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List of medications linked to drug-induced lupus expands
leaving the overall number now standing at 118.
Among the 118 suspected drugs found in VigiBase, the WHO’s global deduplicated individual case safety reports (ICSR) database, 42 had not been previously reported in association with drug-induced lupus (DIL) and 76 had been previously reported in association with DIL in Medline. DIL was reported as a serious adverse event in 55.4% of cases, according to French researchers led by Laurent Arnaud, MD, PhD, of the department of rheumatology at Hôpitaux Universitaires de Strasbourg and Centre National de Références des Maladies Systémiques Rares, Strasbourg, France.
Dr. Arnaud and his colleagues conducted a case-noncase analysis for each drug associated with DIL in order to compare the proportion of specific adverse drug reactions (ADRs) reported for a single drug with the proportion of the same ADR for all other treatments in VigiBase, which receives reports from more than 130 country members of the WHO Programme for International Drug Monitoring and contains over 16 million deduplicated ICSRs recorded by pharmacovigilance centers since 1967. They searched for cases classified as systemic lupus erythematosus (SLE) and identified 12,166 ICSRs of DIL; from these they found 118 suspected drugs with significant pharmacovigilance signal from 8,163 ICSRs that mostly originated from the Americas (65%) and Europe (23%).
In line with what the study authors expected, the drugs associated with the highest number of DIL cases were the antitumor necrosis factor agents infliximab, adalimumab, and etanercept, and the drugs associated with the highest disproportional reporting of DIL were procainamide and hydralazine.
“This is an important finding because these are the two drugs associated with the highest risk of DIL in the literature, therefore confirming the reliability of our approach using a large pharmacovigilance database,” the researchers wrote in Annals of the Rheumatic Diseases.
Overall, DIL was considered definite for 9 drugs (procainamide, hydralazine, minocycline, quinidine, isoniazid, terbinafine, methyldopa, dihydralazine, and chlorpromazine), probable for 19 drugs, and possible for 45 drugs.
The median age of DIL onset was 49 years, which the authors noted was about 2 decades older than that of spontaneous SLE.
They also observed a marked predominance in females (female to male sex ratio, 4.3), a finding that contrasted with previous studies reporting a female to male sex ratio closer to 1:1.
Dr. Arnaud and his colleagues stated that their finding of a median delay between the reported start of suspected treatment and DIL occurrence of 172 days (interquartile range, 35-610 days) suggested that DIL mostly appears after a few months and usually within the first 2 years of treatment with the suspected drug.
“The analysis of the median reporting years for each suspected drug shows a clear evolution of suspected drugs during the past decades. This further underlines that the constantly changing spectrum of DIL should be monitored continuously, and further validates the interest of our approach using the WHO international pharmacovigilance database, the biggest database of this kind with over 16 million deduplicated ICSRs,” they wrote.
The researchers added that distinguishing DIL from SLE is important because its prognosis is usually good when the drug is withdrawn, but the spectrum of DIL is constantly evolving, with drugs once described as strongly linked to DIL now prescribed less frequently.
“The first case of DIL was reported in 1945 with sulfadiazine, while hydralazine DIL was first reported in 1953. Since then, pharmacopoeia has strongly evolved, and one could hypothesize that so has the spectrum of drugs that can induce DIL,” they wrote.
“The detailed list of suspected drugs may prove useful to physicians when confronted with potential DIL cases. Altogether, these findings may help in improving the identification of this constantly evolving disease,” they concluded.
The current study was limited by the lack of a uniform set of criteria for the diagnosis of DIL and by the level of reported details available in VigiBase.
The authors had no outside funding for the study and reported having no conflicts of interest.
SOURCE: Arnaud L et al. Ann Rheum Dis. 2019 Feb 4. doi: 10.1136/annrheumdis-2018-214598.
This new and updated list of possible lupus-inducing drugs includes a growing range of treatment categories, chemical structures, and pharmacologic actions. Yet it is still unclear what the common denominator is that links them.
Drug-induced lupus (DIL) is a peculiar adverse drug reaction that appears to be unrelated to any known property of the inducing agent, although cytokine modulating biologics are a possible exception. Nevertheless, the in vivo metabolism of dissimilar drugs to products with a common, reactive property may go some way to explaining how compounds with different pharmacologic and chemical structures could induce similar adverse reactions.
The findings by Arnaud et al. need better documentation than just positive pharmacovigilance signals. For example, a drug with a relatively high signal does not necessarily translate to a high propensity for causing lupus-like symptoms. It may be a reflection of high drug usage or an awareness of the report contributors for detecting new-onset systemic lupus erythematosus.
Regardless, this research serves to help and inform the medical community to increase the vigilance of previously unreported DIL and perhaps motivate the publication of novel, convincing case reports.
Robert L. Rubin, PhD, is with the University of New Mexico, Albuquerque. His comments are adapted from an editorial accompanying the report by Arnaud et al. (Ann Rheum Dis. 2019 Feb 13. doi: annrheumdis-2018-214785). He reported having no relevant disclosures.
This new and updated list of possible lupus-inducing drugs includes a growing range of treatment categories, chemical structures, and pharmacologic actions. Yet it is still unclear what the common denominator is that links them.
Drug-induced lupus (DIL) is a peculiar adverse drug reaction that appears to be unrelated to any known property of the inducing agent, although cytokine modulating biologics are a possible exception. Nevertheless, the in vivo metabolism of dissimilar drugs to products with a common, reactive property may go some way to explaining how compounds with different pharmacologic and chemical structures could induce similar adverse reactions.
The findings by Arnaud et al. need better documentation than just positive pharmacovigilance signals. For example, a drug with a relatively high signal does not necessarily translate to a high propensity for causing lupus-like symptoms. It may be a reflection of high drug usage or an awareness of the report contributors for detecting new-onset systemic lupus erythematosus.
Regardless, this research serves to help and inform the medical community to increase the vigilance of previously unreported DIL and perhaps motivate the publication of novel, convincing case reports.
Robert L. Rubin, PhD, is with the University of New Mexico, Albuquerque. His comments are adapted from an editorial accompanying the report by Arnaud et al. (Ann Rheum Dis. 2019 Feb 13. doi: annrheumdis-2018-214785). He reported having no relevant disclosures.
This new and updated list of possible lupus-inducing drugs includes a growing range of treatment categories, chemical structures, and pharmacologic actions. Yet it is still unclear what the common denominator is that links them.
Drug-induced lupus (DIL) is a peculiar adverse drug reaction that appears to be unrelated to any known property of the inducing agent, although cytokine modulating biologics are a possible exception. Nevertheless, the in vivo metabolism of dissimilar drugs to products with a common, reactive property may go some way to explaining how compounds with different pharmacologic and chemical structures could induce similar adverse reactions.
The findings by Arnaud et al. need better documentation than just positive pharmacovigilance signals. For example, a drug with a relatively high signal does not necessarily translate to a high propensity for causing lupus-like symptoms. It may be a reflection of high drug usage or an awareness of the report contributors for detecting new-onset systemic lupus erythematosus.
Regardless, this research serves to help and inform the medical community to increase the vigilance of previously unreported DIL and perhaps motivate the publication of novel, convincing case reports.
Robert L. Rubin, PhD, is with the University of New Mexico, Albuquerque. His comments are adapted from an editorial accompanying the report by Arnaud et al. (Ann Rheum Dis. 2019 Feb 13. doi: annrheumdis-2018-214785). He reported having no relevant disclosures.
leaving the overall number now standing at 118.
Among the 118 suspected drugs found in VigiBase, the WHO’s global deduplicated individual case safety reports (ICSR) database, 42 had not been previously reported in association with drug-induced lupus (DIL) and 76 had been previously reported in association with DIL in Medline. DIL was reported as a serious adverse event in 55.4% of cases, according to French researchers led by Laurent Arnaud, MD, PhD, of the department of rheumatology at Hôpitaux Universitaires de Strasbourg and Centre National de Références des Maladies Systémiques Rares, Strasbourg, France.
Dr. Arnaud and his colleagues conducted a case-noncase analysis for each drug associated with DIL in order to compare the proportion of specific adverse drug reactions (ADRs) reported for a single drug with the proportion of the same ADR for all other treatments in VigiBase, which receives reports from more than 130 country members of the WHO Programme for International Drug Monitoring and contains over 16 million deduplicated ICSRs recorded by pharmacovigilance centers since 1967. They searched for cases classified as systemic lupus erythematosus (SLE) and identified 12,166 ICSRs of DIL; from these they found 118 suspected drugs with significant pharmacovigilance signal from 8,163 ICSRs that mostly originated from the Americas (65%) and Europe (23%).
In line with what the study authors expected, the drugs associated with the highest number of DIL cases were the antitumor necrosis factor agents infliximab, adalimumab, and etanercept, and the drugs associated with the highest disproportional reporting of DIL were procainamide and hydralazine.
“This is an important finding because these are the two drugs associated with the highest risk of DIL in the literature, therefore confirming the reliability of our approach using a large pharmacovigilance database,” the researchers wrote in Annals of the Rheumatic Diseases.
Overall, DIL was considered definite for 9 drugs (procainamide, hydralazine, minocycline, quinidine, isoniazid, terbinafine, methyldopa, dihydralazine, and chlorpromazine), probable for 19 drugs, and possible for 45 drugs.
The median age of DIL onset was 49 years, which the authors noted was about 2 decades older than that of spontaneous SLE.
They also observed a marked predominance in females (female to male sex ratio, 4.3), a finding that contrasted with previous studies reporting a female to male sex ratio closer to 1:1.
Dr. Arnaud and his colleagues stated that their finding of a median delay between the reported start of suspected treatment and DIL occurrence of 172 days (interquartile range, 35-610 days) suggested that DIL mostly appears after a few months and usually within the first 2 years of treatment with the suspected drug.
“The analysis of the median reporting years for each suspected drug shows a clear evolution of suspected drugs during the past decades. This further underlines that the constantly changing spectrum of DIL should be monitored continuously, and further validates the interest of our approach using the WHO international pharmacovigilance database, the biggest database of this kind with over 16 million deduplicated ICSRs,” they wrote.
The researchers added that distinguishing DIL from SLE is important because its prognosis is usually good when the drug is withdrawn, but the spectrum of DIL is constantly evolving, with drugs once described as strongly linked to DIL now prescribed less frequently.
“The first case of DIL was reported in 1945 with sulfadiazine, while hydralazine DIL was first reported in 1953. Since then, pharmacopoeia has strongly evolved, and one could hypothesize that so has the spectrum of drugs that can induce DIL,” they wrote.
“The detailed list of suspected drugs may prove useful to physicians when confronted with potential DIL cases. Altogether, these findings may help in improving the identification of this constantly evolving disease,” they concluded.
The current study was limited by the lack of a uniform set of criteria for the diagnosis of DIL and by the level of reported details available in VigiBase.
The authors had no outside funding for the study and reported having no conflicts of interest.
SOURCE: Arnaud L et al. Ann Rheum Dis. 2019 Feb 4. doi: 10.1136/annrheumdis-2018-214598.
leaving the overall number now standing at 118.
Among the 118 suspected drugs found in VigiBase, the WHO’s global deduplicated individual case safety reports (ICSR) database, 42 had not been previously reported in association with drug-induced lupus (DIL) and 76 had been previously reported in association with DIL in Medline. DIL was reported as a serious adverse event in 55.4% of cases, according to French researchers led by Laurent Arnaud, MD, PhD, of the department of rheumatology at Hôpitaux Universitaires de Strasbourg and Centre National de Références des Maladies Systémiques Rares, Strasbourg, France.
Dr. Arnaud and his colleagues conducted a case-noncase analysis for each drug associated with DIL in order to compare the proportion of specific adverse drug reactions (ADRs) reported for a single drug with the proportion of the same ADR for all other treatments in VigiBase, which receives reports from more than 130 country members of the WHO Programme for International Drug Monitoring and contains over 16 million deduplicated ICSRs recorded by pharmacovigilance centers since 1967. They searched for cases classified as systemic lupus erythematosus (SLE) and identified 12,166 ICSRs of DIL; from these they found 118 suspected drugs with significant pharmacovigilance signal from 8,163 ICSRs that mostly originated from the Americas (65%) and Europe (23%).
In line with what the study authors expected, the drugs associated with the highest number of DIL cases were the antitumor necrosis factor agents infliximab, adalimumab, and etanercept, and the drugs associated with the highest disproportional reporting of DIL were procainamide and hydralazine.
“This is an important finding because these are the two drugs associated with the highest risk of DIL in the literature, therefore confirming the reliability of our approach using a large pharmacovigilance database,” the researchers wrote in Annals of the Rheumatic Diseases.
Overall, DIL was considered definite for 9 drugs (procainamide, hydralazine, minocycline, quinidine, isoniazid, terbinafine, methyldopa, dihydralazine, and chlorpromazine), probable for 19 drugs, and possible for 45 drugs.
The median age of DIL onset was 49 years, which the authors noted was about 2 decades older than that of spontaneous SLE.
They also observed a marked predominance in females (female to male sex ratio, 4.3), a finding that contrasted with previous studies reporting a female to male sex ratio closer to 1:1.
Dr. Arnaud and his colleagues stated that their finding of a median delay between the reported start of suspected treatment and DIL occurrence of 172 days (interquartile range, 35-610 days) suggested that DIL mostly appears after a few months and usually within the first 2 years of treatment with the suspected drug.
