Fracture risk prediction: No benefit to repeat BMD testing in postmenopausal women

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Repeat bone mineral density testing did not improve fracture-risk prediction in a large prospective cohort of postmenopausal women beyond baseline BMD measurement alone, according to new 12-year follow-up data.

Thinkstock

On the basis of the findings, published online in JAMA Internal Medicine, the authors recommend against routine repeat testing in postmenopausal women. Other experts, however, caution that the results may not be so broadly generalizable.

For the investigation, Carolyn J. Crandall, MD, of the division of general internal medicine and health services research at the University of California, Los Angeles, and colleagues analyzed data from 7,419 women enrolled in the prospective Women’s Health Initiative study and who underwent baseline and repeat dual-energy x-ray absorptiometry (DXA) between 1993 and 2010. The researchers excluded patients who reported using bisphosphonates, calcitonin, or selective estrogen-receptor modulators, those with a history of major osteoporotic fracture, or those who lacked follow-up visits. The mean body mass index (BMI) of the study population was 28.7 kg/m2, and the mean age was 66.1 years.

The mean follow-up after the repeat BMD test was 9.0 years, during which period 732 (9.9%) of the women experienced a major osteoporotic fracture, and 139 (1.9%) experienced hip fractures.

To determine whether repeat testing improved fracture risk discrimination, the researchers calculated area under the receiver operating characteristic curve (AUROC) for baseline BMD, absolute change in BMD, and the combination of baseline BMD and change in BMD.



With respect to any major osteoporotic fracture risk, the AUROC values for total hip BMD at baseline, change in total hip BMD at 3 years, and the combination of the two, respectively, were 0.61 (95% confidence interval, 0.59-0.63), 0.53 (95% CI, 0.51-0.55), and 0.61 (95% CI, 0.59-0.63). For hip fracture risk, the respective AUROC values were 0.71 (95% CI, 0.67-0.75), 0.61 (95% CI, 0.56-0.65), and 0.73 (95% CI, 0.69-0.77), the authors reported.

Similar results were observed for femoral neck and lumbar spine BMD measurements. The associations between BMD changes and fracture risk were consistent across age, race, ethnicity, BMI, and baseline BMD T-score subgroups.

Although baseline BMD and change in BMD were independently associated with incident fracture, the association was stronger for lower baseline BMD than the 3-year absolute change in BMD, the authors stated.

The findings, which are consistent with those of previous investigations that involved older adults, are notable because of the age range of the population, according to the authors. “To our knowledge, this is the first prospective study that addressed this issue in a study cohort that included younger postmenopausal U.S. women,” they wrote. “Forty-four percent of our study population was younger than 65 years.”

The authors wrote that, given the lack of benefit associated with repeat BMD testing, such tests should no longer be routinely performed. “Our findings further suggest that resources should be devoted to increasing the underuse of baseline BMD testing among women aged [between] 65 and 85 years, one-quarter of whom do not receive an initial BMD test.”

Loyola University
Dr. Pauline Camacho

However, some experts are not comfortable with the broad recommendation to skip repeat testing in the general population. “This is a great study, and it gives important information. However, we know, even in the real world, that patients can lose BMD in this time frame and not really fracture. This does not mean that they will not fracture further down the road,” said Pauline Camacho, MD, director of Loyola University Medical Center’s Osteoporosis and Metabolic Bone Disease Center in Chicago,. “The value of doing BMD goes beyond predicting fracture risk. It also helps assess patient compliance and detect the presence of uncorrected secondary causes of osteoporosis that are limiting the response to therapy, including failure to absorb oral bisphosphonates, vitamin D deficiency, or hyperparathyroidism.”

In addition, patients for whom treatment is initiated would want to know whether it’s working. “Seeing the BMD response to therapy is helpful to both clinicians and patients,” Dr. Camacho said in an interview.

Another concern is the study population. “The study was designed to assess the clinical utility of repeating a screening BMD test in a population of low-risk women -- older postmenopausal women with remarkably good BMD on initial testing,” according to E. Michael Lewiecki, MD, vice president of the National Osteoporosis Foundation and director of the New Mexico Clinical Research and Osteoporosis Center in Albuquerque. “Not surprisingly, with what we know about the expected age-related rate of bone loss, there was only a modest decrease in BMD and little clinical utility in repeating DXA in 3 years. However, repeat testing is an important component in the care of many patients seen in clinical practice.”

UNM Health Sciences Center
Dr. E. Michael Lewiecki

There are numerous situations in clinical practice in which repeat BMD testing can enhance patient care and potentially improve outcomes, Dr. Lewiecki said in an interview. “Repeating BMD 1-2 years after starting osteoporosis therapy is a useful way to assess response and determine whether the patient is on a pathway to achieving an acceptable level of fracture risk with a strategy called treat to target.”

Additionally, patients starting high-dose glucocorticoids who are at high risk for rapid bone loss may benefit from undergoing baseline BMD testing and having a follow-up test 1 year later or even sooner, he said. Further, for early postmenopausal women, the rate of bone loss may be accelerated and may be faster than age-related bone loss later in life. For this reason, “close monitoring of BMD may be used to determine when a treatment threshold has been crossed and pharmacological therapy is indicated.”

The most important message from this study for clinicians and healthcare policymakers is not the relative value of the repeat BMD testing, Dr. Lewiecki stated. Rather, it is the call to action regarding the underuse of BMD testing. “There is a global crisis in the care of osteoporosis that is characterized by underdiagnosis and undertreatment of patients at risk for fracture. Many patients who could benefit from treatment to reduce fracture risk are not receiving it, resulting in disability and deaths from fractures that might have been prevented. We need more bone density testing in appropriately selected patients to identify high-risk patients and intervene to reduce fracture risk,” he said. “DXA is an inexpensive and highly versatile clinical tool with many applications in clinical practice. When used wisely, it can be extraordinarily useful to identify and monitor high-risk patients, with the goal of reducing the burden of osteoporotic fractures.”

The barriers to performing baseline BMD measurement in this population are poorly understood and not well researched, Dr. Crandall said in an interview. “I expect that they relate to the multiple competing demands on primary care physicians, who are, for example, trying to juggle hypertension, a sprained ankle, diabetes, and complex social situations simultaneously with identifying appropriate candidates for osteoporosis screening and considering numerous other screening guidelines.”

The Women’s Health Initiative is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The study authors reported relationships with multiple companies, including Amgen, Pfizer, Bayer, Mithra, Norton Rose Fulbright, TherapeuticsMD, AbbVie, Radius, and Allergan. Dr. Camacho reported relationships with Amgen and Shire. Dr. Lewiecki reported relationships with Amgen, Radius Health, Alexion, Samsung Bioepis, Sandoz, Mereo, and Bindex.

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

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Repeat bone mineral density testing did not improve fracture-risk prediction in a large prospective cohort of postmenopausal women beyond baseline BMD measurement alone, according to new 12-year follow-up data.

Thinkstock

On the basis of the findings, published online in JAMA Internal Medicine, the authors recommend against routine repeat testing in postmenopausal women. Other experts, however, caution that the results may not be so broadly generalizable.

For the investigation, Carolyn J. Crandall, MD, of the division of general internal medicine and health services research at the University of California, Los Angeles, and colleagues analyzed data from 7,419 women enrolled in the prospective Women’s Health Initiative study and who underwent baseline and repeat dual-energy x-ray absorptiometry (DXA) between 1993 and 2010. The researchers excluded patients who reported using bisphosphonates, calcitonin, or selective estrogen-receptor modulators, those with a history of major osteoporotic fracture, or those who lacked follow-up visits. The mean body mass index (BMI) of the study population was 28.7 kg/m2, and the mean age was 66.1 years.

The mean follow-up after the repeat BMD test was 9.0 years, during which period 732 (9.9%) of the women experienced a major osteoporotic fracture, and 139 (1.9%) experienced hip fractures.

To determine whether repeat testing improved fracture risk discrimination, the researchers calculated area under the receiver operating characteristic curve (AUROC) for baseline BMD, absolute change in BMD, and the combination of baseline BMD and change in BMD.



With respect to any major osteoporotic fracture risk, the AUROC values for total hip BMD at baseline, change in total hip BMD at 3 years, and the combination of the two, respectively, were 0.61 (95% confidence interval, 0.59-0.63), 0.53 (95% CI, 0.51-0.55), and 0.61 (95% CI, 0.59-0.63). For hip fracture risk, the respective AUROC values were 0.71 (95% CI, 0.67-0.75), 0.61 (95% CI, 0.56-0.65), and 0.73 (95% CI, 0.69-0.77), the authors reported.

Similar results were observed for femoral neck and lumbar spine BMD measurements. The associations between BMD changes and fracture risk were consistent across age, race, ethnicity, BMI, and baseline BMD T-score subgroups.

Although baseline BMD and change in BMD were independently associated with incident fracture, the association was stronger for lower baseline BMD than the 3-year absolute change in BMD, the authors stated.

The findings, which are consistent with those of previous investigations that involved older adults, are notable because of the age range of the population, according to the authors. “To our knowledge, this is the first prospective study that addressed this issue in a study cohort that included younger postmenopausal U.S. women,” they wrote. “Forty-four percent of our study population was younger than 65 years.”

The authors wrote that, given the lack of benefit associated with repeat BMD testing, such tests should no longer be routinely performed. “Our findings further suggest that resources should be devoted to increasing the underuse of baseline BMD testing among women aged [between] 65 and 85 years, one-quarter of whom do not receive an initial BMD test.”

Loyola University
Dr. Pauline Camacho

However, some experts are not comfortable with the broad recommendation to skip repeat testing in the general population. “This is a great study, and it gives important information. However, we know, even in the real world, that patients can lose BMD in this time frame and not really fracture. This does not mean that they will not fracture further down the road,” said Pauline Camacho, MD, director of Loyola University Medical Center’s Osteoporosis and Metabolic Bone Disease Center in Chicago,. “The value of doing BMD goes beyond predicting fracture risk. It also helps assess patient compliance and detect the presence of uncorrected secondary causes of osteoporosis that are limiting the response to therapy, including failure to absorb oral bisphosphonates, vitamin D deficiency, or hyperparathyroidism.”

In addition, patients for whom treatment is initiated would want to know whether it’s working. “Seeing the BMD response to therapy is helpful to both clinicians and patients,” Dr. Camacho said in an interview.

Another concern is the study population. “The study was designed to assess the clinical utility of repeating a screening BMD test in a population of low-risk women -- older postmenopausal women with remarkably good BMD on initial testing,” according to E. Michael Lewiecki, MD, vice president of the National Osteoporosis Foundation and director of the New Mexico Clinical Research and Osteoporosis Center in Albuquerque. “Not surprisingly, with what we know about the expected age-related rate of bone loss, there was only a modest decrease in BMD and little clinical utility in repeating DXA in 3 years. However, repeat testing is an important component in the care of many patients seen in clinical practice.”

UNM Health Sciences Center
Dr. E. Michael Lewiecki

There are numerous situations in clinical practice in which repeat BMD testing can enhance patient care and potentially improve outcomes, Dr. Lewiecki said in an interview. “Repeating BMD 1-2 years after starting osteoporosis therapy is a useful way to assess response and determine whether the patient is on a pathway to achieving an acceptable level of fracture risk with a strategy called treat to target.”

Additionally, patients starting high-dose glucocorticoids who are at high risk for rapid bone loss may benefit from undergoing baseline BMD testing and having a follow-up test 1 year later or even sooner, he said. Further, for early postmenopausal women, the rate of bone loss may be accelerated and may be faster than age-related bone loss later in life. For this reason, “close monitoring of BMD may be used to determine when a treatment threshold has been crossed and pharmacological therapy is indicated.”

The most important message from this study for clinicians and healthcare policymakers is not the relative value of the repeat BMD testing, Dr. Lewiecki stated. Rather, it is the call to action regarding the underuse of BMD testing. “There is a global crisis in the care of osteoporosis that is characterized by underdiagnosis and undertreatment of patients at risk for fracture. Many patients who could benefit from treatment to reduce fracture risk are not receiving it, resulting in disability and deaths from fractures that might have been prevented. We need more bone density testing in appropriately selected patients to identify high-risk patients and intervene to reduce fracture risk,” he said. “DXA is an inexpensive and highly versatile clinical tool with many applications in clinical practice. When used wisely, it can be extraordinarily useful to identify and monitor high-risk patients, with the goal of reducing the burden of osteoporotic fractures.”

The barriers to performing baseline BMD measurement in this population are poorly understood and not well researched, Dr. Crandall said in an interview. “I expect that they relate to the multiple competing demands on primary care physicians, who are, for example, trying to juggle hypertension, a sprained ankle, diabetes, and complex social situations simultaneously with identifying appropriate candidates for osteoporosis screening and considering numerous other screening guidelines.”

The Women’s Health Initiative is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The study authors reported relationships with multiple companies, including Amgen, Pfizer, Bayer, Mithra, Norton Rose Fulbright, TherapeuticsMD, AbbVie, Radius, and Allergan. Dr. Camacho reported relationships with Amgen and Shire. Dr. Lewiecki reported relationships with Amgen, Radius Health, Alexion, Samsung Bioepis, Sandoz, Mereo, and Bindex.

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

Repeat bone mineral density testing did not improve fracture-risk prediction in a large prospective cohort of postmenopausal women beyond baseline BMD measurement alone, according to new 12-year follow-up data.

Thinkstock

On the basis of the findings, published online in JAMA Internal Medicine, the authors recommend against routine repeat testing in postmenopausal women. Other experts, however, caution that the results may not be so broadly generalizable.

For the investigation, Carolyn J. Crandall, MD, of the division of general internal medicine and health services research at the University of California, Los Angeles, and colleagues analyzed data from 7,419 women enrolled in the prospective Women’s Health Initiative study and who underwent baseline and repeat dual-energy x-ray absorptiometry (DXA) between 1993 and 2010. The researchers excluded patients who reported using bisphosphonates, calcitonin, or selective estrogen-receptor modulators, those with a history of major osteoporotic fracture, or those who lacked follow-up visits. The mean body mass index (BMI) of the study population was 28.7 kg/m2, and the mean age was 66.1 years.

The mean follow-up after the repeat BMD test was 9.0 years, during which period 732 (9.9%) of the women experienced a major osteoporotic fracture, and 139 (1.9%) experienced hip fractures.

To determine whether repeat testing improved fracture risk discrimination, the researchers calculated area under the receiver operating characteristic curve (AUROC) for baseline BMD, absolute change in BMD, and the combination of baseline BMD and change in BMD.



With respect to any major osteoporotic fracture risk, the AUROC values for total hip BMD at baseline, change in total hip BMD at 3 years, and the combination of the two, respectively, were 0.61 (95% confidence interval, 0.59-0.63), 0.53 (95% CI, 0.51-0.55), and 0.61 (95% CI, 0.59-0.63). For hip fracture risk, the respective AUROC values were 0.71 (95% CI, 0.67-0.75), 0.61 (95% CI, 0.56-0.65), and 0.73 (95% CI, 0.69-0.77), the authors reported.

Similar results were observed for femoral neck and lumbar spine BMD measurements. The associations between BMD changes and fracture risk were consistent across age, race, ethnicity, BMI, and baseline BMD T-score subgroups.

Although baseline BMD and change in BMD were independently associated with incident fracture, the association was stronger for lower baseline BMD than the 3-year absolute change in BMD, the authors stated.

The findings, which are consistent with those of previous investigations that involved older adults, are notable because of the age range of the population, according to the authors. “To our knowledge, this is the first prospective study that addressed this issue in a study cohort that included younger postmenopausal U.S. women,” they wrote. “Forty-four percent of our study population was younger than 65 years.”

The authors wrote that, given the lack of benefit associated with repeat BMD testing, such tests should no longer be routinely performed. “Our findings further suggest that resources should be devoted to increasing the underuse of baseline BMD testing among women aged [between] 65 and 85 years, one-quarter of whom do not receive an initial BMD test.”

Loyola University
Dr. Pauline Camacho

However, some experts are not comfortable with the broad recommendation to skip repeat testing in the general population. “This is a great study, and it gives important information. However, we know, even in the real world, that patients can lose BMD in this time frame and not really fracture. This does not mean that they will not fracture further down the road,” said Pauline Camacho, MD, director of Loyola University Medical Center’s Osteoporosis and Metabolic Bone Disease Center in Chicago,. “The value of doing BMD goes beyond predicting fracture risk. It also helps assess patient compliance and detect the presence of uncorrected secondary causes of osteoporosis that are limiting the response to therapy, including failure to absorb oral bisphosphonates, vitamin D deficiency, or hyperparathyroidism.”

