Federal Practitioner

The U.S. Food and Drug Administration (FDA) has approved a combination pill containing celecoxib and tramadol (Seglentis) for the treatment of adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.

Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.

“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.

Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.

“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.

The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.

Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.

Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.

Full prescribing information is available online.

A version of this article was first published on Medscape.com.

The U.S. Food and Drug Administration (FDA) has approved a combination pill containing celecoxib and tramadol (Seglentis) for the treatment of adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.

Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.

“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.

Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.

“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.

The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.

Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.

Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.

Full prescribing information is available online.

A version of this article was first published on Medscape.com.

The U.S. Food and Drug Administration (FDA) has approved a combination pill containing celecoxib and tramadol (Seglentis) for the treatment of adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.

Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.

“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.

Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.

“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.

The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.

Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.

Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.

Full prescribing information is available online.

A version of this article was first published on Medscape.com.

In patients with unresectable or metastatic hepatocellular carcinoma (HCC), donafenib was superior to sorafenib in improving overall survival (OS), according to a head-to-head study published in the Journal of Clinical Oncology. This novel multikinase inhibitor and deuterated sorafenib derivative also showed improved safety and tolerability, rendering it a potential first-line monotherapy for patients with advanced HCC.

“An improvement in the pharmacotherapy of advanced HCC remains a clinical need,” wrote Feng Bi, MD, of Sichuan University, in Chengdu, China, and colleagues.

Liver cancer is one of the most common cancers worldwide, with HCC representing 90% of liver malignancies. HCC most commonly occurs in people with liver disease, particularly in those with chronic hepatitis B and C and although rare, HCC is the ninth leading cause of cancer deaths in the United States. Most patients are diagnosed at the advanced stage with a median survival of 6-8 months. Sorafenib, the standard first-line therapy for advanced HCC, has demonstrated the median OS of 10.7 to 14.7 months. No other monotherapy has shown a significant improvement in OS, compared with sorafenib. Donafenib has shown favorable efficacy and safety in phase 1 studies.

This phase 2-3 trial evaluated the efficacy and safety of first-line donafenib, compared with sorafenib, in 668 Chinese patients with advanced HCC. Patients were randomly assigned to receive twice-daily oral donafenib 0.2 g or sorafenib 0.4 g until intolerable toxicity or disease progression. The primary end point was OS, tested for noninferiority and superiority. 

Compared with sorafenib, donafenib significantly prolonged OS, 10.3 and 12.1 months, respectively, (hazard ratio, 95% confidence interval, 0.699-0.988; 0.83; P = .0245), and the superiority criteria for OS were met. Donafenib also presented improved safety and tolerability. Common drug-related adverse events, such as hand-foot skin reactions and diarrhea, and drug-related grade 3 or higher adverse events, occurred in fewer patients receiving donafenib than sorafenib, (38% vs. 50%; P = .0018). The authors noted that this lower frequency in adverse events with donafenib “contributed to improved patient adherence and decreased levels of drug interruption and discontinuation.”

Donafenib is a novel, oral, small-molecule, multikinase inhibitor that suppresses tumor cell proliferation and angiogenesis by inhibiting vascular endothelial growth factor receptors and platelet-derived growth factor receptors, and Raf kinases. It is a derivative of sorafenib and in June 2021, it was approved in China as a treatment for unresectable hepatocellular carcinoma for patients who have not received systemic treatment. It is not yet available in the United States.

“This pivotal head-to-head comparison study is the first to demonstrate noninferiority and superiority of a monotherapy, donafenib, with statistically significant extension in OS over sorafenib for first-line treatment of advanced HCC,” the authors wrote. “Compared with international trials, patients in this study presented with more severe baseline disease states, further emphasizing the positive response observed with donafenib.”

Another study, published in the same issue of the Journal of Clinical Oncology, compared tremelimumab and durvalumab as monotherapies and in combination for patients with unresectable HCC, found that use a single priming dose of tremelimumab combined with durvalumab showed the best benefit-risk profile.

In patients with unresectable or metastatic hepatocellular carcinoma (HCC), donafenib was superior to sorafenib in improving overall survival (OS), according to a head-to-head study published in the Journal of Clinical Oncology. This novel multikinase inhibitor and deuterated sorafenib derivative also showed improved safety and tolerability, rendering it a potential first-line monotherapy for patients with advanced HCC.

“An improvement in the pharmacotherapy of advanced HCC remains a clinical need,” wrote Feng Bi, MD, of Sichuan University, in Chengdu, China, and colleagues.

Liver cancer is one of the most common cancers worldwide, with HCC representing 90% of liver malignancies. HCC most commonly occurs in people with liver disease, particularly in those with chronic hepatitis B and C and although rare, HCC is the ninth leading cause of cancer deaths in the United States. Most patients are diagnosed at the advanced stage with a median survival of 6-8 months. Sorafenib, the standard first-line therapy for advanced HCC, has demonstrated the median OS of 10.7 to 14.7 months. No other monotherapy has shown a significant improvement in OS, compared with sorafenib. Donafenib has shown favorable efficacy and safety in phase 1 studies.

This phase 2-3 trial evaluated the efficacy and safety of first-line donafenib, compared with sorafenib, in 668 Chinese patients with advanced HCC. Patients were randomly assigned to receive twice-daily oral donafenib 0.2 g or sorafenib 0.4 g until intolerable toxicity or disease progression. The primary end point was OS, tested for noninferiority and superiority. 

Compared with sorafenib, donafenib significantly prolonged OS, 10.3 and 12.1 months, respectively, (hazard ratio, 95% confidence interval, 0.699-0.988; 0.83; P = .0245), and the superiority criteria for OS were met. Donafenib also presented improved safety and tolerability. Common drug-related adverse events, such as hand-foot skin reactions and diarrhea, and drug-related grade 3 or higher adverse events, occurred in fewer patients receiving donafenib than sorafenib, (38% vs. 50%; P = .0018). The authors noted that this lower frequency in adverse events with donafenib “contributed to improved patient adherence and decreased levels of drug interruption and discontinuation.”

Donafenib is a novel, oral, small-molecule, multikinase inhibitor that suppresses tumor cell proliferation and angiogenesis by inhibiting vascular endothelial growth factor receptors and platelet-derived growth factor receptors, and Raf kinases. It is a derivative of sorafenib and in June 2021, it was approved in China as a treatment for unresectable hepatocellular carcinoma for patients who have not received systemic treatment. It is not yet available in the United States.

“This pivotal head-to-head comparison study is the first to demonstrate noninferiority and superiority of a monotherapy, donafenib, with statistically significant extension in OS over sorafenib for first-line treatment of advanced HCC,” the authors wrote. “Compared with international trials, patients in this study presented with more severe baseline disease states, further emphasizing the positive response observed with donafenib.”

Another study, published in the same issue of the Journal of Clinical Oncology, compared tremelimumab and durvalumab as monotherapies and in combination for patients with unresectable HCC, found that use a single priming dose of tremelimumab combined with durvalumab showed the best benefit-risk profile.

In patients with unresectable or metastatic hepatocellular carcinoma (HCC), donafenib was superior to sorafenib in improving overall survival (OS), according to a head-to-head study published in the Journal of Clinical Oncology. This novel multikinase inhibitor and deuterated sorafenib derivative also showed improved safety and tolerability, rendering it a potential first-line monotherapy for patients with advanced HCC.

“An improvement in the pharmacotherapy of advanced HCC remains a clinical need,” wrote Feng Bi, MD, of Sichuan University, in Chengdu, China, and colleagues.

Liver cancer is one of the most common cancers worldwide, with HCC representing 90% of liver malignancies. HCC most commonly occurs in people with liver disease, particularly in those with chronic hepatitis B and C and although rare, HCC is the ninth leading cause of cancer deaths in the United States. Most patients are diagnosed at the advanced stage with a median survival of 6-8 months. Sorafenib, the standard first-line therapy for advanced HCC, has demonstrated the median OS of 10.7 to 14.7 months. No other monotherapy has shown a significant improvement in OS, compared with sorafenib. Donafenib has shown favorable efficacy and safety in phase 1 studies.

This phase 2-3 trial evaluated the efficacy and safety of first-line donafenib, compared with sorafenib, in 668 Chinese patients with advanced HCC. Patients were randomly assigned to receive twice-daily oral donafenib 0.2 g or sorafenib 0.4 g until intolerable toxicity or disease progression. The primary end point was OS, tested for noninferiority and superiority. 

Compared with sorafenib, donafenib significantly prolonged OS, 10.3 and 12.1 months, respectively, (hazard ratio, 95% confidence interval, 0.699-0.988; 0.83; P = .0245), and the superiority criteria for OS were met. Donafenib also presented improved safety and tolerability. Common drug-related adverse events, such as hand-foot skin reactions and diarrhea, and drug-related grade 3 or higher adverse events, occurred in fewer patients receiving donafenib than sorafenib, (38% vs. 50%; P = .0018). The authors noted that this lower frequency in adverse events with donafenib “contributed to improved patient adherence and decreased levels of drug interruption and discontinuation.”

Donafenib is a novel, oral, small-molecule, multikinase inhibitor that suppresses tumor cell proliferation and angiogenesis by inhibiting vascular endothelial growth factor receptors and platelet-derived growth factor receptors, and Raf kinases. It is a derivative of sorafenib and in June 2021, it was approved in China as a treatment for unresectable hepatocellular carcinoma for patients who have not received systemic treatment. It is not yet available in the United States.

“This pivotal head-to-head comparison study is the first to demonstrate noninferiority and superiority of a monotherapy, donafenib, with statistically significant extension in OS over sorafenib for first-line treatment of advanced HCC,” the authors wrote. “Compared with international trials, patients in this study presented with more severe baseline disease states, further emphasizing the positive response observed with donafenib.”

Another study, published in the same issue of the Journal of Clinical Oncology, compared tremelimumab and durvalumab as monotherapies and in combination for patients with unresectable HCC, found that use a single priming dose of tremelimumab combined with durvalumab showed the best benefit-risk profile.

Tramadol is increasingly used to manage chronic noncancer pain, but as compared with opioids, it appears to be linked to a higher risk for adverse outcomes, according to new data.

Among a cohort of patients who received a prescription for either tramadol or codeine for orthopedic-related pain, tramadol was significantly associated with a higher risk of mortality, cardiovascular events, and fractures.

However, there was no significant difference in the risk of falls, delirium, constipation, opioid abuse/dependence, or sleep disorders between the two drugs.

“However, this is a retrospective cohort study, and despite it providing information that would otherwise be impossible to gather – such as from randomized controlled trials – clinicians should not solely base their decision on this study,” cautioned lead author Carlen Reyes, MD, PhD, of the Institut Universitari d’Investigació en Atenció Primària (IDIAP Jordi Gol), Barcelona.

Dr. Reyes noted that the intake of tramadol and codeine was analyzed using the number of “packages” that were dispensed, as an approximation of the real intake. “Logically we could think that the more packages dispensed of one drug, the more dose the patient is taking, but this is not always true given the availability of different doses commercialized of tramadol and different doses prescribed,” she said. “Given that we did not account for the real dose prescribed, we can only suspect an increased risk of these outcomes and reinforce the need for further prospective studies with more specific dose-response analysis comparing tramadol and codeine.”

The paper was published Oct. 19 in JAMA.

Tramadol has been considered to be a relatively safe opioid and was even strongly recommended by the American Academy of Orthopaedic Surgeons for patients experiencing symptomatic knee osteoarthritis. The authors point out that studies looking at opioid use from 2019 to 2020 show that tramadol was the most prescribed opioid in England, the Netherlands, and Spain.

In the United States, the age-adjusted rate of drug overdose deaths from synthetic opioids rose from 1.0 per 100 000 in 2013 to 11.4 in 2019. Most of these deaths were attributable to fentanyl but some were also related to tramadol.

But despite its wide use in managing chronic noncancer pain, results of recent studies suggest adverse outcomes as compared with other agents. Last year, one study found that older patients who received tramadol had a significant increase in the risk of hip fracture vs. those using NSAIDs or codeine. Another study, also published in 2020, showed that patients with osteoarthritis who were treated with tramadol had a 20%-50% higher risk of dying during the first year of treatment than did patients who were treated with NSAIDs.

In the current paper, Dr. Reyes and colleagues evaluated the association of tramadol with mortality and other adverse clinical outcomes in outpatient settings, compared with codeine.

