User login
Mechanism for Dust mite–triggered Atopic Dermatitis Identified
Researchers have identified a possible mechanism by which house dust mites could trigger the development of atopic dermatitis in individuals with a genetic predisposition.
The study, published online Feb. 10 in Science Translational Medicine, took skin and blood samples from individuals with atopic dermatitis and healthy controls, then exposed the samples to house dust mite allergen.
They found that in individuals with atopic dermatitis, this exposure modified phospholipids in the skin to release lipid antigens that then drove T-cell reactivity and inflammation (Sci Transl Med. 2016 Feb 10. doi: 10.1126/scitranslmed.aad6833).
Furthermore, the study suggested that the skin barrier protein filaggrin can inhibit the modified phospholipid activity and decrease the skin inflammation caused by allergen exposure in atopic dermatitis; however, individuals with atopic dermatitis are more likely to have defective filaggrin.
“The data would support therapeutic approaches to inhibit allergen-derived PLA2 [phospholipase A2] activity, together with treatments that target the downstream immunological effector pathways,” wrote Dr. Rachael Jarrett of the University of Oxford (England) and coauthors.
The study was funded by the U.K. Medical Research Council and National Institute for Health Research Biomedical Research Centre, the National Institutes of Health, and the Burroughs Wellcome Fund in Translational Medicine. Several of the researchers acknowledged grants and pharmaceutical company support. No conflicts of interest were declared.
Researchers have identified a possible mechanism by which house dust mites could trigger the development of atopic dermatitis in individuals with a genetic predisposition.
The study, published online Feb. 10 in Science Translational Medicine, took skin and blood samples from individuals with atopic dermatitis and healthy controls, then exposed the samples to house dust mite allergen.
They found that in individuals with atopic dermatitis, this exposure modified phospholipids in the skin to release lipid antigens that then drove T-cell reactivity and inflammation (Sci Transl Med. 2016 Feb 10. doi: 10.1126/scitranslmed.aad6833).
Furthermore, the study suggested that the skin barrier protein filaggrin can inhibit the modified phospholipid activity and decrease the skin inflammation caused by allergen exposure in atopic dermatitis; however, individuals with atopic dermatitis are more likely to have defective filaggrin.
“The data would support therapeutic approaches to inhibit allergen-derived PLA2 [phospholipase A2] activity, together with treatments that target the downstream immunological effector pathways,” wrote Dr. Rachael Jarrett of the University of Oxford (England) and coauthors.
The study was funded by the U.K. Medical Research Council and National Institute for Health Research Biomedical Research Centre, the National Institutes of Health, and the Burroughs Wellcome Fund in Translational Medicine. Several of the researchers acknowledged grants and pharmaceutical company support. No conflicts of interest were declared.
Researchers have identified a possible mechanism by which house dust mites could trigger the development of atopic dermatitis in individuals with a genetic predisposition.
The study, published online Feb. 10 in Science Translational Medicine, took skin and blood samples from individuals with atopic dermatitis and healthy controls, then exposed the samples to house dust mite allergen.
They found that in individuals with atopic dermatitis, this exposure modified phospholipids in the skin to release lipid antigens that then drove T-cell reactivity and inflammation (Sci Transl Med. 2016 Feb 10. doi: 10.1126/scitranslmed.aad6833).
Furthermore, the study suggested that the skin barrier protein filaggrin can inhibit the modified phospholipid activity and decrease the skin inflammation caused by allergen exposure in atopic dermatitis; however, individuals with atopic dermatitis are more likely to have defective filaggrin.
“The data would support therapeutic approaches to inhibit allergen-derived PLA2 [phospholipase A2] activity, together with treatments that target the downstream immunological effector pathways,” wrote Dr. Rachael Jarrett of the University of Oxford (England) and coauthors.
The study was funded by the U.K. Medical Research Council and National Institute for Health Research Biomedical Research Centre, the National Institutes of Health, and the Burroughs Wellcome Fund in Translational Medicine. Several of the researchers acknowledged grants and pharmaceutical company support. No conflicts of interest were declared.
FROM SCIENCE TRANSLATIONAL MEDICINE
Mechanism for dust mite–triggered atopic dermatitis identified
Researchers have identified a possible mechanism by which house dust mites could trigger the development of atopic dermatitis in individuals with a genetic predisposition.
The study, published online Feb. 10 in Science Translational Medicine, took skin and blood samples from individuals with atopic dermatitis and healthy controls, then exposed the samples to house dust mite allergen.
They found that in individuals with atopic dermatitis, this exposure modified phospholipids in the skin to release lipid antigens that then drove T-cell reactivity and inflammation (Sci Transl Med. 2016 Feb 10. doi: 10.1126/scitranslmed.aad6833).
Furthermore, the study suggested that the skin barrier protein filaggrin can inhibit the modified phospholipid activity and decrease the skin inflammation caused by allergen exposure in atopic dermatitis; however, individuals with atopic dermatitis are more likely to have defective filaggrin.
“The data would support therapeutic approaches to inhibit allergen-derived PLA2 [phospholipase A2] activity, together with treatments that target the downstream immunological effector pathways,” wrote Dr. Rachael Jarrett of the University of Oxford (England) and coauthors.
The study was funded by the U.K. Medical Research Council and National Institute for Health Research Biomedical Research Centre, the National Institutes of Health, and the Burroughs Wellcome Fund in Translational Medicine. Several of the researchers acknowledged grants and pharmaceutical company support. No conflicts of interest were declared.
Researchers have identified a possible mechanism by which house dust mites could trigger the development of atopic dermatitis in individuals with a genetic predisposition.
The study, published online Feb. 10 in Science Translational Medicine, took skin and blood samples from individuals with atopic dermatitis and healthy controls, then exposed the samples to house dust mite allergen.
They found that in individuals with atopic dermatitis, this exposure modified phospholipids in the skin to release lipid antigens that then drove T-cell reactivity and inflammation (Sci Transl Med. 2016 Feb 10. doi: 10.1126/scitranslmed.aad6833).
Furthermore, the study suggested that the skin barrier protein filaggrin can inhibit the modified phospholipid activity and decrease the skin inflammation caused by allergen exposure in atopic dermatitis; however, individuals with atopic dermatitis are more likely to have defective filaggrin.
“The data would support therapeutic approaches to inhibit allergen-derived PLA2 [phospholipase A2] activity, together with treatments that target the downstream immunological effector pathways,” wrote Dr. Rachael Jarrett of the University of Oxford (England) and coauthors.
The study was funded by the U.K. Medical Research Council and National Institute for Health Research Biomedical Research Centre, the National Institutes of Health, and the Burroughs Wellcome Fund in Translational Medicine. Several of the researchers acknowledged grants and pharmaceutical company support. No conflicts of interest were declared.
Researchers have identified a possible mechanism by which house dust mites could trigger the development of atopic dermatitis in individuals with a genetic predisposition.
The study, published online Feb. 10 in Science Translational Medicine, took skin and blood samples from individuals with atopic dermatitis and healthy controls, then exposed the samples to house dust mite allergen.
They found that in individuals with atopic dermatitis, this exposure modified phospholipids in the skin to release lipid antigens that then drove T-cell reactivity and inflammation (Sci Transl Med. 2016 Feb 10. doi: 10.1126/scitranslmed.aad6833).
Furthermore, the study suggested that the skin barrier protein filaggrin can inhibit the modified phospholipid activity and decrease the skin inflammation caused by allergen exposure in atopic dermatitis; however, individuals with atopic dermatitis are more likely to have defective filaggrin.
“The data would support therapeutic approaches to inhibit allergen-derived PLA2 [phospholipase A2] activity, together with treatments that target the downstream immunological effector pathways,” wrote Dr. Rachael Jarrett of the University of Oxford (England) and coauthors.
The study was funded by the U.K. Medical Research Council and National Institute for Health Research Biomedical Research Centre, the National Institutes of Health, and the Burroughs Wellcome Fund in Translational Medicine. Several of the researchers acknowledged grants and pharmaceutical company support. No conflicts of interest were declared.
FROM SCIENCE TRANSLATIONAL MEDICINE
Key clinical point: Dust mite allergen modifies skin phospholipids and triggers inflammation in atopic dermatitis.
Major finding: Individuals with atopic dermatitis have a defective skin protein that increases their reactivity to house dust mite allergen.
Data source: Laboratory study.
Disclosures: The study was funded by the U.K. Medical Research Council and National Institute for Health Research Biomedical Research Centre, the National Institutes of Health, and the Burroughs Wellcome Fund in Translational Medicine. Several of the researchers acknowledged grants and pharmaceutical company support. No conflicts of interest were declared.
Limited benefits with mesh versus tissue repair for prolapse
There is limited evidence in favor of permanent transvaginal mesh or grafts over native tissue repair for vaginal prolapse, according to a systematic review of 37 randomized controlled trials.
Researchers reviewed trials involving 4,023 women comparing transvaginal grafts with traditional native tissue repair for vaginal prolapse. They found that permanent mesh repair was associated with a 34% lower likelihood of awareness of prolapse at 1-3 years after the procedure (risk ratio, 0.66) and a 60% lower likelihood of recurrent prolapse on examination (RR, 0.40), compared with native tissue repair, according to a paper published online Feb. 9 (Cochrane Database Syst Rev. doi: 10.1002/14651858.CD012079).
Women who underwent permanent mesh repair also had 47% lower rates of repeat surgery for prolapse than those who had native tissue repair (RR, 0.53), although neither approach achieved a significant difference in rates of repeat surgery for continence.
Overall, more than twice as many women in the mesh group needed repeat surgery for a combined outcome of prolapse, stress incontinence, or mesh exposure (RR, 2.40).
“This suggests that if 5% of women require repeat surgery after native tissue repair, between 7% and 18% in the permanent mesh group will do so,” wrote Dr. Christopher Maher of the Royal Brisbane and Women’s Hospital, Australia, and his coauthors.
However permanent mesh was also associated with 39% higher rates of de novo stress incontinence (RR, 1.39) and nearly a four-fold greater risk of bladder injury (RR, 3.92), compared with native tissue repair. There were no differences between the groups in rates of de novo dyspareunia and the researchers could not determine the impact on quality of life due to very low-quality evidence.
