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High caffeine levels may lower body fat, type 2 diabetes risks
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BMJ MEDICINE
Few women identify breast density as a breast cancer risk
Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.
The study was published earlier this year in JAMA Network Open.
“Forty [percent] to 50% of women who undergo mammography fall into the two highest breast density categories,” said the study’s lead author Christine Gunn, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice, N.H. “Breast cancer risk increases from 1.2-4.0 times depending on the level of breast density. By comparison, a first-degree family history of breast cancer, particularly in premenopausal women, confers a two-fold higher breast cancer risk.”
Dr. Gunn’s study is based on a survey of 2,306 women (between 40 and 76 years old) that was conducted between 2019 and 2020. The goal was to determine how well women understood cancer risks associated with dense breast tissue. The final analysis included 1,858 women (9% Asian, 27% Black, 14% Hispanic, 43% White, and 7% other race or ethnicity).
Breast density was thought to be a greater risk than not having children, drinking daily, and having had a prior breast biopsy, according to 52%, 53%, and 48% of respondents, respectively. Breast density was believed to be a lesser breast cancer risk than having a first-degree relative with breast cancer by 93% of women, and 65% of women felt it was a lesser risk than being overweight or obese.
Of the 61 women who completed follow-up interviews, 6 described breast density as a contributing factor to breast cancer risk. And, 17 women did not know whether it was possible to reduce their breast cancer risk.
Doctors must notify patients in writing
Breast tissue falls under one of four categories: fatty tissue, scattered areas of dense fibroglandular tissue, many areas of glandular and connective tissue, or extremely dense tissue. The tissue is considered dense if it falls under heterogeneously dense or extremely dense, and in those cases, follow-up testing with ultrasound or MRI may be necessary. This is important, Dr. Gunn said, because dense tissue can make “it harder to find cancers because connective tissue appears white on the mammogram, potentially masking tumors.”
Prior studies have found that many clinicians are uncomfortable counseling patients on the implications of breast density and cancer risk, the authors wrote.
However, under the Mammography Quality Standards Act, which was updated on March 10, the Food and Drug Administration requires that patients be provided with a mammography report summary that “identifies whether the patient has dense or nondense breast tissue.” The report, which should be written in lay language, should also specify the “significance” of the dense tissue.
While some states mandate notification regardless of the density level, most only notify women if heterogeneously dense or extremely dense tissue has been identified, Dr. Gunn said. But the rules are inconsistent, she said. In some facilities in Massachusetts, for example, women may receive a mammography report letter and a separate breast density letter. “For some, it has been really confusing. They received a letter saying that their mammography was normal and then another one saying that they have dense breasts – resulting in a lot of uncertainty and anxiety. We don’t want to overly alarm people. We want them to understand their risk,” she said.
Breast density can be considered among other risk factors, including alcohol use, obesity, diet, parity, prior breast biopsy, and inherited unfavorable genetic mutations. “If the total lifetime risk is above 20%, that opens up further screening options, such as a breast MRI, which will catch more cancers than a breast mammogram by itself,” Dr. Gunn said.
“The challenges for physicians and patients around collecting and understanding breast density information in the context of other risk factors can potentially lead to disparities in who gets to know their risk and who doesn’t,” Dr. Gunn said. It would be possible, she speculated, to create or use existing risk calculators integrated into medical records and populated with information gathered in premammography visit questionnaires. Ideally, a radiologist could hand the patient results in real time at the end of the mammography visit, integrating risk estimates with mammography findings to make recommendations.
This study was supported by grant RSG-133017-CPHPS from the American Cancer Society.
Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.
The study was published earlier this year in JAMA Network Open.
“Forty [percent] to 50% of women who undergo mammography fall into the two highest breast density categories,” said the study’s lead author Christine Gunn, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice, N.H. “Breast cancer risk increases from 1.2-4.0 times depending on the level of breast density. By comparison, a first-degree family history of breast cancer, particularly in premenopausal women, confers a two-fold higher breast cancer risk.”
Dr. Gunn’s study is based on a survey of 2,306 women (between 40 and 76 years old) that was conducted between 2019 and 2020. The goal was to determine how well women understood cancer risks associated with dense breast tissue. The final analysis included 1,858 women (9% Asian, 27% Black, 14% Hispanic, 43% White, and 7% other race or ethnicity).
Breast density was thought to be a greater risk than not having children, drinking daily, and having had a prior breast biopsy, according to 52%, 53%, and 48% of respondents, respectively. Breast density was believed to be a lesser breast cancer risk than having a first-degree relative with breast cancer by 93% of women, and 65% of women felt it was a lesser risk than being overweight or obese.
Of the 61 women who completed follow-up interviews, 6 described breast density as a contributing factor to breast cancer risk. And, 17 women did not know whether it was possible to reduce their breast cancer risk.
Doctors must notify patients in writing
Breast tissue falls under one of four categories: fatty tissue, scattered areas of dense fibroglandular tissue, many areas of glandular and connective tissue, or extremely dense tissue. The tissue is considered dense if it falls under heterogeneously dense or extremely dense, and in those cases, follow-up testing with ultrasound or MRI may be necessary. This is important, Dr. Gunn said, because dense tissue can make “it harder to find cancers because connective tissue appears white on the mammogram, potentially masking tumors.”
Prior studies have found that many clinicians are uncomfortable counseling patients on the implications of breast density and cancer risk, the authors wrote.
However, under the Mammography Quality Standards Act, which was updated on March 10, the Food and Drug Administration requires that patients be provided with a mammography report summary that “identifies whether the patient has dense or nondense breast tissue.” The report, which should be written in lay language, should also specify the “significance” of the dense tissue.
While some states mandate notification regardless of the density level, most only notify women if heterogeneously dense or extremely dense tissue has been identified, Dr. Gunn said. But the rules are inconsistent, she said. In some facilities in Massachusetts, for example, women may receive a mammography report letter and a separate breast density letter. “For some, it has been really confusing. They received a letter saying that their mammography was normal and then another one saying that they have dense breasts – resulting in a lot of uncertainty and anxiety. We don’t want to overly alarm people. We want them to understand their risk,” she said.
Breast density can be considered among other risk factors, including alcohol use, obesity, diet, parity, prior breast biopsy, and inherited unfavorable genetic mutations. “If the total lifetime risk is above 20%, that opens up further screening options, such as a breast MRI, which will catch more cancers than a breast mammogram by itself,” Dr. Gunn said.
“The challenges for physicians and patients around collecting and understanding breast density information in the context of other risk factors can potentially lead to disparities in who gets to know their risk and who doesn’t,” Dr. Gunn said. It would be possible, she speculated, to create or use existing risk calculators integrated into medical records and populated with information gathered in premammography visit questionnaires. Ideally, a radiologist could hand the patient results in real time at the end of the mammography visit, integrating risk estimates with mammography findings to make recommendations.
This study was supported by grant RSG-133017-CPHPS from the American Cancer Society.
Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.
The study was published earlier this year in JAMA Network Open.
“Forty [percent] to 50% of women who undergo mammography fall into the two highest breast density categories,” said the study’s lead author Christine Gunn, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice, N.H. “Breast cancer risk increases from 1.2-4.0 times depending on the level of breast density. By comparison, a first-degree family history of breast cancer, particularly in premenopausal women, confers a two-fold higher breast cancer risk.”
Dr. Gunn’s study is based on a survey of 2,306 women (between 40 and 76 years old) that was conducted between 2019 and 2020. The goal was to determine how well women understood cancer risks associated with dense breast tissue. The final analysis included 1,858 women (9% Asian, 27% Black, 14% Hispanic, 43% White, and 7% other race or ethnicity).
Breast density was thought to be a greater risk than not having children, drinking daily, and having had a prior breast biopsy, according to 52%, 53%, and 48% of respondents, respectively. Breast density was believed to be a lesser breast cancer risk than having a first-degree relative with breast cancer by 93% of women, and 65% of women felt it was a lesser risk than being overweight or obese.
Of the 61 women who completed follow-up interviews, 6 described breast density as a contributing factor to breast cancer risk. And, 17 women did not know whether it was possible to reduce their breast cancer risk.
Doctors must notify patients in writing
Breast tissue falls under one of four categories: fatty tissue, scattered areas of dense fibroglandular tissue, many areas of glandular and connective tissue, or extremely dense tissue. The tissue is considered dense if it falls under heterogeneously dense or extremely dense, and in those cases, follow-up testing with ultrasound or MRI may be necessary. This is important, Dr. Gunn said, because dense tissue can make “it harder to find cancers because connective tissue appears white on the mammogram, potentially masking tumors.”
Prior studies have found that many clinicians are uncomfortable counseling patients on the implications of breast density and cancer risk, the authors wrote.
However, under the Mammography Quality Standards Act, which was updated on March 10, the Food and Drug Administration requires that patients be provided with a mammography report summary that “identifies whether the patient has dense or nondense breast tissue.” The report, which should be written in lay language, should also specify the “significance” of the dense tissue.
While some states mandate notification regardless of the density level, most only notify women if heterogeneously dense or extremely dense tissue has been identified, Dr. Gunn said. But the rules are inconsistent, she said. In some facilities in Massachusetts, for example, women may receive a mammography report letter and a separate breast density letter. “For some, it has been really confusing. They received a letter saying that their mammography was normal and then another one saying that they have dense breasts – resulting in a lot of uncertainty and anxiety. We don’t want to overly alarm people. We want them to understand their risk,” she said.
Breast density can be considered among other risk factors, including alcohol use, obesity, diet, parity, prior breast biopsy, and inherited unfavorable genetic mutations. “If the total lifetime risk is above 20%, that opens up further screening options, such as a breast MRI, which will catch more cancers than a breast mammogram by itself,” Dr. Gunn said.
