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Are Your Patients With COPD Inhaling Eucalyptus Oil? Know the Risks
There’s been renewed interest in recent years for concentrated essential oils to replace or complement pharmaceutical treatments. This is especially concerning among patients with chronic obstructive pulmonary disease (COPD), who might be eager to turn to alternatives but are unaware that COPD increases sensitivity to lung irritants like essential oils.
Eucalyptus oil might be at or near the top of the essential oils list for these patients, given its storied history in both ancient and modern medicine for treating colds and respiratory illnesses. Its inclusion in the United States and European pharmacopoeias has also reinforced its legitimacy. And, today, patients are at risk of confusing the primary active ingredient in eucalyptus — the monoterpene 1,8-cineole (eucalyptol, which has been shown to reduce COPD exacerbations when used adjunctively) — with concentrated essential oils that can be purchased online and in stores here in the United States.
“The more potent active ingredient, eucalyptol (in capsule form), is approved in Germany — not the essential oil of eucalyptus, which contains other compounds. I recommend against using any sort of inhaled essential oils for patients with chronic respiratory illnesses, mainly because they are unregulated and unstandardized,” explained Ni-Chen Liang, MD, an integrative pulmonologist affiliated with Scripps Memorial Hospital Encinitas in Encinitas, California.
“The substances that come out when you create eucalyptus oil are a ‘gamash’ of all sorts of chemicals — some benign, some which taste good, and some that may be irritating or even dangerous,” said Neil Schachter, MD, pulmonologist and professor of medicine (pulmonary, critical care, and sleep medicine) at the Icahn School of Medicine at Mount Sinai, New York City.
“They can also produce volatile organic compounds (VOCs) related to their formulas, which contain fillers and other constituents,” Liang said.
Hidden Dangers
Eucalyptus oil was first used by Aboriginal Australians, who crushed the leaves for their antiseptic properties or steamed them for their expectorant activity. Today, eucalyptus oil can be found in mouthwash and soap, used topically to relieve pain or repel insects, or added to cleaning products due to its disinfectant properties.
However, inhalation via diffusers or directly from the bottle can trigger different respiratory reactions, including cough, wheezing, shortness of breath, as well as respiratory distress.
“The vapors contain oil, ie, fatty products that can be irritating in and of themselves,” said Schachter. “There are cases where people have inhaled these oils and developed lipid pneumonia, which is very hard to treat,” he said.
Anything inhaled into the lungs is a risk, said Juan Rojas, MD, assistant professor, Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine at Rush University Medical Center in Chicago. Rojas compared inhaling essential oils to e-cigarettes, which, in addition to tobacco, contain a variety of chemicals and additives that cause a lung reaction in the short term and create inflammatory patterns in the medium and long term.
“Another problem is that when ingested, eucalyptus oil can be distressing to the gastrointestinal tract. In larger doses, it can actually have some neurological impact as well, including seizures,” said Kalilah L. Gates, MD, associate professor of medicine (pulmonary and critical care) and assistant dean of medical education at Northwestern Feinberg School of Medicine in Chicago.
Clinical trial data have also shown a significant association between long-term exposure to essential oils and cardiopulmonary effects such as increased heart rate and blood pressure and a decline in percentage predicted peak expiratory flow rate in healthy volunteers. In the study of 200 participants (who were homemakers), long-term exposure referred to daily hours (> 4/d) and the study period, which was 10 years.
About Eucalyptol
Eucalyptol is rapidly absorbed and quickly distributed throughout the bloodstream, which allows it to reach the bronchial system, where it is expelled by the lungs. It’s been shown in various preclinical studies to have anti-inflammatory, antioxidant, mucolytic, and bronchodilatory activity, as well as antimicrobial effects.
For the past decade, enteric-coated eucalyptol capsules containing 100 mg or 200 mg of 1,8-cineole have been available in Germany for adjunctive treatment of inflammatory respiratory disorders, including asthma and COPD. Due to its limited bioactivity, frequent administration is required.
Clinical evidence of eucalyptol’s effectiveness is somewhat limited. Findings from a 2009 double-blind, placebo-controlled, multicenter study also demonstrated that when used along with beta-agonists, anticholinergics, corticosteroids, or combinations in patients with stable COPD, severity and duration of exacerbations over 6 months were significantly decreased compared with placebo.
However, Liang was quick to point out that studies of oral eucalyptol preparations in pulmonary patients have not been robust enough.
“I haven’t been able to find anything written by a multitude of different authors, which, to me, is a red flag. We want naturally occurring substances to be well tested in multicenter studies across a variety of different patient populations outside of Germany to ensure that results are reproducible,” she said.
Rojas concurred. “Even with the data in Europe, I would say that the studies have been underpowered to support large-scale adoption or suggest that the active ingredient for patients with moderate or severe COPD could be considered an adjunctive therapy with traditional medications,” he said.
“It would be difficult for me to make a recommendation without knowing the full impact,” said Rojas.
Open Dialogue
Like many chronic diseases, it’s important to meet patients where they are, including their use of unapproved or unwise treatment strategies.
“More times than not, they’ve already figured out their triggers for worsening respiratory symptoms, what does and doesn’t work for them, and what predicts a good vs a bad day from a respiratory standpoint,” said Liang.
“There’s a lot of popularity and claims related to essential oil use, and ultimately, we need to partner to find healing modalities (which may or may not include essential oils) that are ultimately helpful and minimize harm,” she said.
Gates suggested that when it comes to eucalyptus essential oil vs eucalyptol, education of both patients and doctors is key.
“The issue is that we had a study showing that a particular component — the active ingredient of eucalyptus oil was isolated and put into the capsule form and showed benefit. And then we extrapolated and said, ‘well, let’s just take (or inhale) eucalyptus oil. It’s not the same thing,” she said.
“I feel that it’s my responsibility to make sure that patients have the information they need to make informed decisions. It’s about being willing to communicate and have open conversations about what they may be taking in addition to medications that I prescribe,” said Gates.
Liang, Schachter, Rojas, and Gates reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There’s been renewed interest in recent years for concentrated essential oils to replace or complement pharmaceutical treatments. This is especially concerning among patients with chronic obstructive pulmonary disease (COPD), who might be eager to turn to alternatives but are unaware that COPD increases sensitivity to lung irritants like essential oils.
Eucalyptus oil might be at or near the top of the essential oils list for these patients, given its storied history in both ancient and modern medicine for treating colds and respiratory illnesses. Its inclusion in the United States and European pharmacopoeias has also reinforced its legitimacy. And, today, patients are at risk of confusing the primary active ingredient in eucalyptus — the monoterpene 1,8-cineole (eucalyptol, which has been shown to reduce COPD exacerbations when used adjunctively) — with concentrated essential oils that can be purchased online and in stores here in the United States.
“The more potent active ingredient, eucalyptol (in capsule form), is approved in Germany — not the essential oil of eucalyptus, which contains other compounds. I recommend against using any sort of inhaled essential oils for patients with chronic respiratory illnesses, mainly because they are unregulated and unstandardized,” explained Ni-Chen Liang, MD, an integrative pulmonologist affiliated with Scripps Memorial Hospital Encinitas in Encinitas, California.
“The substances that come out when you create eucalyptus oil are a ‘gamash’ of all sorts of chemicals — some benign, some which taste good, and some that may be irritating or even dangerous,” said Neil Schachter, MD, pulmonologist and professor of medicine (pulmonary, critical care, and sleep medicine) at the Icahn School of Medicine at Mount Sinai, New York City.
“They can also produce volatile organic compounds (VOCs) related to their formulas, which contain fillers and other constituents,” Liang said.
Hidden Dangers
Eucalyptus oil was first used by Aboriginal Australians, who crushed the leaves for their antiseptic properties or steamed them for their expectorant activity. Today, eucalyptus oil can be found in mouthwash and soap, used topically to relieve pain or repel insects, or added to cleaning products due to its disinfectant properties.
However, inhalation via diffusers or directly from the bottle can trigger different respiratory reactions, including cough, wheezing, shortness of breath, as well as respiratory distress.
“The vapors contain oil, ie, fatty products that can be irritating in and of themselves,” said Schachter. “There are cases where people have inhaled these oils and developed lipid pneumonia, which is very hard to treat,” he said.
Anything inhaled into the lungs is a risk, said Juan Rojas, MD, assistant professor, Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine at Rush University Medical Center in Chicago. Rojas compared inhaling essential oils to e-cigarettes, which, in addition to tobacco, contain a variety of chemicals and additives that cause a lung reaction in the short term and create inflammatory patterns in the medium and long term.
“Another problem is that when ingested, eucalyptus oil can be distressing to the gastrointestinal tract. In larger doses, it can actually have some neurological impact as well, including seizures,” said Kalilah L. Gates, MD, associate professor of medicine (pulmonary and critical care) and assistant dean of medical education at Northwestern Feinberg School of Medicine in Chicago.
Clinical trial data have also shown a significant association between long-term exposure to essential oils and cardiopulmonary effects such as increased heart rate and blood pressure and a decline in percentage predicted peak expiratory flow rate in healthy volunteers. In the study of 200 participants (who were homemakers), long-term exposure referred to daily hours (> 4/d) and the study period, which was 10 years.
About Eucalyptol
Eucalyptol is rapidly absorbed and quickly distributed throughout the bloodstream, which allows it to reach the bronchial system, where it is expelled by the lungs. It’s been shown in various preclinical studies to have anti-inflammatory, antioxidant, mucolytic, and bronchodilatory activity, as well as antimicrobial effects.