The researchers also examined the relative impact of absorbable mesh, compared with native tissue repair and, while the evidence for the effectiveness of either at 2 years was found to be of very low quality, the risk of recurrent prolapse on examination was 29% lower with the absorbable mesh group, compared with native tissue repair.
Similarly, studies comparing biological graft with native tissue repair were of low quality and found no evidence of a significant difference in the impact on the risk of recurrent prolapse or repeat surgery for prolapse.
Given the higher rates of repeat surgery for prolapse, stress urinary incontinence, mesh exposure, as well as higher rates of bladder injury at surgery and de novo stress incontinence, the review authors commented that the risk-benefit profile of transvaginal mesh suggested it had limited utility in primary surgery.
“While it is possible that in women with higher risk of recurrence the benefits may outweigh the risks, there is currently no evidence to support this position,” the authors wrote.
Overall, the quality of study evidence ranged from very low to moderate, with the main limitations being poor reporting of study methods, inconsistency, and imprecision.
“In 2011, many transvaginal permanent meshes were voluntarily withdrawn from the market, and the newer, lightweight transvaginal permanent meshes still available have not been evaluated within a randomized controlled trial,” the authors wrote. “In the meantime, these newer transvaginal meshes should be utilised under the discretion of the ethics committee.”
Dr. Maher reported involvement in two trials of pelvic prolapse. There were no other conflicts of interest reported.
There is limited evidence in favor of permanent transvaginal mesh or grafts over native tissue repair for vaginal prolapse, according to a systematic review of 37 randomized controlled trials.
Researchers reviewed trials involving 4,023 women comparing transvaginal grafts with traditional native tissue repair for vaginal prolapse. They found that permanent mesh repair was associated with a 34% lower likelihood of awareness of prolapse at 1-3 years after the procedure (risk ratio, 0.66) and a 60% lower likelihood of recurrent prolapse on examination (RR, 0.40), compared with native tissue repair, according to a paper published online Feb. 9 (Cochrane Database Syst Rev. doi: 10.1002/14651858.CD012079).
Women who underwent permanent mesh repair also had 47% lower rates of repeat surgery for prolapse than those who had native tissue repair (RR, 0.53), although neither approach achieved a significant difference in rates of repeat surgery for continence.
Overall, more than twice as many women in the mesh group needed repeat surgery for a combined outcome of prolapse, stress incontinence, or mesh exposure (RR, 2.40).
“This suggests that if 5% of women require repeat surgery after native tissue repair, between 7% and 18% in the permanent mesh group will do so,” wrote Dr. Christopher Maher of the Royal Brisbane and Women’s Hospital, Australia, and his coauthors.
However permanent mesh was also associated with 39% higher rates of de novo stress incontinence (RR, 1.39) and nearly a four-fold greater risk of bladder injury (RR, 3.92), compared with native tissue repair. There were no differences between the groups in rates of de novo dyspareunia and the researchers could not determine the impact on quality of life due to very low-quality evidence.
The researchers also examined the relative impact of absorbable mesh, compared with native tissue repair and, while the evidence for the effectiveness of either at 2 years was found to be of very low quality, the risk of recurrent prolapse on examination was 29% lower with the absorbable mesh group, compared with native tissue repair.
Similarly, studies comparing biological graft with native tissue repair were of low quality and found no evidence of a significant difference in the impact on the risk of recurrent prolapse or repeat surgery for prolapse.
Given the higher rates of repeat surgery for prolapse, stress urinary incontinence, mesh exposure, as well as higher rates of bladder injury at surgery and de novo stress incontinence, the review authors commented that the risk-benefit profile of transvaginal mesh suggested it had limited utility in primary surgery.
“While it is possible that in women with higher risk of recurrence the benefits may outweigh the risks, there is currently no evidence to support this position,” the authors wrote.
Overall, the quality of study evidence ranged from very low to moderate, with the main limitations being poor reporting of study methods, inconsistency, and imprecision.
“In 2011, many transvaginal permanent meshes were voluntarily withdrawn from the market, and the newer, lightweight transvaginal permanent meshes still available have not been evaluated within a randomized controlled trial,” the authors wrote. “In the meantime, these newer transvaginal meshes should be utilised under the discretion of the ethics committee.”
Dr. Maher reported involvement in two trials of pelvic prolapse. There were no other conflicts of interest reported.
There is limited evidence in favor of permanent transvaginal mesh or grafts over native tissue repair for vaginal prolapse, according to a systematic review of 37 randomized controlled trials.
Researchers reviewed trials involving 4,023 women comparing transvaginal grafts with traditional native tissue repair for vaginal prolapse. They found that permanent mesh repair was associated with a 34% lower likelihood of awareness of prolapse at 1-3 years after the procedure (risk ratio, 0.66) and a 60% lower likelihood of recurrent prolapse on examination (RR, 0.40), compared with native tissue repair, according to a paper published online Feb. 9 (Cochrane Database Syst Rev. doi: 10.1002/14651858.CD012079).
Women who underwent permanent mesh repair also had 47% lower rates of repeat surgery for prolapse than those who had native tissue repair (RR, 0.53), although neither approach achieved a significant difference in rates of repeat surgery for continence.
Overall, more than twice as many women in the mesh group needed repeat surgery for a combined outcome of prolapse, stress incontinence, or mesh exposure (RR, 2.40).
“This suggests that if 5% of women require repeat surgery after native tissue repair, between 7% and 18% in the permanent mesh group will do so,” wrote Dr. Christopher Maher of the Royal Brisbane and Women’s Hospital, Australia, and his coauthors.
However permanent mesh was also associated with 39% higher rates of de novo stress incontinence (RR, 1.39) and nearly a four-fold greater risk of bladder injury (RR, 3.92), compared with native tissue repair. There were no differences between the groups in rates of de novo dyspareunia and the researchers could not determine the impact on quality of life due to very low-quality evidence.
The researchers also examined the relative impact of absorbable mesh, compared with native tissue repair and, while the evidence for the effectiveness of either at 2 years was found to be of very low quality, the risk of recurrent prolapse on examination was 29% lower with the absorbable mesh group, compared with native tissue repair.
Similarly, studies comparing biological graft with native tissue repair were of low quality and found no evidence of a significant difference in the impact on the risk of recurrent prolapse or repeat surgery for prolapse.
Given the higher rates of repeat surgery for prolapse, stress urinary incontinence, mesh exposure, as well as higher rates of bladder injury at surgery and de novo stress incontinence, the review authors commented that the risk-benefit profile of transvaginal mesh suggested it had limited utility in primary surgery.
“While it is possible that in women with higher risk of recurrence the benefits may outweigh the risks, there is currently no evidence to support this position,” the authors wrote.
Overall, the quality of study evidence ranged from very low to moderate, with the main limitations being poor reporting of study methods, inconsistency, and imprecision.
“In 2011, many transvaginal permanent meshes were voluntarily withdrawn from the market, and the newer, lightweight transvaginal permanent meshes still available have not been evaluated within a randomized controlled trial,” the authors wrote. “In the meantime, these newer transvaginal meshes should be utilised under the discretion of the ethics committee.”
Dr. Maher reported involvement in two trials of pelvic prolapse. There were no other conflicts of interest reported.
FROM THE COCHRANE DATABASE OF SYSTEMATIC REVIEWS
Key clinical point: Permanent mesh offers some advantages over native tissue repair for vaginal prolapse but with a greater risk of repeat surgery and incontinence.
Major finding: Permanent mesh repair is associated with a 34% lower likelihood of awareness of prolapse at 1-3 years after the procedure, compared with native tissue repair.
Data source: Review of 37 randomized controlled trials in 4,023 women with vaginal prolapse.
Disclosures: Dr. Maher reported involvement in two trials of pelvic prolapse. There were no other conflicts of interest reported.
MI, heart failure mortality rates slightly lower in VA hospitals
Mortality rates among older men in Veterans Affairs hospitals were lower for acute myocardial infarction and heart failure but higher for pneumonia, compared with non–Veterans Affairs hospitals, a study has found.
Researchers conducted a cross-sectional analysis of more than 7,900 male Medicare fee-for-service beneficiaries aged 65 years and older who were hospitalized in 104 VA and 1,513 non-VA acute care hospitals for acute myocardial infarction, heart failure, or pneumonia between 2010 and 2013.
The analysis, published online Feb. 9, showed that, for the VA hospitals, after adjusting for risk, 30-day mortality for acute MI was 0.17 percentage points lower (P = .02) and 30-day heart failure mortality was 0.44 percentage points lower (P = .008), compared with non-VA hospitals (JAMA. 2016;315[6]:582-92. doi: 10.1001/jama.2016.0278).
The differences between VA and non-VA hospitals were even greater when the comparison was made between hospitals in the same metropolitan statistical area: differences of 0.22 percentage points for 30-day mortality for acute MI (P = .02) and 0.63 percentage points for heart failure (P < .001).
“The finding that risk standardized mortality rates for cardiovascular conditions were lower, albeit with small absolute differences, in VA hospitals may reflect higher quality of care in VA hospitals as represented by adherence to process measures,” wrote Sudhakar V. Nuti of the Center for Outcomes Research and Evaluation at Yale-New Haven (Conn.) Hospital and coauthors.
“The lower mortality rates also may be due to the quality improvement efforts that can be implemented across the VA’s integrated delivery system,” they added.
Mortality rates for pneumonia were 0.46 percentage points higher in VA hospitals, compared with non-VA hospitals (P = .045). But after comparing hospitals within the same metropolitan area, this difference disappeared.
VA hospitals also had higher readmission rates than non-VA hospitals for all three conditions: 0.63 percentage points higher for acute MI, 1.2 points higher for heart failure, and 0.76 points higher for pneumonia (P < .001 for all).
This difference persisted when hospitals within the same area were compared.
Commenting on the readmission differences, the investigators suggested that VA hospitals may have a greater propensity to readmit patients, or that veterans may have to travel further to VA hospitals – which has been associated with higher readmission rates among veterans. They also pointed out, however, that non-VA hospitals had recently been subject to national interventions to reduce readmissions.