In addition, patients for whom treatment is initiated would want to know whether it’s working. “Seeing the BMD response to therapy is helpful to both clinicians and patients,” Dr. Camacho said in an interview.

Another concern is the study population. “The study was designed to assess the clinical utility of repeating a screening BMD test in a population of low-risk women -- older postmenopausal women with remarkably good BMD on initial testing,” according to E. Michael Lewiecki, MD, vice president of the National Osteoporosis Foundation and director of the New Mexico Clinical Research and Osteoporosis Center in Albuquerque. “Not surprisingly, with what we know about the expected age-related rate of bone loss, there was only a modest decrease in BMD and little clinical utility in repeating DXA in 3 years. However, repeat testing is an important component in the care of many patients seen in clinical practice.”

UNM Health Sciences Center
Dr. E. Michael Lewiecki

There are numerous situations in clinical practice in which repeat BMD testing can enhance patient care and potentially improve outcomes, Dr. Lewiecki said in an interview. “Repeating BMD 1-2 years after starting osteoporosis therapy is a useful way to assess response and determine whether the patient is on a pathway to achieving an acceptable level of fracture risk with a strategy called treat to target.”

Additionally, patients starting high-dose glucocorticoids who are at high risk for rapid bone loss may benefit from undergoing baseline BMD testing and having a follow-up test 1 year later or even sooner, he said. Further, for early postmenopausal women, the rate of bone loss may be accelerated and may be faster than age-related bone loss later in life. For this reason, “close monitoring of BMD may be used to determine when a treatment threshold has been crossed and pharmacological therapy is indicated.”

The most important message from this study for clinicians and healthcare policymakers is not the relative value of the repeat BMD testing, Dr. Lewiecki stated. Rather, it is the call to action regarding the underuse of BMD testing. “There is a global crisis in the care of osteoporosis that is characterized by underdiagnosis and undertreatment of patients at risk for fracture. Many patients who could benefit from treatment to reduce fracture risk are not receiving it, resulting in disability and deaths from fractures that might have been prevented. We need more bone density testing in appropriately selected patients to identify high-risk patients and intervene to reduce fracture risk,” he said. “DXA is an inexpensive and highly versatile clinical tool with many applications in clinical practice. When used wisely, it can be extraordinarily useful to identify and monitor high-risk patients, with the goal of reducing the burden of osteoporotic fractures.”

The barriers to performing baseline BMD measurement in this population are poorly understood and not well researched, Dr. Crandall said in an interview. “I expect that they relate to the multiple competing demands on primary care physicians, who are, for example, trying to juggle hypertension, a sprained ankle, diabetes, and complex social situations simultaneously with identifying appropriate candidates for osteoporosis screening and considering numerous other screening guidelines.”

The Women’s Health Initiative is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The study authors reported relationships with multiple companies, including Amgen, Pfizer, Bayer, Mithra, Norton Rose Fulbright, TherapeuticsMD, AbbVie, Radius, and Allergan. Dr. Camacho reported relationships with Amgen and Shire. Dr. Lewiecki reported relationships with Amgen, Radius Health, Alexion, Samsung Bioepis, Sandoz, Mereo, and Bindex.

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

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A doctor conquers his demons

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Tue, 08/18/2020 - 08:23

Adam B. Hill, MD, is home on a “staycation” this week. Today, he took a 3-hour nap. I know this because I follow Dr. Hill on Twitter, where he has an active feed, a lot of posts, retweets, and more than 20,000 followers.

I also know from Twitter that he is married and has three young children, that he was once suicidal, and has been treated for major depression and alcoholism. As a palliative care doctor, Dr. Hill was required by his state medical board to blow into a breathalyzer several times a day for 5 years – something he felt quite shamed by – and while I’ve never met him, I felt just a little bit proud of this stranger when he was released from the medical board’s oversight.

Dr. Hill’s memoir, “Long Walk Out of the Woods: A Physician’s Story of Addiction, Depression, Hope, and Recovery” (Central Recovery Press, 2019) is the culmination of his efforts to use his difficulties as a way of offering hope and connection to anyone who struggled as he has, or to anyone who has struggled at all. Like his Twitter feed, it is a display of vulnerability and gratitude by someone who has been through dark times then returned to conquer his monsters.

Courtesy Central Recovery Press

He begins by setting the stage for us. “My name is Adam,” he announces in the preface. He tells us his various titles: human being, husband, father, physician, recovering alcoholic, and psychiatric patient. “In the midst of these struggles, working in modern medicine fractured my identity, stole my authenticity, and left me a shell of the person I wanted to be.”

We learn that he tried to buy a gun, but there was a waiting period and he could not purchase the firearm. Instead, he walked into the woods to drink himself to death, with sleeping pills as an add-on – obviously, he didn’t die, and his journey back from his failed suicidal mission is the meat of the book.

Dr. Hill was a quiet and timid child, and he was bullied at school in a way that has lingered on. He struggles with perfectionism and with a sense of never quite belonging. He was a good student, and later a competitive tennis player who was destined for a regional competition until he broke his ankle after drinking just days before the competition. He did well in college, felt more accepted, and went on to medical school after getting in from the wait list. He went on to do a pediatrics residency, and he and his wife moved from Indiana to North Carolina so he could do a hematology oncology fellowship. It was toward the end of his 2-year fellowship when he tried to purchase a gun, then walked into those woods.

His wife called, asked him to come to dinner, and he left the woods before he’d overdosed. After a meeting with his wife, parents, and sister, he returned to psychiatric care, restarted antidepressants, went to Alcoholics Anonymous, and told his employer that he had a problem. This admission started a distressing series of events, including years of being monitored by state medical boards and being labeled an “impaired physician.”

This is the only thing I didn’t like about Dr. Hill’s memoir: As open as he is about his emotional life, there were pieces missing with respect to what actually happened. At this point, I was befuddled as to why he self-reported his difficulties, and it wasn’t until he talked about starting a second fellowship in palliative care in his home state of Indiana that I could fill in some missing pieces. Dr. Hill and his wife purchased a house, and in November, he started his fellowship. The timing was off from the usual start in July, and I realized that perhaps he had gone to an inpatient setting for a number of months – his disclosure to his employer was voluntary, but his treatment likely interfered with his training and couldn’t be hidden. What else transpired he hints at: bottles hidden, driving while intoxicated, a nurse who gave him IV hydration when he came to work with a hangover.

From here, Dr. Hill’s story becomes every doctor’s nightmare. Settled into his new house and weeks into his fellowship, he is called in and fired: His application for a medical license in Indiana has been denied because of his addiction history. He met with a friend of his father’s who worked in a large pediatrics practice. The meeting went well, but the group felt he was too much of a malpractice risk.

He now needs to pay his mortgage and student loans, so he takes a position in Oklahoma with the Indian Health Service. He’s 700 miles from home, living alone in a hotel room, feeling like the work is beneath him, and the chapter is titled “Exile.” His new boss greets him with, “Listen, we all had our own stories that led us here.” Surprisingly, he likes the work and feels supported. If only it weren’t for all that loneliness, and not surprisingly, he relapses despite the mandated breathalyzer. Six beers later, and Dr. Hill is off to Chicago for a rehab program, then back to Oklahoma to finish off his stint.

What happens next is the second time I wondered about the plot of his life: Through “connections and concession,” he returns to Indiana for the palliative care fellowship, and goes on to work at Riley Children’s Hospital.

Dr. Adam B. Hill

When a colleague unexpectedly dies from suicide, Dr. Hill tells others that he, too, once entertained suicidal thoughts. The story from here gets better and better: He uses his history of addiction and depression to help others – patients, their parents, and other medical professionals – to conquer their shame, to share their stories, to feel less alone. He and his wife become parents, he remains sober and healthy, and therapy leads him to a place of self-discovery and success.

Intertwined with telling his story, Dr. Hill takes on some of the institutional issues surrounding addiction and mental illness. He feels shamed and punished by the state medical board that mandates the terms of his medical license. Any physician who reads this book will think twice about revealing a diagnosis of depression or substance use disorder. It’s not a new idea that to protect the public, medical boards should ask about current impairments, not a past history or conditions that have been successfully treated. They should encourage treatment, not punish those who seek care.

Dr. Hill writes about how helpful it has been to allow himself to be vulnerable in the aftermath:


In my experience, the more vulnerability I show, the more opportunities I have to connect to other people. I learned the hard way that when I hide my true self from others, I spiral toward shame. Conversely, when I bury my shame, I begin to accept myself as a beautifully flawed human being, and my perspective on the world reflects that. A turn of the vulnerability dial has opened up connections to other people, while turning away pity, judgment, fear, and shame. Meanwhile, when I am to create spaces for vulnerability, permission is granted to have open and honest conversations about mental health conditions on a larger scale. But I would never have learned these lessons without having been humbled by this disease.


Perhaps the thing I liked best about Dr. Hill’s memoir is that he proposes some solutions. He talks about the importance of fighting stigma, how he finds it everywhere, and how the medical field equates mental illnesses with weakness, thereby perpetuating a self-deprecating cycle in those who have them.

Dr. Dinah Miller


In palliative care, there is an acronym – SPIKES (Set up, Perception, Invitation, Knowledge, Explore emotions, and Summary) that provides guidelines for how to deliver bad news to a family. Dr. Hill suggests using this format to discuss mental health and addictions with patients, colleagues, students. He talks about having “Compassion Rounds” to provide a safe space for his colleagues to talk about their emotional reactions to treating very ill children. And he talks about providing mental health care for trainees as an “opt out” – he schedules all his residents for a counseling session – they can cancel without repercussion, but this serves to “normalize” seeking care. I love the idea that each resident might have someone they’ve met with at least once whom they can call if the going gets rough. “As a result,” Dr. Hill writes, “once secretive conversations about attending counseling happen openly, and the physicians actually feel more comfortable going.”

Adam Hill’s memoir is short, it’s an engaging read, his openness is refreshing, and his plea to let doctors be human beings with human problems is so needed in medicine today. Thank you, Adam.
 

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

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Adam B. Hill, MD, is home on a “staycation” this week. Today, he took a 3-hour nap. I know this because I follow Dr. Hill on Twitter, where he has an active feed, a lot of posts, retweets, and more than 20,000 followers.

I also know from Twitter that he is married and has three young children, that he was once suicidal, and has been treated for major depression and alcoholism. As a palliative care doctor, Dr. Hill was required by his state medical board to blow into a breathalyzer several times a day for 5 years – something he felt quite shamed by – and while I’ve never met him, I felt just a little bit proud of this stranger when he was released from the medical board’s oversight.

Dr. Hill’s memoir, “Long Walk Out of the Woods: A Physician’s Story of Addiction, Depression, Hope, and Recovery” (Central Recovery Press, 2019) is the culmination of his efforts to use his difficulties as a way of offering hope and connection to anyone who struggled as he has, or to anyone who has struggled at all. Like his Twitter feed, it is a display of vulnerability and gratitude by someone who has been through dark times then returned to conquer his monsters.

Courtesy Central Recovery Press

He begins by setting the stage for us. “My name is Adam,” he announces in the preface. He tells us his various titles: human being, husband, father, physician, recovering alcoholic, and psychiatric patient. “In the midst of these struggles, working in modern medicine fractured my identity, stole my authenticity, and left me a shell of the person I wanted to be.”

We learn that he tried to buy a gun, but there was a waiting period and he could not purchase the firearm. Instead, he walked into the woods to drink himself to death, with sleeping pills as an add-on – obviously, he didn’t die, and his journey back from his failed suicidal mission is the meat of the book.

Dr. Hill was a quiet and timid child, and he was bullied at school in a way that has lingered on. He struggles with perfectionism and with a sense of never quite belonging. He was a good student, and later a competitive tennis player who was destined for a regional competition until he broke his ankle after drinking just days before the competition. He did well in college, felt more accepted, and went on to medical school after getting in from the wait list. He went on to do a pediatrics residency, and he and his wife moved from Indiana to North Carolina so he could do a hematology oncology fellowship. It was toward the end of his 2-year fellowship when he tried to purchase a gun, then walked into those woods.

His wife called, asked him to come to dinner, and he left the woods before he’d overdosed. After a meeting with his wife, parents, and sister, he returned to psychiatric care, restarted antidepressants, went to Alcoholics Anonymous, and told his employer that he had a problem. This admission started a distressing series of events, including years of being monitored by state medical boards and being labeled an “impaired physician.”

This is the only thing I didn’t like about Dr. Hill’s memoir: As open as he is about his emotional life, there were pieces missing with respect to what actually happened. At this point, I was befuddled as to why he self-reported his difficulties, and it wasn’t until he talked about starting a second fellowship in palliative care in his home state of Indiana that I could fill in some missing pieces. Dr. Hill and his wife purchased a house, and in November, he started his fellowship. The timing was off from the usual start in July, and I realized that perhaps he had gone to an inpatient setting for a number of months – his disclosure to his employer was voluntary, but his treatment likely interfered with his training and couldn’t be hidden. What else transpired he hints at: bottles hidden, driving while intoxicated, a nurse who gave him IV hydration when he came to work with a hangover.

From here, Dr. Hill’s story becomes every doctor’s nightmare. Settled into his new house and weeks into his fellowship, he is called in and fired: His application for a medical license in Indiana has been denied because of his addiction history. He met with a friend of his father’s who worked in a large pediatrics practice. The meeting went well, but the group felt he was too much of a malpractice risk.

He now needs to pay his mortgage and student loans, so he takes a position in Oklahoma with the Indian Health Service. He’s 700 miles from home, living alone in a hotel room, feeling like the work is beneath him, and the chapter is titled “Exile.” His new boss greets him with, “Listen, we all had our own stories that led us here.” Surprisingly, he likes the work and feels supported. If only it weren’t for all that loneliness, and not surprisingly, he relapses despite the mandated breathalyzer. Six beers later, and Dr. Hill is off to Chicago for a rehab program, then back to Oklahoma to finish off his stint.

What happens next is the second time I wondered about the plot of his life: Through “connections and concession,” he returns to Indiana for the palliative care fellowship, and goes on to work at Riley Children’s Hospital.

Dr. Adam B. Hill

When a colleague unexpectedly dies from suicide, Dr. Hill tells others that he, too, once entertained suicidal thoughts. The story from here gets better and better: He uses his history of addiction and depression to help others – patients, their parents, and other medical professionals – to conquer their shame, to share their stories, to feel less alone. He and his wife become parents, he remains sober and healthy, and therapy leads him to a place of self-discovery and success.

Intertwined with telling his story, Dr. Hill takes on some of the institutional issues surrounding addiction and mental illness. He feels shamed and punished by the state medical board that mandates the terms of his medical license. Any physician who reads this book will think twice about revealing a diagnosis of depression or substance use disorder. It’s not a new idea that to protect the public, medical boards should ask about current impairments, not a past history or conditions that have been successfully treated. They should encourage treatment, not punish those who seek care.

Dr. Hill writes about how helpful it has been to allow himself to be vulnerable in the aftermath:


In my experience, the more vulnerability I show, the more opportunities I have to connect to other people. I learned the hard way that when I hide my true self from others, I spiral toward shame. Conversely, when I bury my shame, I begin to accept myself as a beautifully flawed human being, and my perspective on the world reflects that. A turn of the vulnerability dial has opened up connections to other people, while turning away pity, judgment, fear, and shame. Meanwhile, when I am to create spaces for vulnerability, permission is granted to have open and honest conversations about mental health conditions on a larger scale. But I would never have learned these lessons without having been humbled by this disease.


Perhaps the thing I liked best about Dr. Hill’s memoir is that he proposes some solutions. He talks about the importance of fighting stigma, how he finds it everywhere, and how the medical field equates mental illnesses with weakness, thereby perpetuating a self-deprecating cycle in those who have them.

Dr. Dinah Miller


In palliative care, there is an acronym – SPIKES (Set up, Perception, Invitation, Knowledge, Explore emotions, and Summary) that provides guidelines for how to deliver bad news to a family. Dr. Hill suggests using this format to discuss mental health and addictions with patients, colleagues, students. He talks about having “Compassion Rounds” to provide a safe space for his colleagues to talk about their emotional reactions to treating very ill children. And he talks about providing mental health care for trainees as an “opt out” – he schedules all his residents for a counseling session – they can cancel without repercussion, but this serves to “normalize” seeking care. I love the idea that each resident might have someone they’ve met with at least once whom they can call if the going gets rough. “As a result,” Dr. Hill writes, “once secretive conversations about attending counseling happen openly, and the physicians actually feel more comfortable going.”

Adam Hill’s memoir is short, it’s an engaging read, his openness is refreshing, and his plea to let doctors be human beings with human problems is so needed in medicine today. Thank you, Adam.
 

