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Novel device provides real-time glucose monitoring of critically ill
WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.
“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.
The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”
The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.
The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.
The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”
The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.
WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.
“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.
The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”
The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.
The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.
The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”
The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.
WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.
“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.
The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”
The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.
The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.
The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”
The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.
AT THE AAST ANNUAL MEETING
Key clinical point:
Major finding: An analysis of 3,735 paired readings revealed that the mean absolute relative deviation (MARD) was 7.6%, which achieved the primary endpoint for accuracy.
Data source: A trial which set out to evaluate the safety and accuracy of the OptiScanner in 200 patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring.
Disclosures: The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.
VIDEO: Harvoni shows safety, efficacy in adolescents for hepatitis C
MONTREAL – One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.
“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.
The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.
Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.
The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.
Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.
Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.
“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
MONTREAL – One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.
“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.
The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.
Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.
The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.
Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.
Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.
“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
MONTREAL – One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.
“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.
The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.
Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.
The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.
Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.
Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.
“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT WCPGHAN 2016
Key clinical point:
Major finding: Hepatitis C virus was undetectable after 12 weeks of treatment in 98%; the remaining two patients were lost to follow-up.
Data source: A multicenter, open-label study with 100 patients, aged 12-17 years old, and chronically infected with hepatitis C genotype 1.
Disclosures: The study was sponsored by Gilead, the company that markets ledipasvir/sofosbuvir (Harvoni). Dr. Murray has received research support from Gilead and is a shareholder in Merck.
POP severity not linked to risk of de novo stress urinary incontinence
DENVER – Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.
But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.
Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.
A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).
Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).
Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).
The researchers did not report information on funding sources or financial disclosures.
DENVER – Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.
But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.
Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.
A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).
Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).
Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).
The researchers did not report information on funding sources or financial disclosures.
DENVER – Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.
But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.
Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.
A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).
Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).
Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).
The researchers did not report information on funding sources or financial disclosures.
AT PFD WEEK 2016
Key clinical point:
Major finding: Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).
Data source: A single-center retrospective study of 206 patients who underwent surgical correction of POP and had no objective evidence of SUI at baseline.
Disclosures: The researchers did not report information on funding sources or financial disclosures.
Severe joint pain in adults with arthritis continues to rise
The prevalence of severe joint pain among adults with diagnosed arthritis continues to increase, researchers from the Centers for Disease Control and Prevention reported in the Oct. 7 Morbidity and Mortality Weekly Report.
In 2014, more than one-fourth of adults with arthritis had severe joint pain. That is about 14.6 million Americans with severe joint pain, a significant increase from 2002 when there were an estimated 10.5 million adults with severe joint pain, according to Kamil E. Barbour, PhD, and his associates from the National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 7;65[39]:1052-6).
Severe joint pain was also more prevalent among patients with overall fair or poor health who were obese or had heart disease, diabetes, or serious psychological distress, the investigators reported.
The investigators defined people with arthritis as those who had “been told by a doctor or other health professional” that they have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia. Severe joint pain was defined as a response of 7 or higher on a scale of 0-10 for rating joint pain on average over the past 30 days.
Recently, the U.S. Department of Health & Human Services released its National Pain Strategy, the nation’s first broad, federal effort aimed at developing strategies to reduce the burden of pain among Americans. The initiatives major objectives are to take steps to reduce barriers to pain care, and to increase patient knowledge of treatment options and risks, Dr. Barbour and his associates wrote.
“Health care providers and public health practitioners can begin to implement the recommendations [from the National Pain Strategy] and improve pain care among adults with arthritis and [severe joint pain] by prioritizing self-management education and appropriate physical activity interventions as effective nonpharmacologic ways to reduce pain and improve health outcomes,” the researchers added.
[email protected]
On Twitter @jessnicolecraig
The prevalence of severe joint pain among adults with diagnosed arthritis continues to increase, researchers from the Centers for Disease Control and Prevention reported in the Oct. 7 Morbidity and Mortality Weekly Report.
In 2014, more than one-fourth of adults with arthritis had severe joint pain. That is about 14.6 million Americans with severe joint pain, a significant increase from 2002 when there were an estimated 10.5 million adults with severe joint pain, according to Kamil E. Barbour, PhD, and his associates from the National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 7;65[39]:1052-6).
Severe joint pain was also more prevalent among patients with overall fair or poor health who were obese or had heart disease, diabetes, or serious psychological distress, the investigators reported.
The investigators defined people with arthritis as those who had “been told by a doctor or other health professional” that they have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia. Severe joint pain was defined as a response of 7 or higher on a scale of 0-10 for rating joint pain on average over the past 30 days.
Recently, the U.S. Department of Health & Human Services released its National Pain Strategy, the nation’s first broad, federal effort aimed at developing strategies to reduce the burden of pain among Americans. The initiatives major objectives are to take steps to reduce barriers to pain care, and to increase patient knowledge of treatment options and risks, Dr. Barbour and his associates wrote.
“Health care providers and public health practitioners can begin to implement the recommendations [from the National Pain Strategy] and improve pain care among adults with arthritis and [severe joint pain] by prioritizing self-management education and appropriate physical activity interventions as effective nonpharmacologic ways to reduce pain and improve health outcomes,” the researchers added.
[email protected]
On Twitter @jessnicolecraig
The prevalence of severe joint pain among adults with diagnosed arthritis continues to increase, researchers from the Centers for Disease Control and Prevention reported in the Oct. 7 Morbidity and Mortality Weekly Report.
In 2014, more than one-fourth of adults with arthritis had severe joint pain. That is about 14.6 million Americans with severe joint pain, a significant increase from 2002 when there were an estimated 10.5 million adults with severe joint pain, according to Kamil E. Barbour, PhD, and his associates from the National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 7;65[39]:1052-6).
Severe joint pain was also more prevalent among patients with overall fair or poor health who were obese or had heart disease, diabetes, or serious psychological distress, the investigators reported.
The investigators defined people with arthritis as those who had “been told by a doctor or other health professional” that they have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia. Severe joint pain was defined as a response of 7 or higher on a scale of 0-10 for rating joint pain on average over the past 30 days.
Recently, the U.S. Department of Health & Human Services released its National Pain Strategy, the nation’s first broad, federal effort aimed at developing strategies to reduce the burden of pain among Americans. The initiatives major objectives are to take steps to reduce barriers to pain care, and to increase patient knowledge of treatment options and risks, Dr. Barbour and his associates wrote.