“The analysis of the median reporting years for each suspected drug shows a clear evolution of suspected drugs during the past decades. This further underlines that the constantly changing spectrum of DIL should be monitored continuously, and further validates the interest of our approach using the WHO international pharmacovigilance database, the biggest database of this kind with over 16 million deduplicated ICSRs,” they wrote.
The researchers added that distinguishing DIL from SLE is important because its prognosis is usually good when the drug is withdrawn, but the spectrum of DIL is constantly evolving, with drugs once described as strongly linked to DIL now prescribed less frequently.
“The first case of DIL was reported in 1945 with sulfadiazine, while hydralazine DIL was first reported in 1953. Since then, pharmacopoeia has strongly evolved, and one could hypothesize that so has the spectrum of drugs that can induce DIL,” they wrote.
“The detailed list of suspected drugs may prove useful to physicians when confronted with potential DIL cases. Altogether, these findings may help in improving the identification of this constantly evolving disease,” they concluded.
The current study was limited by the lack of a uniform set of criteria for the diagnosis of DIL and by the level of reported details available in VigiBase.
The authors had no outside funding for the study and reported having no conflicts of interest.
SOURCE: Arnaud L et al. Ann Rheum Dis. 2019 Feb 4. doi: 10.1136/annrheumdis-2018-214598.
FROM ANNALS OF THE RHEUMATIC DISEASES
Criteria-based fibromyalgia diagnosis and rheumatologists’ clinical diagnosis often disagree
particularly the most recent revision of criteria from 2011 that rely on patients’ self-report of symptoms.
Frederick Wolfe, MD, of the National Data Bank for Rheumatic Diseases and the University of Kansas, Wichita, and his colleagues reported in Arthritis Care & Research that clinicians failed to identify almost half of cases that met the 2011 modification of the American College of Rheumatology’s self-report criteria for fibromyalgia during a 3-month period at Rush Medical College, Chicago. This led them to conclude that the “overall agreement between clinicians’ diagnosis of fibromyalgia and diagnosis by fibromyalgia criteria is only fair.”
The findings call into question studies of fibromyalgia based on ICD-10 diagnosis, according to the authors.
Several widely accepted criteria sets have provided definitions and methods of diagnosis, but a number of studies have suggested that fibromyalgia is overdiagnosed, the authors wrote.
“In the current study, we consider underdiagnosis as well as the form of overdiagnosis that lead to diagnosis when fibromyalgia criteria are not satisfied and symptoms are insufficient for diagnosis,” they added.
The research included 497 consecutive patients attending the Rush Medical College rheumatology clinic who completed a questionnaire assessing fibromyalgia diagnostic variables used in the ACR 2010 preliminary diagnostic criteria for fibromyalgia and its 2011 modification for self-report immediately prior to being seen at the clinic. Clinicians were not given instructions on how any diseases were to be diagnosed, including no instructions on using 2011 fibromyalgia criteria.
The results showed that 121 (24.3%) of the patients satisfied the 2011 fibromyalgia criteria. The agreement between clinicians and criteria was 79.2%, but agreement beyond chance was considered “fair” based on a kappa score of 0.41 and a probabilistic benchmark interval of 0.21-0.40. The researchers wrote that this benchmark represents “the probability for each coefficient of falling into the selected benchmark interval along with the cumulative probability of exceeding the predetermined threshold associated with the interval.”
A total of 104 (20.9%) received a clinician ICD-10 diagnosis of fibromyalgia, but only 61 (58.7%) actually satisfied criteria. Physicians failed to identify 60 (49.6%) criteria-positive patients and incorrectly identified 43 (11.4%) criteria-negative patients.
In a subset of 88 patients with RA, agreement was 84.1%, and the kappa score was 0.32, indicating “slight to fair” agreement (probabilistic benchmark interval, 0.00-0.20). Among 13 RA patients with criteria-positive fibromyalgia, 5 were identified by clinicians; among those who were criteria negative, 6 were deemed positive by clinicians.
The authors noted than “even worse” results were obtained in patients with systemic lupus erythematosus, where the agreement between criteria and clinician ICD diagnosis yielded a kappa value of 0.08. In patients with osteoarthritis, the kappa score was 0.51 (probabilistic benchmark interval, 0.21-0.40).
Overall, the results showed that women and patients with more symptoms but fewer pain areas were more likely to receive a clinician’s diagnosis than to satisfy fibromyalgia criteria. “Clinicians gave greater weight in making a diagnosis to being a woman and having increased symptoms and were willing to diagnose patients with lower WPI [Widespread Pain Index] and PSD [polysymptomatic distress] scores,” the researchers noted.
Dr. Wolfe and his associates wrote that it is unclear why the physicians in the study who misclassified fibromyalgia and missed patients with the diagnosis did not do better. “They may have simply misdiagnosed the condition or not accepted the use of the formal diagnostic system as necessary or clinically useful for identifying fibromyalgia in routine care.”
The researchers noted that it is likely that diagnosis in the community by general physicians, for whom the criteria are not as well known, is even more inaccurate. “It is likely that misdiagnosis is a public health problem and one that can lead to overdiagnosis and overtreatment as well as to inappropriate treatment of individuals not recognized to have fibromyalgia symptoms.”
No disclosures or funding were reported.
SOURCE: Wolfe F et al. Arthritis Care Res. 2019 Feb 6. doi: 10.1002/acr.23731.
Despite voicing concern regarding the “self-report nature of fibromyalgia,” Wolfe et al. selected the 2011 self-report fibromyalgia criteria as their “gold standard” for fibromyalgia diagnosis. Their findings therefore should not be surprising.
The authors’ conclusion that expert physicians often misdiagnose fibromyalgia implies that published criteria are superior to expert clinical judgment for individual patient diagnosis.
However, this view fails to take into account the myriad variables seen by the clinician in the clinic. Until biomarkers or genetic testing allows for more objective disease markers, common conditions like fibromyalgia will continue to be symptom-based diagnoses. Therefore, the gold standard diagnostic criteria for fibromyalgia and other common illnesses is expert opinion.
Rheumatologists are the go-to experts for the diagnosis of fibromyalgia, whether or not we readily accept that role.
These comments are adapted from an accompanying editorial by Don Goldenberg, MD, of Oregon Health & Science University, Portland, and Tufts University, Boston (Arthritis Care Res. 2019 Feb 6. doi: 10.1002/acr.23727).
Despite voicing concern regarding the “self-report nature of fibromyalgia,” Wolfe et al. selected the 2011 self-report fibromyalgia criteria as their “gold standard” for fibromyalgia diagnosis. Their findings therefore should not be surprising.
The authors’ conclusion that expert physicians often misdiagnose fibromyalgia implies that published criteria are superior to expert clinical judgment for individual patient diagnosis.
However, this view fails to take into account the myriad variables seen by the clinician in the clinic. Until biomarkers or genetic testing allows for more objective disease markers, common conditions like fibromyalgia will continue to be symptom-based diagnoses. Therefore, the gold standard diagnostic criteria for fibromyalgia and other common illnesses is expert opinion.
Rheumatologists are the go-to experts for the diagnosis of fibromyalgia, whether or not we readily accept that role.
These comments are adapted from an accompanying editorial by Don Goldenberg, MD, of Oregon Health & Science University, Portland, and Tufts University, Boston (Arthritis Care Res. 2019 Feb 6. doi: 10.1002/acr.23727).
Despite voicing concern regarding the “self-report nature of fibromyalgia,” Wolfe et al. selected the 2011 self-report fibromyalgia criteria as their “gold standard” for fibromyalgia diagnosis. Their findings therefore should not be surprising.
The authors’ conclusion that expert physicians often misdiagnose fibromyalgia implies that published criteria are superior to expert clinical judgment for individual patient diagnosis.
However, this view fails to take into account the myriad variables seen by the clinician in the clinic. Until biomarkers or genetic testing allows for more objective disease markers, common conditions like fibromyalgia will continue to be symptom-based diagnoses. Therefore, the gold standard diagnostic criteria for fibromyalgia and other common illnesses is expert opinion.
Rheumatologists are the go-to experts for the diagnosis of fibromyalgia, whether or not we readily accept that role.
These comments are adapted from an accompanying editorial by Don Goldenberg, MD, of Oregon Health & Science University, Portland, and Tufts University, Boston (Arthritis Care Res. 2019 Feb 6. doi: 10.1002/acr.23727).
particularly the most recent revision of criteria from 2011 that rely on patients’ self-report of symptoms.
Frederick Wolfe, MD, of the National Data Bank for Rheumatic Diseases and the University of Kansas, Wichita, and his colleagues reported in Arthritis Care & Research that clinicians failed to identify almost half of cases that met the 2011 modification of the American College of Rheumatology’s self-report criteria for fibromyalgia during a 3-month period at Rush Medical College, Chicago. This led them to conclude that the “overall agreement between clinicians’ diagnosis of fibromyalgia and diagnosis by fibromyalgia criteria is only fair.”
The findings call into question studies of fibromyalgia based on ICD-10 diagnosis, according to the authors.
Several widely accepted criteria sets have provided definitions and methods of diagnosis, but a number of studies have suggested that fibromyalgia is overdiagnosed, the authors wrote.
“In the current study, we consider underdiagnosis as well as the form of overdiagnosis that lead to diagnosis when fibromyalgia criteria are not satisfied and symptoms are insufficient for diagnosis,” they added.
The research included 497 consecutive patients attending the Rush Medical College rheumatology clinic who completed a questionnaire assessing fibromyalgia diagnostic variables used in the ACR 2010 preliminary diagnostic criteria for fibromyalgia and its 2011 modification for self-report immediately prior to being seen at the clinic. Clinicians were not given instructions on how any diseases were to be diagnosed, including no instructions on using 2011 fibromyalgia criteria.
The results showed that 121 (24.3%) of the patients satisfied the 2011 fibromyalgia criteria. The agreement between clinicians and criteria was 79.2%, but agreement beyond chance was considered “fair” based on a kappa score of 0.41 and a probabilistic benchmark interval of 0.21-0.40. The researchers wrote that this benchmark represents “the probability for each coefficient of falling into the selected benchmark interval along with the cumulative probability of exceeding the predetermined threshold associated with the interval.”
A total of 104 (20.9%) received a clinician ICD-10 diagnosis of fibromyalgia, but only 61 (58.7%) actually satisfied criteria. Physicians failed to identify 60 (49.6%) criteria-positive patients and incorrectly identified 43 (11.4%) criteria-negative patients.
In a subset of 88 patients with RA, agreement was 84.1%, and the kappa score was 0.32, indicating “slight to fair” agreement (probabilistic benchmark interval, 0.00-0.20). Among 13 RA patients with criteria-positive fibromyalgia, 5 were identified by clinicians; among those who were criteria negative, 6 were deemed positive by clinicians.
The authors noted than “even worse” results were obtained in patients with systemic lupus erythematosus, where the agreement between criteria and clinician ICD diagnosis yielded a kappa value of 0.08. In patients with osteoarthritis, the kappa score was 0.51 (probabilistic benchmark interval, 0.21-0.40).
Overall, the results showed that women and patients with more symptoms but fewer pain areas were more likely to receive a clinician’s diagnosis than to satisfy fibromyalgia criteria. “Clinicians gave greater weight in making a diagnosis to being a woman and having increased symptoms and were willing to diagnose patients with lower WPI [Widespread Pain Index] and PSD [polysymptomatic distress] scores,” the researchers noted.
Dr. Wolfe and his associates wrote that it is unclear why the physicians in the study who misclassified fibromyalgia and missed patients with the diagnosis did not do better. “They may have simply misdiagnosed the condition or not accepted the use of the formal diagnostic system as necessary or clinically useful for identifying fibromyalgia in routine care.”
The researchers noted that it is likely that diagnosis in the community by general physicians, for whom the criteria are not as well known, is even more inaccurate. “It is likely that misdiagnosis is a public health problem and one that can lead to overdiagnosis and overtreatment as well as to inappropriate treatment of individuals not recognized to have fibromyalgia symptoms.”
No disclosures or funding were reported.
SOURCE: Wolfe F et al. Arthritis Care Res. 2019 Feb 6. doi: 10.1002/acr.23731.
particularly the most recent revision of criteria from 2011 that rely on patients’ self-report of symptoms.
Frederick Wolfe, MD, of the National Data Bank for Rheumatic Diseases and the University of Kansas, Wichita, and his colleagues reported in Arthritis Care & Research that clinicians failed to identify almost half of cases that met the 2011 modification of the American College of Rheumatology’s self-report criteria for fibromyalgia during a 3-month period at Rush Medical College, Chicago. This led them to conclude that the “overall agreement between clinicians’ diagnosis of fibromyalgia and diagnosis by fibromyalgia criteria is only fair.”
The findings call into question studies of fibromyalgia based on ICD-10 diagnosis, according to the authors.
Several widely accepted criteria sets have provided definitions and methods of diagnosis, but a number of studies have suggested that fibromyalgia is overdiagnosed, the authors wrote.
“In the current study, we consider underdiagnosis as well as the form of overdiagnosis that lead to diagnosis when fibromyalgia criteria are not satisfied and symptoms are insufficient for diagnosis,” they added.
The research included 497 consecutive patients attending the Rush Medical College rheumatology clinic who completed a questionnaire assessing fibromyalgia diagnostic variables used in the ACR 2010 preliminary diagnostic criteria for fibromyalgia and its 2011 modification for self-report immediately prior to being seen at the clinic. Clinicians were not given instructions on how any diseases were to be diagnosed, including no instructions on using 2011 fibromyalgia criteria.