They conducted a retrospective, population-based, propensity score–matched cohort study using a primary care database that routinely collects medical records and pharmacy dispensations for more than 80% of the population of Catalonia, Spain. The cohort included people 18 years or older who had been prescribed tramadol or codeine from 2007 to 2017 and were followed up to Dec. 31, 2017.

After propensity score matching, the final analysis included 368,960 participants: 184,480 in the tramadol arm and 184,480 in the codeine arm.

The mean age of patients was 52.7 years in the tramadol arm and 53.5 years in the codeine arm, and the prevalence of cancer was 3.2% and 3.3%, respectively. The most common diagnoses in this cohort were back pain (47.5% vs. 48.5%), neck/shoulder pain (28.6% vs. 29.5%), and osteoarthritis (15.3% vs. 15.5%). The most commonly used drugs were ibuprofen (34.4% vs. 34.3%) and paracetamol/acetaminophen (37.1% vs. 36.8%)

Higher risk of adverse outcomes

As compared with codeine, tramadol use was significantly associated with a higher risk of mortality (13.00 vs. 5.61 per 1,000 person-years; hazard ratio, 2.31; 95% confidence interval, 2.08-2.56); absolute rate differences (7.37 per 1,000 person-years; 95% CI, 6.09-8.78), cardiovascular events (10.03 vs. 8.67 per 1,000 person-years; HR, 1.15; 95% CI, 1.05-1.27; ARD, 1.36 per 1,000 person-years; 95% CI, 0.45-2.36), and fractures (12.26 vs. 8.13 per 1,000 person-years; HR, 1.50; 95% CI, 1.37-1.65; ARD, 4.10 per 1,000 person-years; 95% CI, 3.02-5.29).

A subgroup and sensitivity analysis showed that the increased mortality risk associated with tramadol was significantly higher in younger persons vs. older ones (HR, 3.14; 95% CI, 1.82-5.41 vs. 2.39; 95% CI, 2.20-2.60]; P < .001 for interaction). In addition, women had a significantly greater risk of cardiovascular events versus men (HR, 1.32; 95% CI, 1.19-1.46] vs. 1.03; 95% CI, 0.9-1.13]; P < .001 for interaction).
 

Potential for confounding

Weighing in on the data, Daniel Solomon, MD, MPH, chief of clinical sciences, division of rheumatology, Brigham and Women’s Hospital, and professor of medicine, Harvard Medical School, Boston, noted that because it is extremely unlikely that anyone will ever conduct a large, head-to-head safety trial comparing different opioids, the results of this paper are important to consider.

“However, as the authors appropriately caution, this type of analysis is limited by the strong potential for residual confounding,” he said. “In other words, even though the authors used state-of-the-art methods to limit imbalances between the patients initiating tramadol versus codeine, there is strong reason to believe that imbalances that may account for the differences in adverse events exist.”

For example, he noted that if one looks at the distribution of comorbid conditions in the before-matching group, tramadol initiators demonstrate a higher frequency of chronic kidney disease, diabetes, and overall chronic comorbid diseases. “This suggests to me that prescribers apply selection criteria when choosing who to prescribe which opioid,” Dr. Solomon explained.

“While the authors’ use of propensity score matching limits confounding, it only can improve balance for measured confounders,” he said. “Other factors not measured in this type of data set – blood pressure, pain, physical activity, tobacco use, body mass index – may still demonstrate imbalances even after matching.”

But after these limitations are taken into consideration, the results remain concerning, Dr. Solomon emphasized, particularly the all-cause mortality excess of tramadol versus codeine users. “This study did not include cause of death, which would help the reader understand why users of tramadol were dying more frequently,” he added. “It also might help in understanding whether this is a true biologic effect or residual confounding.”

Perceived safety

In an accompanying editorial, Howard S. Kim, MD, MS, and colleagues from Northwestern University, Chicago, write that the greatest risk of tramadol may involve the perception that it is “inherently safer than other opioids.”

“In actuality, the mechanisms of action and variable metabolism of tramadol in a given population create considerable therapeutic uncertainty and introduce additional risk exposure,” they say, as demonstrated in the current study.

Therefore, when clinicians determine that an opioid is needed for pain relief, it may be a better option to select a pure opioid agonist that has a more predictable therapeutic effect and known adverse effect profile, such as morphine or hydrocodone. “This would allow clinicians and patients to more properly weigh the risks and benefits of initiating opioid therapy through shared decision-making and prompt the level of counseling on safe use, storage, and disposal practices that all opioids deserve,” write the editorialists.

The study was funded by the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina. The research was supported by the National Institute for Health Research Oxford Biomedical Research Centre. Dr. Reyes has disclosed no relevant financial relationships. Dr. Solomon disclosed salary support from research contracts to his hospital from Amgen, AbbVie, Moderna, the Rheumatology Research Foundation, and National Institutes of Health; and royalties from UpToDate. Dr. Kim reported unrelated grant support from the Agency for Healthcare Research and Quality.
 

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

Tramadol is increasingly used to manage chronic noncancer pain, but as compared with opioids, it appears to be linked to a higher risk for adverse outcomes, according to new data.

Among a cohort of patients who received a prescription for either tramadol or codeine for orthopedic-related pain, tramadol was significantly associated with a higher risk of mortality, cardiovascular events, and fractures.

However, there was no significant difference in the risk of falls, delirium, constipation, opioid abuse/dependence, or sleep disorders between the two drugs.

“However, this is a retrospective cohort study, and despite it providing information that would otherwise be impossible to gather – such as from randomized controlled trials – clinicians should not solely base their decision on this study,” cautioned lead author Carlen Reyes, MD, PhD, of the Institut Universitari d’Investigació en Atenció Primària (IDIAP Jordi Gol), Barcelona.

Dr. Reyes noted that the intake of tramadol and codeine was analyzed using the number of “packages” that were dispensed, as an approximation of the real intake. “Logically we could think that the more packages dispensed of one drug, the more dose the patient is taking, but this is not always true given the availability of different doses commercialized of tramadol and different doses prescribed,” she said. “Given that we did not account for the real dose prescribed, we can only suspect an increased risk of these outcomes and reinforce the need for further prospective studies with more specific dose-response analysis comparing tramadol and codeine.”

The paper was published Oct. 19 in JAMA.

Tramadol has been considered to be a relatively safe opioid and was even strongly recommended by the American Academy of Orthopaedic Surgeons for patients experiencing symptomatic knee osteoarthritis. The authors point out that studies looking at opioid use from 2019 to 2020 show that tramadol was the most prescribed opioid in England, the Netherlands, and Spain.

In the United States, the age-adjusted rate of drug overdose deaths from synthetic opioids rose from 1.0 per 100 000 in 2013 to 11.4 in 2019. Most of these deaths were attributable to fentanyl but some were also related to tramadol.

But despite its wide use in managing chronic noncancer pain, results of recent studies suggest adverse outcomes as compared with other agents. Last year, one study found that older patients who received tramadol had a significant increase in the risk of hip fracture vs. those using NSAIDs or codeine. Another study, also published in 2020, showed that patients with osteoarthritis who were treated with tramadol had a 20%-50% higher risk of dying during the first year of treatment than did patients who were treated with NSAIDs.

In the current paper, Dr. Reyes and colleagues evaluated the association of tramadol with mortality and other adverse clinical outcomes in outpatient settings, compared with codeine.

They conducted a retrospective, population-based, propensity score–matched cohort study using a primary care database that routinely collects medical records and pharmacy dispensations for more than 80% of the population of Catalonia, Spain. The cohort included people 18 years or older who had been prescribed tramadol or codeine from 2007 to 2017 and were followed up to Dec. 31, 2017.

After propensity score matching, the final analysis included 368,960 participants: 184,480 in the tramadol arm and 184,480 in the codeine arm.

The mean age of patients was 52.7 years in the tramadol arm and 53.5 years in the codeine arm, and the prevalence of cancer was 3.2% and 3.3%, respectively. The most common diagnoses in this cohort were back pain (47.5% vs. 48.5%), neck/shoulder pain (28.6% vs. 29.5%), and osteoarthritis (15.3% vs. 15.5%). The most commonly used drugs were ibuprofen (34.4% vs. 34.3%) and paracetamol/acetaminophen (37.1% vs. 36.8%)

Higher risk of adverse outcomes

As compared with codeine, tramadol use was significantly associated with a higher risk of mortality (13.00 vs. 5.61 per 1,000 person-years; hazard ratio, 2.31; 95% confidence interval, 2.08-2.56); absolute rate differences (7.37 per 1,000 person-years; 95% CI, 6.09-8.78), cardiovascular events (10.03 vs. 8.67 per 1,000 person-years; HR, 1.15; 95% CI, 1.05-1.27; ARD, 1.36 per 1,000 person-years; 95% CI, 0.45-2.36), and fractures (12.26 vs. 8.13 per 1,000 person-years; HR, 1.50; 95% CI, 1.37-1.65; ARD, 4.10 per 1,000 person-years; 95% CI, 3.02-5.29).

A subgroup and sensitivity analysis showed that the increased mortality risk associated with tramadol was significantly higher in younger persons vs. older ones (HR, 3.14; 95% CI, 1.82-5.41 vs. 2.39; 95% CI, 2.20-2.60]; P < .001 for interaction). In addition, women had a significantly greater risk of cardiovascular events versus men (HR, 1.32; 95% CI, 1.19-1.46] vs. 1.03; 95% CI, 0.9-1.13]; P < .001 for interaction).
 

Potential for confounding

Weighing in on the data, Daniel Solomon, MD, MPH, chief of clinical sciences, division of rheumatology, Brigham and Women’s Hospital, and professor of medicine, Harvard Medical School, Boston, noted that because it is extremely unlikely that anyone will ever conduct a large, head-to-head safety trial comparing different opioids, the results of this paper are important to consider.

“However, as the authors appropriately caution, this type of analysis is limited by the strong potential for residual confounding,” he said. “In other words, even though the authors used state-of-the-art methods to limit imbalances between the patients initiating tramadol versus codeine, there is strong reason to believe that imbalances that may account for the differences in adverse events exist.”

For example, he noted that if one looks at the distribution of comorbid conditions in the before-matching group, tramadol initiators demonstrate a higher frequency of chronic kidney disease, diabetes, and overall chronic comorbid diseases. “This suggests to me that prescribers apply selection criteria when choosing who to prescribe which opioid,” Dr. Solomon explained.

“While the authors’ use of propensity score matching limits confounding, it only can improve balance for measured confounders,” he said. “Other factors not measured in this type of data set – blood pressure, pain, physical activity, tobacco use, body mass index – may still demonstrate imbalances even after matching.”

But after these limitations are taken into consideration, the results remain concerning, Dr. Solomon emphasized, particularly the all-cause mortality excess of tramadol versus codeine users. “This study did not include cause of death, which would help the reader understand why users of tramadol were dying more frequently,” he added. “It also might help in understanding whether this is a true biologic effect or residual confounding.”

Perceived safety

In an accompanying editorial, Howard S. Kim, MD, MS, and colleagues from Northwestern University, Chicago, write that the greatest risk of tramadol may involve the perception that it is “inherently safer than other opioids.”

“In actuality, the mechanisms of action and variable metabolism of tramadol in a given population create considerable therapeutic uncertainty and introduce additional risk exposure,” they say, as demonstrated in the current study.

Therefore, when clinicians determine that an opioid is needed for pain relief, it may be a better option to select a pure opioid agonist that has a more predictable therapeutic effect and known adverse effect profile, such as morphine or hydrocodone. “This would allow clinicians and patients to more properly weigh the risks and benefits of initiating opioid therapy through shared decision-making and prompt the level of counseling on safe use, storage, and disposal practices that all opioids deserve,” write the editorialists.

The study was funded by the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina. The research was supported by the National Institute for Health Research Oxford Biomedical Research Centre. Dr. Reyes has disclosed no relevant financial relationships. Dr. Solomon disclosed salary support from research contracts to his hospital from Amgen, AbbVie, Moderna, the Rheumatology Research Foundation, and National Institutes of Health; and royalties from UpToDate. Dr. Kim reported unrelated grant support from the Agency for Healthcare Research and Quality.
 

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

Tramadol is increasingly used to manage chronic noncancer pain, but as compared with opioids, it appears to be linked to a higher risk for adverse outcomes, according to new data.

Among a cohort of patients who received a prescription for either tramadol or codeine for orthopedic-related pain, tramadol was significantly associated with a higher risk of mortality, cardiovascular events, and fractures.