“Health care providers and public health practitioners can begin to implement the recommendations [from the National Pain Strategy] and improve pain care among adults with arthritis and [severe joint pain] by prioritizing self-management education and appropriate physical activity interventions as effective nonpharmacologic ways to reduce pain and improve health outcomes,” the researchers added.
[email protected]
On Twitter @jessnicolecraig
FROM MMWR
Key clinical point:
Major finding: The estimated number of U.S. adults with severe joint pain rose from 10.5 million in 2002 to 14.6 million in 2014.
Data source: Analysis of data from the National Health Interview Survey in 2002, 2003, 2006, 2009, and 2014.
Disclosures: The authors are federal government employees and have no financial disclosures.
FDA reaffirms rivaroxaban’s atrial fib efficacy in ROCKET AF
The Food and Drug Administration reaffirmed its confidence in the data supporting the claim that rivaroxaban (Xarelto) is a safe and effective alternative to warfarin for preventing strokes and blood clots in patients with nonvalvular atrial fibrillation.
“The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation,” the agency said in a statement released on Oct. 11.
In response to these events the FDA “completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET AF study results. The agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal,” the agency said in its statement.
Researchers associated with ROCKET AF published their own analysis of the impact of the faulty device on bleeding rates among patients treated with warfarin in the trial and concluded that device malfunction did not appear to influence the results (N Engl J Med. 2016 Feb 25;374[8]:785-8).
Rivaroxaban is one of four new oral anticoagulants (NOACs) on the U.S. market that are alternatives to warfarin for stroke and clot prevention in patients with nonvalvular atrial fibrillation. An analysis of 2014 data on U.S. office-based prescriptions for NOACs in atrial fibrillation patients showed that rivaroxaban was by far the most commonly prescribed drug in the class, prescribed for patients during 48% of physician office visits that led to a NOAC prescription (Am J Med. 2015 Dec;128[12]:1300-5).
[email protected]
On Twitter @mitchelzoler
The Food and Drug Administration reaffirmed its confidence in the data supporting the claim that rivaroxaban (Xarelto) is a safe and effective alternative to warfarin for preventing strokes and blood clots in patients with nonvalvular atrial fibrillation.
“The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation,” the agency said in a statement released on Oct. 11.
In response to these events the FDA “completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET AF study results. The agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal,” the agency said in its statement.
Researchers associated with ROCKET AF published their own analysis of the impact of the faulty device on bleeding rates among patients treated with warfarin in the trial and concluded that device malfunction did not appear to influence the results (N Engl J Med. 2016 Feb 25;374[8]:785-8).
Rivaroxaban is one of four new oral anticoagulants (NOACs) on the U.S. market that are alternatives to warfarin for stroke and clot prevention in patients with nonvalvular atrial fibrillation. An analysis of 2014 data on U.S. office-based prescriptions for NOACs in atrial fibrillation patients showed that rivaroxaban was by far the most commonly prescribed drug in the class, prescribed for patients during 48% of physician office visits that led to a NOAC prescription (Am J Med. 2015 Dec;128[12]:1300-5).
[email protected]
On Twitter @mitchelzoler
The Food and Drug Administration reaffirmed its confidence in the data supporting the claim that rivaroxaban (Xarelto) is a safe and effective alternative to warfarin for preventing strokes and blood clots in patients with nonvalvular atrial fibrillation.
“The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation,” the agency said in a statement released on Oct. 11.
In response to these events the FDA “completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET AF study results. The agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal,” the agency said in its statement.
Researchers associated with ROCKET AF published their own analysis of the impact of the faulty device on bleeding rates among patients treated with warfarin in the trial and concluded that device malfunction did not appear to influence the results (N Engl J Med. 2016 Feb 25;374[8]:785-8).
Rivaroxaban is one of four new oral anticoagulants (NOACs) on the U.S. market that are alternatives to warfarin for stroke and clot prevention in patients with nonvalvular atrial fibrillation. An analysis of 2014 data on U.S. office-based prescriptions for NOACs in atrial fibrillation patients showed that rivaroxaban was by far the most commonly prescribed drug in the class, prescribed for patients during 48% of physician office visits that led to a NOAC prescription (Am J Med. 2015 Dec;128[12]:1300-5).
[email protected]
On Twitter @mitchelzoler
Hanging on as small practices slowly die
I’ve had to skip several paychecks this year to keep my practice afloat. That makes it hard to pay for my routine personal expenses, like a mortgage, so I have to take the money out of my family’s “rainy day” savings.
This gets old after a few years of the same cycle. I’m pretty sick of it.
Granted, I chose this path. Solo practice suits me. I’ve been in a large group, and it took me roughly 2 years to realize it was a poor fit for me. I’ve been on my own since 2000 and been pretty happy here.
I’ve come to accept that taking a vacation means a temporary drop in salary down the road. My family is important to me, and I don’t want them to remember me as the never-home father immortalized by Harry Chapin’s “Cat’s in the Cradle.”
Trouble is this: What if you still work hard, and find your income falling? I see patients from 8 to 4 most days, with a full schedule, but reimbursements keep dropping and costs keep climbing. Isn’t the idea that hard work will bring success central to the American Dream? Especially when you toss in 9 years of medical school and residency? Apparently not. The American Dream, whatever it is, is pretty much dead for most small-practice doctors.
These are tough times for solo docs, regardless of field. I’ve seen several posts on sites such as Sermo that show I’m not the only one in this boat, skipping paychecks to keep the door open and lights on. Most small practices are running into the same issue. Some, like me, are slugging it out and hoping things get better. Others are folding up and moving, or joining large groups, or signing up with a hospital system.
I’m not sure those last two are options I want. Most of the docs I know who’ve joined hospital outpatient systems are pretty unhappy with them, too. They talk about computer systems designed for billing rather than patient care; unrealistic amounts of time allotted to each patient by a nonmedical person; and jumping through hoops to get certain tests or treatments done.
I suspect it’s a combination of factors, though others see more sinister forces at work. Some posts I read suggest that it’s part of a government and/or insurance conspiracy to destroy small practices.
Regardless, it seems to be succeeding. Small practices are in crisis. Doctor suicides are up. And solo practice has been found to be a risk factor for suicide. There are days when I can see how that seems like the only way out for those who came here just to care for people, and now find that economic circumstances won’t let them.
