Listening to Tim Ferriss

Article Type
Changed
Fri, 09/25/2020 - 15:04

Let me tell you about Tim Ferriss. A few years ago, I started reading his best-selling book, The 4-Hour Body. Ferris detailed how he made himself into a one-man experiment – he’d make changes to his diet, checked his weight and his labs, maybe he even had metabolic studies done.

Courtesy Taylor Prinsen
Tim Ferriss (above) was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness research.

He’d take these measures after soaking in hot baths, then ice baths, and while I admired his discipline, he did lose me during the chapter where he was using steroids. In the end, he advised a dairy-free, low-carbohydrate diet of green vegetables, beans or lentils, and protein for four meals a day, 6 days a week, with free-for-all eating on the 7th day. Then, there was a weight-lifting routine with kettle bells and ice packs to be placed on your shoulders for a set amount of time each day.

I may not remember the program’s details, but something about Ferris fascinated me. He brands himself as being a “human guinea pig,” about “lifestyle design,” and whatever that is, I like it. Perhaps I am attracted to the idea that we might control the trajectories of our generally uncontrollable lives.

Tim Ferriss graduated from Princeton, he’s written five best-selling books and has a popular podcast, he’s been a TED speaker, and he’s been on Fortune’s “40 under 40” list – and there’s so much more. Ferriss is brilliant, innovative, handsome, charismatic, prolific, extraordinarily athletic. I may have forgotten to mention that he was the National Chinese Kickboxing Champion and was a semifinalist in the World Champion Tango competition in Buenos Aires. He’s adventuresome and fearless, and if that isn’t enough, he speaks five languages. In the genetic dice roll, Mr. Ferriss did well, and he’s a driven and energetic hard worker who is open to new experiences.

I subscribe to the Tim Ferriss podcast – as of this writing, there are 466 episodes, with an incredible lineup of interviews with famous and successful guests. I also subscribe to his “5-Bullet Friday” email list where he mentions the interesting things he is reading, watching, learning about, or eating, and the products he is trying – single-ply toilet paper gets a thumbs down – then ends with a thought-provoking quote. This gentleman spends a tremendous amount of time searching and striving, working on himself and his own emotional growth and self-improvement, and yet he still has time for incredible explorations and experiences.

A search for psychic peace

Honestly, were it not for a few little details, I would like to be Tim Ferriss. Who wouldn’t? But what stops me from actually wanting to be Ferriss is that early on while listening to him, I realized that his drive has been fueled by intense psychic pain. He talks openly about being very close to suicide in college, about a tormenting mood disorder, demons to tame, and productivity as an antidote to a fear of failure, not always as a joy for life. There are moments that I have felt so sad for this remarkable stranger. Tim Ferriss is a searcher and what I believe he searches for most is his own psychic peace.

Dr. Dinah Miller

In a forum for psychiatrists, I wish I could write that Ferriss has found solace with our Food and Drug Administration–approved pharmaceuticals and with psychotherapy, but that’s not what he says. What Ferriss has found helpful, however, is psychedelics, and a wide variety of psychological and philosophical teachings ranging from meditation to Stoicism. And most notably, Ferriss has been an advocate for using hallucinogens as a legal medical intervention. Ferriss was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness Research. He’s helped to move this field forward and to improve its credibility.

On Sept. 14, 2020, Tim Ferriss released a podcast he recorded with his dance partner and close friend, Debbie Millman, and when he recorded it, he was not certain he would release it. None of his usual sponsors endorsed during the podcast. He starts Episode #464 with, “For me, this is the most important podcast episode I’ve ever published. In it, I describe the most life-shaping, certainly the most difficult, and certainly the most transformative journey of my 43 years on this planet. I’ve never shared it before.”

I applaud Mr. Ferriss for going through with posting the podcast, a confessional about how he was repeatedly sexually molested over a 2-year period as a young child by a babysitter’s son. He worried about how this would affect his family, if they would be left feeling guilty or devastated. He says, “Please note that I expect to be completely overwhelmed emotionally and otherwise when this is published and please understand if I’m not able to reply to any outreach.”

Ferriss and Millman had a long discussion about their sexual abuse as children. Millman was abused by her stepfather at the age of 9, and she talks about confronting him many years later. Ferriss has not confronted his perpetrator, though he has contemplated doing so.

Sexual violence and violation at any age leaves people scarred. In a recent letter to the New York Times in response to President Trump’s words of support to Ghislaine Maxwell, the woman who helped Jeffrey Epstein find his victims, Baltimore psychiatrist Robin Weiss wrote, “Thirty-eight years ago, when I was 32, I was raped. I was married, I was a doctor – you might say I was in pretty stable shape. Yet the shame and guilt I felt were overwhelming. Why didn’t I fight harder? How did I let this happen? I knew better, yet it took me years to overcome those irrational feelings.” These feelings of shame, guilt, self-doubt, and self-blame are nearly universal in survivors of sexual trauma. In children, they can be even worse, as children often don’t have an understanding that what is being done to them is wrong. They lack the language and the maturity to process the events, and ongoing abuse may be accompanied by threats to life of the child or their family members if they tell others, as was the case with Millman. She chose to process her abuse and the consequent difficulties she had by seeking psychiatric care. She took antidepressants and has been in psychoanalysis, both of which she has found to be helpful. Her treatment has tamed her demons, it is ongoing decades later and those demons have not vanished.
 

 

 

Abuse comes back in ‘a tidal wave’

Not surprisingly, Ferriss struggled with whether to make these events public. While so much of his story feels familiar to those of us who help patients process their trauma, it’s not completely typical. Ferriss remembered these episodes of sexual abuse “in high resolution,” while using ayahuasca, a hallucinogen, about 5 years ago. He describes suppressing and discounting these memories until he attended a 10-day silent retreat where he used psilocybin. I found it interesting that Ferriss fasted for 5 days before attending the retreat “to increase the depth of the experience.” He goes on to say, “Around day 6 of this silent retreat, all of this abuse came back to me like a tidal wave and it was replaying as if I was wearing a virtual reality headset. I was immersed, I wasn’t an observer, it was as though I was being traumatized and retraumatized 24/7.” He describes an excruciating and horrifying experience and he referred to it as a “psychotic break.”

Ferriss goes on to talk about how bringing these memories to light has affected him, how it’s explained many of his behaviors and ways of relating in a way that has helped him organize and understand his life.

“It was at the tail end of the retreat that I realized that these 17 seemingly inexplicable behaviors of mine – these vicious cycles or triggers that I had been treating like separate problems to be solved, were all downstream of this trauma. Oh, now that you click that puzzle piece into place, these really strange behaviors – this self-loathing, this rage that was seemingly so exaggerated and disproportionate – leading to the near-suicide I had in college – all these things fell into places making sense.” It gave him a sense of relief but was simultaneously overwhelming.

Both Ferriss and Millman talk about books and treatments that have been helpful to them. Their knowledge of trauma treatments and resources is impressive and can be found at: Tim Ferriss – My Healing Journey After Childhood Abuse (Includes Extensive Resource List). Their wish is to share their suffering as a way to help others, impart hope, and better connect.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

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Let me tell you about Tim Ferriss. A few years ago, I started reading his best-selling book, The 4-Hour Body. Ferris detailed how he made himself into a one-man experiment – he’d make changes to his diet, checked his weight and his labs, maybe he even had metabolic studies done.

Courtesy Taylor Prinsen
Tim Ferriss (above) was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness research.

He’d take these measures after soaking in hot baths, then ice baths, and while I admired his discipline, he did lose me during the chapter where he was using steroids. In the end, he advised a dairy-free, low-carbohydrate diet of green vegetables, beans or lentils, and protein for four meals a day, 6 days a week, with free-for-all eating on the 7th day. Then, there was a weight-lifting routine with kettle bells and ice packs to be placed on your shoulders for a set amount of time each day.

I may not remember the program’s details, but something about Ferris fascinated me. He brands himself as being a “human guinea pig,” about “lifestyle design,” and whatever that is, I like it. Perhaps I am attracted to the idea that we might control the trajectories of our generally uncontrollable lives.

Tim Ferriss graduated from Princeton, he’s written five best-selling books and has a popular podcast, he’s been a TED speaker, and he’s been on Fortune’s “40 under 40” list – and there’s so much more. Ferriss is brilliant, innovative, handsome, charismatic, prolific, extraordinarily athletic. I may have forgotten to mention that he was the National Chinese Kickboxing Champion and was a semifinalist in the World Champion Tango competition in Buenos Aires. He’s adventuresome and fearless, and if that isn’t enough, he speaks five languages. In the genetic dice roll, Mr. Ferriss did well, and he’s a driven and energetic hard worker who is open to new experiences.

I subscribe to the Tim Ferriss podcast – as of this writing, there are 466 episodes, with an incredible lineup of interviews with famous and successful guests. I also subscribe to his “5-Bullet Friday” email list where he mentions the interesting things he is reading, watching, learning about, or eating, and the products he is trying – single-ply toilet paper gets a thumbs down – then ends with a thought-provoking quote. This gentleman spends a tremendous amount of time searching and striving, working on himself and his own emotional growth and self-improvement, and yet he still has time for incredible explorations and experiences.

A search for psychic peace

Honestly, were it not for a few little details, I would like to be Tim Ferriss. Who wouldn’t? But what stops me from actually wanting to be Ferriss is that early on while listening to him, I realized that his drive has been fueled by intense psychic pain. He talks openly about being very close to suicide in college, about a tormenting mood disorder, demons to tame, and productivity as an antidote to a fear of failure, not always as a joy for life. There are moments that I have felt so sad for this remarkable stranger. Tim Ferriss is a searcher and what I believe he searches for most is his own psychic peace.

Dr. Dinah Miller

In a forum for psychiatrists, I wish I could write that Ferriss has found solace with our Food and Drug Administration–approved pharmaceuticals and with psychotherapy, but that’s not what he says. What Ferriss has found helpful, however, is psychedelics, and a wide variety of psychological and philosophical teachings ranging from meditation to Stoicism. And most notably, Ferriss has been an advocate for using hallucinogens as a legal medical intervention. Ferriss was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness Research. He’s helped to move this field forward and to improve its credibility.

On Sept. 14, 2020, Tim Ferriss released a podcast he recorded with his dance partner and close friend, Debbie Millman, and when he recorded it, he was not certain he would release it. None of his usual sponsors endorsed during the podcast. He starts Episode #464 with, “For me, this is the most important podcast episode I’ve ever published. In it, I describe the most life-shaping, certainly the most difficult, and certainly the most transformative journey of my 43 years on this planet. I’ve never shared it before.”

I applaud Mr. Ferriss for going through with posting the podcast, a confessional about how he was repeatedly sexually molested over a 2-year period as a young child by a babysitter’s son. He worried about how this would affect his family, if they would be left feeling guilty or devastated. He says, “Please note that I expect to be completely overwhelmed emotionally and otherwise when this is published and please understand if I’m not able to reply to any outreach.”

Ferriss and Millman had a long discussion about their sexual abuse as children. Millman was abused by her stepfather at the age of 9, and she talks about confronting him many years later. Ferriss has not confronted his perpetrator, though he has contemplated doing so.

Sexual violence and violation at any age leaves people scarred. In a recent letter to the New York Times in response to President Trump’s words of support to Ghislaine Maxwell, the woman who helped Jeffrey Epstein find his victims, Baltimore psychiatrist Robin Weiss wrote, “Thirty-eight years ago, when I was 32, I was raped. I was married, I was a doctor – you might say I was in pretty stable shape. Yet the shame and guilt I felt were overwhelming. Why didn’t I fight harder? How did I let this happen? I knew better, yet it took me years to overcome those irrational feelings.” These feelings of shame, guilt, self-doubt, and self-blame are nearly universal in survivors of sexual trauma. In children, they can be even worse, as children often don’t have an understanding that what is being done to them is wrong. They lack the language and the maturity to process the events, and ongoing abuse may be accompanied by threats to life of the child or their family members if they tell others, as was the case with Millman. She chose to process her abuse and the consequent difficulties she had by seeking psychiatric care. She took antidepressants and has been in psychoanalysis, both of which she has found to be helpful. Her treatment has tamed her demons, it is ongoing decades later and those demons have not vanished.
 

 

 

Abuse comes back in ‘a tidal wave’

Not surprisingly, Ferriss struggled with whether to make these events public. While so much of his story feels familiar to those of us who help patients process their trauma, it’s not completely typical. Ferriss remembered these episodes of sexual abuse “in high resolution,” while using ayahuasca, a hallucinogen, about 5 years ago. He describes suppressing and discounting these memories until he attended a 10-day silent retreat where he used psilocybin. I found it interesting that Ferriss fasted for 5 days before attending the retreat “to increase the depth of the experience.” He goes on to say, “Around day 6 of this silent retreat, all of this abuse came back to me like a tidal wave and it was replaying as if I was wearing a virtual reality headset. I was immersed, I wasn’t an observer, it was as though I was being traumatized and retraumatized 24/7.” He describes an excruciating and horrifying experience and he referred to it as a “psychotic break.”

Ferriss goes on to talk about how bringing these memories to light has affected him, how it’s explained many of his behaviors and ways of relating in a way that has helped him organize and understand his life.

“It was at the tail end of the retreat that I realized that these 17 seemingly inexplicable behaviors of mine – these vicious cycles or triggers that I had been treating like separate problems to be solved, were all downstream of this trauma. Oh, now that you click that puzzle piece into place, these really strange behaviors – this self-loathing, this rage that was seemingly so exaggerated and disproportionate – leading to the near-suicide I had in college – all these things fell into places making sense.” It gave him a sense of relief but was simultaneously overwhelming.

Both Ferriss and Millman talk about books and treatments that have been helpful to them. Their knowledge of trauma treatments and resources is impressive and can be found at: Tim Ferriss – My Healing Journey After Childhood Abuse (Includes Extensive Resource List). Their wish is to share their suffering as a way to help others, impart hope, and better connect.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

Let me tell you about Tim Ferriss. A few years ago, I started reading his best-selling book, The 4-Hour Body. Ferris detailed how he made himself into a one-man experiment – he’d make changes to his diet, checked his weight and his labs, maybe he even had metabolic studies done.

Courtesy Taylor Prinsen
Tim Ferriss (above) was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness research.

He’d take these measures after soaking in hot baths, then ice baths, and while I admired his discipline, he did lose me during the chapter where he was using steroids. In the end, he advised a dairy-free, low-carbohydrate diet of green vegetables, beans or lentils, and protein for four meals a day, 6 days a week, with free-for-all eating on the 7th day. Then, there was a weight-lifting routine with kettle bells and ice packs to be placed on your shoulders for a set amount of time each day.

I may not remember the program’s details, but something about Ferris fascinated me. He brands himself as being a “human guinea pig,” about “lifestyle design,” and whatever that is, I like it. Perhaps I am attracted to the idea that we might control the trajectories of our generally uncontrollable lives.

Tim Ferriss graduated from Princeton, he’s written five best-selling books and has a popular podcast, he’s been a TED speaker, and he’s been on Fortune’s “40 under 40” list – and there’s so much more. Ferriss is brilliant, innovative, handsome, charismatic, prolific, extraordinarily athletic. I may have forgotten to mention that he was the National Chinese Kickboxing Champion and was a semifinalist in the World Champion Tango competition in Buenos Aires. He’s adventuresome and fearless, and if that isn’t enough, he speaks five languages. In the genetic dice roll, Mr. Ferriss did well, and he’s a driven and energetic hard worker who is open to new experiences.

I subscribe to the Tim Ferriss podcast – as of this writing, there are 466 episodes, with an incredible lineup of interviews with famous and successful guests. I also subscribe to his “5-Bullet Friday” email list where he mentions the interesting things he is reading, watching, learning about, or eating, and the products he is trying – single-ply toilet paper gets a thumbs down – then ends with a thought-provoking quote. This gentleman spends a tremendous amount of time searching and striving, working on himself and his own emotional growth and self-improvement, and yet he still has time for incredible explorations and experiences.

A search for psychic peace

Honestly, were it not for a few little details, I would like to be Tim Ferriss. Who wouldn’t? But what stops me from actually wanting to be Ferriss is that early on while listening to him, I realized that his drive has been fueled by intense psychic pain. He talks openly about being very close to suicide in college, about a tormenting mood disorder, demons to tame, and productivity as an antidote to a fear of failure, not always as a joy for life. There are moments that I have felt so sad for this remarkable stranger. Tim Ferriss is a searcher and what I believe he searches for most is his own psychic peace.

Dr. Dinah Miller

In a forum for psychiatrists, I wish I could write that Ferriss has found solace with our Food and Drug Administration–approved pharmaceuticals and with psychotherapy, but that’s not what he says. What Ferriss has found helpful, however, is psychedelics, and a wide variety of psychological and philosophical teachings ranging from meditation to Stoicism. And most notably, Ferriss has been an advocate for using hallucinogens as a legal medical intervention. Ferriss was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness Research. He’s helped to move this field forward and to improve its credibility.