However, there was no significant difference in the risk of falls, delirium, constipation, opioid abuse/dependence, or sleep disorders between the two drugs.

“However, this is a retrospective cohort study, and despite it providing information that would otherwise be impossible to gather – such as from randomized controlled trials – clinicians should not solely base their decision on this study,” cautioned lead author Carlen Reyes, MD, PhD, of the Institut Universitari d’Investigació en Atenció Primària (IDIAP Jordi Gol), Barcelona.

Dr. Reyes noted that the intake of tramadol and codeine was analyzed using the number of “packages” that were dispensed, as an approximation of the real intake. “Logically we could think that the more packages dispensed of one drug, the more dose the patient is taking, but this is not always true given the availability of different doses commercialized of tramadol and different doses prescribed,” she said. “Given that we did not account for the real dose prescribed, we can only suspect an increased risk of these outcomes and reinforce the need for further prospective studies with more specific dose-response analysis comparing tramadol and codeine.”

The paper was published Oct. 19 in JAMA.

Tramadol has been considered to be a relatively safe opioid and was even strongly recommended by the American Academy of Orthopaedic Surgeons for patients experiencing symptomatic knee osteoarthritis. The authors point out that studies looking at opioid use from 2019 to 2020 show that tramadol was the most prescribed opioid in England, the Netherlands, and Spain.

In the United States, the age-adjusted rate of drug overdose deaths from synthetic opioids rose from 1.0 per 100 000 in 2013 to 11.4 in 2019. Most of these deaths were attributable to fentanyl but some were also related to tramadol.

But despite its wide use in managing chronic noncancer pain, results of recent studies suggest adverse outcomes as compared with other agents. Last year, one study found that older patients who received tramadol had a significant increase in the risk of hip fracture vs. those using NSAIDs or codeine. Another study, also published in 2020, showed that patients with osteoarthritis who were treated with tramadol had a 20%-50% higher risk of dying during the first year of treatment than did patients who were treated with NSAIDs.

In the current paper, Dr. Reyes and colleagues evaluated the association of tramadol with mortality and other adverse clinical outcomes in outpatient settings, compared with codeine.

They conducted a retrospective, population-based, propensity score–matched cohort study using a primary care database that routinely collects medical records and pharmacy dispensations for more than 80% of the population of Catalonia, Spain. The cohort included people 18 years or older who had been prescribed tramadol or codeine from 2007 to 2017 and were followed up to Dec. 31, 2017.

After propensity score matching, the final analysis included 368,960 participants: 184,480 in the tramadol arm and 184,480 in the codeine arm.

The mean age of patients was 52.7 years in the tramadol arm and 53.5 years in the codeine arm, and the prevalence of cancer was 3.2% and 3.3%, respectively. The most common diagnoses in this cohort were back pain (47.5% vs. 48.5%), neck/shoulder pain (28.6% vs. 29.5%), and osteoarthritis (15.3% vs. 15.5%). The most commonly used drugs were ibuprofen (34.4% vs. 34.3%) and paracetamol/acetaminophen (37.1% vs. 36.8%)

Higher risk of adverse outcomes

As compared with codeine, tramadol use was significantly associated with a higher risk of mortality (13.00 vs. 5.61 per 1,000 person-years; hazard ratio, 2.31; 95% confidence interval, 2.08-2.56); absolute rate differences (7.37 per 1,000 person-years; 95% CI, 6.09-8.78), cardiovascular events (10.03 vs. 8.67 per 1,000 person-years; HR, 1.15; 95% CI, 1.05-1.27; ARD, 1.36 per 1,000 person-years; 95% CI, 0.45-2.36), and fractures (12.26 vs. 8.13 per 1,000 person-years; HR, 1.50; 95% CI, 1.37-1.65; ARD, 4.10 per 1,000 person-years; 95% CI, 3.02-5.29).

A subgroup and sensitivity analysis showed that the increased mortality risk associated with tramadol was significantly higher in younger persons vs. older ones (HR, 3.14; 95% CI, 1.82-5.41 vs. 2.39; 95% CI, 2.20-2.60]; P < .001 for interaction). In addition, women had a significantly greater risk of cardiovascular events versus men (HR, 1.32; 95% CI, 1.19-1.46] vs. 1.03; 95% CI, 0.9-1.13]; P < .001 for interaction).
 

Potential for confounding

Weighing in on the data, Daniel Solomon, MD, MPH, chief of clinical sciences, division of rheumatology, Brigham and Women’s Hospital, and professor of medicine, Harvard Medical School, Boston, noted that because it is extremely unlikely that anyone will ever conduct a large, head-to-head safety trial comparing different opioids, the results of this paper are important to consider.

“However, as the authors appropriately caution, this type of analysis is limited by the strong potential for residual confounding,” he said. “In other words, even though the authors used state-of-the-art methods to limit imbalances between the patients initiating tramadol versus codeine, there is strong reason to believe that imbalances that may account for the differences in adverse events exist.”

For example, he noted that if one looks at the distribution of comorbid conditions in the before-matching group, tramadol initiators demonstrate a higher frequency of chronic kidney disease, diabetes, and overall chronic comorbid diseases. “This suggests to me that prescribers apply selection criteria when choosing who to prescribe which opioid,” Dr. Solomon explained.

“While the authors’ use of propensity score matching limits confounding, it only can improve balance for measured confounders,” he said. “Other factors not measured in this type of data set – blood pressure, pain, physical activity, tobacco use, body mass index – may still demonstrate imbalances even after matching.”

But after these limitations are taken into consideration, the results remain concerning, Dr. Solomon emphasized, particularly the all-cause mortality excess of tramadol versus codeine users. “This study did not include cause of death, which would help the reader understand why users of tramadol were dying more frequently,” he added. “It also might help in understanding whether this is a true biologic effect or residual confounding.”

Perceived safety

In an accompanying editorial, Howard S. Kim, MD, MS, and colleagues from Northwestern University, Chicago, write that the greatest risk of tramadol may involve the perception that it is “inherently safer than other opioids.”

“In actuality, the mechanisms of action and variable metabolism of tramadol in a given population create considerable therapeutic uncertainty and introduce additional risk exposure,” they say, as demonstrated in the current study.

Therefore, when clinicians determine that an opioid is needed for pain relief, it may be a better option to select a pure opioid agonist that has a more predictable therapeutic effect and known adverse effect profile, such as morphine or hydrocodone. “This would allow clinicians and patients to more properly weigh the risks and benefits of initiating opioid therapy through shared decision-making and prompt the level of counseling on safe use, storage, and disposal practices that all opioids deserve,” write the editorialists.

The study was funded by the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina. The research was supported by the National Institute for Health Research Oxford Biomedical Research Centre. Dr. Reyes has disclosed no relevant financial relationships. Dr. Solomon disclosed salary support from research contracts to his hospital from Amgen, AbbVie, Moderna, the Rheumatology Research Foundation, and National Institutes of Health; and royalties from UpToDate. Dr. Kim reported unrelated grant support from the Agency for Healthcare Research and Quality.
 

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

Approximately one-third of colonoscopies with inadequate bowel preparation were repeated within 1 year despite current guidelines, according to data from a new study of more than 260,000 procedures.

Eraxion/Thinkstock

Previous studies have shown that poor bowel prep, which occurs in approximately 25% of colonoscopies, can lead to lesion miss rates of as much as 42%-48%, Audrey H. Calderwood, MD, an associate professor of medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues wrote. However, factors affecting recommendations for repeat colonoscopies following poor bowel prep have not been examined.

In the study, published in Gastrointestinal Endoscopy, the researchers conducted a cross-sectional retrospective analysis of 260,314 colonoscopies reported to the GI Quality Improvement Consortium (GIQuIC) from 2011 to 2018. The review included adults aged 50-75 years in whom bowel preparation was deemed inadequate. The GIQuIC database defines adequate bowel preparation as “sufficient to accurately detect polyps greater than 5 mm in size,” the researchers noted. The procedures in this study were performed at 672 sites by 4,001 endoscopists, and the primary outcome was a recommendation for a repeat colonoscopy within 1 year.

In 31.9% of the procedures, the recommended follow-up interval for repeat colonoscopy was within 1 year, and there were no significant differences according to indication for the procedures (32.3% of screening and 31.2% of surveillance). Of these, 54.9% of patients received a follow-up interval of 1 year and 24.7% a follow-up interval within 3 months. Only 2.4% were advised they required no follow-up procedure.

The researchers found that patients with more severe disease had a higher likelihood of receiving a recommendation for follow-up colonoscopy within 1 year – 84% with adenocarcinoma, 51.8% with advanced lesions, and 23.2% with one to two small adenomas.

In the multivariate analysis, there were specific patient factors significantly associated with 1-year follow-up recommendations. The researchers found patients aged 70-75 years were less likely than younger patients (adjusted odds ratio, 0.96; 95% confidence interval, 0.93-0.98) to receive a 1-year follow-up recommendation; men were more likely than women (aOR, 1.04; 95% CI, 1.02-1.06) to receive a 1-year follow-up recommendation; and patients with adenocarcinoma findings more likely to receive a 1-year follow-up recommendation compared to those with no adenocarcinoma (aOR, 10.43; 95% CI, 7.77-13.98). In addition, they found patients residing in the Northeast and those whose procedure was performed by an endoscopist with an adenoma detection rate of at least25% were more likely to receive recommendations for a repeat colonoscopy within 1 year.

“The recommendation for repeat screening or surveillance colonoscopy within 1 year when the index colonoscopy has an inadequate bowel preparation is currently a quality measure in gastroenterology,” the researchers noted. “Although our study period started in 2011, when we looked at the time period of 2014 to 2018, which is after publication of guidelines of when to repeat colonoscopy after inadequate bowel preparation, there were still low rates of guideline-concordant recommendations.”

These overall low rates, which are consistent with other studies, may be due uncertainty on the part of the endoscopist in determining inadequate bowel prep based on evolving guidelines, the researchers noted. However, the higher frequency of recommendations for repeat procedures within 1 year for patients with advanced disease suggests that endoscopists are taking pathology into account.

The study findings were limited by several factors, including the lack of standardized assessment of bowel prep quality, variation in descriptions of bowel cleanliness, and lack of information on the primary factor in follow-up recommendations. However, the results were strengthened by the large sample size, the inclusion of multiple sites and providers, and the low volume of timely repeat procedures, which has clinical implications in terms of missed lesions, “including potential interval CRC [colorectal cancer],” the researchers said.
 

Get the word out on describing preps and planning follow-ups

The current study is important because it highlights that, even when endoscopists have a reasonable understanding on how to set follow-up intervals for polyp follow-up, what to do with a patient who comes in poorly prepped is more of a problem, Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.

Dr Isaacs said she was not surprised by the study findings. “There are all gradations of inadequate preps that limit visualization in different ways, and there are many ways of recording this on procedure reports. The findings in the current study emphasize several points. The first is that the recommendation of following up an inadequate or poor prep in a year needs to be widely disseminated. The second is that there needs to be more education on standardization on how preps are described. In some poor preps, much of the colon can be seen, and clinicians can identify polyps 5-6 mm, so a 1-year follow-up may not be needed.” This type of research is challenging if the data are not standardized, she added. 

Dr. Isaacs agreed with the authors’ description of repeat colonoscopies after poor bowel prep as a quality improvement area given the variability in following current recommendations, which leads into next steps for research.

“Understanding reasons for the recommendations that endoscopists made for follow-up would be the next step in this type of research,” Dr Isaacs noted. “After that, studies on the impact of an educational intervention, followed by repeating the initial assessment.”

The study received no outside funding. The researchers had no financial conflicts to disclose; however, lead author Dr. Calderwood disclosed support from the National Cancer Institute, the Dartmouth-Hitchcock Cancer Research Fellows Program, the Dartmouth-Hitchcock Norris Cotton Cancer Center, and the Dartmouth Clinical and Translational Science Institute. Dr Isaacs had no financial conflicts to disclose but has previously served on the editorial board of GI & Hepatology News.

Approximately one-third of colonoscopies with inadequate bowel preparation were repeated within 1 year despite current guidelines, according to data from a new study of more than 260,000 procedures.

Eraxion/Thinkstock

Previous studies have shown that poor bowel prep, which occurs in approximately 25% of colonoscopies, can lead to lesion miss rates of as much as 42%-48%, Audrey H. Calderwood, MD, an associate professor of medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues wrote. However, factors affecting recommendations for repeat colonoscopies following poor bowel prep have not been examined.