For the past decade, enteric-coated eucalyptol capsules containing 100 mg or 200 mg of 1,8-cineole have been available in Germany for adjunctive treatment of inflammatory respiratory disorders, including asthma and COPD. Due to its limited bioactivity, frequent administration is required.
Clinical evidence of eucalyptol’s effectiveness is somewhat limited. Findings from a 2009 double-blind, placebo-controlled, multicenter study also demonstrated that when used along with beta-agonists, anticholinergics, corticosteroids, or combinations in patients with stable COPD, severity and duration of exacerbations over 6 months were significantly decreased compared with placebo.
However, Liang was quick to point out that studies of oral eucalyptol preparations in pulmonary patients have not been robust enough.
“I haven’t been able to find anything written by a multitude of different authors, which, to me, is a red flag. We want naturally occurring substances to be well tested in multicenter studies across a variety of different patient populations outside of Germany to ensure that results are reproducible,” she said.
Rojas concurred. “Even with the data in Europe, I would say that the studies have been underpowered to support large-scale adoption or suggest that the active ingredient for patients with moderate or severe COPD could be considered an adjunctive therapy with traditional medications,” he said.
“It would be difficult for me to make a recommendation without knowing the full impact,” said Rojas.
Open Dialogue
Like many chronic diseases, it’s important to meet patients where they are, including their use of unapproved or unwise treatment strategies.
“More times than not, they’ve already figured out their triggers for worsening respiratory symptoms, what does and doesn’t work for them, and what predicts a good vs a bad day from a respiratory standpoint,” said Liang.
“There’s a lot of popularity and claims related to essential oil use, and ultimately, we need to partner to find healing modalities (which may or may not include essential oils) that are ultimately helpful and minimize harm,” she said.
Gates suggested that when it comes to eucalyptus essential oil vs eucalyptol, education of both patients and doctors is key.
“The issue is that we had a study showing that a particular component — the active ingredient of eucalyptus oil was isolated and put into the capsule form and showed benefit. And then we extrapolated and said, ‘well, let’s just take (or inhale) eucalyptus oil. It’s not the same thing,” she said.
“I feel that it’s my responsibility to make sure that patients have the information they need to make informed decisions. It’s about being willing to communicate and have open conversations about what they may be taking in addition to medications that I prescribe,” said Gates.
Liang, Schachter, Rojas, and Gates reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There’s been renewed interest in recent years for concentrated essential oils to replace or complement pharmaceutical treatments. This is especially concerning among patients with chronic obstructive pulmonary disease (COPD), who might be eager to turn to alternatives but are unaware that COPD increases sensitivity to lung irritants like essential oils.
Eucalyptus oil might be at or near the top of the essential oils list for these patients, given its storied history in both ancient and modern medicine for treating colds and respiratory illnesses. Its inclusion in the United States and European pharmacopoeias has also reinforced its legitimacy. And, today, patients are at risk of confusing the primary active ingredient in eucalyptus — the monoterpene 1,8-cineole (eucalyptol, which has been shown to reduce COPD exacerbations when used adjunctively) — with concentrated essential oils that can be purchased online and in stores here in the United States.
“The more potent active ingredient, eucalyptol (in capsule form), is approved in Germany — not the essential oil of eucalyptus, which contains other compounds. I recommend against using any sort of inhaled essential oils for patients with chronic respiratory illnesses, mainly because they are unregulated and unstandardized,” explained Ni-Chen Liang, MD, an integrative pulmonologist affiliated with Scripps Memorial Hospital Encinitas in Encinitas, California.
“The substances that come out when you create eucalyptus oil are a ‘gamash’ of all sorts of chemicals — some benign, some which taste good, and some that may be irritating or even dangerous,” said Neil Schachter, MD, pulmonologist and professor of medicine (pulmonary, critical care, and sleep medicine) at the Icahn School of Medicine at Mount Sinai, New York City.
“They can also produce volatile organic compounds (VOCs) related to their formulas, which contain fillers and other constituents,” Liang said.
Hidden Dangers
Eucalyptus oil was first used by Aboriginal Australians, who crushed the leaves for their antiseptic properties or steamed them for their expectorant activity. Today, eucalyptus oil can be found in mouthwash and soap, used topically to relieve pain or repel insects, or added to cleaning products due to its disinfectant properties.
However, inhalation via diffusers or directly from the bottle can trigger different respiratory reactions, including cough, wheezing, shortness of breath, as well as respiratory distress.
“The vapors contain oil, ie, fatty products that can be irritating in and of themselves,” said Schachter. “There are cases where people have inhaled these oils and developed lipid pneumonia, which is very hard to treat,” he said.
Anything inhaled into the lungs is a risk, said Juan Rojas, MD, assistant professor, Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine at Rush University Medical Center in Chicago. Rojas compared inhaling essential oils to e-cigarettes, which, in addition to tobacco, contain a variety of chemicals and additives that cause a lung reaction in the short term and create inflammatory patterns in the medium and long term.
“Another problem is that when ingested, eucalyptus oil can be distressing to the gastrointestinal tract. In larger doses, it can actually have some neurological impact as well, including seizures,” said Kalilah L. Gates, MD, associate professor of medicine (pulmonary and critical care) and assistant dean of medical education at Northwestern Feinberg School of Medicine in Chicago.
Clinical trial data have also shown a significant association between long-term exposure to essential oils and cardiopulmonary effects such as increased heart rate and blood pressure and a decline in percentage predicted peak expiratory flow rate in healthy volunteers. In the study of 200 participants (who were homemakers), long-term exposure referred to daily hours (> 4/d) and the study period, which was 10 years.
About Eucalyptol
Eucalyptol is rapidly absorbed and quickly distributed throughout the bloodstream, which allows it to reach the bronchial system, where it is expelled by the lungs. It’s been shown in various preclinical studies to have anti-inflammatory, antioxidant, mucolytic, and bronchodilatory activity, as well as antimicrobial effects.
For the past decade, enteric-coated eucalyptol capsules containing 100 mg or 200 mg of 1,8-cineole have been available in Germany for adjunctive treatment of inflammatory respiratory disorders, including asthma and COPD. Due to its limited bioactivity, frequent administration is required.
Clinical evidence of eucalyptol’s effectiveness is somewhat limited. Findings from a 2009 double-blind, placebo-controlled, multicenter study also demonstrated that when used along with beta-agonists, anticholinergics, corticosteroids, or combinations in patients with stable COPD, severity and duration of exacerbations over 6 months were significantly decreased compared with placebo.
However, Liang was quick to point out that studies of oral eucalyptol preparations in pulmonary patients have not been robust enough.
“I haven’t been able to find anything written by a multitude of different authors, which, to me, is a red flag. We want naturally occurring substances to be well tested in multicenter studies across a variety of different patient populations outside of Germany to ensure that results are reproducible,” she said.
Rojas concurred. “Even with the data in Europe, I would say that the studies have been underpowered to support large-scale adoption or suggest that the active ingredient for patients with moderate or severe COPD could be considered an adjunctive therapy with traditional medications,” he said.
“It would be difficult for me to make a recommendation without knowing the full impact,” said Rojas.
Open Dialogue
Like many chronic diseases, it’s important to meet patients where they are, including their use of unapproved or unwise treatment strategies.
“More times than not, they’ve already figured out their triggers for worsening respiratory symptoms, what does and doesn’t work for them, and what predicts a good vs a bad day from a respiratory standpoint,” said Liang.
“There’s a lot of popularity and claims related to essential oil use, and ultimately, we need to partner to find healing modalities (which may or may not include essential oils) that are ultimately helpful and minimize harm,” she said.
Gates suggested that when it comes to eucalyptus essential oil vs eucalyptol, education of both patients and doctors is key.
“The issue is that we had a study showing that a particular component — the active ingredient of eucalyptus oil was isolated and put into the capsule form and showed benefit. And then we extrapolated and said, ‘well, let’s just take (or inhale) eucalyptus oil. It’s not the same thing,” she said.
“I feel that it’s my responsibility to make sure that patients have the information they need to make informed decisions. It’s about being willing to communicate and have open conversations about what they may be taking in addition to medications that I prescribe,” said Gates.
Liang, Schachter, Rojas, and Gates reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
GLP-1s Hold Promise for Addiction but Questions Remain
Glucagon-like peptide 1 receptor agonist (GLP-1) prescriptions for diabetes and obesity treatment are soaring, as is the interest in their potential for treating an array of other conditions. One area in particular is addiction, which, like obesity and diabetes, has been increasing, both in terms of case numbers and deaths from drug overdose, excessive alcohol use, and tobacco/e-cigarettes.
“The evidence is very preliminary and very exciting,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA). “The studies have been going on for more than a decade looking at the effects of GLP medications, mostly first generation and predominantly in rodents,” she said.
GLP “drugs like exenatide and liraglutide all reduced consumption of nicotine, of alcohol, of cocaine, and response to opioids,” Volkow said.
Clinical, Real-World Data Promising
Second-generation agents like semaglutide appear to hold greater promise than their first-generation counterparts. Volkow noted that not only is semaglutide a “much more potent drug,” but pointed to recent findings that saw significant declines in heavy drinking days among patients with alcohol use disorder (AUD).
At the Research Society on Alcohol’s annual meeting in June, researchers from the University of North Carolina at Chapel Hill presented findings of a 2-month, phase 2, randomized clinical trial comparing two low doses (0.25 mg/wk, 0.5 mg/wk) of semaglutide with placebo in 48 participants reporting symptoms of AUD. Though preliminary and unpublished, the data showed a reduction in drinking quantity and heavy drinking in the semaglutide vs placebo groups.