I don’t have a castle, or drive a Rolls-Royce, or send my kids to private school. We live fairly modestly, but even then it’s getting hard to keep up with costs.
We’re in an election year, and, as always, medical care is bandied about by both parties as a bargaining chip to get votes. But I haven’t heard either side talk about this, nor do I get the impression that either major candidate really cares. Both of them, and members of Congress, get pretty top-notch care without having to worry about cost. This isn’t reassuring to me and all the other solo docs hanging on by our fingernails and trying to practice ethical, honest medicine.
I’m sure some will say it’s progress, but I think the gradual death of the American small and solo practice is sad. It’s a model that’s been the backbone of Western medicine for a few hundred years now, caring for people in big cities, small towns, and everywhere in between. Portrayed in fiction as Marcus Welby, Michaela Quinn, Joel Fleischman, and (my favorite, from Willa Cather’s “Neighbour Rosicky”) Ed Burleigh. Sometimes brilliant, sometimes quirky, sometimes all-too-human ... but still doctors, caring for their patients and communities.
Like the unnamed protagonist in Dr. Seuss’ “I Had Trouble in getting to Solla Sollew,” I tend to find that no matter where you go there will be troubles, and sometimes you’re best off staying in one place and fighting the ones you know.
And, for now, that’s where I am and hope to stay. But I’m scared.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve had to skip several paychecks this year to keep my practice afloat. That makes it hard to pay for my routine personal expenses, like a mortgage, so I have to take the money out of my family’s “rainy day” savings.
This gets old after a few years of the same cycle. I’m pretty sick of it.
Granted, I chose this path. Solo practice suits me. I’ve been in a large group, and it took me roughly 2 years to realize it was a poor fit for me. I’ve been on my own since 2000 and been pretty happy here.
I’ve come to accept that taking a vacation means a temporary drop in salary down the road. My family is important to me, and I don’t want them to remember me as the never-home father immortalized by Harry Chapin’s “Cat’s in the Cradle.”
Trouble is this: What if you still work hard, and find your income falling? I see patients from 8 to 4 most days, with a full schedule, but reimbursements keep dropping and costs keep climbing. Isn’t the idea that hard work will bring success central to the American Dream? Especially when you toss in 9 years of medical school and residency? Apparently not. The American Dream, whatever it is, is pretty much dead for most small-practice doctors.
These are tough times for solo docs, regardless of field. I’ve seen several posts on sites such as Sermo that show I’m not the only one in this boat, skipping paychecks to keep the door open and lights on. Most small practices are running into the same issue. Some, like me, are slugging it out and hoping things get better. Others are folding up and moving, or joining large groups, or signing up with a hospital system.
I’m not sure those last two are options I want. Most of the docs I know who’ve joined hospital outpatient systems are pretty unhappy with them, too. They talk about computer systems designed for billing rather than patient care; unrealistic amounts of time allotted to each patient by a nonmedical person; and jumping through hoops to get certain tests or treatments done.
I suspect it’s a combination of factors, though others see more sinister forces at work. Some posts I read suggest that it’s part of a government and/or insurance conspiracy to destroy small practices.
Regardless, it seems to be succeeding. Small practices are in crisis. Doctor suicides are up. And solo practice has been found to be a risk factor for suicide. There are days when I can see how that seems like the only way out for those who came here just to care for people, and now find that economic circumstances won’t let them.
I don’t have a castle, or drive a Rolls-Royce, or send my kids to private school. We live fairly modestly, but even then it’s getting hard to keep up with costs.
We’re in an election year, and, as always, medical care is bandied about by both parties as a bargaining chip to get votes. But I haven’t heard either side talk about this, nor do I get the impression that either major candidate really cares. Both of them, and members of Congress, get pretty top-notch care without having to worry about cost. This isn’t reassuring to me and all the other solo docs hanging on by our fingernails and trying to practice ethical, honest medicine.
I’m sure some will say it’s progress, but I think the gradual death of the American small and solo practice is sad. It’s a model that’s been the backbone of Western medicine for a few hundred years now, caring for people in big cities, small towns, and everywhere in between. Portrayed in fiction as Marcus Welby, Michaela Quinn, Joel Fleischman, and (my favorite, from Willa Cather’s “Neighbour Rosicky”) Ed Burleigh. Sometimes brilliant, sometimes quirky, sometimes all-too-human ... but still doctors, caring for their patients and communities.
Like the unnamed protagonist in Dr. Seuss’ “I Had Trouble in getting to Solla Sollew,” I tend to find that no matter where you go there will be troubles, and sometimes you’re best off staying in one place and fighting the ones you know.
And, for now, that’s where I am and hope to stay. But I’m scared.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve had to skip several paychecks this year to keep my practice afloat. That makes it hard to pay for my routine personal expenses, like a mortgage, so I have to take the money out of my family’s “rainy day” savings.
This gets old after a few years of the same cycle. I’m pretty sick of it.
Granted, I chose this path. Solo practice suits me. I’ve been in a large group, and it took me roughly 2 years to realize it was a poor fit for me. I’ve been on my own since 2000 and been pretty happy here.
I’ve come to accept that taking a vacation means a temporary drop in salary down the road. My family is important to me, and I don’t want them to remember me as the never-home father immortalized by Harry Chapin’s “Cat’s in the Cradle.”
Trouble is this: What if you still work hard, and find your income falling? I see patients from 8 to 4 most days, with a full schedule, but reimbursements keep dropping and costs keep climbing. Isn’t the idea that hard work will bring success central to the American Dream? Especially when you toss in 9 years of medical school and residency? Apparently not. The American Dream, whatever it is, is pretty much dead for most small-practice doctors.
These are tough times for solo docs, regardless of field. I’ve seen several posts on sites such as Sermo that show I’m not the only one in this boat, skipping paychecks to keep the door open and lights on. Most small practices are running into the same issue. Some, like me, are slugging it out and hoping things get better. Others are folding up and moving, or joining large groups, or signing up with a hospital system.
I’m not sure those last two are options I want. Most of the docs I know who’ve joined hospital outpatient systems are pretty unhappy with them, too. They talk about computer systems designed for billing rather than patient care; unrealistic amounts of time allotted to each patient by a nonmedical person; and jumping through hoops to get certain tests or treatments done.
I suspect it’s a combination of factors, though others see more sinister forces at work. Some posts I read suggest that it’s part of a government and/or insurance conspiracy to destroy small practices.
