Anxiety Disorders

TOPLINE:

Postpartum exercise reduces the severity of depressive and anxiety symptoms. Initiating exercise within 12 weeks post partum is linked to greater reductions in depressive symptoms.

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis including 35 studies with a total of 4072 participants.
• The review included randomized controlled trials and nonrandomized interventions examining the impact of postpartum exercise on depression and anxiety.
• Participants were postpartum individuals within the first year after childbirth, with interventions including various types of exercise.
• Data sources included online databases with data up to January 2024, reference lists, and hand searches.
• The Grading of Recommendations, Assessment, Development, and Evaluation framework was used to assess the certainty of evidence.

TAKEAWAY:

• Postpartum exercise-only interventions resulted in a moderate reduction in the severity of depressive symptoms (standardized mean difference [SMD], –0.52; 95% CI, –0.80 to –0.24).
• Exercise-only interventions were associated with a small reduction in the severity of anxiety symptoms (SMD, –0.25; 95% CI, –0.43 to –0.08).
• Initiating exercise within 12 weeks post partum was associated with a greater reduction in depressive symptoms, compared with starting later.
• Postpartum exercise was associated with a 45% reduction in the odds of developing depression (odds ratio, 0.55; 95% CI, 0.32-0.95).

IN PRACTICE:

“Further investigation should aim to investigate the effects of postpartum exercise in individuals who experienced perinatal complications and in those who had limitations to exercise during pregnancy. Additionally, more investigation is required to address the possible lasting effects of postpartum exercise on maternal mental health as there were very limited studies reporting on this outcome,” the authors of the study wrote.

SOURCE:

This study was led by Margie H. Davenport, University of Alberta in Edmonton, Canada. It was published online in British Journal of Sports Medicine.

LIMITATIONS:

This study’s limitations included high heterogeneity among included studies, small sample sizes in some studies, and the combination of exercise with other interventions in some cases. These factors may have affected the generalizability and precision of the findings.

DISCLOSURES:

This study was funded by the Christenson Professorship in Active Healthy Living. Davenport is funded by a Christenson Professorship in Active Healthy Living. One coauthor is funded by the Université du Québec à Trois-Rivières research chair in physical activity and maternal and neonatal health. No relevant conflicts of interest were disclosed by the authors.

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:

Postpartum exercise reduces the severity of depressive and anxiety symptoms. Initiating exercise within 12 weeks post partum is linked to greater reductions in depressive symptoms.

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis including 35 studies with a total of 4072 participants.
• The review included randomized controlled trials and nonrandomized interventions examining the impact of postpartum exercise on depression and anxiety.
• Participants were postpartum individuals within the first year after childbirth, with interventions including various types of exercise.
• Data sources included online databases with data up to January 2024, reference lists, and hand searches.
• The Grading of Recommendations, Assessment, Development, and Evaluation framework was used to assess the certainty of evidence.

TAKEAWAY:

• Postpartum exercise-only interventions resulted in a moderate reduction in the severity of depressive symptoms (standardized mean difference [SMD], –0.52; 95% CI, –0.80 to –0.24).
• Exercise-only interventions were associated with a small reduction in the severity of anxiety symptoms (SMD, –0.25; 95% CI, –0.43 to –0.08).
• Initiating exercise within 12 weeks post partum was associated with a greater reduction in depressive symptoms, compared with starting later.
• Postpartum exercise was associated with a 45% reduction in the odds of developing depression (odds ratio, 0.55; 95% CI, 0.32-0.95).

IN PRACTICE:

“Further investigation should aim to investigate the effects of postpartum exercise in individuals who experienced perinatal complications and in those who had limitations to exercise during pregnancy. Additionally, more investigation is required to address the possible lasting effects of postpartum exercise on maternal mental health as there were very limited studies reporting on this outcome,” the authors of the study wrote.

SOURCE:

This study was led by Margie H. Davenport, University of Alberta in Edmonton, Canada. It was published online in British Journal of Sports Medicine.

LIMITATIONS:

This study’s limitations included high heterogeneity among included studies, small sample sizes in some studies, and the combination of exercise with other interventions in some cases. These factors may have affected the generalizability and precision of the findings.

DISCLOSURES:

This study was funded by the Christenson Professorship in Active Healthy Living. Davenport is funded by a Christenson Professorship in Active Healthy Living. One coauthor is funded by the Université du Québec à Trois-Rivières research chair in physical activity and maternal and neonatal health. No relevant conflicts of interest were disclosed by the authors.

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:

Postpartum exercise reduces the severity of depressive and anxiety symptoms. Initiating exercise within 12 weeks post partum is linked to greater reductions in depressive symptoms.

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis including 35 studies with a total of 4072 participants.
• The review included randomized controlled trials and nonrandomized interventions examining the impact of postpartum exercise on depression and anxiety.
• Participants were postpartum individuals within the first year after childbirth, with interventions including various types of exercise.
• Data sources included online databases with data up to January 2024, reference lists, and hand searches.
• The Grading of Recommendations, Assessment, Development, and Evaluation framework was used to assess the certainty of evidence.

TAKEAWAY:

• Postpartum exercise-only interventions resulted in a moderate reduction in the severity of depressive symptoms (standardized mean difference [SMD], –0.52; 95% CI, –0.80 to –0.24).
• Exercise-only interventions were associated with a small reduction in the severity of anxiety symptoms (SMD, –0.25; 95% CI, –0.43 to –0.08).
• Initiating exercise within 12 weeks post partum was associated with a greater reduction in depressive symptoms, compared with starting later.
• Postpartum exercise was associated with a 45% reduction in the odds of developing depression (odds ratio, 0.55; 95% CI, 0.32-0.95).

IN PRACTICE:

“Further investigation should aim to investigate the effects of postpartum exercise in individuals who experienced perinatal complications and in those who had limitations to exercise during pregnancy. Additionally, more investigation is required to address the possible lasting effects of postpartum exercise on maternal mental health as there were very limited studies reporting on this outcome,” the authors of the study wrote.

SOURCE:

This study was led by Margie H. Davenport, University of Alberta in Edmonton, Canada. It was published online in British Journal of Sports Medicine.

LIMITATIONS:

This study’s limitations included high heterogeneity among included studies, small sample sizes in some studies, and the combination of exercise with other interventions in some cases. These factors may have affected the generalizability and precision of the findings.

DISCLOSURES:

This study was funded by the Christenson Professorship in Active Healthy Living. Davenport is funded by a Christenson Professorship in Active Healthy Living. One coauthor is funded by the Université du Québec à Trois-Rivières research chair in physical activity and maternal and neonatal health. No relevant conflicts of interest were disclosed by the authors.

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.

Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. The connections between health and climate have been recognized by physicians and patients even when climatology did not have the status of an exact science. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.

Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
 

Extreme Rainfall and Health

The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.

The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
 

Rain and Mortality

Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.

The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.

The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
 

Points of Concern

According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:

• Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
• Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
• Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.

The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.

The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.

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.

Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. The connections between health and climate have been recognized by physicians and patients even when climatology did not have the status of an exact science. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.

Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
 

Extreme Rainfall and Health

The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.

The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
 

Rain and Mortality

Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.

The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.

The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
 

Points of Concern

According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:

• Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
• Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
• Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.

The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.

The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.

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.

Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. The connections between health and climate have been recognized by physicians and patients even when climatology did not have the status of an exact science. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.

Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
 

Extreme Rainfall and Health

The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.

The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
 

Rain and Mortality

Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.

The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.

The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
 

Points of Concern

According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:

• Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
• Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
• Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.

The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.

The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.

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.

The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.

Duloxetine (Cymbalta) is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy.

The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.

Nitrosamines are common in water and foods, and exposure to some levels of the chemical is common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.

“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website.

The recall was initiated by Breckenridge Pharmaceutical and covers 7107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI.

The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.

The recall was initiated on October 10 and is ongoing.

“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled. Prescribers may also determine whether there is an alternative treatment option for patients.”

The FDA has labeled this a “class II” recall, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.

The impurities may be found in drugs for a number of reasons, the agency reported. The source may be from a drug’s manufacturing process, chemical structure, or the conditions under which it is stored or packaged.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.

Duloxetine (Cymbalta) is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy.

The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.

Nitrosamines are common in water and foods, and exposure to some levels of the chemical is common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.

“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website.

The recall was initiated by Breckenridge Pharmaceutical and covers 7107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI.

The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.

The recall was initiated on October 10 and is ongoing.

“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled. Prescribers may also determine whether there is an alternative treatment option for patients.”

The FDA has labeled this a “class II” recall, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.

The impurities may be found in drugs for a number of reasons, the agency reported. The source may be from a drug’s manufacturing process, chemical structure, or the conditions under which it is stored or packaged.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.

Duloxetine (Cymbalta) is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy.

The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.

Nitrosamines are common in water and foods, and exposure to some levels of the chemical is common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.

“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website.

The recall was initiated by Breckenridge Pharmaceutical and covers 7107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI.

The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.

The recall was initiated on October 10 and is ongoing.

“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled. Prescribers may also determine whether there is an alternative treatment option for patients.”

The FDA has labeled this a “class II” recall, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.

The impurities may be found in drugs for a number of reasons, the agency reported. The source may be from a drug’s manufacturing process, chemical structure, or the conditions under which it is stored or packaged.
 

A version of this article appeared on Medscape.com.

Premenstrual disorders (PMDs), including premenstrual dysphoric disorder (PMDD), adversely affect the lives of millions of women worldwide. Most girls and women — as many as 80%-90%— will experience some premenstrual discomfort such as irritability, depressed mood, food or alcohol cravings, bloating, body aches, breast pain, constipation, or fatigue.

Diagnosable menstrual disorders include, collectively, premenstrual syndrome (PMS); PMDD, formerly called late luteal phase dysphoric disorder; and premenstrual worsening of another medical condition.

The most debilitating of these is PMDD, which has an estimated prevalence of about 4%-8% in women of reproductive age, according to obstetrician/gynecologist Hoosna Haque, MD, assistant professor of medicine at Columbia University Irving Medical Center in New York City.

“It’s difficult to be sure because this condition is underreported,” said Luu D. Ireland, MD, MPH, assistant professor of obstetrics and gynecology at UMass Memorial Medical Center in Worcester, Massachusetts. “But more women are coming forward, and there’s more discussion and media coverage of this condition.”

Occurring in the same post-follicular timeframe as PMS, PMDD takes cyclical discomfort to a more intense level, with a trifecta of affective comorbidities, somatic manifestations, and behavioral changes, all of which can seriously impair daily functioning, including work, physical activities, and personal relationships. Romantic and marital relationships can be particularly impaired.

Although recent cost figures are lacking, PMDs exact a considerable economic toll with increased direct healthcare costs from doctor visits and pharmaceuticals. A 2010 study found that US women with PMS were more likely to accrue in excess of $500 in healthcare visit costs over 2 years, and the figure would likely be higher today. PMDs also increase work/school absenteeism and reduce productivity.
 

Etiology

Brain areas that regulate emotion and behavior contain receptors for estrogen, progesterone, and other sex hormones, which affect the functioning of neurotransmitter systems influencing mood and thinking. Although the precise pathophysiology remains unclear, PMDD is likely multifactorial and results in a heightened sensitivity to normal fluctuations in estrogen and progesterone during the luteal phase of the menstrual cycle and dysfunction of the serotonin and gamma-aminobutyric acid neurotransmitter systems.

Patients with PMDD have lower levels of cortisol and beta-endorphins during both the follicular and luteal phases, suggesting abnormalities in the hypothalamic-pituitary-gonadal axis (HPGA), which is consistent with dysregulation in mood disorders.
 

Risk Factors

These include family history, past traumatic events, smoking, chronic pain syndrome, and obesity. There may be a genetic component as recent studies have suggested the involvement of the gene that codes for the serotonergic 5HT1A receptor and allelic variants of ESR1 in the development of PMS/PMDD.

A particularly concerning aspect of PMDs of any sort is their possible association with a higher risk for death from non-natural causes. In a recent Swedish study, which did not distinguish between PMDs in general and PMDD in particular, patients had an almost 60% greater risk for death from non-natural causes and nearly twice the risk for death by suicide compared with women without PMDs.

Those diagnosed with a PMD at an early age showed excess mortality, and the risk for suicide was elevated regardless of age. “These findings support the need for careful follow-up for young women with PMDs and the need for suicide prevention strategies,” wrote lead author Marion Opatowski, PhD, a medical epidemiologist at Karolinska Institutet in Stockholm, Sweden. “Women with severe PMDD should definitely be monitored for suicidal thoughts or behavior and they should have an emergency outreach plan in place,” Haque added.
 

Diagnosis

Although the somatic manifestations of PMDD resemble those of PMS, they are more severe and associated psychological symptoms are greater. “In my experience, PMDD symptoms can last the whole 2 weeks of the luteal phase, whereas PMS might occur a couple of days before menstruation,” said Ireland.

Symptoms include labile mood, nervousness, hopelessness, anger and aggressiveness, as well as tension and irritability. Those affected may have suicidal thoughts or even behaviors. In addition to a lethargic loss of interest in normal activities, patients with PMDD may feel paranoid, confused, exhausted, or out of control and experience insomnia or hypersomnia. They may have trouble concentrating or remembering. Some patients with PMDD may already be prone to attention-deficit/hyperactivity disorder and non–cycle-related depression, anxiety, and panic attacks.

Diagnosis is based on the presence of any five of the typical affective, somatic, or behavioral symptoms outlined above in the week before onset of menses.

“It’s important to do a careful diagnosis for PMDD and rule out other underlying conditions such as existing depressive or anxiety disorders,” said Haque. “Symptoms tend to be more intense in periods of high hormonal fluctuation such as in the postpartum and perimenopause periods. Women with PMDD should be monitored for postpartum depression.”

PMDD is considered both a gynecologic-genitourinary disorder and an affective condition.

In 2013, it was controversially included as a depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Strongly advocated by some patients, psychiatrists, and pharmaceutical companies, its inclusion was criticized by psychologists and generalists, who feared it would lead to overdiagnosis and pathologization of normal female hormonal changes. Women’s advocates protested that this inclusion would stigmatize female biology and harm their advance in society and the workplace, while some doctors continued to dismiss PMDD as not a serious concern.
 

Treatments

In its latest clinical practice guideline on PMDs, the American College of Obstetricians and Gynecologists (ACOG), for which Ireland served as the lead author, recommends that most patients with PMDD get medical treatment and outlines the following therapies, based on varying degrees of evidence strength.

Antidepressants. These may benefit patients with strong affective symptoms. Selective serotonin reuptake inhibitors such as sertraline (Zoloft), citalopram (Celexa), escitalopram (Lexapro), or fluoxetine (Prozac) are first choices.

Antidepressants may interrupt aberrant signaling in the HPGA, the circuit linking brain and ovaries and regulating the reproductive cycle. Serotonin norepinephrine reuptake inhibitor venlafaxine (Effexor) may also improve symptoms, but other types of antidepressants have not proven effective.