On Sept. 14, 2020, Tim Ferriss released a podcast he recorded with his dance partner and close friend, Debbie Millman, and when he recorded it, he was not certain he would release it. None of his usual sponsors endorsed during the podcast. He starts Episode #464 with, “For me, this is the most important podcast episode I’ve ever published. In it, I describe the most life-shaping, certainly the most difficult, and certainly the most transformative journey of my 43 years on this planet. I’ve never shared it before.”

I applaud Mr. Ferriss for going through with posting the podcast, a confessional about how he was repeatedly sexually molested over a 2-year period as a young child by a babysitter’s son. He worried about how this would affect his family, if they would be left feeling guilty or devastated. He says, “Please note that I expect to be completely overwhelmed emotionally and otherwise when this is published and please understand if I’m not able to reply to any outreach.”

Ferriss and Millman had a long discussion about their sexual abuse as children. Millman was abused by her stepfather at the age of 9, and she talks about confronting him many years later. Ferriss has not confronted his perpetrator, though he has contemplated doing so.

Sexual violence and violation at any age leaves people scarred. In a recent letter to the New York Times in response to President Trump’s words of support to Ghislaine Maxwell, the woman who helped Jeffrey Epstein find his victims, Baltimore psychiatrist Robin Weiss wrote, “Thirty-eight years ago, when I was 32, I was raped. I was married, I was a doctor – you might say I was in pretty stable shape. Yet the shame and guilt I felt were overwhelming. Why didn’t I fight harder? How did I let this happen? I knew better, yet it took me years to overcome those irrational feelings.” These feelings of shame, guilt, self-doubt, and self-blame are nearly universal in survivors of sexual trauma. In children, they can be even worse, as children often don’t have an understanding that what is being done to them is wrong. They lack the language and the maturity to process the events, and ongoing abuse may be accompanied by threats to life of the child or their family members if they tell others, as was the case with Millman. She chose to process her abuse and the consequent difficulties she had by seeking psychiatric care. She took antidepressants and has been in psychoanalysis, both of which she has found to be helpful. Her treatment has tamed her demons, it is ongoing decades later and those demons have not vanished.
 

 

 

Abuse comes back in ‘a tidal wave’

Not surprisingly, Ferriss struggled with whether to make these events public. While so much of his story feels familiar to those of us who help patients process their trauma, it’s not completely typical. Ferriss remembered these episodes of sexual abuse “in high resolution,” while using ayahuasca, a hallucinogen, about 5 years ago. He describes suppressing and discounting these memories until he attended a 10-day silent retreat where he used psilocybin. I found it interesting that Ferriss fasted for 5 days before attending the retreat “to increase the depth of the experience.” He goes on to say, “Around day 6 of this silent retreat, all of this abuse came back to me like a tidal wave and it was replaying as if I was wearing a virtual reality headset. I was immersed, I wasn’t an observer, it was as though I was being traumatized and retraumatized 24/7.” He describes an excruciating and horrifying experience and he referred to it as a “psychotic break.”

Ferriss goes on to talk about how bringing these memories to light has affected him, how it’s explained many of his behaviors and ways of relating in a way that has helped him organize and understand his life.

“It was at the tail end of the retreat that I realized that these 17 seemingly inexplicable behaviors of mine – these vicious cycles or triggers that I had been treating like separate problems to be solved, were all downstream of this trauma. Oh, now that you click that puzzle piece into place, these really strange behaviors – this self-loathing, this rage that was seemingly so exaggerated and disproportionate – leading to the near-suicide I had in college – all these things fell into places making sense.” It gave him a sense of relief but was simultaneously overwhelming.

Both Ferriss and Millman talk about books and treatments that have been helpful to them. Their knowledge of trauma treatments and resources is impressive and can be found at: Tim Ferriss – My Healing Journey After Childhood Abuse (Includes Extensive Resource List). Their wish is to share their suffering as a way to help others, impart hope, and better connect.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

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Antidepressant use shows gender, racial disparities

Article Type
Changed
Mon, 09/14/2020 - 13:22

Women are more than twice as likely as men to use antidepressants, and use among White women is at least double that of other races/ethnicities, according to a new analysis from the National Center for Health Statistics.

Here are the actual numbers: 17.7% of women and 8.4% of men used an antidepressant in the 30 days before being interviewed for the National Health and Nutrition Examination Survey (NHANES). Put them together, and it works out to 13.2% of all adults over the 4-year period from 2015 to 2018, Debra J. Brody, MPH, and Qiuping Gu, MD, PhD, said Sept. 4 in an NCHS data brief.

The racial/ethnic differences in antidepressant use were even greater, at least for women. Non-Hispanic White women had a past-30-day prevalence of 22.3%, compared with 10.0% for non-Hispanic Black women, 3.4% for non-Hispanic Asian women, and 8.9% for Hispanic women, based on the NHANES data.



The order was the same for men, but the numbers are lower. Non-Hispanic Whites had the highest antidepressant use at 10.5%, followed by non-Hispanic Blacks (5.0%), non-Hispanic Asians (2.1%), and Hispanics (4.0%). All of the differences between Whites and non-Whites were significant for both women and men, the researchers noted.

A look at trends over time shows that the gap between men and women has widened in the last 10 years. Past-30-day use among women went from 13.8% in 2009-2010 to 18.6% in 2017-2018, with a corresponding increase from 7.1% to 8.7% in men. For women, that change was significant; for men, it was not, Ms. Brody and Dr. Gu said.

The sample size averaged just over 6,000 for each of the five 2-year NHANES cycles included in the analysis. The survey includes a household interview and a physical examination at a mobile exam center.

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Women are more than twice as likely as men to use antidepressants, and use among White women is at least double that of other races/ethnicities, according to a new analysis from the National Center for Health Statistics.

Here are the actual numbers: 17.7% of women and 8.4% of men used an antidepressant in the 30 days before being interviewed for the National Health and Nutrition Examination Survey (NHANES). Put them together, and it works out to 13.2% of all adults over the 4-year period from 2015 to 2018, Debra J. Brody, MPH, and Qiuping Gu, MD, PhD, said Sept. 4 in an NCHS data brief.

The racial/ethnic differences in antidepressant use were even greater, at least for women. Non-Hispanic White women had a past-30-day prevalence of 22.3%, compared with 10.0% for non-Hispanic Black women, 3.4% for non-Hispanic Asian women, and 8.9% for Hispanic women, based on the NHANES data.



The order was the same for men, but the numbers are lower. Non-Hispanic Whites had the highest antidepressant use at 10.5%, followed by non-Hispanic Blacks (5.0%), non-Hispanic Asians (2.1%), and Hispanics (4.0%). All of the differences between Whites and non-Whites were significant for both women and men, the researchers noted.

A look at trends over time shows that the gap between men and women has widened in the last 10 years. Past-30-day use among women went from 13.8% in 2009-2010 to 18.6% in 2017-2018, with a corresponding increase from 7.1% to 8.7% in men. For women, that change was significant; for men, it was not, Ms. Brody and Dr. Gu said.

The sample size averaged just over 6,000 for each of the five 2-year NHANES cycles included in the analysis. The survey includes a household interview and a physical examination at a mobile exam center.

Women are more than twice as likely as men to use antidepressants, and use among White women is at least double that of other races/ethnicities, according to a new analysis from the National Center for Health Statistics.

Here are the actual numbers: 17.7% of women and 8.4% of men used an antidepressant in the 30 days before being interviewed for the National Health and Nutrition Examination Survey (NHANES). Put them together, and it works out to 13.2% of all adults over the 4-year period from 2015 to 2018, Debra J. Brody, MPH, and Qiuping Gu, MD, PhD, said Sept. 4 in an NCHS data brief.

The racial/ethnic differences in antidepressant use were even greater, at least for women. Non-Hispanic White women had a past-30-day prevalence of 22.3%, compared with 10.0% for non-Hispanic Black women, 3.4% for non-Hispanic Asian women, and 8.9% for Hispanic women, based on the NHANES data.



The order was the same for men, but the numbers are lower. Non-Hispanic Whites had the highest antidepressant use at 10.5%, followed by non-Hispanic Blacks (5.0%), non-Hispanic Asians (2.1%), and Hispanics (4.0%). All of the differences between Whites and non-Whites were significant for both women and men, the researchers noted.

A look at trends over time shows that the gap between men and women has widened in the last 10 years. Past-30-day use among women went from 13.8% in 2009-2010 to 18.6% in 2017-2018, with a corresponding increase from 7.1% to 8.7% in men. For women, that change was significant; for men, it was not, Ms. Brody and Dr. Gu said.

The sample size averaged just over 6,000 for each of the five 2-year NHANES cycles included in the analysis. The survey includes a household interview and a physical examination at a mobile exam center.

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Oral Relugolix Yields Superior Testosterone Suppression and Decreased Cardiovascular Events Compared With GnRH Agonist

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Thu, 07/30/2020 - 13:23
Display Headline
Oral Relugolix Yields Superior Testosterone Suppression and Decreased Cardiovascular Events Compared With GnRH Agonist

Study Overview

Objective. To evaluate the safety and efficacy of the highly selective oral gonadotropin-releasing hormone (GnRH) antagonist relugolix in men with advanced prostate cancer.

Design. Global, multicenter, randomized, open-label, phase 3 trial.

Intervention. Patients were randomized in a 2:1 ratio to receive either relugolix 120 mg once daily after receiving a single loading dose of 360 mg, or 22.5 mg of leuprolide acetate every 3 months. Patients in Japan and Taiwan received 11.25 mg of leuprolide. The randomization was stratified by age (> 75 years or ≤ 75 years), metastatic disease status, and geographic region (Asia, Europe, North and South America). The intervention period was 48 weeks.

Setting and participants. 1327 patients were screened, and 934 patients underwent randomization: 622 patients to the relugolix group and 308 to the leuprolide group. Patients had histologically or cytologically confirmed adenocarcinoma of the prostate. All patients had to have 1 of the following: evidence of biochemical or clinical relapse after primary curative therapy, newly diagnosed hormone-sensitive metastatic disease, or advance localized disease unlikely to be cured by local primary intervention. The patients with disease progression or rising prostate-specific antigen (PSA) had the option to receive enzalutamide or docetaxel after the confirmation of progression. Patients were excluded if they had a major cardiovascular event within 6 months of enrollment.

Main outcome measures. The primary endpoint was sustained castration rate, defined as the cumulative probability of testosterone suppression to ≤ 50 ng/dL while on study treatment from week 5 through week 48. Secondary endpoints included noninferiority of relugolix to leuprolide in regard to sustained castration rate. Superiority testing was performed if the noninferiority margin of –10 percentage points was met. Additional secondary endpoints were probability of testosterone suppression to ≤ 50 ng/dL on day 4 and day 15 and the percentage of patients with a > 50% decrease in PSA at day 15 and follicle-stimulating hormone (FSH) levels at the end of week 24.

Main results. The baseline characteristics were well balanced between the treatment groups. Approximately 30% of the patients in each group had metastatic disease. Approximately 50% of patients enrolled had biochemical recurrence following primary treatment for prostate cancer. The mean PSA was 104.2 ng/mL in the relugolix group and 68.6 ng/mL in the leuprolide group. The majority of patients had at least 1 cardiovascular risk factor (ie, tobacco use, obesity, diabetes, hypertension, or a history of a major adverse cardiac event [MACE]). Adherence to oral therapy was reported as 99% in both groups. The median follow-up time was 52 weeks; 90% of patients in the relugolix arm and 89% in the leuprolide arm completed 48 weeks of treatment.

Sustained testosterone suppression to ≤ 50 ng/dL from day 29 through week 48 was seen in 96.7% of patients in the relugolix group and 88.8% in the leuprolide group, which was determined to be noninferior. Additionally, relugolix was also found to be superior to leuprolide in regard to sustained testosterone suppression (P < 0.001). These results were consistent across all subgroups. Relugolix was also found to be superior to leuprolide for all secondary endpoints, including cumulative probability of castration on day 4 (56% vs 0%) and day 15 (98.7% vs 12%) and testosterone suppression to ≤ 20 ng/dL on day 15 (78.4% vs 1%). Confirmed PSA response on day 15 was seen in 79.4% of patients in the relugolix arm and in 19.8% in the leuprolide arm (P < 0.001). FSH suppression was greater in the relugolix arm compared with the leuprolide arm by the end of week 24. An increase of testosterone levels from baseline was noted in the leuprolide patients at day 4, with the level decreasing to castrate level by day 29. In contrast, relugolix patients maintained castrate testosterone levels from day 4 throughout the intervention period. Testosterone recovery at 90 days was seen in 54% of patients in the relugolix group compared with 3% in the leuprolide group (P = 0.002).

 

 

The most frequent adverse event seen in both groups was hot flashes (54.3% in the relugolix group and 51.6% in the leuprolide group). The second most common adverse event report was fatigue, which occurred in 21.5% of patients in the relugolix arm and 18.5% in the leuprolide arm. Diarrhea was reported more frequently with relugolix than with leuprolide (12.2% vs 6.8%); however, diarrhea did not lead to discontinuation of therapy in any patient. Fatal events were reported more frequently in the leuprolide group (2.9%) compared with the relugolix group (1.1%). MACE were defined as nonfatal myocardial infarction, stroke, and death from any cause. After completing the intervention period of 48 weeks, the relugolix group had a 2.9% incidence of major cardiovascular events, compared with 6.2% in the leuprolide group. In patients having a medical history of cardiovascular events, the adverse event rate during the trial period was 3.6% in the relugolix group and 17.8% in leuprolide group. This translated into a 54% lower risk of MACE in the relugolix arm compared with the leuprolide arm.

Conclusion. The use of relugolix in advanced prostate cancer led to rapid, sustained suppression and faster recovery of testosterone level compared with leuprolide. Relugolix appeared safer to use for men with a medical history of cardiovascular events and showed a 54% lower risk of MACE than leuprolide.

Commentary

Relugolix is a highly selective oral GnRH antagonist that rapidly inhibits pituitary release of luteinizing hormone and FSH. The current phase 3 HERO trial highlights the efficacy of relugolix in regard to testosterone suppression, adding to potential therapeutic options for these men. Relugolix yielded superior sustained testosterone suppression to less than 50 ng/dL throughout the 48-week study period, meeting its primary endpoint. Additionally, relugolix showed superiority in all secondary endpoints across all subgroups of patients. To date, the only GnRH antagonist on the market is degarelix, which is given as a monthly subcutaneous injection.1 Injection-site reactions remain an issue with this formulation.

Cardiovascular disease is the leading cause of death in the United States, and it is known that men with prostate cancer have a higher incidence of cardiovascular disease.2 While data regarding adverse cardiac outcomes with androgen deprivation therapy have been mixed, it is thought that this therapy increases the risk for MACE. There is mounting evidence that GnRH antagonists may have a less detrimental effect on cardiovascular outcomes compared with GnRH agonists. For example, a pooled analysis of 6 phase 3 trials showed a lower incidence of cardiovascular events in men with preexisting cardiovascular disease using the GnRH antagonist degarelix compared with GnRH agonists after 12 months of treatment.3 Furthermore, a more recent phase 2 randomized trial showed that 20% of patients treated with a GnRH agonist developed cardiovascular events, compared to 3% in the GnRH antagonist group. The absolute risk reduction of cardiovascular events at 12 months was 18%.4 The results of the current trial support such findings, showing a 54% reduction in MACE after 48 weeks of therapy when compared with leuprolide (2.9% in relugolix arm vs 6.2% in leuprolide arm). More importantly perhaps, in the subgroup of men with preexisting cardiovascular disease, the benefit was even greater, with a MACE incidence of 3.6% with relugolix compared with 17.8% with leuprolide.

Studies have also shown that second-generation antiandrogens such as enzalutamide are associated with an increased risk of death from cardiovascular causes. For example, data from the recently updated PROSPER trial, which evaluated the use of enzalutamide in men with nonmetastatic, castration-resistant prostate cancer, showed an increased risk of adverse events, including falls, fatigue, hypertension, and death from cardiovascular events.5 Furthermore, adding second-generation antiandrogens to GnRH-agonist therapy is associated with a high risk of cardiovascular events in men with preexisting cardiovascular disease.3 These results were noted in all of the trials of second-generation antiandrogens, including enzalutamide, apalutamide, and darolutamide, in combination with GnRH agonists.6-8 Taken together, one might consider whether the use of a GnRH antagonist would result in improved cardiovascular outcomes in high-risk patients.

 

 

In light of the efficacy of relugolix in regard to testosterone suppression highlighted in the current trial, it is likely that its efficacy in regard to cancer outcomes will be similar; however, to date there is no level 1 evidence to support this. Nevertheless, there is a clear association of adverse cardiovascular outcomes in men treated with GnRH agonists, and the notable 54% risk reduction seen in the current trial certainly would support considering the use of a GnRH antagonist for the subgroup of patients with preexisting cardiovascular disease or those at high risk for MACE. Further work is needed to define the role of GnRH antagonists in conjunction with second-generation antiandrogens to help mitigate cardiovascular toxicities.

Clinical Implications

The use of GnRH antagonists should be considered in men with advanced prostate cancer who have underlying cardiovascular disease to help mitigate the risk of MACE. Currently, degarelix is the only commercially available agent; however, pending regulatory approval, oral relugolix may be considered an appropriate oral option in such patients, with data supporting superior testosterone suppressive effects. Further follow-up will be needed.