Regardless, it seems to be succeeding. Small practices are in crisis. Doctor suicides are up. And solo practice has been found to be a risk factor for suicide. There are days when I can see how that seems like the only way out for those who came here just to care for people, and now find that economic circumstances won’t let them.
I don’t have a castle, or drive a Rolls-Royce, or send my kids to private school. We live fairly modestly, but even then it’s getting hard to keep up with costs.
We’re in an election year, and, as always, medical care is bandied about by both parties as a bargaining chip to get votes. But I haven’t heard either side talk about this, nor do I get the impression that either major candidate really cares. Both of them, and members of Congress, get pretty top-notch care without having to worry about cost. This isn’t reassuring to me and all the other solo docs hanging on by our fingernails and trying to practice ethical, honest medicine.
I’m sure some will say it’s progress, but I think the gradual death of the American small and solo practice is sad. It’s a model that’s been the backbone of Western medicine for a few hundred years now, caring for people in big cities, small towns, and everywhere in between. Portrayed in fiction as Marcus Welby, Michaela Quinn, Joel Fleischman, and (my favorite, from Willa Cather’s “Neighbour Rosicky”) Ed Burleigh. Sometimes brilliant, sometimes quirky, sometimes all-too-human ... but still doctors, caring for their patients and communities.
Like the unnamed protagonist in Dr. Seuss’ “I Had Trouble in getting to Solla Sollew,” I tend to find that no matter where you go there will be troubles, and sometimes you’re best off staying in one place and fighting the ones you know.
And, for now, that’s where I am and hope to stay. But I’m scared.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Brief screen helps identify patients with PTSD, depression
WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.
At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.
The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.
In an effort to create a brief screening tool to identify those at risk for PTSD and depression following traumatic injury, Dr. deRoon-Cassini and her associates scoured existing medical literature on the topic to review risk factors and created an item pool of questions based on those risk factors. They came up with 47 items and statistically “funneled out the items to create the most parsimonious model predicting who goes on to develop PTSD and depression separately,” she explained. They then created the Injured Trauma Survivor Screen (ITSS), a nine-item list of yes/no questions that takes about 5 minutes to administer: five items for PTSD and five items for depression, with one item that overlaps. The five ITSS PTSD questions are:
• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).
• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).
• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).
• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).
• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).
The five ITSS depression questions are:
• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).
• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).
• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).
• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).
• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).
The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.
One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.
“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”
The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.
WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.
At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.
The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.
In an effort to create a brief screening tool to identify those at risk for PTSD and depression following traumatic injury, Dr. deRoon-Cassini and her associates scoured existing medical literature on the topic to review risk factors and created an item pool of questions based on those risk factors. They came up with 47 items and statistically “funneled out the items to create the most parsimonious model predicting who goes on to develop PTSD and depression separately,” she explained. They then created the Injured Trauma Survivor Screen (ITSS), a nine-item list of yes/no questions that takes about 5 minutes to administer: five items for PTSD and five items for depression, with one item that overlaps. The five ITSS PTSD questions are:
• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).
• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).
• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).
• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).
• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).
The five ITSS depression questions are:
• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).
• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).
• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).
• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).
• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).
The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.
One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.
“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”
The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.
WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.
At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.
The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.
In an effort to create a brief screening tool to identify those at risk for PTSD and depression following traumatic injury, Dr. deRoon-Cassini and her associates scoured existing medical literature on the topic to review risk factors and created an item pool of questions based on those risk factors. They came up with 47 items and statistically “funneled out the items to create the most parsimonious model predicting who goes on to develop PTSD and depression separately,” she explained. They then created the Injured Trauma Survivor Screen (ITSS), a nine-item list of yes/no questions that takes about 5 minutes to administer: five items for PTSD and five items for depression, with one item that overlaps. The five ITSS PTSD questions are:
• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).
• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).
• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).
• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).
• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).
The five ITSS depression questions are:
• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).
• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).
• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).
• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).
• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).
The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.
One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.
“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”
The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.
Key clinical point:
Major finding: Administration of the Injured Trauma Survivor Screen (ITSS) within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression.
Data source: An analysis of 139 patients from two trauma centers who completed the ITSS.
Disclosures: The study was funded by a grant from the Medical College of Wisconsin. Dr. deRoon-Cassini reported having no financial disclosures.
VIDEO: What will be the NIMH’s focus under Dr. Joshua Gordon?
NEW YORK – “Most clinicians probably don’t have problems identifying patients who are depressed and giving them a trial of an antidepressant or a second antidepressant, but where do they run into stumbling blocks?” That’s a question Joshua A. Gordon, MD, PhD, the new director of the National Institute of Mental Health, said he is pondering as he steps into his new role.
Both a practicing clinical psychiatrist and a neuroscientist with a lab chiefly dedicated to optogenetics, Dr. Gordon shared his thoughts about what the priorities of the world’s largest mental health research institute should be, and how to balance immediate patient needs with the development of future interventions.
Conducted in New York City, where Dr. Gordon saw patients, maintained a lab, and was an associate professor of psychiatry at Columbia University for nearly 2 decades, this is the last installment in a series of interviews.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
NEW YORK – “Most clinicians probably don’t have problems identifying patients who are depressed and giving them a trial of an antidepressant or a second antidepressant, but where do they run into stumbling blocks?” That’s a question Joshua A. Gordon, MD, PhD, the new director of the National Institute of Mental Health, said he is pondering as he steps into his new role.
Both a practicing clinical psychiatrist and a neuroscientist with a lab chiefly dedicated to optogenetics, Dr. Gordon shared his thoughts about what the priorities of the world’s largest mental health research institute should be, and how to balance immediate patient needs with the development of future interventions.
Conducted in New York City, where Dr. Gordon saw patients, maintained a lab, and was an associate professor of psychiatry at Columbia University for nearly 2 decades, this is the last installment in a series of interviews.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
NEW YORK – “Most clinicians probably don’t have problems identifying patients who are depressed and giving them a trial of an antidepressant or a second antidepressant, but where do they run into stumbling blocks?” That’s a question Joshua A. Gordon, MD, PhD, the new director of the National Institute of Mental Health, said he is pondering as he steps into his new role.
Both a practicing clinical psychiatrist and a neuroscientist with a lab chiefly dedicated to optogenetics, Dr. Gordon shared his thoughts about what the priorities of the world’s largest mental health research institute should be, and how to balance immediate patient needs with the development of future interventions.
