, volvulus, or mesenteric ischemia. Only signs of fatty liver were found.
 

A Neighbor’s Tip

During all examinations, the patient’s abdomen was repeatedly palpated to promptly detect signs of an acute abdomen. However, there was never any defense tension at any point.

Intravenous analgesics and proton pump inhibitors (ie, paracetamol, phloroglucin, and pantoprazole) did not relieve the patient’s symptoms. Morphine was administered intravenously for sedation.

Only after a frustrating diagnostic process did a neighbor of the patient inform a nurse that he suspected the patient of stealing and consuming hand sanitizer. With the patient’s consent, a blood alcohol test was performed, revealing a blood alcohol concentration of 0.2% (2 g/L). A urine test, also conducted with the patient’s consent, tested positive for tetrahydrocannabinol. Additional tests showed the following results:

  • Venous pH: 7.29 (normal, 7.32-7.38)
  • Anion gap (mEq/L): 14 (normal, 3-9)
  • Ketone bodies (mmol/L): 0.2 (normal, < 0.6)
  • Calculated serum osmolality (mOsm/kg): 292 (normal, 285-295)
  • Measured serum osmolality (mOsm/kg): 320 (normal, 285-295)
  • Osmolality gap (mOsm/kg): 2 (normal, < 10)

The patient was informed of the test results and confessed to feigning abdominal pain. He was dependent on alcohol and experiencing withdrawal symptoms. The patient had stolen seven 475-mL bottles of hand sanitizer and consumed one and a half in the past 4-6 hours. According to the authors, the sanitizer consisted of 80% ethanol, 1.45% glycerol, and 0.13% hydrogen peroxide.
 

Discussion

In Germany, alcohol consumption results in approximately €57 billion in direct economic costs annually, according to data from the Federal Ministry of Health. In 2021, about 7.9 million people aged 18-64 years consumed alcohol in a risky manner (approximately 9.6% of the German population). About 9 million people (approximately 11%) were classified as alcoholics.

The authors of the case report pointed out that those in the advanced stages of alcohol addiction often consume any alcoholic liquid they can access. This includes alcoholic hand sanitizers commonly used in hospitals. Therefore, staff in emergency departments, where potential abusers encounter a wide range of potential abuse items, should exercise caution.

Although hand sanitizers are mainly composed of ethanol, they may also contain isopropanol, methanol, or acetone. Methanol poisoning can cause abdominal pain, visual disturbances, central nervous system damage, and death. Other alcohols such as ethylene glycol, commonly found in antifreeze, can distort blood values (lactate) and complicate a correct diagnosis.

Physicians working in emergency departments should proceed with caution when suspecting alcohol abuse. Questioning the patient’s environment and determining additional laboratory parameters (such as osmolality gap in the case report) can help unmask substance abuse if it is in doubt.

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Since the COVID-19 pandemic, alcoholic hand sanitizers have become widely accessible nationwide. They can pose a problem, especially for emergency departments, when alcohol-dependent patients start drinking them. One example that demonstrates the challenge of diagnosing alcohol abuse is the medical history of a young man, as reported by Mahmoud El Hussein, MD, and colleagues from Hôpital Lariboisière in Paris, France.

Presentation and History

A 26-year-old man presented with severe abdominal pain at the emergency department. Upon arrival, he was hemodynamically stable but nervous and verbally aggressive at times. The patient reported no relevant preexisting conditions and was not taking any medications.

Findings

Upon initial physical examination, the patient had a soft, diffusely tender abdomen; tachycardia; and notably poor hygiene. The patient was afebrile. An ECG confirmed the tachycardia but showed no signs of ischemia. Blood work, except for slightly elevated liver values, did not reveal any abnormalities, particularly ruling out bleeding or kidney disease.

A urease rapid test to rule out kidney stones also showed no pathologic findings. In consultation with the surgical department, a CT scan of the abdomen was performed to rule out organ perforation, volvulus, or mesenteric ischemia. Only signs of fatty liver were found.
 

A Neighbor’s Tip

During all examinations, the patient’s abdomen was repeatedly palpated to promptly detect signs of an acute abdomen. However, there was never any defense tension at any point.

Intravenous analgesics and proton pump inhibitors (ie, paracetamol, phloroglucin, and pantoprazole) did not relieve the patient’s symptoms. Morphine was administered intravenously for sedation.

Only after a frustrating diagnostic process did a neighbor of the patient inform a nurse that he suspected the patient of stealing and consuming hand sanitizer. With the patient’s consent, a blood alcohol test was performed, revealing a blood alcohol concentration of 0.2% (2 g/L). A urine test, also conducted with the patient’s consent, tested positive for tetrahydrocannabinol. Additional tests showed the following results:

  • Venous pH: 7.29 (normal, 7.32-7.38)
  • Anion gap (mEq/L): 14 (normal, 3-9)
  • Ketone bodies (mmol/L): 0.2 (normal, < 0.6)
  • Calculated serum osmolality (mOsm/kg): 292 (normal, 285-295)
  • Measured serum osmolality (mOsm/kg): 320 (normal, 285-295)
  • Osmolality gap (mOsm/kg): 2 (normal, < 10)

The patient was informed of the test results and confessed to feigning abdominal pain. He was dependent on alcohol and experiencing withdrawal symptoms. The patient had stolen seven 475-mL bottles of hand sanitizer and consumed one and a half in the past 4-6 hours. According to the authors, the sanitizer consisted of 80% ethanol, 1.45% glycerol, and 0.13% hydrogen peroxide.
 

Discussion

In Germany, alcohol consumption results in approximately €57 billion in direct economic costs annually, according to data from the Federal Ministry of Health. In 2021, about 7.9 million people aged 18-64 years consumed alcohol in a risky manner (approximately 9.6% of the German population). About 9 million people (approximately 11%) were classified as alcoholics.

The authors of the case report pointed out that those in the advanced stages of alcohol addiction often consume any alcoholic liquid they can access. This includes alcoholic hand sanitizers commonly used in hospitals. Therefore, staff in emergency departments, where potential abusers encounter a wide range of potential abuse items, should exercise caution.

Although hand sanitizers are mainly composed of ethanol, they may also contain isopropanol, methanol, or acetone. Methanol poisoning can cause abdominal pain, visual disturbances, central nervous system damage, and death. Other alcohols such as ethylene glycol, commonly found in antifreeze, can distort blood values (lactate) and complicate a correct diagnosis.

Physicians working in emergency departments should proceed with caution when suspecting alcohol abuse. Questioning the patient’s environment and determining additional laboratory parameters (such as osmolality gap in the case report) can help unmask substance abuse if it is in doubt.

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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