–Saud Alsubait, MD, Michigan State University, East Lansing, MI
–Daniel Isaac, MD, MS

References

1. Barkin J, Burton S, Lambert C. Optimizing subcutaneous injection of the gonadotropin-releasing hormone receptor antagonist degarelix. Can J Urol. 2016;23:8179-8183.

2. Higano CS. Cardiovascular disease and androgen axis-targeted drugs for prostate cancer. N Engl J Med. 2020;382:2257-2259.

3. Albertsen PC, Klotz L, Tombal B, et al. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. Eur Urol. 2014;65:565-573.

4. Margel D, Peer A, Ber Y, et al. Cardiovascular morbidity in a randomized trial comparing GnRH agonist and GnRH antagonist among patients with advanced prostate cancer and preexisting cardiovascular disease. J Urol. 2019;202:1199-1208.

5. Sternberg CN, Fizazi K, Saad F, et al. Enzalutamide and survival in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2020;382:2197-2206.

6. Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378:1408-1418.

7. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380:1235-1246.

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Study Overview

Objective. To evaluate the safety and efficacy of the highly selective oral gonadotropin-releasing hormone (GnRH) antagonist relugolix in men with advanced prostate cancer.

Design. Global, multicenter, randomized, open-label, phase 3 trial.

Intervention. Patients were randomized in a 2:1 ratio to receive either relugolix 120 mg once daily after receiving a single loading dose of 360 mg, or 22.5 mg of leuprolide acetate every 3 months. Patients in Japan and Taiwan received 11.25 mg of leuprolide. The randomization was stratified by age (> 75 years or ≤ 75 years), metastatic disease status, and geographic region (Asia, Europe, North and South America). The intervention period was 48 weeks.

Setting and participants. 1327 patients were screened, and 934 patients underwent randomization: 622 patients to the relugolix group and 308 to the leuprolide group. Patients had histologically or cytologically confirmed adenocarcinoma of the prostate. All patients had to have 1 of the following: evidence of biochemical or clinical relapse after primary curative therapy, newly diagnosed hormone-sensitive metastatic disease, or advance localized disease unlikely to be cured by local primary intervention. The patients with disease progression or rising prostate-specific antigen (PSA) had the option to receive enzalutamide or docetaxel after the confirmation of progression. Patients were excluded if they had a major cardiovascular event within 6 months of enrollment.

Main outcome measures. The primary endpoint was sustained castration rate, defined as the cumulative probability of testosterone suppression to ≤ 50 ng/dL while on study treatment from week 5 through week 48. Secondary endpoints included noninferiority of relugolix to leuprolide in regard to sustained castration rate. Superiority testing was performed if the noninferiority margin of –10 percentage points was met. Additional secondary endpoints were probability of testosterone suppression to ≤ 50 ng/dL on day 4 and day 15 and the percentage of patients with a > 50% decrease in PSA at day 15 and follicle-stimulating hormone (FSH) levels at the end of week 24.

Main results. The baseline characteristics were well balanced between the treatment groups. Approximately 30% of the patients in each group had metastatic disease. Approximately 50% of patients enrolled had biochemical recurrence following primary treatment for prostate cancer. The mean PSA was 104.2 ng/mL in the relugolix group and 68.6 ng/mL in the leuprolide group. The majority of patients had at least 1 cardiovascular risk factor (ie, tobacco use, obesity, diabetes, hypertension, or a history of a major adverse cardiac event [MACE]). Adherence to oral therapy was reported as 99% in both groups. The median follow-up time was 52 weeks; 90% of patients in the relugolix arm and 89% in the leuprolide arm completed 48 weeks of treatment.

Sustained testosterone suppression to ≤ 50 ng/dL from day 29 through week 48 was seen in 96.7% of patients in the relugolix group and 88.8% in the leuprolide group, which was determined to be noninferior. Additionally, relugolix was also found to be superior to leuprolide in regard to sustained testosterone suppression (P < 0.001). These results were consistent across all subgroups. Relugolix was also found to be superior to leuprolide for all secondary endpoints, including cumulative probability of castration on day 4 (56% vs 0%) and day 15 (98.7% vs 12%) and testosterone suppression to ≤ 20 ng/dL on day 15 (78.4% vs 1%). Confirmed PSA response on day 15 was seen in 79.4% of patients in the relugolix arm and in 19.8% in the leuprolide arm (P < 0.001). FSH suppression was greater in the relugolix arm compared with the leuprolide arm by the end of week 24. An increase of testosterone levels from baseline was noted in the leuprolide patients at day 4, with the level decreasing to castrate level by day 29. In contrast, relugolix patients maintained castrate testosterone levels from day 4 throughout the intervention period. Testosterone recovery at 90 days was seen in 54% of patients in the relugolix group compared with 3% in the leuprolide group (P = 0.002).

 

 

The most frequent adverse event seen in both groups was hot flashes (54.3% in the relugolix group and 51.6% in the leuprolide group). The second most common adverse event report was fatigue, which occurred in 21.5% of patients in the relugolix arm and 18.5% in the leuprolide arm. Diarrhea was reported more frequently with relugolix than with leuprolide (12.2% vs 6.8%); however, diarrhea did not lead to discontinuation of therapy in any patient. Fatal events were reported more frequently in the leuprolide group (2.9%) compared with the relugolix group (1.1%). MACE were defined as nonfatal myocardial infarction, stroke, and death from any cause. After completing the intervention period of 48 weeks, the relugolix group had a 2.9% incidence of major cardiovascular events, compared with 6.2% in the leuprolide group. In patients having a medical history of cardiovascular events, the adverse event rate during the trial period was 3.6% in the relugolix group and 17.8% in leuprolide group. This translated into a 54% lower risk of MACE in the relugolix arm compared with the leuprolide arm.

Conclusion. The use of relugolix in advanced prostate cancer led to rapid, sustained suppression and faster recovery of testosterone level compared with leuprolide. Relugolix appeared safer to use for men with a medical history of cardiovascular events and showed a 54% lower risk of MACE than leuprolide.

Commentary

Relugolix is a highly selective oral GnRH antagonist that rapidly inhibits pituitary release of luteinizing hormone and FSH. The current phase 3 HERO trial highlights the efficacy of relugolix in regard to testosterone suppression, adding to potential therapeutic options for these men. Relugolix yielded superior sustained testosterone suppression to less than 50 ng/dL throughout the 48-week study period, meeting its primary endpoint. Additionally, relugolix showed superiority in all secondary endpoints across all subgroups of patients. To date, the only GnRH antagonist on the market is degarelix, which is given as a monthly subcutaneous injection.1 Injection-site reactions remain an issue with this formulation.

Cardiovascular disease is the leading cause of death in the United States, and it is known that men with prostate cancer have a higher incidence of cardiovascular disease.2 While data regarding adverse cardiac outcomes with androgen deprivation therapy have been mixed, it is thought that this therapy increases the risk for MACE. There is mounting evidence that GnRH antagonists may have a less detrimental effect on cardiovascular outcomes compared with GnRH agonists. For example, a pooled analysis of 6 phase 3 trials showed a lower incidence of cardiovascular events in men with preexisting cardiovascular disease using the GnRH antagonist degarelix compared with GnRH agonists after 12 months of treatment.3 Furthermore, a more recent phase 2 randomized trial showed that 20% of patients treated with a GnRH agonist developed cardiovascular events, compared to 3% in the GnRH antagonist group. The absolute risk reduction of cardiovascular events at 12 months was 18%.4 The results of the current trial support such findings, showing a 54% reduction in MACE after 48 weeks of therapy when compared with leuprolide (2.9% in relugolix arm vs 6.2% in leuprolide arm). More importantly perhaps, in the subgroup of men with preexisting cardiovascular disease, the benefit was even greater, with a MACE incidence of 3.6% with relugolix compared with 17.8% with leuprolide.

Studies have also shown that second-generation antiandrogens such as enzalutamide are associated with an increased risk of death from cardiovascular causes. For example, data from the recently updated PROSPER trial, which evaluated the use of enzalutamide in men with nonmetastatic, castration-resistant prostate cancer, showed an increased risk of adverse events, including falls, fatigue, hypertension, and death from cardiovascular events.5 Furthermore, adding second-generation antiandrogens to GnRH-agonist therapy is associated with a high risk of cardiovascular events in men with preexisting cardiovascular disease.3 These results were noted in all of the trials of second-generation antiandrogens, including enzalutamide, apalutamide, and darolutamide, in combination with GnRH agonists.6-8 Taken together, one might consider whether the use of a GnRH antagonist would result in improved cardiovascular outcomes in high-risk patients.

 

 

In light of the efficacy of relugolix in regard to testosterone suppression highlighted in the current trial, it is likely that its efficacy in regard to cancer outcomes will be similar; however, to date there is no level 1 evidence to support this. Nevertheless, there is a clear association of adverse cardiovascular outcomes in men treated with GnRH agonists, and the notable 54% risk reduction seen in the current trial certainly would support considering the use of a GnRH antagonist for the subgroup of patients with preexisting cardiovascular disease or those at high risk for MACE. Further work is needed to define the role of GnRH antagonists in conjunction with second-generation antiandrogens to help mitigate cardiovascular toxicities.

Clinical Implications

The use of GnRH antagonists should be considered in men with advanced prostate cancer who have underlying cardiovascular disease to help mitigate the risk of MACE. Currently, degarelix is the only commercially available agent; however, pending regulatory approval, oral relugolix may be considered an appropriate oral option in such patients, with data supporting superior testosterone suppressive effects. Further follow-up will be needed.

–Saud Alsubait, MD, Michigan State University, East Lansing, MI
–Daniel Isaac, MD, MS

Study Overview

Objective. To evaluate the safety and efficacy of the highly selective oral gonadotropin-releasing hormone (GnRH) antagonist relugolix in men with advanced prostate cancer.

Design. Global, multicenter, randomized, open-label, phase 3 trial.

Intervention. Patients were randomized in a 2:1 ratio to receive either relugolix 120 mg once daily after receiving a single loading dose of 360 mg, or 22.5 mg of leuprolide acetate every 3 months. Patients in Japan and Taiwan received 11.25 mg of leuprolide. The randomization was stratified by age (> 75 years or ≤ 75 years), metastatic disease status, and geographic region (Asia, Europe, North and South America). The intervention period was 48 weeks.

Setting and participants. 1327 patients were screened, and 934 patients underwent randomization: 622 patients to the relugolix group and 308 to the leuprolide group. Patients had histologically or cytologically confirmed adenocarcinoma of the prostate. All patients had to have 1 of the following: evidence of biochemical or clinical relapse after primary curative therapy, newly diagnosed hormone-sensitive metastatic disease, or advance localized disease unlikely to be cured by local primary intervention. The patients with disease progression or rising prostate-specific antigen (PSA) had the option to receive enzalutamide or docetaxel after the confirmation of progression. Patients were excluded if they had a major cardiovascular event within 6 months of enrollment.

Main outcome measures. The primary endpoint was sustained castration rate, defined as the cumulative probability of testosterone suppression to ≤ 50 ng/dL while on study treatment from week 5 through week 48. Secondary endpoints included noninferiority of relugolix to leuprolide in regard to sustained castration rate. Superiority testing was performed if the noninferiority margin of –10 percentage points was met. Additional secondary endpoints were probability of testosterone suppression to ≤ 50 ng/dL on day 4 and day 15 and the percentage of patients with a > 50% decrease in PSA at day 15 and follicle-stimulating hormone (FSH) levels at the end of week 24.

Main results. The baseline characteristics were well balanced between the treatment groups. Approximately 30% of the patients in each group had metastatic disease. Approximately 50% of patients enrolled had biochemical recurrence following primary treatment for prostate cancer. The mean PSA was 104.2 ng/mL in the relugolix group and 68.6 ng/mL in the leuprolide group. The majority of patients had at least 1 cardiovascular risk factor (ie, tobacco use, obesity, diabetes, hypertension, or a history of a major adverse cardiac event [MACE]). Adherence to oral therapy was reported as 99% in both groups. The median follow-up time was 52 weeks; 90% of patients in the relugolix arm and 89% in the leuprolide arm completed 48 weeks of treatment.

Sustained testosterone suppression to ≤ 50 ng/dL from day 29 through week 48 was seen in 96.7% of patients in the relugolix group and 88.8% in the leuprolide group, which was determined to be noninferior. Additionally, relugolix was also found to be superior to leuprolide in regard to sustained testosterone suppression (P < 0.001). These results were consistent across all subgroups. Relugolix was also found to be superior to leuprolide for all secondary endpoints, including cumulative probability of castration on day 4 (56% vs 0%) and day 15 (98.7% vs 12%) and testosterone suppression to ≤ 20 ng/dL on day 15 (78.4% vs 1%). Confirmed PSA response on day 15 was seen in 79.4% of patients in the relugolix arm and in 19.8% in the leuprolide arm (P < 0.001). FSH suppression was greater in the relugolix arm compared with the leuprolide arm by the end of week 24. An increase of testosterone levels from baseline was noted in the leuprolide patients at day 4, with the level decreasing to castrate level by day 29. In contrast, relugolix patients maintained castrate testosterone levels from day 4 throughout the intervention period. Testosterone recovery at 90 days was seen in 54% of patients in the relugolix group compared with 3% in the leuprolide group (P = 0.002).

 

 

The most frequent adverse event seen in both groups was hot flashes (54.3% in the relugolix group and 51.6% in the leuprolide group). The second most common adverse event report was fatigue, which occurred in 21.5% of patients in the relugolix arm and 18.5% in the leuprolide arm. Diarrhea was reported more frequently with relugolix than with leuprolide (12.2% vs 6.8%); however, diarrhea did not lead to discontinuation of therapy in any patient. Fatal events were reported more frequently in the leuprolide group (2.9%) compared with the relugolix group (1.1%). MACE were defined as nonfatal myocardial infarction, stroke, and death from any cause. After completing the intervention period of 48 weeks, the relugolix group had a 2.9% incidence of major cardiovascular events, compared with 6.2% in the leuprolide group. In patients having a medical history of cardiovascular events, the adverse event rate during the trial period was 3.6% in the relugolix group and 17.8% in leuprolide group. This translated into a 54% lower risk of MACE in the relugolix arm compared with the leuprolide arm.

Conclusion. The use of relugolix in advanced prostate cancer led to rapid, sustained suppression and faster recovery of testosterone level compared with leuprolide. Relugolix appeared safer to use for men with a medical history of cardiovascular events and showed a 54% lower risk of MACE than leuprolide.

Commentary

Relugolix is a highly selective oral GnRH antagonist that rapidly inhibits pituitary release of luteinizing hormone and FSH. The current phase 3 HERO trial highlights the efficacy of relugolix in regard to testosterone suppression, adding to potential therapeutic options for these men. Relugolix yielded superior sustained testosterone suppression to less than 50 ng/dL throughout the 48-week study period, meeting its primary endpoint. Additionally, relugolix showed superiority in all secondary endpoints across all subgroups of patients. To date, the only GnRH antagonist on the market is degarelix, which is given as a monthly subcutaneous injection.1 Injection-site reactions remain an issue with this formulation.

Cardiovascular disease is the leading cause of death in the United States, and it is known that men with prostate cancer have a higher incidence of cardiovascular disease.2 While data regarding adverse cardiac outcomes with androgen deprivation therapy have been mixed, it is thought that this therapy increases the risk for MACE. There is mounting evidence that GnRH antagonists may have a less detrimental effect on cardiovascular outcomes compared with GnRH agonists. For example, a pooled analysis of 6 phase 3 trials showed a lower incidence of cardiovascular events in men with preexisting cardiovascular disease using the GnRH antagonist degarelix compared with GnRH agonists after 12 months of treatment.3 Furthermore, a more recent phase 2 randomized trial showed that 20% of patients treated with a GnRH agonist developed cardiovascular events, compared to 3% in the GnRH antagonist group. The absolute risk reduction of cardiovascular events at 12 months was 18%.4 The results of the current trial support such findings, showing a 54% reduction in MACE after 48 weeks of therapy when compared with leuprolide (2.9% in relugolix arm vs 6.2% in leuprolide arm). More importantly perhaps, in the subgroup of men with preexisting cardiovascular disease, the benefit was even greater, with a MACE incidence of 3.6% with relugolix compared with 17.8% with leuprolide.

Studies have also shown that second-generation antiandrogens such as enzalutamide are associated with an increased risk of death from cardiovascular causes. For example, data from the recently updated PROSPER trial, which evaluated the use of enzalutamide in men with nonmetastatic, castration-resistant prostate cancer, showed an increased risk of adverse events, including falls, fatigue, hypertension, and death from cardiovascular events.5 Furthermore, adding second-generation antiandrogens to GnRH-agonist therapy is associated with a high risk of cardiovascular events in men with preexisting cardiovascular disease.3 These results were noted in all of the trials of second-generation antiandrogens, including enzalutamide, apalutamide, and darolutamide, in combination with GnRH agonists.6-8 Taken together, one might consider whether the use of a GnRH antagonist would result in improved cardiovascular outcomes in high-risk patients.