Real-world evidence from electronic health records has also underscored the potential benefit of semaglutide in AUD. In a 12-month retrospective cohort analysis of the records of patients with obesity and no prior AUD diagnosis prescribed semaglutide (n = 45,797) or non-GLP-1 anti-obesity medications (naltrexone, topiramate, n = 38,028), semaglutide was associated with a 50% lower risk for a recurrent AUD diagnosis and a 56% significantly lower risk for incidence AUD diagnosis across gender, age group, and race, and in patients with/without type 2 diabetes.
Likewise, findings from another cohort analysis assigned 1306 treatment-naive patients with type 2 diabetes and no prior AUD diagnosis to semaglutide or non-GLP-1 anti-diabetes medications and followed them for 12 months. Compared with people prescribed non-GLP-1 diabetes medications, those who took semaglutide had a 42% lower risk for recurrent alcohol use diagnosis, consistent across gender, age group, and race, whether the person had been diagnosed with obesity.
However, AUD is not the only addiction where semaglutide appears to have potential benefit. Cohort studies conducted by Volkow and her colleagues have suggested as much as a 78% reduced risk or opioid overdose in patients with comorbid obesity and type 2 diabetes) and a 44% reduction in cannabis use disorder in type 2 diabetes patients without a prior cannabis use disorder history.
Unclear Mechanisms, Multiple Theories
It’s not entirely clear how semaglutide provides a path for addicts to reduce their cravings or which patients might benefit most.
Preclinical studies have suggested that GLP-1 receptors are expressed throughout the mesolimbic dopamine system and transmit dopamine directly to reward centers in the forebrain, for example, the nucleus accumbens. The drugs appear to reduce dopamine release and transmission to these reward centers, as well as to areas that are responsible for impulse control.
“What we’re seeing is counteracting mechanisms that allow you to self-regulate are also involved in addiction, but I don’t know to what extent these medications could help strengthen that,” said Volkow.
Henry Kranzler, MD, professor of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, has a paper in press looking at genetic correlation between body mass index (BMI) and AUD. “Genetic analysis showed that many of the same genes are working in both disorders but in opposite directions,” he said.
The bottom line is that “they share genetics, but by no means are they the same; this gives us reason to believe that the GLP-1s could be beneficial in obesity but not nearly as beneficial for treating addiction,” said Kranzler.
Behind Closed Doors
Like many people with overweight or obesity who are on semaglutide, Bridget Pilloud, a writer who divides her time between Washington State and Arizona, no longer has any desire to drink.
“I used to really enjoy sitting and slowly sipping an Old Fashioned. I used to really enjoy specific whiskeys. Now, I don’t even like the flavor; the pleasure of drinking is gone,” she said.
Inexplicably, Pilloud said that she’s also given up compulsive shopping; “The hunt and acquisition of it was always really delicious to me,” she said.
Pilloud’s experience is not unique. Angela Fitch, MD, an obesity medicine specialist, co-founder and CMO of knownwell health, and former president of the Obesity Medicine Association, has had patients on semaglutide tell her that they’re not shopping as much.
But self-reports about alcohol consumption are far more common.
A 2023 analysis of social media posts reinforced that the experience is quite common, albeit self-reported.
Researchers used machine learning attribution mapping of 68,250 posts related to GLP-1 or GLP-1/glucose-dependent insulinotropic polypeptide agonists on the Reddit platform. Among the 1580 alcohol-related posts, 71% (1134/1580) of users of either drug said they had reduced cravings and decreased desire to drink. In a remote companion study of 153 people with obesity taking semaglutide (n = 56), tirzepatide (n = 50), or neither (n = 47), there appeared to be a reduced suppression of the desire to consume alcohol, with users reporting fewer drinks and binge episodes than control individuals.
Self-reports also underscored the association between either of the medications and less stimulating/sedative effects of alcohol compared with before starting the medications and to controls.
Behind closed doors, there appears to be as much chatter about the potential of these agents for AUD and other addiction disorders as there are questions about factors like treatment duration, safety of long-term, chronic use, and dosage.
“We don’t have data around people with normal weight and how much risk that is to them if they start taking these medications for addiction and reduce their BMI as low as 18,” said Fitch.
There’s also the question of when and how to wean patients off the medications, a consideration that is quite important for patients with addiction problems, said Volkow.
“What happens when you become addicted to drugs is that you start to degrade social support systems needed for well-being,” she explained. “The big difference with drugs versus foods is that you can live happily with no drugs at all, whereas you die if you don’t eat. So, there are greater challenges in the ability to change the environment (eg, help stabilize everyday life so people have alternative reinforcers) when you remove the reward.”
Additional considerations range from overuse and the development of treatment-resistant obesity to the need to ensure that patients on these drugs receive ongoing management and, of course, access, noted Fitch.
Still, the NIDA coffers are open. “We’re waiting for proposals,” said Volkow.
Fitch is cofounder and CMO of knownwell health. Volkow reported no relevant financial relationships. Kranzler is a member of advisory boards for Altimmune, Clearmind Medicine, Dicerna Pharmaceuticals, Enthion Pharmaceuticals, Eli Lilly and Company, and Sophrosyne Pharmaceuticals; a consultant to Sobrera Pharma and Altimmune; the recipient of research funding and medication supplies for an investigator-initiated study from Alkermes; a member of the American Society of Clinical Psychopharmacology’s Alcohol Clinical Trials Initiative, which was supported in the past 3 years by Alkermes, Dicerna Pharmaceuticals, Ethypharm, Imbrium, Indivior, Kinnov, Eli Lilly, Otsuka, and Pear; and a holder of US patent 10,900,082 titled: “Genotype-guided dosing of opioid agonists,” issued on January 26, 2021.
A version of this article appeared on Medscape.com.
Glucagon-like peptide 1 receptor agonist (GLP-1) prescriptions for diabetes and obesity treatment are soaring, as is the interest in their potential for treating an array of other conditions. One area in particular is addiction, which, like obesity and diabetes, has been increasing, both in terms of case numbers and deaths from drug overdose, excessive alcohol use, and tobacco/e-cigarettes.
“The evidence is very preliminary and very exciting,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA). “The studies have been going on for more than a decade looking at the effects of GLP medications, mostly first generation and predominantly in rodents,” she said.
GLP “drugs like exenatide and liraglutide all reduced consumption of nicotine, of alcohol, of cocaine, and response to opioids,” Volkow said.
Clinical, Real-World Data Promising
Second-generation agents like semaglutide appear to hold greater promise than their first-generation counterparts. Volkow noted that not only is semaglutide a “much more potent drug,” but pointed to recent findings that saw significant declines in heavy drinking days among patients with alcohol use disorder (AUD).
At the Research Society on Alcohol’s annual meeting in June, researchers from the University of North Carolina at Chapel Hill presented findings of a 2-month, phase 2, randomized clinical trial comparing two low doses (0.25 mg/wk, 0.5 mg/wk) of semaglutide with placebo in 48 participants reporting symptoms of AUD. Though preliminary and unpublished, the data showed a reduction in drinking quantity and heavy drinking in the semaglutide vs placebo groups.
Real-world evidence from electronic health records has also underscored the potential benefit of semaglutide in AUD. In a 12-month retrospective cohort analysis of the records of patients with obesity and no prior AUD diagnosis prescribed semaglutide (n = 45,797) or non-GLP-1 anti-obesity medications (naltrexone, topiramate, n = 38,028), semaglutide was associated with a 50% lower risk for a recurrent AUD diagnosis and a 56% significantly lower risk for incidence AUD diagnosis across gender, age group, and race, and in patients with/without type 2 diabetes.
Likewise, findings from another cohort analysis assigned 1306 treatment-naive patients with type 2 diabetes and no prior AUD diagnosis to semaglutide or non-GLP-1 anti-diabetes medications and followed them for 12 months. Compared with people prescribed non-GLP-1 diabetes medications, those who took semaglutide had a 42% lower risk for recurrent alcohol use diagnosis, consistent across gender, age group, and race, whether the person had been diagnosed with obesity.
However, AUD is not the only addiction where semaglutide appears to have potential benefit. Cohort studies conducted by Volkow and her colleagues have suggested as much as a 78% reduced risk or opioid overdose in patients with comorbid obesity and type 2 diabetes) and a 44% reduction in cannabis use disorder in type 2 diabetes patients without a prior cannabis use disorder history.
Unclear Mechanisms, Multiple Theories
It’s not entirely clear how semaglutide provides a path for addicts to reduce their cravings or which patients might benefit most.
Preclinical studies have suggested that GLP-1 receptors are expressed throughout the mesolimbic dopamine system and transmit dopamine directly to reward centers in the forebrain, for example, the nucleus accumbens. The drugs appear to reduce dopamine release and transmission to these reward centers, as well as to areas that are responsible for impulse control.
“What we’re seeing is counteracting mechanisms that allow you to self-regulate are also involved in addiction, but I don’t know to what extent these medications could help strengthen that,” said Volkow.
Henry Kranzler, MD, professor of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, has a paper in press looking at genetic correlation between body mass index (BMI) and AUD. “Genetic analysis showed that many of the same genes are working in both disorders but in opposite directions,” he said.
The bottom line is that “they share genetics, but by no means are they the same; this gives us reason to believe that the GLP-1s could be beneficial in obesity but not nearly as beneficial for treating addiction,” said Kranzler.