In the study, published in Gastrointestinal Endoscopy, the researchers conducted a cross-sectional retrospective analysis of 260,314 colonoscopies reported to the GI Quality Improvement Consortium (GIQuIC) from 2011 to 2018. The review included adults aged 50-75 years in whom bowel preparation was deemed inadequate. The GIQuIC database defines adequate bowel preparation as “sufficient to accurately detect polyps greater than 5 mm in size,” the researchers noted. The procedures in this study were performed at 672 sites by 4,001 endoscopists, and the primary outcome was a recommendation for a repeat colonoscopy within 1 year.

In 31.9% of the procedures, the recommended follow-up interval for repeat colonoscopy was within 1 year, and there were no significant differences according to indication for the procedures (32.3% of screening and 31.2% of surveillance). Of these, 54.9% of patients received a follow-up interval of 1 year and 24.7% a follow-up interval within 3 months. Only 2.4% were advised they required no follow-up procedure.

The researchers found that patients with more severe disease had a higher likelihood of receiving a recommendation for follow-up colonoscopy within 1 year – 84% with adenocarcinoma, 51.8% with advanced lesions, and 23.2% with one to two small adenomas.

In the multivariate analysis, there were specific patient factors significantly associated with 1-year follow-up recommendations. The researchers found patients aged 70-75 years were less likely than younger patients (adjusted odds ratio, 0.96; 95% confidence interval, 0.93-0.98) to receive a 1-year follow-up recommendation; men were more likely than women (aOR, 1.04; 95% CI, 1.02-1.06) to receive a 1-year follow-up recommendation; and patients with adenocarcinoma findings more likely to receive a 1-year follow-up recommendation compared to those with no adenocarcinoma (aOR, 10.43; 95% CI, 7.77-13.98). In addition, they found patients residing in the Northeast and those whose procedure was performed by an endoscopist with an adenoma detection rate of at least25% were more likely to receive recommendations for a repeat colonoscopy within 1 year.

“The recommendation for repeat screening or surveillance colonoscopy within 1 year when the index colonoscopy has an inadequate bowel preparation is currently a quality measure in gastroenterology,” the researchers noted. “Although our study period started in 2011, when we looked at the time period of 2014 to 2018, which is after publication of guidelines of when to repeat colonoscopy after inadequate bowel preparation, there were still low rates of guideline-concordant recommendations.”

These overall low rates, which are consistent with other studies, may be due uncertainty on the part of the endoscopist in determining inadequate bowel prep based on evolving guidelines, the researchers noted. However, the higher frequency of recommendations for repeat procedures within 1 year for patients with advanced disease suggests that endoscopists are taking pathology into account.

The study findings were limited by several factors, including the lack of standardized assessment of bowel prep quality, variation in descriptions of bowel cleanliness, and lack of information on the primary factor in follow-up recommendations. However, the results were strengthened by the large sample size, the inclusion of multiple sites and providers, and the low volume of timely repeat procedures, which has clinical implications in terms of missed lesions, “including potential interval CRC [colorectal cancer],” the researchers said.
 

Get the word out on describing preps and planning follow-ups

The current study is important because it highlights that, even when endoscopists have a reasonable understanding on how to set follow-up intervals for polyp follow-up, what to do with a patient who comes in poorly prepped is more of a problem, Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.

Dr Isaacs said she was not surprised by the study findings. “There are all gradations of inadequate preps that limit visualization in different ways, and there are many ways of recording this on procedure reports. The findings in the current study emphasize several points. The first is that the recommendation of following up an inadequate or poor prep in a year needs to be widely disseminated. The second is that there needs to be more education on standardization on how preps are described. In some poor preps, much of the colon can be seen, and clinicians can identify polyps 5-6 mm, so a 1-year follow-up may not be needed.” This type of research is challenging if the data are not standardized, she added. 

Dr. Isaacs agreed with the authors’ description of repeat colonoscopies after poor bowel prep as a quality improvement area given the variability in following current recommendations, which leads into next steps for research.

“Understanding reasons for the recommendations that endoscopists made for follow-up would be the next step in this type of research,” Dr Isaacs noted. “After that, studies on the impact of an educational intervention, followed by repeating the initial assessment.”

The study received no outside funding. The researchers had no financial conflicts to disclose; however, lead author Dr. Calderwood disclosed support from the National Cancer Institute, the Dartmouth-Hitchcock Cancer Research Fellows Program, the Dartmouth-Hitchcock Norris Cotton Cancer Center, and the Dartmouth Clinical and Translational Science Institute. Dr Isaacs had no financial conflicts to disclose but has previously served on the editorial board of GI & Hepatology News.

Approximately one-third of colonoscopies with inadequate bowel preparation were repeated within 1 year despite current guidelines, according to data from a new study of more than 260,000 procedures.

Eraxion/Thinkstock

Previous studies have shown that poor bowel prep, which occurs in approximately 25% of colonoscopies, can lead to lesion miss rates of as much as 42%-48%, Audrey H. Calderwood, MD, an associate professor of medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues wrote. However, factors affecting recommendations for repeat colonoscopies following poor bowel prep have not been examined.

In the study, published in Gastrointestinal Endoscopy, the researchers conducted a cross-sectional retrospective analysis of 260,314 colonoscopies reported to the GI Quality Improvement Consortium (GIQuIC) from 2011 to 2018. The review included adults aged 50-75 years in whom bowel preparation was deemed inadequate. The GIQuIC database defines adequate bowel preparation as “sufficient to accurately detect polyps greater than 5 mm in size,” the researchers noted. The procedures in this study were performed at 672 sites by 4,001 endoscopists, and the primary outcome was a recommendation for a repeat colonoscopy within 1 year.

In 31.9% of the procedures, the recommended follow-up interval for repeat colonoscopy was within 1 year, and there were no significant differences according to indication for the procedures (32.3% of screening and 31.2% of surveillance). Of these, 54.9% of patients received a follow-up interval of 1 year and 24.7% a follow-up interval within 3 months. Only 2.4% were advised they required no follow-up procedure.

The researchers found that patients with more severe disease had a higher likelihood of receiving a recommendation for follow-up colonoscopy within 1 year – 84% with adenocarcinoma, 51.8% with advanced lesions, and 23.2% with one to two small adenomas.

In the multivariate analysis, there were specific patient factors significantly associated with 1-year follow-up recommendations. The researchers found patients aged 70-75 years were less likely than younger patients (adjusted odds ratio, 0.96; 95% confidence interval, 0.93-0.98) to receive a 1-year follow-up recommendation; men were more likely than women (aOR, 1.04; 95% CI, 1.02-1.06) to receive a 1-year follow-up recommendation; and patients with adenocarcinoma findings more likely to receive a 1-year follow-up recommendation compared to those with no adenocarcinoma (aOR, 10.43; 95% CI, 7.77-13.98). In addition, they found patients residing in the Northeast and those whose procedure was performed by an endoscopist with an adenoma detection rate of at least25% were more likely to receive recommendations for a repeat colonoscopy within 1 year.

“The recommendation for repeat screening or surveillance colonoscopy within 1 year when the index colonoscopy has an inadequate bowel preparation is currently a quality measure in gastroenterology,” the researchers noted. “Although our study period started in 2011, when we looked at the time period of 2014 to 2018, which is after publication of guidelines of when to repeat colonoscopy after inadequate bowel preparation, there were still low rates of guideline-concordant recommendations.”

These overall low rates, which are consistent with other studies, may be due uncertainty on the part of the endoscopist in determining inadequate bowel prep based on evolving guidelines, the researchers noted. However, the higher frequency of recommendations for repeat procedures within 1 year for patients with advanced disease suggests that endoscopists are taking pathology into account.

The study findings were limited by several factors, including the lack of standardized assessment of bowel prep quality, variation in descriptions of bowel cleanliness, and lack of information on the primary factor in follow-up recommendations. However, the results were strengthened by the large sample size, the inclusion of multiple sites and providers, and the low volume of timely repeat procedures, which has clinical implications in terms of missed lesions, “including potential interval CRC [colorectal cancer],” the researchers said.
 

Get the word out on describing preps and planning follow-ups

The current study is important because it highlights that, even when endoscopists have a reasonable understanding on how to set follow-up intervals for polyp follow-up, what to do with a patient who comes in poorly prepped is more of a problem, Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.

Dr Isaacs said she was not surprised by the study findings. “There are all gradations of inadequate preps that limit visualization in different ways, and there are many ways of recording this on procedure reports. The findings in the current study emphasize several points. The first is that the recommendation of following up an inadequate or poor prep in a year needs to be widely disseminated. The second is that there needs to be more education on standardization on how preps are described. In some poor preps, much of the colon can be seen, and clinicians can identify polyps 5-6 mm, so a 1-year follow-up may not be needed.” This type of research is challenging if the data are not standardized, she added. 

Dr. Isaacs agreed with the authors’ description of repeat colonoscopies after poor bowel prep as a quality improvement area given the variability in following current recommendations, which leads into next steps for research.

“Understanding reasons for the recommendations that endoscopists made for follow-up would be the next step in this type of research,” Dr Isaacs noted. “After that, studies on the impact of an educational intervention, followed by repeating the initial assessment.”

The study received no outside funding. The researchers had no financial conflicts to disclose; however, lead author Dr. Calderwood disclosed support from the National Cancer Institute, the Dartmouth-Hitchcock Cancer Research Fellows Program, the Dartmouth-Hitchcock Norris Cotton Cancer Center, and the Dartmouth Clinical and Translational Science Institute. Dr Isaacs had no financial conflicts to disclose but has previously served on the editorial board of GI & Hepatology News.

A physician assistant who runs a pediatric clinic in Washington State says he’ll fight against a license suspension over prescribing ivermectin as a cure for COVID, among other allegations.

The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.

“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”

Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”

Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.

“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.

Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”

In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.

Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.

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

A physician assistant who runs a pediatric clinic in Washington State says he’ll fight against a license suspension over prescribing ivermectin as a cure for COVID, among other allegations.

The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.

“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”

Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”

Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.

“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.

Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”

In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.

Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.

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

A physician assistant who runs a pediatric clinic in Washington State says he’ll fight against a license suspension over prescribing ivermectin as a cure for COVID, among other allegations.

The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.

“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”

Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”

Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.

“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.

Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”

In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.

Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

An inpatient psychiatric diagnosis at some point over a lifetime is significantly associated with a range of sleep problems, results from the largest study of its kind show.

A prior diagnosis of major depression, schizophrenia, anxiety, or bipolar disorder was associated with a later bedtime, earlier waking time, and significantly poorer sleep quality that included frequent awakenings during the night and shorter sleep bouts.

“We were struck by the pervasiveness of sleep problems across all the diagnoses of mental illness and sleep parameters we looked at,” study investigator Michael Wainberg, PhD, a postdoctoral fellow at the Krembil Centre for Neuroinformatics at the Center for Addiction and Mental Health (CAMH), Toronto, told this news organization. “This suggests there may need to be even more of an emphasis on sleep in these patients than there already is.”

The study, which includes data from nearly 90,000 adults in the United Kingdom, was published online October 12 in PLoS Medicine.

Wavebreak Media/Thinkstockphotos

Trove of data

Data for the analysis comes from the UK Biobank, a large-scale biomedical database launched in 2006 that has collected biological and medical data on more than 500,000 individuals who consented to provide blood, urine, and saliva samples and detailed lifestyle information that is matched to their medical records.

Between 2013 and 2015, more than 103,000 of these participants agreed to wear accelerometers on their wrists for 24 hours a day for 7 days, collecting a trove of data for researchers to mine.

“This allows us to get at objectively derived sleep measures and to measure them in greater numbers of people who have experienced mental illness,” said senior author Shreejoy Tripathy, PhD, assistant professor at the University of Toronto and independent scientist for CAMH. “You can study multiple disorders at once and the influence of other variables that might not be possible in the context of other studies.”

The research is the first known large-scale transdiagnostic study of objectively measured sleep and mental health. Insomnia and other sleep disorders are common among people with mental illness, as shown in prior research, including at least one study that used the same dataset the team employed for this project.

The new findings add to that body of work, Dr. Wainberg said, and look beyond just how long a person sleeps to the quality of the sleep they get.

“We found that the metrics of sleep quality seem to be affected more than mere sleep duration,” he said.
 

Unexpected finding

After excluding participants with faulty accelerometers and those who didn’t wear them for the entire 7-day study period, data from 89,205 participants (aged 43-79, 56% female, 97% self-reported White) was included. Lifetime inpatient psychiatric diagnoses were reported in 2.5% of the entire cohort.