“The response to these well-tolerated drugs is rapid and can happen in the first 2 days,” said Ireland. The drugs may be taken either just in the luteal period or over the month, especially by patients with chronic depression or anxiety.

Hormonal therapy. ACOG recommends the use of combined oral contraceptives (COCs), gonadotropin-releasing hormone (GnRH) agonists to induce anovulation (with combined add-back hormones), progestin-only methods, and noncontraceptive continuous estrogen formulations. It notes, however, that COCs have not been more effective than placebo in reducing depressive symptom scores.

If symptoms do not improve over two to three cycles, an alternate therapy should be considered. Haque recommends an assessment after three cycles and then yearly.

Some women in her practice take both antidepressant and hormone therapy. “Unfortunately, there are no new pharmaceutical treatments on the horizon, but we have good ones already and we would love for patients to utilize them more often,” Ireland said.

Nonsteroidal anti-inflammatory drugs. Limited evidence shows these may reduce physical symptoms such as abdominal cramps, headaches, and general body aches, as well as some mood-related symptoms, which may be an indirect effect of pain alleviation.

Surgery. For women with the most severe intractable symptoms, bilateral oophorectomy with or without hysterectomy may be a last-resort option when medical management has failed. A trial period of GnRH agonist therapy (with or without adjunctive estrogen add-back treatment) is advised before surgery to predict a patient’s response to surgical management.

Acupuncture. ACOG suggests that acupuncture may help manage physical and affective premenstrual symptoms.

Diet. The usual dietary advice for premenstrual symptoms — such as consuming less caffeine, sugar, or alcohol and eating smaller, more frequent meals — is unlikely to help women with PMDD.

Exercise. Although it has not been well studied for PMDD, aerobic exercises such as walking, swimming, and biking tend to improve mood and energy levels in general. Exercise may reduce symptoms through several pathways, including effects on beta-endorphin, cortisol, and ovarian hormone levels.

Supplements. Vitamin B6, calcium and magnesium supplements, and herbal remedies are not supported by consistent or compelling evidence of efficacy. ACOG conditionally recommends calcium supplementation of 100-200 mg/d in adults to help manage physical and affective symptoms.

A small study suggested that supplemental zinc may improve both physical and psychological symptoms.

Cognitive-behavioral therapy. This treatment aims to interrupt negative and irrational thought patterns and may include awareness and education, as well as relaxation techniques, problem-solving and coping skills, and stress management. It has been associated with small to moderate improvement in anxiety and depression, said Ireland.

Peer support. Patients should consider joining a support group. The International Association for Premenstrual Disorders can help patients connect and develop coping skills.

The bottom line is that people with strong symptomatic evidence of PMDD should have medical intervention — to the benefit of their health and quality of life. Screening for PMDD should be part of women’s wellness examinations, said Ireland. “The impact of PMDD should not be minimized or dismissed,” said Haque. “And patients need to know there are very effective treatments.”

Ireland and Haque had no competing interests with regard to their comments.
 

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

Premenstrual disorders (PMDs), including premenstrual dysphoric disorder (PMDD), adversely affect the lives of millions of women worldwide. Most girls and women — as many as 80%-90%— will experience some premenstrual discomfort such as irritability, depressed mood, food or alcohol cravings, bloating, body aches, breast pain, constipation, or fatigue.

Diagnosable menstrual disorders include, collectively, premenstrual syndrome (PMS); PMDD, formerly called late luteal phase dysphoric disorder; and premenstrual worsening of another medical condition.

The most debilitating of these is PMDD, which has an estimated prevalence of about 4%-8% in women of reproductive age, according to obstetrician/gynecologist Hoosna Haque, MD, assistant professor of medicine at Columbia University Irving Medical Center in New York City.

“It’s difficult to be sure because this condition is underreported,” said Luu D. Ireland, MD, MPH, assistant professor of obstetrics and gynecology at UMass Memorial Medical Center in Worcester, Massachusetts. “But more women are coming forward, and there’s more discussion and media coverage of this condition.”

Occurring in the same post-follicular timeframe as PMS, PMDD takes cyclical discomfort to a more intense level, with a trifecta of affective comorbidities, somatic manifestations, and behavioral changes, all of which can seriously impair daily functioning, including work, physical activities, and personal relationships. Romantic and marital relationships can be particularly impaired.

Although recent cost figures are lacking, PMDs exact a considerable economic toll with increased direct healthcare costs from doctor visits and pharmaceuticals. A 2010 study found that US women with PMS were more likely to accrue in excess of $500 in healthcare visit costs over 2 years, and the figure would likely be higher today. PMDs also increase work/school absenteeism and reduce productivity.
 

Etiology

Brain areas that regulate emotion and behavior contain receptors for estrogen, progesterone, and other sex hormones, which affect the functioning of neurotransmitter systems influencing mood and thinking. Although the precise pathophysiology remains unclear, PMDD is likely multifactorial and results in a heightened sensitivity to normal fluctuations in estrogen and progesterone during the luteal phase of the menstrual cycle and dysfunction of the serotonin and gamma-aminobutyric acid neurotransmitter systems.

Patients with PMDD have lower levels of cortisol and beta-endorphins during both the follicular and luteal phases, suggesting abnormalities in the hypothalamic-pituitary-gonadal axis (HPGA), which is consistent with dysregulation in mood disorders.
 

Risk Factors

These include family history, past traumatic events, smoking, chronic pain syndrome, and obesity. There may be a genetic component as recent studies have suggested the involvement of the gene that codes for the serotonergic 5HT1A receptor and allelic variants of ESR1 in the development of PMS/PMDD.

A particularly concerning aspect of PMDs of any sort is their possible association with a higher risk for death from non-natural causes. In a recent Swedish study, which did not distinguish between PMDs in general and PMDD in particular, patients had an almost 60% greater risk for death from non-natural causes and nearly twice the risk for death by suicide compared with women without PMDs.

Those diagnosed with a PMD at an early age showed excess mortality, and the risk for suicide was elevated regardless of age. “These findings support the need for careful follow-up for young women with PMDs and the need for suicide prevention strategies,” wrote lead author Marion Opatowski, PhD, a medical epidemiologist at Karolinska Institutet in Stockholm, Sweden. “Women with severe PMDD should definitely be monitored for suicidal thoughts or behavior and they should have an emergency outreach plan in place,” Haque added.
 

Diagnosis

Although the somatic manifestations of PMDD resemble those of PMS, they are more severe and associated psychological symptoms are greater. “In my experience, PMDD symptoms can last the whole 2 weeks of the luteal phase, whereas PMS might occur a couple of days before menstruation,” said Ireland.

Symptoms include labile mood, nervousness, hopelessness, anger and aggressiveness, as well as tension and irritability. Those affected may have suicidal thoughts or even behaviors. In addition to a lethargic loss of interest in normal activities, patients with PMDD may feel paranoid, confused, exhausted, or out of control and experience insomnia or hypersomnia. They may have trouble concentrating or remembering. Some patients with PMDD may already be prone to attention-deficit/hyperactivity disorder and non–cycle-related depression, anxiety, and panic attacks.

Diagnosis is based on the presence of any five of the typical affective, somatic, or behavioral symptoms outlined above in the week before onset of menses.

“It’s important to do a careful diagnosis for PMDD and rule out other underlying conditions such as existing depressive or anxiety disorders,” said Haque. “Symptoms tend to be more intense in periods of high hormonal fluctuation such as in the postpartum and perimenopause periods. Women with PMDD should be monitored for postpartum depression.”

PMDD is considered both a gynecologic-genitourinary disorder and an affective condition.

In 2013, it was controversially included as a depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Strongly advocated by some patients, psychiatrists, and pharmaceutical companies, its inclusion was criticized by psychologists and generalists, who feared it would lead to overdiagnosis and pathologization of normal female hormonal changes. Women’s advocates protested that this inclusion would stigmatize female biology and harm their advance in society and the workplace, while some doctors continued to dismiss PMDD as not a serious concern.
 

Treatments

In its latest clinical practice guideline on PMDs, the American College of Obstetricians and Gynecologists (ACOG), for which Ireland served as the lead author, recommends that most patients with PMDD get medical treatment and outlines the following therapies, based on varying degrees of evidence strength.

Antidepressants. These may benefit patients with strong affective symptoms. Selective serotonin reuptake inhibitors such as sertraline (Zoloft), citalopram (Celexa), escitalopram (Lexapro), or fluoxetine (Prozac) are first choices.

Antidepressants may interrupt aberrant signaling in the HPGA, the circuit linking brain and ovaries and regulating the reproductive cycle. Serotonin norepinephrine reuptake inhibitor venlafaxine (Effexor) may also improve symptoms, but other types of antidepressants have not proven effective.

“The response to these well-tolerated drugs is rapid and can happen in the first 2 days,” said Ireland. The drugs may be taken either just in the luteal period or over the month, especially by patients with chronic depression or anxiety.

Hormonal therapy. ACOG recommends the use of combined oral contraceptives (COCs), gonadotropin-releasing hormone (GnRH) agonists to induce anovulation (with combined add-back hormones), progestin-only methods, and noncontraceptive continuous estrogen formulations. It notes, however, that COCs have not been more effective than placebo in reducing depressive symptom scores.

If symptoms do not improve over two to three cycles, an alternate therapy should be considered. Haque recommends an assessment after three cycles and then yearly.

Some women in her practice take both antidepressant and hormone therapy. “Unfortunately, there are no new pharmaceutical treatments on the horizon, but we have good ones already and we would love for patients to utilize them more often,” Ireland said.

Nonsteroidal anti-inflammatory drugs. Limited evidence shows these may reduce physical symptoms such as abdominal cramps, headaches, and general body aches, as well as some mood-related symptoms, which may be an indirect effect of pain alleviation.

Surgery. For women with the most severe intractable symptoms, bilateral oophorectomy with or without hysterectomy may be a last-resort option when medical management has failed. A trial period of GnRH agonist therapy (with or without adjunctive estrogen add-back treatment) is advised before surgery to predict a patient’s response to surgical management.

Acupuncture. ACOG suggests that acupuncture may help manage physical and affective premenstrual symptoms.

Diet. The usual dietary advice for premenstrual symptoms — such as consuming less caffeine, sugar, or alcohol and eating smaller, more frequent meals — is unlikely to help women with PMDD.

Exercise. Although it has not been well studied for PMDD, aerobic exercises such as walking, swimming, and biking tend to improve mood and energy levels in general. Exercise may reduce symptoms through several pathways, including effects on beta-endorphin, cortisol, and ovarian hormone levels.

Supplements. Vitamin B6, calcium and magnesium supplements, and herbal remedies are not supported by consistent or compelling evidence of efficacy. ACOG conditionally recommends calcium supplementation of 100-200 mg/d in adults to help manage physical and affective symptoms.

A small study suggested that supplemental zinc may improve both physical and psychological symptoms.

Cognitive-behavioral therapy. This treatment aims to interrupt negative and irrational thought patterns and may include awareness and education, as well as relaxation techniques, problem-solving and coping skills, and stress management. It has been associated with small to moderate improvement in anxiety and depression, said Ireland.

Peer support. Patients should consider joining a support group. The International Association for Premenstrual Disorders can help patients connect and develop coping skills.

The bottom line is that people with strong symptomatic evidence of PMDD should have medical intervention — to the benefit of their health and quality of life. Screening for PMDD should be part of women’s wellness examinations, said Ireland. “The impact of PMDD should not be minimized or dismissed,” said Haque. “And patients need to know there are very effective treatments.”

Ireland and Haque had no competing interests with regard to their comments.
 

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

Premenstrual disorders (PMDs), including premenstrual dysphoric disorder (PMDD), adversely affect the lives of millions of women worldwide. Most girls and women — as many as 80%-90%— will experience some premenstrual discomfort such as irritability, depressed mood, food or alcohol cravings, bloating, body aches, breast pain, constipation, or fatigue.

Diagnosable menstrual disorders include, collectively, premenstrual syndrome (PMS); PMDD, formerly called late luteal phase dysphoric disorder; and premenstrual worsening of another medical condition.

The most debilitating of these is PMDD, which has an estimated prevalence of about 4%-8% in women of reproductive age, according to obstetrician/gynecologist Hoosna Haque, MD, assistant professor of medicine at Columbia University Irving Medical Center in New York City.

“It’s difficult to be sure because this condition is underreported,” said Luu D. Ireland, MD, MPH, assistant professor of obstetrics and gynecology at UMass Memorial Medical Center in Worcester, Massachusetts. “But more women are coming forward, and there’s more discussion and media coverage of this condition.”

Occurring in the same post-follicular timeframe as PMS, PMDD takes cyclical discomfort to a more intense level, with a trifecta of affective comorbidities, somatic manifestations, and behavioral changes, all of which can seriously impair daily functioning, including work, physical activities, and personal relationships. Romantic and marital relationships can be particularly impaired.

Although recent cost figures are lacking, PMDs exact a considerable economic toll with increased direct healthcare costs from doctor visits and pharmaceuticals. A 2010 study found that US women with PMS were more likely to accrue in excess of $500 in healthcare visit costs over 2 years, and the figure would likely be higher today. PMDs also increase work/school absenteeism and reduce productivity.
 

Etiology

Brain areas that regulate emotion and behavior contain receptors for estrogen, progesterone, and other sex hormones, which affect the functioning of neurotransmitter systems influencing mood and thinking. Although the precise pathophysiology remains unclear, PMDD is likely multifactorial and results in a heightened sensitivity to normal fluctuations in estrogen and progesterone during the luteal phase of the menstrual cycle and dysfunction of the serotonin and gamma-aminobutyric acid neurotransmitter systems.

Patients with PMDD have lower levels of cortisol and beta-endorphins during both the follicular and luteal phases, suggesting abnormalities in the hypothalamic-pituitary-gonadal axis (HPGA), which is consistent with dysregulation in mood disorders.
 

Risk Factors

These include family history, past traumatic events, smoking, chronic pain syndrome, and obesity. There may be a genetic component as recent studies have suggested the involvement of the gene that codes for the serotonergic 5HT1A receptor and allelic variants of ESR1 in the development of PMS/PMDD.

A particularly concerning aspect of PMDs of any sort is their possible association with a higher risk for death from non-natural causes. In a recent Swedish study, which did not distinguish between PMDs in general and PMDD in particular, patients had an almost 60% greater risk for death from non-natural causes and nearly twice the risk for death by suicide compared with women without PMDs.

Those diagnosed with a PMD at an early age showed excess mortality, and the risk for suicide was elevated regardless of age. “These findings support the need for careful follow-up for young women with PMDs and the need for suicide prevention strategies,” wrote lead author Marion Opatowski, PhD, a medical epidemiologist at Karolinska Institutet in Stockholm, Sweden. “Women with severe PMDD should definitely be monitored for suicidal thoughts or behavior and they should have an emergency outreach plan in place,” Haque added.
 