The results showed that 121 (24.3%) of the patients satisfied the 2011 fibromyalgia criteria. The agreement between clinicians and criteria was 79.2%, but agreement beyond chance was considered “fair” based on a kappa score of 0.41 and a probabilistic benchmark interval of 0.21-0.40. The researchers wrote that this benchmark represents “the probability for each coefficient of falling into the selected benchmark interval along with the cumulative probability of exceeding the predetermined threshold associated with the interval.”
A total of 104 (20.9%) received a clinician ICD-10 diagnosis of fibromyalgia, but only 61 (58.7%) actually satisfied criteria. Physicians failed to identify 60 (49.6%) criteria-positive patients and incorrectly identified 43 (11.4%) criteria-negative patients.
In a subset of 88 patients with RA, agreement was 84.1%, and the kappa score was 0.32, indicating “slight to fair” agreement (probabilistic benchmark interval, 0.00-0.20). Among 13 RA patients with criteria-positive fibromyalgia, 5 were identified by clinicians; among those who were criteria negative, 6 were deemed positive by clinicians.
The authors noted than “even worse” results were obtained in patients with systemic lupus erythematosus, where the agreement between criteria and clinician ICD diagnosis yielded a kappa value of 0.08. In patients with osteoarthritis, the kappa score was 0.51 (probabilistic benchmark interval, 0.21-0.40).
Overall, the results showed that women and patients with more symptoms but fewer pain areas were more likely to receive a clinician’s diagnosis than to satisfy fibromyalgia criteria. “Clinicians gave greater weight in making a diagnosis to being a woman and having increased symptoms and were willing to diagnose patients with lower WPI [Widespread Pain Index] and PSD [polysymptomatic distress] scores,” the researchers noted.
Dr. Wolfe and his associates wrote that it is unclear why the physicians in the study who misclassified fibromyalgia and missed patients with the diagnosis did not do better. “They may have simply misdiagnosed the condition or not accepted the use of the formal diagnostic system as necessary or clinically useful for identifying fibromyalgia in routine care.”
The researchers noted that it is likely that diagnosis in the community by general physicians, for whom the criteria are not as well known, is even more inaccurate. “It is likely that misdiagnosis is a public health problem and one that can lead to overdiagnosis and overtreatment as well as to inappropriate treatment of individuals not recognized to have fibromyalgia symptoms.”
No disclosures or funding were reported.
SOURCE: Wolfe F et al. Arthritis Care Res. 2019 Feb 6. doi: 10.1002/acr.23731.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point: Clinicians failed to identify nearly 50% of criteria-positive cases
Major finding: Physicians failed to identify 60 (49.6%) criteria-positive patients and incorrectly identified 43 (11.4%) criteria-negative patients.
Study details: A group of 497 consecutive unselected rheumatology clinic attendees who completed a questionnaire assessing fibromyalgia diagnostic variables used in the American College of Rheumatology 2010 preliminary diagnostic criteria for fibromyalgia and its 2011 modification for self-report.
Disclosures: No disclosures or funding were reported.
Source: Wolfe F et al. Arthritis Care Res. 2019 Feb 6. doi: 10.1002/acr.23731.
Compounded pain creams no better than placebo creams in localized chronic pain
Specially formulated topical pain creams are no better than placebo creams for relieving localized chronic pain, according to results from a double-blind, randomized, placebo-controlled trial.
Study authors led by Robert E. Brutcher, PharmD, PhD, of Walter Reed National Military Medical Center in Bethesda, Md., said their findings published Feb. 4 in Annals of Internal Medicine suggest compounded pain creams should not be routinely used for chronic pain conditions.
The researchers noted that the use of compounded topical pain creams has increased dramatically despite “weak evidence” supporting their efficacy to treat localized pain, and this is particularly the case in military personnel, where the authors said treatments without central effect may be particularly beneficial because “opioid therapy may render a service member nondeployable and medications that affect the central nervous system may have a negative effect on judgment and motor skills.”
They noted a report from the U.S. Government Accountability Office that showed Tricare’s pharmacy benefits program paid $259 million for compounded medications in the 2013 fiscal year, a figure that increased to $746 million in 2014.
“The soaring costs, coupled with sparse efficacy data prompted the Defense Health Agency to evaluate this issue,” they wrote.
The objectives of the current study were to assess the efficacy of compounded pain creams for chronic pain conditions and determine whether efficacy differed for the various pain classifications.
“We hypothesized that, compared with placebo, compounded topical pain creams would provide greater pain relief and functional improvement,” they said.
The randomized trial involved 133 patients diagnosed with neuropathic pain, 133 with nociceptive pain, and 133 with mixed pain who had attended pain clinics at Walter Reed. Patients were aged between 18 and 90 years and had localized pain in the face, back or buttocks, neck, abdomen, chest, groin, or in up to two extremities. To be included in the study, they were also required to have an average pain score of 4 or greater on a 0- to 10-point numerical rating scale during the preceding week and have symptoms lasting longer than 6 weeks.
Patients in all three pain subgroups were randomized in a 1:1 ratio to receive either a compounded pain cream or a placebo cream. The authors noted that their “pain cream formulations were selected on the basis of accepted systemic indications for neuropathic and nociceptive pain.”
The formulation given to participants with neuropathic pain (n = 68) contained 10% ketamine, 6% gabapentin, 0.2% clonidine, and 2% lidocaine. The patients with nociceptive pain (n = 66) received a cream with 10% ketoprofen, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. Those with mixed pain (n = 68) were given a cream containing 10% ketamine, 6% gabapentin, 3% diclofenac, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. The authors said the concentrations of individual medications were based on previous trials that evaluated topical use.
The patients, who had a mean age across the groups that ranged from 48 to 57 years, applied cream to affected areas three times per day, with the amount dispensed determined by the size of the area experiencing pain. About half of the patients were women.
The primary outcome measures were an average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed to 3 months.
Change in the primary outcome of average pain score at 1 month did not differ between the active cream and placebo groups for any type of pain classification. The change was only –0.1 points (95% confidence interval, –0.8 to 0.5 points) for neuropathic pain, –0.3 points (95% CI, –0.9 to 0.2 points) for nociceptive pain, and –0.3 points (95% CI, –0.9 to 0.2 points) for mixed pain.
Among all patients combined, an overall change in average pain scores of –0.3 points (95% CI, –0.6 to 0.1 points) that favored the active-ingredient cream also did not differ between the treatment and placebo groups.
“The lower 95% confidence bounds for the 1-month between-group differences were all 0.9 points or less and excluded clinically meaningful benefits with the compounded topical pain cream,” the authors wrote.
Secondary outcomes also did not differ between the two study groups for any type of pain classification or for the entire cohort.
“Although participants in both treatment and control groups had improvement in their pain throughout the study, no significant differences were observed in pain scores, functional improvement, or satisfaction in the cohort or in any subgroup,” the authors concluded.
They noted that their findings were consistent with previous studies that also showed a lack of efficacy for most topical pain creams.
While some randomized trials have suggested positive findings for capsaicin, lidocaine, and NSAIDs, the authors noted that they did not find a similar benefit in their study population.
“Administered as stand-alone agents, lidocaine and NSAIDs may alleviate pain, although the effect size is small and the number needed to treat is large,” they wrote.
“Considering the increased costs of using a non–FDA-approved and regulated compounded cream rather than a single agent, we caution against routine use of compounded creams for chronic pain,” they wrote.
They noted that their study had several limitations, including that conventional treatments had failed in some of the participants before they enrolled in the study, increasing the likelihood that subsequent therapy would not be effective.
The authors suggested that future studies should aim to establish whether targeting specific types of pain or adding other agents like dimethyl sulfoxide would result in better outcomes.
The Centers for Rehabilitation Sciences Research in the U.S. Department of Defense’s Defense Health Agency funded the study. Two authors reported receiving grants and personal fees from several pharmaceutical companies.
SOURCE: Brutcher RE et al. Ann Intern Med. 2019 Feb 4. doi: 10.7326/M18-2736.
Specially formulated topical pain creams are no better than placebo creams for relieving localized chronic pain, according to results from a double-blind, randomized, placebo-controlled trial.
Study authors led by Robert E. Brutcher, PharmD, PhD, of Walter Reed National Military Medical Center in Bethesda, Md., said their findings published Feb. 4 in Annals of Internal Medicine suggest compounded pain creams should not be routinely used for chronic pain conditions.
The researchers noted that the use of compounded topical pain creams has increased dramatically despite “weak evidence” supporting their efficacy to treat localized pain, and this is particularly the case in military personnel, where the authors said treatments without central effect may be particularly beneficial because “opioid therapy may render a service member nondeployable and medications that affect the central nervous system may have a negative effect on judgment and motor skills.”
They noted a report from the U.S. Government Accountability Office that showed Tricare’s pharmacy benefits program paid $259 million for compounded medications in the 2013 fiscal year, a figure that increased to $746 million in 2014.
“The soaring costs, coupled with sparse efficacy data prompted the Defense Health Agency to evaluate this issue,” they wrote.
The objectives of the current study were to assess the efficacy of compounded pain creams for chronic pain conditions and determine whether efficacy differed for the various pain classifications.
“We hypothesized that, compared with placebo, compounded topical pain creams would provide greater pain relief and functional improvement,” they said.
The randomized trial involved 133 patients diagnosed with neuropathic pain, 133 with nociceptive pain, and 133 with mixed pain who had attended pain clinics at Walter Reed. Patients were aged between 18 and 90 years and had localized pain in the face, back or buttocks, neck, abdomen, chest, groin, or in up to two extremities. To be included in the study, they were also required to have an average pain score of 4 or greater on a 0- to 10-point numerical rating scale during the preceding week and have symptoms lasting longer than 6 weeks.
Patients in all three pain subgroups were randomized in a 1:1 ratio to receive either a compounded pain cream or a placebo cream. The authors noted that their “pain cream formulations were selected on the basis of accepted systemic indications for neuropathic and nociceptive pain.”
The formulation given to participants with neuropathic pain (n = 68) contained 10% ketamine, 6% gabapentin, 0.2% clonidine, and 2% lidocaine. The patients with nociceptive pain (n = 66) received a cream with 10% ketoprofen, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. Those with mixed pain (n = 68) were given a cream containing 10% ketamine, 6% gabapentin, 3% diclofenac, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. The authors said the concentrations of individual medications were based on previous trials that evaluated topical use.
The patients, who had a mean age across the groups that ranged from 48 to 57 years, applied cream to affected areas three times per day, with the amount dispensed determined by the size of the area experiencing pain. About half of the patients were women.
The primary outcome measures were an average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed to 3 months.
Change in the primary outcome of average pain score at 1 month did not differ between the active cream and placebo groups for any type of pain classification. The change was only –0.1 points (95% confidence interval, –0.8 to 0.5 points) for neuropathic pain, –0.3 points (95% CI, –0.9 to 0.2 points) for nociceptive pain, and –0.3 points (95% CI, –0.9 to 0.2 points) for mixed pain.
Among all patients combined, an overall change in average pain scores of –0.3 points (95% CI, –0.6 to 0.1 points) that favored the active-ingredient cream also did not differ between the treatment and placebo groups.
“The lower 95% confidence bounds for the 1-month between-group differences were all 0.9 points or less and excluded clinically meaningful benefits with the compounded topical pain cream,” the authors wrote.
Secondary outcomes also did not differ between the two study groups for any type of pain classification or for the entire cohort.
“Although participants in both treatment and control groups had improvement in their pain throughout the study, no significant differences were observed in pain scores, functional improvement, or satisfaction in the cohort or in any subgroup,” the authors concluded.
They noted that their findings were consistent with previous studies that also showed a lack of efficacy for most topical pain creams.
While some randomized trials have suggested positive findings for capsaicin, lidocaine, and NSAIDs, the authors noted that they did not find a similar benefit in their study population.
“Administered as stand-alone agents, lidocaine and NSAIDs may alleviate pain, although the effect size is small and the number needed to treat is large,” they wrote.
“Considering the increased costs of using a non–FDA-approved and regulated compounded cream rather than a single agent, we caution against routine use of compounded creams for chronic pain,” they wrote.
They noted that their study had several limitations, including that conventional treatments had failed in some of the participants before they enrolled in the study, increasing the likelihood that subsequent therapy would not be effective.
The authors suggested that future studies should aim to establish whether targeting specific types of pain or adding other agents like dimethyl sulfoxide would result in better outcomes.
The Centers for Rehabilitation Sciences Research in the U.S. Department of Defense’s Defense Health Agency funded the study. Two authors reported receiving grants and personal fees from several pharmaceutical companies.
SOURCE: Brutcher RE et al. Ann Intern Med. 2019 Feb 4. doi: 10.7326/M18-2736.
Specially formulated topical pain creams are no better than placebo creams for relieving localized chronic pain, according to results from a double-blind, randomized, placebo-controlled trial.
Study authors led by Robert E. Brutcher, PharmD, PhD, of Walter Reed National Military Medical Center in Bethesda, Md., said their findings published Feb. 4 in Annals of Internal Medicine suggest compounded pain creams should not be routinely used for chronic pain conditions.
The researchers noted that the use of compounded topical pain creams has increased dramatically despite “weak evidence” supporting their efficacy to treat localized pain, and this is particularly the case in military personnel, where the authors said treatments without central effect may be particularly beneficial because “opioid therapy may render a service member nondeployable and medications that affect the central nervous system may have a negative effect on judgment and motor skills.”
They noted a report from the U.S. Government Accountability Office that showed Tricare’s pharmacy benefits program paid $259 million for compounded medications in the 2013 fiscal year, a figure that increased to $746 million in 2014.