Behind Closed Doors
Like many people with overweight or obesity who are on semaglutide, Bridget Pilloud, a writer who divides her time between Washington State and Arizona, no longer has any desire to drink.
“I used to really enjoy sitting and slowly sipping an Old Fashioned. I used to really enjoy specific whiskeys. Now, I don’t even like the flavor; the pleasure of drinking is gone,” she said.
Inexplicably, Pilloud said that she’s also given up compulsive shopping; “The hunt and acquisition of it was always really delicious to me,” she said.
Pilloud’s experience is not unique. Angela Fitch, MD, an obesity medicine specialist, co-founder and CMO of knownwell health, and former president of the Obesity Medicine Association, has had patients on semaglutide tell her that they’re not shopping as much.
But self-reports about alcohol consumption are far more common.
A 2023 analysis of social media posts reinforced that the experience is quite common, albeit self-reported.
Researchers used machine learning attribution mapping of 68,250 posts related to GLP-1 or GLP-1/glucose-dependent insulinotropic polypeptide agonists on the Reddit platform. Among the 1580 alcohol-related posts, 71% (1134/1580) of users of either drug said they had reduced cravings and decreased desire to drink. In a remote companion study of 153 people with obesity taking semaglutide (n = 56), tirzepatide (n = 50), or neither (n = 47), there appeared to be a reduced suppression of the desire to consume alcohol, with users reporting fewer drinks and binge episodes than control individuals.
Self-reports also underscored the association between either of the medications and less stimulating/sedative effects of alcohol compared with before starting the medications and to controls.
Behind closed doors, there appears to be as much chatter about the potential of these agents for AUD and other addiction disorders as there are questions about factors like treatment duration, safety of long-term, chronic use, and dosage.
“We don’t have data around people with normal weight and how much risk that is to them if they start taking these medications for addiction and reduce their BMI as low as 18,” said Fitch.
There’s also the question of when and how to wean patients off the medications, a consideration that is quite important for patients with addiction problems, said Volkow.
“What happens when you become addicted to drugs is that you start to degrade social support systems needed for well-being,” she explained. “The big difference with drugs versus foods is that you can live happily with no drugs at all, whereas you die if you don’t eat. So, there are greater challenges in the ability to change the environment (eg, help stabilize everyday life so people have alternative reinforcers) when you remove the reward.”
Additional considerations range from overuse and the development of treatment-resistant obesity to the need to ensure that patients on these drugs receive ongoing management and, of course, access, noted Fitch.
Still, the NIDA coffers are open. “We’re waiting for proposals,” said Volkow.
Fitch is cofounder and CMO of knownwell health. Volkow reported no relevant financial relationships. Kranzler is a member of advisory boards for Altimmune, Clearmind Medicine, Dicerna Pharmaceuticals, Enthion Pharmaceuticals, Eli Lilly and Company, and Sophrosyne Pharmaceuticals; a consultant to Sobrera Pharma and Altimmune; the recipient of research funding and medication supplies for an investigator-initiated study from Alkermes; a member of the American Society of Clinical Psychopharmacology’s Alcohol Clinical Trials Initiative, which was supported in the past 3 years by Alkermes, Dicerna Pharmaceuticals, Ethypharm, Imbrium, Indivior, Kinnov, Eli Lilly, Otsuka, and Pear; and a holder of US patent 10,900,082 titled: “Genotype-guided dosing of opioid agonists,” issued on January 26, 2021.
A version of this article appeared on Medscape.com.
Glucagon-like peptide 1 receptor agonist (GLP-1) prescriptions for diabetes and obesity treatment are soaring, as is the interest in their potential for treating an array of other conditions. One area in particular is addiction, which, like obesity and diabetes, has been increasing, both in terms of case numbers and deaths from drug overdose, excessive alcohol use, and tobacco/e-cigarettes.
“The evidence is very preliminary and very exciting,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA). “The studies have been going on for more than a decade looking at the effects of GLP medications, mostly first generation and predominantly in rodents,” she said.
GLP “drugs like exenatide and liraglutide all reduced consumption of nicotine, of alcohol, of cocaine, and response to opioids,” Volkow said.
Clinical, Real-World Data Promising
Second-generation agents like semaglutide appear to hold greater promise than their first-generation counterparts. Volkow noted that not only is semaglutide a “much more potent drug,” but pointed to recent findings that saw significant declines in heavy drinking days among patients with alcohol use disorder (AUD).
At the Research Society on Alcohol’s annual meeting in June, researchers from the University of North Carolina at Chapel Hill presented findings of a 2-month, phase 2, randomized clinical trial comparing two low doses (0.25 mg/wk, 0.5 mg/wk) of semaglutide with placebo in 48 participants reporting symptoms of AUD. Though preliminary and unpublished, the data showed a reduction in drinking quantity and heavy drinking in the semaglutide vs placebo groups.
Real-world evidence from electronic health records has also underscored the potential benefit of semaglutide in AUD. In a 12-month retrospective cohort analysis of the records of patients with obesity and no prior AUD diagnosis prescribed semaglutide (n = 45,797) or non-GLP-1 anti-obesity medications (naltrexone, topiramate, n = 38,028), semaglutide was associated with a 50% lower risk for a recurrent AUD diagnosis and a 56% significantly lower risk for incidence AUD diagnosis across gender, age group, and race, and in patients with/without type 2 diabetes.
Likewise, findings from another cohort analysis assigned 1306 treatment-naive patients with type 2 diabetes and no prior AUD diagnosis to semaglutide or non-GLP-1 anti-diabetes medications and followed them for 12 months. Compared with people prescribed non-GLP-1 diabetes medications, those who took semaglutide had a 42% lower risk for recurrent alcohol use diagnosis, consistent across gender, age group, and race, whether the person had been diagnosed with obesity.
However, AUD is not the only addiction where semaglutide appears to have potential benefit. Cohort studies conducted by Volkow and her colleagues have suggested as much as a 78% reduced risk or opioid overdose in patients with comorbid obesity and type 2 diabetes) and a 44% reduction in cannabis use disorder in type 2 diabetes patients without a prior cannabis use disorder history.
Unclear Mechanisms, Multiple Theories
It’s not entirely clear how semaglutide provides a path for addicts to reduce their cravings or which patients might benefit most.
Preclinical studies have suggested that GLP-1 receptors are expressed throughout the mesolimbic dopamine system and transmit dopamine directly to reward centers in the forebrain, for example, the nucleus accumbens. The drugs appear to reduce dopamine release and transmission to these reward centers, as well as to areas that are responsible for impulse control.
“What we’re seeing is counteracting mechanisms that allow you to self-regulate are also involved in addiction, but I don’t know to what extent these medications could help strengthen that,” said Volkow.
Henry Kranzler, MD, professor of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, has a paper in press looking at genetic correlation between body mass index (BMI) and AUD. “Genetic analysis showed that many of the same genes are working in both disorders but in opposite directions,” he said.
The bottom line is that “they share genetics, but by no means are they the same; this gives us reason to believe that the GLP-1s could be beneficial in obesity but not nearly as beneficial for treating addiction,” said Kranzler.
Behind Closed Doors
Like many people with overweight or obesity who are on semaglutide, Bridget Pilloud, a writer who divides her time between Washington State and Arizona, no longer has any desire to drink.
“I used to really enjoy sitting and slowly sipping an Old Fashioned. I used to really enjoy specific whiskeys. Now, I don’t even like the flavor; the pleasure of drinking is gone,” she said.
Inexplicably, Pilloud said that she’s also given up compulsive shopping; “The hunt and acquisition of it was always really delicious to me,” she said.
Pilloud’s experience is not unique. Angela Fitch, MD, an obesity medicine specialist, co-founder and CMO of knownwell health, and former president of the Obesity Medicine Association, has had patients on semaglutide tell her that they’re not shopping as much.
But self-reports about alcohol consumption are far more common.
A 2023 analysis of social media posts reinforced that the experience is quite common, albeit self-reported.
Researchers used machine learning attribution mapping of 68,250 posts related to GLP-1 or GLP-1/glucose-dependent insulinotropic polypeptide agonists on the Reddit platform. Among the 1580 alcohol-related posts, 71% (1134/1580) of users of either drug said they had reduced cravings and decreased desire to drink. In a remote companion study of 153 people with obesity taking semaglutide (n = 56), tirzepatide (n = 50), or neither (n = 47), there appeared to be a reduced suppression of the desire to consume alcohol, with users reporting fewer drinks and binge episodes than control individuals.
Self-reports also underscored the association between either of the medications and less stimulating/sedative effects of alcohol compared with before starting the medications and to controls.
Behind closed doors, there appears to be as much chatter about the potential of these agents for AUD and other addiction disorders as there are questions about factors like treatment duration, safety of long-term, chronic use, and dosage.
“We don’t have data around people with normal weight and how much risk that is to them if they start taking these medications for addiction and reduce their BMI as low as 18,” said Fitch.
There’s also the question of when and how to wean patients off the medications, a consideration that is quite important for patients with addiction problems, said Volkow.
“What happens when you become addicted to drugs is that you start to degrade social support systems needed for well-being,” she explained. “The big difference with drugs versus foods is that you can live happily with no drugs at all, whereas you die if you don’t eat. So, there are greater challenges in the ability to change the environment (eg, help stabilize everyday life so people have alternative reinforcers) when you remove the reward.”
Additional considerations range from overuse and the development of treatment-resistant obesity to the need to ensure that patients on these drugs receive ongoing management and, of course, access, noted Fitch.