Diagnosis

Although the somatic manifestations of PMDD resemble those of PMS, they are more severe and associated psychological symptoms are greater. “In my experience, PMDD symptoms can last the whole 2 weeks of the luteal phase, whereas PMS might occur a couple of days before menstruation,” said Ireland.

Symptoms include labile mood, nervousness, hopelessness, anger and aggressiveness, as well as tension and irritability. Those affected may have suicidal thoughts or even behaviors. In addition to a lethargic loss of interest in normal activities, patients with PMDD may feel paranoid, confused, exhausted, or out of control and experience insomnia or hypersomnia. They may have trouble concentrating or remembering. Some patients with PMDD may already be prone to attention-deficit/hyperactivity disorder and non–cycle-related depression, anxiety, and panic attacks.

Diagnosis is based on the presence of any five of the typical affective, somatic, or behavioral symptoms outlined above in the week before onset of menses.

“It’s important to do a careful diagnosis for PMDD and rule out other underlying conditions such as existing depressive or anxiety disorders,” said Haque. “Symptoms tend to be more intense in periods of high hormonal fluctuation such as in the postpartum and perimenopause periods. Women with PMDD should be monitored for postpartum depression.”

PMDD is considered both a gynecologic-genitourinary disorder and an affective condition.

In 2013, it was controversially included as a depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Strongly advocated by some patients, psychiatrists, and pharmaceutical companies, its inclusion was criticized by psychologists and generalists, who feared it would lead to overdiagnosis and pathologization of normal female hormonal changes. Women’s advocates protested that this inclusion would stigmatize female biology and harm their advance in society and the workplace, while some doctors continued to dismiss PMDD as not a serious concern.
 

Treatments

In its latest clinical practice guideline on PMDs, the American College of Obstetricians and Gynecologists (ACOG), for which Ireland served as the lead author, recommends that most patients with PMDD get medical treatment and outlines the following therapies, based on varying degrees of evidence strength.

Antidepressants. These may benefit patients with strong affective symptoms. Selective serotonin reuptake inhibitors such as sertraline (Zoloft), citalopram (Celexa), escitalopram (Lexapro), or fluoxetine (Prozac) are first choices.

Antidepressants may interrupt aberrant signaling in the HPGA, the circuit linking brain and ovaries and regulating the reproductive cycle. Serotonin norepinephrine reuptake inhibitor venlafaxine (Effexor) may also improve symptoms, but other types of antidepressants have not proven effective.

“The response to these well-tolerated drugs is rapid and can happen in the first 2 days,” said Ireland. The drugs may be taken either just in the luteal period or over the month, especially by patients with chronic depression or anxiety.

Hormonal therapy. ACOG recommends the use of combined oral contraceptives (COCs), gonadotropin-releasing hormone (GnRH) agonists to induce anovulation (with combined add-back hormones), progestin-only methods, and noncontraceptive continuous estrogen formulations. It notes, however, that COCs have not been more effective than placebo in reducing depressive symptom scores.

If symptoms do not improve over two to three cycles, an alternate therapy should be considered. Haque recommends an assessment after three cycles and then yearly.

Some women in her practice take both antidepressant and hormone therapy. “Unfortunately, there are no new pharmaceutical treatments on the horizon, but we have good ones already and we would love for patients to utilize them more often,” Ireland said.

Nonsteroidal anti-inflammatory drugs. Limited evidence shows these may reduce physical symptoms such as abdominal cramps, headaches, and general body aches, as well as some mood-related symptoms, which may be an indirect effect of pain alleviation.

Surgery. For women with the most severe intractable symptoms, bilateral oophorectomy with or without hysterectomy may be a last-resort option when medical management has failed. A trial period of GnRH agonist therapy (with or without adjunctive estrogen add-back treatment) is advised before surgery to predict a patient’s response to surgical management.

Acupuncture. ACOG suggests that acupuncture may help manage physical and affective premenstrual symptoms.

Diet. The usual dietary advice for premenstrual symptoms — such as consuming less caffeine, sugar, or alcohol and eating smaller, more frequent meals — is unlikely to help women with PMDD.

Exercise. Although it has not been well studied for PMDD, aerobic exercises such as walking, swimming, and biking tend to improve mood and energy levels in general. Exercise may reduce symptoms through several pathways, including effects on beta-endorphin, cortisol, and ovarian hormone levels.

Supplements. Vitamin B6, calcium and magnesium supplements, and herbal remedies are not supported by consistent or compelling evidence of efficacy. ACOG conditionally recommends calcium supplementation of 100-200 mg/d in adults to help manage physical and affective symptoms.

A small study suggested that supplemental zinc may improve both physical and psychological symptoms.

Cognitive-behavioral therapy. This treatment aims to interrupt negative and irrational thought patterns and may include awareness and education, as well as relaxation techniques, problem-solving and coping skills, and stress management. It has been associated with small to moderate improvement in anxiety and depression, said Ireland.

Peer support. Patients should consider joining a support group. The International Association for Premenstrual Disorders can help patients connect and develop coping skills.

The bottom line is that people with strong symptomatic evidence of PMDD should have medical intervention — to the benefit of their health and quality of life. Screening for PMDD should be part of women’s wellness examinations, said Ireland. “The impact of PMDD should not be minimized or dismissed,” said Haque. “And patients need to know there are very effective treatments.”

Ireland and Haque had no competing interests with regard to their comments.
 

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

TOPLINE:

About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.

METHODOLOGY:

• Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
• This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
• Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
• Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
• Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
•  

TAKEAWAY:

• Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
• Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
• Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
• Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
•  

IN PRACTICE:

“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.

SOURCE:

The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.

DISCLOSURES:

The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.

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:

About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.

METHODOLOGY:

• Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
• This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
• Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
• Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
• Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
•  

TAKEAWAY:

• Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
• Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
• Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
• Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
•  

IN PRACTICE:

“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.

SOURCE:

The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.

DISCLOSURES:

The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.

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:

About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.

METHODOLOGY:

• Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
• This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
• Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
• Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
• Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
•  

TAKEAWAY:

• Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
• Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
• Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
• Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
•  

IN PRACTICE:

“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.

SOURCE:

The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.

DISCLOSURES:

The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.

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.

As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.

However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.

This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.

So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
 

What the Research Shows

Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.

“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.

Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.

Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.

“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.

tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.

As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.

Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.

On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.

In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.

Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
 

On-Demand Brain Stim

As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.

Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.

So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.

In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.

Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.

Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”

Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
 

A Quick Fix for a Broken System?

Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.

“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.

There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.

“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.

Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”

“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.

As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.

He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.

In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.

“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.

“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
 

Ethical Considerations

Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.

“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.

In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.

On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.

The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.

“This raises concerns because the way you use the device is important,” he said.

Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.

This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.

“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.

Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.

Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.

Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
 

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

As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.

However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.

This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.

So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
 

What the Research Shows

Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.

“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.

Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.

Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.

“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.

tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.

As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.

Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.

On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.

In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.

Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
 

On-Demand Brain Stim

As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.

Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.

So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.

In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.

Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.

Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”

Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
 

A Quick Fix for a Broken System?

Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.

“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.

There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.

“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.

Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”

“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.

As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.

He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.

In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.

“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.

“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
 

Ethical Considerations

Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.

“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.

In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.

On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.

The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.

“This raises concerns because the way you use the device is important,” he said.

Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.

This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.

“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.

Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.

Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.

Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
 

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

As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.

However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.

This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.

So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
 

What the Research Shows

Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.

“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.

Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.

Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.

“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.

tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.

As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.

Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.

On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.

In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.

Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
 

On-Demand Brain Stim

As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.

Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.

So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.

In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.

Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.

Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”

Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
 

A Quick Fix for a Broken System?

Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.

“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.

There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.

“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.

Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”

“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.

As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.

He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.

In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.

“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.

“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
 

Ethical Considerations

Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.

“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.

In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.

On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.

The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.

“This raises concerns because the way you use the device is important,” he said.

Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.

This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.

“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.

Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.

Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.

Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
 

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

Palliative care has proven to be one of the most promising fields for research on interventions with psychedelic substances. One of the most prominent researchers in this area was the American psychopharmacologist Roland Griffiths, PhD.

In 2016, Dr. Griffiths and his team at Johns Hopkins University in Baltimore, Maryland, published one of the most relevant contributions to the field by demonstrating in a placebo-controlled study that psilocybin can reduce depressive and anxiety symptoms in patients with cancer. The study, conducted with 51 patients diagnosed with advanced-stage cancer, compared the effects of a low dose and a high dose of psilocybin, showing that the high dose resulted in improvements in mood, quality of life, and sense of life, reducing death-related anxiety.

In 2021, after a routine examination, Dr. Griffiths himself was diagnosed with advanced colon cancer. Unexpectedly, the researcher found himself in the position of his research subjects. In an interview with The New York Times in April 2023, he stated that, after some resistance, he agreed to undergo an LSD session.

In the conversation, he revealed that he had a 50% chance of being alive by Halloween. Despite the diagnosis, he showed no discouragement. “As a scientist, I feel like a kid in a candy store, considering all the research and questions that need to be answered about psychedelics and the theme of human flourishing,” he said.

In his last months of life, in the various appearances and interviews he gave, Dr. Griffiths demonstrated a perception of life uncommon in people facing death. “I’m excited to communicate, to shake off the dust and tell people: ‘Come on, wake up!’ ”

He passed away on October 16, 2023, at age 77 years, opening new horizons for clinical research with psychedelics and becoming an example of the therapeutic potential of these substances.
 

Innovative Treatments

“I believe this will be one of the next conditions, if not the next condition, to be considered for the designation of innovative treatment in future psilocybin regulation in the United States, where the field is more advanced,” said Lucas Maia, PhD, a psychopharmacologist and researcher affiliated with the Advanced Center for Psychedelic Medicine (CAMP) at the Federal University of Rio Grande do Norte (UFRN) and the Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO) at the State University of Campinas in São Paulo, Brazil.

Currently, MDMA (for the treatment of posttraumatic stress disorder), psilocybin (for depressive disorder), and MM120 (an LSD analogue used to treat generalized anxiety disorder) are the only psychedelic substances that have received the designation of innovative treatment by the Food and Drug Administration (FDA).

In 2022, Dr. Maia and a colleague from ICARO, Ana Cláudia Mesquita Garcia, PhD, a professor at the School of Nursing at the Federal University of Alfenas in Brazil and leader of the Interdisciplinary Center for Studies in Palliative Care, published a systematic review in the Journal of Pain and Symptom Management that evaluated the use of psychedelic-assisted treatments for symptom control in patients with serious or terminal illnesses.

Of the 20 articles reviewed, 9 (45%) used LSD, 5 (25%) psilocybin, 2 (10%) dipropyltryptamine (DPT), 1 (5%) used ketamine, and 1 (5%) used MDMA. In 10% of the studies, LSD and DPT were combined. Altogether, 347 participants (54%) received LSD, 116 (18%) psilocybin, 81 (13%) LSD and DPT, 64 (10%) DPT, 18 (3%) MDMA, and 14 (2%) ketamine.

The conclusion of the study is that psychedelics provide therapeutic effects on physical, psychological, social, and existential outcomes. They are associated with a reduction in pain and improvement in sleep. A decrease in depressive and anxiety symptoms is also observed; such symptoms are common in patients with serious diseases. In addition, interpersonal relationships become closer and more empathetic. Finally, there is a reduction in the fear of death and suffering, an increase in acceptance, and a redefinition of the disease.

In 55% of the studies, the adverse effects were mild to moderate and transient. They included nausea, vomiting, dry mouth, and fatigue, as well as anxiety, panic, and hallucinations. The researchers concluded that the scarcity and difficulty of access to professional training in psychedelic-assisted treatments represent a significant challenge for the advancement of these interventions, especially in countries in the Global South.

Another systematic review and meta-analysis published in July by researchers at the University of Michigan in Ann Arbor, Michigan, included seven studies with 132 participants and showed significant improvements in quality of life, pain control, and anxiety relief after psychedelic-assisted psychotherapy with psilocybin. The combined effects indicated statistically significant reductions in anxiety symptoms after 4.0-4.5 months and after 6.0-6.5 months post administration, compared with the initial evaluations.

One of the most advanced research studies currently being conducted is led by Stephen Ross, MD, a psychiatrist affiliated with New York University’s Langone Medical Center, New York City. The phase 2b clinical study is randomized, double blind, and placebo controlled, and involves 300 participants. The study aims to evaluate the effects of psilocybin-assisted psychotherapy on psychiatric and existential distress in patients with advanced cancer. Its expected completion date is in 2027.

“We still lack effective interventions in minimizing psychological, spiritual, and existential suffering,” said Dr. Garcia. “In this sense, respecting the contraindications of a physical nature (including pre-existing illnesses at study initiation, disease staging, patient functionality level, comorbidities, concurrent pharmacological treatments, etc) and of a psychiatric nature for the use of psychedelics, depending on the clinical picture, end-of-life patients facing existential crises and psychological suffering will likely benefit more from psychedelic-assisted psychotherapy, which highlights the need for more research and the integration of this treatment into clinical practice.”
 

Changing Perceptions

Since 2021, the Cancer Institute of the State of São Paulo (Icesp) has been providing palliative treatment with ketamine — an atypical psychedelic — following a rigorous and carefully monitored clinical protocol. The substance is already used off label to treat refractory depressive disorder. In addition, in 2020, Brazil’s National Health Surveillance Agency approved the use of Spravato, an intranasal antidepressant based on the ketamine derivative esketamine.

Icesp has hospice beds for clinical oncology patients, and a pain management team evaluates which patients meet the inclusion criteria for ketamine use. In addition to difficult-to-control pain, it is important that the patient present emotional, existential, or spiritual symptoms that amplify that pain.

After this evaluation, a psychoeducation process takes place, in which the patient receives clear information about the treatment, its potential benefits and risks, and understands how ketamine can be a viable option for managing their symptoms. Finally, it is essential that the patient accept the referral and demonstrate a willingness to participate in the treatment, agreeing to the proposed terms.

The treatment takes place in a hospital environment, with an ambiance that aims to provide comfort and safety. Clinicians consider not only the substance dose (such as 0.5 mg/kg) but also the emotional state (“set”) and the treatment environment (“setting”). The experience is facilitated through psychological support for the patient during and after treatment.

According to Alessandro Campolina, MD, PhD, a researcher at the Center for Translational Oncology Research at Icesp, it is important to highlight that quality of life is intrinsically linked to the patient’s self-perception, including how they see themselves in terms of health and in the context in which they live.

The doctor explains that psychedelic interventions can provide a “window of opportunity,” allowing a qualified clinician to help the patient explore new perspectives based on their experiences.

“Often, although the intensity of pain remains the same, the way the patient perceives it can change significantly. For example, a patient may report that, despite the pain, they now feel less concerned about it because they were able to contemplate more significant aspects of their life,” said Dr. Campolina.