“The soaring costs, coupled with sparse efficacy data prompted the Defense Health Agency to evaluate this issue,” they wrote.
The objectives of the current study were to assess the efficacy of compounded pain creams for chronic pain conditions and determine whether efficacy differed for the various pain classifications.
“We hypothesized that, compared with placebo, compounded topical pain creams would provide greater pain relief and functional improvement,” they said.
The randomized trial involved 133 patients diagnosed with neuropathic pain, 133 with nociceptive pain, and 133 with mixed pain who had attended pain clinics at Walter Reed. Patients were aged between 18 and 90 years and had localized pain in the face, back or buttocks, neck, abdomen, chest, groin, or in up to two extremities. To be included in the study, they were also required to have an average pain score of 4 or greater on a 0- to 10-point numerical rating scale during the preceding week and have symptoms lasting longer than 6 weeks.
Patients in all three pain subgroups were randomized in a 1:1 ratio to receive either a compounded pain cream or a placebo cream. The authors noted that their “pain cream formulations were selected on the basis of accepted systemic indications for neuropathic and nociceptive pain.”
The formulation given to participants with neuropathic pain (n = 68) contained 10% ketamine, 6% gabapentin, 0.2% clonidine, and 2% lidocaine. The patients with nociceptive pain (n = 66) received a cream with 10% ketoprofen, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. Those with mixed pain (n = 68) were given a cream containing 10% ketamine, 6% gabapentin, 3% diclofenac, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. The authors said the concentrations of individual medications were based on previous trials that evaluated topical use.
The patients, who had a mean age across the groups that ranged from 48 to 57 years, applied cream to affected areas three times per day, with the amount dispensed determined by the size of the area experiencing pain. About half of the patients were women.
The primary outcome measures were an average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed to 3 months.
Change in the primary outcome of average pain score at 1 month did not differ between the active cream and placebo groups for any type of pain classification. The change was only –0.1 points (95% confidence interval, –0.8 to 0.5 points) for neuropathic pain, –0.3 points (95% CI, –0.9 to 0.2 points) for nociceptive pain, and –0.3 points (95% CI, –0.9 to 0.2 points) for mixed pain.
Among all patients combined, an overall change in average pain scores of –0.3 points (95% CI, –0.6 to 0.1 points) that favored the active-ingredient cream also did not differ between the treatment and placebo groups.
“The lower 95% confidence bounds for the 1-month between-group differences were all 0.9 points or less and excluded clinically meaningful benefits with the compounded topical pain cream,” the authors wrote.
Secondary outcomes also did not differ between the two study groups for any type of pain classification or for the entire cohort.
“Although participants in both treatment and control groups had improvement in their pain throughout the study, no significant differences were observed in pain scores, functional improvement, or satisfaction in the cohort or in any subgroup,” the authors concluded.
They noted that their findings were consistent with previous studies that also showed a lack of efficacy for most topical pain creams.
While some randomized trials have suggested positive findings for capsaicin, lidocaine, and NSAIDs, the authors noted that they did not find a similar benefit in their study population.
“Administered as stand-alone agents, lidocaine and NSAIDs may alleviate pain, although the effect size is small and the number needed to treat is large,” they wrote.
“Considering the increased costs of using a non–FDA-approved and regulated compounded cream rather than a single agent, we caution against routine use of compounded creams for chronic pain,” they wrote.
They noted that their study had several limitations, including that conventional treatments had failed in some of the participants before they enrolled in the study, increasing the likelihood that subsequent therapy would not be effective.
The authors suggested that future studies should aim to establish whether targeting specific types of pain or adding other agents like dimethyl sulfoxide would result in better outcomes.
The Centers for Rehabilitation Sciences Research in the U.S. Department of Defense’s Defense Health Agency funded the study. Two authors reported receiving grants and personal fees from several pharmaceutical companies.
SOURCE: Brutcher RE et al. Ann Intern Med. 2019 Feb 4. doi: 10.7326/M18-2736.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Compounded pain creams should not be routinely used to treat chronic localized pain.
Major finding: At 1 month, the researchers found no significant differences in pain scores, functional improvement, or satisfaction between study participants with localized pain who had received specifically formulated pain creams and those who had received a placebo cream.
Study details: This double-blind, randomized, controlled trial involved 399 patients with localized pain who received either a pain cream specifically compounded for their type of pain – neuropathic, nociceptive, or mixed – or a placebo cream.
Disclosures: The Centers for Rehabilitation Sciences Research in the U.S. Department of Defense’s Defense Health Agency funded the study. Two authors reported receiving grants and personal fees from several pharmaceutical companies.
Source: Brutcher RE et al. Ann Intern Med. 2019 Feb 4. doi: 10.7326/M18-2736.
Topical retinoid found effective as microneedling for acne scars
according to a new study.
In a prospective, randomized, split-face study of adults with postacne scarring, both treatments resulted in similar efficacy after 6 months, reported T.P. Afra, MD, and associates from the department of dermatology, venereology, and leprology at the Postgraduate Institute of Medical Education and Research in Chandigarh, India. While the clinical usefulness of microneedling as a procedure for postacne scarring is well established, research exploring the effectiveness of topical therapies for acne scarring that could be used at home is lacking. “A home-based topical treatment with a comparable efficacy to microneedling and that is well tolerated would be a useful addition in the armamentarium of acne scar management,” they wrote in the study, published in JAMA Facial Plastic Surgery.
The study included 34 patients, aged 18-30 years, with grade 2-4 facial atrophic acne scars at their initial visit to the research team’s skin clinic. One side of each participants face was randomized to receive microneedling treatment for four sessions over 3 months (using a dermaroller with 1.5-mm needles). Topical tazarotene gel 0.1%, a retinoid approved by the Food and Drug Administration as a treatment for mild to moderate facial acne, was applied to the other side of their face once a night during the same time. Almost 81% were skin phototypes IV, the rest were type III or V. Patients followed up every month for 3 months, then at 6 months.
Changes in acne scar severity from baseline, the primary outcome, were assessed using Goodman and Baron quantitative and qualitative scores and a subjective dermatologist score. Patient satisfaction measured with a Patient Global Assessment (PGA) score and adverse events were secondary outcomes.
In 31 patients (91.2%), overall improvements from baseline to the 6-month visit in quantitative acne scar severity scores for both treatments were seen, with significant improvements from baseline to 6 months: A median improvement of 3 on the sides of the face treated with microneedling and a median improvement of 2.5 on the sides of the face treated with tazarotene (between-group comparison, P = .42). The qualitative acne scar severity score did not significantly improve with either treatment, the investigators noted.
The median improvement in the independent dermatologist score was also comparable for both methods at 3 and 6 months.
At 6 months, improvement in the mean PGA score was “slightly but significantly superior” for the microneedling treatment, compared with that for tazarotene (mean of 5.86 vs. 5.76, respectively; P less than .001), with both falling into the “satisfactory” range for the PGA, the investigators wrote. They also noted a positive correlation between previous exposure to oral isotretinoin and patient satisfaction.
“Although collagen accumulation has been considered a drawback of isotretinoin therapy owing to the development of hypertrophic scars, the better atrophic acne scar outcomes observed for both the present treatment groups in patients with a history of isotretinoin treatment indicates that the collagen accumulation in this case may actually be beneficial,” they wrote.
The topical retinoid was well tolerated by participants, with less than a third reporting dryness and scaling, and adverse effects associated with microneedling were described as “minimal.”
“The use of a modality such as tazarotene that prevents acne flares while addressing acne scarring is a practical addition to clinical practice,” the investigators concluded. “Tazarotene gel 0.1% would be a useful alternative to microneedling in the management of atrophic acne scars. Such a home-based medical management option for acne scarring may decrease physician dependence and health care expenditures for patients with postacne scarring.”
The study authors noted that, as collagen remodeling is a continuous process lasting more than 1 year, a limitation of their study was its short-follow-up of 6 months. However, a strength of the study was its use of validated acne scar severity scoring tools as well as patient and physician assessment of scar improvement in the outcome assessments.
The authors had no disclosures to report.
SOURCE: Afra TP et al. JAMA Facial Plast Surg. 2018 Nov 15. doi: 10.1001/jamafacial.2018.1404.
according to a new study.
In a prospective, randomized, split-face study of adults with postacne scarring, both treatments resulted in similar efficacy after 6 months, reported T.P. Afra, MD, and associates from the department of dermatology, venereology, and leprology at the Postgraduate Institute of Medical Education and Research in Chandigarh, India. While the clinical usefulness of microneedling as a procedure for postacne scarring is well established, research exploring the effectiveness of topical therapies for acne scarring that could be used at home is lacking. “A home-based topical treatment with a comparable efficacy to microneedling and that is well tolerated would be a useful addition in the armamentarium of acne scar management,” they wrote in the study, published in JAMA Facial Plastic Surgery.
The study included 34 patients, aged 18-30 years, with grade 2-4 facial atrophic acne scars at their initial visit to the research team’s skin clinic. One side of each participants face was randomized to receive microneedling treatment for four sessions over 3 months (using a dermaroller with 1.5-mm needles). Topical tazarotene gel 0.1%, a retinoid approved by the Food and Drug Administration as a treatment for mild to moderate facial acne, was applied to the other side of their face once a night during the same time. Almost 81% were skin phototypes IV, the rest were type III or V. Patients followed up every month for 3 months, then at 6 months.
Changes in acne scar severity from baseline, the primary outcome, were assessed using Goodman and Baron quantitative and qualitative scores and a subjective dermatologist score. Patient satisfaction measured with a Patient Global Assessment (PGA) score and adverse events were secondary outcomes.
In 31 patients (91.2%), overall improvements from baseline to the 6-month visit in quantitative acne scar severity scores for both treatments were seen, with significant improvements from baseline to 6 months: A median improvement of 3 on the sides of the face treated with microneedling and a median improvement of 2.5 on the sides of the face treated with tazarotene (between-group comparison, P = .42). The qualitative acne scar severity score did not significantly improve with either treatment, the investigators noted.
The median improvement in the independent dermatologist score was also comparable for both methods at 3 and 6 months.
At 6 months, improvement in the mean PGA score was “slightly but significantly superior” for the microneedling treatment, compared with that for tazarotene (mean of 5.86 vs. 5.76, respectively; P less than .001), with both falling into the “satisfactory” range for the PGA, the investigators wrote. They also noted a positive correlation between previous exposure to oral isotretinoin and patient satisfaction.
“Although collagen accumulation has been considered a drawback of isotretinoin therapy owing to the development of hypertrophic scars, the better atrophic acne scar outcomes observed for both the present treatment groups in patients with a history of isotretinoin treatment indicates that the collagen accumulation in this case may actually be beneficial,” they wrote.
The topical retinoid was well tolerated by participants, with less than a third reporting dryness and scaling, and adverse effects associated with microneedling were described as “minimal.”
“The use of a modality such as tazarotene that prevents acne flares while addressing acne scarring is a practical addition to clinical practice,” the investigators concluded. “Tazarotene gel 0.1% would be a useful alternative to microneedling in the management of atrophic acne scars. Such a home-based medical management option for acne scarring may decrease physician dependence and health care expenditures for patients with postacne scarring.”
The study authors noted that, as collagen remodeling is a continuous process lasting more than 1 year, a limitation of their study was its short-follow-up of 6 months. However, a strength of the study was its use of validated acne scar severity scoring tools as well as patient and physician assessment of scar improvement in the outcome assessments.
The authors had no disclosures to report.
SOURCE: Afra TP et al. JAMA Facial Plast Surg. 2018 Nov 15. doi: 10.1001/jamafacial.2018.1404.
according to a new study.
In a prospective, randomized, split-face study of adults with postacne scarring, both treatments resulted in similar efficacy after 6 months, reported T.P. Afra, MD, and associates from the department of dermatology, venereology, and leprology at the Postgraduate Institute of Medical Education and Research in Chandigarh, India. While the clinical usefulness of microneedling as a procedure for postacne scarring is well established, research exploring the effectiveness of topical therapies for acne scarring that could be used at home is lacking. “A home-based topical treatment with a comparable efficacy to microneedling and that is well tolerated would be a useful addition in the armamentarium of acne scar management,” they wrote in the study, published in JAMA Facial Plastic Surgery.
The study included 34 patients, aged 18-30 years, with grade 2-4 facial atrophic acne scars at their initial visit to the research team’s skin clinic. One side of each participants face was randomized to receive microneedling treatment for four sessions over 3 months (using a dermaroller with 1.5-mm needles). Topical tazarotene gel 0.1%, a retinoid approved by the Food and Drug Administration as a treatment for mild to moderate facial acne, was applied to the other side of their face once a night during the same time. Almost 81% were skin phototypes IV, the rest were type III or V. Patients followed up every month for 3 months, then at 6 months.
Changes in acne scar severity from baseline, the primary outcome, were assessed using Goodman and Baron quantitative and qualitative scores and a subjective dermatologist score. Patient satisfaction measured with a Patient Global Assessment (PGA) score and adverse events were secondary outcomes.
In 31 patients (91.2%), overall improvements from baseline to the 6-month visit in quantitative acne scar severity scores for both treatments were seen, with significant improvements from baseline to 6 months: A median improvement of 3 on the sides of the face treated with microneedling and a median improvement of 2.5 on the sides of the face treated with tazarotene (between-group comparison, P = .42). The qualitative acne scar severity score did not significantly improve with either treatment, the investigators noted.
The median improvement in the independent dermatologist score was also comparable for both methods at 3 and 6 months.