“The challenges for physicians and patients around collecting and understanding breast density information in the context of other risk factors can potentially lead to disparities in who gets to know their risk and who doesn’t,” Dr. Gunn said. It would be possible, she speculated, to create or use existing risk calculators integrated into medical records and populated with information gathered in premammography visit questionnaires. Ideally, a radiologist could hand the patient results in real time at the end of the mammography visit, integrating risk estimates with mammography findings to make recommendations.
This study was supported by grant RSG-133017-CPHPS from the American Cancer Society.
FROM JAMA NETWORK OPEN
AI helps predict ulcerative colitis remission/activity, flare-ups
The AI tool predicted UC disease activity with 89% accuracy and inflammation at the biopsy site with 80% accuracy. Its ability to stratify risk of UC flare was on par with human pathologists.
“This tool in the near future will speed up, simplify, and standardize histological assessment of ulcerative colitis and provide the clinician with accurate prognostic information in real time,” co–lead author Marietta Iacucci, MD, PhD, from the University of Birmingham (England), and University College Cork (Ireland), said in an interview.
“The tool needs to be refined and further validated before it is ready for daily clinical practice. That work is ongoing now,” Dr. Iacucci said.
The researchers describe their advanced AI-based computer-aided detection tool in a study published online in Gastroenterology.
‘Strong’ performance
They used 535 digitized biopsies from 273 patients with UC (mean age, 48 years; 41% women) to develop and test the tool. They used a subset of 118 to train it to distinguish remission from activity, 42 to calibrate it, and 375 to test it. An additional 154 biopsies from 58 patients with UC were used to externally validate the tool.
The model also was tested to predict the corresponding endoscopic assessment and occurrence of flares at 12 months.
UC disease activity was defined by three different histologic indices: the Robarts Histopathology Index (RHI), the Nancy Histological Index (NHI), and the newly developed PICaSSO Histologic Remission Index (PHRI).
The AI tool had “strong diagnostic performance to detect disease activity” (PHRI > 0) with an overall area under the receiver operating characteristic curve of 0.87 and sensitivity and specificity of 89% and 85%, respectively.
The researchers note that, while the AI tool was trained for the PHRI, its sensitivity for RHI and NHI histologic remission/activity was also high (94% and 89%, respectively).
Despite the different mix of severity grades, the AI model “maintained a good diagnostic performance, proving its applicability outside the original development setting,” they reported.
The AI tool could also predict the presence of endoscopic inflammation in the biopsy area with about 80% accuracy.
“Though imperfect, this result is consistent with human-assessed correlation between endoscopy and histology,” the researchers noted.
The model predicted the corresponding endoscopic remission/activity with 79% and 82% accuracy for UCEIS and PICaSSO, respectively.
The hazard ratios for disease flare-up between the AI system and pathologists assessed by PHRI was similar (4.64 and 3.56, respectively), “demonstrating the ability of the computer to stratify the risk of flare comparably well to pathologists,” they added.
Both histology and outcome prediction were confirmed in the external validation cohort.
The AI system delivered results in an average of 9.8 seconds per slide.
Potential ‘game changer’
UC is a “complex condition to predict, and developing machine learning–derived systems to make this diagnostic job quicker and more accurate could be a game changer,” Dr. Iacucci said in a news release.
With refinement, the AI tool will have an impact on both clinical trials and daily practice, the researchers wrote. In clinical practice, histological reporting remains “largely descriptive and nonstandard, thus would greatly benefit from a quick and objective assessment. Similarly, clinical trials in UC could efficiently overcome costly central readings.”
Assessing and measuring improvement in endoscopy and histology are difficult parts of treating UC, said David Hudesman, MD, codirector of the Inflammatory Bowel Disease Center at New York University Langone Health.
“We do not know how much improvement is associated with improved long-term outcomes,” Dr. Hudesman said in an interview. “For example, does a patient need complete healing or is 50% better enough?” Dr. Hudesman was not involved with the current research.
“This study showed that AI can predict – with good accuracy – endoscopy and histology scores, as well as 1-year patient outcomes. If this is validated in larger studies, AI can help determine if we should adjust/change therapies or continue, which is very important,” he said.
This research was supported by the National Institute for Health Research Birmingham Biomedical Research Centre. Dr. Iacucci and Dr. Hudesman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The AI tool predicted UC disease activity with 89% accuracy and inflammation at the biopsy site with 80% accuracy. Its ability to stratify risk of UC flare was on par with human pathologists.
“This tool in the near future will speed up, simplify, and standardize histological assessment of ulcerative colitis and provide the clinician with accurate prognostic information in real time,” co–lead author Marietta Iacucci, MD, PhD, from the University of Birmingham (England), and University College Cork (Ireland), said in an interview.
“The tool needs to be refined and further validated before it is ready for daily clinical practice. That work is ongoing now,” Dr. Iacucci said.
The researchers describe their advanced AI-based computer-aided detection tool in a study published online in Gastroenterology.
‘Strong’ performance
They used 535 digitized biopsies from 273 patients with UC (mean age, 48 years; 41% women) to develop and test the tool. They used a subset of 118 to train it to distinguish remission from activity, 42 to calibrate it, and 375 to test it. An additional 154 biopsies from 58 patients with UC were used to externally validate the tool.
The model also was tested to predict the corresponding endoscopic assessment and occurrence of flares at 12 months.
UC disease activity was defined by three different histologic indices: the Robarts Histopathology Index (RHI), the Nancy Histological Index (NHI), and the newly developed PICaSSO Histologic Remission Index (PHRI).
The AI tool had “strong diagnostic performance to detect disease activity” (PHRI > 0) with an overall area under the receiver operating characteristic curve of 0.87 and sensitivity and specificity of 89% and 85%, respectively.
The researchers note that, while the AI tool was trained for the PHRI, its sensitivity for RHI and NHI histologic remission/activity was also high (94% and 89%, respectively).
Despite the different mix of severity grades, the AI model “maintained a good diagnostic performance, proving its applicability outside the original development setting,” they reported.
The AI tool could also predict the presence of endoscopic inflammation in the biopsy area with about 80% accuracy.
“Though imperfect, this result is consistent with human-assessed correlation between endoscopy and histology,” the researchers noted.
The model predicted the corresponding endoscopic remission/activity with 79% and 82% accuracy for UCEIS and PICaSSO, respectively.
The hazard ratios for disease flare-up between the AI system and pathologists assessed by PHRI was similar (4.64 and 3.56, respectively), “demonstrating the ability of the computer to stratify the risk of flare comparably well to pathologists,” they added.
Both histology and outcome prediction were confirmed in the external validation cohort.
The AI system delivered results in an average of 9.8 seconds per slide.
Potential ‘game changer’
UC is a “complex condition to predict, and developing machine learning–derived systems to make this diagnostic job quicker and more accurate could be a game changer,” Dr. Iacucci said in a news release.
With refinement, the AI tool will have an impact on both clinical trials and daily practice, the researchers wrote. In clinical practice, histological reporting remains “largely descriptive and nonstandard, thus would greatly benefit from a quick and objective assessment. Similarly, clinical trials in UC could efficiently overcome costly central readings.”
Assessing and measuring improvement in endoscopy and histology are difficult parts of treating UC, said David Hudesman, MD, codirector of the Inflammatory Bowel Disease Center at New York University Langone Health.
“We do not know how much improvement is associated with improved long-term outcomes,” Dr. Hudesman said in an interview. “For example, does a patient need complete healing or is 50% better enough?” Dr. Hudesman was not involved with the current research.
“This study showed that AI can predict – with good accuracy – endoscopy and histology scores, as well as 1-year patient outcomes. If this is validated in larger studies, AI can help determine if we should adjust/change therapies or continue, which is very important,” he said.
This research was supported by the National Institute for Health Research Birmingham Biomedical Research Centre. Dr. Iacucci and Dr. Hudesman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The AI tool predicted UC disease activity with 89% accuracy and inflammation at the biopsy site with 80% accuracy. Its ability to stratify risk of UC flare was on par with human pathologists.
“This tool in the near future will speed up, simplify, and standardize histological assessment of ulcerative colitis and provide the clinician with accurate prognostic information in real time,” co–lead author Marietta Iacucci, MD, PhD, from the University of Birmingham (England), and University College Cork (Ireland), said in an interview.
“The tool needs to be refined and further validated before it is ready for daily clinical practice. That work is ongoing now,” Dr. Iacucci said.
The researchers describe their advanced AI-based computer-aided detection tool in a study published online in Gastroenterology.
‘Strong’ performance
They used 535 digitized biopsies from 273 patients with UC (mean age, 48 years; 41% women) to develop and test the tool. They used a subset of 118 to train it to distinguish remission from activity, 42 to calibrate it, and 375 to test it. An additional 154 biopsies from 58 patients with UC were used to externally validate the tool.
The model also was tested to predict the corresponding endoscopic assessment and occurrence of flares at 12 months.
UC disease activity was defined by three different histologic indices: the Robarts Histopathology Index (RHI), the Nancy Histological Index (NHI), and the newly developed PICaSSO Histologic Remission Index (PHRI).
The AI tool had “strong diagnostic performance to detect disease activity” (PHRI > 0) with an overall area under the receiver operating characteristic curve of 0.87 and sensitivity and specificity of 89% and 85%, respectively.
The researchers note that, while the AI tool was trained for the PHRI, its sensitivity for RHI and NHI histologic remission/activity was also high (94% and 89%, respectively).
Despite the different mix of severity grades, the AI model “maintained a good diagnostic performance, proving its applicability outside the original development setting,” they reported.
The AI tool could also predict the presence of endoscopic inflammation in the biopsy area with about 80% accuracy.
“Though imperfect, this result is consistent with human-assessed correlation between endoscopy and histology,” the researchers noted.
The model predicted the corresponding endoscopic remission/activity with 79% and 82% accuracy for UCEIS and PICaSSO, respectively.
The hazard ratios for disease flare-up between the AI system and pathologists assessed by PHRI was similar (4.64 and 3.56, respectively), “demonstrating the ability of the computer to stratify the risk of flare comparably well to pathologists,” they added.