Researchers looked at 10 sleep measures: bedtime, wake-up time, sleep duration, wake after sleep onset, sleep efficiency, number of awakenings, duration of longest sleep bout, number of naps, and variability in bedtime and sleep duration.

Although the effect sizes were small, having any psychiatric diagnosis was associated with significantly lower scores on every sleep measure except sleep duration.

Compared with those with no inpatient psychiatric diagnosis, those with any psychiatric diagnosis were significantly more likely to:

• have a later bedtime (beta = 0.07; 95% confidence interval, 0.06-0.09)
• have later wake-up time (beta = 0.10; 95% CI, 0.09-0.11)
• wake after sleep onset (beta = 0.10; 95% CI, 0.09-0.12)
• have poorer sleep efficiency (beta = –0.12; 95% CI, −0.14 to −0.11)
• have more awakenings (beta = 0.10; 95% CI, 0.09-0.11)
• have shorter duration of their longest sleep bout (beta = –0.09; 95% CI, −0.11 to −0.08)
• take more naps (beta = 0.11; 95% CI, 0.09-0.12)
• have greater variability in their bedtime (beta = 0.08; 95% CI, 0.06-0.09)
• have greater variability in their sleep duration (beta = 0.10; 95% CI, 0.09-0.12)

The only significant differences in sleep duration were found in those with lifetime major depressive disorder, who slept significantly less (beta = −0.02; P = .003), and in those with lifetime schizophrenia, who slept significantly longer (beta = 0.02; P = .0008).

Researchers found similar results when they examined patient-reported sleep measures collected when participants enrolled in the biobank, long before they agreed to wear an accelerometer.

“Everyone with a lifetime mental illness diagnosis trended toward worse sleep quality, regardless of their diagnosis,” Dr. Tripathy said. “We didn’t expect to see that.”

Limitations of the biobank data prohibited analysis by age and past or current use of psychiatric medications. In addition, investigators were unable to determine whether mental illness was active or controlled at the time of the study. Information on these, and other factors, is needed to truly begin to understand the real-world status of sleep patterns in people with mental illness, the researchers note.

However, the biobank data demonstrates how this type of information can be collected, helping Dr. Tripathy and others to design a new study that will launch next year with patients at CAMH. This effort is part of the BrainHealth Databank, a project that aims to develop a patient data bank similar to the one in the UK that was used for this study.

“We’ve shown that you can use wearable devices to measure correlates of sleep and derive insights about the objective measurements of sleep and associate them with mental illness diagnosis,” Dr. Tripathy said.

The study received no outside funding. Dr. Wainberg and Dr. Tripathy report receiving funding from Kavli Foundation, Krembil Foundation, CAMH Discovery Fund, the McLaughlin Foundation, NSERC, and CIHR. Disclosures for other authors are fully listed in the original article.

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

An inpatient psychiatric diagnosis at some point over a lifetime is significantly associated with a range of sleep problems, results from the largest study of its kind show.

A prior diagnosis of major depression, schizophrenia, anxiety, or bipolar disorder was associated with a later bedtime, earlier waking time, and significantly poorer sleep quality that included frequent awakenings during the night and shorter sleep bouts.

“We were struck by the pervasiveness of sleep problems across all the diagnoses of mental illness and sleep parameters we looked at,” study investigator Michael Wainberg, PhD, a postdoctoral fellow at the Krembil Centre for Neuroinformatics at the Center for Addiction and Mental Health (CAMH), Toronto, told this news organization. “This suggests there may need to be even more of an emphasis on sleep in these patients than there already is.”

The study, which includes data from nearly 90,000 adults in the United Kingdom, was published online October 12 in PLoS Medicine.

Wavebreak Media/Thinkstockphotos

Trove of data

Data for the analysis comes from the UK Biobank, a large-scale biomedical database launched in 2006 that has collected biological and medical data on more than 500,000 individuals who consented to provide blood, urine, and saliva samples and detailed lifestyle information that is matched to their medical records.

Between 2013 and 2015, more than 103,000 of these participants agreed to wear accelerometers on their wrists for 24 hours a day for 7 days, collecting a trove of data for researchers to mine.

“This allows us to get at objectively derived sleep measures and to measure them in greater numbers of people who have experienced mental illness,” said senior author Shreejoy Tripathy, PhD, assistant professor at the University of Toronto and independent scientist for CAMH. “You can study multiple disorders at once and the influence of other variables that might not be possible in the context of other studies.”

The research is the first known large-scale transdiagnostic study of objectively measured sleep and mental health. Insomnia and other sleep disorders are common among people with mental illness, as shown in prior research, including at least one study that used the same dataset the team employed for this project.

The new findings add to that body of work, Dr. Wainberg said, and look beyond just how long a person sleeps to the quality of the sleep they get.

“We found that the metrics of sleep quality seem to be affected more than mere sleep duration,” he said.
 

Unexpected finding

After excluding participants with faulty accelerometers and those who didn’t wear them for the entire 7-day study period, data from 89,205 participants (aged 43-79, 56% female, 97% self-reported White) was included. Lifetime inpatient psychiatric diagnoses were reported in 2.5% of the entire cohort.

Researchers looked at 10 sleep measures: bedtime, wake-up time, sleep duration, wake after sleep onset, sleep efficiency, number of awakenings, duration of longest sleep bout, number of naps, and variability in bedtime and sleep duration.

Although the effect sizes were small, having any psychiatric diagnosis was associated with significantly lower scores on every sleep measure except sleep duration.

Compared with those with no inpatient psychiatric diagnosis, those with any psychiatric diagnosis were significantly more likely to:

• have a later bedtime (beta = 0.07; 95% confidence interval, 0.06-0.09)
• have later wake-up time (beta = 0.10; 95% CI, 0.09-0.11)
• wake after sleep onset (beta = 0.10; 95% CI, 0.09-0.12)
• have poorer sleep efficiency (beta = –0.12; 95% CI, −0.14 to −0.11)
• have more awakenings (beta = 0.10; 95% CI, 0.09-0.11)
• have shorter duration of their longest sleep bout (beta = –0.09; 95% CI, −0.11 to −0.08)
• take more naps (beta = 0.11; 95% CI, 0.09-0.12)
• have greater variability in their bedtime (beta = 0.08; 95% CI, 0.06-0.09)
• have greater variability in their sleep duration (beta = 0.10; 95% CI, 0.09-0.12)

The only significant differences in sleep duration were found in those with lifetime major depressive disorder, who slept significantly less (beta = −0.02; P = .003), and in those with lifetime schizophrenia, who slept significantly longer (beta = 0.02; P = .0008).

Researchers found similar results when they examined patient-reported sleep measures collected when participants enrolled in the biobank, long before they agreed to wear an accelerometer.

“Everyone with a lifetime mental illness diagnosis trended toward worse sleep quality, regardless of their diagnosis,” Dr. Tripathy said. “We didn’t expect to see that.”

Limitations of the biobank data prohibited analysis by age and past or current use of psychiatric medications. In addition, investigators were unable to determine whether mental illness was active or controlled at the time of the study. Information on these, and other factors, is needed to truly begin to understand the real-world status of sleep patterns in people with mental illness, the researchers note.

However, the biobank data demonstrates how this type of information can be collected, helping Dr. Tripathy and others to design a new study that will launch next year with patients at CAMH. This effort is part of the BrainHealth Databank, a project that aims to develop a patient data bank similar to the one in the UK that was used for this study.

“We’ve shown that you can use wearable devices to measure correlates of sleep and derive insights about the objective measurements of sleep and associate them with mental illness diagnosis,” Dr. Tripathy said.

The study received no outside funding. Dr. Wainberg and Dr. Tripathy report receiving funding from Kavli Foundation, Krembil Foundation, CAMH Discovery Fund, the McLaughlin Foundation, NSERC, and CIHR. Disclosures for other authors are fully listed in the original article.

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

An inpatient psychiatric diagnosis at some point over a lifetime is significantly associated with a range of sleep problems, results from the largest study of its kind show.

A prior diagnosis of major depression, schizophrenia, anxiety, or bipolar disorder was associated with a later bedtime, earlier waking time, and significantly poorer sleep quality that included frequent awakenings during the night and shorter sleep bouts.

“We were struck by the pervasiveness of sleep problems across all the diagnoses of mental illness and sleep parameters we looked at,” study investigator Michael Wainberg, PhD, a postdoctoral fellow at the Krembil Centre for Neuroinformatics at the Center for Addiction and Mental Health (CAMH), Toronto, told this news organization. “This suggests there may need to be even more of an emphasis on sleep in these patients than there already is.”

The study, which includes data from nearly 90,000 adults in the United Kingdom, was published online October 12 in PLoS Medicine.

Wavebreak Media/Thinkstockphotos

Trove of data

Data for the analysis comes from the UK Biobank, a large-scale biomedical database launched in 2006 that has collected biological and medical data on more than 500,000 individuals who consented to provide blood, urine, and saliva samples and detailed lifestyle information that is matched to their medical records.

Between 2013 and 2015, more than 103,000 of these participants agreed to wear accelerometers on their wrists for 24 hours a day for 7 days, collecting a trove of data for researchers to mine.

“This allows us to get at objectively derived sleep measures and to measure them in greater numbers of people who have experienced mental illness,” said senior author Shreejoy Tripathy, PhD, assistant professor at the University of Toronto and independent scientist for CAMH. “You can study multiple disorders at once and the influence of other variables that might not be possible in the context of other studies.”

The research is the first known large-scale transdiagnostic study of objectively measured sleep and mental health. Insomnia and other sleep disorders are common among people with mental illness, as shown in prior research, including at least one study that used the same dataset the team employed for this project.

The new findings add to that body of work, Dr. Wainberg said, and look beyond just how long a person sleeps to the quality of the sleep they get.

“We found that the metrics of sleep quality seem to be affected more than mere sleep duration,” he said.
 

Unexpected finding

After excluding participants with faulty accelerometers and those who didn’t wear them for the entire 7-day study period, data from 89,205 participants (aged 43-79, 56% female, 97% self-reported White) was included. Lifetime inpatient psychiatric diagnoses were reported in 2.5% of the entire cohort.

Researchers looked at 10 sleep measures: bedtime, wake-up time, sleep duration, wake after sleep onset, sleep efficiency, number of awakenings, duration of longest sleep bout, number of naps, and variability in bedtime and sleep duration.

Although the effect sizes were small, having any psychiatric diagnosis was associated with significantly lower scores on every sleep measure except sleep duration.

Compared with those with no inpatient psychiatric diagnosis, those with any psychiatric diagnosis were significantly more likely to:

• have a later bedtime (beta = 0.07; 95% confidence interval, 0.06-0.09)
• have later wake-up time (beta = 0.10; 95% CI, 0.09-0.11)
• wake after sleep onset (beta = 0.10; 95% CI, 0.09-0.12)
• have poorer sleep efficiency (beta = –0.12; 95% CI, −0.14 to −0.11)
• have more awakenings (beta = 0.10; 95% CI, 0.09-0.11)
• have shorter duration of their longest sleep bout (beta = –0.09; 95% CI, −0.11 to −0.08)
• take more naps (beta = 0.11; 95% CI, 0.09-0.12)
• have greater variability in their bedtime (beta = 0.08; 95% CI, 0.06-0.09)
• have greater variability in their sleep duration (beta = 0.10; 95% CI, 0.09-0.12)

The only significant differences in sleep duration were found in those with lifetime major depressive disorder, who slept significantly less (beta = −0.02; P = .003), and in those with lifetime schizophrenia, who slept significantly longer (beta = 0.02; P = .0008).

Researchers found similar results when they examined patient-reported sleep measures collected when participants enrolled in the biobank, long before they agreed to wear an accelerometer.

“Everyone with a lifetime mental illness diagnosis trended toward worse sleep quality, regardless of their diagnosis,” Dr. Tripathy said. “We didn’t expect to see that.”

Limitations of the biobank data prohibited analysis by age and past or current use of psychiatric medications. In addition, investigators were unable to determine whether mental illness was active or controlled at the time of the study. Information on these, and other factors, is needed to truly begin to understand the real-world status of sleep patterns in people with mental illness, the researchers note.

However, the biobank data demonstrates how this type of information can be collected, helping Dr. Tripathy and others to design a new study that will launch next year with patients at CAMH. This effort is part of the BrainHealth Databank, a project that aims to develop a patient data bank similar to the one in the UK that was used for this study.