At 6 months, improvement in the mean PGA score was “slightly but significantly superior” for the microneedling treatment, compared with that for tazarotene (mean of 5.86 vs. 5.76, respectively; P less than .001), with both falling into the “satisfactory” range for the PGA, the investigators wrote. They also noted a positive correlation between previous exposure to oral isotretinoin and patient satisfaction.
“Although collagen accumulation has been considered a drawback of isotretinoin therapy owing to the development of hypertrophic scars, the better atrophic acne scar outcomes observed for both the present treatment groups in patients with a history of isotretinoin treatment indicates that the collagen accumulation in this case may actually be beneficial,” they wrote.
The topical retinoid was well tolerated by participants, with less than a third reporting dryness and scaling, and adverse effects associated with microneedling were described as “minimal.”
“The use of a modality such as tazarotene that prevents acne flares while addressing acne scarring is a practical addition to clinical practice,” the investigators concluded. “Tazarotene gel 0.1% would be a useful alternative to microneedling in the management of atrophic acne scars. Such a home-based medical management option for acne scarring may decrease physician dependence and health care expenditures for patients with postacne scarring.”
The study authors noted that, as collagen remodeling is a continuous process lasting more than 1 year, a limitation of their study was its short-follow-up of 6 months. However, a strength of the study was its use of validated acne scar severity scoring tools as well as patient and physician assessment of scar improvement in the outcome assessments.
The authors had no disclosures to report.
SOURCE: Afra TP et al. JAMA Facial Plast Surg. 2018 Nov 15. doi: 10.1001/jamafacial.2018.1404.
FROM JAMA FACIAL PLASTIC SURGERY
Key clinical point: The topical retinoid tazarotene could be a home-based option for treating atrophic acne scarring.
Major finding: Improvements in acne scarring were similar with microneedling and nightly applications of tazarotene gel 0.1% after 6 months.
Study details: A prospective, observer-blinded, split-face, randomized, clinical trial involving 34 patients with grade 2-4 facial atrophic postacne scars.
Disclosures: The authors had no disclosures to report.
Source: Afra TP et al. JAMA Facial Plast Surg. 2018 Nov 15. doi: 10.1001/jamafacial.2018.1404.
Symptomatic hyperuricemia may respond to urate-lowering therapy
Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.
, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.
Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.
The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”
Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.
The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.
Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.
No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).
In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).
The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).
When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.
However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.
In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.
The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.
“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”
No disclosures were declared.
SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.
, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.
Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.
The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”
Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.
The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.
Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.
No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).
In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).
The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).
When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.
However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.
In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.
The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.
“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”
No disclosures were declared.
SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.
, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.
Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.
The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”
Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.
The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.
Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.
No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).
In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).
The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).
When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.
However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.
In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.
The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.
“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”
No disclosures were declared.
SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point: Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate (MSU) deposition within joints that is responsive to urate-lowering therapy.
Major finding: Persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to ultrasound.
Study details: Case-control study involving 16 hyperuricemic individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria.
Disclosures: No disclosures were declared.
Source: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
Careful follow-up is key in lupus psychosis
Psychosis, a rare manifestation of systemic lupus erythematosus (SLE), generally appears early in the disease course. But treatment can lead to good outcomes for most patients with careful follow-up, according to a large international study.
The findings “confirm and expand upon the results of previous cross-sectional and historical studies of psychosis in SLE,” John G. Hanly, MD, and his associates wrote in Arthritis & Rheumatology.
The prospective study involved 1,826 patients enrolled in the Systemic Lupus International Collaborating Clinics (SLICC) network who were seen at 31 centers across 10 countries, including the United States and Canada.
Patients were followed for an average of 7.4 years, the majority were women (88.8%), almost half the cohort were white (48.8%), and the mean age was 35.1 years, reported Dr. Hanly, of Dalhousie University, Halifax, N.S., and his associates.
The researchers used the American College of Rheumatology definition of psychosis: delusions or hallucinations without insight; (ii) causing clinical distress or impairment in social, occupational or other relevant areas of functioning; (iii) disturbance should not occur exclusively during delirium; (iv) not better accounted for by another mental disorder.
During study follow-up, 28 patients experienced 31 psychotic events (1.53%); 26 of these patients had one event, one patient had two, and one had three events, Dr. Hanly and his associates said.
Using two attribution models, the investigators found that most psychotic events were directly attributed to SLE, and (80%) had their first episode either in the year prior to or within 3 years following a diagnosis of SLE.
The factors positively associated with psychosis on multivariate analysis were African ancestry (hazard ratio, 4.59; 95% confidence interval, 1.79-11.76), previous SLE neuropsychiatric events (HR, 3.59; 95% CI, 1.16-11.14), male sex (HR 3, 95% CI, 1.20-7.50), and younger age at the time of SLE diagnosis (per 10 years, HR, 1.45; 95% CI. 1.01-2.07).
More than 80% of the psychotic events had resolved by the second annual assessment after onset of the event, the investigators reported.
In terms of impact on quality of life, all subscales of the 36-Item Short-Form Health Survey (SF-36) were negatively affected in patients with lupus psychosis.
However, the investigators said.
“Psychosis is an infrequent manifestation of [neuropsychiatric SLE]. Generally, it occurs early after SLE onset and has a significant negative impact on health status,” they concluded. “As determined by patient and physician report, the short- and long-term outlook is good for most patients, though careful follow-up is required.”
Dr. Hanly disclosed grant support from the Canadian Institutes of Health. His associates reported financial support from several entities, including the Basque Government, the Danish Rheumatism Association, the Hopkins Lupus Cohort, and the National Institute for Health Research/Wellcome Trust Birmingham Clinical Research Facility.
SOURCE: Hanly JG et al. Arthritis Rheumatol. 2018. doi: 10.1002/art.40764.
Psychosis, a rare manifestation of systemic lupus erythematosus (SLE), generally appears early in the disease course. But treatment can lead to good outcomes for most patients with careful follow-up, according to a large international study.
The findings “confirm and expand upon the results of previous cross-sectional and historical studies of psychosis in SLE,” John G. Hanly, MD, and his associates wrote in Arthritis & Rheumatology.
The prospective study involved 1,826 patients enrolled in the Systemic Lupus International Collaborating Clinics (SLICC) network who were seen at 31 centers across 10 countries, including the United States and Canada.
Patients were followed for an average of 7.4 years, the majority were women (88.8%), almost half the cohort were white (48.8%), and the mean age was 35.1 years, reported Dr. Hanly, of Dalhousie University, Halifax, N.S., and his associates.
The researchers used the American College of Rheumatology definition of psychosis: delusions or hallucinations without insight; (ii) causing clinical distress or impairment in social, occupational or other relevant areas of functioning; (iii) disturbance should not occur exclusively during delirium; (iv) not better accounted for by another mental disorder.
During study follow-up, 28 patients experienced 31 psychotic events (1.53%); 26 of these patients had one event, one patient had two, and one had three events, Dr. Hanly and his associates said.
Using two attribution models, the investigators found that most psychotic events were directly attributed to SLE, and (80%) had their first episode either in the year prior to or within 3 years following a diagnosis of SLE.
The factors positively associated with psychosis on multivariate analysis were African ancestry (hazard ratio, 4.59; 95% confidence interval, 1.79-11.76), previous SLE neuropsychiatric events (HR, 3.59; 95% CI, 1.16-11.14), male sex (HR 3, 95% CI, 1.20-7.50), and younger age at the time of SLE diagnosis (per 10 years, HR, 1.45; 95% CI. 1.01-2.07).
More than 80% of the psychotic events had resolved by the second annual assessment after onset of the event, the investigators reported.
In terms of impact on quality of life, all subscales of the 36-Item Short-Form Health Survey (SF-36) were negatively affected in patients with lupus psychosis.
However, the investigators said.
“Psychosis is an infrequent manifestation of [neuropsychiatric SLE]. Generally, it occurs early after SLE onset and has a significant negative impact on health status,” they concluded. “As determined by patient and physician report, the short- and long-term outlook is good for most patients, though careful follow-up is required.”
Dr. Hanly disclosed grant support from the Canadian Institutes of Health. His associates reported financial support from several entities, including the Basque Government, the Danish Rheumatism Association, the Hopkins Lupus Cohort, and the National Institute for Health Research/Wellcome Trust Birmingham Clinical Research Facility.
SOURCE: Hanly JG et al. Arthritis Rheumatol. 2018. doi: 10.1002/art.40764.
Psychosis, a rare manifestation of systemic lupus erythematosus (SLE), generally appears early in the disease course. But treatment can lead to good outcomes for most patients with careful follow-up, according to a large international study.
The findings “confirm and expand upon the results of previous cross-sectional and historical studies of psychosis in SLE,” John G. Hanly, MD, and his associates wrote in Arthritis & Rheumatology.
The prospective study involved 1,826 patients enrolled in the Systemic Lupus International Collaborating Clinics (SLICC) network who were seen at 31 centers across 10 countries, including the United States and Canada.
Patients were followed for an average of 7.4 years, the majority were women (88.8%), almost half the cohort were white (48.8%), and the mean age was 35.1 years, reported Dr. Hanly, of Dalhousie University, Halifax, N.S., and his associates.
The researchers used the American College of Rheumatology definition of psychosis: delusions or hallucinations without insight; (ii) causing clinical distress or impairment in social, occupational or other relevant areas of functioning; (iii) disturbance should not occur exclusively during delirium; (iv) not better accounted for by another mental disorder.
During study follow-up, 28 patients experienced 31 psychotic events (1.53%); 26 of these patients had one event, one patient had two, and one had three events, Dr. Hanly and his associates said.
Using two attribution models, the investigators found that most psychotic events were directly attributed to SLE, and (80%) had their first episode either in the year prior to or within 3 years following a diagnosis of SLE.
The factors positively associated with psychosis on multivariate analysis were African ancestry (hazard ratio, 4.59; 95% confidence interval, 1.79-11.76), previous SLE neuropsychiatric events (HR, 3.59; 95% CI, 1.16-11.14), male sex (HR 3, 95% CI, 1.20-7.50), and younger age at the time of SLE diagnosis (per 10 years, HR, 1.45; 95% CI. 1.01-2.07).
More than 80% of the psychotic events had resolved by the second annual assessment after onset of the event, the investigators reported.
In terms of impact on quality of life, all subscales of the 36-Item Short-Form Health Survey (SF-36) were negatively affected in patients with lupus psychosis.
However, the investigators said.
“Psychosis is an infrequent manifestation of [neuropsychiatric SLE]. Generally, it occurs early after SLE onset and has a significant negative impact on health status,” they concluded. “As determined by patient and physician report, the short- and long-term outlook is good for most patients, though careful follow-up is required.”
Dr. Hanly disclosed grant support from the Canadian Institutes of Health. His associates reported financial support from several entities, including the Basque Government, the Danish Rheumatism Association, the Hopkins Lupus Cohort, and the National Institute for Health Research/Wellcome Trust Birmingham Clinical Research Facility.
SOURCE: Hanly JG et al. Arthritis Rheumatol. 2018. doi: 10.1002/art.40764.
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point: Psychosis, a rare manifestation of systemic lupus erythematosus, is treatable with good short- and long-term outcomes.
Major finding: Twenty-eight patients experienced 31 psychotic events (1.53%); 80% had their first episode either in the year prior to or within 3 years of an SLE diagnosis.
Study details: Prospective study involving 1,826 patients from the Systemic Lupus International Collaborating Clinics network seen at 31 centers across 10 countries.
Disclosures: Dr. Hanly disclosed grant support from the Canadian Institutes of Health. His associates reported financial support from several entities, including the Basque Government, the Danish Rheumatism Association, the Hopkins Lupus Cohort, and the National Institute for Health Research/Wellcome Trust Birmingham Clinical Research Facility.Source: Hanly JG et al. Arthritis Rheumatol. 2018. doi: 10.1002/art.40764.
Adjunctive testosterone may reduce depressive symptoms in men
Testosterone treatment has potential as an adjunct therapy for men with depressive disorders, a meta-analysis has suggested. However, more research is needed.
“This meta-analysis provides important new evidence that testosterone treatment may also be effective and efficacious for eugonadal and older men when higher testosterone dosages are administered,” Andreas Walther, PhD, and his coauthors wrote Nov. 14 in JAMA Psychiatry. However, they noted that safety monitoring in testosterone treatment trials remained important because of an absence of sufficiently powered, long-term studies to assess the increased risk of adverse events with treatment.
The link between testosterone and depression has been debated extensively because testosterone is a neuroactive steroid hormone known to influence mood and appetitive behavior, Dr. Walther and his coauthors wrote. Although testosterone treatment for various disorders in hypogonadal men has been backed by evidence, the results of randomized, placebo-controlled clinical trials for its use in depression have been inconsistent. Indeed, testosterone treatment was currently not recommended in national or international guidelines because of an “prevailing uncertainty about its efficacy, age criteria, dosage, ideal duration and method of application,” wrote Dr. Walther, of the department of biological psychology at Technische Universität Dresden (Germany).
For the current review, the researchers identified 27 randomized, controlled trials altogether including 1,890 men who were receiving testosterone treatment and had reported depressive symptoms on validated depression scales.
Results showed evidence for a moderate antidepressant association of testosterone treatment, compared with placebo (Hedges g, 0.21; 95% confidence interval, 0.10-0.32), and an efficacy odds ratio of 2.30 (95% CI, 1.30-4.06). According to the researchers, based on reference ranges for depressive symptoms, “The National Institute for Health and Care Excellence guidelines on depression suggest a reduction of 3.0 and 2.0 points on BDI scores to be clinically significant for normal depression and treatment-resistant depression, respectively,” they wrote.