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

Adam B. Hill, MD, is home on a “staycation” this week. Today, he took a 3-hour nap. I know this because I follow Dr. Hill on Twitter, where he has an active feed, a lot of posts, retweets, and more than 20,000 followers.

I also know from Twitter that he is married and has three young children, that he was once suicidal, and has been treated for major depression and alcoholism. As a palliative care doctor, Dr. Hill was required by his state medical board to blow into a breathalyzer several times a day for 5 years – something he felt quite shamed by – and while I’ve never met him, I felt just a little bit proud of this stranger when he was released from the medical board’s oversight.

Dr. Hill’s memoir, “Long Walk Out of the Woods: A Physician’s Story of Addiction, Depression, Hope, and Recovery” (Central Recovery Press, 2019) is the culmination of his efforts to use his difficulties as a way of offering hope and connection to anyone who struggled as he has, or to anyone who has struggled at all. Like his Twitter feed, it is a display of vulnerability and gratitude by someone who has been through dark times then returned to conquer his monsters.

Courtesy Central Recovery Press

He begins by setting the stage for us. “My name is Adam,” he announces in the preface. He tells us his various titles: human being, husband, father, physician, recovering alcoholic, and psychiatric patient. “In the midst of these struggles, working in modern medicine fractured my identity, stole my authenticity, and left me a shell of the person I wanted to be.”

We learn that he tried to buy a gun, but there was a waiting period and he could not purchase the firearm. Instead, he walked into the woods to drink himself to death, with sleeping pills as an add-on – obviously, he didn’t die, and his journey back from his failed suicidal mission is the meat of the book.

Dr. Hill was a quiet and timid child, and he was bullied at school in a way that has lingered on. He struggles with perfectionism and with a sense of never quite belonging. He was a good student, and later a competitive tennis player who was destined for a regional competition until he broke his ankle after drinking just days before the competition. He did well in college, felt more accepted, and went on to medical school after getting in from the wait list. He went on to do a pediatrics residency, and he and his wife moved from Indiana to North Carolina so he could do a hematology oncology fellowship. It was toward the end of his 2-year fellowship when he tried to purchase a gun, then walked into those woods.

His wife called, asked him to come to dinner, and he left the woods before he’d overdosed. After a meeting with his wife, parents, and sister, he returned to psychiatric care, restarted antidepressants, went to Alcoholics Anonymous, and told his employer that he had a problem. This admission started a distressing series of events, including years of being monitored by state medical boards and being labeled an “impaired physician.”

This is the only thing I didn’t like about Dr. Hill’s memoir: As open as he is about his emotional life, there were pieces missing with respect to what actually happened. At this point, I was befuddled as to why he self-reported his difficulties, and it wasn’t until he talked about starting a second fellowship in palliative care in his home state of Indiana that I could fill in some missing pieces. Dr. Hill and his wife purchased a house, and in November, he started his fellowship. The timing was off from the usual start in July, and I realized that perhaps he had gone to an inpatient setting for a number of months – his disclosure to his employer was voluntary, but his treatment likely interfered with his training and couldn’t be hidden. What else transpired he hints at: bottles hidden, driving while intoxicated, a nurse who gave him IV hydration when he came to work with a hangover.

From here, Dr. Hill’s story becomes every doctor’s nightmare. Settled into his new house and weeks into his fellowship, he is called in and fired: His application for a medical license in Indiana has been denied because of his addiction history. He met with a friend of his father’s who worked in a large pediatrics practice. The meeting went well, but the group felt he was too much of a malpractice risk.

He now needs to pay his mortgage and student loans, so he takes a position in Oklahoma with the Indian Health Service. He’s 700 miles from home, living alone in a hotel room, feeling like the work is beneath him, and the chapter is titled “Exile.” His new boss greets him with, “Listen, we all had our own stories that led us here.” Surprisingly, he likes the work and feels supported. If only it weren’t for all that loneliness, and not surprisingly, he relapses despite the mandated breathalyzer. Six beers later, and Dr. Hill is off to Chicago for a rehab program, then back to Oklahoma to finish off his stint.

What happens next is the second time I wondered about the plot of his life: Through “connections and concession,” he returns to Indiana for the palliative care fellowship, and goes on to work at Riley Children’s Hospital.

Dr. Adam B. Hill

When a colleague unexpectedly dies from suicide, Dr. Hill tells others that he, too, once entertained suicidal thoughts. The story from here gets better and better: He uses his history of addiction and depression to help others – patients, their parents, and other medical professionals – to conquer their shame, to share their stories, to feel less alone. He and his wife become parents, he remains sober and healthy, and therapy leads him to a place of self-discovery and success.

Intertwined with telling his story, Dr. Hill takes on some of the institutional issues surrounding addiction and mental illness. He feels shamed and punished by the state medical board that mandates the terms of his medical license. Any physician who reads this book will think twice about revealing a diagnosis of depression or substance use disorder. It’s not a new idea that to protect the public, medical boards should ask about current impairments, not a past history or conditions that have been successfully treated. They should encourage treatment, not punish those who seek care.

Dr. Hill writes about how helpful it has been to allow himself to be vulnerable in the aftermath:


In my experience, the more vulnerability I show, the more opportunities I have to connect to other people. I learned the hard way that when I hide my true self from others, I spiral toward shame. Conversely, when I bury my shame, I begin to accept myself as a beautifully flawed human being, and my perspective on the world reflects that. A turn of the vulnerability dial has opened up connections to other people, while turning away pity, judgment, fear, and shame. Meanwhile, when I am to create spaces for vulnerability, permission is granted to have open and honest conversations about mental health conditions on a larger scale. But I would never have learned these lessons without having been humbled by this disease.


Perhaps the thing I liked best about Dr. Hill’s memoir is that he proposes some solutions. He talks about the importance of fighting stigma, how he finds it everywhere, and how the medical field equates mental illnesses with weakness, thereby perpetuating a self-deprecating cycle in those who have them.

Dr. Dinah Miller


In palliative care, there is an acronym – SPIKES (Set up, Perception, Invitation, Knowledge, Explore emotions, and Summary) that provides guidelines for how to deliver bad news to a family. Dr. Hill suggests using this format to discuss mental health and addictions with patients, colleagues, students. He talks about having “Compassion Rounds” to provide a safe space for his colleagues to talk about their emotional reactions to treating very ill children. And he talks about providing mental health care for trainees as an “opt out” – he schedules all his residents for a counseling session – they can cancel without repercussion, but this serves to “normalize” seeking care. I love the idea that each resident might have someone they’ve met with at least once whom they can call if the going gets rough. “As a result,” Dr. Hill writes, “once secretive conversations about attending counseling happen openly, and the physicians actually feel more comfortable going.”

Adam Hill’s memoir is short, it’s an engaging read, his openness is refreshing, and his plea to let doctors be human beings with human problems is so needed in medicine today. Thank you, Adam.
 

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

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Model identified heavy drinkers at highest risk of ALD progression

Real knowledge may bring behavioral change
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Tue, 08/04/2020 - 14:28

In heavy drinkers with alcohol-related liver disease, a Markov model based on age, sex, body mass index, and duration and extent of alcohol use predicted risk for disease progression, researchers reported in Clinical Gastroenterology and Hepatology.

The study included 2,334 hospitalized adults with consistently abnormal liver test results who had consumed at least 50 grams of alcohol (about 3.5-4 drinks) per day for the previous 5 years. The model was developed using data from 1,599 individuals with baseline liver biopsies and validated in 735 individuals with no baseline liver biopsies but available data on the presence or absence of hepatic decompensation.

For a 40-year-old man with F0-F2 fibrosis who had been drinking alcohol for 15 years, who drank 150 grams of alcohol daily, and who had a body mass index (BMI) of 22 kg/m2, the model predicted a 31.8% likelihood of having a normal liver at baseline, a 61.5% probability of baseline steatosis, and a 6.7% probability of baseline steatohepatitis. In women with the same baseline variables, respective probabilities were 25.1%, 66.5%, and 8.4%. Based on these findings, the 5-year weighted risk for liver complications ranged from 0.2% for men with normal initial liver findings to 10.3% for men with baseline steatohepatitis. Among women, the corresponding risk estimates ranged from 0.5% to 14.7%, wrote PhD student Claire Delacôte of Centre Hospitalier Universitaire de Lille (France), and associates.

“This tool might be used by general practitioners or hepatologists to identify heavy drinkers at high risk for alcohol-related liver disease progression,” the investigators added. “This model might be used to adapt patient care pathways.”

The patients in this study were admitted to the hepatogastroenterology unit of a French hospital between 1982 and 1997. The Markov model incorporated seven stages of alcohol-related liver disease: normal liver (no fibrosis or steatosis), steatosis and F0-F2 fibrosis, alcohol-induced steatohepatitis and F0-F2 fibrosis, steatosis and F3-F4 fibrosis, alcohol-induced steatohepatitis and F3-F4 fibrosis, liver complications without steatohepatitis, and liver complications with alcohol-induced steatohepatitis. Liver complications were defined as hepatocellular carcinoma or liver decompensation (bilirubin >50 mmol/L, gastrointestinal hemorrhage, or ascites). Risk for progressing to liver complications was based on METAVIR score and onset of alcohol-induced steatohepatitis.

The researchers also looked specifically at F3-F4 (severe) fibrosis because of its clinical significance and common use as a study endpoint. Among 40-year-olds with a 15-year history of heavy drinking, the estimated prevalence of alcohol-induced steatohepatitis was 30.0% for men and 33.3% for women. The 5-year risk for liver complications was higher in women (30.1%) than men (24.5%) and was highest among women with baseline alcohol-induced steatohepatitis (41.0%). Overall, women had a 24.8% greater risk for disease progression than men (hazard ratio, 1.248).

Risk for liver complications also increased with age, and each 1-year increase in age at the beginning of heavy drinking heightened the risk for disease progression by 3.8%, regardless of stage of liver disease. “Based on these predictions, 50-year-old women are a high-risk subgroup of [alcohol-related liver] disease progression and should receive close follow-up,” the researchers wrote.

In addition, obese individuals (BMI, 30) had an 11.8% greater risk for progression of alcohol-related liver disease, compared with those with a BMI of 22. Consuming an additional 10 grams of alcohol per day had less impact on risk, the researchers noted.

“If patients are identified as being heavy drinkers by the general practitioner with no evaluation of fibrosis, these patients should be referred to a hepatologist. Nevertheless, we think that the threshold defining the high-risk population, which has been arbitrarily fixed at 5%, should be discussed by experts because it affects the patient’s care pathway. An online application is being developed to help clinicians and general practitioners in their daily practice,” they wrote.

No funding sources were reported. Ms. Delacôte reported having no conflicts of interest. Three coinvestigators disclosed ties to AbbVie, Bayer Healthcare, Eisai, Gilead, MSD, Novartis, Sanofi, and Servier. The others reported having no conflicts.
 

SOURCE: Delacôte C et al. Clin Gastroenterol Hepatol. 2020 Jan 11. doi: 10.1016/j.cgh.2019.12.041.
 

Body

 

In the life of a hepatologist few things are as gratifying as when a patient with alcohol-related liver disease (ALD) quits drinking. Though we wish this were the norm, ALD is both increasingly common and morbid. Tools to connect with and empower real change in our patients with ALD are urgently needed. Unfortunately, our toolbox is somewhat bare.

Dr. Elliot Tapper
To improve, we must become accustomed to (and partner with experts in) the care of substance use disorder. We must learn to maximize the impact of our counseling on our patients. Behavioral interventions for ALD require goal-setting and self-regulation and both depend on the patient’s outcome expectations. All would be immeasurably strengthened with concrete prognostic data.

This is why the Delacôte study is important. The authors create a multistate model with inputs from cohorts of patients with biopsy-proven and staged ALD. The result is a specific 5-year risk of cirrhotic decompensation or hepatocellular carcinoma tailored to the patient’s age, sex, body mass index, alcohol use duration, and liver histology. Although this model’s estimates have confidence intervals and their generalizability would be improved if histology were replaced with noninvasive indices, these data are amongst the most tangible illustrations of risk available for patient-doctor deliberations.

Knowledge, when communicated effectively, is the cornerstone of behavioral change. Translating the abstract concept of progressive ALD into personalized, modifiable risks is a leap forward. We have a new tool, let’s use it.

Elliot B. Tapper, MD, is an assistant professor in gastroenterology and internal medicine at Michigan Medicine, Ann Arbor. He has no conflicts of interest.

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In the life of a hepatologist few things are as gratifying as when a patient with alcohol-related liver disease (ALD) quits drinking. Though we wish this were the norm, ALD is both increasingly common and morbid. Tools to connect with and empower real change in our patients with ALD are urgently needed. Unfortunately, our toolbox is somewhat bare.

Dr. Elliot Tapper
To improve, we must become accustomed to (and partner with experts in) the care of substance use disorder. We must learn to maximize the impact of our counseling on our patients. Behavioral interventions for ALD require goal-setting and self-regulation and both depend on the patient’s outcome expectations. All would be immeasurably strengthened with concrete prognostic data.

This is why the Delacôte study is important. The authors create a multistate model with inputs from cohorts of patients with biopsy-proven and staged ALD. The result is a specific 5-year risk of cirrhotic decompensation or hepatocellular carcinoma tailored to the patient’s age, sex, body mass index, alcohol use duration, and liver histology. Although this model’s estimates have confidence intervals and their generalizability would be improved if histology were replaced with noninvasive indices, these data are amongst the most tangible illustrations of risk available for patient-doctor deliberations.

Knowledge, when communicated effectively, is the cornerstone of behavioral change. Translating the abstract concept of progressive ALD into personalized, modifiable risks is a leap forward. We have a new tool, let’s use it.

Elliot B. Tapper, MD, is an assistant professor in gastroenterology and internal medicine at Michigan Medicine, Ann Arbor. He has no conflicts of interest.

Body

 

In the life of a hepatologist few things are as gratifying as when a patient with alcohol-related liver disease (ALD) quits drinking. Though we wish this were the norm, ALD is both increasingly common and morbid. Tools to connect with and empower real change in our patients with ALD are urgently needed. Unfortunately, our toolbox is somewhat bare.

Dr. Elliot Tapper
To improve, we must become accustomed to (and partner with experts in) the care of substance use disorder. We must learn to maximize the impact of our counseling on our patients. Behavioral interventions for ALD require goal-setting and self-regulation and both depend on the patient’s outcome expectations. All would be immeasurably strengthened with concrete prognostic data.

This is why the Delacôte study is important. The authors create a multistate model with inputs from cohorts of patients with biopsy-proven and staged ALD. The result is a specific 5-year risk of cirrhotic decompensation or hepatocellular carcinoma tailored to the patient’s age, sex, body mass index, alcohol use duration, and liver histology. Although this model’s estimates have confidence intervals and their generalizability would be improved if histology were replaced with noninvasive indices, these data are amongst the most tangible illustrations of risk available for patient-doctor deliberations.

Knowledge, when communicated effectively, is the cornerstone of behavioral change. Translating the abstract concept of progressive ALD into personalized, modifiable risks is a leap forward. We have a new tool, let’s use it.

Elliot B. Tapper, MD, is an assistant professor in gastroenterology and internal medicine at Michigan Medicine, Ann Arbor. He has no conflicts of interest.

Title
Real knowledge may bring behavioral change
Real knowledge may bring behavioral change

In heavy drinkers with alcohol-related liver disease, a Markov model based on age, sex, body mass index, and duration and extent of alcohol use predicted risk for disease progression, researchers reported in Clinical Gastroenterology and Hepatology.

The study included 2,334 hospitalized adults with consistently abnormal liver test results who had consumed at least 50 grams of alcohol (about 3.5-4 drinks) per day for the previous 5 years. The model was developed using data from 1,599 individuals with baseline liver biopsies and validated in 735 individuals with no baseline liver biopsies but available data on the presence or absence of hepatic decompensation.

For a 40-year-old man with F0-F2 fibrosis who had been drinking alcohol for 15 years, who drank 150 grams of alcohol daily, and who had a body mass index (BMI) of 22 kg/m2, the model predicted a 31.8% likelihood of having a normal liver at baseline, a 61.5% probability of baseline steatosis, and a 6.7% probability of baseline steatohepatitis. In women with the same baseline variables, respective probabilities were 25.1%, 66.5%, and 8.4%. Based on these findings, the 5-year weighted risk for liver complications ranged from 0.2% for men with normal initial liver findings to 10.3% for men with baseline steatohepatitis. Among women, the corresponding risk estimates ranged from 0.5% to 14.7%, wrote PhD student Claire Delacôte of Centre Hospitalier Universitaire de Lille (France), and associates.

“This tool might be used by general practitioners or hepatologists to identify heavy drinkers at high risk for alcohol-related liver disease progression,” the investigators added. “This model might be used to adapt patient care pathways.”