“This observation shows that treatment is not limited to addressing the pain or primary symptoms, but also addresses the associated suffering. While some patients have profound insights, many others experience more subtle changes that, under the guidance of a competent therapist, can turn into valuable clinical insights, thus improving quality of life and how they deal with their pathologies.”

Dr. Griffiths exemplified this in the interview with the Times when he reflected on his own cancer. He came to believe, as if guided an external observer, that “there is a meaning and a purpose in this [disease] that go beyond your understanding, and the way you are dealing with it is exactly how you should.”

Toshio Chiba, MD, chief physician of the Palliative Care Service at Icesp, emphasized that ketamine is already in use. “It is not feasible to wait years for the approval of psilocybin or for the FDA’s decision on MDMA, especially if the patient needs immediate care,” he said.

Furthermore, recreational and therapeutic uses are distinct. “It is essential to note that responsibilities are shared between the professional and the patient,” said Dr. Chiba. “In the therapeutic setting, there is an ethical and civil responsibility of the medical professional, as well as the patient actively engaging in treatment.”

Early palliative care can also facilitate the establishment of care goals. “I prefer to avoid terms like ‘coping’ or ‘fighting the disease,’” said Dr. Chiba. “Nowadays, dealing with cancer is more about coexisting with the disease properly, as treatments can last for years. 

“Of course, there are still highly lethal tumors. However, for neoplasms like breast, colorectal, and prostate cancers, we often talk about 5, 10, or even 15 years of coexistence [with the condition]. The lack of this information [about the disease, treatments, and existential issues] can generate distress in some patients, who end up excessively worrying about the future,” he added.

But palliative treatment with psychedelics as a panacea, he said.

In addition, Marcelo Falchi, MD, medical director of CAMP at UFRN, also emphasized that psychedelics are not a risk-free intervention. Substances like LSD and psilocybin, for example, can cause increases in blood pressure and tachycardia, which, may limit their use for patients at high cardiovascular risk. Crises of anxiety or dissociative symptoms also may occur, and they require mitigation strategies such as psychological support and attention to set and setting.

“But research seems to agree that the risks can be managed effectively through a diligent process, allowing for the responsible exploration of the therapeutic potential of psychedelics,” said Dr. Falchi, who is responsible for CAMP’s postgraduate course in psychedelic therapies. The program provides training in substances used in Brazil, such as ketamine and ibogaine.

The use of psychedelics in palliative care requires a significant shift in how professionals relate to patients.

Unlike in traditional practice, where the prescription is followed by quick consultations, palliative care with psychedelics requires deep and continuous involvement, as Dr. Campolina pointed out. “We joke that it’s not a high-tech specialty, but ‘high touch,’ because it demands the constant presence of the doctor or therapist with the patient. This can involve sessions of several hours, with frequent monitoring and regular contact after sessions. This dynamic emphasizes the importance of human touch and connection during the process, reflecting a new way of practicing medicine.”

In his last months of life, Dr. Griffiths sought to emphasize this point, suggesting that, from a broader perspective, doctors and patients face the same fundamental questions. “We all know we are terminal,” he said. “Essentially, we shouldn’t need a stage 4 cancer diagnosis to awaken to this reality.”

This story was translated from the Medscape Portuguese edition 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.

Palliative care has proven to be one of the most promising fields for research on interventions with psychedelic substances. One of the most prominent researchers in this area was the American psychopharmacologist Roland Griffiths, PhD.

In 2016, Dr. Griffiths and his team at Johns Hopkins University in Baltimore, Maryland, published one of the most relevant contributions to the field by demonstrating in a placebo-controlled study that psilocybin can reduce depressive and anxiety symptoms in patients with cancer. The study, conducted with 51 patients diagnosed with advanced-stage cancer, compared the effects of a low dose and a high dose of psilocybin, showing that the high dose resulted in improvements in mood, quality of life, and sense of life, reducing death-related anxiety.

In 2021, after a routine examination, Dr. Griffiths himself was diagnosed with advanced colon cancer. Unexpectedly, the researcher found himself in the position of his research subjects. In an interview with The New York Times in April 2023, he stated that, after some resistance, he agreed to undergo an LSD session.

In the conversation, he revealed that he had a 50% chance of being alive by Halloween. Despite the diagnosis, he showed no discouragement. “As a scientist, I feel like a kid in a candy store, considering all the research and questions that need to be answered about psychedelics and the theme of human flourishing,” he said.

In his last months of life, in the various appearances and interviews he gave, Dr. Griffiths demonstrated a perception of life uncommon in people facing death. “I’m excited to communicate, to shake off the dust and tell people: ‘Come on, wake up!’ ”

He passed away on October 16, 2023, at age 77 years, opening new horizons for clinical research with psychedelics and becoming an example of the therapeutic potential of these substances.
 

Innovative Treatments

“I believe this will be one of the next conditions, if not the next condition, to be considered for the designation of innovative treatment in future psilocybin regulation in the United States, where the field is more advanced,” said Lucas Maia, PhD, a psychopharmacologist and researcher affiliated with the Advanced Center for Psychedelic Medicine (CAMP) at the Federal University of Rio Grande do Norte (UFRN) and the Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO) at the State University of Campinas in São Paulo, Brazil.

Currently, MDMA (for the treatment of posttraumatic stress disorder), psilocybin (for depressive disorder), and MM120 (an LSD analogue used to treat generalized anxiety disorder) are the only psychedelic substances that have received the designation of innovative treatment by the Food and Drug Administration (FDA).

In 2022, Dr. Maia and a colleague from ICARO, Ana Cláudia Mesquita Garcia, PhD, a professor at the School of Nursing at the Federal University of Alfenas in Brazil and leader of the Interdisciplinary Center for Studies in Palliative Care, published a systematic review in the Journal of Pain and Symptom Management that evaluated the use of psychedelic-assisted treatments for symptom control in patients with serious or terminal illnesses.

Of the 20 articles reviewed, 9 (45%) used LSD, 5 (25%) psilocybin, 2 (10%) dipropyltryptamine (DPT), 1 (5%) used ketamine, and 1 (5%) used MDMA. In 10% of the studies, LSD and DPT were combined. Altogether, 347 participants (54%) received LSD, 116 (18%) psilocybin, 81 (13%) LSD and DPT, 64 (10%) DPT, 18 (3%) MDMA, and 14 (2%) ketamine.

The conclusion of the study is that psychedelics provide therapeutic effects on physical, psychological, social, and existential outcomes. They are associated with a reduction in pain and improvement in sleep. A decrease in depressive and anxiety symptoms is also observed; such symptoms are common in patients with serious diseases. In addition, interpersonal relationships become closer and more empathetic. Finally, there is a reduction in the fear of death and suffering, an increase in acceptance, and a redefinition of the disease.

In 55% of the studies, the adverse effects were mild to moderate and transient. They included nausea, vomiting, dry mouth, and fatigue, as well as anxiety, panic, and hallucinations. The researchers concluded that the scarcity and difficulty of access to professional training in psychedelic-assisted treatments represent a significant challenge for the advancement of these interventions, especially in countries in the Global South.

Another systematic review and meta-analysis published in July by researchers at the University of Michigan in Ann Arbor, Michigan, included seven studies with 132 participants and showed significant improvements in quality of life, pain control, and anxiety relief after psychedelic-assisted psychotherapy with psilocybin. The combined effects indicated statistically significant reductions in anxiety symptoms after 4.0-4.5 months and after 6.0-6.5 months post administration, compared with the initial evaluations.

One of the most advanced research studies currently being conducted is led by Stephen Ross, MD, a psychiatrist affiliated with New York University’s Langone Medical Center, New York City. The phase 2b clinical study is randomized, double blind, and placebo controlled, and involves 300 participants. The study aims to evaluate the effects of psilocybin-assisted psychotherapy on psychiatric and existential distress in patients with advanced cancer. Its expected completion date is in 2027.

“We still lack effective interventions in minimizing psychological, spiritual, and existential suffering,” said Dr. Garcia. “In this sense, respecting the contraindications of a physical nature (including pre-existing illnesses at study initiation, disease staging, patient functionality level, comorbidities, concurrent pharmacological treatments, etc) and of a psychiatric nature for the use of psychedelics, depending on the clinical picture, end-of-life patients facing existential crises and psychological suffering will likely benefit more from psychedelic-assisted psychotherapy, which highlights the need for more research and the integration of this treatment into clinical practice.”
 

Changing Perceptions

Since 2021, the Cancer Institute of the State of São Paulo (Icesp) has been providing palliative treatment with ketamine — an atypical psychedelic — following a rigorous and carefully monitored clinical protocol. The substance is already used off label to treat refractory depressive disorder. In addition, in 2020, Brazil’s National Health Surveillance Agency approved the use of Spravato, an intranasal antidepressant based on the ketamine derivative esketamine.

Icesp has hospice beds for clinical oncology patients, and a pain management team evaluates which patients meet the inclusion criteria for ketamine use. In addition to difficult-to-control pain, it is important that the patient present emotional, existential, or spiritual symptoms that amplify that pain.

After this evaluation, a psychoeducation process takes place, in which the patient receives clear information about the treatment, its potential benefits and risks, and understands how ketamine can be a viable option for managing their symptoms. Finally, it is essential that the patient accept the referral and demonstrate a willingness to participate in the treatment, agreeing to the proposed terms.

The treatment takes place in a hospital environment, with an ambiance that aims to provide comfort and safety. Clinicians consider not only the substance dose (such as 0.5 mg/kg) but also the emotional state (“set”) and the treatment environment (“setting”). The experience is facilitated through psychological support for the patient during and after treatment.

According to Alessandro Campolina, MD, PhD, a researcher at the Center for Translational Oncology Research at Icesp, it is important to highlight that quality of life is intrinsically linked to the patient’s self-perception, including how they see themselves in terms of health and in the context in which they live.

The doctor explains that psychedelic interventions can provide a “window of opportunity,” allowing a qualified clinician to help the patient explore new perspectives based on their experiences.

“Often, although the intensity of pain remains the same, the way the patient perceives it can change significantly. For example, a patient may report that, despite the pain, they now feel less concerned about it because they were able to contemplate more significant aspects of their life,” said Dr. Campolina.

“This observation shows that treatment is not limited to addressing the pain or primary symptoms, but also addresses the associated suffering. While some patients have profound insights, many others experience more subtle changes that, under the guidance of a competent therapist, can turn into valuable clinical insights, thus improving quality of life and how they deal with their pathologies.”

Dr. Griffiths exemplified this in the interview with the Times when he reflected on his own cancer. He came to believe, as if guided an external observer, that “there is a meaning and a purpose in this [disease] that go beyond your understanding, and the way you are dealing with it is exactly how you should.”

Toshio Chiba, MD, chief physician of the Palliative Care Service at Icesp, emphasized that ketamine is already in use. “It is not feasible to wait years for the approval of psilocybin or for the FDA’s decision on MDMA, especially if the patient needs immediate care,” he said.

Furthermore, recreational and therapeutic uses are distinct. “It is essential to note that responsibilities are shared between the professional and the patient,” said Dr. Chiba. “In the therapeutic setting, there is an ethical and civil responsibility of the medical professional, as well as the patient actively engaging in treatment.”

Early palliative care can also facilitate the establishment of care goals. “I prefer to avoid terms like ‘coping’ or ‘fighting the disease,’” said Dr. Chiba. “Nowadays, dealing with cancer is more about coexisting with the disease properly, as treatments can last for years. 

“Of course, there are still highly lethal tumors. However, for neoplasms like breast, colorectal, and prostate cancers, we often talk about 5, 10, or even 15 years of coexistence [with the condition]. The lack of this information [about the disease, treatments, and existential issues] can generate distress in some patients, who end up excessively worrying about the future,” he added.

But palliative treatment with psychedelics as a panacea, he said.

In addition, Marcelo Falchi, MD, medical director of CAMP at UFRN, also emphasized that psychedelics are not a risk-free intervention. Substances like LSD and psilocybin, for example, can cause increases in blood pressure and tachycardia, which, may limit their use for patients at high cardiovascular risk. Crises of anxiety or dissociative symptoms also may occur, and they require mitigation strategies such as psychological support and attention to set and setting.

“But research seems to agree that the risks can be managed effectively through a diligent process, allowing for the responsible exploration of the therapeutic potential of psychedelics,” said Dr. Falchi, who is responsible for CAMP’s postgraduate course in psychedelic therapies. The program provides training in substances used in Brazil, such as ketamine and ibogaine.

The use of psychedelics in palliative care requires a significant shift in how professionals relate to patients.

Unlike in traditional practice, where the prescription is followed by quick consultations, palliative care with psychedelics requires deep and continuous involvement, as Dr. Campolina pointed out. “We joke that it’s not a high-tech specialty, but ‘high touch,’ because it demands the constant presence of the doctor or therapist with the patient. This can involve sessions of several hours, with frequent monitoring and regular contact after sessions. This dynamic emphasizes the importance of human touch and connection during the process, reflecting a new way of practicing medicine.”

In his last months of life, Dr. Griffiths sought to emphasize this point, suggesting that, from a broader perspective, doctors and patients face the same fundamental questions. “We all know we are terminal,” he said. “Essentially, we shouldn’t need a stage 4 cancer diagnosis to awaken to this reality.”

This story was translated from the Medscape Portuguese edition 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.

Palliative care has proven to be one of the most promising fields for research on interventions with psychedelic substances. One of the most prominent researchers in this area was the American psychopharmacologist Roland Griffiths, PhD.

In 2016, Dr. Griffiths and his team at Johns Hopkins University in Baltimore, Maryland, published one of the most relevant contributions to the field by demonstrating in a placebo-controlled study that psilocybin can reduce depressive and anxiety symptoms in patients with cancer. The study, conducted with 51 patients diagnosed with advanced-stage cancer, compared the effects of a low dose and a high dose of psilocybin, showing that the high dose resulted in improvements in mood, quality of life, and sense of life, reducing death-related anxiety.

In 2021, after a routine examination, Dr. Griffiths himself was diagnosed with advanced colon cancer. Unexpectedly, the researcher found himself in the position of his research subjects. In an interview with The New York Times in April 2023, he stated that, after some resistance, he agreed to undergo an LSD session.

In the conversation, he revealed that he had a 50% chance of being alive by Halloween. Despite the diagnosis, he showed no discouragement. “As a scientist, I feel like a kid in a candy store, considering all the research and questions that need to be answered about psychedelics and the theme of human flourishing,” he said.

In his last months of life, in the various appearances and interviews he gave, Dr. Griffiths demonstrated a perception of life uncommon in people facing death. “I’m excited to communicate, to shake off the dust and tell people: ‘Come on, wake up!’ ”

He passed away on October 16, 2023, at age 77 years, opening new horizons for clinical research with psychedelics and becoming an example of the therapeutic potential of these substances.
 