Both histology and outcome prediction were confirmed in the external validation cohort.
The AI system delivered results in an average of 9.8 seconds per slide.
Potential ‘game changer’
UC is a “complex condition to predict, and developing machine learning–derived systems to make this diagnostic job quicker and more accurate could be a game changer,” Dr. Iacucci said in a news release.
With refinement, the AI tool will have an impact on both clinical trials and daily practice, the researchers wrote. In clinical practice, histological reporting remains “largely descriptive and nonstandard, thus would greatly benefit from a quick and objective assessment. Similarly, clinical trials in UC could efficiently overcome costly central readings.”
Assessing and measuring improvement in endoscopy and histology are difficult parts of treating UC, said David Hudesman, MD, codirector of the Inflammatory Bowel Disease Center at New York University Langone Health.
“We do not know how much improvement is associated with improved long-term outcomes,” Dr. Hudesman said in an interview. “For example, does a patient need complete healing or is 50% better enough?” Dr. Hudesman was not involved with the current research.
“This study showed that AI can predict – with good accuracy – endoscopy and histology scores, as well as 1-year patient outcomes. If this is validated in larger studies, AI can help determine if we should adjust/change therapies or continue, which is very important,” he said.
This research was supported by the National Institute for Health Research Birmingham Biomedical Research Centre. Dr. Iacucci and Dr. Hudesman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM GASTROENTEROLOGY
High school athletes sustaining worse injuries
High school students are injuring themselves more severely even as overall injury rates have declined, according to a new study presented at the annual meeting of the American Academy of Orthopaedic Surgeons.
The study compared injuries from a 4-year period ending in 2019 to data from 2005 and 2006. The overall rate of injuries dropped 9%, from 2.51 injuries per 1,000 athletic games or practices to 2.29 per 1,000; injuries requiring less than 1 week of recovery time fell by 13%. But, the number of head and neck injuries increased by 10%, injuries requiring surgery increased by 1%, and injuries leading to medical disqualification jumped by 11%.
“It’s wonderful that the injury rate is declining,” said Jordan Neoma Pizzarro, a medical student at George Washington University, Washington, who led the study. “But the data does suggest that the injuries that are happening are worse.”
The increases may also reflect increased education and awareness of how to detect concussions and other injuries that need medical attention, said Micah Lissy, MD, MS, an orthopedic surgeon specializing in sports medicine at Michigan State University, East Lansing. Dr. Lissy cautioned against physicians and others taking the data at face value.
“We need to be implementing preventive measures wherever possible, but I think we can also consider that there may be some confounding factors in the data,” Dr. Lissy told this news organization.
Ms. Pizzarro and her team analyzed data collected from athletic trainers at 100 high schools across the country for the ongoing National Health School Sports-Related Injury Surveillance Study.
Athletes participating in sports such as football, soccer, basketball, volleyball, and softball were included in the analysis. Trainers report the number of injuries for every competition and practice, also known as “athletic exposures.”
Boys’ football carried the highest injury rate, with 3.96 injuries per 1,000 AEs, amounting to 44% of all injuries reported. Girls’ soccer and boys’ wrestling followed, with injury rates of 2.65 and 1.56, respectively.
Sprains and strains accounted for 37% of injuries, followed by concussions (21.6%). The head and/or face was the most injured body site, followed by the ankles and/or knees. Most injuries took place during competitions rather than in practices (relative risk, 3.39; 95% confidence interval, 3.28-3.49; P < .05).
Ms. Pizzarro said that an overall increase in intensity, physical contact, and collisions may account for the spike in more severe injuries.
“Kids are encouraged to specialize in one sport early on and stick with it year-round,” she said. “They’re probably becoming more agile and better athletes, but they’re probably also getting more competitive.”
Dr. Lissy, who has worked with high school athletes as a surgeon, physical therapist, athletic trainer, and coach, said that some of the increases in severity of injuries may reflect trends in sports over the past two decades: Student athletes have become stronger and faster and have put on more muscle mass.
“When you have something that’s much larger, moving much faster and with more force, you’re going to have more force when you bump into things,” he said. “This can lead to more significant injuries.”
The study was independently supported. Study authors report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
High school students are injuring themselves more severely even as overall injury rates have declined, according to a new study presented at the annual meeting of the American Academy of Orthopaedic Surgeons.
The study compared injuries from a 4-year period ending in 2019 to data from 2005 and 2006. The overall rate of injuries dropped 9%, from 2.51 injuries per 1,000 athletic games or practices to 2.29 per 1,000; injuries requiring less than 1 week of recovery time fell by 13%. But, the number of head and neck injuries increased by 10%, injuries requiring surgery increased by 1%, and injuries leading to medical disqualification jumped by 11%.
“It’s wonderful that the injury rate is declining,” said Jordan Neoma Pizzarro, a medical student at George Washington University, Washington, who led the study. “But the data does suggest that the injuries that are happening are worse.”
The increases may also reflect increased education and awareness of how to detect concussions and other injuries that need medical attention, said Micah Lissy, MD, MS, an orthopedic surgeon specializing in sports medicine at Michigan State University, East Lansing. Dr. Lissy cautioned against physicians and others taking the data at face value.
“We need to be implementing preventive measures wherever possible, but I think we can also consider that there may be some confounding factors in the data,” Dr. Lissy told this news organization.
Ms. Pizzarro and her team analyzed data collected from athletic trainers at 100 high schools across the country for the ongoing National Health School Sports-Related Injury Surveillance Study.
Athletes participating in sports such as football, soccer, basketball, volleyball, and softball were included in the analysis. Trainers report the number of injuries for every competition and practice, also known as “athletic exposures.”
Boys’ football carried the highest injury rate, with 3.96 injuries per 1,000 AEs, amounting to 44% of all injuries reported. Girls’ soccer and boys’ wrestling followed, with injury rates of 2.65 and 1.56, respectively.
Sprains and strains accounted for 37% of injuries, followed by concussions (21.6%). The head and/or face was the most injured body site, followed by the ankles and/or knees. Most injuries took place during competitions rather than in practices (relative risk, 3.39; 95% confidence interval, 3.28-3.49; P < .05).
Ms. Pizzarro said that an overall increase in intensity, physical contact, and collisions may account for the spike in more severe injuries.
“Kids are encouraged to specialize in one sport early on and stick with it year-round,” she said. “They’re probably becoming more agile and better athletes, but they’re probably also getting more competitive.”
Dr. Lissy, who has worked with high school athletes as a surgeon, physical therapist, athletic trainer, and coach, said that some of the increases in severity of injuries may reflect trends in sports over the past two decades: Student athletes have become stronger and faster and have put on more muscle mass.
“When you have something that’s much larger, moving much faster and with more force, you’re going to have more force when you bump into things,” he said. “This can lead to more significant injuries.”
The study was independently supported. Study authors report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
High school students are injuring themselves more severely even as overall injury rates have declined, according to a new study presented at the annual meeting of the American Academy of Orthopaedic Surgeons.
The study compared injuries from a 4-year period ending in 2019 to data from 2005 and 2006. The overall rate of injuries dropped 9%, from 2.51 injuries per 1,000 athletic games or practices to 2.29 per 1,000; injuries requiring less than 1 week of recovery time fell by 13%. But, the number of head and neck injuries increased by 10%, injuries requiring surgery increased by 1%, and injuries leading to medical disqualification jumped by 11%.
“It’s wonderful that the injury rate is declining,” said Jordan Neoma Pizzarro, a medical student at George Washington University, Washington, who led the study. “But the data does suggest that the injuries that are happening are worse.”
The increases may also reflect increased education and awareness of how to detect concussions and other injuries that need medical attention, said Micah Lissy, MD, MS, an orthopedic surgeon specializing in sports medicine at Michigan State University, East Lansing. Dr. Lissy cautioned against physicians and others taking the data at face value.
“We need to be implementing preventive measures wherever possible, but I think we can also consider that there may be some confounding factors in the data,” Dr. Lissy told this news organization.
Ms. Pizzarro and her team analyzed data collected from athletic trainers at 100 high schools across the country for the ongoing National Health School Sports-Related Injury Surveillance Study.
Athletes participating in sports such as football, soccer, basketball, volleyball, and softball were included in the analysis. Trainers report the number of injuries for every competition and practice, also known as “athletic exposures.”
Boys’ football carried the highest injury rate, with 3.96 injuries per 1,000 AEs, amounting to 44% of all injuries reported. Girls’ soccer and boys’ wrestling followed, with injury rates of 2.65 and 1.56, respectively.
Sprains and strains accounted for 37% of injuries, followed by concussions (21.6%). The head and/or face was the most injured body site, followed by the ankles and/or knees. Most injuries took place during competitions rather than in practices (relative risk, 3.39; 95% confidence interval, 3.28-3.49; P < .05).
Ms. Pizzarro said that an overall increase in intensity, physical contact, and collisions may account for the spike in more severe injuries.
“Kids are encouraged to specialize in one sport early on and stick with it year-round,” she said. “They’re probably becoming more agile and better athletes, but they’re probably also getting more competitive.”
Dr. Lissy, who has worked with high school athletes as a surgeon, physical therapist, athletic trainer, and coach, said that some of the increases in severity of injuries may reflect trends in sports over the past two decades: Student athletes have become stronger and faster and have put on more muscle mass.
“When you have something that’s much larger, moving much faster and with more force, you’re going to have more force when you bump into things,” he said. “This can lead to more significant injuries.”
The study was independently supported. Study authors report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
What do I have? How to tell patients you’re not sure
Physicians often struggle with telling patients when they are unsure about a diagnosis. In the absence of clarity, doctors may fear losing a patient’s trust by appearing unsure.
Yet diagnostic uncertainty is an inevitable part of medicine.