Still, the NIDA coffers are open. “We’re waiting for proposals,” said Volkow.
Fitch is cofounder and CMO of knownwell health. Volkow reported no relevant financial relationships. Kranzler is a member of advisory boards for Altimmune, Clearmind Medicine, Dicerna Pharmaceuticals, Enthion Pharmaceuticals, Eli Lilly and Company, and Sophrosyne Pharmaceuticals; a consultant to Sobrera Pharma and Altimmune; the recipient of research funding and medication supplies for an investigator-initiated study from Alkermes; a member of the American Society of Clinical Psychopharmacology’s Alcohol Clinical Trials Initiative, which was supported in the past 3 years by Alkermes, Dicerna Pharmaceuticals, Ethypharm, Imbrium, Indivior, Kinnov, Eli Lilly, Otsuka, and Pear; and a holder of US patent 10,900,082 titled: “Genotype-guided dosing of opioid agonists,” issued on January 26, 2021.
A version of this article appeared on Medscape.com.
Will Psychedelics Break the Major Depression Logjam?
With tens of millions of Euros in the offing, researchers across the European Union have eagerly taken up the gauntlet to find novel interventions for difficult-to-treat mental health and pain conditions. Their target is psychedelics, including classic compounds like psilocybin and atypical ones like ketamine and MDMA. Some of these still carry a stigma as party drugs and spiritual gateways to holotropic experiences.
Twelve groups make up the European College of Neuropsychopharmacology’s psychedelic research network. Along with several affiliates, the groups span nine countries (Denmark, Sweden, Finland, Switzerland, Germany, the Netherlands, the Czech Republic, Greece, and the United Kingdom) and are focused on the use of psychedelic compounds as potential treatments for psychiatric conditions like treatment-resistant depression, addiction, attention-deficit/hyperactivity disorder, anorexia, and obsessive-compulsive disorder.
One of the largest endeavors is PsyPal, a 4-year, randomized controlled trial investigating the potential of psilocybin for treating psychological distress in palliative care patients with life-limiting conditions. PsyPal is the first multisite clinical trial funded by the European Union to explore psychedelic-assisted therapy.
At PsyPal’s helm is Robert Schoevers, MD, PhD, professor of psychiatry and Department Head at University Medical Center Groningen (UMCG), Groningen, the Netherlands, a major hub for psychedelic research.
Schoevers is a bit of a pioneer who said he entered psychedelic research somewhat reluctantly. A decade ago, a colleague showed him a few papers on ketamine and depression. Because UMCG has a large population of patients with treatment-resistant depression, he agreed to do a pilot study. Since then, he has put together an interdisciplinary team of 25 researchers, published numerous papers, and currently has seven studies, including PsyPal, in various stages of progress.
Schoevers is also building a large national consortium that aims to investigate and, if shown effective, implement novel psychiatry treatments much more rapidly and efficiently than current drug development and approval processes, which can take 12 years or longer. He has just secured millions in government funding to start this process.
Next year, Schoevers and his team will decide to test either MDMA for posttraumatic stress disorder (PTSD) or psilocybin for depression in a large clinical trial, with the aim of getting a treatment as near to formal registration as possible. This will involve working with the European Medicines Agency and its Dutch counterpart, talking to experts who are familiar with the US Food and Drug Administration’s rejection of Lykos Therapeutics’ MDMA treatment for PTSD, and working directly with patients through the National Patient Alliance. The team is also talking to insurers and pharma companies.
The ultimate goal is to “see if we can build a platform in the Netherlands that would have a European perspective, serve as a point of entry for researchers with good ideas, and [attract] public funding as well as companies who have interesting compounds we think would be worthwhile to study,” Schoevers said.
His multiple endeavors emphasize a transdisciplinary and transdiagnostic approach he has been honing for decades. He and his colleagues are investigating the clinical, psychological, and neurobiological parallels between different treatment- resistant conditions and seeking to understand how contextual factors might influence patients, experiences, and outcomes.
Connecting the Dots
Jens H. van Dalfsen, PhD, a postdoctoral researcher in biological psychiatry, is the principal investigator of another UMCG group looking into the neurobiological mechanisms of major depressive disorder and treatment-resistant depression. His team’s strategy entails an elaborate coordination between the preclinical and clinical research settings.
For example, Sarah Massetti, a PhD candidate in biological psychiatry, is using blood samples collected in clinical trials to investigate the molecular mechanisms underpinning the neuroplasticity and immune-modulating effects produced by psychedelic compounds.
Another line of research spearheaded by Rutger Boesjes, a PhD candidate in biological psychiatry, is exploring the interactions between drugs like ketamine and the circadian system and how they might relate to antidepressant responses in animal models. It could be that the timing of administration of these drugs is relevant, he explained.
The Patient Factor
How psychedelics work and in whom is a big question for the UMCG team and across the research landscape.
“When researchers and the general public talk about psychedelics, they frequently refer to how they promote synaptic plasticity and new connections in the brain,” said van Dalfsen. “But traditional compounds also do that. So the ultimate question that we’ve been exploring is whether findings reflect an actual pharmacological effect or if expectancy also plays a role. In other words: How can we explain why psychedelics might or might not be effective in treatment-resistant patients?” he explained.
This is where the connection to the clinical experience becomes paramount and Joost Breeksema, PhD, comes in.
Breeksema divides his time between UMCG research and his role as executive director and co-founder of the Open Foundation, a nonprofit dedicated to advancing scientific psychedelic research. The work he’s doing outside the university is helping to frame the investigations of the wider group.
So far he has conducted two qualitative studies.
One was an off-label study in which patients with treatment-resistant depression were administered esketamine.
The other was a randomized clinical trial in which participants were blinded to a single 10- or 25-mg dose of psilocybin versus a 1-mg psilocybin microdose placebo that is too small to invoke any effects.
A key insight was the degree to which participants were unprepared for the intensity of their experiences, especially with regards to ketamine. Breeksema said the sessions might not have been so intense or negative for some participants had they been informed beforehand to expect the drugs could provoke “quite overwhelming experiences” and had they been accompanied by an experienced guide providing reassurance and support.
The format for the psilocybin trial met part of this criteria. Participants received a micro (placebo), medium, or high dose in a single session accompanied by two trained therapists. They then engaged in two sessions afterward to process their experiences. A single psilocybin experience appeared to be not enough or too much depending on the dose they were assigned and if they had prior experience with the compound.
Trial participants also felt they needed more help making sense of the experience. “This is a common and important theme,” said Breeksema. “Think about it. If you’ve been depressed for 10, 15 years and … you uncover something and break through something that’s been stuck, you need to process it.”
Jeanine Kamphuis, PhD, a psychiatrist and senior researcher at UMCG and one of the trial study co-authors, explained that they want to find a way to identify who will be too overwhelmed by these experiences if the dose should be adjusted or if some time needs to pass between dosing sessions. They also want to spend more time preparing patients for these sessions.
She emphasized that the studies have provided a reality check. “These are not wonder pills or wonder experiences. And in these types of patients, they’re not intended for a personal growth experience,” she said. “You have a patient who is sitting in front of you who seeks therapy and relief from very severe mood complaints, and the suffering is high,” she said, adding that expectancy bias further complicates patient participation and, likely, outcomes.
The Challenges
For all the potential and opportunity that psychedelics may hold for treatment, UMCG’s work has underscored some challenges.
The field of psychedelic research is characterized by methodological issues, explained van Dalfsen, such as blinding, expectancy, and overestimation of treatment effects. When looking at efficacy, “Is it the compound or the expectancy and promise? This is why it’s important to study how the drugs differ from each other in their biological effects and why they are or are not effective,” he said.
The team has also experienced issues with trial recruitment.
Martijn Godschalk, MD, a PhD candidate in psychiatry, has been addressing this problem while working on RESET-TRD, a phase 3, randomized controlled trial comparing an oral esketamine drink with electroconvulsive therapy in patients with treatment-resistant depression.
He’s been coordinating with local university hospitals, general hospitals, and municipal healthcare clinics to meet inclusion criteria and ensure the trial has enough power to demonstrate effectiveness. In turn, these sites are able to participate in a trial they wouldn’t normally be involved in due to lack of resources.
But Godschalk said he was concerned that many patients have gotten wind of the hype surrounding psychedelic treatments within psychiatry — a factor that has contributed to recruitment challenges. “There are a lot of patients who are interested in the non-registered drug and don’t necessarily have an interest in the other [control] arm,” he said.
Despite the challenges, the classic psychedelics such as MDMA and psilocybin “seem to catalyze a psychological process that may be harder to get with regular psychotherapies,” said Schoevers.
He remains cautious, noting there are still unanswered questions, such as who are the best candidates for these drugs and whether they might cause harm in certain patients while benefiting others. “I do think that this is the first time in 20 or 30 years that there is a group of potential treatments that would really make a difference.”
Schoevers received grants and other funding from The Netherlands Organisation for Health Research & Development, Horizon 2020, Horizon 2023, the National Institute of Mental Health (USA), UMCG, Stichting tot Steun VCVGZ, Nationaal programma Groningen, Healthcare Innovation Funds, Janssen Pharmaceuticals, Novartis, Compass Pathways, Clexio Biosciences, and GH research.
A version of this article appeared on Medscape.com.
With tens of millions of Euros in the offing, researchers across the European Union have eagerly taken up the gauntlet to find novel interventions for difficult-to-treat mental health and pain conditions. Their target is psychedelics, including classic compounds like psilocybin and atypical ones like ketamine and MDMA. Some of these still carry a stigma as party drugs and spiritual gateways to holotropic experiences.