Innovative Treatments

“I believe this will be one of the next conditions, if not the next condition, to be considered for the designation of innovative treatment in future psilocybin regulation in the United States, where the field is more advanced,” said Lucas Maia, PhD, a psychopharmacologist and researcher affiliated with the Advanced Center for Psychedelic Medicine (CAMP) at the Federal University of Rio Grande do Norte (UFRN) and the Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO) at the State University of Campinas in São Paulo, Brazil.

Currently, MDMA (for the treatment of posttraumatic stress disorder), psilocybin (for depressive disorder), and MM120 (an LSD analogue used to treat generalized anxiety disorder) are the only psychedelic substances that have received the designation of innovative treatment by the Food and Drug Administration (FDA).

In 2022, Dr. Maia and a colleague from ICARO, Ana Cláudia Mesquita Garcia, PhD, a professor at the School of Nursing at the Federal University of Alfenas in Brazil and leader of the Interdisciplinary Center for Studies in Palliative Care, published a systematic review in the Journal of Pain and Symptom Management that evaluated the use of psychedelic-assisted treatments for symptom control in patients with serious or terminal illnesses.

Of the 20 articles reviewed, 9 (45%) used LSD, 5 (25%) psilocybin, 2 (10%) dipropyltryptamine (DPT), 1 (5%) used ketamine, and 1 (5%) used MDMA. In 10% of the studies, LSD and DPT were combined. Altogether, 347 participants (54%) received LSD, 116 (18%) psilocybin, 81 (13%) LSD and DPT, 64 (10%) DPT, 18 (3%) MDMA, and 14 (2%) ketamine.

The conclusion of the study is that psychedelics provide therapeutic effects on physical, psychological, social, and existential outcomes. They are associated with a reduction in pain and improvement in sleep. A decrease in depressive and anxiety symptoms is also observed; such symptoms are common in patients with serious diseases. In addition, interpersonal relationships become closer and more empathetic. Finally, there is a reduction in the fear of death and suffering, an increase in acceptance, and a redefinition of the disease.

In 55% of the studies, the adverse effects were mild to moderate and transient. They included nausea, vomiting, dry mouth, and fatigue, as well as anxiety, panic, and hallucinations. The researchers concluded that the scarcity and difficulty of access to professional training in psychedelic-assisted treatments represent a significant challenge for the advancement of these interventions, especially in countries in the Global South.

Another systematic review and meta-analysis published in July by researchers at the University of Michigan in Ann Arbor, Michigan, included seven studies with 132 participants and showed significant improvements in quality of life, pain control, and anxiety relief after psychedelic-assisted psychotherapy with psilocybin. The combined effects indicated statistically significant reductions in anxiety symptoms after 4.0-4.5 months and after 6.0-6.5 months post administration, compared with the initial evaluations.

One of the most advanced research studies currently being conducted is led by Stephen Ross, MD, a psychiatrist affiliated with New York University’s Langone Medical Center, New York City. The phase 2b clinical study is randomized, double blind, and placebo controlled, and involves 300 participants. The study aims to evaluate the effects of psilocybin-assisted psychotherapy on psychiatric and existential distress in patients with advanced cancer. Its expected completion date is in 2027.

“We still lack effective interventions in minimizing psychological, spiritual, and existential suffering,” said Dr. Garcia. “In this sense, respecting the contraindications of a physical nature (including pre-existing illnesses at study initiation, disease staging, patient functionality level, comorbidities, concurrent pharmacological treatments, etc) and of a psychiatric nature for the use of psychedelics, depending on the clinical picture, end-of-life patients facing existential crises and psychological suffering will likely benefit more from psychedelic-assisted psychotherapy, which highlights the need for more research and the integration of this treatment into clinical practice.”
 

Changing Perceptions

Since 2021, the Cancer Institute of the State of São Paulo (Icesp) has been providing palliative treatment with ketamine — an atypical psychedelic — following a rigorous and carefully monitored clinical protocol. The substance is already used off label to treat refractory depressive disorder. In addition, in 2020, Brazil’s National Health Surveillance Agency approved the use of Spravato, an intranasal antidepressant based on the ketamine derivative esketamine.

Icesp has hospice beds for clinical oncology patients, and a pain management team evaluates which patients meet the inclusion criteria for ketamine use. In addition to difficult-to-control pain, it is important that the patient present emotional, existential, or spiritual symptoms that amplify that pain.

After this evaluation, a psychoeducation process takes place, in which the patient receives clear information about the treatment, its potential benefits and risks, and understands how ketamine can be a viable option for managing their symptoms. Finally, it is essential that the patient accept the referral and demonstrate a willingness to participate in the treatment, agreeing to the proposed terms.

The treatment takes place in a hospital environment, with an ambiance that aims to provide comfort and safety. Clinicians consider not only the substance dose (such as 0.5 mg/kg) but also the emotional state (“set”) and the treatment environment (“setting”). The experience is facilitated through psychological support for the patient during and after treatment.

According to Alessandro Campolina, MD, PhD, a researcher at the Center for Translational Oncology Research at Icesp, it is important to highlight that quality of life is intrinsically linked to the patient’s self-perception, including how they see themselves in terms of health and in the context in which they live.

The doctor explains that psychedelic interventions can provide a “window of opportunity,” allowing a qualified clinician to help the patient explore new perspectives based on their experiences.

“Often, although the intensity of pain remains the same, the way the patient perceives it can change significantly. For example, a patient may report that, despite the pain, they now feel less concerned about it because they were able to contemplate more significant aspects of their life,” said Dr. Campolina.

“This observation shows that treatment is not limited to addressing the pain or primary symptoms, but also addresses the associated suffering. While some patients have profound insights, many others experience more subtle changes that, under the guidance of a competent therapist, can turn into valuable clinical insights, thus improving quality of life and how they deal with their pathologies.”

Dr. Griffiths exemplified this in the interview with the Times when he reflected on his own cancer. He came to believe, as if guided an external observer, that “there is a meaning and a purpose in this [disease] that go beyond your understanding, and the way you are dealing with it is exactly how you should.”

Toshio Chiba, MD, chief physician of the Palliative Care Service at Icesp, emphasized that ketamine is already in use. “It is not feasible to wait years for the approval of psilocybin or for the FDA’s decision on MDMA, especially if the patient needs immediate care,” he said.

Furthermore, recreational and therapeutic uses are distinct. “It is essential to note that responsibilities are shared between the professional and the patient,” said Dr. Chiba. “In the therapeutic setting, there is an ethical and civil responsibility of the medical professional, as well as the patient actively engaging in treatment.”

Early palliative care can also facilitate the establishment of care goals. “I prefer to avoid terms like ‘coping’ or ‘fighting the disease,’” said Dr. Chiba. “Nowadays, dealing with cancer is more about coexisting with the disease properly, as treatments can last for years. 

“Of course, there are still highly lethal tumors. However, for neoplasms like breast, colorectal, and prostate cancers, we often talk about 5, 10, or even 15 years of coexistence [with the condition]. The lack of this information [about the disease, treatments, and existential issues] can generate distress in some patients, who end up excessively worrying about the future,” he added.

But palliative treatment with psychedelics as a panacea, he said.

In addition, Marcelo Falchi, MD, medical director of CAMP at UFRN, also emphasized that psychedelics are not a risk-free intervention. Substances like LSD and psilocybin, for example, can cause increases in blood pressure and tachycardia, which, may limit their use for patients at high cardiovascular risk. Crises of anxiety or dissociative symptoms also may occur, and they require mitigation strategies such as psychological support and attention to set and setting.

“But research seems to agree that the risks can be managed effectively through a diligent process, allowing for the responsible exploration of the therapeutic potential of psychedelics,” said Dr. Falchi, who is responsible for CAMP’s postgraduate course in psychedelic therapies. The program provides training in substances used in Brazil, such as ketamine and ibogaine.

The use of psychedelics in palliative care requires a significant shift in how professionals relate to patients.

Unlike in traditional practice, where the prescription is followed by quick consultations, palliative care with psychedelics requires deep and continuous involvement, as Dr. Campolina pointed out. “We joke that it’s not a high-tech specialty, but ‘high touch,’ because it demands the constant presence of the doctor or therapist with the patient. This can involve sessions of several hours, with frequent monitoring and regular contact after sessions. This dynamic emphasizes the importance of human touch and connection during the process, reflecting a new way of practicing medicine.”

In his last months of life, Dr. Griffiths sought to emphasize this point, suggesting that, from a broader perspective, doctors and patients face the same fundamental questions. “We all know we are terminal,” he said. “Essentially, we shouldn’t need a stage 4 cancer diagnosis to awaken to this reality.”

This story was translated from the Medscape Portuguese edition 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.

In 2012, Tara Rynders’ sister was diagnosed with acute disseminated encephalomyelitis. For Ms. Rynders, a registered nurse in Denver, Colorado, the news was devastating.

“She was this beautiful 26-year-old woman, strong and healthy, and within 12 hours, she went into a coma and couldn’t move or speak,” Ms. Rynders remembered. She flew to her sister in Reno, Nevada, and moved into her intensive care unit room. The helplessness she felt wasn’t just as a sister, but as a healthcare provider.

“As a nurse, we love to fix things,” Ms. Rynders said. “But when my sister was sick, I couldn’t do anything to fix her. The doctors didn’t even know what was going on.”

When Ms. Rynders’ sister woke from the coma, she couldn’t speak. The only comfort Ms. Rynders could provide was her presence and the ability to put a smile on her sister’s face. So, Ms. Rynders did what came naturally ...

She danced.

In that tiny hospital room, she blasted her sister’s favorite song — “Party in the U.S.A.” by Miley Cyrus — and danced around the room, doing anything she could to make her sister laugh.

And this patient who could not form words found her voice.

“She’d holler so deeply, it almost sounded like she was crying,” Ms. Rynders remembered. “The depths of her grief and the depths of her joy coming out simultaneously. It was really amazing and so healing for both of us.”
 

Do You Know How Powerful Dancing Really Is?

Ms. Rynders is far from the only healthcare professional who’s discovered the healing power of dance. In recent years, doctors and nurses across the country, from Los Angeles, California, to Atlanta, Georgia; from TikTok’s “Dancing Nurse,” Cindy Jones, to Max Chiu, Nebraska’s breakdancing oncologist, have demonstrated that finding new ways to move your body isn’t just good advice for patients but could be exactly what healthcare providers need to stay mentally and physically healthy.

It comes at a time when the field faces a “mental health crisis,” according to a 2023 report from the Centers for Disease Control and Prevention. Medscape Physician Burnout & Depression Report 2024 found current rates of 49% for burnout and 20% for depression.

And medical professionals are often hesitant about seeking help. Nearly 40% of physicians reported reluctance to seek out mental health treatment over fears of professional repercussions, according to 2024 recommendations by the Mayo Clinic.

The solution? It just might be dancing.

There’s ample evidence. A 2024 study from the University of Sydney, Australia, found that dancing offers more psychological and cognitive benefits — helping with everything from depression to motivation to emotional well-being — than any other type of exercise.

Another study, published in February by The BMJ medical journal, compared the mental health benefits of everything from aerobic exercise to cognitive behavioral therapy with antidepressants and found that dance consistently offered the largest reductions in depression.

Structured dance, where you learn specific movements, can offer a huge boost to mental health, according to a 2024 University of Sydney study. But so does unchoreographed dancing, where you’re basically just letting your limbs do their own thing. A 2021 study, published in Complementary Therapies in Clinical Practice, found that 95% of dancers who just moved their bodies, regardless of how it looked to the outside world, still had huge benefits with depression, anxiety, and trauma.
 

How to Turn a Mastectomy Into a Dance Party

Deborah Cohan, MD, 55, an obstetrician at Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, discovered firsthand the power of dance back in 2013. After finding a lump in her breast during a self-exam, Dr. Cohan feared the worst. Days later, her radiologist confirmed she had invasive ductal carcinoma.

“It was a complete shock,” Dr. Cohan remembered. “I took care of myself. I ate right. I had no obvious risk factors. I did work the night shift, and there’s actually an increased risk for breast cancer among ob.gyn. workers who do night shift work. But still, it took me completely by surprise. My kids were 5 and 8 at the time, and I was terrified that they’d grow up without a mom.”

So, Dr. Cohan turned to the only thing that gave her comfort — dance class. Dancing had been an escape for Dr. Cohan since she took her first ballet class at age 3. So, she skipped work and went to her weekly Soul Motion dance class, where she found herself doing the exact opposite of escaping. She embraced her fears.

“I visualized death as a dance partner,” Dr. Cohan said. “I felt a freedom come over my body. It didn’t make sense to me at the time, but it was almost joyful. Not that I was accepting death or anticipating death, but just that I acknowledged its presence. There’s so much pressure among people with cancer to be positive. [But] that’s something that needs to come from within a person, not from outside. Nobody can dictate how someone should be feeling. And as I danced, I was genuinely feeling joy even as I recognized my own fears and didn’t turn away from them. I was experiencing all the emotions at once. It was such a relief to realize this wasn’t all going to be about sadness.”

The experience was so healing for Dr. Cohan that she decided to see if she could bring those same feelings into her bilateral mastectomy. When meeting with her surgical team, Dr. Cohan made an unorthodox request: Could her pre-op include a dance party?

“I asked the anesthesiologist in the pre-op appointment if I could dance, and he said yes,” she remembered, laughing. “And then I checked with the surgeon, and he said yes. And then I asked the perioperative nurse, and he said yes, ‘but only if you don’t make me dance, too’. So somehow it all came together.”

Dr. Cohan decided on the Beyoncé song “Get Me Bodied,” which she says resonated with her because “it’s all about being in your body and being your full self. I was like, that is exactly how I want to show up in the operating room.” The moment the music kicked in and Dr. Cohan broke into dance, all of her stress melted away.

“Even though I’d been given permission to dance, I never expected anybody else to join in,” Dr. Cohan said. But that’s exactly what they did. A friend took a video, which shows Dr. Cohan in a hospital gown and bouffant cap, dancing alongside her surgical and anesthesia teams, all of whom are dressed in scrubs, at Mount Zion Hospital in San Francisco, California.

“It’s weird to say, especially about a mastectomy,” Dr. Cohan said, “but it was one of the most joyful moments of my life.”

The video’s been viewed 8.4 million times and is so inspirational — we dare you to watch it and not want to jump out of your chair to dance — that soon others were following Dr. Cohan’s lead.

• Sixteen-year-old Amari Hall danced to celebrate her successful heart transplant.
• Ana-Alecia Ayala, a 32-year-old uterine cancer survivor, danced along to “Juju on That Beat” to make chemotherapy more tolerable.
• Doreta Norris, a patient with breast cancer, chose “Gangnam Style” to serenade her into surgery.

Bringing Dance to Other Medical Pros

Ms. Rynders realized the true power of dance years before her sister’s illness, when her mother died of cancer. “I’ve always considered myself to be very resilient as a human, but I couldn’t bounce back after my mom died,” she said. “I was nursing full time in the emergency room, and I was sad all the time. And then one day I realized, you know what brings me joy? It’s always been dance.”