 

 

In light of the efficacy of relugolix in regard to testosterone suppression highlighted in the current trial, it is likely that its efficacy in regard to cancer outcomes will be similar; however, to date there is no level 1 evidence to support this. Nevertheless, there is a clear association of adverse cardiovascular outcomes in men treated with GnRH agonists, and the notable 54% risk reduction seen in the current trial certainly would support considering the use of a GnRH antagonist for the subgroup of patients with preexisting cardiovascular disease or those at high risk for MACE. Further work is needed to define the role of GnRH antagonists in conjunction with second-generation antiandrogens to help mitigate cardiovascular toxicities.

Clinical Implications

The use of GnRH antagonists should be considered in men with advanced prostate cancer who have underlying cardiovascular disease to help mitigate the risk of MACE. Currently, degarelix is the only commercially available agent; however, pending regulatory approval, oral relugolix may be considered an appropriate oral option in such patients, with data supporting superior testosterone suppressive effects. Further follow-up will be needed.

–Saud Alsubait, MD, Michigan State University, East Lansing, MI
–Daniel Isaac, MD, MS

References

1. Barkin J, Burton S, Lambert C. Optimizing subcutaneous injection of the gonadotropin-releasing hormone receptor antagonist degarelix. Can J Urol. 2016;23:8179-8183.

2. Higano CS. Cardiovascular disease and androgen axis-targeted drugs for prostate cancer. N Engl J Med. 2020;382:2257-2259.

3. Albertsen PC, Klotz L, Tombal B, et al. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. Eur Urol. 2014;65:565-573.

4. Margel D, Peer A, Ber Y, et al. Cardiovascular morbidity in a randomized trial comparing GnRH agonist and GnRH antagonist among patients with advanced prostate cancer and preexisting cardiovascular disease. J Urol. 2019;202:1199-1208.

5. Sternberg CN, Fizazi K, Saad F, et al. Enzalutamide and survival in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2020;382:2197-2206.

6. Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378:1408-1418.

7. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380:1235-1246.

References

1. Barkin J, Burton S, Lambert C. Optimizing subcutaneous injection of the gonadotropin-releasing hormone receptor antagonist degarelix. Can J Urol. 2016;23:8179-8183.

2. Higano CS. Cardiovascular disease and androgen axis-targeted drugs for prostate cancer. N Engl J Med. 2020;382:2257-2259.

3. Albertsen PC, Klotz L, Tombal B, et al. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. Eur Urol. 2014;65:565-573.

4. Margel D, Peer A, Ber Y, et al. Cardiovascular morbidity in a randomized trial comparing GnRH agonist and GnRH antagonist among patients with advanced prostate cancer and preexisting cardiovascular disease. J Urol. 2019;202:1199-1208.

5. Sternberg CN, Fizazi K, Saad F, et al. Enzalutamide and survival in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2020;382:2197-2206.

6. Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378:1408-1418.

7. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380:1235-1246.

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He Doesn’t Love It Warts and All

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ANSWER

The correct answer is lichen planus (choice “c”).

DISCUSSION

Condyloma accuminata can demonstrate amazing lability, sometimes appearing decades after exposure. And spouses may not always be truthful when questioned about such exposure. To further confuse the issue, it's entirely possible that a patient may be unaware he or she has condyloma. So, this might well have been condyloma. But the differential for penile lesions would include this condition—and more.

Psoriasis (choice “a”) commonly affects the penis, manifesting as pinkish plaques and papules. But there is a good chance that examination would have revealed corroborative signs of this disease. Furthermore, the histologic results would have been entirely different.

While syphilis (choice “b”), especially in its primary stage, can present with nonhealing sores, in no way do they resemble the patient’s lesions. There is also no source for such an infection. And biopsy would have shown a predominately plasma cell infiltrate in an entirely different pattern.

Lichen sclerosus et atrophicus (choice “d”) is quite uncommon, especially on the penis, where it is usually known as balanitis xerotica obliterans (BXO). As its name suggests, BXO is usually atrophic—therefore macular—and whitish. Exclusive to uncircumcised men, it bears no resemblance to condyloma.

Though idiopathic, lichen planus is not contagious. Unless neglected, this condition seldom causes any suffering aside from mental anguish over its appearance. To make a more accurate diagnosis, it is always helpful for providers to consider a mnemonic device for “7 Ps” associated with lichen planus:

  • Penile
  • Pruritic
  • Plaque-like
  • Purple
  • Papular
  • Planar
  • Puzzling.

TREATMENT

Fortunately, lichen planus affecting the penis responds readily to treatment with mid-strength topical steroid cream and the "tincture of time," which improves its appearance until it eventually disappears. For this patient, the PCP treated the affected area with triamcinolone 0.1% cream bid for 2 weeks. This was then applied once a day every other day for a month, which cleared the patient’s lesions.

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Joe R. Monroe, MPAS, PA, practices at Dermatology Associates of Oklahoma in Tulsa. He is also the founder of the Society of Dermatology Physician Assistants.

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Joe R. Monroe, MPAS, PA, practices at Dermatology Associates of Oklahoma in Tulsa. He is also the founder of the Society of Dermatology Physician Assistants.

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Joe R. Monroe, MPAS, PA, practices at Dermatology Associates of Oklahoma in Tulsa. He is also the founder of the Society of Dermatology Physician Assistants.

ANSWER

The correct answer is lichen planus (choice “c”).

DISCUSSION

Condyloma accuminata can demonstrate amazing lability, sometimes appearing decades after exposure. And spouses may not always be truthful when questioned about such exposure. To further confuse the issue, it's entirely possible that a patient may be unaware he or she has condyloma. So, this might well have been condyloma. But the differential for penile lesions would include this condition—and more.

Psoriasis (choice “a”) commonly affects the penis, manifesting as pinkish plaques and papules. But there is a good chance that examination would have revealed corroborative signs of this disease. Furthermore, the histologic results would have been entirely different.

While syphilis (choice “b”), especially in its primary stage, can present with nonhealing sores, in no way do they resemble the patient’s lesions. There is also no source for such an infection. And biopsy would have shown a predominately plasma cell infiltrate in an entirely different pattern.

Lichen sclerosus et atrophicus (choice “d”) is quite uncommon, especially on the penis, where it is usually known as balanitis xerotica obliterans (BXO). As its name suggests, BXO is usually atrophic—therefore macular—and whitish. Exclusive to uncircumcised men, it bears no resemblance to condyloma.

Though idiopathic, lichen planus is not contagious. Unless neglected, this condition seldom causes any suffering aside from mental anguish over its appearance. To make a more accurate diagnosis, it is always helpful for providers to consider a mnemonic device for “7 Ps” associated with lichen planus:

  • Penile
  • Pruritic
  • Plaque-like
  • Purple
  • Papular
  • Planar
  • Puzzling.

TREATMENT

Fortunately, lichen planus affecting the penis responds readily to treatment with mid-strength topical steroid cream and the "tincture of time," which improves its appearance until it eventually disappears. For this patient, the PCP treated the affected area with triamcinolone 0.1% cream bid for 2 weeks. This was then applied once a day every other day for a month, which cleared the patient’s lesions.

ANSWER

The correct answer is lichen planus (choice “c”).

DISCUSSION

Condyloma accuminata can demonstrate amazing lability, sometimes appearing decades after exposure. And spouses may not always be truthful when questioned about such exposure. To further confuse the issue, it's entirely possible that a patient may be unaware he or she has condyloma. So, this might well have been condyloma. But the differential for penile lesions would include this condition—and more.

Psoriasis (choice “a”) commonly affects the penis, manifesting as pinkish plaques and papules. But there is a good chance that examination would have revealed corroborative signs of this disease. Furthermore, the histologic results would have been entirely different.

While syphilis (choice “b”), especially in its primary stage, can present with nonhealing sores, in no way do they resemble the patient’s lesions. There is also no source for such an infection. And biopsy would have shown a predominately plasma cell infiltrate in an entirely different pattern.

Lichen sclerosus et atrophicus (choice “d”) is quite uncommon, especially on the penis, where it is usually known as balanitis xerotica obliterans (BXO). As its name suggests, BXO is usually atrophic—therefore macular—and whitish. Exclusive to uncircumcised men, it bears no resemblance to condyloma.

Though idiopathic, lichen planus is not contagious. Unless neglected, this condition seldom causes any suffering aside from mental anguish over its appearance. To make a more accurate diagnosis, it is always helpful for providers to consider a mnemonic device for “7 Ps” associated with lichen planus:

  • Penile
  • Pruritic
  • Plaque-like
  • Purple
  • Papular
  • Planar
  • Puzzling.

TREATMENT

Fortunately, lichen planus affecting the penis responds readily to treatment with mid-strength topical steroid cream and the "tincture of time," which improves its appearance until it eventually disappears. For this patient, the PCP treated the affected area with triamcinolone 0.1% cream bid for 2 weeks. This was then applied once a day every other day for a month, which cleared the patient’s lesions.

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Wart

A 41-year-old man is understandably upset when his primary care provider (PCP) diagnoses him with penile warts. Still, he is more than willing to allow his PCP to treat the area with liquid nitrogen, which clears the affected area. However, after about a month, the warts reappear in the same area, with the same appearance, and the patient decides to consult his PCP about additional treatment.

To his distress, his PCP suggests that the warts may continue to return despite treatment. This prompts the patient to ask a more upsetting question: How had he even acquired the warts? Neither he nor his wife of 20 years has had any other sexual contact. Prior to marriage, he had no sexual encounters by which he might have acquired human papillomavirus (HPV).

The patient is otherwise quite healthy, though anxious to have his warts treated again despite the possibility of recurrence. At no point have the warts been symptomatic. His wife's Pap smears have been completely normal.

Examination reveals 4 tiny, pink, planar (flat-topped), 2-to-4-mm papules in 2 locations on the penile shaft. Each has a soft shiny surface. There is also a soft, smooth, pink, annular, 2-cm plaque on the distal shaft that spills over onto the corona focally.

Shave biopsy of 1 lesion shows a brisk lymphocytic infiltrate, which obliterated the dermo-epidermal junction, imparting a jagged sawtooth pattern to its usually smooth wave-like pattern. There are no signs of HPV. The patient has no other remarkable lesions or changes on his elbows, knees, trunk, legs, nails, or scalp.

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How can we better engage black men as patients?

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I’m a black man, husband, father, son, brother, and a board-certified psychiatrist, child and adolescent psychiatry fellow, and addiction medicine fellow. I write this article as the latter, a colleague, from the former’s perspective, which you would not need to verify via Google, social media, or a badge upon meeting me.

Motortion/Getty Images

July is Minority Mental Health Awareness Month, established to bring awareness to the unique struggles that marginalized groups face concerning mental illness in the United States.

Given the events of the last few months, including a global pandemic and videotaped killings of Ahmaud Arbery and George Floyd, two unarmed black men, America’s structural racism and inequality are being challenged in historic ways. Black people are suffering. In fact, I was not surprised to learn1 that some black families with sons have expanded the “talk” – which traditionally has focused on dealing with police officers – to include vigilantes.

Because of my extensive work with and treatment of men of color, I would like to answer a key question: “How do psychiatrists and other mental health clinicians better engage men of color? Before the “how,” let’s review the state of black men’s mental health.

According to Healthy People 2020, mental disorders are the leading cause of disability in the United States.2 Among those with diagnosable mental disorders, black people are more likely than are their white counterparts to experience severe symptoms and protracted diseases. Roughly 7% of black men meet the criteria for a lifetime prevalence of major depressive disorder.3 Applying that figure to recent national population estimates means that there are 1.4 million black men currently suffering from major depression. Suicide has been on a continued uptrend among black male youth for more than 2 decades. Moreover, given the high rates of stigma and unmet need in this population, it is likely that these figures are even more dire.

Compared with other groups, black men in the United States face a disproportionate burden of preventable morbidity and mortality rates. Of all the health concerns faced by black men, mental health challenges may be among the most stigmatized.4 Evidence suggests that black men have more adverse life experiences than do men of other racial/ethnic groups, and consequently, experience poorer mental health.5 Black men experience high rates of poverty, unemployment, and underemployment, and are incarcerated at much higher rates than those of men of other racial/ethnic groups.6 It is notable that black male youth are often perceived as older by law enforcement, beginning as early as 10 years old, often resulting in negative interactions.7

Despite those challenges, black men are often expected to project strength, they are expected to minimize displays of emotion when off the field or court (i.e., “Just shut up and dribble”), and they are expected to be true versions of folk hero John Henry. This caricature of black males is used at times to validate shootings of unarmed black males (adults and youth).

Black men’s mental health should be a priority for those in the mental health field. This is particularly the case light of our field’s historical involvement in and promotion of stereotyped clinical descriptions of black men and contributing to health disparities that persist. Black men are nearly six times as likely to be diagnosed with schizophrenia as are white men. To read about holdovers from the days of targeted advertising against black protesters of the 1960s and 1970s, check out “The Protest Psychosis” (Beacon Press, 2010) by psychiatrist and anthropologist Jonathan Metzl, MD, PhD. If you go further back in psychiatric history, the late 1800s, you can learn about the devious diagnosis of drapetomania attributed to enslaved people who were seeking freedom.

Those on the front lines providing mental health services should understand black men’s mental health from an ecological perspective. Beyond the emotional burden that mental illness imposes on the individual, there are more considerable interpersonal and societal implications for the state of black men’s mental health. As such, in our full capacity like other men, black men play an essential role within families, churches, neighborhoods, and organizations.

Dr. Kevin M. Simon

Given our brief review, we can reconsider our question, “How do psychiatrists and mental health clinicians better engage men of color?”

I will suggest a few fundamental principles that honestly can be applied to any patient but should be strongly considered with your black male patients – given they are likely not accustomed to engaging with the health care system, let alone with a mental health clinician:

1. Create a comfortable environment. Because of stigma, persistent myths, and lack of normalcy with talking to a mental health professional, many patients, including black men, do not have a framework for a psychiatric/psychological evaluation or treatment. It would be essential to set the frame of your encounter. Evidence suggests this can improve engagement and follow-up care among black men.8 In addition, keep in mind that “fictive kin”9 tend to play a major role in the transmission of culture, health promotion, and decision-making in the black community. This helps explain why barbershop initiatives10 are effective. If clinicians are able to allow black male patients to feel comfortable, the clinician, too, might become part of that fictive community and enhance the patient-provider relationship.

2. Allow for storytelling. In the age of the checklist, it can be relatively easy to lose sight that our patients, including black men, have their own narratives. Evidence suggests that physicians interrupt patients early and often. Challenge yourself to allow the patient to tell his story. In consideration of an initial evaluation, it may help to begin by first gathering sociodemographic information (i.e. housing, education, employment, family, etc.); doing so will allow the patient time to get comfortable before you assess possible psychiatric symptoms.

3. Confidentiality assurance. Many black men have a distrust for the health care profession; as such, it is vital that clinicians emphasize that their patients’ information and history will be used only to help the patient. It will be important to inform black male patients of their rights, because often in the greater society, their rights seem to be negated.

4. Be aware of nonverbal language. Given black men’s stereotyped roles in society and recognition that they are regularly perceived as threats, many black men have become adept at reading nonverbal cues (i.e., purse clutched, side comment, etc.). In doing so, clinicians must be attuned to their own nonverbal language. For example, a glance at one’s watch might be interpreted as you’re not listening. It would be better to be upfront and candid by saying something like, “I need to check the time,” rather than attempting to be stealth. Being transparent in that way will let the patient know that you will be upfront with him.

5. Be respectful. During an encounter, and in particular when discussing treatment plans, clinicians must allow the patient space to process and be involved in his care. Allowing the patient time to think through how he would want to proceed provides him a sense of personal agency and lets him know that he is capable of improving his mental wellness.

Black male patients need to feel comfortable, safe, able to trust the clinician. They must feel listened to, understood, and respected. This information might help some clinicians better understand what needs to happen between a black male patient and a nonblack clinician so the patient can feel good about his mental health engagement. To some, these recommendations might seem obvious or too simple, yet if we consider the countless reports of poor patient treatment engagement, adherence, and retention, we cannot deny the need for change. Having black male patients disclose important information during encounters could prevent poor clinical interactions that leave them feeling uncomfortable, uncertain, skeptical, disrespected, and further cynical about mental health care.

 

Dr. Simon practices at Boston Children’s Hospital. He has no disclosures.

References

1. Bunn C. After Arbery shooting, black parents are rethinking “the talk” to explain white vigilantes. NBC News. 2020 May 19.

2. U.S. Department of Health and Human Services. Office of Disease Prevention and Promotion. Healthy People 2020.

3. Ward E and Mangesha M. Am J Orthopsychiatry. 2013 Apr-Jul;83(2 0 3):386-97.

4. Holden KB et al. J Mens health. 2012 Jun 1;9(2):63-9.

5. Brown TH et al. Fam Community Health. 2015 Oct-Dec;38(4):307-18.

6. Jäggi et al. Soc Ment Health. 2016 Nov;6(3):187-296.

7. Goff PA et al. J Pers Soc Psychol. 2014;106(4):526-45.

8. Alsan M et al. National Bureau of Economic Research. NBER Working Paper No. 24787. 2018 Jun. Revised 2019 Aug.

9. Spruill IJ. J Nat Black Nurses Assoc. 2014 Dec;25(2):23-30.

10. Graham LF et al. Am J Mens Health. 2018 Sep;12(5):1307-16.

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I’m a black man, husband, father, son, brother, and a board-certified psychiatrist, child and adolescent psychiatry fellow, and addiction medicine fellow. I write this article as the latter, a colleague, from the former’s perspective, which you would not need to verify via Google, social media, or a badge upon meeting me.