Conducted in New York City, where Dr. Gordon saw patients, maintained a lab, and was an associate professor of psychiatry at Columbia University for nearly 2 decades, this is the last installment in a series of interviews.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
VIDEO: New NIMH director talks ethics, optogenetics, novel treatments for depression
NEW YORK – Will it ever be possible to trace the neuronal pathways of specific mental states as they speed through our brains? Hear Joshua A. Gordon, MD, PhD, the National Institute of Mental Health’s new director, share his thoughts on just such a technology in an interview recorded just days before he assumed his new role at the world’s largest mental health research organization.
In the interview, Dr. Gordon also addresses whether the use of “optogenetics” – a novel therapy developed by neuroscientists that, if it works, promises to track mental disorders such as anxiety or depression – creates ethical dilemmas when deciding whether these disorders should be turned “on” or “off.”
“When I treat patients, I treat them because they are overwhelmed with depression, or because they’re hearing voices that are scary or ruining their lives, or because they have intractable anxiety,” Dr. Gordon said. “To relieve those symptoms, there is no ethical dilemma in my mind.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
NEW YORK – Will it ever be possible to trace the neuronal pathways of specific mental states as they speed through our brains? Hear Joshua A. Gordon, MD, PhD, the National Institute of Mental Health’s new director, share his thoughts on just such a technology in an interview recorded just days before he assumed his new role at the world’s largest mental health research organization.
In the interview, Dr. Gordon also addresses whether the use of “optogenetics” – a novel therapy developed by neuroscientists that, if it works, promises to track mental disorders such as anxiety or depression – creates ethical dilemmas when deciding whether these disorders should be turned “on” or “off.”
“When I treat patients, I treat them because they are overwhelmed with depression, or because they’re hearing voices that are scary or ruining their lives, or because they have intractable anxiety,” Dr. Gordon said. “To relieve those symptoms, there is no ethical dilemma in my mind.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
NEW YORK – Will it ever be possible to trace the neuronal pathways of specific mental states as they speed through our brains? Hear Joshua A. Gordon, MD, PhD, the National Institute of Mental Health’s new director, share his thoughts on just such a technology in an interview recorded just days before he assumed his new role at the world’s largest mental health research organization.
In the interview, Dr. Gordon also addresses whether the use of “optogenetics” – a novel therapy developed by neuroscientists that, if it works, promises to track mental disorders such as anxiety or depression – creates ethical dilemmas when deciding whether these disorders should be turned “on” or “off.”
“When I treat patients, I treat them because they are overwhelmed with depression, or because they’re hearing voices that are scary or ruining their lives, or because they have intractable anxiety,” Dr. Gordon said. “To relieve those symptoms, there is no ethical dilemma in my mind.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
Update on argan oil
• Used traditionally in Northwest Africa for its cosmetic, bactericidal, and fungicidal activity.
• Rich in vitamin E, oleic acid, and linoleic acid, which are believed to contribute to the perceived cutaneous benefits of this vegetable oil.
• Reputed to impart antiacne, antisebum, antiaging, moisturizing, and wound-healing activity, but clinical evidence is sparse.
• In a small study, the nightly topical application of argan oil resulted in a moisturizing effect, and in statistically significant decreases in transepidermal water loss and increases in the water content of the epidermis.
For more than 800 years, native Moroccans and explorers in the region have cited the health benefits of the topical use or consumption of argan oil.1 The oil, derived from the fruit of Argania spinosa, is a slow-growing tree native to the arid climate of Southwestern Morocco2-4 as well as the Algerian province of Tindouf in the Western Mediterranean area.5 For many years, it was primarily the populations of the Essaouira and Souss-Massa-Draa regions of Morocco that benefited from the production and use of argan oil.6 Largely through the efforts of the Moroccan government, as well as cooperating nongovernmental organizations and private entities, argan oil is now also a well-established ingredient on the edible oil as well as cosmetic oil markets throughout the world.6
The vitamin E–rich oil has a reputation for imparting antiaging, hydrating, and antioxidant activity to the skin and ameliorating conditions such as acne, eczema, psoriasis, wrinkles, and xerosis,12 and, in fact, has been used to treat these conditions as well as dry hair,3,13 hair loss, skin inflammation, and joint pain.3 This column will focus on the topical uses of this botanical that has been dubbed “liquid gold.”12
Chemistry
Oleic acid, an omega-9 monounsaturated fatty acid, is abundant in argan oil (43%-49%) and has been found to act as a penetration enhancer by disturbing the skin barrier.14,15 Linoleic acid, an omega-6 polyunsaturated fatty acid, found in concentrations of 29%-36% in the oil, is integral in the biosynthesis of inflammatory prostaglandins through the arachidonic acid pathway.4,16 The presence of linoleic acid may help prevent or mitigate inflammation. Linoleic acid is also a component of ceramide 1 linoleate, which is diminished in dry skin. Topical application of linoleic acid can raise ceramide 1 linoleate levels in the skin, thus reducing xerosis.17 Argan oil also contains the saturated fatty acids palmitic acid (11%-15%) and stearic acid (4%-7%).2
Though argan oil is mainly composed of unsaturated fatty acids (80%),1,18,19 the unsaponifiable fraction (1%) is replete with antioxidants, including sterols, saponins, and polyphenols.4,19 The polyphenolic constituents, primarily gamma-tocopherol, which is considered the most efficient among the tocopherols at scavenging free radicals, are thought to account for the antioxidant effects of argan oil.1,2,18,20,21