The patients in this study were admitted to the hepatogastroenterology unit of a French hospital between 1982 and 1997. The Markov model incorporated seven stages of alcohol-related liver disease: normal liver (no fibrosis or steatosis), steatosis and F0-F2 fibrosis, alcohol-induced steatohepatitis and F0-F2 fibrosis, steatosis and F3-F4 fibrosis, alcohol-induced steatohepatitis and F3-F4 fibrosis, liver complications without steatohepatitis, and liver complications with alcohol-induced steatohepatitis. Liver complications were defined as hepatocellular carcinoma or liver decompensation (bilirubin >50 mmol/L, gastrointestinal hemorrhage, or ascites). Risk for progressing to liver complications was based on METAVIR score and onset of alcohol-induced steatohepatitis.

The researchers also looked specifically at F3-F4 (severe) fibrosis because of its clinical significance and common use as a study endpoint. Among 40-year-olds with a 15-year history of heavy drinking, the estimated prevalence of alcohol-induced steatohepatitis was 30.0% for men and 33.3% for women. The 5-year risk for liver complications was higher in women (30.1%) than men (24.5%) and was highest among women with baseline alcohol-induced steatohepatitis (41.0%). Overall, women had a 24.8% greater risk for disease progression than men (hazard ratio, 1.248).

Risk for liver complications also increased with age, and each 1-year increase in age at the beginning of heavy drinking heightened the risk for disease progression by 3.8%, regardless of stage of liver disease. “Based on these predictions, 50-year-old women are a high-risk subgroup of [alcohol-related liver] disease progression and should receive close follow-up,” the researchers wrote.

In addition, obese individuals (BMI, 30) had an 11.8% greater risk for progression of alcohol-related liver disease, compared with those with a BMI of 22. Consuming an additional 10 grams of alcohol per day had less impact on risk, the researchers noted.

“If patients are identified as being heavy drinkers by the general practitioner with no evaluation of fibrosis, these patients should be referred to a hepatologist. Nevertheless, we think that the threshold defining the high-risk population, which has been arbitrarily fixed at 5%, should be discussed by experts because it affects the patient’s care pathway. An online application is being developed to help clinicians and general practitioners in their daily practice,” they wrote.

No funding sources were reported. Ms. Delacôte reported having no conflicts of interest. Three coinvestigators disclosed ties to AbbVie, Bayer Healthcare, Eisai, Gilead, MSD, Novartis, Sanofi, and Servier. The others reported having no conflicts.
 

SOURCE: Delacôte C et al. Clin Gastroenterol Hepatol. 2020 Jan 11. doi: 10.1016/j.cgh.2019.12.041.
 

In heavy drinkers with alcohol-related liver disease, a Markov model based on age, sex, body mass index, and duration and extent of alcohol use predicted risk for disease progression, researchers reported in Clinical Gastroenterology and Hepatology.

The study included 2,334 hospitalized adults with consistently abnormal liver test results who had consumed at least 50 grams of alcohol (about 3.5-4 drinks) per day for the previous 5 years. The model was developed using data from 1,599 individuals with baseline liver biopsies and validated in 735 individuals with no baseline liver biopsies but available data on the presence or absence of hepatic decompensation.

For a 40-year-old man with F0-F2 fibrosis who had been drinking alcohol for 15 years, who drank 150 grams of alcohol daily, and who had a body mass index (BMI) of 22 kg/m2, the model predicted a 31.8% likelihood of having a normal liver at baseline, a 61.5% probability of baseline steatosis, and a 6.7% probability of baseline steatohepatitis. In women with the same baseline variables, respective probabilities were 25.1%, 66.5%, and 8.4%. Based on these findings, the 5-year weighted risk for liver complications ranged from 0.2% for men with normal initial liver findings to 10.3% for men with baseline steatohepatitis. Among women, the corresponding risk estimates ranged from 0.5% to 14.7%, wrote PhD student Claire Delacôte of Centre Hospitalier Universitaire de Lille (France), and associates.

“This tool might be used by general practitioners or hepatologists to identify heavy drinkers at high risk for alcohol-related liver disease progression,” the investigators added. “This model might be used to adapt patient care pathways.”

The patients in this study were admitted to the hepatogastroenterology unit of a French hospital between 1982 and 1997. The Markov model incorporated seven stages of alcohol-related liver disease: normal liver (no fibrosis or steatosis), steatosis and F0-F2 fibrosis, alcohol-induced steatohepatitis and F0-F2 fibrosis, steatosis and F3-F4 fibrosis, alcohol-induced steatohepatitis and F3-F4 fibrosis, liver complications without steatohepatitis, and liver complications with alcohol-induced steatohepatitis. Liver complications were defined as hepatocellular carcinoma or liver decompensation (bilirubin >50 mmol/L, gastrointestinal hemorrhage, or ascites). Risk for progressing to liver complications was based on METAVIR score and onset of alcohol-induced steatohepatitis.

The researchers also looked specifically at F3-F4 (severe) fibrosis because of its clinical significance and common use as a study endpoint. Among 40-year-olds with a 15-year history of heavy drinking, the estimated prevalence of alcohol-induced steatohepatitis was 30.0% for men and 33.3% for women. The 5-year risk for liver complications was higher in women (30.1%) than men (24.5%) and was highest among women with baseline alcohol-induced steatohepatitis (41.0%). Overall, women had a 24.8% greater risk for disease progression than men (hazard ratio, 1.248).

Risk for liver complications also increased with age, and each 1-year increase in age at the beginning of heavy drinking heightened the risk for disease progression by 3.8%, regardless of stage of liver disease. “Based on these predictions, 50-year-old women are a high-risk subgroup of [alcohol-related liver] disease progression and should receive close follow-up,” the researchers wrote.

In addition, obese individuals (BMI, 30) had an 11.8% greater risk for progression of alcohol-related liver disease, compared with those with a BMI of 22. Consuming an additional 10 grams of alcohol per day had less impact on risk, the researchers noted.

“If patients are identified as being heavy drinkers by the general practitioner with no evaluation of fibrosis, these patients should be referred to a hepatologist. Nevertheless, we think that the threshold defining the high-risk population, which has been arbitrarily fixed at 5%, should be discussed by experts because it affects the patient’s care pathway. An online application is being developed to help clinicians and general practitioners in their daily practice,” they wrote.

No funding sources were reported. Ms. Delacôte reported having no conflicts of interest. Three coinvestigators disclosed ties to AbbVie, Bayer Healthcare, Eisai, Gilead, MSD, Novartis, Sanofi, and Servier. The others reported having no conflicts.
 

SOURCE: Delacôte C et al. Clin Gastroenterol Hepatol. 2020 Jan 11. doi: 10.1016/j.cgh.2019.12.041.
 

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Switching to low-inflammatory diet linked to lower risk for Crohn’s disease

Diet promotes Crohn’s disease through inflammation
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Thu, 08/06/2020 - 08:13

Among adults who consumed a proinflammatory diet, switching to a diet with lower inflammatory potential was associated with a significant subsequent decrease in risk for Crohn’s disease, according to a study of three longitudinal observational cohorts.

Researchers calculated empirical dietary inflammatory pattern (EDIP) scores based on food-frequency questionnaires completed by 166,903 women and 41,931 men who participated in the Nurses’ Health Study, the Nurses’ Health Study II, and the Health Professionals Follow-up Study. Questionnaires were completed at two time points, separated by 8 years. Overall, adults whose cumulative average EDIP scores fell within the highest quartile – meaning their diets had the highest inflammatory potential – were at 51% greater risk for developing Crohn’s disease than were adults whose diets fell within the lowest EDIP quartile (hazard ratio, 1.51; 95% confidence interval, 1.19-2.07; P = .01).

Strikingly, however, adults who initially consumed a proinflammatory diet (which is high in calories, red meat, high-fat dairy, and refined grains) and then switched to a low-inflammatory diet (one based around fruit, vegetables, legumes, whole grains, fish, and lean protein) had a statistically similar risk for Crohn’s disease as adults who consumed a low-inflammatory diet at both time points. The 95% confidence interval for the hazard ratio crossed 1.0 (HR, 1.51; 95% CI, 0.76-3.00). In contrast, adults who initially consumed a low-inflammatory diet and later changed to a proinflammatory diet were at twofold greater risk for Crohn’s disease than were those who remained on a low-inflammatory diet (HR, 2.05; 95% CI, 1.10-3.79).

These findings accounted for potential confounders, such as age, study cohort, time period, race, smoking, physical activity, and use of oral contraceptives and hormone replacement therapy, wrote Chun-Han Lo, MD, of the Harvard T.H. Chan School of Public Health, Boston, together with his associates in Gastroenterology.

The EDIP score is a weighted sum of 18 food groups that characterizes the potential for dietary inflammation based on circulating concentrations of inflammatory biomarkers. A proinflammatory diet may “trigger the onset of intestinal inflammation by inducing changes in [the] gut microbiome, altering host homeostasis, and regulating T-cell immune response,” the investigators noted.

In this study, which included nearly 5 million person-years of follow-up, 328 individuals were diagnosed with Crohn’s disease and 428 individuals developed ulcerative colitis. Median age at inflammatory bowel disease diagnosis was 55 years, with a range of 29-85 years. Notably, change in EDIP score was not linked to ulcerative colitis risk. Diet may be more relevant in Crohn’s disease than ulcerative colitis, and dietary factors linked to ulcerative colitis were not associated with inflammatory markers in the cohorts and, thus, were not factored into EDIP score, the researchers wrote.

The link between EDIP score and Crohn’s disease in this study did not change after controlling for fiber intake. Red wine (which contains anti-inflammatory resveratrol) might be a protective factor, the researchers hypothesized. They also found that pizza – a processed, calorie-dense food – was significantly inversely linked to inflammatory markers, perhaps because pizza contains abundant lycopene (from tomato paste) and fat (which facilitate lycopene absorption).

Prior studies on diet and inflammatory bowel disease assessed diets at only one time point and categorized dietary habits based on food groups, rather than linking foods with inflammatory markers, the researchers wrote. “Here, by identifying a combination of food groups predictive of circulating markers of inflammation, we provide a more robust evidence base behind the association of these foods with inflammation and inflammatory bowel disease.”

Most study participants were white health professionals. The researchers noted that “studies of dietary risk factors have not revealed a strong ethnicity-specific association, [but] extrapolating our findings to individuals of other ethnicity should be performed with caution.”

The National Institutes of Health, the Beker Foundation, the Chleck Family Foundation, and the Crohn’s and Colitis Foundation provided funding. Three coinvestigators disclosed ties to AbbVie, Bayer Pharma AG, Boehringer Ingelheim, Gilead, Janssen, Kyn Therapeutics, Merck Pfizer, Policy Analysis Inc., and Takeda.

SOURCE: Lo C-H et al. Gastroenterology. 2020 May 1. doi: 10.1053/j.gastro.2020.05.011.
 

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Diet is the single most modifiable risk factor influencing inflammatory bowel disease (IBD) development. Accordingly, animal studies show that specific nutrients and food additives impact gut barrier function and/or microbiota, thereby influencing disease development. However, using these studies to provide humans practical dietary advice has been difficult, in part because effects of isolated food components can be quite different from those of complex foods. The complex nature of human foods has also stymied epidemiologic approaches to determine how diet influences IBD risk. This difficulty is exacerbated by the potential of IBD itself to influence diet, likely beginning long before disease diagnosis.

Dr. Andrew T. Gewirtz
Lo and colleagues surmount these problems by developing the “empirical dietary inflammatory pattern” (EDIP), which is a metric that quantifies the proinflammatory potential of one’s overall diet based on the extent to which its components associate with proinflammatory cytokine levels in a large healthy human cohort. Retrospective application of this metric to three large human cohorts found that consumption of proinflammatory diets increased risk of developing Crohn’s disease but not ulcerative colitis. This indicates, perhaps not surprisingly, that a central means by which diet influences risk of Crohn’s is by promoting inflammation in susceptible hosts. Furthermore, while this approach implicated the usual suspects, such as low-fiber processed foods, in promoting Crohn’s, it also found a protective role for pizza, perhaps reflecting the anti-inflammatory action of its tomato-based components. It should soon be possible for persons with high genetic risk for Crohn’s to use the EDIP to discern how their diet is influencing that risk and, moreover, designing practical strategies to mitigate it.

Andrew T. Gewirtz, PhD, is a professor at Georgia State University’s Institute for Biomedical Sciences, Atlanta. He has no conflicts.

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Diet is the single most modifiable risk factor influencing inflammatory bowel disease (IBD) development. Accordingly, animal studies show that specific nutrients and food additives impact gut barrier function and/or microbiota, thereby influencing disease development. However, using these studies to provide humans practical dietary advice has been difficult, in part because effects of isolated food components can be quite different from those of complex foods. The complex nature of human foods has also stymied epidemiologic approaches to determine how diet influences IBD risk. This difficulty is exacerbated by the potential of IBD itself to influence diet, likely beginning long before disease diagnosis.

Dr. Andrew T. Gewirtz
Lo and colleagues surmount these problems by developing the “empirical dietary inflammatory pattern” (EDIP), which is a metric that quantifies the proinflammatory potential of one’s overall diet based on the extent to which its components associate with proinflammatory cytokine levels in a large healthy human cohort. Retrospective application of this metric to three large human cohorts found that consumption of proinflammatory diets increased risk of developing Crohn’s disease but not ulcerative colitis. This indicates, perhaps not surprisingly, that a central means by which diet influences risk of Crohn’s is by promoting inflammation in susceptible hosts. Furthermore, while this approach implicated the usual suspects, such as low-fiber processed foods, in promoting Crohn’s, it also found a protective role for pizza, perhaps reflecting the anti-inflammatory action of its tomato-based components. It should soon be possible for persons with high genetic risk for Crohn’s to use the EDIP to discern how their diet is influencing that risk and, moreover, designing practical strategies to mitigate it.

Andrew T. Gewirtz, PhD, is a professor at Georgia State University’s Institute for Biomedical Sciences, Atlanta. He has no conflicts.

Body

 

Diet is the single most modifiable risk factor influencing inflammatory bowel disease (IBD) development. Accordingly, animal studies show that specific nutrients and food additives impact gut barrier function and/or microbiota, thereby influencing disease development. However, using these studies to provide humans practical dietary advice has been difficult, in part because effects of isolated food components can be quite different from those of complex foods. The complex nature of human foods has also stymied epidemiologic approaches to determine how diet influences IBD risk. This difficulty is exacerbated by the potential of IBD itself to influence diet, likely beginning long before disease diagnosis.

Dr. Andrew T. Gewirtz
Lo and colleagues surmount these problems by developing the “empirical dietary inflammatory pattern” (EDIP), which is a metric that quantifies the proinflammatory potential of one’s overall diet based on the extent to which its components associate with proinflammatory cytokine levels in a large healthy human cohort. Retrospective application of this metric to three large human cohorts found that consumption of proinflammatory diets increased risk of developing Crohn’s disease but not ulcerative colitis. This indicates, perhaps not surprisingly, that a central means by which diet influences risk of Crohn’s is by promoting inflammation in susceptible hosts. Furthermore, while this approach implicated the usual suspects, such as low-fiber processed foods, in promoting Crohn’s, it also found a protective role for pizza, perhaps reflecting the anti-inflammatory action of its tomato-based components. It should soon be possible for persons with high genetic risk for Crohn’s to use the EDIP to discern how their diet is influencing that risk and, moreover, designing practical strategies to mitigate it.

Andrew T. Gewirtz, PhD, is a professor at Georgia State University’s Institute for Biomedical Sciences, Atlanta. He has no conflicts.

Title
Diet promotes Crohn’s disease through inflammation
Diet promotes Crohn’s disease through inflammation

Among adults who consumed a proinflammatory diet, switching to a diet with lower inflammatory potential was associated with a significant subsequent decrease in risk for Crohn’s disease, according to a study of three longitudinal observational cohorts.

Researchers calculated empirical dietary inflammatory pattern (EDIP) scores based on food-frequency questionnaires completed by 166,903 women and 41,931 men who participated in the Nurses’ Health Study, the Nurses’ Health Study II, and the Health Professionals Follow-up Study. Questionnaires were completed at two time points, separated by 8 years. Overall, adults whose cumulative average EDIP scores fell within the highest quartile – meaning their diets had the highest inflammatory potential – were at 51% greater risk for developing Crohn’s disease than were adults whose diets fell within the lowest EDIP quartile (hazard ratio, 1.51; 95% confidence interval, 1.19-2.07; P = .01).