The study also showed that VA hospitals were more likely to be teaching hospitals and were larger and had a greater number of beds than non-VA hospitals. Around 12% of individuals who were initially hospitalized at VA hospitals were readmitted to non-VA hospitals, but less than 1% of individuals admitted to a non-VA hospital initially were later readmitted to a VA hospital, irrespective of their condition.
“The current study serves as an example of national performance comparison for VA and non-VA hospital care, which sets the stage for future performance and quality improvement studies,” the authors reported.
“Moreover, the results of our study and other benchmarking efforts could inform efforts to improve quality in the VA, particularly our findings of variation in performance, by identifying and learning from high performing hospitals and disseminating best practices to lower performing hospitals to elevate the entire performance curve.”
The authors stressed that, since the study population was limited to men over age 65 years who were VA or Medicare patients, the results were not generalizable to younger or female populations.
Some of the study’s authors were supported by grants from the National Institute on Aging; the American Federation for Aging Research; the National Heart, Lung, and Blood Institute; and the VA Connecticut Healthcare System. Two authors declared research agreements from Medtronic and Johnson & Johnson, one declared positions on a cardiac scientific advisory board for UnitedHealth, and four declared contract work for the Centers for Medicare & Medicaid Services. No other conflicts of interest were declared.
“These findings are important because they suggest that despite all of the challenges that VA hospitals have faced, they are still able to deliver high-quality care for some of the sickest, most complicated patients.
“That the VA, an integrated delivery system with a well-functioning information technology infrastructure, has higher readmission rates than non-VA hospitals, which are largely stand-alone entities with a high degree of fragmentation and little information sharing, is important. It is yet more evidence that readmissions primarily measure how sick and poor the patient population is, not how good or how integrated the care is.”
Dr. Ashish K. Jha is with the department of health policy and management at the Harvard T. H. Chan School of Public Health, Boston. These comments are from an accompanying editorial (JAMA. 2016 Feb 9. doi: 10.1001/jama.2016.0243). Dr. Jha disclosed that he is an attending physician at the Boston VA Healthcare System and declared an earlier role as special adviser to former VA Secretary Eric Shinseki through 2012.
“These findings are important because they suggest that despite all of the challenges that VA hospitals have faced, they are still able to deliver high-quality care for some of the sickest, most complicated patients.
“That the VA, an integrated delivery system with a well-functioning information technology infrastructure, has higher readmission rates than non-VA hospitals, which are largely stand-alone entities with a high degree of fragmentation and little information sharing, is important. It is yet more evidence that readmissions primarily measure how sick and poor the patient population is, not how good or how integrated the care is.”
Dr. Ashish K. Jha is with the department of health policy and management at the Harvard T. H. Chan School of Public Health, Boston. These comments are from an accompanying editorial (JAMA. 2016 Feb 9. doi: 10.1001/jama.2016.0243). Dr. Jha disclosed that he is an attending physician at the Boston VA Healthcare System and declared an earlier role as special adviser to former VA Secretary Eric Shinseki through 2012.
“These findings are important because they suggest that despite all of the challenges that VA hospitals have faced, they are still able to deliver high-quality care for some of the sickest, most complicated patients.
“That the VA, an integrated delivery system with a well-functioning information technology infrastructure, has higher readmission rates than non-VA hospitals, which are largely stand-alone entities with a high degree of fragmentation and little information sharing, is important. It is yet more evidence that readmissions primarily measure how sick and poor the patient population is, not how good or how integrated the care is.”
Dr. Ashish K. Jha is with the department of health policy and management at the Harvard T. H. Chan School of Public Health, Boston. These comments are from an accompanying editorial (JAMA. 2016 Feb 9. doi: 10.1001/jama.2016.0243). Dr. Jha disclosed that he is an attending physician at the Boston VA Healthcare System and declared an earlier role as special adviser to former VA Secretary Eric Shinseki through 2012.
Mortality rates among older men in Veterans Affairs hospitals were lower for acute myocardial infarction and heart failure but higher for pneumonia, compared with non–Veterans Affairs hospitals, a study has found.
Researchers conducted a cross-sectional analysis of more than 7,900 male Medicare fee-for-service beneficiaries aged 65 years and older who were hospitalized in 104 VA and 1,513 non-VA acute care hospitals for acute myocardial infarction, heart failure, or pneumonia between 2010 and 2013.
The analysis, published online Feb. 9, showed that, for the VA hospitals, after adjusting for risk, 30-day mortality for acute MI was 0.17 percentage points lower (P = .02) and 30-day heart failure mortality was 0.44 percentage points lower (P = .008), compared with non-VA hospitals (JAMA. 2016;315[6]:582-92. doi: 10.1001/jama.2016.0278).
The differences between VA and non-VA hospitals were even greater when the comparison was made between hospitals in the same metropolitan statistical area: differences of 0.22 percentage points for 30-day mortality for acute MI (P = .02) and 0.63 percentage points for heart failure (P < .001).
“The finding that risk standardized mortality rates for cardiovascular conditions were lower, albeit with small absolute differences, in VA hospitals may reflect higher quality of care in VA hospitals as represented by adherence to process measures,” wrote Sudhakar V. Nuti of the Center for Outcomes Research and Evaluation at Yale-New Haven (Conn.) Hospital and coauthors.
“The lower mortality rates also may be due to the quality improvement efforts that can be implemented across the VA’s integrated delivery system,” they added.
Mortality rates for pneumonia were 0.46 percentage points higher in VA hospitals, compared with non-VA hospitals (P = .045). But after comparing hospitals within the same metropolitan area, this difference disappeared.
VA hospitals also had higher readmission rates than non-VA hospitals for all three conditions: 0.63 percentage points higher for acute MI, 1.2 points higher for heart failure, and 0.76 points higher for pneumonia (P < .001 for all).
This difference persisted when hospitals within the same area were compared.
Commenting on the readmission differences, the investigators suggested that VA hospitals may have a greater propensity to readmit patients, or that veterans may have to travel further to VA hospitals – which has been associated with higher readmission rates among veterans. They also pointed out, however, that non-VA hospitals had recently been subject to national interventions to reduce readmissions.
The study also showed that VA hospitals were more likely to be teaching hospitals and were larger and had a greater number of beds than non-VA hospitals. Around 12% of individuals who were initially hospitalized at VA hospitals were readmitted to non-VA hospitals, but less than 1% of individuals admitted to a non-VA hospital initially were later readmitted to a VA hospital, irrespective of their condition.
“The current study serves as an example of national performance comparison for VA and non-VA hospital care, which sets the stage for future performance and quality improvement studies,” the authors reported.
“Moreover, the results of our study and other benchmarking efforts could inform efforts to improve quality in the VA, particularly our findings of variation in performance, by identifying and learning from high performing hospitals and disseminating best practices to lower performing hospitals to elevate the entire performance curve.”
The authors stressed that, since the study population was limited to men over age 65 years who were VA or Medicare patients, the results were not generalizable to younger or female populations.
Some of the study’s authors were supported by grants from the National Institute on Aging; the American Federation for Aging Research; the National Heart, Lung, and Blood Institute; and the VA Connecticut Healthcare System. Two authors declared research agreements from Medtronic and Johnson & Johnson, one declared positions on a cardiac scientific advisory board for UnitedHealth, and four declared contract work for the Centers for Medicare & Medicaid Services. No other conflicts of interest were declared.
Mortality rates among older men in Veterans Affairs hospitals were lower for acute myocardial infarction and heart failure but higher for pneumonia, compared with non–Veterans Affairs hospitals, a study has found.
Researchers conducted a cross-sectional analysis of more than 7,900 male Medicare fee-for-service beneficiaries aged 65 years and older who were hospitalized in 104 VA and 1,513 non-VA acute care hospitals for acute myocardial infarction, heart failure, or pneumonia between 2010 and 2013.
The analysis, published online Feb. 9, showed that, for the VA hospitals, after adjusting for risk, 30-day mortality for acute MI was 0.17 percentage points lower (P = .02) and 30-day heart failure mortality was 0.44 percentage points lower (P = .008), compared with non-VA hospitals (JAMA. 2016;315[6]:582-92. doi: 10.1001/jama.2016.0278).
The differences between VA and non-VA hospitals were even greater when the comparison was made between hospitals in the same metropolitan statistical area: differences of 0.22 percentage points for 30-day mortality for acute MI (P = .02) and 0.63 percentage points for heart failure (P < .001).
“The finding that risk standardized mortality rates for cardiovascular conditions were lower, albeit with small absolute differences, in VA hospitals may reflect higher quality of care in VA hospitals as represented by adherence to process measures,” wrote Sudhakar V. Nuti of the Center for Outcomes Research and Evaluation at Yale-New Haven (Conn.) Hospital and coauthors.
“The lower mortality rates also may be due to the quality improvement efforts that can be implemented across the VA’s integrated delivery system,” they added.
Mortality rates for pneumonia were 0.46 percentage points higher in VA hospitals, compared with non-VA hospitals (P = .045). But after comparing hospitals within the same metropolitan area, this difference disappeared.
VA hospitals also had higher readmission rates than non-VA hospitals for all three conditions: 0.63 percentage points higher for acute MI, 1.2 points higher for heart failure, and 0.76 points higher for pneumonia (P < .001 for all).
This difference persisted when hospitals within the same area were compared.
Commenting on the readmission differences, the investigators suggested that VA hospitals may have a greater propensity to readmit patients, or that veterans may have to travel further to VA hospitals – which has been associated with higher readmission rates among veterans. They also pointed out, however, that non-VA hospitals had recently been subject to national interventions to reduce readmissions.
The study also showed that VA hospitals were more likely to be teaching hospitals and were larger and had a greater number of beds than non-VA hospitals. Around 12% of individuals who were initially hospitalized at VA hospitals were readmitted to non-VA hospitals, but less than 1% of individuals admitted to a non-VA hospital initially were later readmitted to a VA hospital, irrespective of their condition.
“The current study serves as an example of national performance comparison for VA and non-VA hospital care, which sets the stage for future performance and quality improvement studies,” the authors reported.
“Moreover, the results of our study and other benchmarking efforts could inform efforts to improve quality in the VA, particularly our findings of variation in performance, by identifying and learning from high performing hospitals and disseminating best practices to lower performing hospitals to elevate the entire performance curve.”