Topical uses
Unroasted kernels are used to produce cosmetic-grade argan oil, which is used in moisturizing creams, body lotions, and shampoos.2 Although argan oil contains components that have antioxidant and anti-inflammatory features and there are many patents on the use of argan oil in skin care, there is a dearth of published research studies looking at the effect of argan oil–containing skin care products on aging, inflamed, or dry skin. A study by Dobrev evaluated the efficacy of a sebum control cream composed of saw palmetto extract, sesame seeds, and argan oil applied twice daily to the face over a period of 4 weeks in 20 healthy volunteers, 16 with oily skin and 4 with combination skin. All volunteers tolerated the product. A visible sebum-regulating or antisebum efficacy was observed in 95% of the subjects. Clinical evaluation scores and casual sebum levels decreased significantly after 1 month of treatment. Dobrev concluded that this argan oil-containing formulation was efficacious in lessening the greasiness and improving the appearance of oily facial skin.22
Early in 2015, Boucetta et al. reported on their study of the effects on skin elasticity of the daily application or consumption of argan oil in 60 postmenopausal women. During a 60-day period, the treatment group of 30 subjects consumed dietary argan oil; the 30 members in the control group received olive oil. Both groups also applied topical argan oil to the left volar forearm. Skin parameters, including gross skin elasticity, net elasticity, and biologic elasticity, improved significantly with both oral and topical treatments. The researchers concluded that argan oil use confers an antiaging effect to the skin through enhanced elasticity.24 Boucetta and another team previously showed that daily consumption or topical application of argan oil in postmenopausal women yielded significant reductions in transepidermal water loss and significant increases in epidermal water content, suggesting that the botanical agent ameliorates skin hydration by reviving barrier function and preserving the water-holding capacity.25 The same team also demonstrated in 30 healthy postmenopausal women that the nightly topical application of argan oil over a 2-month period yielded a moisturizing effect, with statistically significant reductions in transepidermal water loss and statistically significant increases in the water content of the epidermis observed.26
As a cosmetic agent, argan oil, which is popular in France, Japan, and North America, is touted for hydrating and revitalizing the skin, treating acne, and imparting shine to the hair. The therapeutic activities of topical argan oil are reputed to be antiacne, antisebum, antiaging, moisturizing, and wound healing, but such claims are based on traditional uses with only a small body of supportive clinical evidence.2,27
Generally, argan oil prices are as high as $40/100 mL in the European, Japanese, and American markets.27 Topical argan oil has been characterized as having a brief shelf-life of approximately 3-4 months.2,28 A 2014 report on a 1-year study of the oxidative stability of cosmetic argan oil by Gharby et al. found that argan oil quality remains satisfactory when stored at 25° C and protected from sunlight, but storage should not exceed 6 months to meet industrial standards. A rapid loss of quality was seen when argan oil was stored at 40° C.29
Conclusion
Although clinical research data on argan oil are limited, its traditional uses and inclusion in novel cosmetic products suggest that further study is warranted. Randomized controlled trials are needed to elucidate cutaneous benefits, if any, from this rare botanical.
1. J Pharm Pharmacol. 2010 Dec;62(12):1669-75.
2. Altern Med Rev. 2011 Sep;16(3):275-9.
3. J Ethnopharmacol. 1999 Oct;67(1):7-14.
4. Pharmacol Res. 2006 Jul;54(1):1-5.
5. Nutr Rev. 2012 May;70(5):266-79.
6. Eur J Lipid Sci Technol. 2014 Oct;116(10):1316-21.
7. Ann Nutr Metab. 2005 May-Jun;49(3):196-201.
8. Nutr Metab Cardiovasc Dis. 2005 Oct;15(5):352-60.
9. Evid Based Complement Alternat Med. 2006 Sep;3(3):317-27.
10. Cancer Invest. 2006 Oct;24(6):588-92.
11. Cancer Detect Prev. 2007;31(1):64-9.
12. “Liquid Gold in Morocco,” by Amy Larocca, The New York Times, Nov. 18, 2007.
13. Phytomedicine. 2010 Feb;17(2):157-60.
14. J Control Release. 1995;37(3):299-306.
15. Thermochimica Acta. 1997 Jun;293:77-85.
16. Prostaglandins Leukot Essent Fatty Acids. 1995 Jun;52(6):387-91.
17. Int J Cosmet Sci. 1996 Feb;18(1):1-12.
18. Crit Rev Food Sci Nutr. 2010 May;50(5):473-7.
19. Eur J Cancer Prev. 2003 Feb;12(1):67-75.
20. Fitoterapia. 2008 Jul;79(5):337-44.
21. Am J Clin Nutr. 2001 Dec;74(6):714-22.
22. J Cosmet Dermatol. 2007;6(2):113-8.
23. Int J Nanomedicine. 2014 Aug 11;9:3855-64.
24. Clin Interv Aging. 2015 Jan 30;10:339-49.
25. Prz Menopauzalny. 2014 Oct;13(5):280-8.
26. Skin Res Technol. 2013;19:356-7.
27. Inflamm Allergy Drug Targets. 2014;13(3):168-76.
28. Nat Prod Commun. 2010 Nov;5(11):1799-802.
29. J Cosmet Sci. 2014 Mar-Apr;65(2):81-7.
Dr. Baumann is the CEO of Baumann Cosmetic & Research Institute in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. She is the author of “Cosmetic Dermatology: Principles and Practice” (New York: McGraw Hill, 2002), and a book for consumers, “The Skin Type Solution,” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients” (McGraw Hill) was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also develops and owns the Baumann Skin Type Solution skin typing solutions and related products.
• Used traditionally in Northwest Africa for its cosmetic, bactericidal, and fungicidal activity.
• Rich in vitamin E, oleic acid, and linoleic acid, which are believed to contribute to the perceived cutaneous benefits of this vegetable oil.
• Reputed to impart antiacne, antisebum, antiaging, moisturizing, and wound-healing activity, but clinical evidence is sparse.
• In a small study, the nightly topical application of argan oil resulted in a moisturizing effect, and in statistically significant decreases in transepidermal water loss and increases in the water content of the epidermis.