Strikingly, however, adults who initially consumed a proinflammatory diet (which is high in calories, red meat, high-fat dairy, and refined grains) and then switched to a low-inflammatory diet (one based around fruit, vegetables, legumes, whole grains, fish, and lean protein) had a statistically similar risk for Crohn’s disease as adults who consumed a low-inflammatory diet at both time points. The 95% confidence interval for the hazard ratio crossed 1.0 (HR, 1.51; 95% CI, 0.76-3.00). In contrast, adults who initially consumed a low-inflammatory diet and later changed to a proinflammatory diet were at twofold greater risk for Crohn’s disease than were those who remained on a low-inflammatory diet (HR, 2.05; 95% CI, 1.10-3.79).

These findings accounted for potential confounders, such as age, study cohort, time period, race, smoking, physical activity, and use of oral contraceptives and hormone replacement therapy, wrote Chun-Han Lo, MD, of the Harvard T.H. Chan School of Public Health, Boston, together with his associates in Gastroenterology.

The EDIP score is a weighted sum of 18 food groups that characterizes the potential for dietary inflammation based on circulating concentrations of inflammatory biomarkers. A proinflammatory diet may “trigger the onset of intestinal inflammation by inducing changes in [the] gut microbiome, altering host homeostasis, and regulating T-cell immune response,” the investigators noted.

In this study, which included nearly 5 million person-years of follow-up, 328 individuals were diagnosed with Crohn’s disease and 428 individuals developed ulcerative colitis. Median age at inflammatory bowel disease diagnosis was 55 years, with a range of 29-85 years. Notably, change in EDIP score was not linked to ulcerative colitis risk. Diet may be more relevant in Crohn’s disease than ulcerative colitis, and dietary factors linked to ulcerative colitis were not associated with inflammatory markers in the cohorts and, thus, were not factored into EDIP score, the researchers wrote.

The link between EDIP score and Crohn’s disease in this study did not change after controlling for fiber intake. Red wine (which contains anti-inflammatory resveratrol) might be a protective factor, the researchers hypothesized. They also found that pizza – a processed, calorie-dense food – was significantly inversely linked to inflammatory markers, perhaps because pizza contains abundant lycopene (from tomato paste) and fat (which facilitate lycopene absorption).

Prior studies on diet and inflammatory bowel disease assessed diets at only one time point and categorized dietary habits based on food groups, rather than linking foods with inflammatory markers, the researchers wrote. “Here, by identifying a combination of food groups predictive of circulating markers of inflammation, we provide a more robust evidence base behind the association of these foods with inflammation and inflammatory bowel disease.”

Most study participants were white health professionals. The researchers noted that “studies of dietary risk factors have not revealed a strong ethnicity-specific association, [but] extrapolating our findings to individuals of other ethnicity should be performed with caution.”

The National Institutes of Health, the Beker Foundation, the Chleck Family Foundation, and the Crohn’s and Colitis Foundation provided funding. Three coinvestigators disclosed ties to AbbVie, Bayer Pharma AG, Boehringer Ingelheim, Gilead, Janssen, Kyn Therapeutics, Merck Pfizer, Policy Analysis Inc., and Takeda.

SOURCE: Lo C-H et al. Gastroenterology. 2020 May 1. doi: 10.1053/j.gastro.2020.05.011.
 

Among adults who consumed a proinflammatory diet, switching to a diet with lower inflammatory potential was associated with a significant subsequent decrease in risk for Crohn’s disease, according to a study of three longitudinal observational cohorts.

Researchers calculated empirical dietary inflammatory pattern (EDIP) scores based on food-frequency questionnaires completed by 166,903 women and 41,931 men who participated in the Nurses’ Health Study, the Nurses’ Health Study II, and the Health Professionals Follow-up Study. Questionnaires were completed at two time points, separated by 8 years. Overall, adults whose cumulative average EDIP scores fell within the highest quartile – meaning their diets had the highest inflammatory potential – were at 51% greater risk for developing Crohn’s disease than were adults whose diets fell within the lowest EDIP quartile (hazard ratio, 1.51; 95% confidence interval, 1.19-2.07; P = .01).

Strikingly, however, adults who initially consumed a proinflammatory diet (which is high in calories, red meat, high-fat dairy, and refined grains) and then switched to a low-inflammatory diet (one based around fruit, vegetables, legumes, whole grains, fish, and lean protein) had a statistically similar risk for Crohn’s disease as adults who consumed a low-inflammatory diet at both time points. The 95% confidence interval for the hazard ratio crossed 1.0 (HR, 1.51; 95% CI, 0.76-3.00). In contrast, adults who initially consumed a low-inflammatory diet and later changed to a proinflammatory diet were at twofold greater risk for Crohn’s disease than were those who remained on a low-inflammatory diet (HR, 2.05; 95% CI, 1.10-3.79).

These findings accounted for potential confounders, such as age, study cohort, time period, race, smoking, physical activity, and use of oral contraceptives and hormone replacement therapy, wrote Chun-Han Lo, MD, of the Harvard T.H. Chan School of Public Health, Boston, together with his associates in Gastroenterology.

The EDIP score is a weighted sum of 18 food groups that characterizes the potential for dietary inflammation based on circulating concentrations of inflammatory biomarkers. A proinflammatory diet may “trigger the onset of intestinal inflammation by inducing changes in [the] gut microbiome, altering host homeostasis, and regulating T-cell immune response,” the investigators noted.

In this study, which included nearly 5 million person-years of follow-up, 328 individuals were diagnosed with Crohn’s disease and 428 individuals developed ulcerative colitis. Median age at inflammatory bowel disease diagnosis was 55 years, with a range of 29-85 years. Notably, change in EDIP score was not linked to ulcerative colitis risk. Diet may be more relevant in Crohn’s disease than ulcerative colitis, and dietary factors linked to ulcerative colitis were not associated with inflammatory markers in the cohorts and, thus, were not factored into EDIP score, the researchers wrote.

The link between EDIP score and Crohn’s disease in this study did not change after controlling for fiber intake. Red wine (which contains anti-inflammatory resveratrol) might be a protective factor, the researchers hypothesized. They also found that pizza – a processed, calorie-dense food – was significantly inversely linked to inflammatory markers, perhaps because pizza contains abundant lycopene (from tomato paste) and fat (which facilitate lycopene absorption).

Prior studies on diet and inflammatory bowel disease assessed diets at only one time point and categorized dietary habits based on food groups, rather than linking foods with inflammatory markers, the researchers wrote. “Here, by identifying a combination of food groups predictive of circulating markers of inflammation, we provide a more robust evidence base behind the association of these foods with inflammation and inflammatory bowel disease.”

Most study participants were white health professionals. The researchers noted that “studies of dietary risk factors have not revealed a strong ethnicity-specific association, [but] extrapolating our findings to individuals of other ethnicity should be performed with caution.”

The National Institutes of Health, the Beker Foundation, the Chleck Family Foundation, and the Crohn’s and Colitis Foundation provided funding. Three coinvestigators disclosed ties to AbbVie, Bayer Pharma AG, Boehringer Ingelheim, Gilead, Janssen, Kyn Therapeutics, Merck Pfizer, Policy Analysis Inc., and Takeda.

SOURCE: Lo C-H et al. Gastroenterology. 2020 May 1. doi: 10.1053/j.gastro.2020.05.011.
 

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For suspected hair disorders, consider trichoscopy before biopsy

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Tue, 08/04/2020 - 14:05

In the clinical experience of Bianca Maria Piraccini, MD, dermoscopic imaging of the scalp and hair can help physicians diagnose a variety of disorders that would normally require an invasive biopsy.

Dr. Bianca Maria Piraccini

Dermoscopic imaging, also known as trichoscopy, “avoids invasive procedures and provides immediate results,” Dr. Piraccini, of the University of Bologna’s division of dermatology in the department of experimental, diagnostic, and specialty medicine, said during the virtual annual meeting of the Society for Pediatric Dermatology. “It is helpful for diagnosing all sorts of alopecia, starting with those that appear at birth, such as aplasia cutis congenita to those that appear in adolescence, such as androgenetic alopecia.”

Dr. Piraccini noted that lanugo hair is produced at 16-20 weeks’ gestation and is shed in utero and replaced by thicker hair at 32-36 weeks. “The speed of transition from vellus to intermediate and terminal hair varies from child to child,” she said. “The scalp at birth presents with thin, intermediate, or thick hair.”

In a dermoscopic evaluation of hair in 45 neonates during their first 30 days of life, Dr. Piraccini and colleagues found that 70% had low density hair while the remaining 30% had high density hair (Br J Dermatol 2013; 169:896-900). Two neonates presented a frontal-temporal pattern of hair loss. Trichoscopy revealed that nine neonates, all in the poor hair density group, had a particular hair shaft dermoscopic feature, characterized by the presence of widespread thin hair.



In some children, she continued, hair in the occipital area does not enter the telogen phase until after birth. These hairs remain on the scalp for 8-12 weeks and then fall out, resulting in neonatal occipital alopecia, which is the most common form of transient neonatal hair loss. Neonatal occipital alopecia is characterized by a band-like shape or oval alopecic patch with a sharp lower margin, but it often goes unnoticed by parents.

“It occurs with higher prevalence in infants born to mothers younger than age 34, in those with a non-cesarean birth, and in those with a gestational age greater than 37 weeks,” Dr. Piraccini said. “There are different degrees of severity. On trichoscopy, the condition appears as thin regrowing hair. The outcome is totally benign, with normal hair growth within the first year of life.”

Any aspect of alopecia in the occipital area in young children may be a sign of hair shaft disorders, which are characterized by increased hair fragility. “Trichoscopy is diagnostic,” she said. “When applied to the hair you see monilethrix, a rare inherited disorder characterized by sparse, brittle hair that often breaks before reaching a few inches in length. As the child grows, the hair gradually acquires the characteristics it will have in adulthood. “It may remain thin and with a short anagen phase for several years, but acute shedding is rare,” she said.

Courtesy Dr. Bianca Maria Piraccini
On trichoscopy, monilethrix appears as sparse, brittle hair that often breaks before reaching a few inches in length.

When an older child presents with increased hair shedding, the first exam to perform is the pull test. If it results in painless traction of several anagen hair without sheaths and with ragged cuticles, think about loose anagen hair syndrome. This condition affects females more than males, usually occurs between the ages of 2 and 5, and is characterized by a defective anchoring of the hair shaft to the hair follicle. The three clinical types of loose anagen hair syndrome are short, rough sparse hair; increased shedding; and areas of alopecia. The syndrome “tends to be inherited but spontaneously improves with aging,” Dr. Piraccini said.

Alopecia areata, another common pediatric hair disorder, occurs in 20% of patients younger than 16 years of age and 9% of those with Down syndrome, and is associated with a family history of the condition. Young age at onset is a negative prognostic factor. “On trichoscopy, common features of alopecia areata are yellow dots, black dots, exclamation mark hairs, and broken hair,” she said. “Trichoscopy can also help you distinguish acute from chronic alopecia areata. The risk of relapse is common, and psychological support is mandatory, because it is very stressful for children.”

Another form of patchy alopecia, trichotillomania, occurs mainly in school-aged children and appears as irregular patches of alopecia with hairs broken at different lengths. “The pull test is negative because all telogen hairs have been pulled out by the patient,” Dr. Piraccini said. “Parents often do not accept the diagnosis as they do not see the child touching his or her hair. It has a good prognosis.”

Trichoscopic signs of trichotillomania include black dots, hair broken at different length, flame hair, clots of hair, and tulip hair. Treatment typically consists of psychological counseling and N-acetylcysteine 600-2,400 g/day.

Dr. Piraccini reported having no relevant financial disclosures.

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In the clinical experience of Bianca Maria Piraccini, MD, dermoscopic imaging of the scalp and hair can help physicians diagnose a variety of disorders that would normally require an invasive biopsy.

Dr. Bianca Maria Piraccini

Dermoscopic imaging, also known as trichoscopy, “avoids invasive procedures and provides immediate results,” Dr. Piraccini, of the University of Bologna’s division of dermatology in the department of experimental, diagnostic, and specialty medicine, said during the virtual annual meeting of the Society for Pediatric Dermatology. “It is helpful for diagnosing all sorts of alopecia, starting with those that appear at birth, such as aplasia cutis congenita to those that appear in adolescence, such as androgenetic alopecia.”

Dr. Piraccini noted that lanugo hair is produced at 16-20 weeks’ gestation and is shed in utero and replaced by thicker hair at 32-36 weeks. “The speed of transition from vellus to intermediate and terminal hair varies from child to child,” she said. “The scalp at birth presents with thin, intermediate, or thick hair.”

In a dermoscopic evaluation of hair in 45 neonates during their first 30 days of life, Dr. Piraccini and colleagues found that 70% had low density hair while the remaining 30% had high density hair (Br J Dermatol 2013; 169:896-900). Two neonates presented a frontal-temporal pattern of hair loss. Trichoscopy revealed that nine neonates, all in the poor hair density group, had a particular hair shaft dermoscopic feature, characterized by the presence of widespread thin hair.



In some children, she continued, hair in the occipital area does not enter the telogen phase until after birth. These hairs remain on the scalp for 8-12 weeks and then fall out, resulting in neonatal occipital alopecia, which is the most common form of transient neonatal hair loss. Neonatal occipital alopecia is characterized by a band-like shape or oval alopecic patch with a sharp lower margin, but it often goes unnoticed by parents.

“It occurs with higher prevalence in infants born to mothers younger than age 34, in those with a non-cesarean birth, and in those with a gestational age greater than 37 weeks,” Dr. Piraccini said. “There are different degrees of severity. On trichoscopy, the condition appears as thin regrowing hair. The outcome is totally benign, with normal hair growth within the first year of life.”

Any aspect of alopecia in the occipital area in young children may be a sign of hair shaft disorders, which are characterized by increased hair fragility. “Trichoscopy is diagnostic,” she said. “When applied to the hair you see monilethrix, a rare inherited disorder characterized by sparse, brittle hair that often breaks before reaching a few inches in length. As the child grows, the hair gradually acquires the characteristics it will have in adulthood. “It may remain thin and with a short anagen phase for several years, but acute shedding is rare,” she said.

Courtesy Dr. Bianca Maria Piraccini
On trichoscopy, monilethrix appears as sparse, brittle hair that often breaks before reaching a few inches in length.

When an older child presents with increased hair shedding, the first exam to perform is the pull test. If it results in painless traction of several anagen hair without sheaths and with ragged cuticles, think about loose anagen hair syndrome. This condition affects females more than males, usually occurs between the ages of 2 and 5, and is characterized by a defective anchoring of the hair shaft to the hair follicle. The three clinical types of loose anagen hair syndrome are short, rough sparse hair; increased shedding; and areas of alopecia. The syndrome “tends to be inherited but spontaneously improves with aging,” Dr. Piraccini said.

Alopecia areata, another common pediatric hair disorder, occurs in 20% of patients younger than 16 years of age and 9% of those with Down syndrome, and is associated with a family history of the condition. Young age at onset is a negative prognostic factor. “On trichoscopy, common features of alopecia areata are yellow dots, black dots, exclamation mark hairs, and broken hair,” she said. “Trichoscopy can also help you distinguish acute from chronic alopecia areata. The risk of relapse is common, and psychological support is mandatory, because it is very stressful for children.”

Another form of patchy alopecia, trichotillomania, occurs mainly in school-aged children and appears as irregular patches of alopecia with hairs broken at different lengths. “The pull test is negative because all telogen hairs have been pulled out by the patient,” Dr. Piraccini said. “Parents often do not accept the diagnosis as they do not see the child touching his or her hair. It has a good prognosis.”

Trichoscopic signs of trichotillomania include black dots, hair broken at different length, flame hair, clots of hair, and tulip hair. Treatment typically consists of psychological counseling and N-acetylcysteine 600-2,400 g/day.

Dr. Piraccini reported having no relevant financial disclosures.

In the clinical experience of Bianca Maria Piraccini, MD, dermoscopic imaging of the scalp and hair can help physicians diagnose a variety of disorders that would normally require an invasive biopsy.

Dr. Bianca Maria Piraccini

Dermoscopic imaging, also known as trichoscopy, “avoids invasive procedures and provides immediate results,” Dr. Piraccini, of the University of Bologna’s division of dermatology in the department of experimental, diagnostic, and specialty medicine, said during the virtual annual meeting of the Society for Pediatric Dermatology. “It is helpful for diagnosing all sorts of alopecia, starting with those that appear at birth, such as aplasia cutis congenita to those that appear in adolescence, such as androgenetic alopecia.”

Dr. Piraccini noted that lanugo hair is produced at 16-20 weeks’ gestation and is shed in utero and replaced by thicker hair at 32-36 weeks. “The speed of transition from vellus to intermediate and terminal hair varies from child to child,” she said. “The scalp at birth presents with thin, intermediate, or thick hair.”