She went back to school to get her Master of Fine Arts in Dance from the University of Colorado at Boulder, which she believes helped her heal. “I was actually able to grieve instead of just pretending I was okay,” she said.

Inspired by these experiences, Ms. Rynders founded The Clinic in 2017, a company that provides dance workshops for healthcare professionals struggling with burnout and secondary traumatic stress.

“I see these nurses running down hospital hallways, covered in blood from patients whose lives are literally hanging on a thread,” she said. “They’re dealing with so much stress and grief and hardship. And then to see them with us, playing and laughing — those deep belly laughs that you haven’t done since you were a kid, the deep laughing that comes from deep in your soul. It can be transformational, for them and for you.”

Ms. Rynders remembers one especially healing workshop in which the participants pretended to be astronauts in deep space, using zero gravity to inform their movements. After the exercise, a veteran hospital nurse took Ms. Rynders aside to thank her, mentioning that she was still dealing with grief for her late son, who had died from suicide years earlier.

“She had a lot of guilt around it,” Ms. Rynders remembered. “And she said to me, ‘When I went to space, I felt closer to him.’ It was just this silly little game, but it gave her this lightness that she hadn’t felt in years. She was able to be free and laugh and play and feel close to her son again.”
 

Good Medicine

Dr. Cohan, who today is cancer free, said her experience made her completely rethink her relationship with patients. She has danced with more than a few of them, though she’s careful never to force it on them. “I never want to project my idea of joy onto others,” she said. “But more than anything, it’s changed my thinking on what it means to take ownership as a patient.”

The one thing Dr. Cohan never wanted as a patient, and the thing she never wants for her own patients, is the loss of agency. “When I danced, I didn’t feel like I was just handing over my body and begrudgingly accepting what was about to happen to me,” she said. “I was taking ownership around my decision, and I felt connected, really connected, to my surgical team.”

As a patient, Dr. Cohan experienced what she calls the “regimented” atmosphere of medicine. “You’re told where to go, what to do, and you have no control over any of it,” recalled Dr. Cohan, who’s now semiretired and runs retreats for women with breast cancer. “But by bringing in dance, it felt really radical that my healthcare team was doing my thing, not the other way around.”
 

(Re)Learning to Move More Consciously

Healthcare providers need these moments of escape just as much as patients living with disease. The difference is, as Ms. Rynders points out, those in the medical field aren’t always as aware of their emotional distress. “I think if you ask a nurse, ‘How can I help you? What do you need?’ They’re usually like, ‘I don’t know. I don’t even know what I need,’ ” Ms. Rynders said. “Even if they did know what they needed, I think it’s hard to ask for it and even harder to receive it.”

At Ms. Rynders’ workshops, not everybody is comfortable dancing, of course. So, new participants are always given the option just to witness, to be in the room and watch what happens. “But I also really encourage people to take advantage of this opportunity to do something different and disrupt the way we live on a daily basis,” Ms. Rynders said. “Let your brain try something new and be courageous. We’ve only had a few people who sat on the sidelines the whole time.”

It’s not always just about feelings, Dr. Cohan added, but physical relaxation. “Sometimes it’s just about remembering how to move consciously. When I was having surgery, I didn’t just dance to relax myself. I wanted my entire surgical team to be relaxed.”

For Ms. Rynders, every time she dances with her patients, or with fellow healthcare workers, she’s reminded of her sister and the comfort she was able to give her when no amount of medicine would make things better.

“We don’t always need to be fixed by things,” she said. “Sometimes we just need to be present with one another and be with each other. And sometimes, the best way to do that is by dancing till the tears roll down your cheeks.”
 

A version of this article appeared on Medscape.com.

In 2012, Tara Rynders’ sister was diagnosed with acute disseminated encephalomyelitis. For Ms. Rynders, a registered nurse in Denver, Colorado, the news was devastating.

“She was this beautiful 26-year-old woman, strong and healthy, and within 12 hours, she went into a coma and couldn’t move or speak,” Ms. Rynders remembered. She flew to her sister in Reno, Nevada, and moved into her intensive care unit room. The helplessness she felt wasn’t just as a sister, but as a healthcare provider.

“As a nurse, we love to fix things,” Ms. Rynders said. “But when my sister was sick, I couldn’t do anything to fix her. The doctors didn’t even know what was going on.”

When Ms. Rynders’ sister woke from the coma, she couldn’t speak. The only comfort Ms. Rynders could provide was her presence and the ability to put a smile on her sister’s face. So, Ms. Rynders did what came naturally ...

She danced.

In that tiny hospital room, she blasted her sister’s favorite song — “Party in the U.S.A.” by Miley Cyrus — and danced around the room, doing anything she could to make her sister laugh.

And this patient who could not form words found her voice.

“She’d holler so deeply, it almost sounded like she was crying,” Ms. Rynders remembered. “The depths of her grief and the depths of her joy coming out simultaneously. It was really amazing and so healing for both of us.”
 

Do You Know How Powerful Dancing Really Is?

Ms. Rynders is far from the only healthcare professional who’s discovered the healing power of dance. In recent years, doctors and nurses across the country, from Los Angeles, California, to Atlanta, Georgia; from TikTok’s “Dancing Nurse,” Cindy Jones, to Max Chiu, Nebraska’s breakdancing oncologist, have demonstrated that finding new ways to move your body isn’t just good advice for patients but could be exactly what healthcare providers need to stay mentally and physically healthy.

It comes at a time when the field faces a “mental health crisis,” according to a 2023 report from the Centers for Disease Control and Prevention. Medscape Physician Burnout & Depression Report 2024 found current rates of 49% for burnout and 20% for depression.

And medical professionals are often hesitant about seeking help. Nearly 40% of physicians reported reluctance to seek out mental health treatment over fears of professional repercussions, according to 2024 recommendations by the Mayo Clinic.

The solution? It just might be dancing.

There’s ample evidence. A 2024 study from the University of Sydney, Australia, found that dancing offers more psychological and cognitive benefits — helping with everything from depression to motivation to emotional well-being — than any other type of exercise.

Another study, published in February by The BMJ medical journal, compared the mental health benefits of everything from aerobic exercise to cognitive behavioral therapy with antidepressants and found that dance consistently offered the largest reductions in depression.

Structured dance, where you learn specific movements, can offer a huge boost to mental health, according to a 2024 University of Sydney study. But so does unchoreographed dancing, where you’re basically just letting your limbs do their own thing. A 2021 study, published in Complementary Therapies in Clinical Practice, found that 95% of dancers who just moved their bodies, regardless of how it looked to the outside world, still had huge benefits with depression, anxiety, and trauma.
 

How to Turn a Mastectomy Into a Dance Party

Deborah Cohan, MD, 55, an obstetrician at Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, discovered firsthand the power of dance back in 2013. After finding a lump in her breast during a self-exam, Dr. Cohan feared the worst. Days later, her radiologist confirmed she had invasive ductal carcinoma.

“It was a complete shock,” Dr. Cohan remembered. “I took care of myself. I ate right. I had no obvious risk factors. I did work the night shift, and there’s actually an increased risk for breast cancer among ob.gyn. workers who do night shift work. But still, it took me completely by surprise. My kids were 5 and 8 at the time, and I was terrified that they’d grow up without a mom.”

So, Dr. Cohan turned to the only thing that gave her comfort — dance class. Dancing had been an escape for Dr. Cohan since she took her first ballet class at age 3. So, she skipped work and went to her weekly Soul Motion dance class, where she found herself doing the exact opposite of escaping. She embraced her fears.

“I visualized death as a dance partner,” Dr. Cohan said. “I felt a freedom come over my body. It didn’t make sense to me at the time, but it was almost joyful. Not that I was accepting death or anticipating death, but just that I acknowledged its presence. There’s so much pressure among people with cancer to be positive. [But] that’s something that needs to come from within a person, not from outside. Nobody can dictate how someone should be feeling. And as I danced, I was genuinely feeling joy even as I recognized my own fears and didn’t turn away from them. I was experiencing all the emotions at once. It was such a relief to realize this wasn’t all going to be about sadness.”

The experience was so healing for Dr. Cohan that she decided to see if she could bring those same feelings into her bilateral mastectomy. When meeting with her surgical team, Dr. Cohan made an unorthodox request: Could her pre-op include a dance party?

“I asked the anesthesiologist in the pre-op appointment if I could dance, and he said yes,” she remembered, laughing. “And then I checked with the surgeon, and he said yes. And then I asked the perioperative nurse, and he said yes, ‘but only if you don’t make me dance, too’. So somehow it all came together.”

Dr. Cohan decided on the Beyoncé song “Get Me Bodied,” which she says resonated with her because “it’s all about being in your body and being your full self. I was like, that is exactly how I want to show up in the operating room.” The moment the music kicked in and Dr. Cohan broke into dance, all of her stress melted away.

“Even though I’d been given permission to dance, I never expected anybody else to join in,” Dr. Cohan said. But that’s exactly what they did. A friend took a video, which shows Dr. Cohan in a hospital gown and bouffant cap, dancing alongside her surgical and anesthesia teams, all of whom are dressed in scrubs, at Mount Zion Hospital in San Francisco, California.

“It’s weird to say, especially about a mastectomy,” Dr. Cohan said, “but it was one of the most joyful moments of my life.”

The video’s been viewed 8.4 million times and is so inspirational — we dare you to watch it and not want to jump out of your chair to dance — that soon others were following Dr. Cohan’s lead.

• Sixteen-year-old Amari Hall danced to celebrate her successful heart transplant.
• Ana-Alecia Ayala, a 32-year-old uterine cancer survivor, danced along to “Juju on That Beat” to make chemotherapy more tolerable.
• Doreta Norris, a patient with breast cancer, chose “Gangnam Style” to serenade her into surgery.

Bringing Dance to Other Medical Pros

Ms. Rynders realized the true power of dance years before her sister’s illness, when her mother died of cancer. “I’ve always considered myself to be very resilient as a human, but I couldn’t bounce back after my mom died,” she said. “I was nursing full time in the emergency room, and I was sad all the time. And then one day I realized, you know what brings me joy? It’s always been dance.”

She went back to school to get her Master of Fine Arts in Dance from the University of Colorado at Boulder, which she believes helped her heal. “I was actually able to grieve instead of just pretending I was okay,” she said.

Inspired by these experiences, Ms. Rynders founded The Clinic in 2017, a company that provides dance workshops for healthcare professionals struggling with burnout and secondary traumatic stress.

“I see these nurses running down hospital hallways, covered in blood from patients whose lives are literally hanging on a thread,” she said. “They’re dealing with so much stress and grief and hardship. And then to see them with us, playing and laughing — those deep belly laughs that you haven’t done since you were a kid, the deep laughing that comes from deep in your soul. It can be transformational, for them and for you.”

Ms. Rynders remembers one especially healing workshop in which the participants pretended to be astronauts in deep space, using zero gravity to inform their movements. After the exercise, a veteran hospital nurse took Ms. Rynders aside to thank her, mentioning that she was still dealing with grief for her late son, who had died from suicide years earlier.

“She had a lot of guilt around it,” Ms. Rynders remembered. “And she said to me, ‘When I went to space, I felt closer to him.’ It was just this silly little game, but it gave her this lightness that she hadn’t felt in years. She was able to be free and laugh and play and feel close to her son again.”
 

Good Medicine

Dr. Cohan, who today is cancer free, said her experience made her completely rethink her relationship with patients. She has danced with more than a few of them, though she’s careful never to force it on them. “I never want to project my idea of joy onto others,” she said. “But more than anything, it’s changed my thinking on what it means to take ownership as a patient.”

The one thing Dr. Cohan never wanted as a patient, and the thing she never wants for her own patients, is the loss of agency. “When I danced, I didn’t feel like I was just handing over my body and begrudgingly accepting what was about to happen to me,” she said. “I was taking ownership around my decision, and I felt connected, really connected, to my surgical team.”

As a patient, Dr. Cohan experienced what she calls the “regimented” atmosphere of medicine. “You’re told where to go, what to do, and you have no control over any of it,” recalled Dr. Cohan, who’s now semiretired and runs retreats for women with breast cancer. “But by bringing in dance, it felt really radical that my healthcare team was doing my thing, not the other way around.”
 

(Re)Learning to Move More Consciously

Healthcare providers need these moments of escape just as much as patients living with disease. The difference is, as Ms. Rynders points out, those in the medical field aren’t always as aware of their emotional distress. “I think if you ask a nurse, ‘How can I help you? What do you need?’ They’re usually like, ‘I don’t know. I don’t even know what I need,’ ” Ms. Rynders said. “Even if they did know what they needed, I think it’s hard to ask for it and even harder to receive it.”

At Ms. Rynders’ workshops, not everybody is comfortable dancing, of course. So, new participants are always given the option just to witness, to be in the room and watch what happens. “But I also really encourage people to take advantage of this opportunity to do something different and disrupt the way we live on a daily basis,” Ms. Rynders said. “Let your brain try something new and be courageous. We’ve only had a few people who sat on the sidelines the whole time.”

It’s not always just about feelings, Dr. Cohan added, but physical relaxation. “Sometimes it’s just about remembering how to move consciously. When I was having surgery, I didn’t just dance to relax myself. I wanted my entire surgical team to be relaxed.”

For Ms. Rynders, every time she dances with her patients, or with fellow healthcare workers, she’s reminded of her sister and the comfort she was able to give her when no amount of medicine would make things better.

“We don’t always need to be fixed by things,” she said. “Sometimes we just need to be present with one another and be with each other. And sometimes, the best way to do that is by dancing till the tears roll down your cheeks.”
 

A version of this article appeared on Medscape.com.

In 2012, Tara Rynders’ sister was diagnosed with acute disseminated encephalomyelitis. For Ms. Rynders, a registered nurse in Denver, Colorado, the news was devastating.

“She was this beautiful 26-year-old woman, strong and healthy, and within 12 hours, she went into a coma and couldn’t move or speak,” Ms. Rynders remembered. She flew to her sister in Reno, Nevada, and moved into her intensive care unit room. The helplessness she felt wasn’t just as a sister, but as a healthcare provider.

“As a nurse, we love to fix things,” Ms. Rynders said. “But when my sister was sick, I couldn’t do anything to fix her. The doctors didn’t even know what was going on.”

When Ms. Rynders’ sister woke from the coma, she couldn’t speak. The only comfort Ms. Rynders could provide was her presence and the ability to put a smile on her sister’s face. So, Ms. Rynders did what came naturally ...

She danced.

In that tiny hospital room, she blasted her sister’s favorite song — “Party in the U.S.A.” by Miley Cyrus — and danced around the room, doing anything she could to make her sister laugh.

And this patient who could not form words found her voice.

“She’d holler so deeply, it almost sounded like she was crying,” Ms. Rynders remembered. “The depths of her grief and the depths of her joy coming out simultaneously. It was really amazing and so healing for both of us.”
 