For more than 800 years, native Moroccans and explorers in the region have cited the health benefits of the topical use or consumption of argan oil.1 The oil, derived from the fruit of Argania spinosa, is a slow-growing tree native to the arid climate of Southwestern Morocco2-4 as well as the Algerian province of Tindouf in the Western Mediterranean area.5 For many years, it was primarily the populations of the Essaouira and Souss-Massa-Draa regions of Morocco that benefited from the production and use of argan oil.6 Largely through the efforts of the Moroccan government, as well as cooperating nongovernmental organizations and private entities, argan oil is now also a well-established ingredient on the edible oil as well as cosmetic oil markets throughout the world.6
The vitamin E–rich oil has a reputation for imparting antiaging, hydrating, and antioxidant activity to the skin and ameliorating conditions such as acne, eczema, psoriasis, wrinkles, and xerosis,12 and, in fact, has been used to treat these conditions as well as dry hair,3,13 hair loss, skin inflammation, and joint pain.3 This column will focus on the topical uses of this botanical that has been dubbed “liquid gold.”12
Chemistry
Oleic acid, an omega-9 monounsaturated fatty acid, is abundant in argan oil (43%-49%) and has been found to act as a penetration enhancer by disturbing the skin barrier.14,15 Linoleic acid, an omega-6 polyunsaturated fatty acid, found in concentrations of 29%-36% in the oil, is integral in the biosynthesis of inflammatory prostaglandins through the arachidonic acid pathway.4,16 The presence of linoleic acid may help prevent or mitigate inflammation. Linoleic acid is also a component of ceramide 1 linoleate, which is diminished in dry skin. Topical application of linoleic acid can raise ceramide 1 linoleate levels in the skin, thus reducing xerosis.17 Argan oil also contains the saturated fatty acids palmitic acid (11%-15%) and stearic acid (4%-7%).2
Though argan oil is mainly composed of unsaturated fatty acids (80%),1,18,19 the unsaponifiable fraction (1%) is replete with antioxidants, including sterols, saponins, and polyphenols.4,19 The polyphenolic constituents, primarily gamma-tocopherol, which is considered the most efficient among the tocopherols at scavenging free radicals, are thought to account for the antioxidant effects of argan oil.1,2,18,20,21
Topical uses
Unroasted kernels are used to produce cosmetic-grade argan oil, which is used in moisturizing creams, body lotions, and shampoos.2 Although argan oil contains components that have antioxidant and anti-inflammatory features and there are many patents on the use of argan oil in skin care, there is a dearth of published research studies looking at the effect of argan oil–containing skin care products on aging, inflamed, or dry skin. A study by Dobrev evaluated the efficacy of a sebum control cream composed of saw palmetto extract, sesame seeds, and argan oil applied twice daily to the face over a period of 4 weeks in 20 healthy volunteers, 16 with oily skin and 4 with combination skin. All volunteers tolerated the product. A visible sebum-regulating or antisebum efficacy was observed in 95% of the subjects. Clinical evaluation scores and casual sebum levels decreased significantly after 1 month of treatment. Dobrev concluded that this argan oil-containing formulation was efficacious in lessening the greasiness and improving the appearance of oily facial skin.22
Early in 2015, Boucetta et al. reported on their study of the effects on skin elasticity of the daily application or consumption of argan oil in 60 postmenopausal women. During a 60-day period, the treatment group of 30 subjects consumed dietary argan oil; the 30 members in the control group received olive oil. Both groups also applied topical argan oil to the left volar forearm. Skin parameters, including gross skin elasticity, net elasticity, and biologic elasticity, improved significantly with both oral and topical treatments. The researchers concluded that argan oil use confers an antiaging effect to the skin through enhanced elasticity.24 Boucetta and another team previously showed that daily consumption or topical application of argan oil in postmenopausal women yielded significant reductions in transepidermal water loss and significant increases in epidermal water content, suggesting that the botanical agent ameliorates skin hydration by reviving barrier function and preserving the water-holding capacity.25 The same team also demonstrated in 30 healthy postmenopausal women that the nightly topical application of argan oil over a 2-month period yielded a moisturizing effect, with statistically significant reductions in transepidermal water loss and statistically significant increases in the water content of the epidermis observed.26
As a cosmetic agent, argan oil, which is popular in France, Japan, and North America, is touted for hydrating and revitalizing the skin, treating acne, and imparting shine to the hair. The therapeutic activities of topical argan oil are reputed to be antiacne, antisebum, antiaging, moisturizing, and wound healing, but such claims are based on traditional uses with only a small body of supportive clinical evidence.2,27
Generally, argan oil prices are as high as $40/100 mL in the European, Japanese, and American markets.27 Topical argan oil has been characterized as having a brief shelf-life of approximately 3-4 months.2,28 A 2014 report on a 1-year study of the oxidative stability of cosmetic argan oil by Gharby et al. found that argan oil quality remains satisfactory when stored at 25° C and protected from sunlight, but storage should not exceed 6 months to meet industrial standards. A rapid loss of quality was seen when argan oil was stored at 40° C.29
Conclusion
Although clinical research data on argan oil are limited, its traditional uses and inclusion in novel cosmetic products suggest that further study is warranted. Randomized controlled trials are needed to elucidate cutaneous benefits, if any, from this rare botanical.
1. J Pharm Pharmacol. 2010 Dec;62(12):1669-75.
2. Altern Med Rev. 2011 Sep;16(3):275-9.
3. J Ethnopharmacol. 1999 Oct;67(1):7-14.
4. Pharmacol Res. 2006 Jul;54(1):1-5.
5. Nutr Rev. 2012 May;70(5):266-79.
6. Eur J Lipid Sci Technol. 2014 Oct;116(10):1316-21.
7. Ann Nutr Metab. 2005 May-Jun;49(3):196-201.
8. Nutr Metab Cardiovasc Dis. 2005 Oct;15(5):352-60.
9. Evid Based Complement Alternat Med. 2006 Sep;3(3):317-27.
10. Cancer Invest. 2006 Oct;24(6):588-92.
11. Cancer Detect Prev. 2007;31(1):64-9.
12. “Liquid Gold in Morocco,” by Amy Larocca, The New York Times, Nov. 18, 2007.
13. Phytomedicine. 2010 Feb;17(2):157-60.
14. J Control Release. 1995;37(3):299-306.
15. Thermochimica Acta. 1997 Jun;293:77-85.
16. Prostaglandins Leukot Essent Fatty Acids. 1995 Jun;52(6):387-91.
17. Int J Cosmet Sci. 1996 Feb;18(1):1-12.
18. Crit Rev Food Sci Nutr. 2010 May;50(5):473-7.
19. Eur J Cancer Prev. 2003 Feb;12(1):67-75.
20. Fitoterapia. 2008 Jul;79(5):337-44.
21. Am J Clin Nutr. 2001 Dec;74(6):714-22.
22. J Cosmet Dermatol. 2007;6(2):113-8.
23. Int J Nanomedicine. 2014 Aug 11;9:3855-64.
24. Clin Interv Aging. 2015 Jan 30;10:339-49.
25. Prz Menopauzalny. 2014 Oct;13(5):280-8.
26. Skin Res Technol. 2013;19:356-7.
27. Inflamm Allergy Drug Targets. 2014;13(3):168-76.
28. Nat Prod Commun. 2010 Nov;5(11):1799-802.
29. J Cosmet Sci. 2014 Mar-Apr;65(2):81-7.
Dr. Baumann is the CEO of Baumann Cosmetic & Research Institute in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. She is the author of “Cosmetic Dermatology: Principles and Practice” (New York: McGraw Hill, 2002), and a book for consumers, “The Skin Type Solution,” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients” (McGraw Hill) was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also develops and owns the Baumann Skin Type Solution skin typing solutions and related products.