The authors stressed that, since the study population was limited to men over age 65 years who were VA or Medicare patients, the results were not generalizable to younger or female populations.
Some of the study’s authors were supported by grants from the National Institute on Aging; the American Federation for Aging Research; the National Heart, Lung, and Blood Institute; and the VA Connecticut Healthcare System. Two authors declared research agreements from Medtronic and Johnson & Johnson, one declared positions on a cardiac scientific advisory board for UnitedHealth, and four declared contract work for the Centers for Medicare & Medicaid Services. No other conflicts of interest were declared.
FROM JAMA
Key clinical point: Veterans Affairs hospitals have slightly lower mortality rates for cardiovascular conditions but slightly higher readmission rates.
Major finding: VA hospitals had a 0.17 percentage point lower 30-day mortality for acute MI and 0.44 percentage point lower mortality for heart failure, compared with non-VA hospitals.
Data source: A cross-sectional analysis of more than 7,900 male Medicare fee-for-service beneficiaries hospitalized in 105 VA and 1,513 non-VA acute care hospitals.
Disclosures: Some of the study’s authors were supported by grants from the National Institute on Aging; the American Federation for Aging Research; the National Heart, Lung, and Blood Institute; and the VA Connecticut Healthcare System. Two authors declared research agreements from Medtronic and Johnson & Johnson, one declared positions on a cardiac scientific advisory board for UnitedHealth, and four declared contract work for the Centers for Medicare & Medicaid Services. No other conflicts of interest were declared.
Clonal CD4+ T-cells a reservoir of infectious HIV
Researchers have identified a long-lived reservoir of infectious HIV-1 in clonally expanded CD4+ T-cells found in a patient with persistent viremia, even after years of combination antiretroviral therapy.
The existence, persistence, and expansion of clonal HIV-1 cells in antiretroviral-treated patients has been demonstrated previously, but it was not known whether these cells could contain replication-competent provirus.
The case study, published online February 8 in PNAS Early Edition, reported on a 58-year-old man first diagnosed with HIV-1 infection in 2000, who experienced an increase in viral load 12 years after starting combined antiretroviral therapy.
“SGS [single genome sequencing] of the viral RNA in plasma revealed two distinct populations: a genetically diverse group of drug-resistant viruses and a second population of identical viruses that lacked drug resistance mutations,” wrote Dr. Frank Maldarelli of the HIV Dynamics and Replication Program at the National Cancer Institute, and his coauthors.
While the authors suggested only a fraction of the clonal cells were producing HIV at any given time, the clones were able to persist and clonally expand to around nine million cells (PNAS Early Edition. 2015 Feb 8. doi: 10.1073/pnas.1522675113).
“The data presented here demonstrate that clonally expanded cells containing an intact, infectious provirus can persist and produce virus for many years in a patient on [combination antiretroviral therapy],” the authors wrote, calling for a better understanding of the contribution these clonal cells make to the replication-competent viral reservoir, and how to target and eliminate them.
The study was supported by the National Cancer Foundation, the National Institutes of Health, Leidos Biomedical Research, and the F. M. Kirby Foundation. One author declared a consultancy for Gilead Sciences and shares in Cocrystal. No other conflicts of interest were declared.
Researchers have identified a long-lived reservoir of infectious HIV-1 in clonally expanded CD4+ T-cells found in a patient with persistent viremia, even after years of combination antiretroviral therapy.
The existence, persistence, and expansion of clonal HIV-1 cells in antiretroviral-treated patients has been demonstrated previously, but it was not known whether these cells could contain replication-competent provirus.
The case study, published online February 8 in PNAS Early Edition, reported on a 58-year-old man first diagnosed with HIV-1 infection in 2000, who experienced an increase in viral load 12 years after starting combined antiretroviral therapy.
“SGS [single genome sequencing] of the viral RNA in plasma revealed two distinct populations: a genetically diverse group of drug-resistant viruses and a second population of identical viruses that lacked drug resistance mutations,” wrote Dr. Frank Maldarelli of the HIV Dynamics and Replication Program at the National Cancer Institute, and his coauthors.
While the authors suggested only a fraction of the clonal cells were producing HIV at any given time, the clones were able to persist and clonally expand to around nine million cells (PNAS Early Edition. 2015 Feb 8. doi: 10.1073/pnas.1522675113).
“The data presented here demonstrate that clonally expanded cells containing an intact, infectious provirus can persist and produce virus for many years in a patient on [combination antiretroviral therapy],” the authors wrote, calling for a better understanding of the contribution these clonal cells make to the replication-competent viral reservoir, and how to target and eliminate them.
The study was supported by the National Cancer Foundation, the National Institutes of Health, Leidos Biomedical Research, and the F. M. Kirby Foundation. One author declared a consultancy for Gilead Sciences and shares in Cocrystal. No other conflicts of interest were declared.
Researchers have identified a long-lived reservoir of infectious HIV-1 in clonally expanded CD4+ T-cells found in a patient with persistent viremia, even after years of combination antiretroviral therapy.
The existence, persistence, and expansion of clonal HIV-1 cells in antiretroviral-treated patients has been demonstrated previously, but it was not known whether these cells could contain replication-competent provirus.
The case study, published online February 8 in PNAS Early Edition, reported on a 58-year-old man first diagnosed with HIV-1 infection in 2000, who experienced an increase in viral load 12 years after starting combined antiretroviral therapy.
“SGS [single genome sequencing] of the viral RNA in plasma revealed two distinct populations: a genetically diverse group of drug-resistant viruses and a second population of identical viruses that lacked drug resistance mutations,” wrote Dr. Frank Maldarelli of the HIV Dynamics and Replication Program at the National Cancer Institute, and his coauthors.
While the authors suggested only a fraction of the clonal cells were producing HIV at any given time, the clones were able to persist and clonally expand to around nine million cells (PNAS Early Edition. 2015 Feb 8. doi: 10.1073/pnas.1522675113).
“The data presented here demonstrate that clonally expanded cells containing an intact, infectious provirus can persist and produce virus for many years in a patient on [combination antiretroviral therapy],” the authors wrote, calling for a better understanding of the contribution these clonal cells make to the replication-competent viral reservoir, and how to target and eliminate them.
The study was supported by the National Cancer Foundation, the National Institutes of Health, Leidos Biomedical Research, and the F. M. Kirby Foundation. One author declared a consultancy for Gilead Sciences and shares in Cocrystal. No other conflicts of interest were declared.
FROM PNAS EARLY EDITION
Key clinical point: Clonally expanded CD4+ T-cells may provide a reservoir of infectious HIV-1.
Major finding: Clonal CD4+ T-cells can act as a reservoir of replication-competent HIV-1 that persists in individuals treated long-term with combined antiretroviral therapy.
Data source: Case study of a 58-year-old male diagnosed with HIV-1 infection.
Disclosures: The study was partly supported by the National Cancer Foundation, the National Institutes of Health, Leidos Biomedical Research, and the F. M. Kirby Foundation. One author declared a consultancy for Gilead Sciences and shares in Cocrystal. No other conflicts of interest were declared.
Books, text messages increase sun protection behaviors
An intervention consisting of text-message reminders, read-along books, and swim shirts achieved significant improvements in sun protection behaviors in children, compared with information about sun protection alone, according to the results of a randomized controlled trial.
The study, published online Feb. 8 in JAMA Pediatrics, enrolled 300 caregiver-child pairs (children aged 2-6 years), randomizing 153 to receive a read-along book emphasizing sun protection behaviors, a swim shirt, and weekly text messages asking about sun protection measures undertaken and 147 to the usual information about sun protection given at a well-child visit.
After 4 weeks, the intervention group showed significantly higher scores for sunscreen use both on sunny and cloudy days, significantly higher scores relating to wearing a shirt on sunny days, and significantly lower increases in skin melanin indices on the sun-protected upper arm, compared with the control group (JAMA Pediatr. 2016 Feb 8. doi: 10.1001/jamapediatrics.2015.4373).
“Pediatricians’ seasonal age-specific sun protection recommendations will be more effective if supported by an effective, easily accessible, multicomponent program that can be reinforced at home,” said Byron K. Ho of Northwestern University, Chicago, and his coauthors.
The study was funded by the Pediatric Sun Protection Foundation. No conflicts of interest were declared.
The choice by the investigators to educate both the caregiver and the child through the use of an active read-aloud book was a pragmatic one because this process engages both caregivers and their children to recruit each other in reinforcing recommended behaviors.
Supplying rather than simply recommending sun-protective clothing as part of the study encourages adherence by eliminating the obstacle of having families purchase the sun-protective clothing themselves, thus removing associated economic barriers.
D. Albert C. Yan and Dr. Leslie Castelo-Soccio are with the section of dermatology at the Children’s Hospital of Philadelphia and from the departments of pediatrics and dermatology at the University of Pennsylvania. These comments are excerpted from an accompanying editorial (JAMA Pediatr. Feb 8. doi: 10.1001/jamapediatrics.2015.4524). Dr. Yan declared consultancies for Galderma, Johnson & Johnson, Pierre Fabre, and Procter & Gamble. No other conflicts of interest were declared.
The choice by the investigators to educate both the caregiver and the child through the use of an active read-aloud book was a pragmatic one because this process engages both caregivers and their children to recruit each other in reinforcing recommended behaviors.
Supplying rather than simply recommending sun-protective clothing as part of the study encourages adherence by eliminating the obstacle of having families purchase the sun-protective clothing themselves, thus removing associated economic barriers.
D. Albert C. Yan and Dr. Leslie Castelo-Soccio are with the section of dermatology at the Children’s Hospital of Philadelphia and from the departments of pediatrics and dermatology at the University of Pennsylvania. These comments are excerpted from an accompanying editorial (JAMA Pediatr. Feb 8. doi: 10.1001/jamapediatrics.2015.4524). Dr. Yan declared consultancies for Galderma, Johnson & Johnson, Pierre Fabre, and Procter & Gamble. No other conflicts of interest were declared.
The choice by the investigators to educate both the caregiver and the child through the use of an active read-aloud book was a pragmatic one because this process engages both caregivers and their children to recruit each other in reinforcing recommended behaviors.