“We’ve shown that you can use wearable devices to measure correlates of sleep and derive insights about the objective measurements of sleep and associate them with mental illness diagnosis,” Dr. Tripathy said.

The study received no outside funding. Dr. Wainberg and Dr. Tripathy report receiving funding from Kavli Foundation, Krembil Foundation, CAMH Discovery Fund, the McLaughlin Foundation, NSERC, and CIHR. Disclosures for other authors are fully listed in the original article.

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

Adding art therapy to standard drug treatment in Parkinson’s disease (PD) not only improves severity of both motor and nonmotor symptoms, but also slows rates of disease progression, new research suggests.

TimothyOLeary/Thinkstock

Fifty PD patients were randomly assigned to receive either art therapy, including sculpting and drawing, plus drug therapy or drug therapy alone, and followed up over 12 months.

Patients receiving combined therapy experienced improvements in symptoms, depression, and cognitive scores, and had reduced tremor and daytime sleepiness. They were also substantially less likely to experience disease progression.

“The use of art therapy can reduce the severity of motor and nonmotor manifestations of Parkinson’s disease,” said study investigator Iryna Khubetova, MD, PhD, head of the neurology department, Odessa (Ukraine) Regional Clinical Hospital.

Crucially, the positive effects “persisted throughout the observation period,” she added.

The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
 

A promising approach

Dr. Khubetova told this news organization that offering art therapy to PD patients was “very affordable,” especially as professional artists “provided materials for painting and other art supplies free of charge.”

“We hope this approach is very promising and would be widely adopted.”

She suggested the positive effect of art therapy could be related to “activating the brain’s reward neural network.”

This may be via improved visual attention acting on visuospatial mechanisms and emotional drive, with “activation of the medial orbitofrontal cortex, ventral striatum, and other structures.”

The researchers note PD, a “multisystem progressive neurodegenerative disease,” is among the three most common neurological disorders, with an incidence of 100-150 cases per 100,000 people.

They also note that nonpharmacologic approaches are “widely used” as an adjunct to drug therapy and as part of an “integrated approach” to disease management.

To examine the clinical efficacy of art therapy, the team recruited patients with PD who had preserved facility for independent movement, defined as stages 1-2.5 on the Hoehn and Yahr scale.

Patients were randomly assigned to art therapy sessions alongside standard drug therapy or to standard drug therapy alone. The art therapy included sculpting, free drawing, and coloring patterns.
 

Multiple benefits

Participants were assessed at baseline and at 6 and 12 months with the Unified Parkinson Disease Rating Scale (UPDRS), the Beck Depression Inventory, the Montreal Cognitive Assessment, and the Pegboard Test of finger dexterity.

Fifty patients were included in the study, with 30 assigned to standard drug therapy alone and 20 to the combined intervention. Participants had a mean age of 57.8 years, and 46% were women.

Over the study period, investigators found patients assigned to art therapy plus drug treatment had improved mood, as well as decreased daytime sleeping, reduced tremor, and a decrease in anxiety and fear intensity.

Between baseline and the 6- and 12-month assessments, patients in the combined therapy group showed improvements in scores on all of the questionnaires, and on the Pegboard Test. In contrast, scores were either stable or worsened in the standard drug therapy–alone group.

The team notes that there was also a marked difference in rates of disease progression, defined as a change on the Hoehn and Yahr scale of at least 0.5 points, between the two groups.

Only two (10%) patients in the combined drug and art therapy progressed over the study period, compared with 10 (33%) in the control group (P = .05).

The findings complement those of a recent study conducted by Alberto Cucca, MD, of the Fresco Institute for Parkinson’s and Movement Disorders, New York University, and colleagues.

Eighteen patients took part in the prospective, open-label trial. They were assessed before and after 20 sessions of art therapy on a range of measures.

Results revealed that following the art therapy, patients had improvements in the Navon Test (which assesses visual neglect, eye tracking, and UPDRS scores), as well as significantly increased functional connectivity levels in the visual cortex on resting-state functional MRI.
 

Many benefits, no side effects

Rebecca Gilbert, MD, PhD, vice president and chief scientific officer of the American Parkinson Disease Association, who was not involved in either study, told this news organization that the idea of art therapy for patients with Parkinson’s is “very reasonable.”

She highlighted that “people with Parkinson’s have many issues with their visuospatial abilities,” as well as their depth and distance perception, and so “enhancing that aspect could potentially be very beneficial.”

“So I’m hopeful that it’s a really good avenue to explore, and the preliminary data are very exciting.”

Dr. Gilbert also highlighted that the “wonderful” aspect of art therapy is that there are “so many benefits and not really any side effects.” Patients can “take the meds … and then enhance that with various therapies, and this would be an additional option.”

Another notable aspect of art therapy is the “social element” and the sense of “camaraderie,” although that has “to be teased out from the benefits you would get from the actual art therapy.”

Finally, Dr. Gilbert pointed out that the difference between the current trial and Dr. Cucca’s trial is the presence of a control group.

“Of course, it’s not blinded, because you know whether you got therapy or not … but that extra element of being able to compare with a group that didn’t get the treatment gives it a little more weight in terms of the field.”

No funding was declared. The authors have disclosed no relevant financial relationships.

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

Adding art therapy to standard drug treatment in Parkinson’s disease (PD) not only improves severity of both motor and nonmotor symptoms, but also slows rates of disease progression, new research suggests.

TimothyOLeary/Thinkstock

Fifty PD patients were randomly assigned to receive either art therapy, including sculpting and drawing, plus drug therapy or drug therapy alone, and followed up over 12 months.

Patients receiving combined therapy experienced improvements in symptoms, depression, and cognitive scores, and had reduced tremor and daytime sleepiness. They were also substantially less likely to experience disease progression.

“The use of art therapy can reduce the severity of motor and nonmotor manifestations of Parkinson’s disease,” said study investigator Iryna Khubetova, MD, PhD, head of the neurology department, Odessa (Ukraine) Regional Clinical Hospital.

Crucially, the positive effects “persisted throughout the observation period,” she added.

The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
 

A promising approach

Dr. Khubetova told this news organization that offering art therapy to PD patients was “very affordable,” especially as professional artists “provided materials for painting and other art supplies free of charge.”

“We hope this approach is very promising and would be widely adopted.”

She suggested the positive effect of art therapy could be related to “activating the brain’s reward neural network.”

This may be via improved visual attention acting on visuospatial mechanisms and emotional drive, with “activation of the medial orbitofrontal cortex, ventral striatum, and other structures.”

The researchers note PD, a “multisystem progressive neurodegenerative disease,” is among the three most common neurological disorders, with an incidence of 100-150 cases per 100,000 people.

They also note that nonpharmacologic approaches are “widely used” as an adjunct to drug therapy and as part of an “integrated approach” to disease management.

To examine the clinical efficacy of art therapy, the team recruited patients with PD who had preserved facility for independent movement, defined as stages 1-2.5 on the Hoehn and Yahr scale.

Patients were randomly assigned to art therapy sessions alongside standard drug therapy or to standard drug therapy alone. The art therapy included sculpting, free drawing, and coloring patterns.
 

Multiple benefits

Participants were assessed at baseline and at 6 and 12 months with the Unified Parkinson Disease Rating Scale (UPDRS), the Beck Depression Inventory, the Montreal Cognitive Assessment, and the Pegboard Test of finger dexterity.

Fifty patients were included in the study, with 30 assigned to standard drug therapy alone and 20 to the combined intervention. Participants had a mean age of 57.8 years, and 46% were women.

Over the study period, investigators found patients assigned to art therapy plus drug treatment had improved mood, as well as decreased daytime sleeping, reduced tremor, and a decrease in anxiety and fear intensity.

Between baseline and the 6- and 12-month assessments, patients in the combined therapy group showed improvements in scores on all of the questionnaires, and on the Pegboard Test. In contrast, scores were either stable or worsened in the standard drug therapy–alone group.

The team notes that there was also a marked difference in rates of disease progression, defined as a change on the Hoehn and Yahr scale of at least 0.5 points, between the two groups.

Only two (10%) patients in the combined drug and art therapy progressed over the study period, compared with 10 (33%) in the control group (P = .05).

The findings complement those of a recent study conducted by Alberto Cucca, MD, of the Fresco Institute for Parkinson’s and Movement Disorders, New York University, and colleagues.

Eighteen patients took part in the prospective, open-label trial. They were assessed before and after 20 sessions of art therapy on a range of measures.

Results revealed that following the art therapy, patients had improvements in the Navon Test (which assesses visual neglect, eye tracking, and UPDRS scores), as well as significantly increased functional connectivity levels in the visual cortex on resting-state functional MRI.
 

Many benefits, no side effects

Rebecca Gilbert, MD, PhD, vice president and chief scientific officer of the American Parkinson Disease Association, who was not involved in either study, told this news organization that the idea of art therapy for patients with Parkinson’s is “very reasonable.”

She highlighted that “people with Parkinson’s have many issues with their visuospatial abilities,” as well as their depth and distance perception, and so “enhancing that aspect could potentially be very beneficial.”

“So I’m hopeful that it’s a really good avenue to explore, and the preliminary data are very exciting.”

Dr. Gilbert also highlighted that the “wonderful” aspect of art therapy is that there are “so many benefits and not really any side effects.” Patients can “take the meds … and then enhance that with various therapies, and this would be an additional option.”

Another notable aspect of art therapy is the “social element” and the sense of “camaraderie,” although that has “to be teased out from the benefits you would get from the actual art therapy.”

Finally, Dr. Gilbert pointed out that the difference between the current trial and Dr. Cucca’s trial is the presence of a control group.

“Of course, it’s not blinded, because you know whether you got therapy or not … but that extra element of being able to compare with a group that didn’t get the treatment gives it a little more weight in terms of the field.”

No funding was declared. The authors have disclosed no relevant financial relationships.

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

Adding art therapy to standard drug treatment in Parkinson’s disease (PD) not only improves severity of both motor and nonmotor symptoms, but also slows rates of disease progression, new research suggests.

TimothyOLeary/Thinkstock

Fifty PD patients were randomly assigned to receive either art therapy, including sculpting and drawing, plus drug therapy or drug therapy alone, and followed up over 12 months.

Patients receiving combined therapy experienced improvements in symptoms, depression, and cognitive scores, and had reduced tremor and daytime sleepiness. They were also substantially less likely to experience disease progression.

“The use of art therapy can reduce the severity of motor and nonmotor manifestations of Parkinson’s disease,” said study investigator Iryna Khubetova, MD, PhD, head of the neurology department, Odessa (Ukraine) Regional Clinical Hospital.

Crucially, the positive effects “persisted throughout the observation period,” she added.

The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
 

A promising approach

Dr. Khubetova told this news organization that offering art therapy to PD patients was “very affordable,” especially as professional artists “provided materials for painting and other art supplies free of charge.”

“We hope this approach is very promising and would be widely adopted.”

She suggested the positive effect of art therapy could be related to “activating the brain’s reward neural network.”

This may be via improved visual attention acting on visuospatial mechanisms and emotional drive, with “activation of the medial orbitofrontal cortex, ventral striatum, and other structures.”

The researchers note PD, a “multisystem progressive neurodegenerative disease,” is among the three most common neurological disorders, with an incidence of 100-150 cases per 100,000 people.

They also note that nonpharmacologic approaches are “widely used” as an adjunct to drug therapy and as part of an “integrated approach” to disease management.

To examine the clinical efficacy of art therapy, the team recruited patients with PD who had preserved facility for independent movement, defined as stages 1-2.5 on the Hoehn and Yahr scale.

Patients were randomly assigned to art therapy sessions alongside standard drug therapy or to standard drug therapy alone. The art therapy included sculpting, free drawing, and coloring patterns.
 

Multiple benefits

Participants were assessed at baseline and at 6 and 12 months with the Unified Parkinson Disease Rating Scale (UPDRS), the Beck Depression Inventory, the Montreal Cognitive Assessment, and the Pegboard Test of finger dexterity.

Fifty patients were included in the study, with 30 assigned to standard drug therapy alone and 20 to the combined intervention. Participants had a mean age of 57.8 years, and 46% were women.

Over the study period, investigators found patients assigned to art therapy plus drug treatment had improved mood, as well as decreased daytime sleeping, reduced tremor, and a decrease in anxiety and fear intensity.