Do You Know How Powerful Dancing Really Is?

Ms. Rynders is far from the only healthcare professional who’s discovered the healing power of dance. In recent years, doctors and nurses across the country, from Los Angeles, California, to Atlanta, Georgia; from TikTok’s “Dancing Nurse,” Cindy Jones, to Max Chiu, Nebraska’s breakdancing oncologist, have demonstrated that finding new ways to move your body isn’t just good advice for patients but could be exactly what healthcare providers need to stay mentally and physically healthy.

It comes at a time when the field faces a “mental health crisis,” according to a 2023 report from the Centers for Disease Control and Prevention. Medscape Physician Burnout & Depression Report 2024 found current rates of 49% for burnout and 20% for depression.

And medical professionals are often hesitant about seeking help. Nearly 40% of physicians reported reluctance to seek out mental health treatment over fears of professional repercussions, according to 2024 recommendations by the Mayo Clinic.

The solution? It just might be dancing.

There’s ample evidence. A 2024 study from the University of Sydney, Australia, found that dancing offers more psychological and cognitive benefits — helping with everything from depression to motivation to emotional well-being — than any other type of exercise.

Another study, published in February by The BMJ medical journal, compared the mental health benefits of everything from aerobic exercise to cognitive behavioral therapy with antidepressants and found that dance consistently offered the largest reductions in depression.

Structured dance, where you learn specific movements, can offer a huge boost to mental health, according to a 2024 University of Sydney study. But so does unchoreographed dancing, where you’re basically just letting your limbs do their own thing. A 2021 study, published in Complementary Therapies in Clinical Practice, found that 95% of dancers who just moved their bodies, regardless of how it looked to the outside world, still had huge benefits with depression, anxiety, and trauma.
 

How to Turn a Mastectomy Into a Dance Party

Deborah Cohan, MD, 55, an obstetrician at Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, discovered firsthand the power of dance back in 2013. After finding a lump in her breast during a self-exam, Dr. Cohan feared the worst. Days later, her radiologist confirmed she had invasive ductal carcinoma.

“It was a complete shock,” Dr. Cohan remembered. “I took care of myself. I ate right. I had no obvious risk factors. I did work the night shift, and there’s actually an increased risk for breast cancer among ob.gyn. workers who do night shift work. But still, it took me completely by surprise. My kids were 5 and 8 at the time, and I was terrified that they’d grow up without a mom.”

So, Dr. Cohan turned to the only thing that gave her comfort — dance class. Dancing had been an escape for Dr. Cohan since she took her first ballet class at age 3. So, she skipped work and went to her weekly Soul Motion dance class, where she found herself doing the exact opposite of escaping. She embraced her fears.

“I visualized death as a dance partner,” Dr. Cohan said. “I felt a freedom come over my body. It didn’t make sense to me at the time, but it was almost joyful. Not that I was accepting death or anticipating death, but just that I acknowledged its presence. There’s so much pressure among people with cancer to be positive. [But] that’s something that needs to come from within a person, not from outside. Nobody can dictate how someone should be feeling. And as I danced, I was genuinely feeling joy even as I recognized my own fears and didn’t turn away from them. I was experiencing all the emotions at once. It was such a relief to realize this wasn’t all going to be about sadness.”

The experience was so healing for Dr. Cohan that she decided to see if she could bring those same feelings into her bilateral mastectomy. When meeting with her surgical team, Dr. Cohan made an unorthodox request: Could her pre-op include a dance party?

“I asked the anesthesiologist in the pre-op appointment if I could dance, and he said yes,” she remembered, laughing. “And then I checked with the surgeon, and he said yes. And then I asked the perioperative nurse, and he said yes, ‘but only if you don’t make me dance, too’. So somehow it all came together.”

Dr. Cohan decided on the Beyoncé song “Get Me Bodied,” which she says resonated with her because “it’s all about being in your body and being your full self. I was like, that is exactly how I want to show up in the operating room.” The moment the music kicked in and Dr. Cohan broke into dance, all of her stress melted away.

“Even though I’d been given permission to dance, I never expected anybody else to join in,” Dr. Cohan said. But that’s exactly what they did. A friend took a video, which shows Dr. Cohan in a hospital gown and bouffant cap, dancing alongside her surgical and anesthesia teams, all of whom are dressed in scrubs, at Mount Zion Hospital in San Francisco, California.

“It’s weird to say, especially about a mastectomy,” Dr. Cohan said, “but it was one of the most joyful moments of my life.”

The video’s been viewed 8.4 million times and is so inspirational — we dare you to watch it and not want to jump out of your chair to dance — that soon others were following Dr. Cohan’s lead.

• Sixteen-year-old Amari Hall danced to celebrate her successful heart transplant.
• Ana-Alecia Ayala, a 32-year-old uterine cancer survivor, danced along to “Juju on That Beat” to make chemotherapy more tolerable.
• Doreta Norris, a patient with breast cancer, chose “Gangnam Style” to serenade her into surgery.

Bringing Dance to Other Medical Pros

Ms. Rynders realized the true power of dance years before her sister’s illness, when her mother died of cancer. “I’ve always considered myself to be very resilient as a human, but I couldn’t bounce back after my mom died,” she said. “I was nursing full time in the emergency room, and I was sad all the time. And then one day I realized, you know what brings me joy? It’s always been dance.”

She went back to school to get her Master of Fine Arts in Dance from the University of Colorado at Boulder, which she believes helped her heal. “I was actually able to grieve instead of just pretending I was okay,” she said.

Inspired by these experiences, Ms. Rynders founded The Clinic in 2017, a company that provides dance workshops for healthcare professionals struggling with burnout and secondary traumatic stress.

“I see these nurses running down hospital hallways, covered in blood from patients whose lives are literally hanging on a thread,” she said. “They’re dealing with so much stress and grief and hardship. And then to see them with us, playing and laughing — those deep belly laughs that you haven’t done since you were a kid, the deep laughing that comes from deep in your soul. It can be transformational, for them and for you.”

Ms. Rynders remembers one especially healing workshop in which the participants pretended to be astronauts in deep space, using zero gravity to inform their movements. After the exercise, a veteran hospital nurse took Ms. Rynders aside to thank her, mentioning that she was still dealing with grief for her late son, who had died from suicide years earlier.

“She had a lot of guilt around it,” Ms. Rynders remembered. “And she said to me, ‘When I went to space, I felt closer to him.’ It was just this silly little game, but it gave her this lightness that she hadn’t felt in years. She was able to be free and laugh and play and feel close to her son again.”
 

Good Medicine

Dr. Cohan, who today is cancer free, said her experience made her completely rethink her relationship with patients. She has danced with more than a few of them, though she’s careful never to force it on them. “I never want to project my idea of joy onto others,” she said. “But more than anything, it’s changed my thinking on what it means to take ownership as a patient.”

The one thing Dr. Cohan never wanted as a patient, and the thing she never wants for her own patients, is the loss of agency. “When I danced, I didn’t feel like I was just handing over my body and begrudgingly accepting what was about to happen to me,” she said. “I was taking ownership around my decision, and I felt connected, really connected, to my surgical team.”

As a patient, Dr. Cohan experienced what she calls the “regimented” atmosphere of medicine. “You’re told where to go, what to do, and you have no control over any of it,” recalled Dr. Cohan, who’s now semiretired and runs retreats for women with breast cancer. “But by bringing in dance, it felt really radical that my healthcare team was doing my thing, not the other way around.”
 

(Re)Learning to Move More Consciously

Healthcare providers need these moments of escape just as much as patients living with disease. The difference is, as Ms. Rynders points out, those in the medical field aren’t always as aware of their emotional distress. “I think if you ask a nurse, ‘How can I help you? What do you need?’ They’re usually like, ‘I don’t know. I don’t even know what I need,’ ” Ms. Rynders said. “Even if they did know what they needed, I think it’s hard to ask for it and even harder to receive it.”

At Ms. Rynders’ workshops, not everybody is comfortable dancing, of course. So, new participants are always given the option just to witness, to be in the room and watch what happens. “But I also really encourage people to take advantage of this opportunity to do something different and disrupt the way we live on a daily basis,” Ms. Rynders said. “Let your brain try something new and be courageous. We’ve only had a few people who sat on the sidelines the whole time.”

It’s not always just about feelings, Dr. Cohan added, but physical relaxation. “Sometimes it’s just about remembering how to move consciously. When I was having surgery, I didn’t just dance to relax myself. I wanted my entire surgical team to be relaxed.”

For Ms. Rynders, every time she dances with her patients, or with fellow healthcare workers, she’s reminded of her sister and the comfort she was able to give her when no amount of medicine would make things better.

“We don’t always need to be fixed by things,” she said. “Sometimes we just need to be present with one another and be with each other. And sometimes, the best way to do that is by dancing till the tears roll down your cheeks.”
 

A version of this article appeared on Medscape.com.

MILAN — Psilocybin leads to a better overall outcome in the treatment of moderate to severe major depressive disorder (MDD) than the selective serotonin reuptake inhibitor (SSRI) escitalopram, results of the first long-term comparison of the two treatments suggest.

“This is the first work to compare the long-term effects of these two drugs in the context of overall well-being, not just freedom from depression,” study investigator Tommaso Barba, PhD candidate at Imperial College London in England, said in a press release. “Psilocybin outperformed escitalopram in several measures of well-being, meaning in life, work, and social functioning.”

Findings from the 6-month follow-up study of a phase 2 double-blind, randomized, controlled trial were presented at the 37th European College of Neuropsychopharmacology (ECNP) Congress and published simultaneously in The Lancet eClinicalMedicine

Addressing a Treatment ‘Mismatch’

The findings are important because they address “a mismatch” between what psychiatrists and what patients think is important, Mr. Barba said in an interview.

“Psychiatrists really focus on negative symptoms of depression. So, if you are not sad anymore, if your sleep or appetite is not impaired, they think you’re better. But if you look at what patients define as important, they say it’s the degree in which their life is meaningful, in which they can connect with people around them, in which they can function in everyday life,” Mr. Barba said.

“The study suggests that psilocybin therapy might be a more holistic treatment option for depression,” added co–first author David Erritzoe, MD, PhD, clinical director and deputy head of the Centre for Psychedelic Research, Imperial College London. “This could make a substantial difference in the overall happiness and daily activities of those suffering from depression, providing a more joined-up approach to mental health treatment.”

The initial single-center study included 59 adults with MDD (mean age, 41 years) who were randomized to receive either psilocybin or escitalopram over a 6-week period. The psilocybin arm (n = 30) received two 25-mg oral doses of psilocybin therapy (PT), and the escitalopram arm (n = 29) received 10-20 mg of daily escitalopram plus two (placebo-like) 1-mg doses of psilocybin (ET). Both groups received psychological support.

Based on change in depression scores on the 16-item Quick Inventory of Depressive Symptomatology–Self-Report (QIDS-SR-16) at week 6, the initial study results suggested noninferiority between the two treatments in terms of depressive symptoms (primary outcome), but superiority of PT for secondary outcomes including “well-being, anhedonia, social functioning, sexual functioning, and related variables, with fewer side effects compared to ET,” the researchers noted.

The new 6-month follow-up findings, with monthly questionnaires and no additional study treatment or psychiatric treatment restrictions, measured the QIDS-SR-16, plus Work and Social Adjustment Scale (WSAS), Meaning in Life Questionnaire, Flourishing Scale (FS), and Watts Connectedness Scale (WCS).

Again, both groups maintained similar results on the QIDS-SR-16, with slightly greater reductions in depressive symptoms for PT in the first month (positive false discovery rate [pFDR] = 0.021), but not thereafter.

At both 3 and 6 months, there were greater improvements in WSAS scores for the PT group (pFDR < 0.001 and pFDR = 0.01, respectively), and also greater improvements in meaning in life across all follow-up timepoints (pFDR < 0.001).

There was also greater improvement in the PT group regarding WCS at both 3 and 6 months (pFDR = 0.02, and pFDR = 0.04) and comparable FS improvements for both groups across all timepoints.

Confounding follow-up interventions may have muddied the results, with 30.7% of PT participants and 43.5% of ET participants receiving an additional intervention during this period.

The researchers conclude that while a short course of SSRIs combined with intensive therapeutic support (around 20 hours) “might be enough to induce sustained antidepressant effects,” patients treated with psilocybin showed greater improvements in general functioning, connectedness, and meaning in life.

Although not reassessed in the follow-up, the initial study showed that adverse events, particularly sexual functioning, favored psilocybin, said Mr. Barba. “The two treatments seemed to go in opposite directions with psilocybin seeming to improve it and the antidepressant to suppress it. Other side effects associated with psilocybin were less diverse — mainly headaches at the end of the day — but with escitalopram they were way more diverse and more impairing.”

Although many therapists may be unfamiliar with psilocybin-assisted psychotherapy, “it’s not a difficult skill to master. It might require some specialization, but I think if you’re a good psychotherapist, you can learn how to implement psilocybin into your practice,” he said.

“Normally the journey is quite inward, so patients do not require active support during the psychedelic experience [around 6 hours]. Sometimes they do require some hand-holding, or helping them to ‘let go’, or breathing exercises. The important part is the integration work that comes afterwards,” Mr. Barba added.

He said he envisions a therapy program that involves “psychiatrists working together with psychotherapists. The psychotherapists would be more in charge of the active guiding, and the psychiatrist would do the prescribing, with the follow-up psychological support on Zoom.”

He added a word of caution for therapists that “psilocybin requires active confrontation of painful, negative emotions and people who take this drug need to be open and prepared for the idea that they are going into a state where they may probably end up crying and confronting whatever they are maybe running away from in their lives. Not everyone may want to do this.”
 

A New Treatment Paradigm?

In a comment, Johan Lundberg, MD, PhD, adjunct professor of psychiatry at the Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden, said the study addresses a key outstanding question about the long-term effects of one or two doses of psilocybin.

“It’s a 6-month follow-up of a short treatment intervention, so in that sense, it’s of high interest. It has been talked about that psilocybin might have a long-term effect, but this is the first study that has followed this for a longer term.”

But Dr. Lundberg also pointed out that one shortcoming of the study is the diversity of treatments following the intervention.

“They didn’t have control over whether patients received other treatments or when they started. So, that is a key concern. But they transparently reported that, and we do know there was a difference in reported ability to perform activities of daily life, and that is important.”

He added that if psilocybin is eventually approved, it would likely come with an education package for providers — “which is already the case with other treatments like ECT [electroconvulsive therapy] or TMS [transcranial magnetic stimulation] — you have to learn how to do it.”

James Rucker, MD, PhD, psychiatrist and senior clinical lecturer at King’s College London, who was not involved in the research, also noted that they have tended to attribute differences observed in this study to comparative differences between the drugs themselves.