In a dermoscopic evaluation of hair in 45 neonates during their first 30 days of life, Dr. Piraccini and colleagues found that 70% had low density hair while the remaining 30% had high density hair (Br J Dermatol 2013; 169:896-900). Two neonates presented a frontal-temporal pattern of hair loss. Trichoscopy revealed that nine neonates, all in the poor hair density group, had a particular hair shaft dermoscopic feature, characterized by the presence of widespread thin hair.



In some children, she continued, hair in the occipital area does not enter the telogen phase until after birth. These hairs remain on the scalp for 8-12 weeks and then fall out, resulting in neonatal occipital alopecia, which is the most common form of transient neonatal hair loss. Neonatal occipital alopecia is characterized by a band-like shape or oval alopecic patch with a sharp lower margin, but it often goes unnoticed by parents.

“It occurs with higher prevalence in infants born to mothers younger than age 34, in those with a non-cesarean birth, and in those with a gestational age greater than 37 weeks,” Dr. Piraccini said. “There are different degrees of severity. On trichoscopy, the condition appears as thin regrowing hair. The outcome is totally benign, with normal hair growth within the first year of life.”

Any aspect of alopecia in the occipital area in young children may be a sign of hair shaft disorders, which are characterized by increased hair fragility. “Trichoscopy is diagnostic,” she said. “When applied to the hair you see monilethrix, a rare inherited disorder characterized by sparse, brittle hair that often breaks before reaching a few inches in length. As the child grows, the hair gradually acquires the characteristics it will have in adulthood. “It may remain thin and with a short anagen phase for several years, but acute shedding is rare,” she said.

Courtesy Dr. Bianca Maria Piraccini
On trichoscopy, monilethrix appears as sparse, brittle hair that often breaks before reaching a few inches in length.

When an older child presents with increased hair shedding, the first exam to perform is the pull test. If it results in painless traction of several anagen hair without sheaths and with ragged cuticles, think about loose anagen hair syndrome. This condition affects females more than males, usually occurs between the ages of 2 and 5, and is characterized by a defective anchoring of the hair shaft to the hair follicle. The three clinical types of loose anagen hair syndrome are short, rough sparse hair; increased shedding; and areas of alopecia. The syndrome “tends to be inherited but spontaneously improves with aging,” Dr. Piraccini said.

Alopecia areata, another common pediatric hair disorder, occurs in 20% of patients younger than 16 years of age and 9% of those with Down syndrome, and is associated with a family history of the condition. Young age at onset is a negative prognostic factor. “On trichoscopy, common features of alopecia areata are yellow dots, black dots, exclamation mark hairs, and broken hair,” she said. “Trichoscopy can also help you distinguish acute from chronic alopecia areata. The risk of relapse is common, and psychological support is mandatory, because it is very stressful for children.”

Another form of patchy alopecia, trichotillomania, occurs mainly in school-aged children and appears as irregular patches of alopecia with hairs broken at different lengths. “The pull test is negative because all telogen hairs have been pulled out by the patient,” Dr. Piraccini said. “Parents often do not accept the diagnosis as they do not see the child touching his or her hair. It has a good prognosis.”

Trichoscopic signs of trichotillomania include black dots, hair broken at different length, flame hair, clots of hair, and tulip hair. Treatment typically consists of psychological counseling and N-acetylcysteine 600-2,400 g/day.

Dr. Piraccini reported having no relevant financial disclosures.

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Hospital vs. outpatient management comparable for elderly syncope patients

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Tue, 08/04/2020 - 12:58

Background: In the United States, there are over 1 million visits to EDs for syncope with a greater than 50% hospitalization rate for older adult patients. There remains uncertainty around which patients without an identified cause for the syncope could be discharged from the ED and managed as an outpatient.

Dr. Halle Field


Study design: Propensity score analysis.

Setting: EDs from 11 nonprofit academic hospitals.

Synopsis: Prospective data for 2,492 patients aged 60 years and older who did not have an identified cause in the ED for their presenting complaint of syncope were included in the propensity score analysis resulting in a sample size of 1,064 with 532 patients in each of the discharged and hospitalized groups. There was no significant difference in risk of 30-day post-ED serious adverse events between the hospitalized patients (4.89%; 95% confidence interval, 3.06%-6.72%) and discharged patients (2.82%; 95% CI, 1.41%-4.23%; risk difference 2.07%; 95% CI, –0.24% to 4.38%). There was also no statistically significant difference in 30-day mortality post–ED visit.

These results show no clinical benefit in hospitalization for older adults with unexplained syncope after ED evaluation suggesting that it would be reasonable to proceed with outpatient management and evaluation of these patients.

Bottom line: Consider discharging older patients home from the ED who do not have high risk factors and no identified cause of their syncope.

Citation: Probst MA et al. Clinical benefit of hospitalization for older adults with unexplained syncope: A propensity-matched analysis. Ann Emerg Med. 2019 Aug;74(2):260-9.

Dr. Field is a hospitalist at Ochsner Health System, New Orleans.

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Background: In the United States, there are over 1 million visits to EDs for syncope with a greater than 50% hospitalization rate for older adult patients. There remains uncertainty around which patients without an identified cause for the syncope could be discharged from the ED and managed as an outpatient.

Dr. Halle Field


Study design: Propensity score analysis.

Setting: EDs from 11 nonprofit academic hospitals.

Synopsis: Prospective data for 2,492 patients aged 60 years and older who did not have an identified cause in the ED for their presenting complaint of syncope were included in the propensity score analysis resulting in a sample size of 1,064 with 532 patients in each of the discharged and hospitalized groups. There was no significant difference in risk of 30-day post-ED serious adverse events between the hospitalized patients (4.89%; 95% confidence interval, 3.06%-6.72%) and discharged patients (2.82%; 95% CI, 1.41%-4.23%; risk difference 2.07%; 95% CI, –0.24% to 4.38%). There was also no statistically significant difference in 30-day mortality post–ED visit.

These results show no clinical benefit in hospitalization for older adults with unexplained syncope after ED evaluation suggesting that it would be reasonable to proceed with outpatient management and evaluation of these patients.

Bottom line: Consider discharging older patients home from the ED who do not have high risk factors and no identified cause of their syncope.

Citation: Probst MA et al. Clinical benefit of hospitalization for older adults with unexplained syncope: A propensity-matched analysis. Ann Emerg Med. 2019 Aug;74(2):260-9.

Dr. Field is a hospitalist at Ochsner Health System, New Orleans.

Background: In the United States, there are over 1 million visits to EDs for syncope with a greater than 50% hospitalization rate for older adult patients. There remains uncertainty around which patients without an identified cause for the syncope could be discharged from the ED and managed as an outpatient.

Dr. Halle Field


Study design: Propensity score analysis.

Setting: EDs from 11 nonprofit academic hospitals.

Synopsis: Prospective data for 2,492 patients aged 60 years and older who did not have an identified cause in the ED for their presenting complaint of syncope were included in the propensity score analysis resulting in a sample size of 1,064 with 532 patients in each of the discharged and hospitalized groups. There was no significant difference in risk of 30-day post-ED serious adverse events between the hospitalized patients (4.89%; 95% confidence interval, 3.06%-6.72%) and discharged patients (2.82%; 95% CI, 1.41%-4.23%; risk difference 2.07%; 95% CI, –0.24% to 4.38%). There was also no statistically significant difference in 30-day mortality post–ED visit.

These results show no clinical benefit in hospitalization for older adults with unexplained syncope after ED evaluation suggesting that it would be reasonable to proceed with outpatient management and evaluation of these patients.

Bottom line: Consider discharging older patients home from the ED who do not have high risk factors and no identified cause of their syncope.

Citation: Probst MA et al. Clinical benefit of hospitalization for older adults with unexplained syncope: A propensity-matched analysis. Ann Emerg Med. 2019 Aug;74(2):260-9.

Dr. Field is a hospitalist at Ochsner Health System, New Orleans.

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New psoriasis guidelines focus on topical and alternative treatments, and severity measures

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Topical agents, alternative medicine, and disease severity assessment are the subjects of the latest updated set of guidelines for the management and treatment of psoriasis issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

©Rodd100/thinkstockphotos.com

The guidelines, published in the Journal of the American Academy of Dermatology, focus on treatment for adults, and follow the release of other AAD-NPF guidelines on biologics for psoriasis, psoriasis-related comorbidities, pediatric psoriasis, and phototherapy in 2019, and earlier this year, guidelines for systemic nonbiologic treatments. The latest guidelines’ section on topical treatment outlines evidence for the efficacy, effectiveness, and adverse events related to topical steroids, topical tacrolimus and pimecrolimus, vitamin D analogues, tazarotene, moisturizers, salicylic acid, anthralin, coal tar, combinations with biologic agents, and combinations with nonbiologic treatments (methotrexate, cyclosporine, acitretin, and apremilast).

The guidelines noted the “key role” of topical corticosteroids in treating psoriasis “especially for localized disease,” and include a review of the data on low-, moderate-, high-, and ultrahigh-potency topical steroids for psoriasis.

In general, all topical steroids can be used in combination with biologics, according to the guidelines, but the strongest recommendations based on the latest evidence include the addition of an ultra-high potency topical corticosteroid to standard dose etanercept for 12 weeks. Currently, 11 biologics are approved by the Food and Drug Administration for the treatment of psoriasis.

In addition, “while not FDA approved for psoriasis, the topical calcineurin inhibitors tacrolimus and pimecrolimus are often employed in the treatment of psoriasis,” can be helpful for “thinner skin such as facial and intertriginous areas,” and can be steroid sparing when used for more than 4 weeks, according to the guidelines.

Don’t discount the role of patient preferences when choosing topical treatments, the authors noted. “The optimal vehicle choice is the one the patient is mostly likely to use.”



The guidelines also address the evidence for effectiveness, and adverse events in the use of several alternative medicines for psoriasis including traditional Chinese medicine, and the herbal therapies aloe vera and St. John’s wort, as well as the potential role of dietary supplements including fish oil, vitamin D, turmeric, and zinc in managing psoriasis, and the potential role of a gluten-free diet.

In general, research on the efficacy, effectiveness, and potential adverse effects of these strategies are limited, according to the guidelines, although many patients express interest in supplements and herbal products. For example, “Many patients ask about the overall role of vitamin D in skin health. Rather than adding oral vitamin D supplementation, topical therapy with vitamin D agents is effective for the treatment of psoriasis,” the authors noted.

In addition, they noted that mind/body strategies, namely hypnosis and stress reduction or meditation techniques, have been shown to improve symptoms and can be helpful for some patients, but clinical evidence is limited.

The guidelines also addressed methods for assessing disease severity in psoriasis. They recommended using body surface area (BSA) to assess psoriasis severity and patient response to treatment in the clinical setting. However, BSA is a provider assessment tool that “does not take into account location on the body, clinical characteristics of the plaques, symptoms, or quality of life issues,” the authors noted. The Psoriasis Area and Severity Index (PASI) measures erythema, induration, and scaling and is more suited to assessing psoriasis severity and response to treatment in clinical trials rather than in practice, they said.

Prior AAD guidelines on psoriasis were published more than 10 years ago, and major developments including the availability of new biologic drugs and new data on comorbidities have been recognized in the past decade, working group cochair and author of the guidelines Alan Menter, MD, said in an interview.

Dr. Alan Menter

The key game-changers from previous guidelines include the full section published on comorbidities plus the development of two new important cytokine classes: three IL-17 drugs and three new IL-23 drugs now available for moderate to severe psoriasis, said Dr. Menter, chairman of the division of dermatology at Baylor University Medical Center, Dallas.

Barriers to implementing the guidelines in practice may occur when “third party payers make the decision on which of the 11 biologic drugs now approved for moderate to severe psoriasis should be used,” he noted.

As for next steps in psoriasis studies, “new biomarker research is currently underway,” Dr. Menter said. With 11 biologic agents new formally approved by the FDA for moderate to severe psoriasis, the next steps are to determine which drug is likely to be the most appropriate for each individual patient.

Dr. Menter disclosed relationships with multiple companies that develop and manufacture psoriasis therapies, including Abbott Labs, AbbVie, Amgen, Eli Lilly and Company, Galderma USA, Janssen Pharmaceuticals, LEO Pharma US, Menlo Therapeutics, and Novartis. The updated guidelines were designed by a multidisciplinary work group of psoriasis experts including dermatologists, a rheumatologist, a cardiologist, and representatives from a patient advocacy organization.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2020 Jul 29. doi: 10.1016/j.jaad.2020.07.087.

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Topical agents, alternative medicine, and disease severity assessment are the subjects of the latest updated set of guidelines for the management and treatment of psoriasis issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

©Rodd100/thinkstockphotos.com

The guidelines, published in the Journal of the American Academy of Dermatology, focus on treatment for adults, and follow the release of other AAD-NPF guidelines on biologics for psoriasis, psoriasis-related comorbidities, pediatric psoriasis, and phototherapy in 2019, and earlier this year, guidelines for systemic nonbiologic treatments. The latest guidelines’ section on topical treatment outlines evidence for the efficacy, effectiveness, and adverse events related to topical steroids, topical tacrolimus and pimecrolimus, vitamin D analogues, tazarotene, moisturizers, salicylic acid, anthralin, coal tar, combinations with biologic agents, and combinations with nonbiologic treatments (methotrexate, cyclosporine, acitretin, and apremilast).

The guidelines noted the “key role” of topical corticosteroids in treating psoriasis “especially for localized disease,” and include a review of the data on low-, moderate-, high-, and ultrahigh-potency topical steroids for psoriasis.

In general, all topical steroids can be used in combination with biologics, according to the guidelines, but the strongest recommendations based on the latest evidence include the addition of an ultra-high potency topical corticosteroid to standard dose etanercept for 12 weeks. Currently, 11 biologics are approved by the Food and Drug Administration for the treatment of psoriasis.

In addition, “while not FDA approved for psoriasis, the topical calcineurin inhibitors tacrolimus and pimecrolimus are often employed in the treatment of psoriasis,” can be helpful for “thinner skin such as facial and intertriginous areas,” and can be steroid sparing when used for more than 4 weeks, according to the guidelines.

Don’t discount the role of patient preferences when choosing topical treatments, the authors noted. “The optimal vehicle choice is the one the patient is mostly likely to use.”



The guidelines also address the evidence for effectiveness, and adverse events in the use of several alternative medicines for psoriasis including traditional Chinese medicine, and the herbal therapies aloe vera and St. John’s wort, as well as the potential role of dietary supplements including fish oil, vitamin D, turmeric, and zinc in managing psoriasis, and the potential role of a gluten-free diet.

In general, research on the efficacy, effectiveness, and potential adverse effects of these strategies are limited, according to the guidelines, although many patients express interest in supplements and herbal products. For example, “Many patients ask about the overall role of vitamin D in skin health. Rather than adding oral vitamin D supplementation, topical therapy with vitamin D agents is effective for the treatment of psoriasis,” the authors noted.

In addition, they noted that mind/body strategies, namely hypnosis and stress reduction or meditation techniques, have been shown to improve symptoms and can be helpful for some patients, but clinical evidence is limited.

The guidelines also addressed methods for assessing disease severity in psoriasis. They recommended using body surface area (BSA) to assess psoriasis severity and patient response to treatment in the clinical setting. However, BSA is a provider assessment tool that “does not take into account location on the body, clinical characteristics of the plaques, symptoms, or quality of life issues,” the authors noted. The Psoriasis Area and Severity Index (PASI) measures erythema, induration, and scaling and is more suited to assessing psoriasis severity and response to treatment in clinical trials rather than in practice, they said.

Prior AAD guidelines on psoriasis were published more than 10 years ago, and major developments including the availability of new biologic drugs and new data on comorbidities have been recognized in the past decade, working group cochair and author of the guidelines Alan Menter, MD, said in an interview.

Dr. Alan Menter

The key game-changers from previous guidelines include the full section published on comorbidities plus the development of two new important cytokine classes: three IL-17 drugs and three new IL-23 drugs now available for moderate to severe psoriasis, said Dr. Menter, chairman of the division of dermatology at Baylor University Medical Center, Dallas.

Barriers to implementing the guidelines in practice may occur when “third party payers make the decision on which of the 11 biologic drugs now approved for moderate to severe psoriasis should be used,” he noted.

As for next steps in psoriasis studies, “new biomarker research is currently underway,” Dr. Menter said. With 11 biologic agents new formally approved by the FDA for moderate to severe psoriasis, the next steps are to determine which drug is likely to be the most appropriate for each individual patient.