Motortion/Getty Images

July is Minority Mental Health Awareness Month, established to bring awareness to the unique struggles that marginalized groups face concerning mental illness in the United States.

Given the events of the last few months, including a global pandemic and videotaped killings of Ahmaud Arbery and George Floyd, two unarmed black men, America’s structural racism and inequality are being challenged in historic ways. Black people are suffering. In fact, I was not surprised to learn1 that some black families with sons have expanded the “talk” – which traditionally has focused on dealing with police officers – to include vigilantes.

Because of my extensive work with and treatment of men of color, I would like to answer a key question: “How do psychiatrists and other mental health clinicians better engage men of color? Before the “how,” let’s review the state of black men’s mental health.

According to Healthy People 2020, mental disorders are the leading cause of disability in the United States.2 Among those with diagnosable mental disorders, black people are more likely than are their white counterparts to experience severe symptoms and protracted diseases. Roughly 7% of black men meet the criteria for a lifetime prevalence of major depressive disorder.3 Applying that figure to recent national population estimates means that there are 1.4 million black men currently suffering from major depression. Suicide has been on a continued uptrend among black male youth for more than 2 decades. Moreover, given the high rates of stigma and unmet need in this population, it is likely that these figures are even more dire.

Compared with other groups, black men in the United States face a disproportionate burden of preventable morbidity and mortality rates. Of all the health concerns faced by black men, mental health challenges may be among the most stigmatized.4 Evidence suggests that black men have more adverse life experiences than do men of other racial/ethnic groups, and consequently, experience poorer mental health.5 Black men experience high rates of poverty, unemployment, and underemployment, and are incarcerated at much higher rates than those of men of other racial/ethnic groups.6 It is notable that black male youth are often perceived as older by law enforcement, beginning as early as 10 years old, often resulting in negative interactions.7

Despite those challenges, black men are often expected to project strength, they are expected to minimize displays of emotion when off the field or court (i.e., “Just shut up and dribble”), and they are expected to be true versions of folk hero John Henry. This caricature of black males is used at times to validate shootings of unarmed black males (adults and youth).

Black men’s mental health should be a priority for those in the mental health field. This is particularly the case light of our field’s historical involvement in and promotion of stereotyped clinical descriptions of black men and contributing to health disparities that persist. Black men are nearly six times as likely to be diagnosed with schizophrenia as are white men. To read about holdovers from the days of targeted advertising against black protesters of the 1960s and 1970s, check out “The Protest Psychosis” (Beacon Press, 2010) by psychiatrist and anthropologist Jonathan Metzl, MD, PhD. If you go further back in psychiatric history, the late 1800s, you can learn about the devious diagnosis of drapetomania attributed to enslaved people who were seeking freedom.

Those on the front lines providing mental health services should understand black men’s mental health from an ecological perspective. Beyond the emotional burden that mental illness imposes on the individual, there are more considerable interpersonal and societal implications for the state of black men’s mental health. As such, in our full capacity like other men, black men play an essential role within families, churches, neighborhoods, and organizations.

Dr. Kevin M. Simon

Given our brief review, we can reconsider our question, “How do psychiatrists and mental health clinicians better engage men of color?”

I will suggest a few fundamental principles that honestly can be applied to any patient but should be strongly considered with your black male patients – given they are likely not accustomed to engaging with the health care system, let alone with a mental health clinician:

1. Create a comfortable environment. Because of stigma, persistent myths, and lack of normalcy with talking to a mental health professional, many patients, including black men, do not have a framework for a psychiatric/psychological evaluation or treatment. It would be essential to set the frame of your encounter. Evidence suggests this can improve engagement and follow-up care among black men.8 In addition, keep in mind that “fictive kin”9 tend to play a major role in the transmission of culture, health promotion, and decision-making in the black community. This helps explain why barbershop initiatives10 are effective. If clinicians are able to allow black male patients to feel comfortable, the clinician, too, might become part of that fictive community and enhance the patient-provider relationship.

2. Allow for storytelling. In the age of the checklist, it can be relatively easy to lose sight that our patients, including black men, have their own narratives. Evidence suggests that physicians interrupt patients early and often. Challenge yourself to allow the patient to tell his story. In consideration of an initial evaluation, it may help to begin by first gathering sociodemographic information (i.e. housing, education, employment, family, etc.); doing so will allow the patient time to get comfortable before you assess possible psychiatric symptoms.

3. Confidentiality assurance. Many black men have a distrust for the health care profession; as such, it is vital that clinicians emphasize that their patients’ information and history will be used only to help the patient. It will be important to inform black male patients of their rights, because often in the greater society, their rights seem to be negated.

4. Be aware of nonverbal language. Given black men’s stereotyped roles in society and recognition that they are regularly perceived as threats, many black men have become adept at reading nonverbal cues (i.e., purse clutched, side comment, etc.). In doing so, clinicians must be attuned to their own nonverbal language. For example, a glance at one’s watch might be interpreted as you’re not listening. It would be better to be upfront and candid by saying something like, “I need to check the time,” rather than attempting to be stealth. Being transparent in that way will let the patient know that you will be upfront with him.

5. Be respectful. During an encounter, and in particular when discussing treatment plans, clinicians must allow the patient space to process and be involved in his care. Allowing the patient time to think through how he would want to proceed provides him a sense of personal agency and lets him know that he is capable of improving his mental wellness.

Black male patients need to feel comfortable, safe, able to trust the clinician. They must feel listened to, understood, and respected. This information might help some clinicians better understand what needs to happen between a black male patient and a nonblack clinician so the patient can feel good about his mental health engagement. To some, these recommendations might seem obvious or too simple, yet if we consider the countless reports of poor patient treatment engagement, adherence, and retention, we cannot deny the need for change. Having black male patients disclose important information during encounters could prevent poor clinical interactions that leave them feeling uncomfortable, uncertain, skeptical, disrespected, and further cynical about mental health care.

 

Dr. Simon practices at Boston Children’s Hospital. He has no disclosures.

References

1. Bunn C. After Arbery shooting, black parents are rethinking “the talk” to explain white vigilantes. NBC News. 2020 May 19.

2. U.S. Department of Health and Human Services. Office of Disease Prevention and Promotion. Healthy People 2020.

3. Ward E and Mangesha M. Am J Orthopsychiatry. 2013 Apr-Jul;83(2 0 3):386-97.

4. Holden KB et al. J Mens health. 2012 Jun 1;9(2):63-9.

5. Brown TH et al. Fam Community Health. 2015 Oct-Dec;38(4):307-18.

6. Jäggi et al. Soc Ment Health. 2016 Nov;6(3):187-296.

7. Goff PA et al. J Pers Soc Psychol. 2014;106(4):526-45.

8. Alsan M et al. National Bureau of Economic Research. NBER Working Paper No. 24787. 2018 Jun. Revised 2019 Aug.

9. Spruill IJ. J Nat Black Nurses Assoc. 2014 Dec;25(2):23-30.

10. Graham LF et al. Am J Mens Health. 2018 Sep;12(5):1307-16.

I’m a black man, husband, father, son, brother, and a board-certified psychiatrist, child and adolescent psychiatry fellow, and addiction medicine fellow. I write this article as the latter, a colleague, from the former’s perspective, which you would not need to verify via Google, social media, or a badge upon meeting me.

Motortion/Getty Images

July is Minority Mental Health Awareness Month, established to bring awareness to the unique struggles that marginalized groups face concerning mental illness in the United States.

Given the events of the last few months, including a global pandemic and videotaped killings of Ahmaud Arbery and George Floyd, two unarmed black men, America’s structural racism and inequality are being challenged in historic ways. Black people are suffering. In fact, I was not surprised to learn1 that some black families with sons have expanded the “talk” – which traditionally has focused on dealing with police officers – to include vigilantes.

Because of my extensive work with and treatment of men of color, I would like to answer a key question: “How do psychiatrists and other mental health clinicians better engage men of color? Before the “how,” let’s review the state of black men’s mental health.

According to Healthy People 2020, mental disorders are the leading cause of disability in the United States.2 Among those with diagnosable mental disorders, black people are more likely than are their white counterparts to experience severe symptoms and protracted diseases. Roughly 7% of black men meet the criteria for a lifetime prevalence of major depressive disorder.3 Applying that figure to recent national population estimates means that there are 1.4 million black men currently suffering from major depression. Suicide has been on a continued uptrend among black male youth for more than 2 decades. Moreover, given the high rates of stigma and unmet need in this population, it is likely that these figures are even more dire.

Compared with other groups, black men in the United States face a disproportionate burden of preventable morbidity and mortality rates. Of all the health concerns faced by black men, mental health challenges may be among the most stigmatized.4 Evidence suggests that black men have more adverse life experiences than do men of other racial/ethnic groups, and consequently, experience poorer mental health.5 Black men experience high rates of poverty, unemployment, and underemployment, and are incarcerated at much higher rates than those of men of other racial/ethnic groups.6 It is notable that black male youth are often perceived as older by law enforcement, beginning as early as 10 years old, often resulting in negative interactions.7

Despite those challenges, black men are often expected to project strength, they are expected to minimize displays of emotion when off the field or court (i.e., “Just shut up and dribble”), and they are expected to be true versions of folk hero John Henry. This caricature of black males is used at times to validate shootings of unarmed black males (adults and youth).

Black men’s mental health should be a priority for those in the mental health field. This is particularly the case light of our field’s historical involvement in and promotion of stereotyped clinical descriptions of black men and contributing to health disparities that persist. Black men are nearly six times as likely to be diagnosed with schizophrenia as are white men. To read about holdovers from the days of targeted advertising against black protesters of the 1960s and 1970s, check out “The Protest Psychosis” (Beacon Press, 2010) by psychiatrist and anthropologist Jonathan Metzl, MD, PhD. If you go further back in psychiatric history, the late 1800s, you can learn about the devious diagnosis of drapetomania attributed to enslaved people who were seeking freedom.

Those on the front lines providing mental health services should understand black men’s mental health from an ecological perspective. Beyond the emotional burden that mental illness imposes on the individual, there are more considerable interpersonal and societal implications for the state of black men’s mental health. As such, in our full capacity like other men, black men play an essential role within families, churches, neighborhoods, and organizations.

Dr. Kevin M. Simon

Given our brief review, we can reconsider our question, “How do psychiatrists and mental health clinicians better engage men of color?”

I will suggest a few fundamental principles that honestly can be applied to any patient but should be strongly considered with your black male patients – given they are likely not accustomed to engaging with the health care system, let alone with a mental health clinician:

1. Create a comfortable environment. Because of stigma, persistent myths, and lack of normalcy with talking to a mental health professional, many patients, including black men, do not have a framework for a psychiatric/psychological evaluation or treatment. It would be essential to set the frame of your encounter. Evidence suggests this can improve engagement and follow-up care among black men.8 In addition, keep in mind that “fictive kin”9 tend to play a major role in the transmission of culture, health promotion, and decision-making in the black community. This helps explain why barbershop initiatives10 are effective. If clinicians are able to allow black male patients to feel comfortable, the clinician, too, might become part of that fictive community and enhance the patient-provider relationship.

2. Allow for storytelling. In the age of the checklist, it can be relatively easy to lose sight that our patients, including black men, have their own narratives. Evidence suggests that physicians interrupt patients early and often. Challenge yourself to allow the patient to tell his story. In consideration of an initial evaluation, it may help to begin by first gathering sociodemographic information (i.e. housing, education, employment, family, etc.); doing so will allow the patient time to get comfortable before you assess possible psychiatric symptoms.

3. Confidentiality assurance. Many black men have a distrust for the health care profession; as such, it is vital that clinicians emphasize that their patients’ information and history will be used only to help the patient. It will be important to inform black male patients of their rights, because often in the greater society, their rights seem to be negated.

4. Be aware of nonverbal language. Given black men’s stereotyped roles in society and recognition that they are regularly perceived as threats, many black men have become adept at reading nonverbal cues (i.e., purse clutched, side comment, etc.). In doing so, clinicians must be attuned to their own nonverbal language. For example, a glance at one’s watch might be interpreted as you’re not listening. It would be better to be upfront and candid by saying something like, “I need to check the time,” rather than attempting to be stealth. Being transparent in that way will let the patient know that you will be upfront with him.

5. Be respectful. During an encounter, and in particular when discussing treatment plans, clinicians must allow the patient space to process and be involved in his care. Allowing the patient time to think through how he would want to proceed provides him a sense of personal agency and lets him know that he is capable of improving his mental wellness.

Black male patients need to feel comfortable, safe, able to trust the clinician. They must feel listened to, understood, and respected. This information might help some clinicians better understand what needs to happen between a black male patient and a nonblack clinician so the patient can feel good about his mental health engagement. To some, these recommendations might seem obvious or too simple, yet if we consider the countless reports of poor patient treatment engagement, adherence, and retention, we cannot deny the need for change. Having black male patients disclose important information during encounters could prevent poor clinical interactions that leave them feeling uncomfortable, uncertain, skeptical, disrespected, and further cynical about mental health care.

 

Dr. Simon practices at Boston Children’s Hospital. He has no disclosures.

References

1. Bunn C. After Arbery shooting, black parents are rethinking “the talk” to explain white vigilantes. NBC News. 2020 May 19.

2. U.S. Department of Health and Human Services. Office of Disease Prevention and Promotion. Healthy People 2020.

3. Ward E and Mangesha M. Am J Orthopsychiatry. 2013 Apr-Jul;83(2 0 3):386-97.

4. Holden KB et al. J Mens health. 2012 Jun 1;9(2):63-9.

5. Brown TH et al. Fam Community Health. 2015 Oct-Dec;38(4):307-18.

6. Jäggi et al. Soc Ment Health. 2016 Nov;6(3):187-296.

7. Goff PA et al. J Pers Soc Psychol. 2014;106(4):526-45.

8. Alsan M et al. National Bureau of Economic Research. NBER Working Paper No. 24787. 2018 Jun. Revised 2019 Aug.

9. Spruill IJ. J Nat Black Nurses Assoc. 2014 Dec;25(2):23-30.

10. Graham LF et al. Am J Mens Health. 2018 Sep;12(5):1307-16.

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Does cultural tailoring of sexual health programs lead to safer behavior?

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Among Hispanic adolescents, sexual health interventions have a small but significant effect on improving safe sexual behavior, including abstinence, condom use, and number of sex partners, a meta-analysis of 12 studies suggests.

Furthermore, cultural tailoring may contribute to a program’s success, the data indicate.

“It is important that culturally tailored sexual health programs be available to Hispanic communities across the United States,” the study authors stated in Pediatrics.

To examine the effects of sexual health interventions on behavioral outcomes among Hispanic adolescents and factors that may influence the success of an intervention, Reina Evans, a doctoral student in the department of psychology at North Carolina State University in Raleigh, and colleagues systemically reviewed published studies that included Hispanic adolescents in the United States. Included studies evaluated a sexual health intervention using an experimental or quasiexperimental design and assessed a behavioral outcome.

The researchers synthesized effect sizes from 12 studies that included 4,673 Hispanic adolescents. “As the indicator of effect size, the standardized mean difference, Cohen’s d, was used,” they said. Effect size was interpreted as small at 0.20, medium at 0.50, and large at 0.80.

Sexual health interventions improved abstinence (d = 0.15), condom use (d = 0.44), number of sex partners (d = –0.19), and sexual health knowledge (d = 0.40), compared with control conditions.

Eight of the 12 interventions incorporated Hispanic-specific practices and values such as familialism into the intervention materials. Culturally tailored interventions produced greater change in condom use, compared with interventions that were not culturally tailored. One intervention with a large effect on condom use was developed by researchers in collaboration with community members, the authors said. Another program with a large effect on condom use was designed for Hispanic families.

Ten of the 12 studies included males and females, and two included only females. Intervention dose ranged from less than 10 hours of program content to more than 20 hours of content.

Definitions of abstinence and time frames for reporting recent condom use varied across studies, the researchers noted. Data about patient characteristics, such as the percentage of participants born in the United States, and pregnancy outcomes were limited. These domains could be areas of future research.

“Latinx adolescents are disproportionately burdened with unplanned pregnancy and STIs [sexually transmitted infections]. In this meta-analysis, it is shown that sexual health interventions can play a role in combating these health disparities,” Ms. Evans and associates said.

Among Hispanic adolescents, persistent disparities in sexual and reproductive health “remain a national public health priority,” and “strengthening the effects of future ... interventions for Hispanic adolescents is needed,” said Vincent Guilamo-Ramos, PhD, MPH, and colleagues in an accompanying editorial. Dr. Guilamo-Ramos is a professor of social work and director and founder of the Center for Latino Adolescent and Family Health at New York University.