“It’s often uncertain what is really going on. People have lots of unspecific symptoms,” said Gordon D. Schiff, MD, a patient safety researcher at Harvard Medical School and Brigham and Women’s Hospital in Boston.
By one estimate, more than one-third of patients are discharged from an emergency department without a clear diagnosis. Physicians may order more tests to try to resolve uncertainty, but this method is not foolproof and may lead to increased health care costs. Physicians can use an uncertain diagnosis as an opportunity to improve conversations with patients, Dr. Schiff said.
“How do you talk to patients about that? How do you convey that?” Dr. Schiff asked.
To begin to answer these questions, The scenarios included an enlarged lymph node in a patient in remission for lymphoma, which could suggest recurrence of the disease but not necessarily; a patient with a new-onset headache; and another patient with an unexplained fever and a respiratory tract infection.
For each vignette, the researchers also asked patient advocates – many of whom had experienced receiving an incorrect diagnosis – for their thoughts on how the conversation should go.
Almost 70 people were consulted (24 primary care physicians, 40 patients, and five experts in informatics and quality and safety). Dr. Schiff and his colleagues produced six standardized elements that should be part of a conversation whenever a diagnosis is unclear.
- The most likely diagnosis, along with any alternatives if this isn’t certain, with phrases such as, “Sometimes we don’t have the answers, but we will keep trying to figure out what is going on.”
- Next steps – lab tests, return visits, etc.
- Expected time frame for patient’s improvement and recovery.
- Full disclosure of the limitations of the physical examination or any lab tests.
- Ways to contact the physician going forward.
- Patient insights on their experience and reaction to what they just heard.
The researchers, who published their findings in JAMA Network Open, recommend that the conversation be transcribed in real time using voice recognition software and a microphone, and then printed for the patient to take home. The physician should make eye contact with the patient during the conversation, they suggested.
“Patients felt it was a conversation, that they actually understood what was said. Most patients felt like they were partners during the encounter,” said Maram Khazen, PhD, a coauthor of the paper, who studies communication dynamics. Dr. Khazen was a visiting postdoctoral fellow with Dr. Schiff during the study, and is now a lecturer at the Max Stern Yezreel Valley College in Israel.
Hardeep Singh, MD, MPH, a patient safety researcher at the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, called the new work “a great start,” but said that the complexity of the field warrants more research into the tool. Dr. Singh was not involved in the study.
Dr. Singh pointed out that many of the patient voices came from spokespeople for advocacy groups, and that these participants are not necessarily representative of actual people with unclear diagnoses.
“The choice of words really matters,” said Dr. Singh, who led a 2018 study that showed that people reacted more negatively when physicians bluntly acknowledged uncertainty than when they walked patients through different possible diagnoses. Dr. Schiff and Dr. Khazen’s framework offers good principles for discussing uncertainty, he added, but further research is needed on the optimal language to use during conversations.
“It’s really encouraging that we’re seeing high-quality research like this, that leverages patient engagement principles,” said Dimitrios Papanagnou, MD, MPH, an emergency medicine physician and vice dean of medicine at Thomas Jefferson University in Philadelphia.
Dr. Papanagnou, who was not part of the study, called for diverse patients to be part of conversations about diagnostic uncertainty.
“Are we having patients from diverse experiences, from underrepresented groups, participate in this kind of work?” Dr. Papanagnou asked. Dr. Schiff and Dr. Khazen said they agree that the tool needs to be tested in larger samples of diverse patients.
Some common themes about how to communicate diagnostic uncertainty are emerging in multiple areas of medicine. Dr. Papanagnou helped develop an uncertainty communication checklist for discharging patients from an emergency department to home, with principles similar to those that Dr. Schiff and Dr. Khazen recommend for primary care providers.
The study was funded by Harvard Hospitals’ malpractice insurer, the Controlled Risk Insurance Company. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physicians often struggle with telling patients when they are unsure about a diagnosis. In the absence of clarity, doctors may fear losing a patient’s trust by appearing unsure.
Yet diagnostic uncertainty is an inevitable part of medicine.
“It’s often uncertain what is really going on. People have lots of unspecific symptoms,” said Gordon D. Schiff, MD, a patient safety researcher at Harvard Medical School and Brigham and Women’s Hospital in Boston.
By one estimate, more than one-third of patients are discharged from an emergency department without a clear diagnosis. Physicians may order more tests to try to resolve uncertainty, but this method is not foolproof and may lead to increased health care costs. Physicians can use an uncertain diagnosis as an opportunity to improve conversations with patients, Dr. Schiff said.
“How do you talk to patients about that? How do you convey that?” Dr. Schiff asked.
To begin to answer these questions, The scenarios included an enlarged lymph node in a patient in remission for lymphoma, which could suggest recurrence of the disease but not necessarily; a patient with a new-onset headache; and another patient with an unexplained fever and a respiratory tract infection.
For each vignette, the researchers also asked patient advocates – many of whom had experienced receiving an incorrect diagnosis – for their thoughts on how the conversation should go.
Almost 70 people were consulted (24 primary care physicians, 40 patients, and five experts in informatics and quality and safety). Dr. Schiff and his colleagues produced six standardized elements that should be part of a conversation whenever a diagnosis is unclear.
- The most likely diagnosis, along with any alternatives if this isn’t certain, with phrases such as, “Sometimes we don’t have the answers, but we will keep trying to figure out what is going on.”
- Next steps – lab tests, return visits, etc.
- Expected time frame for patient’s improvement and recovery.
- Full disclosure of the limitations of the physical examination or any lab tests.
- Ways to contact the physician going forward.
- Patient insights on their experience and reaction to what they just heard.
The researchers, who published their findings in JAMA Network Open, recommend that the conversation be transcribed in real time using voice recognition software and a microphone, and then printed for the patient to take home. The physician should make eye contact with the patient during the conversation, they suggested.
“Patients felt it was a conversation, that they actually understood what was said. Most patients felt like they were partners during the encounter,” said Maram Khazen, PhD, a coauthor of the paper, who studies communication dynamics. Dr. Khazen was a visiting postdoctoral fellow with Dr. Schiff during the study, and is now a lecturer at the Max Stern Yezreel Valley College in Israel.
Hardeep Singh, MD, MPH, a patient safety researcher at the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, called the new work “a great start,” but said that the complexity of the field warrants more research into the tool. Dr. Singh was not involved in the study.
Dr. Singh pointed out that many of the patient voices came from spokespeople for advocacy groups, and that these participants are not necessarily representative of actual people with unclear diagnoses.
“The choice of words really matters,” said Dr. Singh, who led a 2018 study that showed that people reacted more negatively when physicians bluntly acknowledged uncertainty than when they walked patients through different possible diagnoses. Dr. Schiff and Dr. Khazen’s framework offers good principles for discussing uncertainty, he added, but further research is needed on the optimal language to use during conversations.
“It’s really encouraging that we’re seeing high-quality research like this, that leverages patient engagement principles,” said Dimitrios Papanagnou, MD, MPH, an emergency medicine physician and vice dean of medicine at Thomas Jefferson University in Philadelphia.
Dr. Papanagnou, who was not part of the study, called for diverse patients to be part of conversations about diagnostic uncertainty.
“Are we having patients from diverse experiences, from underrepresented groups, participate in this kind of work?” Dr. Papanagnou asked. Dr. Schiff and Dr. Khazen said they agree that the tool needs to be tested in larger samples of diverse patients.
Some common themes about how to communicate diagnostic uncertainty are emerging in multiple areas of medicine. Dr. Papanagnou helped develop an uncertainty communication checklist for discharging patients from an emergency department to home, with principles similar to those that Dr. Schiff and Dr. Khazen recommend for primary care providers.
The study was funded by Harvard Hospitals’ malpractice insurer, the Controlled Risk Insurance Company. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physicians often struggle with telling patients when they are unsure about a diagnosis. In the absence of clarity, doctors may fear losing a patient’s trust by appearing unsure.
Yet diagnostic uncertainty is an inevitable part of medicine.
“It’s often uncertain what is really going on. People have lots of unspecific symptoms,” said Gordon D. Schiff, MD, a patient safety researcher at Harvard Medical School and Brigham and Women’s Hospital in Boston.
By one estimate, more than one-third of patients are discharged from an emergency department without a clear diagnosis. Physicians may order more tests to try to resolve uncertainty, but this method is not foolproof and may lead to increased health care costs. Physicians can use an uncertain diagnosis as an opportunity to improve conversations with patients, Dr. Schiff said.
“How do you talk to patients about that? How do you convey that?” Dr. Schiff asked.
To begin to answer these questions, The scenarios included an enlarged lymph node in a patient in remission for lymphoma, which could suggest recurrence of the disease but not necessarily; a patient with a new-onset headache; and another patient with an unexplained fever and a respiratory tract infection.
For each vignette, the researchers also asked patient advocates – many of whom had experienced receiving an incorrect diagnosis – for their thoughts on how the conversation should go.
Almost 70 people were consulted (24 primary care physicians, 40 patients, and five experts in informatics and quality and safety). Dr. Schiff and his colleagues produced six standardized elements that should be part of a conversation whenever a diagnosis is unclear.
- The most likely diagnosis, along with any alternatives if this isn’t certain, with phrases such as, “Sometimes we don’t have the answers, but we will keep trying to figure out what is going on.”
- Next steps – lab tests, return visits, etc.
- Expected time frame for patient’s improvement and recovery.
- Full disclosure of the limitations of the physical examination or any lab tests.
- Ways to contact the physician going forward.
- Patient insights on their experience and reaction to what they just heard.
The researchers, who published their findings in JAMA Network Open, recommend that the conversation be transcribed in real time using voice recognition software and a microphone, and then printed for the patient to take home. The physician should make eye contact with the patient during the conversation, they suggested.
“Patients felt it was a conversation, that they actually understood what was said. Most patients felt like they were partners during the encounter,” said Maram Khazen, PhD, a coauthor of the paper, who studies communication dynamics. Dr. Khazen was a visiting postdoctoral fellow with Dr. Schiff during the study, and is now a lecturer at the Max Stern Yezreel Valley College in Israel.