Supplying rather than simply recommending sun-protective clothing as part of the study encourages adherence by eliminating the obstacle of having families purchase the sun-protective clothing themselves, thus removing associated economic barriers.
D. Albert C. Yan and Dr. Leslie Castelo-Soccio are with the section of dermatology at the Children’s Hospital of Philadelphia and from the departments of pediatrics and dermatology at the University of Pennsylvania. These comments are excerpted from an accompanying editorial (JAMA Pediatr. Feb 8. doi: 10.1001/jamapediatrics.2015.4524). Dr. Yan declared consultancies for Galderma, Johnson & Johnson, Pierre Fabre, and Procter & Gamble. No other conflicts of interest were declared.
An intervention consisting of text-message reminders, read-along books, and swim shirts achieved significant improvements in sun protection behaviors in children, compared with information about sun protection alone, according to the results of a randomized controlled trial.
The study, published online Feb. 8 in JAMA Pediatrics, enrolled 300 caregiver-child pairs (children aged 2-6 years), randomizing 153 to receive a read-along book emphasizing sun protection behaviors, a swim shirt, and weekly text messages asking about sun protection measures undertaken and 147 to the usual information about sun protection given at a well-child visit.
After 4 weeks, the intervention group showed significantly higher scores for sunscreen use both on sunny and cloudy days, significantly higher scores relating to wearing a shirt on sunny days, and significantly lower increases in skin melanin indices on the sun-protected upper arm, compared with the control group (JAMA Pediatr. 2016 Feb 8. doi: 10.1001/jamapediatrics.2015.4373).
“Pediatricians’ seasonal age-specific sun protection recommendations will be more effective if supported by an effective, easily accessible, multicomponent program that can be reinforced at home,” said Byron K. Ho of Northwestern University, Chicago, and his coauthors.
The study was funded by the Pediatric Sun Protection Foundation. No conflicts of interest were declared.
An intervention consisting of text-message reminders, read-along books, and swim shirts achieved significant improvements in sun protection behaviors in children, compared with information about sun protection alone, according to the results of a randomized controlled trial.
The study, published online Feb. 8 in JAMA Pediatrics, enrolled 300 caregiver-child pairs (children aged 2-6 years), randomizing 153 to receive a read-along book emphasizing sun protection behaviors, a swim shirt, and weekly text messages asking about sun protection measures undertaken and 147 to the usual information about sun protection given at a well-child visit.
After 4 weeks, the intervention group showed significantly higher scores for sunscreen use both on sunny and cloudy days, significantly higher scores relating to wearing a shirt on sunny days, and significantly lower increases in skin melanin indices on the sun-protected upper arm, compared with the control group (JAMA Pediatr. 2016 Feb 8. doi: 10.1001/jamapediatrics.2015.4373).
“Pediatricians’ seasonal age-specific sun protection recommendations will be more effective if supported by an effective, easily accessible, multicomponent program that can be reinforced at home,” said Byron K. Ho of Northwestern University, Chicago, and his coauthors.
The study was funded by the Pediatric Sun Protection Foundation. No conflicts of interest were declared.
FROM JAMA PEDIATRICS
Key clinical point: An intervention of books, text-message reminders, and swim shirts can improve sun protection behaviors in children.
Major finding: A multimodal 4-week intervention aimed at increasing sun protection behavior achieved significant increases in sunscreen use and shirt wearing.
Data source: Randomized controlled study involving 300 caregiver-child pairs.
Disclosures: The study was funded by the Pediatric Sun Protection Foundation. No conflicts of interest were declared.
Phenytoin trial in optic neuritis hints at neuroprotection
Patients with acute demyelinating optic neuritis who received the anticonvulsant drug phenytoin lost 30% less of their retinal nerve fiber layer than did placebo-treated patients in a randomized, phase II study.
“The results of this clinical trial support the concept of neuroprotection using phenytoin to inhibit voltage-gated sodium channels in patients with acute optic neuritis,” wrote Dr. Rhian Raftopoulos of the National Hospital for Neurology and Neurosurgery, London, and coauthors (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422(16)00004-1).
The study in 86 individuals with acute optic neuritis randomized 29 participants to receive 4 mg/kg per day of oral phenytoin, 13 to 6 mg/kg per day of oral phenytoin, and 44 to placebo for 3 months; all were randomized within 14 days of vision loss. One-third of the patients had previously been diagnosed with multiple sclerosis or were diagnosed at presentation, and 74% had at least one brain lesion on MRI.
Treatment with phenytoin resulted in a decline of mean retinal nerve fiber layer thickness in the affected eye from 130.62 mcm at baseline to 81.46 mcm at 6 months, compared with a decline from 125.20 mcm to 74.29 mcm in the placebo group, representing an adjusted mean difference of 7.15 mcm that reached statistical significance.
The researchers also noted a significant 34% reduction in macular volume loss in the treatment arm, compared with placebo, representing an adjusted mean difference of 0.20 mm3. However, the treatment had no significant effect on low-contrast visual acuity and visual evoked potentials.
The most common adverse event in the treatment arm was maculopapular rash, which was judged as severe in one patient treated with phenytoin.
The study was supported by the U.S. National Multiple Sclerosis Society, the Multiple Sclerosis Society of Great Britain and Northern Ireland, Novartis, the U.K. National Institute for Health Research, and the NIHR UCLH/UCL Biomedical Research Centre. Several authors declared personal fees, trial funding, grants, and consultancies for pharmaceutical companies, including Novartis.
The absence of regular, early outcome assessments around 1-2 months after initiation of treatment makes it hard to interpret the results because they would have helped to rule out a primarily anti-inflammatory effect of the treatment by tracking retinal nerve fiber layer (RNFL) swelling and possible optic nerve inflammation, especially given that there was higher baseline RNFL thickness and worse low-contrast visual acuity in the patients who received phenytoin. If the true RNFL thickness at baseline in the affected eye of patients in the phenytoin group was higher than those in the placebo group, it could have accounted for the findings even though the investigators made a prespecified adjustment for it.
Although the results of this study are a major advancement and undeniably encouraging, future studies need to include more frequent OCT sampling, as well as more detailed OCT-segmentation-derived retinal measures such as ganglion cell plus inner plexiform layer thickness, which do not swell during acute optic neuritis, mitigating the need for statistical corrections involving the unaffected eye.
Dr. Shiv Saidha and Dr. Peter A. Calabresi are from the division of neuroimmunology and neurological infections at Johns Hopkins University, Baltimore. These comments were taken from an accompanying editorial (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422(16)00024-7). Dr. Saidha declared receiving funding support, consulting fees, grant support, speaking honoraria, and advisory board positions with the pharmaceutical industry, including companies that market MS drugs. Dr. Calabresi declared consultancies, research funding, and advisory board positions with the pharmaceutical industry, including companies that market MS drugs.
The absence of regular, early outcome assessments around 1-2 months after initiation of treatment makes it hard to interpret the results because they would have helped to rule out a primarily anti-inflammatory effect of the treatment by tracking retinal nerve fiber layer (RNFL) swelling and possible optic nerve inflammation, especially given that there was higher baseline RNFL thickness and worse low-contrast visual acuity in the patients who received phenytoin. If the true RNFL thickness at baseline in the affected eye of patients in the phenytoin group was higher than those in the placebo group, it could have accounted for the findings even though the investigators made a prespecified adjustment for it.
Although the results of this study are a major advancement and undeniably encouraging, future studies need to include more frequent OCT sampling, as well as more detailed OCT-segmentation-derived retinal measures such as ganglion cell plus inner plexiform layer thickness, which do not swell during acute optic neuritis, mitigating the need for statistical corrections involving the unaffected eye.
Dr. Shiv Saidha and Dr. Peter A. Calabresi are from the division of neuroimmunology and neurological infections at Johns Hopkins University, Baltimore. These comments were taken from an accompanying editorial (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422(16)00024-7). Dr. Saidha declared receiving funding support, consulting fees, grant support, speaking honoraria, and advisory board positions with the pharmaceutical industry, including companies that market MS drugs. Dr. Calabresi declared consultancies, research funding, and advisory board positions with the pharmaceutical industry, including companies that market MS drugs.
The absence of regular, early outcome assessments around 1-2 months after initiation of treatment makes it hard to interpret the results because they would have helped to rule out a primarily anti-inflammatory effect of the treatment by tracking retinal nerve fiber layer (RNFL) swelling and possible optic nerve inflammation, especially given that there was higher baseline RNFL thickness and worse low-contrast visual acuity in the patients who received phenytoin. If the true RNFL thickness at baseline in the affected eye of patients in the phenytoin group was higher than those in the placebo group, it could have accounted for the findings even though the investigators made a prespecified adjustment for it.
Although the results of this study are a major advancement and undeniably encouraging, future studies need to include more frequent OCT sampling, as well as more detailed OCT-segmentation-derived retinal measures such as ganglion cell plus inner plexiform layer thickness, which do not swell during acute optic neuritis, mitigating the need for statistical corrections involving the unaffected eye.
Dr. Shiv Saidha and Dr. Peter A. Calabresi are from the division of neuroimmunology and neurological infections at Johns Hopkins University, Baltimore. These comments were taken from an accompanying editorial (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422(16)00024-7). Dr. Saidha declared receiving funding support, consulting fees, grant support, speaking honoraria, and advisory board positions with the pharmaceutical industry, including companies that market MS drugs. Dr. Calabresi declared consultancies, research funding, and advisory board positions with the pharmaceutical industry, including companies that market MS drugs.
Patients with acute demyelinating optic neuritis who received the anticonvulsant drug phenytoin lost 30% less of their retinal nerve fiber layer than did placebo-treated patients in a randomized, phase II study.
“The results of this clinical trial support the concept of neuroprotection using phenytoin to inhibit voltage-gated sodium channels in patients with acute optic neuritis,” wrote Dr. Rhian Raftopoulos of the National Hospital for Neurology and Neurosurgery, London, and coauthors (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422(16)00004-1).