Between baseline and the 6- and 12-month assessments, patients in the combined therapy group showed improvements in scores on all of the questionnaires, and on the Pegboard Test. In contrast, scores were either stable or worsened in the standard drug therapy–alone group.

The team notes that there was also a marked difference in rates of disease progression, defined as a change on the Hoehn and Yahr scale of at least 0.5 points, between the two groups.

Only two (10%) patients in the combined drug and art therapy progressed over the study period, compared with 10 (33%) in the control group (P = .05).

The findings complement those of a recent study conducted by Alberto Cucca, MD, of the Fresco Institute for Parkinson’s and Movement Disorders, New York University, and colleagues.

Eighteen patients took part in the prospective, open-label trial. They were assessed before and after 20 sessions of art therapy on a range of measures.

Results revealed that following the art therapy, patients had improvements in the Navon Test (which assesses visual neglect, eye tracking, and UPDRS scores), as well as significantly increased functional connectivity levels in the visual cortex on resting-state functional MRI.
 

Many benefits, no side effects

Rebecca Gilbert, MD, PhD, vice president and chief scientific officer of the American Parkinson Disease Association, who was not involved in either study, told this news organization that the idea of art therapy for patients with Parkinson’s is “very reasonable.”

She highlighted that “people with Parkinson’s have many issues with their visuospatial abilities,” as well as their depth and distance perception, and so “enhancing that aspect could potentially be very beneficial.”

“So I’m hopeful that it’s a really good avenue to explore, and the preliminary data are very exciting.”

Dr. Gilbert also highlighted that the “wonderful” aspect of art therapy is that there are “so many benefits and not really any side effects.” Patients can “take the meds … and then enhance that with various therapies, and this would be an additional option.”

Another notable aspect of art therapy is the “social element” and the sense of “camaraderie,” although that has “to be teased out from the benefits you would get from the actual art therapy.”

Finally, Dr. Gilbert pointed out that the difference between the current trial and Dr. Cucca’s trial is the presence of a control group.

“Of course, it’s not blinded, because you know whether you got therapy or not … but that extra element of being able to compare with a group that didn’t get the treatment gives it a little more weight in terms of the field.”

No funding was declared. The authors have disclosed no relevant financial relationships.

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

Substance use disorders can be a thorny topic in residency because of our role as gatekeepers of mental hospitals during our training. Intoxicated patients often get dismissed as a burden and distraction, malingering their way into a comfortable place to regain sobriety. This is extremely prevalent, often constituting the majority of patients seen during an emergency department call.

A typical interview may elicit any or all symptoms in the DSM yet be best explained by substance use intoxication or withdrawal. Alcohol and other CNS depressants commonly cause feelings of sadness and/or suicidality. Methamphetamine and other CNS stimulants commonly cause symptoms of psychosis or mania, followed by feelings of sadness and/or suicidality.

Different EDs have different degrees of patience for individuals in the process of becoming sober. Some departments will pressure clinicians into quickly discarding those patients and often frown upon any attempt at providing solace by raising the concern of reinforcing maladaptive behavior. A mystery-meat sandwich of admirable blandness may be the extent of help offered. Some more fortunate patients also receive a juice box or even a taxi voucher in an especially generous ED. This is always against our better judgment, of course, as we are told those gestures encourage abuse.

Other EDs will permit patients to remain until sober, allowing for another evaluation without the influence of controlled substances. We are reminded of many conversations with patients with substance use disorders, where topics discussed included: 1. Recommendation to seek substance use services, which are often nonexistent or with wait lists spanning months; 2. Education on the role of mental health hospitals and how patients’ despair in the context of intoxication does not meet some scriptural criteria; 3. Pep talks aided by such previously described sandwiches and juice boxes to encourage a sobering patient to leave the facility of their own will.

Methamphetamine, heroin, and alcohol are rarely one-and-done endeavors. We sparingly see our patients for their very first ED visit while intoxicated or crashing. They know how the system runs and which ED will more readily allow them an overnight stay. The number of times they have been recommended for substance use treatment is beyond counting – they may have been on a wait list a handful of times. They are aware of our reluctance to provide inpatient psychiatric treatment for substance use, but it is worth a shot trying, anyway – sometimes they get lucky. Usually it is the pep talk, relief from hunger pangs, and daylight that get them out the doors – until next time.

It is under this context that many trainees become psychiatrists, a process that solidifies the separation between drug use and mental illness. Many graduate from residency practically equating substance use disorder with malingering or futility. This can take on a surreal quality as many localities have recently adopted particular forms or requirements like the dispensation of naloxone syringes to all patients with substance use disorders. While the desire and effort are noble, it may suggest to a patient presenting for help that society’s main interest is to avoid seeing them die rather than help with available resources for maintaining sobriety.

Therein lies the conundrum, a conundrum that spans psychiatry to society. The conundrum is our ambivalence between punishing the choice of drug use or healing the substance use disorder. Should we discharge the intoxicated patient as soon as they are safe to walk out, or should we make every effort possible to find long-term solutions? Where someone decides to draw the line often seems quite arbitrary.
 

The calculation becomes more complex

A defining moment appears to have been society’s reconsideration of its stance on substance use disorders when affluent White teenagers started dying in the suburbs from pain pills overdoses. Suddenly, those children needed and deserved treatment, not punishment. We find ourselves far away from a time when the loudest societal commentary on substance use entailed mothers advocating for harsher sentences against drunk drivers.

More recently, as psychiatry and large contingents of society have decided to take up the mantle of equity and social justice, we have begun to make progress in decriminalizing substance use in an effort to reverse systemic discrimination toward minority groups. This has taken many shapes, including drug legalization, criminal justice reform, and even the provision of clean substance use paraphernalia for safer use of IV drugs. Police reform has led to reluctance to arrest or press charges for nonviolent crimes and reduced police presence in minority neighborhoods. The “rich White teenager” approach is now recommended in all neighborhoods.

Society’s attempt at decriminalizing drug use has run parallel with psychiatry’s recent attempts at reduced pathologizing of behaviors more prevalent in underprivileged groups and cultures. This runs the gamut, from avoiding the use of the term “agitated” because of its racial connotations, to advocating for reduced rates of schizophrenia diagnoses in Black males.¹ A diagnosis of substance use disorder carries with it similar troublesome societal implications. Decriminalization, legalization, provision of substances to the population, normalization, and other societal reforms will likely have an impact on the prevalence of substance use disorder diagnoses, which involve many criteria dependent on societal context.

It would be expected that criteria such as hazardous use, social problems, and attempts to quit will decrease as social acceptance increases. How might this affect access to substance use treatment, an already extremely limited resource?

Now, as forensic psychiatrists, we find ourselves adjudicating on the role of drugs at a time when society is wrestling with its attitude on the breadth of responsibility possessed by people who use drugs. In California, as in many other states, insanity laws exclude those who were insane as a result of drug use, as a testament to or possibly a remnant of how society feels about the role of choice and responsibility in the use of drugs. Yet another defendant who admits to drug use may on the contrary receive a much more lenient plea deal if willing to commit to sobriety. But in a never-ending maze of differing judgments and opinions, a less understanding district attorney may argue that the additional risk posed by the use of drugs and resulting impulsivity may actually warrant a heavier sentence.

In a recent attempt at atonement for our past punitive stance on drug users, we have found a desire to protect those who use drugs by punishing those who sell, at times forgetting that these populations are deeply intertwined. A recent law permits the federal charge of distribution of fentanyl resulting in death, which carries the mandatory minimum of 20 years in prison. Yet, if the user whom we are trying to protect by this law is also the one selling, what are we left with?

Fentanyl has been a particularly tragic development in the history of mankind and drug use. Substance use has rarely been so easily linked to accidental death. While many physicians can easily explain the safety of fentanyl when used as prescribed and in controlled settings, this is certainly not the case in the community. Measuring micrograms of fentanyl is outside the knowledge and capabilities of most drug dealers, who are not equipped with pharmacy-grade scales. Yet, as a result, they sell and customers buy quantities of fentanyl that range from homeopathically low to lethally high because of a mixture of negligence and deliberate indifference.

Another effort at atonement has been attempts at decriminalizing drug use and releasing many nonviolent offenders. This can, however, encourage bystanders to report more acts as crime rather than public intoxication, to ensure a police response when confronted by intoxicated people. Whereas previously an inebriated person who is homeless may have been called for and asked to seek shelter, they now get called on, and subsequently charged for, allegedly mumbling a threat by a frustrated bystander.

The release of offenders has its limits. Many placements on probation require sobriety and result in longer sentences for the use of substances that are otherwise decriminalized. The decriminalization and reexamination of substance use by society should widen the scope from simply considering crime to examining the use of drugs throughout the legal system and even beyond.

The DSM and psychiatry are not intended or equipped to adjudicate disputes on where the lines should be drawn between determinism and free will. We are knowledgeable of patients with substance use disorders, the effect of intoxicating substances, and the capacity of patients with substance use disorders to act in law-abiding ways. Our field can inform without simply advocating whether our patients should be punished. While society is currently struggling with how to apportion blame, psychiatry should resist the urge to impose medical solutions to social problems. Our solutions would almost certainly be grossly limited as we are still struggling to repent for lobotomizing “uppity” young women² and using electroshock therapy to disrupt perverse impulses in homosexual males.³ Social norms and political zeitgeists change over time while the psychological and physiological principles underlying our understanding of mental illness should, in theory, stay relatively constant. Psychiatry’s answers for societal ills do not usually improve with time but rather have a tendency to be humbling.
 

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com.

Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1.Medlock MM et al., eds. “Racism and Psychiatry: Contemporary Issues and Interventions” (New York: Springer, 2018).

2. Tone A and Koziol M. CMAJ. 2018:190(20):e624-5.

3. McGuire RJ and Vallance M. BMJ. 1964;1(5376):151-3.

Substance use disorders can be a thorny topic in residency because of our role as gatekeepers of mental hospitals during our training. Intoxicated patients often get dismissed as a burden and distraction, malingering their way into a comfortable place to regain sobriety. This is extremely prevalent, often constituting the majority of patients seen during an emergency department call.

A typical interview may elicit any or all symptoms in the DSM yet be best explained by substance use intoxication or withdrawal. Alcohol and other CNS depressants commonly cause feelings of sadness and/or suicidality. Methamphetamine and other CNS stimulants commonly cause symptoms of psychosis or mania, followed by feelings of sadness and/or suicidality.

Different EDs have different degrees of patience for individuals in the process of becoming sober. Some departments will pressure clinicians into quickly discarding those patients and often frown upon any attempt at providing solace by raising the concern of reinforcing maladaptive behavior. A mystery-meat sandwich of admirable blandness may be the extent of help offered. Some more fortunate patients also receive a juice box or even a taxi voucher in an especially generous ED. This is always against our better judgment, of course, as we are told those gestures encourage abuse.

Other EDs will permit patients to remain until sober, allowing for another evaluation without the influence of controlled substances. We are reminded of many conversations with patients with substance use disorders, where topics discussed included: 1. Recommendation to seek substance use services, which are often nonexistent or with wait lists spanning months; 2. Education on the role of mental health hospitals and how patients’ despair in the context of intoxication does not meet some scriptural criteria; 3. Pep talks aided by such previously described sandwiches and juice boxes to encourage a sobering patient to leave the facility of their own will.

Methamphetamine, heroin, and alcohol are rarely one-and-done endeavors. We sparingly see our patients for their very first ED visit while intoxicated or crashing. They know how the system runs and which ED will more readily allow them an overnight stay. The number of times they have been recommended for substance use treatment is beyond counting – they may have been on a wait list a handful of times. They are aware of our reluctance to provide inpatient psychiatric treatment for substance use, but it is worth a shot trying, anyway – sometimes they get lucky. Usually it is the pep talk, relief from hunger pangs, and daylight that get them out the doors – until next time.

It is under this context that many trainees become psychiatrists, a process that solidifies the separation between drug use and mental illness. Many graduate from residency practically equating substance use disorder with malingering or futility. This can take on a surreal quality as many localities have recently adopted particular forms or requirements like the dispensation of naloxone syringes to all patients with substance use disorders. While the desire and effort are noble, it may suggest to a patient presenting for help that society’s main interest is to avoid seeing them die rather than help with available resources for maintaining sobriety.

Therein lies the conundrum, a conundrum that spans psychiatry to society. The conundrum is our ambivalence between punishing the choice of drug use or healing the substance use disorder. Should we discharge the intoxicated patient as soon as they are safe to walk out, or should we make every effort possible to find long-term solutions? Where someone decides to draw the line often seems quite arbitrary.
 