“Evans et al. highlighted that reporting on the foreign-born participant proportions was incomplete across studies, thereby excluding this clinical heterogeneity domain from formal moderation analyses,” said Dr. Guilamo-Ramos and colleagues. People who develop Hispanic sexual and reproductive health interventions may consider whether this domain or other domains moderate intervention effectiveness.

Although sensitivity analyses focused on several potential sources of bias, “other domains of potential methodologic heterogeneity, such as refusal bias, differential attrition, or information bias, remained unaccounted for,” they said.

“Attention to clinical, methodologic, and statistical heterogeneity across studies can yield insights into factors associated with bolstering intervention effectiveness. Cultural tailoring to increase the effectiveness of condom interventions for Hispanic adolescents is one such intervention effect modifier,” Dr. Guilamo-Ramos and associates concluded.

The study authors had no relevant financial disclosures. The research was supported by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS and Sexually Transmitted Disease Prevention, Indiana University School of Public Health–Bloomington, and the Center for Family and Community Engagement, North Carolina State University. The editorialists are supported by the William T. Grant Foundation and the National Institutes of Health. In addition, Dr. Guilamo-Ramos has received grants and personal fees from ViiV Healthcare outside the submitted work and serves as a member of the U.S. Presidential Advisory Council on HIV/AIDS and as the vice chair of the board of directors of the Latino Commission on AIDS. His coauthors had no relevant financial disclosures.

SOURCES: Evans R et al. Pediatrics. 2020 Jun 10. doi: 10.1542/peds.2019-3572; Pediatrics. 2020 Jun 10. doi: 10.1542/peds.2020-1406.

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Among Hispanic adolescents, sexual health interventions have a small but significant effect on improving safe sexual behavior, including abstinence, condom use, and number of sex partners, a meta-analysis of 12 studies suggests.

Furthermore, cultural tailoring may contribute to a program’s success, the data indicate.

“It is important that culturally tailored sexual health programs be available to Hispanic communities across the United States,” the study authors stated in Pediatrics.

To examine the effects of sexual health interventions on behavioral outcomes among Hispanic adolescents and factors that may influence the success of an intervention, Reina Evans, a doctoral student in the department of psychology at North Carolina State University in Raleigh, and colleagues systemically reviewed published studies that included Hispanic adolescents in the United States. Included studies evaluated a sexual health intervention using an experimental or quasiexperimental design and assessed a behavioral outcome.

The researchers synthesized effect sizes from 12 studies that included 4,673 Hispanic adolescents. “As the indicator of effect size, the standardized mean difference, Cohen’s d, was used,” they said. Effect size was interpreted as small at 0.20, medium at 0.50, and large at 0.80.

Sexual health interventions improved abstinence (d = 0.15), condom use (d = 0.44), number of sex partners (d = –0.19), and sexual health knowledge (d = 0.40), compared with control conditions.

Eight of the 12 interventions incorporated Hispanic-specific practices and values such as familialism into the intervention materials. Culturally tailored interventions produced greater change in condom use, compared with interventions that were not culturally tailored. One intervention with a large effect on condom use was developed by researchers in collaboration with community members, the authors said. Another program with a large effect on condom use was designed for Hispanic families.

Ten of the 12 studies included males and females, and two included only females. Intervention dose ranged from less than 10 hours of program content to more than 20 hours of content.

Definitions of abstinence and time frames for reporting recent condom use varied across studies, the researchers noted. Data about patient characteristics, such as the percentage of participants born in the United States, and pregnancy outcomes were limited. These domains could be areas of future research.

“Latinx adolescents are disproportionately burdened with unplanned pregnancy and STIs [sexually transmitted infections]. In this meta-analysis, it is shown that sexual health interventions can play a role in combating these health disparities,” Ms. Evans and associates said.

Among Hispanic adolescents, persistent disparities in sexual and reproductive health “remain a national public health priority,” and “strengthening the effects of future ... interventions for Hispanic adolescents is needed,” said Vincent Guilamo-Ramos, PhD, MPH, and colleagues in an accompanying editorial. Dr. Guilamo-Ramos is a professor of social work and director and founder of the Center for Latino Adolescent and Family Health at New York University.

“Evans et al. highlighted that reporting on the foreign-born participant proportions was incomplete across studies, thereby excluding this clinical heterogeneity domain from formal moderation analyses,” said Dr. Guilamo-Ramos and colleagues. People who develop Hispanic sexual and reproductive health interventions may consider whether this domain or other domains moderate intervention effectiveness.

Although sensitivity analyses focused on several potential sources of bias, “other domains of potential methodologic heterogeneity, such as refusal bias, differential attrition, or information bias, remained unaccounted for,” they said.

“Attention to clinical, methodologic, and statistical heterogeneity across studies can yield insights into factors associated with bolstering intervention effectiveness. Cultural tailoring to increase the effectiveness of condom interventions for Hispanic adolescents is one such intervention effect modifier,” Dr. Guilamo-Ramos and associates concluded.

The study authors had no relevant financial disclosures. The research was supported by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS and Sexually Transmitted Disease Prevention, Indiana University School of Public Health–Bloomington, and the Center for Family and Community Engagement, North Carolina State University. The editorialists are supported by the William T. Grant Foundation and the National Institutes of Health. In addition, Dr. Guilamo-Ramos has received grants and personal fees from ViiV Healthcare outside the submitted work and serves as a member of the U.S. Presidential Advisory Council on HIV/AIDS and as the vice chair of the board of directors of the Latino Commission on AIDS. His coauthors had no relevant financial disclosures.

SOURCES: Evans R et al. Pediatrics. 2020 Jun 10. doi: 10.1542/peds.2019-3572; Pediatrics. 2020 Jun 10. doi: 10.1542/peds.2020-1406.

Among Hispanic adolescents, sexual health interventions have a small but significant effect on improving safe sexual behavior, including abstinence, condom use, and number of sex partners, a meta-analysis of 12 studies suggests.

Furthermore, cultural tailoring may contribute to a program’s success, the data indicate.

“It is important that culturally tailored sexual health programs be available to Hispanic communities across the United States,” the study authors stated in Pediatrics.

To examine the effects of sexual health interventions on behavioral outcomes among Hispanic adolescents and factors that may influence the success of an intervention, Reina Evans, a doctoral student in the department of psychology at North Carolina State University in Raleigh, and colleagues systemically reviewed published studies that included Hispanic adolescents in the United States. Included studies evaluated a sexual health intervention using an experimental or quasiexperimental design and assessed a behavioral outcome.

The researchers synthesized effect sizes from 12 studies that included 4,673 Hispanic adolescents. “As the indicator of effect size, the standardized mean difference, Cohen’s d, was used,” they said. Effect size was interpreted as small at 0.20, medium at 0.50, and large at 0.80.

Sexual health interventions improved abstinence (d = 0.15), condom use (d = 0.44), number of sex partners (d = –0.19), and sexual health knowledge (d = 0.40), compared with control conditions.

Eight of the 12 interventions incorporated Hispanic-specific practices and values such as familialism into the intervention materials. Culturally tailored interventions produced greater change in condom use, compared with interventions that were not culturally tailored. One intervention with a large effect on condom use was developed by researchers in collaboration with community members, the authors said. Another program with a large effect on condom use was designed for Hispanic families.

Ten of the 12 studies included males and females, and two included only females. Intervention dose ranged from less than 10 hours of program content to more than 20 hours of content.

Definitions of abstinence and time frames for reporting recent condom use varied across studies, the researchers noted. Data about patient characteristics, such as the percentage of participants born in the United States, and pregnancy outcomes were limited. These domains could be areas of future research.

“Latinx adolescents are disproportionately burdened with unplanned pregnancy and STIs [sexually transmitted infections]. In this meta-analysis, it is shown that sexual health interventions can play a role in combating these health disparities,” Ms. Evans and associates said.

Among Hispanic adolescents, persistent disparities in sexual and reproductive health “remain a national public health priority,” and “strengthening the effects of future ... interventions for Hispanic adolescents is needed,” said Vincent Guilamo-Ramos, PhD, MPH, and colleagues in an accompanying editorial. Dr. Guilamo-Ramos is a professor of social work and director and founder of the Center for Latino Adolescent and Family Health at New York University.

“Evans et al. highlighted that reporting on the foreign-born participant proportions was incomplete across studies, thereby excluding this clinical heterogeneity domain from formal moderation analyses,” said Dr. Guilamo-Ramos and colleagues. People who develop Hispanic sexual and reproductive health interventions may consider whether this domain or other domains moderate intervention effectiveness.

Although sensitivity analyses focused on several potential sources of bias, “other domains of potential methodologic heterogeneity, such as refusal bias, differential attrition, or information bias, remained unaccounted for,” they said.

“Attention to clinical, methodologic, and statistical heterogeneity across studies can yield insights into factors associated with bolstering intervention effectiveness. Cultural tailoring to increase the effectiveness of condom interventions for Hispanic adolescents is one such intervention effect modifier,” Dr. Guilamo-Ramos and associates concluded.

The study authors had no relevant financial disclosures. The research was supported by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS and Sexually Transmitted Disease Prevention, Indiana University School of Public Health–Bloomington, and the Center for Family and Community Engagement, North Carolina State University. The editorialists are supported by the William T. Grant Foundation and the National Institutes of Health. In addition, Dr. Guilamo-Ramos has received grants and personal fees from ViiV Healthcare outside the submitted work and serves as a member of the U.S. Presidential Advisory Council on HIV/AIDS and as the vice chair of the board of directors of the Latino Commission on AIDS. His coauthors had no relevant financial disclosures.

SOURCES: Evans R et al. Pediatrics. 2020 Jun 10. doi: 10.1542/peds.2019-3572; Pediatrics. 2020 Jun 10. doi: 10.1542/peds.2020-1406.

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Key clinical point: Among Hispanic adolescents, sexual health interventions have a small but significant effect on improving safe sexual behavior. Cultural tailoring may contribute to a program’s success.

Major finding: Sexual health interventions improved abstinence (d = 0.15), condom use (d = 0.44), number of sex partners (d = –0.19), and sexual health knowledge (d = 0.40), compared with control conditions.

Study details: A meta-analysis of 12 studies with 4,673 participants.

Disclosures: The study authors had no relevant financial disclosures. The research was supported by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS and Sexually Transmitted Disease Prevention, Indiana University School of Public Health–Bloomington, and the Center for Family and Community Engagement, North Carolina State University.

Source: Evans R et al. Pediatrics. 2020 Jun 10. doi: 10.1542/peds.2019-3572.

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Erectile dysfunction: How to help patients & partners

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Erectile dysfunction: How to help patients & partners

THE CASE

Eric M,* a 36-year-old new patient, visits a primary care clinic for a check-up accompanied by his wife. A thorough history and physical exam reveal no concerns. He is active and a nonsmoker, drinks only socially, takes no medications, and reports no concerning symptoms. At the end of the visit, though, he says he has been experiencing erectile dysfunction for the past 6 months. What began as intermittent difficulty maintaining erections now “happens a lot.” He is distressed and says, “It just came out of the blue.” The patient’s wife then says she believes men cannot achieve erections if they are having an affair. When the chagrined patient simply asks for “those pills,” his wife says in a raised voice, “He’s a liar!”

● How would you proceed with this patient?

*The patient’s name has been changed to protect his identity.

Some family physicians may feel ill-equipped to talk about sexual and relational problems and lack the skills to effectively counsel on these matters.1 Despite the fact that more than 70% of adult patients want to discuss sexual topics with their family physician, sexual problems are documented in as few as 2% of patient notes.2 One of the most commonly noted sexual health concerns is erectile dysfunction (ED), estimated to occur in 35% of men ages 40 to 70.3 Many ED cases have psychological antecedents including stress, depression, performance anxiety, pornography addiction, and relationship concerns.4,5

Assessing ED. The inability to achieve or maintain an erection needed for satisfactory sexual activity is typically diagnosed through symptom self-report and with thorough history taking and physical examination.6 However, more objective scales can be used. In particular, the International Index of Erectile Function, a 15-question scale, is useful for both diagnosis and treatment monitoring (www.baus.org.uk/_userfiles/pages/files/Patients/Leaflets/iief.pdf).7 Common contributors to ED can be vascular (eg, hypertension), neurologic (eg, multiple sclerosis), psychological (noted earlier), or hormonal (eg, thyroid imbalances).6 In this article, we focus on the relationship context in which ED exists. A review of medical evaluation and management can be found elsewhere.8

Key relational questions

It’s important to address ED as a shared sexual problem that has significant detrimental effects for both heterosexual and same-sex relationships.9 Encourage patients to bring their partner to appointments so a relational assessment may be conducted.10 Ask them both about their satisfaction with the sexual relationship. Questions such as, “Are you both satisfied with your sex life?” or “Do you or your partner have any sexual concerns?”2 can shed light on the couples’ sexual health. This encourages a unified approach to the issue instead of casting things as largely the responsibility of the symptom bearer.

Assess both patient and partner to get a comprehensive understanding of the ED issue.

Identify norms that are specific to the couple. Patients from a variety of cultures prefer that their clinicians initiate the conversation about ED.11,12 We specifically recommend that clinicians, using relationally focused questions, inquire about sexual norms and desires that may be situated in culture, family of origin, or gender (TABLE 1).

Consider asking these focused questions for assessing ED

Continue to: Treating ED within a relationship

 

 

Treating ED within a relationship

Once a couple’s sexual relationship has been fully assessed, you may confidently develop a treatment plan for managing sexual dysfunction relationally as well as medically, an approach to ED advised by the American Urological Association.13 We propose that primary care treatment for ED involve collaboration between the physician, the patient/couple (if the patient is partnered), and, as needed, a behavioral health specialist.

The physician’s role ...

Managing ED relationally is important on many fronts. If, for instance, a type-5 phosphodiesterase (PDE-5) inhibitor is needed, both the patient and partner should learn about best practices for optimizing success, such as avoiding excessive alcohol intake or high-fat meals immediately before and after taking a PDE-5.14

Sex ed. Regardless of the couple’s age, be prepared to offer high-quality sexual education. Either partner may have faulty knowledge (or even a lack of knowledge) of basic sexual functioning. Physicians have an opportunity to explain healthy erectile functioning, the sexual response cycle, and ways in which PDE-5 medications work (and do not work). (For a list of resources to facilitate these discussions, see TABLE 2.)

Resources for discussion of sexual concerns with your patients

Avoid avoidance. Physicians can intervene on patterns of shame that may surround ED simply by discussing sexual functioning openly and honestly. ED often persists due to avoidance—ie, anxiety about sexual performance can lead couples to avoid sex, which perpetuates more anxiety and avoidance. Normalizing typical sexual functioning, encouraging couples to “avoid avoidance,” and providing referrals as needed are core elements of relational intervention for ED.

Use relationally focused questions to inquire about sexual norms and desires that may be situated in culture, family of origin, or gender.

Setting the tone. Family physicians are not routinely trained in couples therapy. However, you can employ communication skills that allow each partner to be heard by using empathic/reflective listening, de-­escalation, and reframing. Asking “What effect are the sexual concerns having on both of you?” and “What were the circumstances of the last sexual encounter that were pleasing to both of you?” can help promote intimacy and mutual satisfaction.

Continue to: The behavioral specialist's role

 

 

The behavioral specialist’s role

Behavioral health specialists may treat ED using methods such as cognitive behavioral therapy or evidence-based couple interventions.4 Cognitive methods for the treatment of ED include examination of maladaptive thoughts around pressure to perform and achieving sexual pleasure. Behavioral methods for treatment of ED are typically aimed at the de-coupling of anxiety and sexual activity. These treatments can include relaxation and desensitization, specifically sensate focus therapy.15

Sensate focus therapy involves a specific set of prescriptive rules for sexual activity, initially restricting touch to non-demand pleasurable touch (eg, holding hands) that allows couples to connect in a low-anxiety context focused on relaxation and connection. As couples are able to control anxiety while engaging in these activities, they engage in increasingly more intimate activities. Additionally, behavioral health specialists trained in couples therapy are vital to helping increase communication regarding sexual activity, sexual scripts, and the relationship in general.4

Identifying a treatment team

In coordinating couples care in the treatment of ED, enlist the help of a therapist who has specific knowledge and skills in the treatment of sexual disorders. While the number of qualified or certified sex therapists is limited, referring providers can visit the American Association of Sexuality Educators, Counselors, and Therapists Web site (www.aasect.org) for possible referral sources. Another option is the American Association for Marriage and Family Therapy Web site (www.aamft.org) under “Find a therapist.” Lastly, the Society for Sex Therapy and Research (www.sstarnet.org) is another professional association that provides information and local referral sources. For patients and partners located in rural areas where access is limited, telehealth options may need to be explored.

THE CASE

Mr. M and his wife were seen for a follow-up appointment by his primary care provider, who ruled out any additional causes of ED (eg, hormonal, vascular), discussed with both the patient and his wife basic sexual health and sexual functioning, dispelled several commonly held myths (ie, individuals cannot obtain an erection because of infidelity or lying), validated sexual concerns as a significant health issue, and prescribed a PDE-5 inhibitor.