The study in 86 individuals with acute optic neuritis randomized 29 participants to receive 4 mg/kg per day of oral phenytoin, 13 to 6 mg/kg per day of oral phenytoin, and 44 to placebo for 3 months; all were randomized within 14 days of vision loss. One-third of the patients had previously been diagnosed with multiple sclerosis or were diagnosed at presentation, and 74% had at least one brain lesion on MRI.
Treatment with phenytoin resulted in a decline of mean retinal nerve fiber layer thickness in the affected eye from 130.62 mcm at baseline to 81.46 mcm at 6 months, compared with a decline from 125.20 mcm to 74.29 mcm in the placebo group, representing an adjusted mean difference of 7.15 mcm that reached statistical significance.
The researchers also noted a significant 34% reduction in macular volume loss in the treatment arm, compared with placebo, representing an adjusted mean difference of 0.20 mm3. However, the treatment had no significant effect on low-contrast visual acuity and visual evoked potentials.
The most common adverse event in the treatment arm was maculopapular rash, which was judged as severe in one patient treated with phenytoin.
The study was supported by the U.S. National Multiple Sclerosis Society, the Multiple Sclerosis Society of Great Britain and Northern Ireland, Novartis, the U.K. National Institute for Health Research, and the NIHR UCLH/UCL Biomedical Research Centre. Several authors declared personal fees, trial funding, grants, and consultancies for pharmaceutical companies, including Novartis.
Patients with acute demyelinating optic neuritis who received the anticonvulsant drug phenytoin lost 30% less of their retinal nerve fiber layer than did placebo-treated patients in a randomized, phase II study.
“The results of this clinical trial support the concept of neuroprotection using phenytoin to inhibit voltage-gated sodium channels in patients with acute optic neuritis,” wrote Dr. Rhian Raftopoulos of the National Hospital for Neurology and Neurosurgery, London, and coauthors (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422(16)00004-1).
The study in 86 individuals with acute optic neuritis randomized 29 participants to receive 4 mg/kg per day of oral phenytoin, 13 to 6 mg/kg per day of oral phenytoin, and 44 to placebo for 3 months; all were randomized within 14 days of vision loss. One-third of the patients had previously been diagnosed with multiple sclerosis or were diagnosed at presentation, and 74% had at least one brain lesion on MRI.
Treatment with phenytoin resulted in a decline of mean retinal nerve fiber layer thickness in the affected eye from 130.62 mcm at baseline to 81.46 mcm at 6 months, compared with a decline from 125.20 mcm to 74.29 mcm in the placebo group, representing an adjusted mean difference of 7.15 mcm that reached statistical significance.
The researchers also noted a significant 34% reduction in macular volume loss in the treatment arm, compared with placebo, representing an adjusted mean difference of 0.20 mm3. However, the treatment had no significant effect on low-contrast visual acuity and visual evoked potentials.
The most common adverse event in the treatment arm was maculopapular rash, which was judged as severe in one patient treated with phenytoin.
The study was supported by the U.S. National Multiple Sclerosis Society, the Multiple Sclerosis Society of Great Britain and Northern Ireland, Novartis, the U.K. National Institute for Health Research, and the NIHR UCLH/UCL Biomedical Research Centre. Several authors declared personal fees, trial funding, grants, and consultancies for pharmaceutical companies, including Novartis.
FROM LANCET NEUROLOGY
Key clinical point: Phenytoin treatment is associated with a reduction in retinal nerve fiber layer loss in individuals with demyelinating optic neuritis.
Major finding: Treatment with phenytoin was associated with a 30% reduction in the extent of retinal nerve fiber layer loss, compared with placebo.
Data source: Randomized, placebo-controlled phase II trial in 86 individuals with acute demyelinating optic neuritis.
Disclosures: The study was supported by the U.S. National Multiple Sclerosis Society, the Multiple Sclerosis Society of Great Britain and Northern Ireland, Novartis, the U.K. National Institute for Health Research, and the NIHR UCLH/UCL Biomedical Research Centre. Several authors declared personal fees, trial funding, grants, and consultancies for pharmaceutical companies, including Novartis.
Three lesions needed for MRI diagnosis of MS
A European expert group has proposed several revisions to the 2010 McDonald criteria for the use of MRI in diagnosing multiple sclerosis.
The MAGNIMS collaborative research network argued that new data on the application of MRI, as well as improvements in MRI technology, demanded changes to the multiple sclerosis (MS) diagnostic criteria.
The first proposed recommendation is that three or more focal lesions, rather than a single lesion, should be present to diagnose the involvement of the periventricular region and to show disease dissemination in space (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422[15]00393-2).
“A single lesion was deemed not sufficiently specific to determine whether involvement of the periventricular region is due to a demyelinating inflammatory event, and the use of one periventricular lesion for assessing dissemination in space has never been formally validated,” wrote Dr. Massimo Filippi of Vita-Salute San Raffaele University, Milan, and his coauthors.
They also pointed out that incidental periventricular lesions can be found in up to 30% of patients with migraine, and in individuals with other neurologic disorders.
In addition, the group recommended that optic nerve lesions be added to the criteria for dissemination in space.
“Clinical documentation of optic nerve atrophy or pallor, neurophysiological confirmation of optic nerve dysfunction (slowed conduction), or imaging features of clinically silent optic nerve inflammation (MRI lesions or retinal nerve fiber layer thinning) support dissemination in space and, in patients without concurrent visual symptoms, dissemination in time.”
According to the new recommendations, disease dissemination in space can be shown by the involvement of at least two areas from a list of five possibilities: three or more periventricular lesions, one or more infratentorial lesions, one or more spinal cord lesions, one or more optic nerve lesions, or one or more cortical or juxtacortical lesions.
However, the group did not propose any significant changes to the criteria for dissemination in time, other than saying that the presence of nonenhancing black holes should not be considered as a potential alternative criterion to show dissemination in time in adult patients.
The committee also backed the existing recommendations that children aged 11 years or older with nonacute disseminated encephalomyelitis–like presentation should be diagnosed with the same criteria as adults, for dissemination in time and space.
“Several studies have confirmed that the 2010 McDonald criteria perform better than or similar to previously proposed pediatric MS criteria for diagnosis of children with nonacute disseminated encephalomyelitis presentations and pediatric patients older than 11 years, and the consensus group therefore recommend caution when using these criteria in children younger than 11 years,” they wrote.
Other recommendations include that there be no distinction required between symptomatic and asymptomatic MRI lesions for diagnosing dissemination in time or space; that the whole spinal cord be imaged to define dissemination in space, particularly in patients who do not fulfill the brain MRI criteria; and that the same criteria for dissemination in space be used for both primary progressive MS and relapse-onset MS, with cerebrospinal fluid results considered for clinically uncertain cases of primary progressive MS.
The expenses of the workshop where the recommendations were formulated were supported by an unrestricted educational grant from Novartis. The authors of the paper declared grants, consultancies, speaking fees, travel support, and honoraria from numerous pharmaceutical companies, including Novartis.
|
Dr. Robert J. Fox |
Including the initial symptomatic lesion in the lesion count to satisfy criteria for dissemination in space and time might be the most useful contribution of the revised criteria to clinical practice.
In addition, the broad applicability of the MRI criteria were affirmed in primary progressive multiple sclerosis, relapse-onset multiple sclerosis, children aged 11 years or older without an acute disseminated encephalomyelitis presentation, and patients with multiple sclerosis in Asia and Latin America.
Dr. Robert J. Fox is from the Mellen Center for MS Treatment and Research at the Cleveland Clinic. These comments were taken from an accompanying editorial (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422[16]00023-5). Dr. Fox declared personal consulting fees from Actelion, Biogen, Genentech, Mallinckrodt, MedDay, Novartis, Teva, and XenoPort; advisory committee roles for Biogen and Novartis; and research grant funding from Novartis.
|
|
Dr. Robert J. Fox |
Including the initial symptomatic lesion in the lesion count to satisfy criteria for dissemination in space and time might be the most useful contribution of the revised criteria to clinical practice.
In addition, the broad applicability of the MRI criteria were affirmed in primary progressive multiple sclerosis, relapse-onset multiple sclerosis, children aged 11 years or older without an acute disseminated encephalomyelitis presentation, and patients with multiple sclerosis in Asia and Latin America.
Dr. Robert J. Fox is from the Mellen Center for MS Treatment and Research at the Cleveland Clinic. These comments were taken from an accompanying editorial (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422[16]00023-5). Dr. Fox declared personal consulting fees from Actelion, Biogen, Genentech, Mallinckrodt, MedDay, Novartis, Teva, and XenoPort; advisory committee roles for Biogen and Novartis; and research grant funding from Novartis.
|
|
Dr. Robert J. Fox |
Including the initial symptomatic lesion in the lesion count to satisfy criteria for dissemination in space and time might be the most useful contribution of the revised criteria to clinical practice.
In addition, the broad applicability of the MRI criteria were affirmed in primary progressive multiple sclerosis, relapse-onset multiple sclerosis, children aged 11 years or older without an acute disseminated encephalomyelitis presentation, and patients with multiple sclerosis in Asia and Latin America.
Dr. Robert J. Fox is from the Mellen Center for MS Treatment and Research at the Cleveland Clinic. These comments were taken from an accompanying editorial (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422[16]00023-5). Dr. Fox declared personal consulting fees from Actelion, Biogen, Genentech, Mallinckrodt, MedDay, Novartis, Teva, and XenoPort; advisory committee roles for Biogen and Novartis; and research grant funding from Novartis.
A European expert group has proposed several revisions to the 2010 McDonald criteria for the use of MRI in diagnosing multiple sclerosis.
The MAGNIMS collaborative research network argued that new data on the application of MRI, as well as improvements in MRI technology, demanded changes to the multiple sclerosis (MS) diagnostic criteria.
The first proposed recommendation is that three or more focal lesions, rather than a single lesion, should be present to diagnose the involvement of the periventricular region and to show disease dissemination in space (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422[15]00393-2).
“A single lesion was deemed not sufficiently specific to determine whether involvement of the periventricular region is due to a demyelinating inflammatory event, and the use of one periventricular lesion for assessing dissemination in space has never been formally validated,” wrote Dr. Massimo Filippi of Vita-Salute San Raffaele University, Milan, and his coauthors.
They also pointed out that incidental periventricular lesions can be found in up to 30% of patients with migraine, and in individuals with other neurologic disorders.