The calculation becomes more complex

A defining moment appears to have been society’s reconsideration of its stance on substance use disorders when affluent White teenagers started dying in the suburbs from pain pills overdoses. Suddenly, those children needed and deserved treatment, not punishment. We find ourselves far away from a time when the loudest societal commentary on substance use entailed mothers advocating for harsher sentences against drunk drivers.

More recently, as psychiatry and large contingents of society have decided to take up the mantle of equity and social justice, we have begun to make progress in decriminalizing substance use in an effort to reverse systemic discrimination toward minority groups. This has taken many shapes, including drug legalization, criminal justice reform, and even the provision of clean substance use paraphernalia for safer use of IV drugs. Police reform has led to reluctance to arrest or press charges for nonviolent crimes and reduced police presence in minority neighborhoods. The “rich White teenager” approach is now recommended in all neighborhoods.

Society’s attempt at decriminalizing drug use has run parallel with psychiatry’s recent attempts at reduced pathologizing of behaviors more prevalent in underprivileged groups and cultures. This runs the gamut, from avoiding the use of the term “agitated” because of its racial connotations, to advocating for reduced rates of schizophrenia diagnoses in Black males.¹ A diagnosis of substance use disorder carries with it similar troublesome societal implications. Decriminalization, legalization, provision of substances to the population, normalization, and other societal reforms will likely have an impact on the prevalence of substance use disorder diagnoses, which involve many criteria dependent on societal context.

It would be expected that criteria such as hazardous use, social problems, and attempts to quit will decrease as social acceptance increases. How might this affect access to substance use treatment, an already extremely limited resource?

Now, as forensic psychiatrists, we find ourselves adjudicating on the role of drugs at a time when society is wrestling with its attitude on the breadth of responsibility possessed by people who use drugs. In California, as in many other states, insanity laws exclude those who were insane as a result of drug use, as a testament to or possibly a remnant of how society feels about the role of choice and responsibility in the use of drugs. Yet another defendant who admits to drug use may on the contrary receive a much more lenient plea deal if willing to commit to sobriety. But in a never-ending maze of differing judgments and opinions, a less understanding district attorney may argue that the additional risk posed by the use of drugs and resulting impulsivity may actually warrant a heavier sentence.

In a recent attempt at atonement for our past punitive stance on drug users, we have found a desire to protect those who use drugs by punishing those who sell, at times forgetting that these populations are deeply intertwined. A recent law permits the federal charge of distribution of fentanyl resulting in death, which carries the mandatory minimum of 20 years in prison. Yet, if the user whom we are trying to protect by this law is also the one selling, what are we left with?

Fentanyl has been a particularly tragic development in the history of mankind and drug use. Substance use has rarely been so easily linked to accidental death. While many physicians can easily explain the safety of fentanyl when used as prescribed and in controlled settings, this is certainly not the case in the community. Measuring micrograms of fentanyl is outside the knowledge and capabilities of most drug dealers, who are not equipped with pharmacy-grade scales. Yet, as a result, they sell and customers buy quantities of fentanyl that range from homeopathically low to lethally high because of a mixture of negligence and deliberate indifference.

Another effort at atonement has been attempts at decriminalizing drug use and releasing many nonviolent offenders. This can, however, encourage bystanders to report more acts as crime rather than public intoxication, to ensure a police response when confronted by intoxicated people. Whereas previously an inebriated person who is homeless may have been called for and asked to seek shelter, they now get called on, and subsequently charged for, allegedly mumbling a threat by a frustrated bystander.

The release of offenders has its limits. Many placements on probation require sobriety and result in longer sentences for the use of substances that are otherwise decriminalized. The decriminalization and reexamination of substance use by society should widen the scope from simply considering crime to examining the use of drugs throughout the legal system and even beyond.

The DSM and psychiatry are not intended or equipped to adjudicate disputes on where the lines should be drawn between determinism and free will. We are knowledgeable of patients with substance use disorders, the effect of intoxicating substances, and the capacity of patients with substance use disorders to act in law-abiding ways. Our field can inform without simply advocating whether our patients should be punished. While society is currently struggling with how to apportion blame, psychiatry should resist the urge to impose medical solutions to social problems. Our solutions would almost certainly be grossly limited as we are still struggling to repent for lobotomizing “uppity” young women² and using electroshock therapy to disrupt perverse impulses in homosexual males.³ Social norms and political zeitgeists change over time while the psychological and physiological principles underlying our understanding of mental illness should, in theory, stay relatively constant. Psychiatry’s answers for societal ills do not usually improve with time but rather have a tendency to be humbling.
 

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com.

Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1.Medlock MM et al., eds. “Racism and Psychiatry: Contemporary Issues and Interventions” (New York: Springer, 2018).

2. Tone A and Koziol M. CMAJ. 2018:190(20):e624-5.

3. McGuire RJ and Vallance M. BMJ. 1964;1(5376):151-3.

Substance use disorders can be a thorny topic in residency because of our role as gatekeepers of mental hospitals during our training. Intoxicated patients often get dismissed as a burden and distraction, malingering their way into a comfortable place to regain sobriety. This is extremely prevalent, often constituting the majority of patients seen during an emergency department call.

A typical interview may elicit any or all symptoms in the DSM yet be best explained by substance use intoxication or withdrawal. Alcohol and other CNS depressants commonly cause feelings of sadness and/or suicidality. Methamphetamine and other CNS stimulants commonly cause symptoms of psychosis or mania, followed by feelings of sadness and/or suicidality.

Different EDs have different degrees of patience for individuals in the process of becoming sober. Some departments will pressure clinicians into quickly discarding those patients and often frown upon any attempt at providing solace by raising the concern of reinforcing maladaptive behavior. A mystery-meat sandwich of admirable blandness may be the extent of help offered. Some more fortunate patients also receive a juice box or even a taxi voucher in an especially generous ED. This is always against our better judgment, of course, as we are told those gestures encourage abuse.

Other EDs will permit patients to remain until sober, allowing for another evaluation without the influence of controlled substances. We are reminded of many conversations with patients with substance use disorders, where topics discussed included: 1. Recommendation to seek substance use services, which are often nonexistent or with wait lists spanning months; 2. Education on the role of mental health hospitals and how patients’ despair in the context of intoxication does not meet some scriptural criteria; 3. Pep talks aided by such previously described sandwiches and juice boxes to encourage a sobering patient to leave the facility of their own will.

Methamphetamine, heroin, and alcohol are rarely one-and-done endeavors. We sparingly see our patients for their very first ED visit while intoxicated or crashing. They know how the system runs and which ED will more readily allow them an overnight stay. The number of times they have been recommended for substance use treatment is beyond counting – they may have been on a wait list a handful of times. They are aware of our reluctance to provide inpatient psychiatric treatment for substance use, but it is worth a shot trying, anyway – sometimes they get lucky. Usually it is the pep talk, relief from hunger pangs, and daylight that get them out the doors – until next time.

It is under this context that many trainees become psychiatrists, a process that solidifies the separation between drug use and mental illness. Many graduate from residency practically equating substance use disorder with malingering or futility. This can take on a surreal quality as many localities have recently adopted particular forms or requirements like the dispensation of naloxone syringes to all patients with substance use disorders. While the desire and effort are noble, it may suggest to a patient presenting for help that society’s main interest is to avoid seeing them die rather than help with available resources for maintaining sobriety.

Therein lies the conundrum, a conundrum that spans psychiatry to society. The conundrum is our ambivalence between punishing the choice of drug use or healing the substance use disorder. Should we discharge the intoxicated patient as soon as they are safe to walk out, or should we make every effort possible to find long-term solutions? Where someone decides to draw the line often seems quite arbitrary.
 

The calculation becomes more complex

A defining moment appears to have been society’s reconsideration of its stance on substance use disorders when affluent White teenagers started dying in the suburbs from pain pills overdoses. Suddenly, those children needed and deserved treatment, not punishment. We find ourselves far away from a time when the loudest societal commentary on substance use entailed mothers advocating for harsher sentences against drunk drivers.

More recently, as psychiatry and large contingents of society have decided to take up the mantle of equity and social justice, we have begun to make progress in decriminalizing substance use in an effort to reverse systemic discrimination toward minority groups. This has taken many shapes, including drug legalization, criminal justice reform, and even the provision of clean substance use paraphernalia for safer use of IV drugs. Police reform has led to reluctance to arrest or press charges for nonviolent crimes and reduced police presence in minority neighborhoods. The “rich White teenager” approach is now recommended in all neighborhoods.

Society’s attempt at decriminalizing drug use has run parallel with psychiatry’s recent attempts at reduced pathologizing of behaviors more prevalent in underprivileged groups and cultures. This runs the gamut, from avoiding the use of the term “agitated” because of its racial connotations, to advocating for reduced rates of schizophrenia diagnoses in Black males.¹ A diagnosis of substance use disorder carries with it similar troublesome societal implications. Decriminalization, legalization, provision of substances to the population, normalization, and other societal reforms will likely have an impact on the prevalence of substance use disorder diagnoses, which involve many criteria dependent on societal context.

It would be expected that criteria such as hazardous use, social problems, and attempts to quit will decrease as social acceptance increases. How might this affect access to substance use treatment, an already extremely limited resource?

Now, as forensic psychiatrists, we find ourselves adjudicating on the role of drugs at a time when society is wrestling with its attitude on the breadth of responsibility possessed by people who use drugs. In California, as in many other states, insanity laws exclude those who were insane as a result of drug use, as a testament to or possibly a remnant of how society feels about the role of choice and responsibility in the use of drugs. Yet another defendant who admits to drug use may on the contrary receive a much more lenient plea deal if willing to commit to sobriety. But in a never-ending maze of differing judgments and opinions, a less understanding district attorney may argue that the additional risk posed by the use of drugs and resulting impulsivity may actually warrant a heavier sentence.

In a recent attempt at atonement for our past punitive stance on drug users, we have found a desire to protect those who use drugs by punishing those who sell, at times forgetting that these populations are deeply intertwined. A recent law permits the federal charge of distribution of fentanyl resulting in death, which carries the mandatory minimum of 20 years in prison. Yet, if the user whom we are trying to protect by this law is also the one selling, what are we left with?

Fentanyl has been a particularly tragic development in the history of mankind and drug use. Substance use has rarely been so easily linked to accidental death. While many physicians can easily explain the safety of fentanyl when used as prescribed and in controlled settings, this is certainly not the case in the community. Measuring micrograms of fentanyl is outside the knowledge and capabilities of most drug dealers, who are not equipped with pharmacy-grade scales. Yet, as a result, they sell and customers buy quantities of fentanyl that range from homeopathically low to lethally high because of a mixture of negligence and deliberate indifference.

Another effort at atonement has been attempts at decriminalizing drug use and releasing many nonviolent offenders. This can, however, encourage bystanders to report more acts as crime rather than public intoxication, to ensure a police response when confronted by intoxicated people. Whereas previously an inebriated person who is homeless may have been called for and asked to seek shelter, they now get called on, and subsequently charged for, allegedly mumbling a threat by a frustrated bystander.

The release of offenders has its limits. Many placements on probation require sobriety and result in longer sentences for the use of substances that are otherwise decriminalized. The decriminalization and reexamination of substance use by society should widen the scope from simply considering crime to examining the use of drugs throughout the legal system and even beyond.

The DSM and psychiatry are not intended or equipped to adjudicate disputes on where the lines should be drawn between determinism and free will. We are knowledgeable of patients with substance use disorders, the effect of intoxicating substances, and the capacity of patients with substance use disorders to act in law-abiding ways. Our field can inform without simply advocating whether our patients should be punished. While society is currently struggling with how to apportion blame, psychiatry should resist the urge to impose medical solutions to social problems. Our solutions would almost certainly be grossly limited as we are still struggling to repent for lobotomizing “uppity” young women² and using electroshock therapy to disrupt perverse impulses in homosexual males.³ Social norms and political zeitgeists change over time while the psychological and physiological principles underlying our understanding of mental illness should, in theory, stay relatively constant. Psychiatry’s answers for societal ills do not usually improve with time but rather have a tendency to be humbling.
 

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com.

Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1.Medlock MM et al., eds. “Racism and Psychiatry: Contemporary Issues and Interventions” (New York: Springer, 2018).

2. Tone A and Koziol M. CMAJ. 2018:190(20):e624-5.

3. McGuire RJ and Vallance M. BMJ. 1964;1(5376):151-3.