Mr. M and his wife were referred to a behavioral health specialist in the clinic who had expertise in couples therapy. At several subsequent visits, the patient and his wife worked on improving the quality and quantity of communication regarding their sexual goals, mutual de-escalation of anxiety, increased emotional intimacy, and sensate focus techniques.

Continue to: As the result of the interventions...

 

 

As the result of these interventions, both the patient and his wife were able to engage in sex with less anxiety, and the patient increasingly was able to achieve more satisfactory erections without the use of the PDE-5 inhibitor. At the conclusion of therapy, the patient and his wife reported an increase in sexual satisfaction.

CORRESPONDENCE
Katherine Buck, PhD, Family Health Center, John Peter Smith Health Network, 1500 S. Main Street, Fort Worth, TX 76104; [email protected].

References

1. Macdowall W, Parker R, Nanchahal K, et al. ‘Talking of Sex’: developing and piloting a sexual health communication tool for use in primary care. Patient Educ Couns. 2010;81:332-337.

2. Sadovsky R. Asking the questions and offering solutions: the ongoing dialogue between the primary care physician and the patient with erectile dysfunction. Rev Urol. 2003;5(suppl 7):S35-S48.

3. Boston University School of Medicine. Sexual Medicine. Epidemiology of ED. 2019. www.bumc.bu.edu/sexualmedicine/physicianinformation/epidemiology-of-ed/. Accessed May 27, 2020.

4. Weeks GR, Gambescia N, Hertlein KM, eds. A Clinician’s Guide to Systemic Sex Therapy. 2nd ed. London, England: Routledge; 2016.

5. Colson MH, Cuzin A, Faix A, et al. Current epidemiology of erectile dysfunction, an update. Sexologies. 2018;27:e7-e13.

6. Rew KT, Heidelbaugh JJ. Erectile dysfunction. Am Fam Physician. 2016;94820-94827.

7. Rosen RC, Cappelleri JC, Smith MD, et al. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999;11:319-326.

8. Rew KT, Heidelbaugh JJ. Erectile dysfunction. Am Fam Physician. 2016;94:820-827.

9. Dean J, Rubio-Aurioles E, McCabe M, et al. Integrating partners into erectile dysfunction treatment: improving the sexual experience for the couple. Int J Clin Pract. 2008;62:127-133.

10. Shamloul R, Ghanem H. Erectile dysfunction. Lancet. 2013; 381:153-165.

11. Lo WH, Fu SN, Wong SN, et al. Prevalence, correlates, attitude and treatment seeking of erectile dysfunction among type 2 diabetic Chinese men attending primary care outpatient clinics. Asian J Androl. 2014;16:755-760.

12. Zweifler J, Padilla A, Schafer S. Barriers to recognition of erectile dysfunction among diabetic Mexican-American men. J Am Board Fam Pract. 1998;11:259-263.

13. American Urological Society. Erectile dysfunction: AUA guideline (2018). www.auanet.org/guidelines/erectile-dysfunction-(ed)-guideline. Accessed May 27, 2020.

14. Huang S, Lie J. Phosphodiesterase-5 (PDE5) inhibitors in the management of erectile dysfunction. P T. 2013;38;414-419.

15. Masters WH, Johnson VE. Human Sexual Inadequacy. Boston: Little Brown; 1970.

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The authors reported no potential conflict of interest relevant to this article.

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[email protected]

The authors reported no potential conflict of interest relevant to this article.

Author and Disclosure Information

Department of Family Medicine, John Peter Smith Health Network, Fort Worth, TX (Dr. Buck); Department of Family Medicine, University of Colorado School of Medicine, Denver (Dr. Stratton); Medical Family Therapy Program, East Carolina University, Greenville, NC (Dr. Hodgson)
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The authors reported no potential conflict of interest relevant to this article.

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THE CASE

Eric M,* a 36-year-old new patient, visits a primary care clinic for a check-up accompanied by his wife. A thorough history and physical exam reveal no concerns. He is active and a nonsmoker, drinks only socially, takes no medications, and reports no concerning symptoms. At the end of the visit, though, he says he has been experiencing erectile dysfunction for the past 6 months. What began as intermittent difficulty maintaining erections now “happens a lot.” He is distressed and says, “It just came out of the blue.” The patient’s wife then says she believes men cannot achieve erections if they are having an affair. When the chagrined patient simply asks for “those pills,” his wife says in a raised voice, “He’s a liar!”

● How would you proceed with this patient?

*The patient’s name has been changed to protect his identity.

Some family physicians may feel ill-equipped to talk about sexual and relational problems and lack the skills to effectively counsel on these matters.1 Despite the fact that more than 70% of adult patients want to discuss sexual topics with their family physician, sexual problems are documented in as few as 2% of patient notes.2 One of the most commonly noted sexual health concerns is erectile dysfunction (ED), estimated to occur in 35% of men ages 40 to 70.3 Many ED cases have psychological antecedents including stress, depression, performance anxiety, pornography addiction, and relationship concerns.4,5

Assessing ED. The inability to achieve or maintain an erection needed for satisfactory sexual activity is typically diagnosed through symptom self-report and with thorough history taking and physical examination.6 However, more objective scales can be used. In particular, the International Index of Erectile Function, a 15-question scale, is useful for both diagnosis and treatment monitoring (www.baus.org.uk/_userfiles/pages/files/Patients/Leaflets/iief.pdf).7 Common contributors to ED can be vascular (eg, hypertension), neurologic (eg, multiple sclerosis), psychological (noted earlier), or hormonal (eg, thyroid imbalances).6 In this article, we focus on the relationship context in which ED exists. A review of medical evaluation and management can be found elsewhere.8

Key relational questions

It’s important to address ED as a shared sexual problem that has significant detrimental effects for both heterosexual and same-sex relationships.9 Encourage patients to bring their partner to appointments so a relational assessment may be conducted.10 Ask them both about their satisfaction with the sexual relationship. Questions such as, “Are you both satisfied with your sex life?” or “Do you or your partner have any sexual concerns?”2 can shed light on the couples’ sexual health. This encourages a unified approach to the issue instead of casting things as largely the responsibility of the symptom bearer.

Assess both patient and partner to get a comprehensive understanding of the ED issue.

Identify norms that are specific to the couple. Patients from a variety of cultures prefer that their clinicians initiate the conversation about ED.11,12 We specifically recommend that clinicians, using relationally focused questions, inquire about sexual norms and desires that may be situated in culture, family of origin, or gender (TABLE 1).

Consider asking these focused questions for assessing ED

Continue to: Treating ED within a relationship

 

 

Treating ED within a relationship

Once a couple’s sexual relationship has been fully assessed, you may confidently develop a treatment plan for managing sexual dysfunction relationally as well as medically, an approach to ED advised by the American Urological Association.13 We propose that primary care treatment for ED involve collaboration between the physician, the patient/couple (if the patient is partnered), and, as needed, a behavioral health specialist.

The physician’s role ...

Managing ED relationally is important on many fronts. If, for instance, a type-5 phosphodiesterase (PDE-5) inhibitor is needed, both the patient and partner should learn about best practices for optimizing success, such as avoiding excessive alcohol intake or high-fat meals immediately before and after taking a PDE-5.14

Sex ed. Regardless of the couple’s age, be prepared to offer high-quality sexual education. Either partner may have faulty knowledge (or even a lack of knowledge) of basic sexual functioning. Physicians have an opportunity to explain healthy erectile functioning, the sexual response cycle, and ways in which PDE-5 medications work (and do not work). (For a list of resources to facilitate these discussions, see TABLE 2.)

Resources for discussion of sexual concerns with your patients

Avoid avoidance. Physicians can intervene on patterns of shame that may surround ED simply by discussing sexual functioning openly and honestly. ED often persists due to avoidance—ie, anxiety about sexual performance can lead couples to avoid sex, which perpetuates more anxiety and avoidance. Normalizing typical sexual functioning, encouraging couples to “avoid avoidance,” and providing referrals as needed are core elements of relational intervention for ED.

Use relationally focused questions to inquire about sexual norms and desires that may be situated in culture, family of origin, or gender.

Setting the tone. Family physicians are not routinely trained in couples therapy. However, you can employ communication skills that allow each partner to be heard by using empathic/reflective listening, de-­escalation, and reframing. Asking “What effect are the sexual concerns having on both of you?” and “What were the circumstances of the last sexual encounter that were pleasing to both of you?” can help promote intimacy and mutual satisfaction.

Continue to: The behavioral specialist's role

 

 

The behavioral specialist’s role

Behavioral health specialists may treat ED using methods such as cognitive behavioral therapy or evidence-based couple interventions.4 Cognitive methods for the treatment of ED include examination of maladaptive thoughts around pressure to perform and achieving sexual pleasure. Behavioral methods for treatment of ED are typically aimed at the de-coupling of anxiety and sexual activity. These treatments can include relaxation and desensitization, specifically sensate focus therapy.15

Sensate focus therapy involves a specific set of prescriptive rules for sexual activity, initially restricting touch to non-demand pleasurable touch (eg, holding hands) that allows couples to connect in a low-anxiety context focused on relaxation and connection. As couples are able to control anxiety while engaging in these activities, they engage in increasingly more intimate activities. Additionally, behavioral health specialists trained in couples therapy are vital to helping increase communication regarding sexual activity, sexual scripts, and the relationship in general.4

Identifying a treatment team

In coordinating couples care in the treatment of ED, enlist the help of a therapist who has specific knowledge and skills in the treatment of sexual disorders. While the number of qualified or certified sex therapists is limited, referring providers can visit the American Association of Sexuality Educators, Counselors, and Therapists Web site (www.aasect.org) for possible referral sources. Another option is the American Association for Marriage and Family Therapy Web site (www.aamft.org) under “Find a therapist.” Lastly, the Society for Sex Therapy and Research (www.sstarnet.org) is another professional association that provides information and local referral sources. For patients and partners located in rural areas where access is limited, telehealth options may need to be explored.

THE CASE

Mr. M and his wife were seen for a follow-up appointment by his primary care provider, who ruled out any additional causes of ED (eg, hormonal, vascular), discussed with both the patient and his wife basic sexual health and sexual functioning, dispelled several commonly held myths (ie, individuals cannot obtain an erection because of infidelity or lying), validated sexual concerns as a significant health issue, and prescribed a PDE-5 inhibitor.

Mr. M and his wife were referred to a behavioral health specialist in the clinic who had expertise in couples therapy. At several subsequent visits, the patient and his wife worked on improving the quality and quantity of communication regarding their sexual goals, mutual de-escalation of anxiety, increased emotional intimacy, and sensate focus techniques.

Continue to: As the result of the interventions...

 

 

As the result of these interventions, both the patient and his wife were able to engage in sex with less anxiety, and the patient increasingly was able to achieve more satisfactory erections without the use of the PDE-5 inhibitor. At the conclusion of therapy, the patient and his wife reported an increase in sexual satisfaction.

CORRESPONDENCE
Katherine Buck, PhD, Family Health Center, John Peter Smith Health Network, 1500 S. Main Street, Fort Worth, TX 76104; [email protected].

THE CASE

Eric M,* a 36-year-old new patient, visits a primary care clinic for a check-up accompanied by his wife. A thorough history and physical exam reveal no concerns. He is active and a nonsmoker, drinks only socially, takes no medications, and reports no concerning symptoms. At the end of the visit, though, he says he has been experiencing erectile dysfunction for the past 6 months. What began as intermittent difficulty maintaining erections now “happens a lot.” He is distressed and says, “It just came out of the blue.” The patient’s wife then says she believes men cannot achieve erections if they are having an affair. When the chagrined patient simply asks for “those pills,” his wife says in a raised voice, “He’s a liar!”

● How would you proceed with this patient?

*The patient’s name has been changed to protect his identity.

Some family physicians may feel ill-equipped to talk about sexual and relational problems and lack the skills to effectively counsel on these matters.1 Despite the fact that more than 70% of adult patients want to discuss sexual topics with their family physician, sexual problems are documented in as few as 2% of patient notes.2 One of the most commonly noted sexual health concerns is erectile dysfunction (ED), estimated to occur in 35% of men ages 40 to 70.3 Many ED cases have psychological antecedents including stress, depression, performance anxiety, pornography addiction, and relationship concerns.4,5

Assessing ED. The inability to achieve or maintain an erection needed for satisfactory sexual activity is typically diagnosed through symptom self-report and with thorough history taking and physical examination.6 However, more objective scales can be used. In particular, the International Index of Erectile Function, a 15-question scale, is useful for both diagnosis and treatment monitoring (www.baus.org.uk/_userfiles/pages/files/Patients/Leaflets/iief.pdf).7 Common contributors to ED can be vascular (eg, hypertension), neurologic (eg, multiple sclerosis), psychological (noted earlier), or hormonal (eg, thyroid imbalances).6 In this article, we focus on the relationship context in which ED exists. A review of medical evaluation and management can be found elsewhere.8

Key relational questions

It’s important to address ED as a shared sexual problem that has significant detrimental effects for both heterosexual and same-sex relationships.9 Encourage patients to bring their partner to appointments so a relational assessment may be conducted.10 Ask them both about their satisfaction with the sexual relationship. Questions such as, “Are you both satisfied with your sex life?” or “Do you or your partner have any sexual concerns?”2 can shed light on the couples’ sexual health. This encourages a unified approach to the issue instead of casting things as largely the responsibility of the symptom bearer.

Assess both patient and partner to get a comprehensive understanding of the ED issue.

Identify norms that are specific to the couple. Patients from a variety of cultures prefer that their clinicians initiate the conversation about ED.11,12 We specifically recommend that clinicians, using relationally focused questions, inquire about sexual norms and desires that may be situated in culture, family of origin, or gender (TABLE 1).

Consider asking these focused questions for assessing ED

Continue to: Treating ED within a relationship

 

 

Treating ED within a relationship

Once a couple’s sexual relationship has been fully assessed, you may confidently develop a treatment plan for managing sexual dysfunction relationally as well as medically, an approach to ED advised by the American Urological Association.13 We propose that primary care treatment for ED involve collaboration between the physician, the patient/couple (if the patient is partnered), and, as needed, a behavioral health specialist.

The physician’s role ...

Managing ED relationally is important on many fronts. If, for instance, a type-5 phosphodiesterase (PDE-5) inhibitor is needed, both the patient and partner should learn about best practices for optimizing success, such as avoiding excessive alcohol intake or high-fat meals immediately before and after taking a PDE-5.14

Sex ed. Regardless of the couple’s age, be prepared to offer high-quality sexual education. Either partner may have faulty knowledge (or even a lack of knowledge) of basic sexual functioning. Physicians have an opportunity to explain healthy erectile functioning, the sexual response cycle, and ways in which PDE-5 medications work (and do not work). (For a list of resources to facilitate these discussions, see TABLE 2.)

Resources for discussion of sexual concerns with your patients

Avoid avoidance. Physicians can intervene on patterns of shame that may surround ED simply by discussing sexual functioning openly and honestly. ED often persists due to avoidance—ie, anxiety about sexual performance can lead couples to avoid sex, which perpetuates more anxiety and avoidance. Normalizing typical sexual functioning, encouraging couples to “avoid avoidance,” and providing referrals as needed are core elements of relational intervention for ED.

Use relationally focused questions to inquire about sexual norms and desires that may be situated in culture, family of origin, or gender.

Setting the tone. Family physicians are not routinely trained in couples therapy. However, you can employ communication skills that allow each partner to be heard by using empathic/reflective listening, de-­escalation, and reframing. Asking “What effect are the sexual concerns having on both of you?” and “What were the circumstances of the last sexual encounter that were pleasing to both of you?” can help promote intimacy and mutual satisfaction.

Continue to: The behavioral specialist's role

 

 

The behavioral specialist’s role

Behavioral health specialists may treat ED using methods such as cognitive behavioral therapy or evidence-based couple interventions.4 Cognitive methods for the treatment of ED include examination of maladaptive thoughts around pressure to perform and achieving sexual pleasure. Behavioral methods for treatment of ED are typically aimed at the de-coupling of anxiety and sexual activity. These treatments can include relaxation and desensitization, specifically sensate focus therapy.15

Sensate focus therapy involves a specific set of prescriptive rules for sexual activity, initially restricting touch to non-demand pleasurable touch (eg, holding hands) that allows couples to connect in a low-anxiety context focused on relaxation and connection. As couples are able to control anxiety while engaging in these activities, they engage in increasingly more intimate activities. Additionally, behavioral health specialists trained in couples therapy are vital to helping increase communication regarding sexual activity, sexual scripts, and the relationship in general.4

Identifying a treatment team

In coordinating couples care in the treatment of ED, enlist the help of a therapist who has specific knowledge and skills in the treatment of sexual disorders. While the number of qualified or certified sex therapists is limited, referring providers can visit the American Association of Sexuality Educators, Counselors, and Therapists Web site (www.aasect.org) for possible referral sources. Another option is the American Association for Marriage and Family Therapy Web site (www.aamft.org) under “Find a therapist.” Lastly, the Society for Sex Therapy and Research (www.sstarnet.org) is another professional association that provides information and local referral sources. For patients and partners located in rural areas where access is limited, telehealth options may need to be explored.