Hardeep Singh, MD, MPH, a patient safety researcher at the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, called the new work “a great start,” but said that the complexity of the field warrants more research into the tool. Dr. Singh was not involved in the study.
Dr. Singh pointed out that many of the patient voices came from spokespeople for advocacy groups, and that these participants are not necessarily representative of actual people with unclear diagnoses.
“The choice of words really matters,” said Dr. Singh, who led a 2018 study that showed that people reacted more negatively when physicians bluntly acknowledged uncertainty than when they walked patients through different possible diagnoses. Dr. Schiff and Dr. Khazen’s framework offers good principles for discussing uncertainty, he added, but further research is needed on the optimal language to use during conversations.
“It’s really encouraging that we’re seeing high-quality research like this, that leverages patient engagement principles,” said Dimitrios Papanagnou, MD, MPH, an emergency medicine physician and vice dean of medicine at Thomas Jefferson University in Philadelphia.
Dr. Papanagnou, who was not part of the study, called for diverse patients to be part of conversations about diagnostic uncertainty.
“Are we having patients from diverse experiences, from underrepresented groups, participate in this kind of work?” Dr. Papanagnou asked. Dr. Schiff and Dr. Khazen said they agree that the tool needs to be tested in larger samples of diverse patients.
Some common themes about how to communicate diagnostic uncertainty are emerging in multiple areas of medicine. Dr. Papanagnou helped develop an uncertainty communication checklist for discharging patients from an emergency department to home, with principles similar to those that Dr. Schiff and Dr. Khazen recommend for primary care providers.
The study was funded by Harvard Hospitals’ malpractice insurer, the Controlled Risk Insurance Company. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Spinosad: New kid on the block for treating scabies
HONOLULU – , Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!
In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.
“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”
The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.
The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.
In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.
“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.
Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later . Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.
“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”
According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.
Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.
Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).
Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).
“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”
In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.
Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.
Medscape and this news organization are owned by the same parent company.
HONOLULU – , Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!
In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.
“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”
The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.
The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.
In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.
“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.
Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later . Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.
“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”
According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.
Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.
Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).
Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).
“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”
In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.
Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.
Medscape and this news organization are owned by the same parent company.
HONOLULU – , Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!
In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.
“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”
The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.
The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.
In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.
“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.
Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later . Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.
“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”
According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.
Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.
Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).
Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).
“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”
In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.
Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.
Medscape and this news organization are owned by the same parent company.
AT THE MEDSCAPELIVE! HAWAII DERMATOLOGY SEMINAR
Antioxidants may ease anxiety and depression
The prevalence of anxiety and depression has increased worldwide, especially in the wake of the COVID-19 pandemic. “Therefore, identifying specific interventions that improve depressive status is critical for public health policy,” wrote Huan Wang, MD, of First Hospital of Jilin University, Changchun, China, and colleagues.
Recent evidence suggests that modifiable lifestyle factors, including nutrition, may have a positive impact on symptoms of anxiety and depression, and observational studies have shown that antioxidant supplements affect depressive status, but data from randomized, controlled trials are limited by small sample sizes, they wrote.
In a study published in the Journal of Affective Disorders, the researchers conducted a meta-analysis of 52 studies with a total of 4,049 patients. Of these, 2,004 received antioxidant supplements and 2,045 received a placebo supplement or no supplements. The median treatment duration was 11 weeks; treatment durations ranged from 2 weeks to 2 years. All 52 studies addressed the effect of antioxidants on depressive status, and 21 studies also assessed anxiety status. The studies used a range of depression scales, including the Beck Depression Inventory, the Edinburgh Postnatal Depression Scale, Montgomery-Asberg Depression Rating Scale, Hamilton Depression Rating Scale, Center for Epidemiologic Studies–Depression, and Hospital Anxiety and Depression Scale.
Overall, the meta-analysis revealed a statistically significant improvement in depressive status associated with antioxidant supplement use (standardized mean difference, 0.60; P < .00001). When broken down by supplement, significant positive effects appeared for magnesium (SMD = 0.16; P = .03), zinc (SMD = 0.59; P = .01), selenium (SMD = 0.33; P = .009), CoQ10 (SMD = 0.97; P = .05), tea and coffee (SMD = 1.15; P = .001) and crocin (MD = 6.04; P < .00001).
As a secondary outcome, antioxidant supplementation had a significantly positive effect on anxiety (SMD = 0.40; P < .00001).
The mechanism of action for the effect of antioxidants remains unclear, the researchers wrote in their discussion, but, “Depriving or boosting the supply of food components with antioxidant capabilities might worsen or lessen oxidative stress,” they said.
The researchers attempted a subgroup analysis across countries, and found that, while antioxidant supplementation improved depressive status in populations from Iran, China, and Italy, “no significant improvement was found in the United States, Australia, Italy and other countries.” The reasons for this difference might be related to fewer studies from these countries, or “the improvement brought about by antioxidants might be particularly pronounced in people with significant depression and higher depression scores,” they wrote. “Studies have shown that Asian countries have fewer psychiatrists and more expensive treatments,” they added.
The findings were limited by several factors including the inability to include all types of antioxidant supplements, the range of depression rating scales, and insufficient subgroup analysis of the range of populations from the included studies, the researchers noted.
“Additional data from large clinical trials are needed to confirm the efficacy and safety of antioxidant supplements in improving depressive status,” they said. However, the results suggest that antioxidants may play a role as an adjunct treatment to conventional antidepressants, they concluded.
The study was funded by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
The prevalence of anxiety and depression has increased worldwide, especially in the wake of the COVID-19 pandemic. “Therefore, identifying specific interventions that improve depressive status is critical for public health policy,” wrote Huan Wang, MD, of First Hospital of Jilin University, Changchun, China, and colleagues.
Recent evidence suggests that modifiable lifestyle factors, including nutrition, may have a positive impact on symptoms of anxiety and depression, and observational studies have shown that antioxidant supplements affect depressive status, but data from randomized, controlled trials are limited by small sample sizes, they wrote.
In a study published in the Journal of Affective Disorders, the researchers conducted a meta-analysis of 52 studies with a total of 4,049 patients. Of these, 2,004 received antioxidant supplements and 2,045 received a placebo supplement or no supplements. The median treatment duration was 11 weeks; treatment durations ranged from 2 weeks to 2 years. All 52 studies addressed the effect of antioxidants on depressive status, and 21 studies also assessed anxiety status. The studies used a range of depression scales, including the Beck Depression Inventory, the Edinburgh Postnatal Depression Scale, Montgomery-Asberg Depression Rating Scale, Hamilton Depression Rating Scale, Center for Epidemiologic Studies–Depression, and Hospital Anxiety and Depression Scale.
Overall, the meta-analysis revealed a statistically significant improvement in depressive status associated with antioxidant supplement use (standardized mean difference, 0.60; P < .00001). When broken down by supplement, significant positive effects appeared for magnesium (SMD = 0.16; P = .03), zinc (SMD = 0.59; P = .01), selenium (SMD = 0.33; P = .009), CoQ10 (SMD = 0.97; P = .05), tea and coffee (SMD = 1.15; P = .001) and crocin (MD = 6.04; P < .00001).
As a secondary outcome, antioxidant supplementation had a significantly positive effect on anxiety (SMD = 0.40; P < .00001).
The mechanism of action for the effect of antioxidants remains unclear, the researchers wrote in their discussion, but, “Depriving or boosting the supply of food components with antioxidant capabilities might worsen or lessen oxidative stress,” they said.
The researchers attempted a subgroup analysis across countries, and found that, while antioxidant supplementation improved depressive status in populations from Iran, China, and Italy, “no significant improvement was found in the United States, Australia, Italy and other countries.” The reasons for this difference might be related to fewer studies from these countries, or “the improvement brought about by antioxidants might be particularly pronounced in people with significant depression and higher depression scores,” they wrote. “Studies have shown that Asian countries have fewer psychiatrists and more expensive treatments,” they added.
The findings were limited by several factors including the inability to include all types of antioxidant supplements, the range of depression rating scales, and insufficient subgroup analysis of the range of populations from the included studies, the researchers noted.
“Additional data from large clinical trials are needed to confirm the efficacy and safety of antioxidant supplements in improving depressive status,” they said. However, the results suggest that antioxidants may play a role as an adjunct treatment to conventional antidepressants, they concluded.
The study was funded by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
The prevalence of anxiety and depression has increased worldwide, especially in the wake of the COVID-19 pandemic. “Therefore, identifying specific interventions that improve depressive status is critical for public health policy,” wrote Huan Wang, MD, of First Hospital of Jilin University, Changchun, China, and colleagues.
Recent evidence suggests that modifiable lifestyle factors, including nutrition, may have a positive impact on symptoms of anxiety and depression, and observational studies have shown that antioxidant supplements affect depressive status, but data from randomized, controlled trials are limited by small sample sizes, they wrote.
In a study published in the Journal of Affective Disorders, the researchers conducted a meta-analysis of 52 studies with a total of 4,049 patients. Of these, 2,004 received antioxidant supplements and 2,045 received a placebo supplement or no supplements. The median treatment duration was 11 weeks; treatment durations ranged from 2 weeks to 2 years. All 52 studies addressed the effect of antioxidants on depressive status, and 21 studies also assessed anxiety status. The studies used a range of depression scales, including the Beck Depression Inventory, the Edinburgh Postnatal Depression Scale, Montgomery-Asberg Depression Rating Scale, Hamilton Depression Rating Scale, Center for Epidemiologic Studies–Depression, and Hospital Anxiety and Depression Scale.