Testosterone treatment also showed an efficacy OR of 2.30, a finding that the authors said suggested the “potential of testosterone treatment as adjunct therapy for men with depressive disorders.”
They said the results suggested that better treatment response might require higher doses but acknowledged that the finding required replication.
In addition, Dr. Walther and his coauthors found acceptability of testosterone treatment was high, with an OR of 0.79 for testosterone treatment–related loss to follow-up, compared with placebo. Remarkably, they added, initial testosterone status did not moderate the effects of testosterone treatment on depressive symptoms.
“Large, preregistered RCTs of good quality investigating testosterone treatment’s effect in men on depression as the primary outcome” are needed, they concluded.
Dr. Walther and his coauthors cited a few limitations, including the low number of randomized, controlled trials addressing the effects of testosterone treatment in men who were depressed but otherwise healthy.
No conflicts of interest were reported.
SOURCE: Walther A et al. JAMA Psychiatry. 2018 14 Nov. doi: 10.1001/jamapsychiatry.2018.2734.
The role of testosterone in the pathophysiology and treatment of depressive disorders in men is controversial. The meta-analysis by Walther et al. is well performed and adds to the body of evidence suggesting that testosterone treatment can lead to small improvements in men with depressive symptoms.
However, it is uncertain whether these improvements are clinically meaningful. The data should not be interpreted as testosterone treatment leads to remission or enhances response to antidepressant treatment in this population. In short, the current meta-analysis suggests testosterone replacement may enhance mood among nondepressed hypogonadal men. It is worth noting that the long-term safety of testosterone treatment remains unknown. Until more research is available, clinicians should continue to follow the Endocrine Society guideline for testosterone replacement therapy of androgen-deficient men. The data do not currently support the use of testosterone therapy, particularly in supraphysiologic doses, for the treatment of depressive disorders in men.
Shalender Bhasin, MD, is affiliated with the Brigham and Women’s Hospital in Boston, and Stuart Seidman, MD, is affiliated with Columbia University, New York. These comments are taken from an accompanying editorial (JAMA Psychiatry. 2018 Nov 14. doi: 10.1001/jamapsychiatry.2018.2661). Dr. Bhasin reported receiving research grants from several sources, and Dr. Seidman reported no disclosures.
The role of testosterone in the pathophysiology and treatment of depressive disorders in men is controversial. The meta-analysis by Walther et al. is well performed and adds to the body of evidence suggesting that testosterone treatment can lead to small improvements in men with depressive symptoms.
However, it is uncertain whether these improvements are clinically meaningful. The data should not be interpreted as testosterone treatment leads to remission or enhances response to antidepressant treatment in this population. In short, the current meta-analysis suggests testosterone replacement may enhance mood among nondepressed hypogonadal men. It is worth noting that the long-term safety of testosterone treatment remains unknown. Until more research is available, clinicians should continue to follow the Endocrine Society guideline for testosterone replacement therapy of androgen-deficient men. The data do not currently support the use of testosterone therapy, particularly in supraphysiologic doses, for the treatment of depressive disorders in men.
Shalender Bhasin, MD, is affiliated with the Brigham and Women’s Hospital in Boston, and Stuart Seidman, MD, is affiliated with Columbia University, New York. These comments are taken from an accompanying editorial (JAMA Psychiatry. 2018 Nov 14. doi: 10.1001/jamapsychiatry.2018.2661). Dr. Bhasin reported receiving research grants from several sources, and Dr. Seidman reported no disclosures.
The role of testosterone in the pathophysiology and treatment of depressive disorders in men is controversial. The meta-analysis by Walther et al. is well performed and adds to the body of evidence suggesting that testosterone treatment can lead to small improvements in men with depressive symptoms.
However, it is uncertain whether these improvements are clinically meaningful. The data should not be interpreted as testosterone treatment leads to remission or enhances response to antidepressant treatment in this population. In short, the current meta-analysis suggests testosterone replacement may enhance mood among nondepressed hypogonadal men. It is worth noting that the long-term safety of testosterone treatment remains unknown. Until more research is available, clinicians should continue to follow the Endocrine Society guideline for testosterone replacement therapy of androgen-deficient men. The data do not currently support the use of testosterone therapy, particularly in supraphysiologic doses, for the treatment of depressive disorders in men.
Shalender Bhasin, MD, is affiliated with the Brigham and Women’s Hospital in Boston, and Stuart Seidman, MD, is affiliated with Columbia University, New York. These comments are taken from an accompanying editorial (JAMA Psychiatry. 2018 Nov 14. doi: 10.1001/jamapsychiatry.2018.2661). Dr. Bhasin reported receiving research grants from several sources, and Dr. Seidman reported no disclosures.
Testosterone treatment has potential as an adjunct therapy for men with depressive disorders, a meta-analysis has suggested. However, more research is needed.
“This meta-analysis provides important new evidence that testosterone treatment may also be effective and efficacious for eugonadal and older men when higher testosterone dosages are administered,” Andreas Walther, PhD, and his coauthors wrote Nov. 14 in JAMA Psychiatry. However, they noted that safety monitoring in testosterone treatment trials remained important because of an absence of sufficiently powered, long-term studies to assess the increased risk of adverse events with treatment.
The link between testosterone and depression has been debated extensively because testosterone is a neuroactive steroid hormone known to influence mood and appetitive behavior, Dr. Walther and his coauthors wrote. Although testosterone treatment for various disorders in hypogonadal men has been backed by evidence, the results of randomized, placebo-controlled clinical trials for its use in depression have been inconsistent. Indeed, testosterone treatment was currently not recommended in national or international guidelines because of an “prevailing uncertainty about its efficacy, age criteria, dosage, ideal duration and method of application,” wrote Dr. Walther, of the department of biological psychology at Technische Universität Dresden (Germany).
For the current review, the researchers identified 27 randomized, controlled trials altogether including 1,890 men who were receiving testosterone treatment and had reported depressive symptoms on validated depression scales.
Results showed evidence for a moderate antidepressant association of testosterone treatment, compared with placebo (Hedges g, 0.21; 95% confidence interval, 0.10-0.32), and an efficacy odds ratio of 2.30 (95% CI, 1.30-4.06). According to the researchers, based on reference ranges for depressive symptoms, “The National Institute for Health and Care Excellence guidelines on depression suggest a reduction of 3.0 and 2.0 points on BDI scores to be clinically significant for normal depression and treatment-resistant depression, respectively,” they wrote.
Testosterone treatment also showed an efficacy OR of 2.30, a finding that the authors said suggested the “potential of testosterone treatment as adjunct therapy for men with depressive disorders.”
They said the results suggested that better treatment response might require higher doses but acknowledged that the finding required replication.
In addition, Dr. Walther and his coauthors found acceptability of testosterone treatment was high, with an OR of 0.79 for testosterone treatment–related loss to follow-up, compared with placebo. Remarkably, they added, initial testosterone status did not moderate the effects of testosterone treatment on depressive symptoms.
“Large, preregistered RCTs of good quality investigating testosterone treatment’s effect in men on depression as the primary outcome” are needed, they concluded.
Dr. Walther and his coauthors cited a few limitations, including the low number of randomized, controlled trials addressing the effects of testosterone treatment in men who were depressed but otherwise healthy.
No conflicts of interest were reported.
SOURCE: Walther A et al. JAMA Psychiatry. 2018 14 Nov. doi: 10.1001/jamapsychiatry.2018.2734.
Testosterone treatment has potential as an adjunct therapy for men with depressive disorders, a meta-analysis has suggested. However, more research is needed.
“This meta-analysis provides important new evidence that testosterone treatment may also be effective and efficacious for eugonadal and older men when higher testosterone dosages are administered,” Andreas Walther, PhD, and his coauthors wrote Nov. 14 in JAMA Psychiatry. However, they noted that safety monitoring in testosterone treatment trials remained important because of an absence of sufficiently powered, long-term studies to assess the increased risk of adverse events with treatment.
The link between testosterone and depression has been debated extensively because testosterone is a neuroactive steroid hormone known to influence mood and appetitive behavior, Dr. Walther and his coauthors wrote. Although testosterone treatment for various disorders in hypogonadal men has been backed by evidence, the results of randomized, placebo-controlled clinical trials for its use in depression have been inconsistent. Indeed, testosterone treatment was currently not recommended in national or international guidelines because of an “prevailing uncertainty about its efficacy, age criteria, dosage, ideal duration and method of application,” wrote Dr. Walther, of the department of biological psychology at Technische Universität Dresden (Germany).
For the current review, the researchers identified 27 randomized, controlled trials altogether including 1,890 men who were receiving testosterone treatment and had reported depressive symptoms on validated depression scales.
Results showed evidence for a moderate antidepressant association of testosterone treatment, compared with placebo (Hedges g, 0.21; 95% confidence interval, 0.10-0.32), and an efficacy odds ratio of 2.30 (95% CI, 1.30-4.06). According to the researchers, based on reference ranges for depressive symptoms, “The National Institute for Health and Care Excellence guidelines on depression suggest a reduction of 3.0 and 2.0 points on BDI scores to be clinically significant for normal depression and treatment-resistant depression, respectively,” they wrote.
Testosterone treatment also showed an efficacy OR of 2.30, a finding that the authors said suggested the “potential of testosterone treatment as adjunct therapy for men with depressive disorders.”
They said the results suggested that better treatment response might require higher doses but acknowledged that the finding required replication.
In addition, Dr. Walther and his coauthors found acceptability of testosterone treatment was high, with an OR of 0.79 for testosterone treatment–related loss to follow-up, compared with placebo. Remarkably, they added, initial testosterone status did not moderate the effects of testosterone treatment on depressive symptoms.
“Large, preregistered RCTs of good quality investigating testosterone treatment’s effect in men on depression as the primary outcome” are needed, they concluded.
Dr. Walther and his coauthors cited a few limitations, including the low number of randomized, controlled trials addressing the effects of testosterone treatment in men who were depressed but otherwise healthy.
No conflicts of interest were reported.
SOURCE: Walther A et al. JAMA Psychiatry. 2018 14 Nov. doi: 10.1001/jamapsychiatry.2018.2734.
FROM JAMA PSYCHIATRY
Key clinical point: Testosterone appears to be moderately effective in reducing depressive symptoms in men.
Major finding: Testosterone treatment was associated with a significant reduction in depressive symptoms, compared with placebo, with an efficacy of odds ratio of 2.30 (95% confidence interval, 1.30-4.06).
Study details: A systematic review and meta-analysis involving 27 randomized, placebo-controlled trials involving a broad range of men who were treated with testosterone and reported depressive symptoms on validated depression scales.
Disclosures: No conflicts of interest were reported.
Source: Walther A et al. JAMA Psychiatry. 2018 Nov 14. doi: 10.1001/jamapsychiatry.2018.2734.
Facial exercises hastened the effects of botulinum toxin in small study
Performing of the injections by 1 day, a small, randomized study has shown.
The study addressed the lack of data regarding whether exercising treated muscles for several hours after injections helped “to enhance uptake” of botulinum toxin, said Murad Alam, MD, chief of cutaneous and aesthetic surgery and a professor of dermatology at Northwestern University, Chicago, and his coauthors.
“The results of this study suggest that a postinjection facial exercise regimen is a safe and effective method for achieving an earlier onset of clinical effect of botulinum toxin injections,” he and his coauthors concluded. The results were reported in the Journal of the American Academy of Dermatology.
The study enrolled 22 women, aged 27-66 years (mean age, 47 years) who received botulinum toxin injections for forehead and glabella dynamic rhytids. Following the injections, half of the women did the exercises for 4 hours and the other half avoided facial contractions for 4 hours. Exercises included raised motions of the forehead and scowls – such as knitting the brows – in three sets of 40 repetitions separated by 10 minutes, according to a Northwestern University press release. At 7 months, the women came back for treatment, and switched groups.
Two blinded dermatologists rated photos of forehead and glabella dynamic creases at baseline and on days 1,2,3,4,7, and 14 with the 5-point Carruthers’ Forehead Lines Grading Scale and the 4-point Gladys study group rating scale for glabellar frown lines. The women also assessed their own dynamic creases using a 7-point Subject Self-Evaluation Improvement Scale.
By day 3, ratings by dermatologists and patients of glabellar and forehead wrinkles were statistically significantly better for patients who had performed the exercises after the injections. When facial exercises followed the injections, women said they saw noticeable glabellar improvement by day 2 or 3, compared with day 3 or 4 among those who did not do facial exercises after the injections (P = .02).
“A significant advantage in the exercise group was detectable as early as day 3, at which point patients’ self-evaluation wrinkle scores increased by approximately twice as much in exercisers compared to non-exercisers,” the study authors noted.
But by 2 weeks, the effects of treatment were similar in both groups, and the effects of treatment lasted for a similar period of time with or without exercises.
“Expediting the time to noticeable benefit, even by one day, may be clinically significant for some patients,” the authors wrote. Exercises could be recommended only to those patients who need faster results “to avoid needless inconvenience,” they added.
The study was supported by research funds from the department of dermatology at Northwestern University. The authors had no relevant disclosures.
SOURCE: Alam M et al. J Am Acad Dermatol. 2018. doi: 10.1016/j.jaad.2018.10.013.
Performing of the injections by 1 day, a small, randomized study has shown.
The study addressed the lack of data regarding whether exercising treated muscles for several hours after injections helped “to enhance uptake” of botulinum toxin, said Murad Alam, MD, chief of cutaneous and aesthetic surgery and a professor of dermatology at Northwestern University, Chicago, and his coauthors.