Twelve groups make up the European College of Neuropsychopharmacology’s psychedelic research network. Along with several affiliates, the groups span nine countries (Denmark, Sweden, Finland, Switzerland, Germany, the Netherlands, the Czech Republic, Greece, and the United Kingdom) and are focused on the use of psychedelic compounds as potential treatments for psychiatric conditions like treatment-resistant depression, addiction, attention-deficit/hyperactivity disorder, anorexia, and obsessive-compulsive disorder.
One of the largest endeavors is PsyPal, a 4-year, randomized controlled trial investigating the potential of psilocybin for treating psychological distress in palliative care patients with life-limiting conditions. PsyPal is the first multisite clinical trial funded by the European Union to explore psychedelic-assisted therapy.
At PsyPal’s helm is Robert Schoevers, MD, PhD, professor of psychiatry and Department Head at University Medical Center Groningen (UMCG), Groningen, the Netherlands, a major hub for psychedelic research.
Schoevers is a bit of a pioneer who said he entered psychedelic research somewhat reluctantly. A decade ago, a colleague showed him a few papers on ketamine and depression. Because UMCG has a large population of patients with treatment-resistant depression, he agreed to do a pilot study. Since then, he has put together an interdisciplinary team of 25 researchers, published numerous papers, and currently has seven studies, including PsyPal, in various stages of progress.
Schoevers is also building a large national consortium that aims to investigate and, if shown effective, implement novel psychiatry treatments much more rapidly and efficiently than current drug development and approval processes, which can take 12 years or longer. He has just secured millions in government funding to start this process.
Next year, Schoevers and his team will decide to test either MDMA for posttraumatic stress disorder (PTSD) or psilocybin for depression in a large clinical trial, with the aim of getting a treatment as near to formal registration as possible. This will involve working with the European Medicines Agency and its Dutch counterpart, talking to experts who are familiar with the US Food and Drug Administration’s rejection of Lykos Therapeutics’ MDMA treatment for PTSD, and working directly with patients through the National Patient Alliance. The team is also talking to insurers and pharma companies.
The ultimate goal is to “see if we can build a platform in the Netherlands that would have a European perspective, serve as a point of entry for researchers with good ideas, and [attract] public funding as well as companies who have interesting compounds we think would be worthwhile to study,” Schoevers said.
His multiple endeavors emphasize a transdisciplinary and transdiagnostic approach he has been honing for decades. He and his colleagues are investigating the clinical, psychological, and neurobiological parallels between different treatment- resistant conditions and seeking to understand how contextual factors might influence patients, experiences, and outcomes.
Connecting the Dots
Jens H. van Dalfsen, PhD, a postdoctoral researcher in biological psychiatry, is the principal investigator of another UMCG group looking into the neurobiological mechanisms of major depressive disorder and treatment-resistant depression. His team’s strategy entails an elaborate coordination between the preclinical and clinical research settings.
For example, Sarah Massetti, a PhD candidate in biological psychiatry, is using blood samples collected in clinical trials to investigate the molecular mechanisms underpinning the neuroplasticity and immune-modulating effects produced by psychedelic compounds.
Another line of research spearheaded by Rutger Boesjes, a PhD candidate in biological psychiatry, is exploring the interactions between drugs like ketamine and the circadian system and how they might relate to antidepressant responses in animal models. It could be that the timing of administration of these drugs is relevant, he explained.
The Patient Factor
How psychedelics work and in whom is a big question for the UMCG team and across the research landscape.
“When researchers and the general public talk about psychedelics, they frequently refer to how they promote synaptic plasticity and new connections in the brain,” said van Dalfsen. “But traditional compounds also do that. So the ultimate question that we’ve been exploring is whether findings reflect an actual pharmacological effect or if expectancy also plays a role. In other words: How can we explain why psychedelics might or might not be effective in treatment-resistant patients?” he explained.
This is where the connection to the clinical experience becomes paramount and Joost Breeksema, PhD, comes in.
Breeksema divides his time between UMCG research and his role as executive director and co-founder of the Open Foundation, a nonprofit dedicated to advancing scientific psychedelic research. The work he’s doing outside the university is helping to frame the investigations of the wider group.
So far he has conducted two qualitative studies.
One was an off-label study in which patients with treatment-resistant depression were administered esketamine.
The other was a randomized clinical trial in which participants were blinded to a single 10- or 25-mg dose of psilocybin versus a 1-mg psilocybin microdose placebo that is too small to invoke any effects.
A key insight was the degree to which participants were unprepared for the intensity of their experiences, especially with regards to ketamine. Breeksema said the sessions might not have been so intense or negative for some participants had they been informed beforehand to expect the drugs could provoke “quite overwhelming experiences” and had they been accompanied by an experienced guide providing reassurance and support.
The format for the psilocybin trial met part of this criteria. Participants received a micro (placebo), medium, or high dose in a single session accompanied by two trained therapists. They then engaged in two sessions afterward to process their experiences. A single psilocybin experience appeared to be not enough or too much depending on the dose they were assigned and if they had prior experience with the compound.
Trial participants also felt they needed more help making sense of the experience. “This is a common and important theme,” said Breeksema. “Think about it. If you’ve been depressed for 10, 15 years and … you uncover something and break through something that’s been stuck, you need to process it.”
Jeanine Kamphuis, PhD, a psychiatrist and senior researcher at UMCG and one of the trial study co-authors, explained that they want to find a way to identify who will be too overwhelmed by these experiences if the dose should be adjusted or if some time needs to pass between dosing sessions. They also want to spend more time preparing patients for these sessions.
She emphasized that the studies have provided a reality check. “These are not wonder pills or wonder experiences. And in these types of patients, they’re not intended for a personal growth experience,” she said. “You have a patient who is sitting in front of you who seeks therapy and relief from very severe mood complaints, and the suffering is high,” she said, adding that expectancy bias further complicates patient participation and, likely, outcomes.
The Challenges
For all the potential and opportunity that psychedelics may hold for treatment, UMCG’s work has underscored some challenges.
The field of psychedelic research is characterized by methodological issues, explained van Dalfsen, such as blinding, expectancy, and overestimation of treatment effects. When looking at efficacy, “Is it the compound or the expectancy and promise? This is why it’s important to study how the drugs differ from each other in their biological effects and why they are or are not effective,” he said.
The team has also experienced issues with trial recruitment.
Martijn Godschalk, MD, a PhD candidate in psychiatry, has been addressing this problem while working on RESET-TRD, a phase 3, randomized controlled trial comparing an oral esketamine drink with electroconvulsive therapy in patients with treatment-resistant depression.
He’s been coordinating with local university hospitals, general hospitals, and municipal healthcare clinics to meet inclusion criteria and ensure the trial has enough power to demonstrate effectiveness. In turn, these sites are able to participate in a trial they wouldn’t normally be involved in due to lack of resources.
But Godschalk said he was concerned that many patients have gotten wind of the hype surrounding psychedelic treatments within psychiatry — a factor that has contributed to recruitment challenges. “There are a lot of patients who are interested in the non-registered drug and don’t necessarily have an interest in the other [control] arm,” he said.
Despite the challenges, the classic psychedelics such as MDMA and psilocybin “seem to catalyze a psychological process that may be harder to get with regular psychotherapies,” said Schoevers.
He remains cautious, noting there are still unanswered questions, such as who are the best candidates for these drugs and whether they might cause harm in certain patients while benefiting others. “I do think that this is the first time in 20 or 30 years that there is a group of potential treatments that would really make a difference.”
Schoevers received grants and other funding from The Netherlands Organisation for Health Research & Development, Horizon 2020, Horizon 2023, the National Institute of Mental Health (USA), UMCG, Stichting tot Steun VCVGZ, Nationaal programma Groningen, Healthcare Innovation Funds, Janssen Pharmaceuticals, Novartis, Compass Pathways, Clexio Biosciences, and GH research.
A version of this article appeared on Medscape.com.
With tens of millions of Euros in the offing, researchers across the European Union have eagerly taken up the gauntlet to find novel interventions for difficult-to-treat mental health and pain conditions. Their target is psychedelics, including classic compounds like psilocybin and atypical ones like ketamine and MDMA. Some of these still carry a stigma as party drugs and spiritual gateways to holotropic experiences.
Twelve groups make up the European College of Neuropsychopharmacology’s psychedelic research network. Along with several affiliates, the groups span nine countries (Denmark, Sweden, Finland, Switzerland, Germany, the Netherlands, the Czech Republic, Greece, and the United Kingdom) and are focused on the use of psychedelic compounds as potential treatments for psychiatric conditions like treatment-resistant depression, addiction, attention-deficit/hyperactivity disorder, anorexia, and obsessive-compulsive disorder.
One of the largest endeavors is PsyPal, a 4-year, randomized controlled trial investigating the potential of psilocybin for treating psychological distress in palliative care patients with life-limiting conditions. PsyPal is the first multisite clinical trial funded by the European Union to explore psychedelic-assisted therapy.
At PsyPal’s helm is Robert Schoevers, MD, PhD, professor of psychiatry and Department Head at University Medical Center Groningen (UMCG), Groningen, the Netherlands, a major hub for psychedelic research.
Schoevers is a bit of a pioneer who said he entered psychedelic research somewhat reluctantly. A decade ago, a colleague showed him a few papers on ketamine and depression. Because UMCG has a large population of patients with treatment-resistant depression, he agreed to do a pilot study. Since then, he has put together an interdisciplinary team of 25 researchers, published numerous papers, and currently has seven studies, including PsyPal, in various stages of progress.