Overall, the meta-analysis revealed a statistically significant improvement in depressive status associated with antioxidant supplement use (standardized mean difference, 0.60; P < .00001). When broken down by supplement, significant positive effects appeared for magnesium (SMD = 0.16; P = .03), zinc (SMD = 0.59; P = .01), selenium (SMD = 0.33; P = .009), CoQ10 (SMD = 0.97; P = .05), tea and coffee (SMD = 1.15; P = .001) and crocin (MD = 6.04; P < .00001).
As a secondary outcome, antioxidant supplementation had a significantly positive effect on anxiety (SMD = 0.40; P < .00001).
The mechanism of action for the effect of antioxidants remains unclear, the researchers wrote in their discussion, but, “Depriving or boosting the supply of food components with antioxidant capabilities might worsen or lessen oxidative stress,” they said.
The researchers attempted a subgroup analysis across countries, and found that, while antioxidant supplementation improved depressive status in populations from Iran, China, and Italy, “no significant improvement was found in the United States, Australia, Italy and other countries.” The reasons for this difference might be related to fewer studies from these countries, or “the improvement brought about by antioxidants might be particularly pronounced in people with significant depression and higher depression scores,” they wrote. “Studies have shown that Asian countries have fewer psychiatrists and more expensive treatments,” they added.
The findings were limited by several factors including the inability to include all types of antioxidant supplements, the range of depression rating scales, and insufficient subgroup analysis of the range of populations from the included studies, the researchers noted.
“Additional data from large clinical trials are needed to confirm the efficacy and safety of antioxidant supplements in improving depressive status,” they said. However, the results suggest that antioxidants may play a role as an adjunct treatment to conventional antidepressants, they concluded.
The study was funded by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
FDA OKs first drug for Rett syndrome
Rett syndrome is a rare, genetic neurodevelopmental disorder that affects about 6,000-9,000 people in the United States, mostly females.
Symptoms typically present between 6 and 18 months of age, with patients experiencing a rapid decline with loss of fine motor and communication skills.
Trofinetide is a synthetic analogue of the amino-terminal tripeptide of insulinlike growth factor-1 (IGF-1), which occurs naturally in the brain. The drug is designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
The approval of trofinetide was supported by results from the pivotal phase 3 LAVENDER study that tested the efficacy and safety of trofinetide vs. placebo in 187 female patients with Rett syndrome, aged 5-20 years.
A total of 93 participants were randomly assigned to twice-daily oral trofinetide, and 94 received placebo for 12 weeks.
After 12 weeks, trofinetide showed a statistically significant improvement from baseline, compared with placebo, on both the caregiver-assessed Rett Syndrome Behavior Questionnaire (RSBQ) and 7-point Clinical Global Impression-Improvement (CGI-I) scale.
The drug also outperformed placebo at 12 weeks in a key secondary endpoint: the composite score on the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist-Social (CSBS-DP-IT Social), a scale on which caregivers assess nonverbal communication.
The most common adverse events with trofinetide treatment were diarrhea and vomiting. Almost all these events were considered mild or moderate.
‘Historic day’
“This is a historic day for the Rett syndrome community and a meaningful moment for the patients and caregivers who have eagerly awaited the arrival of an approved treatment for this condition,” Melissa Kennedy, MHA, chief executive officer of the International Rett Syndrome Foundation, said in a news release issued by Acadia.
“Rett syndrome is a complicated, devastating disease that affects not only the individual patient, but whole families. With today’s FDA decision, those impacted by Rett have a promising new treatment option that has demonstrated benefit across a variety of Rett symptoms, including those that impact the daily lives of those living with Rett and their loved ones,” Ms. Kennedy said.
Trofinetide is expected to be available in the United States by the end of April.
A version of this article first appeared on Medscape.com.
Rett syndrome is a rare, genetic neurodevelopmental disorder that affects about 6,000-9,000 people in the United States, mostly females.
Symptoms typically present between 6 and 18 months of age, with patients experiencing a rapid decline with loss of fine motor and communication skills.
Trofinetide is a synthetic analogue of the amino-terminal tripeptide of insulinlike growth factor-1 (IGF-1), which occurs naturally in the brain. The drug is designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
The approval of trofinetide was supported by results from the pivotal phase 3 LAVENDER study that tested the efficacy and safety of trofinetide vs. placebo in 187 female patients with Rett syndrome, aged 5-20 years.
A total of 93 participants were randomly assigned to twice-daily oral trofinetide, and 94 received placebo for 12 weeks.
After 12 weeks, trofinetide showed a statistically significant improvement from baseline, compared with placebo, on both the caregiver-assessed Rett Syndrome Behavior Questionnaire (RSBQ) and 7-point Clinical Global Impression-Improvement (CGI-I) scale.
The drug also outperformed placebo at 12 weeks in a key secondary endpoint: the composite score on the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist-Social (CSBS-DP-IT Social), a scale on which caregivers assess nonverbal communication.
The most common adverse events with trofinetide treatment were diarrhea and vomiting. Almost all these events were considered mild or moderate.
‘Historic day’
“This is a historic day for the Rett syndrome community and a meaningful moment for the patients and caregivers who have eagerly awaited the arrival of an approved treatment for this condition,” Melissa Kennedy, MHA, chief executive officer of the International Rett Syndrome Foundation, said in a news release issued by Acadia.
“Rett syndrome is a complicated, devastating disease that affects not only the individual patient, but whole families. With today’s FDA decision, those impacted by Rett have a promising new treatment option that has demonstrated benefit across a variety of Rett symptoms, including those that impact the daily lives of those living with Rett and their loved ones,” Ms. Kennedy said.
Trofinetide is expected to be available in the United States by the end of April.
A version of this article first appeared on Medscape.com.
Rett syndrome is a rare, genetic neurodevelopmental disorder that affects about 6,000-9,000 people in the United States, mostly females.
Symptoms typically present between 6 and 18 months of age, with patients experiencing a rapid decline with loss of fine motor and communication skills.
Trofinetide is a synthetic analogue of the amino-terminal tripeptide of insulinlike growth factor-1 (IGF-1), which occurs naturally in the brain. The drug is designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
The approval of trofinetide was supported by results from the pivotal phase 3 LAVENDER study that tested the efficacy and safety of trofinetide vs. placebo in 187 female patients with Rett syndrome, aged 5-20 years.
A total of 93 participants were randomly assigned to twice-daily oral trofinetide, and 94 received placebo for 12 weeks.
After 12 weeks, trofinetide showed a statistically significant improvement from baseline, compared with placebo, on both the caregiver-assessed Rett Syndrome Behavior Questionnaire (RSBQ) and 7-point Clinical Global Impression-Improvement (CGI-I) scale.
The drug also outperformed placebo at 12 weeks in a key secondary endpoint: the composite score on the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist-Social (CSBS-DP-IT Social), a scale on which caregivers assess nonverbal communication.
The most common adverse events with trofinetide treatment were diarrhea and vomiting. Almost all these events were considered mild or moderate.
‘Historic day’
“This is a historic day for the Rett syndrome community and a meaningful moment for the patients and caregivers who have eagerly awaited the arrival of an approved treatment for this condition,” Melissa Kennedy, MHA, chief executive officer of the International Rett Syndrome Foundation, said in a news release issued by Acadia.
“Rett syndrome is a complicated, devastating disease that affects not only the individual patient, but whole families. With today’s FDA decision, those impacted by Rett have a promising new treatment option that has demonstrated benefit across a variety of Rett symptoms, including those that impact the daily lives of those living with Rett and their loved ones,” Ms. Kennedy said.
Trofinetide is expected to be available in the United States by the end of April.
A version of this article first appeared on Medscape.com.
Children and COVID: A look back as the fourth year begins
With 3 years of the COVID-19 experience now past, it’s safe to say that SARS-CoV-2 changed American society in ways that could not have been predicted when the first U.S. cases were reported in January of 2020.
Who would have guessed back then that not one but two vaccines would be developed, approved, and widely distributed before the end of the year? Or that those vaccines would be rejected by large segments of the population on ideological grounds? Could anyone have predicted in early 2020 that schools in 21 states would be forbidden by law to require COVID-19 vaccination in students?
Vaccination is generally considered to be an activity of childhood, but that practice has been turned upside down with COVID-19. Among Americans aged 65 years and older, 95% have received at least one dose of vaccine, versus 27.9% of children younger than 12 years old, according to the Centers for Disease Control and Prevention.
The vaccine situation for children mirrors that of the population as a whole. The oldest children have the highest vaccination rates, and the rates decline along with age: 72.0% of those aged 12-17 years have received at least one dose, compared with 39.8% of 5- to 11-year-olds, 10.5% of 2- to 4-year-olds, and 8.0% of children under age 2, the CDC said on its COVID Data Tracker.
The youngest children were, of course, the last ones to be eligible for the vaccine, but their uptake has been much slower since emergency use was authorized in June of 2022. In the nearly 9 months since then, 9.5% of children aged 4 and under have received at least one dose, versus 66% of children aged 12-15 years in the first 9 months (May 2021 to March 2022).
Altogether, a total of 31.7 million, or 43%, of all children under age 18 had received at least one dose of COVID-19 vaccine as of March 8, 2023, according to the most recent CDC data.
Incidence: Counting COVID
Vaccination and other prevention efforts have tried to stem the tide, but what has COVID actually done to children since the Trump administration declared a nationwide emergency on March 13, 2020?
- 16.6 million cases.
- 186,035 new hospital admissions.
- 2,122 deaths.
Even the proportion of total COVID cases in children, 17.2%, is less than might be expected, given their relatively undervaccinated status.
Seroprevalence estimates seem to support the undercounting of pediatric cases. A survey of commercial laboratories working with the CDC put the seroprevalance of SARS-CoV-2 antibodies in children at 96.3% as of late 2022, based on tests of almost 27,000 specimens performed over an 8-week period from mid-October to mid-December. That would put the number of infected children at 65.7 million children.