In addition, the group recommended that optic nerve lesions be added to the criteria for dissemination in space.
“Clinical documentation of optic nerve atrophy or pallor, neurophysiological confirmation of optic nerve dysfunction (slowed conduction), or imaging features of clinically silent optic nerve inflammation (MRI lesions or retinal nerve fiber layer thinning) support dissemination in space and, in patients without concurrent visual symptoms, dissemination in time.”
According to the new recommendations, disease dissemination in space can be shown by the involvement of at least two areas from a list of five possibilities: three or more periventricular lesions, one or more infratentorial lesions, one or more spinal cord lesions, one or more optic nerve lesions, or one or more cortical or juxtacortical lesions.
However, the group did not propose any significant changes to the criteria for dissemination in time, other than saying that the presence of nonenhancing black holes should not be considered as a potential alternative criterion to show dissemination in time in adult patients.
The committee also backed the existing recommendations that children aged 11 years or older with nonacute disseminated encephalomyelitis–like presentation should be diagnosed with the same criteria as adults, for dissemination in time and space.
“Several studies have confirmed that the 2010 McDonald criteria perform better than or similar to previously proposed pediatric MS criteria for diagnosis of children with nonacute disseminated encephalomyelitis presentations and pediatric patients older than 11 years, and the consensus group therefore recommend caution when using these criteria in children younger than 11 years,” they wrote.
Other recommendations include that there be no distinction required between symptomatic and asymptomatic MRI lesions for diagnosing dissemination in time or space; that the whole spinal cord be imaged to define dissemination in space, particularly in patients who do not fulfill the brain MRI criteria; and that the same criteria for dissemination in space be used for both primary progressive MS and relapse-onset MS, with cerebrospinal fluid results considered for clinically uncertain cases of primary progressive MS.
The expenses of the workshop where the recommendations were formulated were supported by an unrestricted educational grant from Novartis. The authors of the paper declared grants, consultancies, speaking fees, travel support, and honoraria from numerous pharmaceutical companies, including Novartis.
A European expert group has proposed several revisions to the 2010 McDonald criteria for the use of MRI in diagnosing multiple sclerosis.
The MAGNIMS collaborative research network argued that new data on the application of MRI, as well as improvements in MRI technology, demanded changes to the multiple sclerosis (MS) diagnostic criteria.
The first proposed recommendation is that three or more focal lesions, rather than a single lesion, should be present to diagnose the involvement of the periventricular region and to show disease dissemination in space (Lancet Neurol. 2016 Jan 25. doi: 10.1016/S1474-4422[15]00393-2).
“A single lesion was deemed not sufficiently specific to determine whether involvement of the periventricular region is due to a demyelinating inflammatory event, and the use of one periventricular lesion for assessing dissemination in space has never been formally validated,” wrote Dr. Massimo Filippi of Vita-Salute San Raffaele University, Milan, and his coauthors.
They also pointed out that incidental periventricular lesions can be found in up to 30% of patients with migraine, and in individuals with other neurologic disorders.
In addition, the group recommended that optic nerve lesions be added to the criteria for dissemination in space.
“Clinical documentation of optic nerve atrophy or pallor, neurophysiological confirmation of optic nerve dysfunction (slowed conduction), or imaging features of clinically silent optic nerve inflammation (MRI lesions or retinal nerve fiber layer thinning) support dissemination in space and, in patients without concurrent visual symptoms, dissemination in time.”
According to the new recommendations, disease dissemination in space can be shown by the involvement of at least two areas from a list of five possibilities: three or more periventricular lesions, one or more infratentorial lesions, one or more spinal cord lesions, one or more optic nerve lesions, or one or more cortical or juxtacortical lesions.
However, the group did not propose any significant changes to the criteria for dissemination in time, other than saying that the presence of nonenhancing black holes should not be considered as a potential alternative criterion to show dissemination in time in adult patients.
The committee also backed the existing recommendations that children aged 11 years or older with nonacute disseminated encephalomyelitis–like presentation should be diagnosed with the same criteria as adults, for dissemination in time and space.
“Several studies have confirmed that the 2010 McDonald criteria perform better than or similar to previously proposed pediatric MS criteria for diagnosis of children with nonacute disseminated encephalomyelitis presentations and pediatric patients older than 11 years, and the consensus group therefore recommend caution when using these criteria in children younger than 11 years,” they wrote.
Other recommendations include that there be no distinction required between symptomatic and asymptomatic MRI lesions for diagnosing dissemination in time or space; that the whole spinal cord be imaged to define dissemination in space, particularly in patients who do not fulfill the brain MRI criteria; and that the same criteria for dissemination in space be used for both primary progressive MS and relapse-onset MS, with cerebrospinal fluid results considered for clinically uncertain cases of primary progressive MS.
The expenses of the workshop where the recommendations were formulated were supported by an unrestricted educational grant from Novartis. The authors of the paper declared grants, consultancies, speaking fees, travel support, and honoraria from numerous pharmaceutical companies, including Novartis.
FROM LANCET NEUROLOGY
Increased prevalence of pancreatic cysts due to MRI improvements
The apparent increase in the prevalence of incidental pancreatic cysts in recent years may be tied to improvements in MRI scanning technology, results of a study suggest.
Researchers conducted a retrospective analysis of data from 500 patients who underwent an MRI for nonpancreatic indications at a single center between 2005 and 2014; 50 were sampled from each year in chronological order.
A total of 208 patients (41.6%) were found to have an incidental cyst, of which less than a quarter were described in the original MRI report, according to a paper published online in Clinical Gastroenterology and Hepatology.
Analysis showed a very strong association between the type of imaging hardware and software, and the presence of cysts; older hardware found pancreatic cysts in 30.3% of patients and the newest hardware found cysts in 56.3% of patients.
However, MRI field strength was not associated with the frequency of lesion discovery (Clin Gastro Hepatol. 2015 Sep 11. doi: 10.1016/j.cgh.2015.08.038).
Most cysts were relatively small, with a median size of 4 mm. Nearly half of the patients with a cyst only had one described.
Nearly two-thirds of these cysts (62%) had an uncertain diagnosis, but 35% of patients were diagnosed with an intraductal papillary mucinous neoplasm, and one patient showed radiologic evidence of subacute pancreatitis.
When compared to the rest of the cohort, individuals with pancreatic cysts were more likely to be older, have diabetes mellitus, or have a personal history of cancer, particularly nonmelanoma skin cancer and hepatocellular carcinoma.
“Our study demonstrates the relationship between the higher trend of incidental pancreatic cysts observed in the recent years and the improvements in the technical features of MRIs,” wrote Dr. Maria Moris and colleagues from the Mayo Clinic, Jacksonville.
The authors said the real prevalence of pancreatic cystic lesions is estimated to range from 0.2% to 44.7%.
Their finding of a prevalence of 41.6% was higher than that found in similar imaging studies, but the authors suggested some of this may be due to the lack of a size cutoff in their study, as opposed to a 5-mm cutoff used in one earlier study that found a prevalence of 10%.
“Moreover, we believe that we may have even underestimated the real prevalence because of the absence of magnetic resonance cholangiopancreatography sequences (only 19% of the examinations), and the lack of 3-T studies (6% of the MRIs),” they wrote.
The median size of the lesions was lower than those found in previous studies.
“This smaller size was unexpected because, as a result of the exclusion criteria applied, the technical features of the MRIs were not the most specific for [pancreatic cystic lesion] PCL visualization,” the authors wrote, suggesting that this may have been due to the radiologist’s experience in this field.
The study was funded by the Joyce E. Baker Foundation for Research at Mayo Clinic in Jacksonville. One author disclosed grants or travel support from Olympus, Boston Scientific, and Cosmo Pharmaceuticals. There were no other conflicts of interest declared.
AGA Resource
Review the AGA guideline on the management of asymptomatic pancreatic neoplastic cysts at http://www.gastro.org/guidelines/2015/5/29/pancreatic-cysts.
The apparent increase in the prevalence of incidental pancreatic cysts in recent years may be tied to improvements in MRI scanning technology, results of a study suggest.
Researchers conducted a retrospective analysis of data from 500 patients who underwent an MRI for nonpancreatic indications at a single center between 2005 and 2014; 50 were sampled from each year in chronological order.
A total of 208 patients (41.6%) were found to have an incidental cyst, of which less than a quarter were described in the original MRI report, according to a paper published online in Clinical Gastroenterology and Hepatology.
Analysis showed a very strong association between the type of imaging hardware and software, and the presence of cysts; older hardware found pancreatic cysts in 30.3% of patients and the newest hardware found cysts in 56.3% of patients.
However, MRI field strength was not associated with the frequency of lesion discovery (Clin Gastro Hepatol. 2015 Sep 11. doi: 10.1016/j.cgh.2015.08.038).
Most cysts were relatively small, with a median size of 4 mm. Nearly half of the patients with a cyst only had one described.
Nearly two-thirds of these cysts (62%) had an uncertain diagnosis, but 35% of patients were diagnosed with an intraductal papillary mucinous neoplasm, and one patient showed radiologic evidence of subacute pancreatitis.
When compared to the rest of the cohort, individuals with pancreatic cysts were more likely to be older, have diabetes mellitus, or have a personal history of cancer, particularly nonmelanoma skin cancer and hepatocellular carcinoma.
“Our study demonstrates the relationship between the higher trend of incidental pancreatic cysts observed in the recent years and the improvements in the technical features of MRIs,” wrote Dr. Maria Moris and colleagues from the Mayo Clinic, Jacksonville.
The authors said the real prevalence of pancreatic cystic lesions is estimated to range from 0.2% to 44.7%.
Their finding of a prevalence of 41.6% was higher than that found in similar imaging studies, but the authors suggested some of this may be due to the lack of a size cutoff in their study, as opposed to a 5-mm cutoff used in one earlier study that found a prevalence of 10%.
“Moreover, we believe that we may have even underestimated the real prevalence because of the absence of magnetic resonance cholangiopancreatography sequences (only 19% of the examinations), and the lack of 3-T studies (6% of the MRIs),” they wrote.
The median size of the lesions was lower than those found in previous studies.