“The results of this study suggest that a postinjection facial exercise regimen is a safe and effective method for achieving an earlier onset of clinical effect of botulinum toxin injections,” he and his coauthors concluded. The results were reported in the Journal of the American Academy of Dermatology.
The study enrolled 22 women, aged 27-66 years (mean age, 47 years) who received botulinum toxin injections for forehead and glabella dynamic rhytids. Following the injections, half of the women did the exercises for 4 hours and the other half avoided facial contractions for 4 hours. Exercises included raised motions of the forehead and scowls – such as knitting the brows – in three sets of 40 repetitions separated by 10 minutes, according to a Northwestern University press release. At 7 months, the women came back for treatment, and switched groups.
Two blinded dermatologists rated photos of forehead and glabella dynamic creases at baseline and on days 1,2,3,4,7, and 14 with the 5-point Carruthers’ Forehead Lines Grading Scale and the 4-point Gladys study group rating scale for glabellar frown lines. The women also assessed their own dynamic creases using a 7-point Subject Self-Evaluation Improvement Scale.
By day 3, ratings by dermatologists and patients of glabellar and forehead wrinkles were statistically significantly better for patients who had performed the exercises after the injections. When facial exercises followed the injections, women said they saw noticeable glabellar improvement by day 2 or 3, compared with day 3 or 4 among those who did not do facial exercises after the injections (P = .02).
“A significant advantage in the exercise group was detectable as early as day 3, at which point patients’ self-evaluation wrinkle scores increased by approximately twice as much in exercisers compared to non-exercisers,” the study authors noted.
But by 2 weeks, the effects of treatment were similar in both groups, and the effects of treatment lasted for a similar period of time with or without exercises.
“Expediting the time to noticeable benefit, even by one day, may be clinically significant for some patients,” the authors wrote. Exercises could be recommended only to those patients who need faster results “to avoid needless inconvenience,” they added.
The study was supported by research funds from the department of dermatology at Northwestern University. The authors had no relevant disclosures.
SOURCE: Alam M et al. J Am Acad Dermatol. 2018. doi: 10.1016/j.jaad.2018.10.013.
Performing of the injections by 1 day, a small, randomized study has shown.
The study addressed the lack of data regarding whether exercising treated muscles for several hours after injections helped “to enhance uptake” of botulinum toxin, said Murad Alam, MD, chief of cutaneous and aesthetic surgery and a professor of dermatology at Northwestern University, Chicago, and his coauthors.
“The results of this study suggest that a postinjection facial exercise regimen is a safe and effective method for achieving an earlier onset of clinical effect of botulinum toxin injections,” he and his coauthors concluded. The results were reported in the Journal of the American Academy of Dermatology.
The study enrolled 22 women, aged 27-66 years (mean age, 47 years) who received botulinum toxin injections for forehead and glabella dynamic rhytids. Following the injections, half of the women did the exercises for 4 hours and the other half avoided facial contractions for 4 hours. Exercises included raised motions of the forehead and scowls – such as knitting the brows – in three sets of 40 repetitions separated by 10 minutes, according to a Northwestern University press release. At 7 months, the women came back for treatment, and switched groups.
Two blinded dermatologists rated photos of forehead and glabella dynamic creases at baseline and on days 1,2,3,4,7, and 14 with the 5-point Carruthers’ Forehead Lines Grading Scale and the 4-point Gladys study group rating scale for glabellar frown lines. The women also assessed their own dynamic creases using a 7-point Subject Self-Evaluation Improvement Scale.
By day 3, ratings by dermatologists and patients of glabellar and forehead wrinkles were statistically significantly better for patients who had performed the exercises after the injections. When facial exercises followed the injections, women said they saw noticeable glabellar improvement by day 2 or 3, compared with day 3 or 4 among those who did not do facial exercises after the injections (P = .02).
“A significant advantage in the exercise group was detectable as early as day 3, at which point patients’ self-evaluation wrinkle scores increased by approximately twice as much in exercisers compared to non-exercisers,” the study authors noted.
But by 2 weeks, the effects of treatment were similar in both groups, and the effects of treatment lasted for a similar period of time with or without exercises.
“Expediting the time to noticeable benefit, even by one day, may be clinically significant for some patients,” the authors wrote. Exercises could be recommended only to those patients who need faster results “to avoid needless inconvenience,” they added.
The study was supported by research funds from the department of dermatology at Northwestern University. The authors had no relevant disclosures.
SOURCE: Alam M et al. J Am Acad Dermatol. 2018. doi: 10.1016/j.jaad.2018.10.013.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Key clinical point: Recommending facial muscle exercises after botulinum toxin injections to the forehead is now evidence based.
Major finding: Posttreatment facial exercise after botulinum toxin injections reduced the appearance of forehead wrinkles one day earlier.
Study details: A randomized, crossover clinical trial of 22 women treated with botulinum toxin for dynamic rhytids of the forehead and glabella.
Disclosures: The study was supported by research funds from the department of dermatology at Northwestern University. The authors had no relevant disclosures.
Source: Alam M et al. J Am Acad Dermatol. 2018. doi: 10.1016/j.jaad.2018.10.013.
Lay counseling effective for reducing late-life depression
Counseling delivered by trained lay community members can effectively treat depression and anxiety in older adults in low- and middle-income countries, a study shows.
“The [depression in later life] intervention, is to our knowledge, the first randomized clinical trial of indicated depression prevention in older adults living in a [low- and middle-income country] and as such addresses a previously unmet need in global health,” wrote Amit Dias, MD, and his colleagues. The findings show that the intervention could be a viable prevention option for older people living in those countries, which often lack the resources to provide prevention services for this population.
The study randomized 181 adults aged 60 years and older with subsyndromal depressive symptoms who attended rural and urban primary care clinics in Goa, India, to an intervention arm (n = 91) or to usual care (n = 90), reported Dr. Dias and his colleagues. The intervention arm was delivered by lay counselors (LCs) who were members of the local community, aged over 30 years, and graduates of any nonhealth-related field. The LCs, who received training, had weekly supervision and support from experts in the United States via Skype, reported Dr. Dias, of the department of preventive and social medicine at Goa Medical College in Bambolim, India, and his colleagues.
People in the intervention group also were given assistance with accessing medical and social programs. Six sessions lasting 30-40 minutes were delivered either in the patients’ homes or at a local center over a 6-10 week period.
Patients randomized to the control group received care as usual together with the same outcome assessments as the intervention group. Depressive episodes were measured using the Mini-International Neuropsychiatric Interview.
Results showed that 4.4% of participants in the intervention group had a major depressive episode, compared with 14.4% of those in the usual care group (number needed to treat, 9.95; 95% confidence interval, 5.12-182.43; P = 0.04), Dr. Dias and his colleagues wrote in JAMA Psychiatry. Kaplan-Meier estimates showed that 95.1% of patients in the intervention group were free of depression at 12 months, compared with 87.4% of those in the control arm.
The incidence of depression, as measured by General Health Questionnaire–12 scores, also was lower in the intervention group (12-month mean difference, –1.18; 95% CI, –2.03 to –0.31; P less than .001). The intervention also was associated with lower systolic blood pressure at 12 months (difference, –6.98; 95% CI, –11.96 to –2.01; group x time interaction, P less than 0.001) and a change in body mass index (difference, 0.23; 95% CI, –0.97 to 1.43; P = 0.04).
However, the intervention did not affect measures of functional status or cognition.
The researchers concluded that their findings extend earlier work (Lancet. 2010;376[9758]:2086-95)(Lancet. 2017:389[10065]:176-85), which also showed that LCs could effectively treat prevalent cases of depression and anxiety in primary care practice. “If the success of the [depression in later life] intervention in depression prevention can be replicated in other [low- and middle-income countries], then its utility and scalability would be further supported,” they concluded.
Dr. Dias and his colleagues cited several limitations. One is that people with mild cognitive impairment or dementia were excluded from the study.
The study was supported by grants from the U.S. National Institute of Mental Health. The authors reported no conflicts of interest.
SOURCE: Dias A et al. JAMA Psychiatry. 2018 Nov 7. doi: 10.1001/jamapsychaitry.2018.3048.
Depression occurring later in life is the most common mental health issue in the elderly and has been shown to have a negative impact on comorbidities and contribute to the risk for dementia and mortality. There is no doubt later-life depression poses a significant public health challenge. Low-income countries with limited resources can experience those challenges at a deeper level.
The current study contributes to the existing evidence, which shows that interventions carried out by nonhealth care professionals can be effective for addressing mental health conditions in low-resource settings. In addition, previous studies have shown that task sharing as a method is effective in tackling other health conditions such as HIV, hypertension, and tuberculosis in such settings.
However, it should be noted that, in the current study, the intervention was delivered by workers who received regular support. A logical next step, therefore, would be to examine the efficacy of interventions delivered by public health workers. Organizations that currently provide counseling services should be encouraged to adopt a structured approach demonstrated in the current study.
Jagadisha Thirthalli, MD, Palanimuthu T. Sivakumar, MD, and Bangalore N. Gangadhar, MD, are affiliated with the department of psychiatry at the National Institute of Mental Health and Neurosciences in Bengaluru, India. These comments are taken from an accompanying editorial (JAMA Psychiatry. 2018 Nov 7. doi: 10.1001/jamapsychiatry.2018.2898). No conflicts of interest were reported.
Depression occurring later in life is the most common mental health issue in the elderly and has been shown to have a negative impact on comorbidities and contribute to the risk for dementia and mortality. There is no doubt later-life depression poses a significant public health challenge. Low-income countries with limited resources can experience those challenges at a deeper level.
The current study contributes to the existing evidence, which shows that interventions carried out by nonhealth care professionals can be effective for addressing mental health conditions in low-resource settings. In addition, previous studies have shown that task sharing as a method is effective in tackling other health conditions such as HIV, hypertension, and tuberculosis in such settings.
However, it should be noted that, in the current study, the intervention was delivered by workers who received regular support. A logical next step, therefore, would be to examine the efficacy of interventions delivered by public health workers. Organizations that currently provide counseling services should be encouraged to adopt a structured approach demonstrated in the current study.
Jagadisha Thirthalli, MD, Palanimuthu T. Sivakumar, MD, and Bangalore N. Gangadhar, MD, are affiliated with the department of psychiatry at the National Institute of Mental Health and Neurosciences in Bengaluru, India. These comments are taken from an accompanying editorial (JAMA Psychiatry. 2018 Nov 7. doi: 10.1001/jamapsychiatry.2018.2898). No conflicts of interest were reported.
Depression occurring later in life is the most common mental health issue in the elderly and has been shown to have a negative impact on comorbidities and contribute to the risk for dementia and mortality. There is no doubt later-life depression poses a significant public health challenge. Low-income countries with limited resources can experience those challenges at a deeper level.
The current study contributes to the existing evidence, which shows that interventions carried out by nonhealth care professionals can be effective for addressing mental health conditions in low-resource settings. In addition, previous studies have shown that task sharing as a method is effective in tackling other health conditions such as HIV, hypertension, and tuberculosis in such settings.
However, it should be noted that, in the current study, the intervention was delivered by workers who received regular support. A logical next step, therefore, would be to examine the efficacy of interventions delivered by public health workers. Organizations that currently provide counseling services should be encouraged to adopt a structured approach demonstrated in the current study.
Jagadisha Thirthalli, MD, Palanimuthu T. Sivakumar, MD, and Bangalore N. Gangadhar, MD, are affiliated with the department of psychiatry at the National Institute of Mental Health and Neurosciences in Bengaluru, India. These comments are taken from an accompanying editorial (JAMA Psychiatry. 2018 Nov 7. doi: 10.1001/jamapsychiatry.2018.2898). No conflicts of interest were reported.
Counseling delivered by trained lay community members can effectively treat depression and anxiety in older adults in low- and middle-income countries, a study shows.
“The [depression in later life] intervention, is to our knowledge, the first randomized clinical trial of indicated depression prevention in older adults living in a [low- and middle-income country] and as such addresses a previously unmet need in global health,” wrote Amit Dias, MD, and his colleagues. The findings show that the intervention could be a viable prevention option for older people living in those countries, which often lack the resources to provide prevention services for this population.
The study randomized 181 adults aged 60 years and older with subsyndromal depressive symptoms who attended rural and urban primary care clinics in Goa, India, to an intervention arm (n = 91) or to usual care (n = 90), reported Dr. Dias and his colleagues. The intervention arm was delivered by lay counselors (LCs) who were members of the local community, aged over 30 years, and graduates of any nonhealth-related field. The LCs, who received training, had weekly supervision and support from experts in the United States via Skype, reported Dr. Dias, of the department of preventive and social medicine at Goa Medical College in Bambolim, India, and his colleagues.
People in the intervention group also were given assistance with accessing medical and social programs. Six sessions lasting 30-40 minutes were delivered either in the patients’ homes or at a local center over a 6-10 week period.
Patients randomized to the control group received care as usual together with the same outcome assessments as the intervention group. Depressive episodes were measured using the Mini-International Neuropsychiatric Interview.
Results showed that 4.4% of participants in the intervention group had a major depressive episode, compared with 14.4% of those in the usual care group (number needed to treat, 9.95; 95% confidence interval, 5.12-182.43; P = 0.04), Dr. Dias and his colleagues wrote in JAMA Psychiatry. Kaplan-Meier estimates showed that 95.1% of patients in the intervention group were free of depression at 12 months, compared with 87.4% of those in the control arm.