Since Omicron
There has not been another major COVID-19 surge since the winter of 2021-2022, when the weekly rate of new cases reached 1,900 per 100,000 population in children aged 16-17 years in early January 2022 – the highest seen among children of any of the CDC’s age groups (0-4, 5-11, 12-15, 16-17) during the entire pandemic. Since the Omicron surge, the highest weekly rate was 221 per 100,000 during the week of May 15-21, again in 16- to 17-year-olds, the CDC reports.
The widely anticipated surge of COVID in the fall and winter of 2022 and 2023 – the so-called “tripledemic” involving influenza and respiratory syncytial virus – did not occur, possibly because so many Americans were vaccinated or previously infected, experts suggested. New-case rates, emergency room visits, and hospitalizations in children have continued to drop as winter comes to a close, CDC data show.
With 3 years of the COVID-19 experience now past, it’s safe to say that SARS-CoV-2 changed American society in ways that could not have been predicted when the first U.S. cases were reported in January of 2020.
Who would have guessed back then that not one but two vaccines would be developed, approved, and widely distributed before the end of the year? Or that those vaccines would be rejected by large segments of the population on ideological grounds? Could anyone have predicted in early 2020 that schools in 21 states would be forbidden by law to require COVID-19 vaccination in students?
Vaccination is generally considered to be an activity of childhood, but that practice has been turned upside down with COVID-19. Among Americans aged 65 years and older, 95% have received at least one dose of vaccine, versus 27.9% of children younger than 12 years old, according to the Centers for Disease Control and Prevention.
The vaccine situation for children mirrors that of the population as a whole. The oldest children have the highest vaccination rates, and the rates decline along with age: 72.0% of those aged 12-17 years have received at least one dose, compared with 39.8% of 5- to 11-year-olds, 10.5% of 2- to 4-year-olds, and 8.0% of children under age 2, the CDC said on its COVID Data Tracker.
The youngest children were, of course, the last ones to be eligible for the vaccine, but their uptake has been much slower since emergency use was authorized in June of 2022. In the nearly 9 months since then, 9.5% of children aged 4 and under have received at least one dose, versus 66% of children aged 12-15 years in the first 9 months (May 2021 to March 2022).
Altogether, a total of 31.7 million, or 43%, of all children under age 18 had received at least one dose of COVID-19 vaccine as of March 8, 2023, according to the most recent CDC data.
Incidence: Counting COVID
Vaccination and other prevention efforts have tried to stem the tide, but what has COVID actually done to children since the Trump administration declared a nationwide emergency on March 13, 2020?
- 16.6 million cases.
- 186,035 new hospital admissions.
- 2,122 deaths.
Even the proportion of total COVID cases in children, 17.2%, is less than might be expected, given their relatively undervaccinated status.
Seroprevalence estimates seem to support the undercounting of pediatric cases. A survey of commercial laboratories working with the CDC put the seroprevalance of SARS-CoV-2 antibodies in children at 96.3% as of late 2022, based on tests of almost 27,000 specimens performed over an 8-week period from mid-October to mid-December. That would put the number of infected children at 65.7 million children.
Since Omicron
There has not been another major COVID-19 surge since the winter of 2021-2022, when the weekly rate of new cases reached 1,900 per 100,000 population in children aged 16-17 years in early January 2022 – the highest seen among children of any of the CDC’s age groups (0-4, 5-11, 12-15, 16-17) during the entire pandemic. Since the Omicron surge, the highest weekly rate was 221 per 100,000 during the week of May 15-21, again in 16- to 17-year-olds, the CDC reports.
The widely anticipated surge of COVID in the fall and winter of 2022 and 2023 – the so-called “tripledemic” involving influenza and respiratory syncytial virus – did not occur, possibly because so many Americans were vaccinated or previously infected, experts suggested. New-case rates, emergency room visits, and hospitalizations in children have continued to drop as winter comes to a close, CDC data show.
With 3 years of the COVID-19 experience now past, it’s safe to say that SARS-CoV-2 changed American society in ways that could not have been predicted when the first U.S. cases were reported in January of 2020.
Who would have guessed back then that not one but two vaccines would be developed, approved, and widely distributed before the end of the year? Or that those vaccines would be rejected by large segments of the population on ideological grounds? Could anyone have predicted in early 2020 that schools in 21 states would be forbidden by law to require COVID-19 vaccination in students?
Vaccination is generally considered to be an activity of childhood, but that practice has been turned upside down with COVID-19. Among Americans aged 65 years and older, 95% have received at least one dose of vaccine, versus 27.9% of children younger than 12 years old, according to the Centers for Disease Control and Prevention.
The vaccine situation for children mirrors that of the population as a whole. The oldest children have the highest vaccination rates, and the rates decline along with age: 72.0% of those aged 12-17 years have received at least one dose, compared with 39.8% of 5- to 11-year-olds, 10.5% of 2- to 4-year-olds, and 8.0% of children under age 2, the CDC said on its COVID Data Tracker.
The youngest children were, of course, the last ones to be eligible for the vaccine, but their uptake has been much slower since emergency use was authorized in June of 2022. In the nearly 9 months since then, 9.5% of children aged 4 and under have received at least one dose, versus 66% of children aged 12-15 years in the first 9 months (May 2021 to March 2022).
Altogether, a total of 31.7 million, or 43%, of all children under age 18 had received at least one dose of COVID-19 vaccine as of March 8, 2023, according to the most recent CDC data.
Incidence: Counting COVID
Vaccination and other prevention efforts have tried to stem the tide, but what has COVID actually done to children since the Trump administration declared a nationwide emergency on March 13, 2020?
- 16.6 million cases.
- 186,035 new hospital admissions.
- 2,122 deaths.
Even the proportion of total COVID cases in children, 17.2%, is less than might be expected, given their relatively undervaccinated status.
Seroprevalence estimates seem to support the undercounting of pediatric cases. A survey of commercial laboratories working with the CDC put the seroprevalance of SARS-CoV-2 antibodies in children at 96.3% as of late 2022, based on tests of almost 27,000 specimens performed over an 8-week period from mid-October to mid-December. That would put the number of infected children at 65.7 million children.
Since Omicron
There has not been another major COVID-19 surge since the winter of 2021-2022, when the weekly rate of new cases reached 1,900 per 100,000 population in children aged 16-17 years in early January 2022 – the highest seen among children of any of the CDC’s age groups (0-4, 5-11, 12-15, 16-17) during the entire pandemic. Since the Omicron surge, the highest weekly rate was 221 per 100,000 during the week of May 15-21, again in 16- to 17-year-olds, the CDC reports.
The widely anticipated surge of COVID in the fall and winter of 2022 and 2023 – the so-called “tripledemic” involving influenza and respiratory syncytial virus – did not occur, possibly because so many Americans were vaccinated or previously infected, experts suggested. New-case rates, emergency room visits, and hospitalizations in children have continued to drop as winter comes to a close, CDC data show.
Strong support for CBT as first-line treatment for insomnia in seniors
NEW ORLEANS –
“The lack of awareness among clinicians who take care of older adults that CBT for insomnia (CBT-I) is an effective treatment for insomnia is an issue,” Rajesh R. Tampi, MD, professor and chairman of the department of psychiatry, Creighton University, Omaha, Neb., told this news organization.
Dr. Tampi was among the speakers during a session as part of the American Association for Geriatric Psychiatry annual meeting addressing the complex challenges of treating insomnia in older patients, who tend to have higher rates of insomnia than their younger counterparts.
The prevalence of insomnia in older adults is estimated to be 20%-40%, and medication is frequently the first treatment choice, a less than ideal approach, said Dr. Tampi.
“Prescribing sedatives and hypnotics, which can cause severe adverse effects, without a thorough assessment that includes comorbidities that may be causing the insomnia” is among the biggest mistakes clinicians make in the treatment of insomnia in older patients, Dr. Tampi said in an interview.
“It’s our duty as providers to first take a good assessment, talk about polymorbidity, and try to address those conditions, and judiciously use medications in conjunction with at least components of CBT-I,” he said.
Long-term safety, efficacy unclear
About one-third of older adults take at least one form of pharmacological treatment for insomnia symptoms, said Ebony Dix, MD, assistant professor of psychiatry at Yale University, New Haven, Conn., in a separate talk during the session. This, despite the low-risk profile of CBT and recommendations from various medical societies that CBT should be tried first.
Dr. Dix noted that medications approved for insomnia by the U.S. Food and Drug Administration, including melatonin receptor agonists, heterocyclics, and dual orexin receptor antagonists (DORAs), can play an important role in the short-term management of insomnia, but their long-term effects are unknown.
“Pharmacotherapeutic agents may be effective in the short term, but there is a lack of sufficient, statistically significant data to support the long-term safety and efficacy of any [sleep] medication, especially in aging adults, due to the impact of hypnotic drugs on sleep architecture, the impact of aging on pharmacokinetics, as well as polypharmacy and drug-to-drug interactions,” Dr. Dix said. She noted that clinical trials of insomnia drugs rarely include geriatric patients.
The American Academy of Sleep Medicine recommends CBT-I as first-line treatment for insomnia, with the key benefit being its exemplary safety profile, said Shilpa Srinivasan, MD, a professor of clinical psychiatry at the University of South Carolina, Columbia, who also presented during the session.
“The biggest [attribute] of CBT-I management strategies is the low risk of side effects,” she said. “How many medications can we say that about?”
The CBT-I intervention includes a focus on key components of lifestyle and mental health issues to improve sleep. These include the following:
- Strictly restricting sleep hours for bedtime and arising (with napping discouraged).
- Control of stimulus to disrupt falling asleep.
- Cognitive therapy to identify and replace maladaptive beliefs.
- Control of sleep hygiene for optimal sleep.
- Relaxation training.
Keys to success
Dr. Srinivasan noted one recent study of CBT-I among patients aged 60 and older with insomnia and depression. The 156 participants randomized to receive weekly 120-minute CBT-I sessions over 2 months were significantly less likely to develop new or recurrent major depression versus their counterparts randomized to receive sleep education (hazard ratio, 0.51; P = .02).