Dr. Menter disclosed relationships with multiple companies that develop and manufacture psoriasis therapies, including Abbott Labs, AbbVie, Amgen, Eli Lilly and Company, Galderma USA, Janssen Pharmaceuticals, LEO Pharma US, Menlo Therapeutics, and Novartis. The updated guidelines were designed by a multidisciplinary work group of psoriasis experts including dermatologists, a rheumatologist, a cardiologist, and representatives from a patient advocacy organization.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2020 Jul 29. doi: 10.1016/j.jaad.2020.07.087.

Topical agents, alternative medicine, and disease severity assessment are the subjects of the latest updated set of guidelines for the management and treatment of psoriasis issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

©Rodd100/thinkstockphotos.com

The guidelines, published in the Journal of the American Academy of Dermatology, focus on treatment for adults, and follow the release of other AAD-NPF guidelines on biologics for psoriasis, psoriasis-related comorbidities, pediatric psoriasis, and phototherapy in 2019, and earlier this year, guidelines for systemic nonbiologic treatments. The latest guidelines’ section on topical treatment outlines evidence for the efficacy, effectiveness, and adverse events related to topical steroids, topical tacrolimus and pimecrolimus, vitamin D analogues, tazarotene, moisturizers, salicylic acid, anthralin, coal tar, combinations with biologic agents, and combinations with nonbiologic treatments (methotrexate, cyclosporine, acitretin, and apremilast).

The guidelines noted the “key role” of topical corticosteroids in treating psoriasis “especially for localized disease,” and include a review of the data on low-, moderate-, high-, and ultrahigh-potency topical steroids for psoriasis.

In general, all topical steroids can be used in combination with biologics, according to the guidelines, but the strongest recommendations based on the latest evidence include the addition of an ultra-high potency topical corticosteroid to standard dose etanercept for 12 weeks. Currently, 11 biologics are approved by the Food and Drug Administration for the treatment of psoriasis.

In addition, “while not FDA approved for psoriasis, the topical calcineurin inhibitors tacrolimus and pimecrolimus are often employed in the treatment of psoriasis,” can be helpful for “thinner skin such as facial and intertriginous areas,” and can be steroid sparing when used for more than 4 weeks, according to the guidelines.

Don’t discount the role of patient preferences when choosing topical treatments, the authors noted. “The optimal vehicle choice is the one the patient is mostly likely to use.”



The guidelines also address the evidence for effectiveness, and adverse events in the use of several alternative medicines for psoriasis including traditional Chinese medicine, and the herbal therapies aloe vera and St. John’s wort, as well as the potential role of dietary supplements including fish oil, vitamin D, turmeric, and zinc in managing psoriasis, and the potential role of a gluten-free diet.

In general, research on the efficacy, effectiveness, and potential adverse effects of these strategies are limited, according to the guidelines, although many patients express interest in supplements and herbal products. For example, “Many patients ask about the overall role of vitamin D in skin health. Rather than adding oral vitamin D supplementation, topical therapy with vitamin D agents is effective for the treatment of psoriasis,” the authors noted.

In addition, they noted that mind/body strategies, namely hypnosis and stress reduction or meditation techniques, have been shown to improve symptoms and can be helpful for some patients, but clinical evidence is limited.

The guidelines also addressed methods for assessing disease severity in psoriasis. They recommended using body surface area (BSA) to assess psoriasis severity and patient response to treatment in the clinical setting. However, BSA is a provider assessment tool that “does not take into account location on the body, clinical characteristics of the plaques, symptoms, or quality of life issues,” the authors noted. The Psoriasis Area and Severity Index (PASI) measures erythema, induration, and scaling and is more suited to assessing psoriasis severity and response to treatment in clinical trials rather than in practice, they said.

Prior AAD guidelines on psoriasis were published more than 10 years ago, and major developments including the availability of new biologic drugs and new data on comorbidities have been recognized in the past decade, working group cochair and author of the guidelines Alan Menter, MD, said in an interview.

Dr. Alan Menter

The key game-changers from previous guidelines include the full section published on comorbidities plus the development of two new important cytokine classes: three IL-17 drugs and three new IL-23 drugs now available for moderate to severe psoriasis, said Dr. Menter, chairman of the division of dermatology at Baylor University Medical Center, Dallas.

Barriers to implementing the guidelines in practice may occur when “third party payers make the decision on which of the 11 biologic drugs now approved for moderate to severe psoriasis should be used,” he noted.

As for next steps in psoriasis studies, “new biomarker research is currently underway,” Dr. Menter said. With 11 biologic agents new formally approved by the FDA for moderate to severe psoriasis, the next steps are to determine which drug is likely to be the most appropriate for each individual patient.

Dr. Menter disclosed relationships with multiple companies that develop and manufacture psoriasis therapies, including Abbott Labs, AbbVie, Amgen, Eli Lilly and Company, Galderma USA, Janssen Pharmaceuticals, LEO Pharma US, Menlo Therapeutics, and Novartis. The updated guidelines were designed by a multidisciplinary work group of psoriasis experts including dermatologists, a rheumatologist, a cardiologist, and representatives from a patient advocacy organization.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2020 Jul 29. doi: 10.1016/j.jaad.2020.07.087.

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Medscape Article

Postpartum tubal ligation safe in obese women

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Mon, 08/17/2020 - 16:15

Women with a high body mass index who request tubal ligation immediately post partum face no increased risk of complications, compared with normal-weight woman, according to a large, single-institution, retrospective study.

“Our study underscores the overall safety of postpartum tubal ligation among overweight and obese women,” John J. Byrne, MD, MPH, and colleagues at the University of Texas, Dallas, reported in Obstetrics & Gynecology.

“Even among women in the highest BMI category, this procedure is safe and effective,” they noted, despite previous studies identifying body mass index (BMI) higher than 40 kg/m2 “as a significant barrier to this procedure.”

“For the woman who is appropriately counseled and desires permanent contraception, BMI should not impede her access to the procedure,” Dr. Byrne and associates said.

The study included 3,670 women undergoing postpartum tubal ligation after a vaginal delivery between August 2015 and March 2019 at Parkland Hospital, which is operated by the Dallas County Hospital District.

The method used was the Parkland-type tubal ligation – a bilateral midsegment partial salpingectomy performed through a 2-3 cm infraumbilical incision. Women were excluded if they were planning additional surgery, such as ovarian cyst removal or hernia repair at the same time.

Comparing a composite outcome of surgical complications and subsequent pregnancies over a 5-year follow-up, the study found no differences across all maternal BMI categories, which were stratified as: underweight or normal weight (BMI, 24.9 or lower), overweight (25-29.9), class I obesity (30-34.9), class II obesity (35-39.9), and class III obesity (40 or higher).

A full breakdown of the composite morbidity included “blood transfusion, aborted procedure, intraoperative complications (bleeding requiring additional surgery, extension of incision), anesthetic complication (high spinal, bronchospasm, postdural puncture headaches requiring blood patch, and allergic reaction to anesthetic), postoperative complication (deep wound infection, venous thromboembolism, ileus, small bowel obstruction, acute intestinal herniation, peritonitis), return to operating room, incomplete transection of fallopian tube, and subsequent pregnancy,” they reported.

Among the study subjects, the mean BMI was 32.2, with 263 being underweight or normal weight at the time of admission, 1,044 being overweight, 1,371 having class I obesity, 689 having class II obesity, 303 having class III obesity, and 11 patients classified as supermorbidly obese (a BMI of 50 or higher).

Overall, “composite morbidity occurred in 49 (1.3%) women and was not significantly different across BMI categories (P = .07),” noted the authors.

More specifically, there were 19 (1.5%) composite morbidity events in the nonobese cohort and 30 (1.3%) in the obese cohort. “Even among women who had undergone prior abdominal surgery, there was no association of BMI with the rate of procedural complication,” Dr. Byrne and associates added.

The subsequent pregnancy rate was 1.63 per 1,000 procedures performed, which is “significantly lower than previously reported estimates,” they noted. In total, there were six subsequent pregnancies in the cohort: three full term, two ectopic, and one of unknown location.

“Although there was variability in operative time in all BMI categories, this is likely not clinically relevant as the range in operative time overlapped across groups,” reported the authors. “Other surgical metrics, such as estimated blood loss and length of hospitalization after tubal ligation, were found to be no different between BMI categories.”

Their findings “can be generalized to other tubal ligation forms, such as modified Pomeroy and even possibly salpingectomy, if the minilaparotomy incision is the same,” Dr. Byrne and colleagues suggested.

“This innovative study adds an important practical perspective to the literature on postpartum permanent contraception – a finding that should be reassuring for obstetrician/gynecologists,” commented Eve Espey, MD MPH, who was not involved in the research.

Dr. Eve Espey

“Women with high BMI are significantly less likely to receive desired postvaginal delivery tubal ligation, compared to lower-BMI women, as documented in several prior studies,” said Dr. Espey, who is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

“Although those studies did not explore the reasons for nonfulfillment, intuitively concerns about complications or inability to complete the procedure are the most likely explanations,” she added.

“Although this study is limited by its retrospective nature, the smaller number of women in the highest BMI category, and lack of information on patients with unfulfilled requests for tubal ligation, it is overall well designed and should serve to encourage physicians to proceed with postvaginal delivery tubal ligation in patients across all BMI categories,” Dr. Espey concluded.

The study received no external funding; Dr. Byrne and associates reported no relevant financial disclosures. Dr. Espey is a member of the Ob.Gyn. News editorial advisory board, and said she has no relevant financial disclosures.

SOURCE: Byrne JJ et al. Obstet Gynecol. 2020;136:342-8.
 

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Women with a high body mass index who request tubal ligation immediately post partum face no increased risk of complications, compared with normal-weight woman, according to a large, single-institution, retrospective study.

“Our study underscores the overall safety of postpartum tubal ligation among overweight and obese women,” John J. Byrne, MD, MPH, and colleagues at the University of Texas, Dallas, reported in Obstetrics & Gynecology.

“Even among women in the highest BMI category, this procedure is safe and effective,” they noted, despite previous studies identifying body mass index (BMI) higher than 40 kg/m2 “as a significant barrier to this procedure.”

“For the woman who is appropriately counseled and desires permanent contraception, BMI should not impede her access to the procedure,” Dr. Byrne and associates said.

The study included 3,670 women undergoing postpartum tubal ligation after a vaginal delivery between August 2015 and March 2019 at Parkland Hospital, which is operated by the Dallas County Hospital District.

The method used was the Parkland-type tubal ligation – a bilateral midsegment partial salpingectomy performed through a 2-3 cm infraumbilical incision. Women were excluded if they were planning additional surgery, such as ovarian cyst removal or hernia repair at the same time.

Comparing a composite outcome of surgical complications and subsequent pregnancies over a 5-year follow-up, the study found no differences across all maternal BMI categories, which were stratified as: underweight or normal weight (BMI, 24.9 or lower), overweight (25-29.9), class I obesity (30-34.9), class II obesity (35-39.9), and class III obesity (40 or higher).

A full breakdown of the composite morbidity included “blood transfusion, aborted procedure, intraoperative complications (bleeding requiring additional surgery, extension of incision), anesthetic complication (high spinal, bronchospasm, postdural puncture headaches requiring blood patch, and allergic reaction to anesthetic), postoperative complication (deep wound infection, venous thromboembolism, ileus, small bowel obstruction, acute intestinal herniation, peritonitis), return to operating room, incomplete transection of fallopian tube, and subsequent pregnancy,” they reported.

Among the study subjects, the mean BMI was 32.2, with 263 being underweight or normal weight at the time of admission, 1,044 being overweight, 1,371 having class I obesity, 689 having class II obesity, 303 having class III obesity, and 11 patients classified as supermorbidly obese (a BMI of 50 or higher).

Overall, “composite morbidity occurred in 49 (1.3%) women and was not significantly different across BMI categories (P = .07),” noted the authors.

More specifically, there were 19 (1.5%) composite morbidity events in the nonobese cohort and 30 (1.3%) in the obese cohort. “Even among women who had undergone prior abdominal surgery, there was no association of BMI with the rate of procedural complication,” Dr. Byrne and associates added.

The subsequent pregnancy rate was 1.63 per 1,000 procedures performed, which is “significantly lower than previously reported estimates,” they noted. In total, there were six subsequent pregnancies in the cohort: three full term, two ectopic, and one of unknown location.

“Although there was variability in operative time in all BMI categories, this is likely not clinically relevant as the range in operative time overlapped across groups,” reported the authors. “Other surgical metrics, such as estimated blood loss and length of hospitalization after tubal ligation, were found to be no different between BMI categories.”

Their findings “can be generalized to other tubal ligation forms, such as modified Pomeroy and even possibly salpingectomy, if the minilaparotomy incision is the same,” Dr. Byrne and colleagues suggested.

“This innovative study adds an important practical perspective to the literature on postpartum permanent contraception – a finding that should be reassuring for obstetrician/gynecologists,” commented Eve Espey, MD MPH, who was not involved in the research.

Dr. Eve Espey

“Women with high BMI are significantly less likely to receive desired postvaginal delivery tubal ligation, compared to lower-BMI women, as documented in several prior studies,” said Dr. Espey, who is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

“Although those studies did not explore the reasons for nonfulfillment, intuitively concerns about complications or inability to complete the procedure are the most likely explanations,” she added.

“Although this study is limited by its retrospective nature, the smaller number of women in the highest BMI category, and lack of information on patients with unfulfilled requests for tubal ligation, it is overall well designed and should serve to encourage physicians to proceed with postvaginal delivery tubal ligation in patients across all BMI categories,” Dr. Espey concluded.

The study received no external funding; Dr. Byrne and associates reported no relevant financial disclosures. Dr. Espey is a member of the Ob.Gyn. News editorial advisory board, and said she has no relevant financial disclosures.

SOURCE: Byrne JJ et al. Obstet Gynecol. 2020;136:342-8.
 

Women with a high body mass index who request tubal ligation immediately post partum face no increased risk of complications, compared with normal-weight woman, according to a large, single-institution, retrospective study.

“Our study underscores the overall safety of postpartum tubal ligation among overweight and obese women,” John J. Byrne, MD, MPH, and colleagues at the University of Texas, Dallas, reported in Obstetrics & Gynecology.

“Even among women in the highest BMI category, this procedure is safe and effective,” they noted, despite previous studies identifying body mass index (BMI) higher than 40 kg/m2 “as a significant barrier to this procedure.”

“For the woman who is appropriately counseled and desires permanent contraception, BMI should not impede her access to the procedure,” Dr. Byrne and associates said.

The study included 3,670 women undergoing postpartum tubal ligation after a vaginal delivery between August 2015 and March 2019 at Parkland Hospital, which is operated by the Dallas County Hospital District.

The method used was the Parkland-type tubal ligation – a bilateral midsegment partial salpingectomy performed through a 2-3 cm infraumbilical incision. Women were excluded if they were planning additional surgery, such as ovarian cyst removal or hernia repair at the same time.

Comparing a composite outcome of surgical complications and subsequent pregnancies over a 5-year follow-up, the study found no differences across all maternal BMI categories, which were stratified as: underweight or normal weight (BMI, 24.9 or lower), overweight (25-29.9), class I obesity (30-34.9), class II obesity (35-39.9), and class III obesity (40 or higher).

A full breakdown of the composite morbidity included “blood transfusion, aborted procedure, intraoperative complications (bleeding requiring additional surgery, extension of incision), anesthetic complication (high spinal, bronchospasm, postdural puncture headaches requiring blood patch, and allergic reaction to anesthetic), postoperative complication (deep wound infection, venous thromboembolism, ileus, small bowel obstruction, acute intestinal herniation, peritonitis), return to operating room, incomplete transection of fallopian tube, and subsequent pregnancy,” they reported.

Among the study subjects, the mean BMI was 32.2, with 263 being underweight or normal weight at the time of admission, 1,044 being overweight, 1,371 having class I obesity, 689 having class II obesity, 303 having class III obesity, and 11 patients classified as supermorbidly obese (a BMI of 50 or higher).

Overall, “composite morbidity occurred in 49 (1.3%) women and was not significantly different across BMI categories (P = .07),” noted the authors.

More specifically, there were 19 (1.5%) composite morbidity events in the nonobese cohort and 30 (1.3%) in the obese cohort. “Even among women who had undergone prior abdominal surgery, there was no association of BMI with the rate of procedural complication,” Dr. Byrne and associates added.

The subsequent pregnancy rate was 1.63 per 1,000 procedures performed, which is “significantly lower than previously reported estimates,” they noted. In total, there were six subsequent pregnancies in the cohort: three full term, two ectopic, and one of unknown location.

“Although there was variability in operative time in all BMI categories, this is likely not clinically relevant as the range in operative time overlapped across groups,” reported the authors. “Other surgical metrics, such as estimated blood loss and length of hospitalization after tubal ligation, were found to be no different between BMI categories.”