“This smaller size was unexpected because, as a result of the exclusion criteria applied, the technical features of the MRIs were not the most specific for [pancreatic cystic lesion] PCL visualization,” the authors wrote, suggesting that this may have been due to the radiologist’s experience in this field.
The study was funded by the Joyce E. Baker Foundation for Research at Mayo Clinic in Jacksonville. One author disclosed grants or travel support from Olympus, Boston Scientific, and Cosmo Pharmaceuticals. There were no other conflicts of interest declared.
AGA Resource
Review the AGA guideline on the management of asymptomatic pancreatic neoplastic cysts at http://www.gastro.org/guidelines/2015/5/29/pancreatic-cysts.
The apparent increase in the prevalence of incidental pancreatic cysts in recent years may be tied to improvements in MRI scanning technology, results of a study suggest.
Researchers conducted a retrospective analysis of data from 500 patients who underwent an MRI for nonpancreatic indications at a single center between 2005 and 2014; 50 were sampled from each year in chronological order.
A total of 208 patients (41.6%) were found to have an incidental cyst, of which less than a quarter were described in the original MRI report, according to a paper published online in Clinical Gastroenterology and Hepatology.
Analysis showed a very strong association between the type of imaging hardware and software, and the presence of cysts; older hardware found pancreatic cysts in 30.3% of patients and the newest hardware found cysts in 56.3% of patients.
However, MRI field strength was not associated with the frequency of lesion discovery (Clin Gastro Hepatol. 2015 Sep 11. doi: 10.1016/j.cgh.2015.08.038).
Most cysts were relatively small, with a median size of 4 mm. Nearly half of the patients with a cyst only had one described.
Nearly two-thirds of these cysts (62%) had an uncertain diagnosis, but 35% of patients were diagnosed with an intraductal papillary mucinous neoplasm, and one patient showed radiologic evidence of subacute pancreatitis.
When compared to the rest of the cohort, individuals with pancreatic cysts were more likely to be older, have diabetes mellitus, or have a personal history of cancer, particularly nonmelanoma skin cancer and hepatocellular carcinoma.
“Our study demonstrates the relationship between the higher trend of incidental pancreatic cysts observed in the recent years and the improvements in the technical features of MRIs,” wrote Dr. Maria Moris and colleagues from the Mayo Clinic, Jacksonville.
The authors said the real prevalence of pancreatic cystic lesions is estimated to range from 0.2% to 44.7%.
Their finding of a prevalence of 41.6% was higher than that found in similar imaging studies, but the authors suggested some of this may be due to the lack of a size cutoff in their study, as opposed to a 5-mm cutoff used in one earlier study that found a prevalence of 10%.
“Moreover, we believe that we may have even underestimated the real prevalence because of the absence of magnetic resonance cholangiopancreatography sequences (only 19% of the examinations), and the lack of 3-T studies (6% of the MRIs),” they wrote.
The median size of the lesions was lower than those found in previous studies.
“This smaller size was unexpected because, as a result of the exclusion criteria applied, the technical features of the MRIs were not the most specific for [pancreatic cystic lesion] PCL visualization,” the authors wrote, suggesting that this may have been due to the radiologist’s experience in this field.
The study was funded by the Joyce E. Baker Foundation for Research at Mayo Clinic in Jacksonville. One author disclosed grants or travel support from Olympus, Boston Scientific, and Cosmo Pharmaceuticals. There were no other conflicts of interest declared.
AGA Resource
Review the AGA guideline on the management of asymptomatic pancreatic neoplastic cysts at http://www.gastro.org/guidelines/2015/5/29/pancreatic-cysts.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: The apparent increase of the prevalence of incidental pancreatic cysts in recent years may be tied to improvements in MRI scanning technology.
Major finding: Older MRI hardware found pancreatic cysts in 30.3% of patients and the newest hardware found cysts in 56.3% of patients.
Data source: A retrospective analysis of data from 500 patients who underwent an MRI for nonpancreatic indications.
Disclosures: The study was funded by the Joyce E. Baker Foundation for Research at Mayo Clinic in Jacksonville, Fla. One author disclosed grants or travel support from Olympus, Boston Scientific, and Cosmo Pharmaceuticals. There were no other conflicts of interest declared.
Botanical Over-the-Counter Regimen Reduces Acne Lesions
An over-the-counter botanical acne regimen outperformed a conventional acne regimen, with improved skin appearance and fewer lesions after 12 weeks of treatment, in a double-blind randomized controlled trial.
Eighty individuals aged 12 years and older with mild to moderate acne were randomized either to a three-step botanical-based acne treatment regimen (Receutics) consisting of a skin cleanser, breakout treatment, and tone and complexion corrector twice daily, or the currently marketed acne treatment kit, Proactiv (Guthy-Renker).
The botanical-based acne treatment contains a range of botanical ingredients, including algae and lentil seed extracts; cranberry seed, grape seed, and pumpkin seed oils; and allantoin; with 3.4% benzoyl peroxide as the active ingredient. The active ingredient in the cleanser is 2% salicylic acid, and niacinamide is the active ingredient in the tone and complexion corrector; both also contain botanical ingredients.
In the study, published in December, the investigator, Dr. Zoe Diana Draelos, reported that the botanical regimen achieved a significantly greater reduction in lesion count, in terms of closed comedones and inflammatory lesions, by week four, compared with the control treatment (J Drugs Dermatol. 2015 Dec; 14 [12]:1418-21).
This effect persisted at 12 weeks, with fewer closed comedones (P = .006). The botanical regimen also achieved greater reductions in pus, erythema, lesion height, and inflammation at weeks 2 and 4; although this difference disappeared by week 12. By week four and onwards, the botanical regimen also outperformed the conventional treatment on all blinded, investigator-assessed cosmetic appearance parameters, including skin tone, blemishes, erythema, and overall appearance.
While both treatments were effective at improving acne, Dr. Draelos, of Dermatology Consulting Services, High Point, N.C., said the botanical three-step regimen had the advantage of cosmetic ingredients such as emollients, anti-inflammatory/antioxidants, and “sensitive skin modulators.”
“This study demonstrates the value of combining monographed acne ingredients with advanced cosmeceutical technology,” she wrote.
The author received a grant from manufacturer Receutics to conduct the study.
An over-the-counter botanical acne regimen outperformed a conventional acne regimen, with improved skin appearance and fewer lesions after 12 weeks of treatment, in a double-blind randomized controlled trial.
Eighty individuals aged 12 years and older with mild to moderate acne were randomized either to a three-step botanical-based acne treatment regimen (Receutics) consisting of a skin cleanser, breakout treatment, and tone and complexion corrector twice daily, or the currently marketed acne treatment kit, Proactiv (Guthy-Renker).
The botanical-based acne treatment contains a range of botanical ingredients, including algae and lentil seed extracts; cranberry seed, grape seed, and pumpkin seed oils; and allantoin; with 3.4% benzoyl peroxide as the active ingredient. The active ingredient in the cleanser is 2% salicylic acid, and niacinamide is the active ingredient in the tone and complexion corrector; both also contain botanical ingredients.
In the study, published in December, the investigator, Dr. Zoe Diana Draelos, reported that the botanical regimen achieved a significantly greater reduction in lesion count, in terms of closed comedones and inflammatory lesions, by week four, compared with the control treatment (J Drugs Dermatol. 2015 Dec; 14 [12]:1418-21).
This effect persisted at 12 weeks, with fewer closed comedones (P = .006). The botanical regimen also achieved greater reductions in pus, erythema, lesion height, and inflammation at weeks 2 and 4; although this difference disappeared by week 12. By week four and onwards, the botanical regimen also outperformed the conventional treatment on all blinded, investigator-assessed cosmetic appearance parameters, including skin tone, blemishes, erythema, and overall appearance.
While both treatments were effective at improving acne, Dr. Draelos, of Dermatology Consulting Services, High Point, N.C., said the botanical three-step regimen had the advantage of cosmetic ingredients such as emollients, anti-inflammatory/antioxidants, and “sensitive skin modulators.”
“This study demonstrates the value of combining monographed acne ingredients with advanced cosmeceutical technology,” she wrote.
The author received a grant from manufacturer Receutics to conduct the study.
An over-the-counter botanical acne regimen outperformed a conventional acne regimen, with improved skin appearance and fewer lesions after 12 weeks of treatment, in a double-blind randomized controlled trial.
Eighty individuals aged 12 years and older with mild to moderate acne were randomized either to a three-step botanical-based acne treatment regimen (Receutics) consisting of a skin cleanser, breakout treatment, and tone and complexion corrector twice daily, or the currently marketed acne treatment kit, Proactiv (Guthy-Renker).
The botanical-based acne treatment contains a range of botanical ingredients, including algae and lentil seed extracts; cranberry seed, grape seed, and pumpkin seed oils; and allantoin; with 3.4% benzoyl peroxide as the active ingredient. The active ingredient in the cleanser is 2% salicylic acid, and niacinamide is the active ingredient in the tone and complexion corrector; both also contain botanical ingredients.
In the study, published in December, the investigator, Dr. Zoe Diana Draelos, reported that the botanical regimen achieved a significantly greater reduction in lesion count, in terms of closed comedones and inflammatory lesions, by week four, compared with the control treatment (J Drugs Dermatol. 2015 Dec; 14 [12]:1418-21).
This effect persisted at 12 weeks, with fewer closed comedones (P = .006). The botanical regimen also achieved greater reductions in pus, erythema, lesion height, and inflammation at weeks 2 and 4; although this difference disappeared by week 12. By week four and onwards, the botanical regimen also outperformed the conventional treatment on all blinded, investigator-assessed cosmetic appearance parameters, including skin tone, blemishes, erythema, and overall appearance.
While both treatments were effective at improving acne, Dr. Draelos, of Dermatology Consulting Services, High Point, N.C., said the botanical three-step regimen had the advantage of cosmetic ingredients such as emollients, anti-inflammatory/antioxidants, and “sensitive skin modulators.”
“This study demonstrates the value of combining monographed acne ingredients with advanced cosmeceutical technology,” she wrote.
The author received a grant from manufacturer Receutics to conduct the study.
FROM THE JOURNAL OF DRUGS IN DERMATOLOGY