THE CASE

Mr. M and his wife were seen for a follow-up appointment by his primary care provider, who ruled out any additional causes of ED (eg, hormonal, vascular), discussed with both the patient and his wife basic sexual health and sexual functioning, dispelled several commonly held myths (ie, individuals cannot obtain an erection because of infidelity or lying), validated sexual concerns as a significant health issue, and prescribed a PDE-5 inhibitor.

Mr. M and his wife were referred to a behavioral health specialist in the clinic who had expertise in couples therapy. At several subsequent visits, the patient and his wife worked on improving the quality and quantity of communication regarding their sexual goals, mutual de-escalation of anxiety, increased emotional intimacy, and sensate focus techniques.

Continue to: As the result of the interventions...

 

 

As the result of these interventions, both the patient and his wife were able to engage in sex with less anxiety, and the patient increasingly was able to achieve more satisfactory erections without the use of the PDE-5 inhibitor. At the conclusion of therapy, the patient and his wife reported an increase in sexual satisfaction.

CORRESPONDENCE
Katherine Buck, PhD, Family Health Center, John Peter Smith Health Network, 1500 S. Main Street, Fort Worth, TX 76104; [email protected].

References

1. Macdowall W, Parker R, Nanchahal K, et al. ‘Talking of Sex’: developing and piloting a sexual health communication tool for use in primary care. Patient Educ Couns. 2010;81:332-337.

2. Sadovsky R. Asking the questions and offering solutions: the ongoing dialogue between the primary care physician and the patient with erectile dysfunction. Rev Urol. 2003;5(suppl 7):S35-S48.

3. Boston University School of Medicine. Sexual Medicine. Epidemiology of ED. 2019. www.bumc.bu.edu/sexualmedicine/physicianinformation/epidemiology-of-ed/. Accessed May 27, 2020.

4. Weeks GR, Gambescia N, Hertlein KM, eds. A Clinician’s Guide to Systemic Sex Therapy. 2nd ed. London, England: Routledge; 2016.

5. Colson MH, Cuzin A, Faix A, et al. Current epidemiology of erectile dysfunction, an update. Sexologies. 2018;27:e7-e13.

6. Rew KT, Heidelbaugh JJ. Erectile dysfunction. Am Fam Physician. 2016;94820-94827.

7. Rosen RC, Cappelleri JC, Smith MD, et al. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999;11:319-326.

8. Rew KT, Heidelbaugh JJ. Erectile dysfunction. Am Fam Physician. 2016;94:820-827.

9. Dean J, Rubio-Aurioles E, McCabe M, et al. Integrating partners into erectile dysfunction treatment: improving the sexual experience for the couple. Int J Clin Pract. 2008;62:127-133.

10. Shamloul R, Ghanem H. Erectile dysfunction. Lancet. 2013; 381:153-165.

11. Lo WH, Fu SN, Wong SN, et al. Prevalence, correlates, attitude and treatment seeking of erectile dysfunction among type 2 diabetic Chinese men attending primary care outpatient clinics. Asian J Androl. 2014;16:755-760.

12. Zweifler J, Padilla A, Schafer S. Barriers to recognition of erectile dysfunction among diabetic Mexican-American men. J Am Board Fam Pract. 1998;11:259-263.

13. American Urological Society. Erectile dysfunction: AUA guideline (2018). www.auanet.org/guidelines/erectile-dysfunction-(ed)-guideline. Accessed May 27, 2020.

14. Huang S, Lie J. Phosphodiesterase-5 (PDE5) inhibitors in the management of erectile dysfunction. P T. 2013;38;414-419.

15. Masters WH, Johnson VE. Human Sexual Inadequacy. Boston: Little Brown; 1970.

References

1. Macdowall W, Parker R, Nanchahal K, et al. ‘Talking of Sex’: developing and piloting a sexual health communication tool for use in primary care. Patient Educ Couns. 2010;81:332-337.

2. Sadovsky R. Asking the questions and offering solutions: the ongoing dialogue between the primary care physician and the patient with erectile dysfunction. Rev Urol. 2003;5(suppl 7):S35-S48.

3. Boston University School of Medicine. Sexual Medicine. Epidemiology of ED. 2019. www.bumc.bu.edu/sexualmedicine/physicianinformation/epidemiology-of-ed/. Accessed May 27, 2020.

4. Weeks GR, Gambescia N, Hertlein KM, eds. A Clinician’s Guide to Systemic Sex Therapy. 2nd ed. London, England: Routledge; 2016.

5. Colson MH, Cuzin A, Faix A, et al. Current epidemiology of erectile dysfunction, an update. Sexologies. 2018;27:e7-e13.

6. Rew KT, Heidelbaugh JJ. Erectile dysfunction. Am Fam Physician. 2016;94820-94827.

7. Rosen RC, Cappelleri JC, Smith MD, et al. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999;11:319-326.

8. Rew KT, Heidelbaugh JJ. Erectile dysfunction. Am Fam Physician. 2016;94:820-827.

9. Dean J, Rubio-Aurioles E, McCabe M, et al. Integrating partners into erectile dysfunction treatment: improving the sexual experience for the couple. Int J Clin Pract. 2008;62:127-133.

10. Shamloul R, Ghanem H. Erectile dysfunction. Lancet. 2013; 381:153-165.

11. Lo WH, Fu SN, Wong SN, et al. Prevalence, correlates, attitude and treatment seeking of erectile dysfunction among type 2 diabetic Chinese men attending primary care outpatient clinics. Asian J Androl. 2014;16:755-760.

12. Zweifler J, Padilla A, Schafer S. Barriers to recognition of erectile dysfunction among diabetic Mexican-American men. J Am Board Fam Pract. 1998;11:259-263.

13. American Urological Society. Erectile dysfunction: AUA guideline (2018). www.auanet.org/guidelines/erectile-dysfunction-(ed)-guideline. Accessed May 27, 2020.

14. Huang S, Lie J. Phosphodiesterase-5 (PDE5) inhibitors in the management of erectile dysfunction. P T. 2013;38;414-419.

15. Masters WH, Johnson VE. Human Sexual Inadequacy. Boston: Little Brown; 1970.

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Testicular sperm may improve IVF outcomes in some cases

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Wed, 05/20/2020 - 12:56

Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

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Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

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High-intensity exercise builds bone in older men

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Fri, 05/15/2020 - 12:01

A high-intensity exercise program, already shown effective in improving bone density and performance in women, is also effective in older men with low bone density, according to the LIFTMOR-M study, published in Bone. The protocol incorporates barbell-based weightlifting and impact training involving jumping chin-ups.

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“When you’ve got a condition primarily in one of the sexes, the other sex often gets ignored, and that’s absolute the case with osteoporosis,” said lead author Belinda Beck, PhD, a professor at Griffith University, Gold Coast, Australia, in an interview.

In older adults with low bone density, when it comes to building bone and reducing fracture, a review of the literature suggests that exercise doesn’t work. That’s not really true though, according to Dr. Beck. An unpublished analysis of studies of high-intensity exercise only at her institution shows promise. “It looks like exercise doesn’t work. It’s not that, it’s that the wrong kind of exercise doesn’t work,” she stressed.

The original LIFTMOR trial, in women, was inspired by a collaboration with Lisa Weis, an Olympic weightlifter who specialized in training older women, who subsequently showed improvements on bone scans. “That’s what jump-started it, because just like every other scientist, I would have been too scared to do this kind of loading in this fragile population, and that’s the reason why people haven’t been doing it. They don’t want to break people,” said Dr. Beck.

The investigators “cherry-picked some of those exercises and tested them in the LIFTMOR trial. I was nervous about the study because the weights we were lifting were much heavier than most people had applied for people with osteoporosis. The risk was, we would cause the fractures we were trying to prevent,” said Dr. Beck. Her team tested a high-intensity resistance and impact (HiRIT) protocol in postmenopausal women with low bone mass (J Bone Miner Res. 2019 Mar;34[3]:572. Controls underwent a home-based, low-intensity exercise program. They found improvements in bone density and functional performance, compared with controls.

“The exercise was effective and safe for this population if practiced with proper technique under close supervision,” said Dr. Beck, but she emphasized that the exercises must be led by experienced coaches because of the potential for injury.

The investigators then looked at men. “There are still one in five men over 50 who are going to fracture,” Dr. Beck said.



Her team launched LIFTMOR-M, which enrolled 93 men (mean age, 67.1 years) with a lower than average proximal femur areal bone mineral density. Of them, 34 were randomized to HiRIT, 33 to supervised machine-based isometric axial compression (IAC) exercise training, and 26 were designated as controls and self-selected to usual activities.

The intervention included 8 months of twice-weekly, supervised, 30-minute HiRIT sessions, which included five sets of five repetitions, using more than 85% the weight of the single repetition maximum. The routine included the deadlift, squat, and overhead press. The impact component included five sets of five repetitions of jumping chin-ups followed by a firm, flat-footed landing.

After 8 months, there was no difference in compliance between the two intervention groups. Those in the HiRIT group had improved medial femoral neck cortical thickness, compared with controls (5.6% vs. –0.1%; P = .028) and IAC (5.6% vs. 0.7%; P = .044). Those in the HiRIT group maintained distal tibia trabecular area, while the control group experienced a loss (0.2% vs. –1.6%; P = .013). The IAC group did not show any improvement in bone strength in any of the sites examined, though some findings suggest it may counteract age-related loss in bone strength indices in the distal tibia and radius.

The program requires a fluid movement that maintains a neutral spine throughout. Dr. Beck has developed the Onero program (theboneclinic.com.au/onero/) based on the routine, and licenses it to physical therapists and exercise physiologists.

The study was funded by the Australian Research Foundation and the Australian Government Research Training Program. Dr. Beck owns the Bone Clinic, which sells licenses to the Onero program based on the exercise program used in the study.

SOURCE: Beck B et al. Bone. 2020 April 11. doi: 10.1016/j.bone.2020.115362.

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A high-intensity exercise program, already shown effective in improving bone density and performance in women, is also effective in older men with low bone density, according to the LIFTMOR-M study, published in Bone. The protocol incorporates barbell-based weightlifting and impact training involving jumping chin-ups.

sbm Hotting/Fotolia.com

“When you’ve got a condition primarily in one of the sexes, the other sex often gets ignored, and that’s absolute the case with osteoporosis,” said lead author Belinda Beck, PhD, a professor at Griffith University, Gold Coast, Australia, in an interview.

In older adults with low bone density, when it comes to building bone and reducing fracture, a review of the literature suggests that exercise doesn’t work. That’s not really true though, according to Dr. Beck. An unpublished analysis of studies of high-intensity exercise only at her institution shows promise. “It looks like exercise doesn’t work. It’s not that, it’s that the wrong kind of exercise doesn’t work,” she stressed.

The original LIFTMOR trial, in women, was inspired by a collaboration with Lisa Weis, an Olympic weightlifter who specialized in training older women, who subsequently showed improvements on bone scans. “That’s what jump-started it, because just like every other scientist, I would have been too scared to do this kind of loading in this fragile population, and that’s the reason why people haven’t been doing it. They don’t want to break people,” said Dr. Beck.

The investigators “cherry-picked some of those exercises and tested them in the LIFTMOR trial. I was nervous about the study because the weights we were lifting were much heavier than most people had applied for people with osteoporosis. The risk was, we would cause the fractures we were trying to prevent,” said Dr. Beck. Her team tested a high-intensity resistance and impact (HiRIT) protocol in postmenopausal women with low bone mass (J Bone Miner Res. 2019 Mar;34[3]:572. Controls underwent a home-based, low-intensity exercise program. They found improvements in bone density and functional performance, compared with controls.

“The exercise was effective and safe for this population if practiced with proper technique under close supervision,” said Dr. Beck, but she emphasized that the exercises must be led by experienced coaches because of the potential for injury.

The investigators then looked at men. “There are still one in five men over 50 who are going to fracture,” Dr. Beck said.



Her team launched LIFTMOR-M, which enrolled 93 men (mean age, 67.1 years) with a lower than average proximal femur areal bone mineral density. Of them, 34 were randomized to HiRIT, 33 to supervised machine-based isometric axial compression (IAC) exercise training, and 26 were designated as controls and self-selected to usual activities.

The intervention included 8 months of twice-weekly, supervised, 30-minute HiRIT sessions, which included five sets of five repetitions, using more than 85% the weight of the single repetition maximum. The routine included the deadlift, squat, and overhead press. The impact component included five sets of five repetitions of jumping chin-ups followed by a firm, flat-footed landing.

After 8 months, there was no difference in compliance between the two intervention groups. Those in the HiRIT group had improved medial femoral neck cortical thickness, compared with controls (5.6% vs. –0.1%; P = .028) and IAC (5.6% vs. 0.7%; P = .044). Those in the HiRIT group maintained distal tibia trabecular area, while the control group experienced a loss (0.2% vs. –1.6%; P = .013). The IAC group did not show any improvement in bone strength in any of the sites examined, though some findings suggest it may counteract age-related loss in bone strength indices in the distal tibia and radius.

The program requires a fluid movement that maintains a neutral spine throughout. Dr. Beck has developed the Onero program (theboneclinic.com.au/onero/) based on the routine, and licenses it to physical therapists and exercise physiologists.

The study was funded by the Australian Research Foundation and the Australian Government Research Training Program. Dr. Beck owns the Bone Clinic, which sells licenses to the Onero program based on the exercise program used in the study.

SOURCE: Beck B et al. Bone. 2020 April 11. doi: 10.1016/j.bone.2020.115362.

A high-intensity exercise program, already shown effective in improving bone density and performance in women, is also effective in older men with low bone density, according to the LIFTMOR-M study, published in Bone. The protocol incorporates barbell-based weightlifting and impact training involving jumping chin-ups.

sbm Hotting/Fotolia.com

“When you’ve got a condition primarily in one of the sexes, the other sex often gets ignored, and that’s absolute the case with osteoporosis,” said lead author Belinda Beck, PhD, a professor at Griffith University, Gold Coast, Australia, in an interview.

In older adults with low bone density, when it comes to building bone and reducing fracture, a review of the literature suggests that exercise doesn’t work. That’s not really true though, according to Dr. Beck. An unpublished analysis of studies of high-intensity exercise only at her institution shows promise. “It looks like exercise doesn’t work. It’s not that, it’s that the wrong kind of exercise doesn’t work,” she stressed.

The original LIFTMOR trial, in women, was inspired by a collaboration with Lisa Weis, an Olympic weightlifter who specialized in training older women, who subsequently showed improvements on bone scans. “That’s what jump-started it, because just like every other scientist, I would have been too scared to do this kind of loading in this fragile population, and that’s the reason why people haven’t been doing it. They don’t want to break people,” said Dr. Beck.

The investigators “cherry-picked some of those exercises and tested them in the LIFTMOR trial. I was nervous about the study because the weights we were lifting were much heavier than most people had applied for people with osteoporosis. The risk was, we would cause the fractures we were trying to prevent,” said Dr. Beck. Her team tested a high-intensity resistance and impact (HiRIT) protocol in postmenopausal women with low bone mass (J Bone Miner Res. 2019 Mar;34[3]:572. Controls underwent a home-based, low-intensity exercise program. They found improvements in bone density and functional performance, compared with controls.

“The exercise was effective and safe for this population if practiced with proper technique under close supervision,” said Dr. Beck, but she emphasized that the exercises must be led by experienced coaches because of the potential for injury.

The investigators then looked at men. “There are still one in five men over 50 who are going to fracture,” Dr. Beck said.



Her team launched LIFTMOR-M, which enrolled 93 men (mean age, 67.1 years) with a lower than average proximal femur areal bone mineral density. Of them, 34 were randomized to HiRIT, 33 to supervised machine-based isometric axial compression (IAC) exercise training, and 26 were designated as controls and self-selected to usual activities.

The intervention included 8 months of twice-weekly, supervised, 30-minute HiRIT sessions, which included five sets of five repetitions, using more than 85% the weight of the single repetition maximum. The routine included the deadlift, squat, and overhead press. The impact component included five sets of five repetitions of jumping chin-ups followed by a firm, flat-footed landing.

After 8 months, there was no difference in compliance between the two intervention groups. Those in the HiRIT group had improved medial femoral neck cortical thickness, compared with controls (5.6% vs. –0.1%; P = .028) and IAC (5.6% vs. 0.7%; P = .044). Those in the HiRIT group maintained distal tibia trabecular area, while the control group experienced a loss (0.2% vs. –1.6%; P = .013). The IAC group did not show any improvement in bone strength in any of the sites examined, though some findings suggest it may counteract age-related loss in bone strength indices in the distal tibia and radius.

The program requires a fluid movement that maintains a neutral spine throughout. Dr. Beck has developed the Onero program (theboneclinic.com.au/onero/) based on the routine, and licenses it to physical therapists and exercise physiologists.

The study was funded by the Australian Research Foundation and the Australian Government Research Training Program. Dr. Beck owns the Bone Clinic, which sells licenses to the Onero program based on the exercise program used in the study.

SOURCE: Beck B et al. Bone. 2020 April 11. doi: 10.1016/j.bone.2020.115362.

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New ‘atlas’ maps links between mental disorders, physical illnesses

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Wed, 05/27/2020 - 14:09

Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

 

 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

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

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Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

 

 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

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

Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

 

 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

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

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