Schoevers is also building a large national consortium that aims to investigate and, if shown effective, implement novel psychiatry treatments much more rapidly and efficiently than current drug development and approval processes, which can take 12 years or longer. He has just secured millions in government funding to start this process.
Next year, Schoevers and his team will decide to test either MDMA for posttraumatic stress disorder (PTSD) or psilocybin for depression in a large clinical trial, with the aim of getting a treatment as near to formal registration as possible. This will involve working with the European Medicines Agency and its Dutch counterpart, talking to experts who are familiar with the US Food and Drug Administration’s rejection of Lykos Therapeutics’ MDMA treatment for PTSD, and working directly with patients through the National Patient Alliance. The team is also talking to insurers and pharma companies.
The ultimate goal is to “see if we can build a platform in the Netherlands that would have a European perspective, serve as a point of entry for researchers with good ideas, and [attract] public funding as well as companies who have interesting compounds we think would be worthwhile to study,” Schoevers said.
His multiple endeavors emphasize a transdisciplinary and transdiagnostic approach he has been honing for decades. He and his colleagues are investigating the clinical, psychological, and neurobiological parallels between different treatment- resistant conditions and seeking to understand how contextual factors might influence patients, experiences, and outcomes.
Connecting the Dots
Jens H. van Dalfsen, PhD, a postdoctoral researcher in biological psychiatry, is the principal investigator of another UMCG group looking into the neurobiological mechanisms of major depressive disorder and treatment-resistant depression. His team’s strategy entails an elaborate coordination between the preclinical and clinical research settings.
For example, Sarah Massetti, a PhD candidate in biological psychiatry, is using blood samples collected in clinical trials to investigate the molecular mechanisms underpinning the neuroplasticity and immune-modulating effects produced by psychedelic compounds.
Another line of research spearheaded by Rutger Boesjes, a PhD candidate in biological psychiatry, is exploring the interactions between drugs like ketamine and the circadian system and how they might relate to antidepressant responses in animal models. It could be that the timing of administration of these drugs is relevant, he explained.
The Patient Factor
How psychedelics work and in whom is a big question for the UMCG team and across the research landscape.
“When researchers and the general public talk about psychedelics, they frequently refer to how they promote synaptic plasticity and new connections in the brain,” said van Dalfsen. “But traditional compounds also do that. So the ultimate question that we’ve been exploring is whether findings reflect an actual pharmacological effect or if expectancy also plays a role. In other words: How can we explain why psychedelics might or might not be effective in treatment-resistant patients?” he explained.
This is where the connection to the clinical experience becomes paramount and Joost Breeksema, PhD, comes in.
Breeksema divides his time between UMCG research and his role as executive director and co-founder of the Open Foundation, a nonprofit dedicated to advancing scientific psychedelic research. The work he’s doing outside the university is helping to frame the investigations of the wider group.
So far he has conducted two qualitative studies.
One was an off-label study in which patients with treatment-resistant depression were administered esketamine.
The other was a randomized clinical trial in which participants were blinded to a single 10- or 25-mg dose of psilocybin versus a 1-mg psilocybin microdose placebo that is too small to invoke any effects.
A key insight was the degree to which participants were unprepared for the intensity of their experiences, especially with regards to ketamine. Breeksema said the sessions might not have been so intense or negative for some participants had they been informed beforehand to expect the drugs could provoke “quite overwhelming experiences” and had they been accompanied by an experienced guide providing reassurance and support.
The format for the psilocybin trial met part of this criteria. Participants received a micro (placebo), medium, or high dose in a single session accompanied by two trained therapists. They then engaged in two sessions afterward to process their experiences. A single psilocybin experience appeared to be not enough or too much depending on the dose they were assigned and if they had prior experience with the compound.
Trial participants also felt they needed more help making sense of the experience. “This is a common and important theme,” said Breeksema. “Think about it. If you’ve been depressed for 10, 15 years and … you uncover something and break through something that’s been stuck, you need to process it.”
Jeanine Kamphuis, PhD, a psychiatrist and senior researcher at UMCG and one of the trial study co-authors, explained that they want to find a way to identify who will be too overwhelmed by these experiences if the dose should be adjusted or if some time needs to pass between dosing sessions. They also want to spend more time preparing patients for these sessions.
She emphasized that the studies have provided a reality check. “These are not wonder pills or wonder experiences. And in these types of patients, they’re not intended for a personal growth experience,” she said. “You have a patient who is sitting in front of you who seeks therapy and relief from very severe mood complaints, and the suffering is high,” she said, adding that expectancy bias further complicates patient participation and, likely, outcomes.
The Challenges
For all the potential and opportunity that psychedelics may hold for treatment, UMCG’s work has underscored some challenges.
The field of psychedelic research is characterized by methodological issues, explained van Dalfsen, such as blinding, expectancy, and overestimation of treatment effects. When looking at efficacy, “Is it the compound or the expectancy and promise? This is why it’s important to study how the drugs differ from each other in their biological effects and why they are or are not effective,” he said.
The team has also experienced issues with trial recruitment.
Martijn Godschalk, MD, a PhD candidate in psychiatry, has been addressing this problem while working on RESET-TRD, a phase 3, randomized controlled trial comparing an oral esketamine drink with electroconvulsive therapy in patients with treatment-resistant depression.
He’s been coordinating with local university hospitals, general hospitals, and municipal healthcare clinics to meet inclusion criteria and ensure the trial has enough power to demonstrate effectiveness. In turn, these sites are able to participate in a trial they wouldn’t normally be involved in due to lack of resources.
But Godschalk said he was concerned that many patients have gotten wind of the hype surrounding psychedelic treatments within psychiatry — a factor that has contributed to recruitment challenges. “There are a lot of patients who are interested in the non-registered drug and don’t necessarily have an interest in the other [control] arm,” he said.
Despite the challenges, the classic psychedelics such as MDMA and psilocybin “seem to catalyze a psychological process that may be harder to get with regular psychotherapies,” said Schoevers.
He remains cautious, noting there are still unanswered questions, such as who are the best candidates for these drugs and whether they might cause harm in certain patients while benefiting others. “I do think that this is the first time in 20 or 30 years that there is a group of potential treatments that would really make a difference.”
Schoevers received grants and other funding from The Netherlands Organisation for Health Research & Development, Horizon 2020, Horizon 2023, the National Institute of Mental Health (USA), UMCG, Stichting tot Steun VCVGZ, Nationaal programma Groningen, Healthcare Innovation Funds, Janssen Pharmaceuticals, Novartis, Compass Pathways, Clexio Biosciences, and GH research.
A version of this article appeared on Medscape.com.
CBTI Strategy Reduces Sleeping Pill Use in Canadian Seniors
A strategy developed by Canadian researchers for encouraging older patients with insomnia to wean themselves from sleeping pills and improve their sleep through behavioral techniques is effective, data suggest. If proven helpful for the millions of older Canadians who currently rely on nightly benzodiazepines (BZDs) and non-BZDs (colloquially known as Z drugs) for their sleep, it might yield an additional benefit: Reducing resource utilization.
“We know that cognitive behavioral therapy for insomnia (CBTI) works. It’s recommended as first-line therapy because it works,” study author David Gardner, PharmD, professor of psychiatry at Dalhousie University in Halifax, Nova Scotia, Canada, told this news organization.
“We’re sharing information about sleeping pills, information that has been embedded with behavior-change techniques that lead people to second-guess or rethink their long-term use of sedative hypnotics and then bring that information to their provider or pharmacist to discuss it,” he said.
The results were published in JAMA Psychiatry.
Better Sleep, Fewer Pills
Dr. Gardner and his team created a direct-to-patient, patient-directed, multicomponent knowledge mobilization intervention called Sleepwell. It incorporates best practice– and guideline-based evidence and multiple behavioral change techniques with content and graphics. Dr. Gardner emphasized that it represents a directional shift in care that alleviates providers’ burden without removing it entirely.
To test the intervention’s effectiveness, Dr. Gardner and his team chose New Brunswick as a location for a 6-month, three-arm, open-label, randomized controlled trial; the province has one of the highest rates of sedative use and an older adult population that is vulnerable to the serious side effects of these drugs (eg, cognitive impairment, falls, and frailty). The study was called Your Answers When Needing Sleep in New Brunswick (YAWNS NB).
Eligible participants were aged ≥ 65 years, lived in the community, and had taken benzodiazepine receptor agonists (BZRAs) for ≥ 3 nights per week for 3 or more months. Participants were randomly assigned to a control group or one of the two intervention groups. The YAWNS-1 intervention group (n = 195) received a mailed package containing a cover letter, a booklet outlining how to stop sleeping pills, a booklet on how to “get your sleep back,” and a companion website. The YAWNS-2 group (n = 193) received updated versions of the booklets used in a prior trial. The control group (n = 192) was assigned treatment as usual (TAU).
A greater proportion of YAWNS-1 participants discontinued BZRAs at 6 months (26.2%) and had dose reductions (20.4%), compared with YAWNS-2 participants (20.3% and 14.4%, respectively) and TAU participants (7.5% and 12.8%, respectively). The corresponding numbers needed to mail to achieve an additional discontinuation was 5.3 YAWNS-1 packages and 7.8 YAWNS-2 packages.
At 6 months, BZRA cessation was sustained a mean 13.6 weeks for YAWNS-1, 14.3 weeks for YAWNS-2, and 16.9 weeks for TAU.