The incidence of depression, as measured by General Health Questionnaire–12 scores, also was lower in the intervention group (12-month mean difference, –1.18; 95% CI, –2.03 to –0.31; P less than .001). The intervention also was associated with lower systolic blood pressure at 12 months (difference, –6.98; 95% CI, –11.96 to –2.01; group x time interaction, P less than 0.001) and a change in body mass index (difference, 0.23; 95% CI, –0.97 to 1.43; P = 0.04).
However, the intervention did not affect measures of functional status or cognition.
The researchers concluded that their findings extend earlier work (Lancet. 2010;376[9758]:2086-95)(Lancet. 2017:389[10065]:176-85), which also showed that LCs could effectively treat prevalent cases of depression and anxiety in primary care practice. “If the success of the [depression in later life] intervention in depression prevention can be replicated in other [low- and middle-income countries], then its utility and scalability would be further supported,” they concluded.
Dr. Dias and his colleagues cited several limitations. One is that people with mild cognitive impairment or dementia were excluded from the study.
The study was supported by grants from the U.S. National Institute of Mental Health. The authors reported no conflicts of interest.
SOURCE: Dias A et al. JAMA Psychiatry. 2018 Nov 7. doi: 10.1001/jamapsychaitry.2018.3048.
Counseling delivered by trained lay community members can effectively treat depression and anxiety in older adults in low- and middle-income countries, a study shows.
“The [depression in later life] intervention, is to our knowledge, the first randomized clinical trial of indicated depression prevention in older adults living in a [low- and middle-income country] and as such addresses a previously unmet need in global health,” wrote Amit Dias, MD, and his colleagues. The findings show that the intervention could be a viable prevention option for older people living in those countries, which often lack the resources to provide prevention services for this population.
The study randomized 181 adults aged 60 years and older with subsyndromal depressive symptoms who attended rural and urban primary care clinics in Goa, India, to an intervention arm (n = 91) or to usual care (n = 90), reported Dr. Dias and his colleagues. The intervention arm was delivered by lay counselors (LCs) who were members of the local community, aged over 30 years, and graduates of any nonhealth-related field. The LCs, who received training, had weekly supervision and support from experts in the United States via Skype, reported Dr. Dias, of the department of preventive and social medicine at Goa Medical College in Bambolim, India, and his colleagues.
People in the intervention group also were given assistance with accessing medical and social programs. Six sessions lasting 30-40 minutes were delivered either in the patients’ homes or at a local center over a 6-10 week period.
Patients randomized to the control group received care as usual together with the same outcome assessments as the intervention group. Depressive episodes were measured using the Mini-International Neuropsychiatric Interview.
Results showed that 4.4% of participants in the intervention group had a major depressive episode, compared with 14.4% of those in the usual care group (number needed to treat, 9.95; 95% confidence interval, 5.12-182.43; P = 0.04), Dr. Dias and his colleagues wrote in JAMA Psychiatry. Kaplan-Meier estimates showed that 95.1% of patients in the intervention group were free of depression at 12 months, compared with 87.4% of those in the control arm.
The incidence of depression, as measured by General Health Questionnaire–12 scores, also was lower in the intervention group (12-month mean difference, –1.18; 95% CI, –2.03 to –0.31; P less than .001). The intervention also was associated with lower systolic blood pressure at 12 months (difference, –6.98; 95% CI, –11.96 to –2.01; group x time interaction, P less than 0.001) and a change in body mass index (difference, 0.23; 95% CI, –0.97 to 1.43; P = 0.04).
However, the intervention did not affect measures of functional status or cognition.
The researchers concluded that their findings extend earlier work (Lancet. 2010;376[9758]:2086-95)(Lancet. 2017:389[10065]:176-85), which also showed that LCs could effectively treat prevalent cases of depression and anxiety in primary care practice. “If the success of the [depression in later life] intervention in depression prevention can be replicated in other [low- and middle-income countries], then its utility and scalability would be further supported,” they concluded.
Dr. Dias and his colleagues cited several limitations. One is that people with mild cognitive impairment or dementia were excluded from the study.
The study was supported by grants from the U.S. National Institute of Mental Health. The authors reported no conflicts of interest.
SOURCE: Dias A et al. JAMA Psychiatry. 2018 Nov 7. doi: 10.1001/jamapsychaitry.2018.3048.
FROM JAMA PSYCHIATRY
Key clinical point: Lay counseling can be an effective intervention in reducing late-life depression in low- and middle-income countries.
Major finding: More than 4% of those in the intervention group had a major depressive episode, compared with 14.4% of those in the usual care group (number needed to treat, 9.95; 95% confidence interval, 5.12-182.43; P = 0.04).
Study details: Overall, 181 adults aged over 60 years with subsyndromal depressive symptoms who attended a rural and urban primary care clinics in Goa, India, who were randomized to an intervention arm (n = 91) or to usual care (n = 90).
Disclosures: The study was supported by grants from the U.S. National Institute of Mental Health. The authors reported no conflicts of interest.
Source: Dias A et al. JAMA Psychiatry. 2018 Nov 7. doi: 10.1001/jamapsychiatry.2018.3048.
Rate of sling removal 9 years after MUS for SUI over 3%
a British study found.
Ipek Gurol-Urganci, PhD, of the London School of Hygiene and Tropical Medicine, and her coauthors said their study comes as a result of safety concerns around the procedure, which resulted in a suspension of the operation in the United Kingdom.
“There is concern about problems that some women experience following MUS insertion, including pain, dyspareunia, persistent urinary incontinence, and exposure or erosion. However, there is little randomized, clinical trial evidence on these longer-term outcomes,” they wrote in JAMA, noting that an estimated 250,000 MUS operations were performed in 2010 in the United States.
The current study involved 95,057 women in England who underwent an MUS insertion procedure for SUI for the first time in a National Health Service hospital between 2006 and 2015. Overall, 60,194 of the women had a retropubic insertion and 34,863 had a transobturator insertion.
At 9 years after the initial insertion, the mesh was removed in 3.3% of women. The risk of removal was higher for women who had a retropubic insertion (3.6%), compared with those who had a transobturator insertion (2.7%).
“The risk of a removal was about 30% lower if the mesh sling had been inserted via the transobturator route, which may be explained by the removal of transobturator sling being a more complicated procedure,” Dr. Gurol-Urganci and her associates noted.
Mesh sling removal risk decreased with age, with the risk at 4.4% for women aged 18-39 years, compared with 2.1% in women aged 70 years and older at 9 years after insertion.
The authors wrote that the risks of removal and any reoperation (mesh removal and/or reoperation for SUI) were higher among women from a white racial/ethnic background. However, it was not possible to “disentangle explanations” for these possible differences in risk seen with patient characteristics, which ranged from higher morbidity to differences in the reasons for surgery.
Results also showed that the risk of reoperation was 4.5% at 9 years after the initial insertion, and was slightly higher for a transobturator insertion at 5.3%, compared with 4.1% for a retropubic insertion.
The risk of any reoperation, including mesh removal and/or reoperation for SUI, following the initial MUS insertion was 6.9% at 9 years (95% confidence interval, 6.7%-7.1%), but no statistically significant difference was observed between retropubic and transobturator insertion.
“The present results demonstrate that removal and reoperation risks were associated with the insertion route and patient factors,” Dr. Gurol-Urganci and her associates wrote.
“These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence,” they concluded.
The study was supported by a grant from the National Institute for Health Research Health Services and Delivery Research Programme and several of the authors reported receiving National Institute for Health Research research grants. One author reported providing consultancy services to Cambridge Medical Robotics, Femeda, and Astellas.
SOURCE: Gurol-Urganci I et al. JAMA. 2018 Oct 23. doi:10.1001/jama.2018.14997.
a British study found.
Ipek Gurol-Urganci, PhD, of the London School of Hygiene and Tropical Medicine, and her coauthors said their study comes as a result of safety concerns around the procedure, which resulted in a suspension of the operation in the United Kingdom.
“There is concern about problems that some women experience following MUS insertion, including pain, dyspareunia, persistent urinary incontinence, and exposure or erosion. However, there is little randomized, clinical trial evidence on these longer-term outcomes,” they wrote in JAMA, noting that an estimated 250,000 MUS operations were performed in 2010 in the United States.
The current study involved 95,057 women in England who underwent an MUS insertion procedure for SUI for the first time in a National Health Service hospital between 2006 and 2015. Overall, 60,194 of the women had a retropubic insertion and 34,863 had a transobturator insertion.
At 9 years after the initial insertion, the mesh was removed in 3.3% of women. The risk of removal was higher for women who had a retropubic insertion (3.6%), compared with those who had a transobturator insertion (2.7%).
“The risk of a removal was about 30% lower if the mesh sling had been inserted via the transobturator route, which may be explained by the removal of transobturator sling being a more complicated procedure,” Dr. Gurol-Urganci and her associates noted.
Mesh sling removal risk decreased with age, with the risk at 4.4% for women aged 18-39 years, compared with 2.1% in women aged 70 years and older at 9 years after insertion.
The authors wrote that the risks of removal and any reoperation (mesh removal and/or reoperation for SUI) were higher among women from a white racial/ethnic background. However, it was not possible to “disentangle explanations” for these possible differences in risk seen with patient characteristics, which ranged from higher morbidity to differences in the reasons for surgery.
Results also showed that the risk of reoperation was 4.5% at 9 years after the initial insertion, and was slightly higher for a transobturator insertion at 5.3%, compared with 4.1% for a retropubic insertion.
The risk of any reoperation, including mesh removal and/or reoperation for SUI, following the initial MUS insertion was 6.9% at 9 years (95% confidence interval, 6.7%-7.1%), but no statistically significant difference was observed between retropubic and transobturator insertion.
“The present results demonstrate that removal and reoperation risks were associated with the insertion route and patient factors,” Dr. Gurol-Urganci and her associates wrote.
“These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence,” they concluded.
The study was supported by a grant from the National Institute for Health Research Health Services and Delivery Research Programme and several of the authors reported receiving National Institute for Health Research research grants. One author reported providing consultancy services to Cambridge Medical Robotics, Femeda, and Astellas.
SOURCE: Gurol-Urganci I et al. JAMA. 2018 Oct 23. doi:10.1001/jama.2018.14997.
a British study found.
Ipek Gurol-Urganci, PhD, of the London School of Hygiene and Tropical Medicine, and her coauthors said their study comes as a result of safety concerns around the procedure, which resulted in a suspension of the operation in the United Kingdom.
“There is concern about problems that some women experience following MUS insertion, including pain, dyspareunia, persistent urinary incontinence, and exposure or erosion. However, there is little randomized, clinical trial evidence on these longer-term outcomes,” they wrote in JAMA, noting that an estimated 250,000 MUS operations were performed in 2010 in the United States.
The current study involved 95,057 women in England who underwent an MUS insertion procedure for SUI for the first time in a National Health Service hospital between 2006 and 2015. Overall, 60,194 of the women had a retropubic insertion and 34,863 had a transobturator insertion.
At 9 years after the initial insertion, the mesh was removed in 3.3% of women. The risk of removal was higher for women who had a retropubic insertion (3.6%), compared with those who had a transobturator insertion (2.7%).
“The risk of a removal was about 30% lower if the mesh sling had been inserted via the transobturator route, which may be explained by the removal of transobturator sling being a more complicated procedure,” Dr. Gurol-Urganci and her associates noted.
Mesh sling removal risk decreased with age, with the risk at 4.4% for women aged 18-39 years, compared with 2.1% in women aged 70 years and older at 9 years after insertion.
The authors wrote that the risks of removal and any reoperation (mesh removal and/or reoperation for SUI) were higher among women from a white racial/ethnic background. However, it was not possible to “disentangle explanations” for these possible differences in risk seen with patient characteristics, which ranged from higher morbidity to differences in the reasons for surgery.
Results also showed that the risk of reoperation was 4.5% at 9 years after the initial insertion, and was slightly higher for a transobturator insertion at 5.3%, compared with 4.1% for a retropubic insertion.
The risk of any reoperation, including mesh removal and/or reoperation for SUI, following the initial MUS insertion was 6.9% at 9 years (95% confidence interval, 6.7%-7.1%), but no statistically significant difference was observed between retropubic and transobturator insertion.
“The present results demonstrate that removal and reoperation risks were associated with the insertion route and patient factors,” Dr. Gurol-Urganci and her associates wrote.
“These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence,” they concluded.
The study was supported by a grant from the National Institute for Health Research Health Services and Delivery Research Programme and several of the authors reported receiving National Institute for Health Research research grants. One author reported providing consultancy services to Cambridge Medical Robotics, Femeda, and Astellas.
SOURCE: Gurol-Urganci I et al. JAMA. 2018 Oct 23. doi:10.1001/jama.2018.14997.
FROM JAMA
Key clinical point: The findings of this study may inform decision making when choosing treatment for stress urinary incontinence.
Major finding: Within 9 years of a mesh insertion for stress urinary incontinence, the rate of sling removal was 3.3% and the rate of reoperation was 4.5%.
Study details: A prospective, observational study examining long-term mesh removal and reoperations in over 95,000 women who underwent midurethral mesh operations for stress urinary incontinence between 2006 and 2015.
Disclosures: The study was supported by a grant from the National Institute for Health Research Health Services and Delivery Research Programme and several of the authors reported receiving National Institute for Health Research research grants. One author reported providing consultancy services to Cambridge Medical Robotics, Femeda, and Astellas Pharma.
Source: Gurol-Urganci I et al. JAMA. 2018 Oct 23. doi:10.1001/jama.2018.14997.