• Used traditionally in Northwest Africa for its cosmetic, bactericidal, and fungicidal activity.
• Rich in vitamin E, oleic acid, and linoleic acid, which are believed to contribute to the perceived cutaneous benefits of this vegetable oil.
• Reputed to impart antiacne, antisebum, antiaging, moisturizing, and wound-healing activity, but clinical evidence is sparse.
• In a small study, the nightly topical application of argan oil resulted in a moisturizing effect, and in statistically significant decreases in transepidermal water loss and increases in the water content of the epidermis.
For more than 800 years, native Moroccans and explorers in the region have cited the health benefits of the topical use or consumption of argan oil.1 The oil, derived from the fruit of Argania spinosa, is a slow-growing tree native to the arid climate of Southwestern Morocco2-4 as well as the Algerian province of Tindouf in the Western Mediterranean area.5 For many years, it was primarily the populations of the Essaouira and Souss-Massa-Draa regions of Morocco that benefited from the production and use of argan oil.6 Largely through the efforts of the Moroccan government, as well as cooperating nongovernmental organizations and private entities, argan oil is now also a well-established ingredient on the edible oil as well as cosmetic oil markets throughout the world.6
The vitamin E–rich oil has a reputation for imparting antiaging, hydrating, and antioxidant activity to the skin and ameliorating conditions such as acne, eczema, psoriasis, wrinkles, and xerosis,12 and, in fact, has been used to treat these conditions as well as dry hair,3,13 hair loss, skin inflammation, and joint pain.3 This column will focus on the topical uses of this botanical that has been dubbed “liquid gold.”12
Chemistry
Oleic acid, an omega-9 monounsaturated fatty acid, is abundant in argan oil (43%-49%) and has been found to act as a penetration enhancer by disturbing the skin barrier.14,15 Linoleic acid, an omega-6 polyunsaturated fatty acid, found in concentrations of 29%-36% in the oil, is integral in the biosynthesis of inflammatory prostaglandins through the arachidonic acid pathway.4,16 The presence of linoleic acid may help prevent or mitigate inflammation. Linoleic acid is also a component of ceramide 1 linoleate, which is diminished in dry skin. Topical application of linoleic acid can raise ceramide 1 linoleate levels in the skin, thus reducing xerosis.17 Argan oil also contains the saturated fatty acids palmitic acid (11%-15%) and stearic acid (4%-7%).2
Though argan oil is mainly composed of unsaturated fatty acids (80%),1,18,19 the unsaponifiable fraction (1%) is replete with antioxidants, including sterols, saponins, and polyphenols.4,19 The polyphenolic constituents, primarily gamma-tocopherol, which is considered the most efficient among the tocopherols at scavenging free radicals, are thought to account for the antioxidant effects of argan oil.1,2,18,20,21
Topical uses
Unroasted kernels are used to produce cosmetic-grade argan oil, which is used in moisturizing creams, body lotions, and shampoos.2 Although argan oil contains components that have antioxidant and anti-inflammatory features and there are many patents on the use of argan oil in skin care, there is a dearth of published research studies looking at the effect of argan oil–containing skin care products on aging, inflamed, or dry skin. A study by Dobrev evaluated the efficacy of a sebum control cream composed of saw palmetto extract, sesame seeds, and argan oil applied twice daily to the face over a period of 4 weeks in 20 healthy volunteers, 16 with oily skin and 4 with combination skin. All volunteers tolerated the product. A visible sebum-regulating or antisebum efficacy was observed in 95% of the subjects. Clinical evaluation scores and casual sebum levels decreased significantly after 1 month of treatment. Dobrev concluded that this argan oil-containing formulation was efficacious in lessening the greasiness and improving the appearance of oily facial skin.22
Early in 2015, Boucetta et al. reported on their study of the effects on skin elasticity of the daily application or consumption of argan oil in 60 postmenopausal women. During a 60-day period, the treatment group of 30 subjects consumed dietary argan oil; the 30 members in the control group received olive oil. Both groups also applied topical argan oil to the left volar forearm. Skin parameters, including gross skin elasticity, net elasticity, and biologic elasticity, improved significantly with both oral and topical treatments. The researchers concluded that argan oil use confers an antiaging effect to the skin through enhanced elasticity.24 Boucetta and another team previously showed that daily consumption or topical application of argan oil in postmenopausal women yielded significant reductions in transepidermal water loss and significant increases in epidermal water content, suggesting that the botanical agent ameliorates skin hydration by reviving barrier function and preserving the water-holding capacity.25 The same team also demonstrated in 30 healthy postmenopausal women that the nightly topical application of argan oil over a 2-month period yielded a moisturizing effect, with statistically significant reductions in transepidermal water loss and statistically significant increases in the water content of the epidermis observed.26
As a cosmetic agent, argan oil, which is popular in France, Japan, and North America, is touted for hydrating and revitalizing the skin, treating acne, and imparting shine to the hair. The therapeutic activities of topical argan oil are reputed to be antiacne, antisebum, antiaging, moisturizing, and wound healing, but such claims are based on traditional uses with only a small body of supportive clinical evidence.2,27
Generally, argan oil prices are as high as $40/100 mL in the European, Japanese, and American markets.27 Topical argan oil has been characterized as having a brief shelf-life of approximately 3-4 months.2,28 A 2014 report on a 1-year study of the oxidative stability of cosmetic argan oil by Gharby et al. found that argan oil quality remains satisfactory when stored at 25° C and protected from sunlight, but storage should not exceed 6 months to meet industrial standards. A rapid loss of quality was seen when argan oil was stored at 40° C.29
Conclusion
Although clinical research data on argan oil are limited, its traditional uses and inclusion in novel cosmetic products suggest that further study is warranted. Randomized controlled trials are needed to elucidate cutaneous benefits, if any, from this rare botanical.
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Dr. Baumann is the CEO of Baumann Cosmetic & Research Institute in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. She is the author of “Cosmetic Dermatology: Principles and Practice” (New York: McGraw Hill, 2002), and a book for consumers, “The Skin Type Solution,” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients” (McGraw Hill) was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also develops and owns the Baumann Skin Type Solution skin typing solutions and related products.