Their findings “can be generalized to other tubal ligation forms, such as modified Pomeroy and even possibly salpingectomy, if the minilaparotomy incision is the same,” Dr. Byrne and colleagues suggested.

“This innovative study adds an important practical perspective to the literature on postpartum permanent contraception – a finding that should be reassuring for obstetrician/gynecologists,” commented Eve Espey, MD MPH, who was not involved in the research.

Dr. Eve Espey

“Women with high BMI are significantly less likely to receive desired postvaginal delivery tubal ligation, compared to lower-BMI women, as documented in several prior studies,” said Dr. Espey, who is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

“Although those studies did not explore the reasons for nonfulfillment, intuitively concerns about complications or inability to complete the procedure are the most likely explanations,” she added.

“Although this study is limited by its retrospective nature, the smaller number of women in the highest BMI category, and lack of information on patients with unfulfilled requests for tubal ligation, it is overall well designed and should serve to encourage physicians to proceed with postvaginal delivery tubal ligation in patients across all BMI categories,” Dr. Espey concluded.

The study received no external funding; Dr. Byrne and associates reported no relevant financial disclosures. Dr. Espey is a member of the Ob.Gyn. News editorial advisory board, and said she has no relevant financial disclosures.

SOURCE: Byrne JJ et al. Obstet Gynecol. 2020;136:342-8.
 

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FDA approves cannabidiol for tuberous sclerosis complex

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The cannabidiol (CBD) oral solution Epidiolex has been approved by the Food and Drug Administration for the new indication of treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older.

The drug was approved by the FDA in 2018 for the treatment of seizures associated with two rare and severe forms of epilepsyLennox-Gastaut syndrome and Dravet syndrome, as reported by Medscape Medical News.

This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with tuberous sclerosis complex.

CBD is a chemical component of the cannabis sativa plant, but it does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC), which is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions,” Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in an agency press release.

“This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” Dr. Throckmorton said.

He added that the FDA is committed to supporting research on the potential medical uses of cannabis-derived products.
 

Rare genetic disease

Tuberous sclerosis complex is a rare genetic disease that causes benign tumors to grow in the brain and other parts of the body, such as the eyes, heart, kidneys, lungs, and skin.

It usually affects the central nervous system and can result in a combination of symptoms, including seizures, developmental delay, and behavioral problems. The signs and symptoms of the condition, as well as the severity of symptoms, vary widely. The disease affects about 1 in 6,000 individuals.

The effectiveness of Epidiolex in the treatment of seizures associated with tuberous sclerosis complex was established in a randomized, double-blind, placebo-controlled trial in which 148 patients of a total of 224 in the study received the active drug, the FDA noted.

Results showed that for patients treated with CBD, there was a significantly greater reduction in seizure frequency during the treatment period than for patients who received placebo.

This effect was seen within 8 weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in CBD-treated participants were diarrhea, elevated liver enzyme levels, decreased appetite, sleepiness, fever, and vomiting. Additional side effects that have been reported with the product include liver injury, decreased weight, anemia, and increased creatinine level.

As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior or thoughts of self-harm, the FDA reports.

Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression or suicidal thoughts or behavior. They should report behaviors of concern immediately to health care providers, the agency notes.

It also points out that Epidiolex can cause liver injury, of which most cases are generally mild. However, there is a risk for rare but more severe liver injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

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

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The cannabidiol (CBD) oral solution Epidiolex has been approved by the Food and Drug Administration for the new indication of treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older.

The drug was approved by the FDA in 2018 for the treatment of seizures associated with two rare and severe forms of epilepsyLennox-Gastaut syndrome and Dravet syndrome, as reported by Medscape Medical News.

This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with tuberous sclerosis complex.

CBD is a chemical component of the cannabis sativa plant, but it does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC), which is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions,” Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in an agency press release.

“This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” Dr. Throckmorton said.

He added that the FDA is committed to supporting research on the potential medical uses of cannabis-derived products.
 

Rare genetic disease

Tuberous sclerosis complex is a rare genetic disease that causes benign tumors to grow in the brain and other parts of the body, such as the eyes, heart, kidneys, lungs, and skin.

It usually affects the central nervous system and can result in a combination of symptoms, including seizures, developmental delay, and behavioral problems. The signs and symptoms of the condition, as well as the severity of symptoms, vary widely. The disease affects about 1 in 6,000 individuals.

The effectiveness of Epidiolex in the treatment of seizures associated with tuberous sclerosis complex was established in a randomized, double-blind, placebo-controlled trial in which 148 patients of a total of 224 in the study received the active drug, the FDA noted.

Results showed that for patients treated with CBD, there was a significantly greater reduction in seizure frequency during the treatment period than for patients who received placebo.

This effect was seen within 8 weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in CBD-treated participants were diarrhea, elevated liver enzyme levels, decreased appetite, sleepiness, fever, and vomiting. Additional side effects that have been reported with the product include liver injury, decreased weight, anemia, and increased creatinine level.

As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior or thoughts of self-harm, the FDA reports.

Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression or suicidal thoughts or behavior. They should report behaviors of concern immediately to health care providers, the agency notes.

It also points out that Epidiolex can cause liver injury, of which most cases are generally mild. However, there is a risk for rare but more severe liver injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

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

The cannabidiol (CBD) oral solution Epidiolex has been approved by the Food and Drug Administration for the new indication of treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older.

The drug was approved by the FDA in 2018 for the treatment of seizures associated with two rare and severe forms of epilepsyLennox-Gastaut syndrome and Dravet syndrome, as reported by Medscape Medical News.

This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with tuberous sclerosis complex.

CBD is a chemical component of the cannabis sativa plant, but it does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC), which is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions,” Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in an agency press release.

“This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” Dr. Throckmorton said.

He added that the FDA is committed to supporting research on the potential medical uses of cannabis-derived products.
 

Rare genetic disease

Tuberous sclerosis complex is a rare genetic disease that causes benign tumors to grow in the brain and other parts of the body, such as the eyes, heart, kidneys, lungs, and skin.

It usually affects the central nervous system and can result in a combination of symptoms, including seizures, developmental delay, and behavioral problems. The signs and symptoms of the condition, as well as the severity of symptoms, vary widely. The disease affects about 1 in 6,000 individuals.

The effectiveness of Epidiolex in the treatment of seizures associated with tuberous sclerosis complex was established in a randomized, double-blind, placebo-controlled trial in which 148 patients of a total of 224 in the study received the active drug, the FDA noted.

Results showed that for patients treated with CBD, there was a significantly greater reduction in seizure frequency during the treatment period than for patients who received placebo.

This effect was seen within 8 weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in CBD-treated participants were diarrhea, elevated liver enzyme levels, decreased appetite, sleepiness, fever, and vomiting. Additional side effects that have been reported with the product include liver injury, decreased weight, anemia, and increased creatinine level.

As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior or thoughts of self-harm, the FDA reports.

Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression or suicidal thoughts or behavior. They should report behaviors of concern immediately to health care providers, the agency notes.

It also points out that Epidiolex can cause liver injury, of which most cases are generally mild. However, there is a risk for rare but more severe liver injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

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

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Biologics may delay psoriatic arthritis, study finds

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Tue, 02/07/2023 - 16:48

Treatment of psoriasis with biologics was associated with a reduced risk of developing psoriatic arthritis compared with conventional disease-modifying antirheumatic drugs (DMARDs), in a single center retrospective analysis in Argentina that followed patients for almost 2 decades.

About 30%-40% of patients with psoriasis go on to develop psoriatic arthritis (PsA), usually on average about 10 years after the onset of psoriasis. One potential mechanism of PsA onset is through enthesitis, which has been described at subclinical levels in psoriasis.

“It could be speculated that treatment with biologics in patients with psoriasis could prevent the development of psoriatic arthritis, perhaps by inhibiting the subclinical development of enthesitis,” Luciano Lo Giudice, MD, a rheumatology fellow at Hospital Italiano de Buenos Aires, said during his presentation at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Although these results do not prove that treatment of the underlying disease delays progression to PsA, it is suggestive, and highlights an emerging field of research, according to Diamant Thaçi, MD, PhD, professor of medicine at University Hospital Schleswig-Holstein, Germany, who led a live discussion following a prerecorded presentation of the results. “We’re going in this direction – how can we prevent psoriatic arthritis, how can we delay it. We are just starting to think about this,” Dr. Thaçi said in an interview.

The researchers examined medical records of 1,626 patients with psoriasis treated at their center between 2000 and 2019, with a total of 15,152 years of follow-up. Of these patients, 1,293 were treated with topical medication, 229 with conventional DMARDs (methotrexate in 77%, cyclosporine in 13%, and both in 10%), and 104 with biologics, including etanercept (34%), secukinumab (20%), adalimumab (20%), ustekinumab (12%), ixekizumab (9%), and infliximab (5%).



They found that 11% in the topical treatment group developed PsA, as did 3.5% in the conventional DMARD group, 1.9% in the biologics group, and 9.1% overall. Treatment with biologics was associated with a significantly lower odds of developing PsA compared with treatment with conventional DMARDs (3 versus 17.2 per 1,000 patient-years; incidence rate ratio [IRR], 0.17; P = .0177). There was a trend toward reduced odds of developing PsA among those on biologic therapy compared with those on topicals (3 versus 9.8 per 1,000 patient-years; IRR, 0.3; P = .0588).

The researchers confirmed all medical encounters using electronic medical records and the study had a long follow-up time, but was limited by the single center and its retrospective nature. It also could not associate reduced risk with specific biologics.

The findings probably reflect the presence of subclinical PsA that many clinicians don’t see, according to Dr. Thaçi. While a dermatology practice might find PsA in 2% or 3%, or at most, 10% of patients with psoriasis, “in our department it’s about 50 to 60 percent of patients who have psoriatic arthritis, because we diagnose it early,” he said.

He found the results of the study encouraging. “It looks like some of the biologics, for example IL [interleukin]-17 or even IL-23 [blockers] may have an influence on occurrence or delay the occurrence of psoriatic arthritis.”

Dr. Thaçi noted that early treatment of skin lesions can increase the probability of longer remissions, especially with IL-23 blockers. Still, that’s no guarantee the same would hold true for PsA risk. “Skin is skin and joints are joints,” Dr. Thaçi said.

Dr. Thaçi and Dr. Lo Giudice had no relevant financial disclosures.

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Treatment of psoriasis with biologics was associated with a reduced risk of developing psoriatic arthritis compared with conventional disease-modifying antirheumatic drugs (DMARDs), in a single center retrospective analysis in Argentina that followed patients for almost 2 decades.

About 30%-40% of patients with psoriasis go on to develop psoriatic arthritis (PsA), usually on average about 10 years after the onset of psoriasis. One potential mechanism of PsA onset is through enthesitis, which has been described at subclinical levels in psoriasis.

“It could be speculated that treatment with biologics in patients with psoriasis could prevent the development of psoriatic arthritis, perhaps by inhibiting the subclinical development of enthesitis,” Luciano Lo Giudice, MD, a rheumatology fellow at Hospital Italiano de Buenos Aires, said during his presentation at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Although these results do not prove that treatment of the underlying disease delays progression to PsA, it is suggestive, and highlights an emerging field of research, according to Diamant Thaçi, MD, PhD, professor of medicine at University Hospital Schleswig-Holstein, Germany, who led a live discussion following a prerecorded presentation of the results. “We’re going in this direction – how can we prevent psoriatic arthritis, how can we delay it. We are just starting to think about this,” Dr. Thaçi said in an interview.

The researchers examined medical records of 1,626 patients with psoriasis treated at their center between 2000 and 2019, with a total of 15,152 years of follow-up. Of these patients, 1,293 were treated with topical medication, 229 with conventional DMARDs (methotrexate in 77%, cyclosporine in 13%, and both in 10%), and 104 with biologics, including etanercept (34%), secukinumab (20%), adalimumab (20%), ustekinumab (12%), ixekizumab (9%), and infliximab (5%).



They found that 11% in the topical treatment group developed PsA, as did 3.5% in the conventional DMARD group, 1.9% in the biologics group, and 9.1% overall. Treatment with biologics was associated with a significantly lower odds of developing PsA compared with treatment with conventional DMARDs (3 versus 17.2 per 1,000 patient-years; incidence rate ratio [IRR], 0.17; P = .0177). There was a trend toward reduced odds of developing PsA among those on biologic therapy compared with those on topicals (3 versus 9.8 per 1,000 patient-years; IRR, 0.3; P = .0588).

The researchers confirmed all medical encounters using electronic medical records and the study had a long follow-up time, but was limited by the single center and its retrospective nature. It also could not associate reduced risk with specific biologics.

The findings probably reflect the presence of subclinical PsA that many clinicians don’t see, according to Dr. Thaçi. While a dermatology practice might find PsA in 2% or 3%, or at most, 10% of patients with psoriasis, “in our department it’s about 50 to 60 percent of patients who have psoriatic arthritis, because we diagnose it early,” he said.

He found the results of the study encouraging. “It looks like some of the biologics, for example IL [interleukin]-17 or even IL-23 [blockers] may have an influence on occurrence or delay the occurrence of psoriatic arthritis.”

Dr. Thaçi noted that early treatment of skin lesions can increase the probability of longer remissions, especially with IL-23 blockers. Still, that’s no guarantee the same would hold true for PsA risk. “Skin is skin and joints are joints,” Dr. Thaçi said.

Dr. Thaçi and Dr. Lo Giudice had no relevant financial disclosures.

Treatment of psoriasis with biologics was associated with a reduced risk of developing psoriatic arthritis compared with conventional disease-modifying antirheumatic drugs (DMARDs), in a single center retrospective analysis in Argentina that followed patients for almost 2 decades.

About 30%-40% of patients with psoriasis go on to develop psoriatic arthritis (PsA), usually on average about 10 years after the onset of psoriasis. One potential mechanism of PsA onset is through enthesitis, which has been described at subclinical levels in psoriasis.

“It could be speculated that treatment with biologics in patients with psoriasis could prevent the development of psoriatic arthritis, perhaps by inhibiting the subclinical development of enthesitis,” Luciano Lo Giudice, MD, a rheumatology fellow at Hospital Italiano de Buenos Aires, said during his presentation at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Although these results do not prove that treatment of the underlying disease delays progression to PsA, it is suggestive, and highlights an emerging field of research, according to Diamant Thaçi, MD, PhD, professor of medicine at University Hospital Schleswig-Holstein, Germany, who led a live discussion following a prerecorded presentation of the results. “We’re going in this direction – how can we prevent psoriatic arthritis, how can we delay it. We are just starting to think about this,” Dr. Thaçi said in an interview.

The researchers examined medical records of 1,626 patients with psoriasis treated at their center between 2000 and 2019, with a total of 15,152 years of follow-up. Of these patients, 1,293 were treated with topical medication, 229 with conventional DMARDs (methotrexate in 77%, cyclosporine in 13%, and both in 10%), and 104 with biologics, including etanercept (34%), secukinumab (20%), adalimumab (20%), ustekinumab (12%), ixekizumab (9%), and infliximab (5%).



They found that 11% in the topical treatment group developed PsA, as did 3.5% in the conventional DMARD group, 1.9% in the biologics group, and 9.1% overall. Treatment with biologics was associated with a significantly lower odds of developing PsA compared with treatment with conventional DMARDs (3 versus 17.2 per 1,000 patient-years; incidence rate ratio [IRR], 0.17; P = .0177). There was a trend toward reduced odds of developing PsA among those on biologic therapy compared with those on topicals (3 versus 9.8 per 1,000 patient-years; IRR, 0.3; P = .0588).

The researchers confirmed all medical encounters using electronic medical records and the study had a long follow-up time, but was limited by the single center and its retrospective nature. It also could not associate reduced risk with specific biologics.

The findings probably reflect the presence of subclinical PsA that many clinicians don’t see, according to Dr. Thaçi. While a dermatology practice might find PsA in 2% or 3%, or at most, 10% of patients with psoriasis, “in our department it’s about 50 to 60 percent of patients who have psoriatic arthritis, because we diagnose it early,” he said.

He found the results of the study encouraging. “It looks like some of the biologics, for example IL [interleukin]-17 or even IL-23 [blockers] may have an influence on occurrence or delay the occurrence of psoriatic arthritis.”

Dr. Thaçi noted that early treatment of skin lesions can increase the probability of longer remissions, especially with IL-23 blockers. Still, that’s no guarantee the same would hold true for PsA risk. “Skin is skin and joints are joints,” Dr. Thaçi said.

Dr. Thaçi and Dr. Lo Giudice had no relevant financial disclosures.

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