However, he noted, it is also possible that the results reflect biased reporting between groups. This is more likely here because studies involving psilocybin tend to attract those with positive preconceptions about psilocybin and negative preconceptions about conventional antidepressants, and study participants were unblinded during the long-term follow-up phase, so knew which condition they were allocated to.

“This said, the nature of depression varies hugely between individuals, and this calls for the development of a similarly varied suite of treatment paradigms. Psilocybin therapy is certainly a different paradigm of treatment to escitalopram. The observation of similar levels of effectiveness to antidepressants here is encouraging to see alongside the much larger trials of psilocybin currently underway here in the UK, Europe, and the US,” Dr. Rucker added.

This work was supported by The Alexander Mosley Charitable Trust and by the founding partners of Imperial College London’s Centre for Psychedelic Research.

Mr. Barba reported having received consulting fees from Adamo Bioscience. Both Dr. Lundberg and Dr. Rucker are involved in psilocybin research, but neither reported financial links.

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

MILAN — Psilocybin leads to a better overall outcome in the treatment of moderate to severe major depressive disorder (MDD) than the selective serotonin reuptake inhibitor (SSRI) escitalopram, results of the first long-term comparison of the two treatments suggest.

“This is the first work to compare the long-term effects of these two drugs in the context of overall well-being, not just freedom from depression,” study investigator Tommaso Barba, PhD candidate at Imperial College London in England, said in a press release. “Psilocybin outperformed escitalopram in several measures of well-being, meaning in life, work, and social functioning.”

Findings from the 6-month follow-up study of a phase 2 double-blind, randomized, controlled trial were presented at the 37th European College of Neuropsychopharmacology (ECNP) Congress and published simultaneously in The Lancet eClinicalMedicine

Addressing a Treatment ‘Mismatch’

The findings are important because they address “a mismatch” between what psychiatrists and what patients think is important, Mr. Barba said in an interview.

“Psychiatrists really focus on negative symptoms of depression. So, if you are not sad anymore, if your sleep or appetite is not impaired, they think you’re better. But if you look at what patients define as important, they say it’s the degree in which their life is meaningful, in which they can connect with people around them, in which they can function in everyday life,” Mr. Barba said.

“The study suggests that psilocybin therapy might be a more holistic treatment option for depression,” added co–first author David Erritzoe, MD, PhD, clinical director and deputy head of the Centre for Psychedelic Research, Imperial College London. “This could make a substantial difference in the overall happiness and daily activities of those suffering from depression, providing a more joined-up approach to mental health treatment.”

The initial single-center study included 59 adults with MDD (mean age, 41 years) who were randomized to receive either psilocybin or escitalopram over a 6-week period. The psilocybin arm (n = 30) received two 25-mg oral doses of psilocybin therapy (PT), and the escitalopram arm (n = 29) received 10-20 mg of daily escitalopram plus two (placebo-like) 1-mg doses of psilocybin (ET). Both groups received psychological support.

Based on change in depression scores on the 16-item Quick Inventory of Depressive Symptomatology–Self-Report (QIDS-SR-16) at week 6, the initial study results suggested noninferiority between the two treatments in terms of depressive symptoms (primary outcome), but superiority of PT for secondary outcomes including “well-being, anhedonia, social functioning, sexual functioning, and related variables, with fewer side effects compared to ET,” the researchers noted.

The new 6-month follow-up findings, with monthly questionnaires and no additional study treatment or psychiatric treatment restrictions, measured the QIDS-SR-16, plus Work and Social Adjustment Scale (WSAS), Meaning in Life Questionnaire, Flourishing Scale (FS), and Watts Connectedness Scale (WCS).

Again, both groups maintained similar results on the QIDS-SR-16, with slightly greater reductions in depressive symptoms for PT in the first month (positive false discovery rate [pFDR] = 0.021), but not thereafter.

At both 3 and 6 months, there were greater improvements in WSAS scores for the PT group (pFDR < 0.001 and pFDR = 0.01, respectively), and also greater improvements in meaning in life across all follow-up timepoints (pFDR < 0.001).

There was also greater improvement in the PT group regarding WCS at both 3 and 6 months (pFDR = 0.02, and pFDR = 0.04) and comparable FS improvements for both groups across all timepoints.

Confounding follow-up interventions may have muddied the results, with 30.7% of PT participants and 43.5% of ET participants receiving an additional intervention during this period.

The researchers conclude that while a short course of SSRIs combined with intensive therapeutic support (around 20 hours) “might be enough to induce sustained antidepressant effects,” patients treated with psilocybin showed greater improvements in general functioning, connectedness, and meaning in life.

Although not reassessed in the follow-up, the initial study showed that adverse events, particularly sexual functioning, favored psilocybin, said Mr. Barba. “The two treatments seemed to go in opposite directions with psilocybin seeming to improve it and the antidepressant to suppress it. Other side effects associated with psilocybin were less diverse — mainly headaches at the end of the day — but with escitalopram they were way more diverse and more impairing.”

Although many therapists may be unfamiliar with psilocybin-assisted psychotherapy, “it’s not a difficult skill to master. It might require some specialization, but I think if you’re a good psychotherapist, you can learn how to implement psilocybin into your practice,” he said.

“Normally the journey is quite inward, so patients do not require active support during the psychedelic experience [around 6 hours]. Sometimes they do require some hand-holding, or helping them to ‘let go’, or breathing exercises. The important part is the integration work that comes afterwards,” Mr. Barba added.

He said he envisions a therapy program that involves “psychiatrists working together with psychotherapists. The psychotherapists would be more in charge of the active guiding, and the psychiatrist would do the prescribing, with the follow-up psychological support on Zoom.”

He added a word of caution for therapists that “psilocybin requires active confrontation of painful, negative emotions and people who take this drug need to be open and prepared for the idea that they are going into a state where they may probably end up crying and confronting whatever they are maybe running away from in their lives. Not everyone may want to do this.”
 

A New Treatment Paradigm?

In a comment, Johan Lundberg, MD, PhD, adjunct professor of psychiatry at the Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden, said the study addresses a key outstanding question about the long-term effects of one or two doses of psilocybin.

“It’s a 6-month follow-up of a short treatment intervention, so in that sense, it’s of high interest. It has been talked about that psilocybin might have a long-term effect, but this is the first study that has followed this for a longer term.”

But Dr. Lundberg also pointed out that one shortcoming of the study is the diversity of treatments following the intervention.

“They didn’t have control over whether patients received other treatments or when they started. So, that is a key concern. But they transparently reported that, and we do know there was a difference in reported ability to perform activities of daily life, and that is important.”

He added that if psilocybin is eventually approved, it would likely come with an education package for providers — “which is already the case with other treatments like ECT [electroconvulsive therapy] or TMS [transcranial magnetic stimulation] — you have to learn how to do it.”

James Rucker, MD, PhD, psychiatrist and senior clinical lecturer at King’s College London, who was not involved in the research, also noted that they have tended to attribute differences observed in this study to comparative differences between the drugs themselves.

However, he noted, it is also possible that the results reflect biased reporting between groups. This is more likely here because studies involving psilocybin tend to attract those with positive preconceptions about psilocybin and negative preconceptions about conventional antidepressants, and study participants were unblinded during the long-term follow-up phase, so knew which condition they were allocated to.

“This said, the nature of depression varies hugely between individuals, and this calls for the development of a similarly varied suite of treatment paradigms. Psilocybin therapy is certainly a different paradigm of treatment to escitalopram. The observation of similar levels of effectiveness to antidepressants here is encouraging to see alongside the much larger trials of psilocybin currently underway here in the UK, Europe, and the US,” Dr. Rucker added.

This work was supported by The Alexander Mosley Charitable Trust and by the founding partners of Imperial College London’s Centre for Psychedelic Research.

Mr. Barba reported having received consulting fees from Adamo Bioscience. Both Dr. Lundberg and Dr. Rucker are involved in psilocybin research, but neither reported financial links.

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

MILAN — Psilocybin leads to a better overall outcome in the treatment of moderate to severe major depressive disorder (MDD) than the selective serotonin reuptake inhibitor (SSRI) escitalopram, results of the first long-term comparison of the two treatments suggest.

“This is the first work to compare the long-term effects of these two drugs in the context of overall well-being, not just freedom from depression,” study investigator Tommaso Barba, PhD candidate at Imperial College London in England, said in a press release. “Psilocybin outperformed escitalopram in several measures of well-being, meaning in life, work, and social functioning.”

Findings from the 6-month follow-up study of a phase 2 double-blind, randomized, controlled trial were presented at the 37th European College of Neuropsychopharmacology (ECNP) Congress and published simultaneously in The Lancet eClinicalMedicine

Addressing a Treatment ‘Mismatch’

The findings are important because they address “a mismatch” between what psychiatrists and what patients think is important, Mr. Barba said in an interview.

“Psychiatrists really focus on negative symptoms of depression. So, if you are not sad anymore, if your sleep or appetite is not impaired, they think you’re better. But if you look at what patients define as important, they say it’s the degree in which their life is meaningful, in which they can connect with people around them, in which they can function in everyday life,” Mr. Barba said.

“The study suggests that psilocybin therapy might be a more holistic treatment option for depression,” added co–first author David Erritzoe, MD, PhD, clinical director and deputy head of the Centre for Psychedelic Research, Imperial College London. “This could make a substantial difference in the overall happiness and daily activities of those suffering from depression, providing a more joined-up approach to mental health treatment.”

The initial single-center study included 59 adults with MDD (mean age, 41 years) who were randomized to receive either psilocybin or escitalopram over a 6-week period. The psilocybin arm (n = 30) received two 25-mg oral doses of psilocybin therapy (PT), and the escitalopram arm (n = 29) received 10-20 mg of daily escitalopram plus two (placebo-like) 1-mg doses of psilocybin (ET). Both groups received psychological support.

Based on change in depression scores on the 16-item Quick Inventory of Depressive Symptomatology–Self-Report (QIDS-SR-16) at week 6, the initial study results suggested noninferiority between the two treatments in terms of depressive symptoms (primary outcome), but superiority of PT for secondary outcomes including “well-being, anhedonia, social functioning, sexual functioning, and related variables, with fewer side effects compared to ET,” the researchers noted.

The new 6-month follow-up findings, with monthly questionnaires and no additional study treatment or psychiatric treatment restrictions, measured the QIDS-SR-16, plus Work and Social Adjustment Scale (WSAS), Meaning in Life Questionnaire, Flourishing Scale (FS), and Watts Connectedness Scale (WCS).

Again, both groups maintained similar results on the QIDS-SR-16, with slightly greater reductions in depressive symptoms for PT in the first month (positive false discovery rate [pFDR] = 0.021), but not thereafter.

At both 3 and 6 months, there were greater improvements in WSAS scores for the PT group (pFDR < 0.001 and pFDR = 0.01, respectively), and also greater improvements in meaning in life across all follow-up timepoints (pFDR < 0.001).

There was also greater improvement in the PT group regarding WCS at both 3 and 6 months (pFDR = 0.02, and pFDR = 0.04) and comparable FS improvements for both groups across all timepoints.

Confounding follow-up interventions may have muddied the results, with 30.7% of PT participants and 43.5% of ET participants receiving an additional intervention during this period.

The researchers conclude that while a short course of SSRIs combined with intensive therapeutic support (around 20 hours) “might be enough to induce sustained antidepressant effects,” patients treated with psilocybin showed greater improvements in general functioning, connectedness, and meaning in life.

Although not reassessed in the follow-up, the initial study showed that adverse events, particularly sexual functioning, favored psilocybin, said Mr. Barba. “The two treatments seemed to go in opposite directions with psilocybin seeming to improve it and the antidepressant to suppress it. Other side effects associated with psilocybin were less diverse — mainly headaches at the end of the day — but with escitalopram they were way more diverse and more impairing.”

Although many therapists may be unfamiliar with psilocybin-assisted psychotherapy, “it’s not a difficult skill to master. It might require some specialization, but I think if you’re a good psychotherapist, you can learn how to implement psilocybin into your practice,” he said.

“Normally the journey is quite inward, so patients do not require active support during the psychedelic experience [around 6 hours]. Sometimes they do require some hand-holding, or helping them to ‘let go’, or breathing exercises. The important part is the integration work that comes afterwards,” Mr. Barba added.

He said he envisions a therapy program that involves “psychiatrists working together with psychotherapists. The psychotherapists would be more in charge of the active guiding, and the psychiatrist would do the prescribing, with the follow-up psychological support on Zoom.”

He added a word of caution for therapists that “psilocybin requires active confrontation of painful, negative emotions and people who take this drug need to be open and prepared for the idea that they are going into a state where they may probably end up crying and confronting whatever they are maybe running away from in their lives. Not everyone may want to do this.”
 

A New Treatment Paradigm?

In a comment, Johan Lundberg, MD, PhD, adjunct professor of psychiatry at the Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden, said the study addresses a key outstanding question about the long-term effects of one or two doses of psilocybin.

“It’s a 6-month follow-up of a short treatment intervention, so in that sense, it’s of high interest. It has been talked about that psilocybin might have a long-term effect, but this is the first study that has followed this for a longer term.”

But Dr. Lundberg also pointed out that one shortcoming of the study is the diversity of treatments following the intervention.

“They didn’t have control over whether patients received other treatments or when they started. So, that is a key concern. But they transparently reported that, and we do know there was a difference in reported ability to perform activities of daily life, and that is important.”

He added that if psilocybin is eventually approved, it would likely come with an education package for providers — “which is already the case with other treatments like ECT [electroconvulsive therapy] or TMS [transcranial magnetic stimulation] — you have to learn how to do it.”

James Rucker, MD, PhD, psychiatrist and senior clinical lecturer at King’s College London, who was not involved in the research, also noted that they have tended to attribute differences observed in this study to comparative differences between the drugs themselves.

However, he noted, it is also possible that the results reflect biased reporting between groups. This is more likely here because studies involving psilocybin tend to attract those with positive preconceptions about psilocybin and negative preconceptions about conventional antidepressants, and study participants were unblinded during the long-term follow-up phase, so knew which condition they were allocated to.

“This said, the nature of depression varies hugely between individuals, and this calls for the development of a similarly varied suite of treatment paradigms. Psilocybin therapy is certainly a different paradigm of treatment to escitalopram. The observation of similar levels of effectiveness to antidepressants here is encouraging to see alongside the much larger trials of psilocybin currently underway here in the UK, Europe, and the US,” Dr. Rucker added.

This work was supported by The Alexander Mosley Charitable Trust and by the founding partners of Imperial College London’s Centre for Psychedelic Research.

Mr. Barba reported having received consulting fees from Adamo Bioscience. Both Dr. Lundberg and Dr. Rucker are involved in psilocybin research, but neither reported financial links.

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

TOPLINE:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

• The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
• A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
• MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
• Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

• In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
• Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
• Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
• About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

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:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

• The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
• A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
• MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
• Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

• In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
• Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
• Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
• About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

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:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

• The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
• A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
• MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
• Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

• In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
• Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
• Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
• About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

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.