However, CBT-I is more labor intensive than medication and requires provider training and motivation, and commitment on the part of the patient, to be successful.
“We really need to ensure that even when patients are receiving pharmacologic interventions for insomnia that we provide psychoeducation. At the end of the day, some of these nonpharmacologic components can make or break the success of pharmacotherapy,” said Dr. Srinivasan.
Whether using CBT-I alone or in combination with pharmacotherapy, the intervention does not necessarily have to include all components to be beneficial, she said.
“I think one of the challenges in incorporating CBT-I is the misconception that it is an all-or-nothing approach wherein every modality must be utilized,” she said. “While multicomponent CBT-I has been shown to be effective, the individual components can be incorporated into patient encounters in a stepped approach.”
Informing patients that they have options other than medications and involving them in decision-making is key, she added.
“In the case of insomnia, this is particularly relevant because of the physical and emotional distress that it causes,” Dr. Srinivasan said. “Patients often seek over-the-counter medications or other nonprescribed agents to try to obtain relief even before seeking treatment in a health care setting. There is less awareness about evidence-based and effective nonpharmacologic treatments such as CBT-I.”
Dr. Tampi, Dr. Dix, and Dr. Srinivasan have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NEW ORLEANS –
“The lack of awareness among clinicians who take care of older adults that CBT for insomnia (CBT-I) is an effective treatment for insomnia is an issue,” Rajesh R. Tampi, MD, professor and chairman of the department of psychiatry, Creighton University, Omaha, Neb., told this news organization.
Dr. Tampi was among the speakers during a session as part of the American Association for Geriatric Psychiatry annual meeting addressing the complex challenges of treating insomnia in older patients, who tend to have higher rates of insomnia than their younger counterparts.
The prevalence of insomnia in older adults is estimated to be 20%-40%, and medication is frequently the first treatment choice, a less than ideal approach, said Dr. Tampi.
“Prescribing sedatives and hypnotics, which can cause severe adverse effects, without a thorough assessment that includes comorbidities that may be causing the insomnia” is among the biggest mistakes clinicians make in the treatment of insomnia in older patients, Dr. Tampi said in an interview.
“It’s our duty as providers to first take a good assessment, talk about polymorbidity, and try to address those conditions, and judiciously use medications in conjunction with at least components of CBT-I,” he said.
Long-term safety, efficacy unclear
About one-third of older adults take at least one form of pharmacological treatment for insomnia symptoms, said Ebony Dix, MD, assistant professor of psychiatry at Yale University, New Haven, Conn., in a separate talk during the session. This, despite the low-risk profile of CBT and recommendations from various medical societies that CBT should be tried first.
Dr. Dix noted that medications approved for insomnia by the U.S. Food and Drug Administration, including melatonin receptor agonists, heterocyclics, and dual orexin receptor antagonists (DORAs), can play an important role in the short-term management of insomnia, but their long-term effects are unknown.
“Pharmacotherapeutic agents may be effective in the short term, but there is a lack of sufficient, statistically significant data to support the long-term safety and efficacy of any [sleep] medication, especially in aging adults, due to the impact of hypnotic drugs on sleep architecture, the impact of aging on pharmacokinetics, as well as polypharmacy and drug-to-drug interactions,” Dr. Dix said. She noted that clinical trials of insomnia drugs rarely include geriatric patients.
The American Academy of Sleep Medicine recommends CBT-I as first-line treatment for insomnia, with the key benefit being its exemplary safety profile, said Shilpa Srinivasan, MD, a professor of clinical psychiatry at the University of South Carolina, Columbia, who also presented during the session.
“The biggest [attribute] of CBT-I management strategies is the low risk of side effects,” she said. “How many medications can we say that about?”
The CBT-I intervention includes a focus on key components of lifestyle and mental health issues to improve sleep. These include the following:
- Strictly restricting sleep hours for bedtime and arising (with napping discouraged).
- Control of stimulus to disrupt falling asleep.
- Cognitive therapy to identify and replace maladaptive beliefs.
- Control of sleep hygiene for optimal sleep.
- Relaxation training.
Keys to success
Dr. Srinivasan noted one recent study of CBT-I among patients aged 60 and older with insomnia and depression. The 156 participants randomized to receive weekly 120-minute CBT-I sessions over 2 months were significantly less likely to develop new or recurrent major depression versus their counterparts randomized to receive sleep education (hazard ratio, 0.51; P = .02).
However, CBT-I is more labor intensive than medication and requires provider training and motivation, and commitment on the part of the patient, to be successful.
“We really need to ensure that even when patients are receiving pharmacologic interventions for insomnia that we provide psychoeducation. At the end of the day, some of these nonpharmacologic components can make or break the success of pharmacotherapy,” said Dr. Srinivasan.
Whether using CBT-I alone or in combination with pharmacotherapy, the intervention does not necessarily have to include all components to be beneficial, she said.
“I think one of the challenges in incorporating CBT-I is the misconception that it is an all-or-nothing approach wherein every modality must be utilized,” she said. “While multicomponent CBT-I has been shown to be effective, the individual components can be incorporated into patient encounters in a stepped approach.”
Informing patients that they have options other than medications and involving them in decision-making is key, she added.
“In the case of insomnia, this is particularly relevant because of the physical and emotional distress that it causes,” Dr. Srinivasan said. “Patients often seek over-the-counter medications or other nonprescribed agents to try to obtain relief even before seeking treatment in a health care setting. There is less awareness about evidence-based and effective nonpharmacologic treatments such as CBT-I.”
Dr. Tampi, Dr. Dix, and Dr. Srinivasan have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NEW ORLEANS –
“The lack of awareness among clinicians who take care of older adults that CBT for insomnia (CBT-I) is an effective treatment for insomnia is an issue,” Rajesh R. Tampi, MD, professor and chairman of the department of psychiatry, Creighton University, Omaha, Neb., told this news organization.
Dr. Tampi was among the speakers during a session as part of the American Association for Geriatric Psychiatry annual meeting addressing the complex challenges of treating insomnia in older patients, who tend to have higher rates of insomnia than their younger counterparts.
The prevalence of insomnia in older adults is estimated to be 20%-40%, and medication is frequently the first treatment choice, a less than ideal approach, said Dr. Tampi.
“Prescribing sedatives and hypnotics, which can cause severe adverse effects, without a thorough assessment that includes comorbidities that may be causing the insomnia” is among the biggest mistakes clinicians make in the treatment of insomnia in older patients, Dr. Tampi said in an interview.
“It’s our duty as providers to first take a good assessment, talk about polymorbidity, and try to address those conditions, and judiciously use medications in conjunction with at least components of CBT-I,” he said.
Long-term safety, efficacy unclear
About one-third of older adults take at least one form of pharmacological treatment for insomnia symptoms, said Ebony Dix, MD, assistant professor of psychiatry at Yale University, New Haven, Conn., in a separate talk during the session. This, despite the low-risk profile of CBT and recommendations from various medical societies that CBT should be tried first.
Dr. Dix noted that medications approved for insomnia by the U.S. Food and Drug Administration, including melatonin receptor agonists, heterocyclics, and dual orexin receptor antagonists (DORAs), can play an important role in the short-term management of insomnia, but their long-term effects are unknown.
“Pharmacotherapeutic agents may be effective in the short term, but there is a lack of sufficient, statistically significant data to support the long-term safety and efficacy of any [sleep] medication, especially in aging adults, due to the impact of hypnotic drugs on sleep architecture, the impact of aging on pharmacokinetics, as well as polypharmacy and drug-to-drug interactions,” Dr. Dix said. She noted that clinical trials of insomnia drugs rarely include geriatric patients.
The American Academy of Sleep Medicine recommends CBT-I as first-line treatment for insomnia, with the key benefit being its exemplary safety profile, said Shilpa Srinivasan, MD, a professor of clinical psychiatry at the University of South Carolina, Columbia, who also presented during the session.
“The biggest [attribute] of CBT-I management strategies is the low risk of side effects,” she said. “How many medications can we say that about?”
The CBT-I intervention includes a focus on key components of lifestyle and mental health issues to improve sleep. These include the following:
- Strictly restricting sleep hours for bedtime and arising (with napping discouraged).
- Control of stimulus to disrupt falling asleep.
- Cognitive therapy to identify and replace maladaptive beliefs.
- Control of sleep hygiene for optimal sleep.
- Relaxation training.
Keys to success
Dr. Srinivasan noted one recent study of CBT-I among patients aged 60 and older with insomnia and depression. The 156 participants randomized to receive weekly 120-minute CBT-I sessions over 2 months were significantly less likely to develop new or recurrent major depression versus their counterparts randomized to receive sleep education (hazard ratio, 0.51; P = .02).
However, CBT-I is more labor intensive than medication and requires provider training and motivation, and commitment on the part of the patient, to be successful.
“We really need to ensure that even when patients are receiving pharmacologic interventions for insomnia that we provide psychoeducation. At the end of the day, some of these nonpharmacologic components can make or break the success of pharmacotherapy,” said Dr. Srinivasan.
Whether using CBT-I alone or in combination with pharmacotherapy, the intervention does not necessarily have to include all components to be beneficial, she said.
“I think one of the challenges in incorporating CBT-I is the misconception that it is an all-or-nothing approach wherein every modality must be utilized,” she said. “While multicomponent CBT-I has been shown to be effective, the individual components can be incorporated into patient encounters in a stepped approach.”
Informing patients that they have options other than medications and involving them in decision-making is key, she added.
“In the case of insomnia, this is particularly relevant because of the physical and emotional distress that it causes,” Dr. Srinivasan said. “Patients often seek over-the-counter medications or other nonprescribed agents to try to obtain relief even before seeking treatment in a health care setting. There is less awareness about evidence-based and effective nonpharmacologic treatments such as CBT-I.”
Dr. Tampi, Dr. Dix, and Dr. Srinivasan have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AAGP 2023