Sleep measures also improved with YAWNS-1, compared with YAWNs-2 and TAU. Sleep onset latency was reduced by 26.1 minutes among YAWNS-1 participants, compared with YAWNS-2 (P < .001), and by 27.7 minutes, compared with TAU (P < .001). Wake after sleep onset increased by 4.1 minutes in YAWNS-1, 11.1 minutes in YAWNS-2, and 7.5 minutes in TAU.
Although all participants underwent rigorous assessment before inclusion, less than half of participants receiving either intervention (36% in YAWNS-1 and 43% in YAWNS-2) contacted their provider or pharmacist to discuss BZD dose reductions. This finding may have resulted partly from limited access because of the COVID-19 pandemic, according to the authors.
A Stepped-Care Model
The intervention is intended to help patients “change their approach from sleeping pills to a short-term CBTI course for long-term sleep benefits, and then speak to their provider,” said Dr. Gardner.
He pointed to a post-study follow-up of the study participants’ health providers, most of whom had moderate to extensive experience deprescribing BZRAs, which showed that 87.5%-100% fully or nearly fully agreed with or supported using the Sleepwell strategy and its content with older patients who rely on sedatives.
“Providers said that deprescribing is difficult, time-consuming, and often not a productive use of their time,” said Dr. Gardner. “I see insomnia as a health issue well set up for a stepped-care model. Self-help approaches are at the very bottom of that model and can help shift the initial burden to patients and out of the healthcare system.”
Poor uptake has prevented CBTI from demonstrating its potential, which is a challenge that Charles M. Morin, PhD, professor of psychology at Laval University in Quebec City, Quebec, Canada, attributes to two factors. “Clearly, there aren’t enough providers with this kind of expertise, and it’s not always covered by public health insurance, so people have to pay out of pocket to treat their insomnia,” he said.
“Overall, I think that this was a very nice study, well conducted, with an impressive sample size,” said Dr. Morin, who was not involved in the study. “The results are quite encouraging, telling us that even when older adults have used sleep medications for an average of 10 years, it’s still possible to reduce the medication. But this doesn’t happen alone. People need to be guided in doing that, not only to decrease medication use, but they also need an alternative,” he said.
Dr. Morin questioned how many patients agree to start with a low intensity. “Ideally, it should be a shared decision paradigm, where the physician or whoever sees the patient first presents the available options and explains the pluses and minuses of each. Some patients might choose medication because it’s a quick fix,” he said. “But some might want to do CBTI, even if it takes more work. The results are sustainable over time,” he added.
The study was jointly funded by the Public Health Agency of Canada and the government of New Brunswick as a Healthy Seniors Pilot Project. Dr. Gardner and Dr. Morin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A strategy developed by Canadian researchers for encouraging older patients with insomnia to wean themselves from sleeping pills and improve their sleep through behavioral techniques is effective, data suggest. If proven helpful for the millions of older Canadians who currently rely on nightly benzodiazepines (BZDs) and non-BZDs (colloquially known as Z drugs) for their sleep, it might yield an additional benefit: Reducing resource utilization.
“We know that cognitive behavioral therapy for insomnia (CBTI) works. It’s recommended as first-line therapy because it works,” study author David Gardner, PharmD, professor of psychiatry at Dalhousie University in Halifax, Nova Scotia, Canada, told this news organization.
“We’re sharing information about sleeping pills, information that has been embedded with behavior-change techniques that lead people to second-guess or rethink their long-term use of sedative hypnotics and then bring that information to their provider or pharmacist to discuss it,” he said.
The results were published in JAMA Psychiatry.
Better Sleep, Fewer Pills
Dr. Gardner and his team created a direct-to-patient, patient-directed, multicomponent knowledge mobilization intervention called Sleepwell. It incorporates best practice– and guideline-based evidence and multiple behavioral change techniques with content and graphics. Dr. Gardner emphasized that it represents a directional shift in care that alleviates providers’ burden without removing it entirely.
To test the intervention’s effectiveness, Dr. Gardner and his team chose New Brunswick as a location for a 6-month, three-arm, open-label, randomized controlled trial; the province has one of the highest rates of sedative use and an older adult population that is vulnerable to the serious side effects of these drugs (eg, cognitive impairment, falls, and frailty). The study was called Your Answers When Needing Sleep in New Brunswick (YAWNS NB).
Eligible participants were aged ≥ 65 years, lived in the community, and had taken benzodiazepine receptor agonists (BZRAs) for ≥ 3 nights per week for 3 or more months. Participants were randomly assigned to a control group or one of the two intervention groups. The YAWNS-1 intervention group (n = 195) received a mailed package containing a cover letter, a booklet outlining how to stop sleeping pills, a booklet on how to “get your sleep back,” and a companion website. The YAWNS-2 group (n = 193) received updated versions of the booklets used in a prior trial. The control group (n = 192) was assigned treatment as usual (TAU).
A greater proportion of YAWNS-1 participants discontinued BZRAs at 6 months (26.2%) and had dose reductions (20.4%), compared with YAWNS-2 participants (20.3% and 14.4%, respectively) and TAU participants (7.5% and 12.8%, respectively). The corresponding numbers needed to mail to achieve an additional discontinuation was 5.3 YAWNS-1 packages and 7.8 YAWNS-2 packages.
At 6 months, BZRA cessation was sustained a mean 13.6 weeks for YAWNS-1, 14.3 weeks for YAWNS-2, and 16.9 weeks for TAU.
Sleep measures also improved with YAWNS-1, compared with YAWNs-2 and TAU. Sleep onset latency was reduced by 26.1 minutes among YAWNS-1 participants, compared with YAWNS-2 (P < .001), and by 27.7 minutes, compared with TAU (P < .001). Wake after sleep onset increased by 4.1 minutes in YAWNS-1, 11.1 minutes in YAWNS-2, and 7.5 minutes in TAU.
Although all participants underwent rigorous assessment before inclusion, less than half of participants receiving either intervention (36% in YAWNS-1 and 43% in YAWNS-2) contacted their provider or pharmacist to discuss BZD dose reductions. This finding may have resulted partly from limited access because of the COVID-19 pandemic, according to the authors.
A Stepped-Care Model
The intervention is intended to help patients “change their approach from sleeping pills to a short-term CBTI course for long-term sleep benefits, and then speak to their provider,” said Dr. Gardner.
He pointed to a post-study follow-up of the study participants’ health providers, most of whom had moderate to extensive experience deprescribing BZRAs, which showed that 87.5%-100% fully or nearly fully agreed with or supported using the Sleepwell strategy and its content with older patients who rely on sedatives.
“Providers said that deprescribing is difficult, time-consuming, and often not a productive use of their time,” said Dr. Gardner. “I see insomnia as a health issue well set up for a stepped-care model. Self-help approaches are at the very bottom of that model and can help shift the initial burden to patients and out of the healthcare system.”
Poor uptake has prevented CBTI from demonstrating its potential, which is a challenge that Charles M. Morin, PhD, professor of psychology at Laval University in Quebec City, Quebec, Canada, attributes to two factors. “Clearly, there aren’t enough providers with this kind of expertise, and it’s not always covered by public health insurance, so people have to pay out of pocket to treat their insomnia,” he said.
“Overall, I think that this was a very nice study, well conducted, with an impressive sample size,” said Dr. Morin, who was not involved in the study. “The results are quite encouraging, telling us that even when older adults have used sleep medications for an average of 10 years, it’s still possible to reduce the medication. But this doesn’t happen alone. People need to be guided in doing that, not only to decrease medication use, but they also need an alternative,” he said.
Dr. Morin questioned how many patients agree to start with a low intensity. “Ideally, it should be a shared decision paradigm, where the physician or whoever sees the patient first presents the available options and explains the pluses and minuses of each. Some patients might choose medication because it’s a quick fix,” he said. “But some might want to do CBTI, even if it takes more work. The results are sustainable over time,” he added.
The study was jointly funded by the Public Health Agency of Canada and the government of New Brunswick as a Healthy Seniors Pilot Project. Dr. Gardner and Dr. Morin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A strategy developed by Canadian researchers for encouraging older patients with insomnia to wean themselves from sleeping pills and improve their sleep through behavioral techniques is effective, data suggest. If proven helpful for the millions of older Canadians who currently rely on nightly benzodiazepines (BZDs) and non-BZDs (colloquially known as Z drugs) for their sleep, it might yield an additional benefit: Reducing resource utilization.
“We know that cognitive behavioral therapy for insomnia (CBTI) works. It’s recommended as first-line therapy because it works,” study author David Gardner, PharmD, professor of psychiatry at Dalhousie University in Halifax, Nova Scotia, Canada, told this news organization.
“We’re sharing information about sleeping pills, information that has been embedded with behavior-change techniques that lead people to second-guess or rethink their long-term use of sedative hypnotics and then bring that information to their provider or pharmacist to discuss it,” he said.
The results were published in JAMA Psychiatry.
Better Sleep, Fewer Pills
Dr. Gardner and his team created a direct-to-patient, patient-directed, multicomponent knowledge mobilization intervention called Sleepwell. It incorporates best practice– and guideline-based evidence and multiple behavioral change techniques with content and graphics. Dr. Gardner emphasized that it represents a directional shift in care that alleviates providers’ burden without removing it entirely.
To test the intervention’s effectiveness, Dr. Gardner and his team chose New Brunswick as a location for a 6-month, three-arm, open-label, randomized controlled trial; the province has one of the highest rates of sedative use and an older adult population that is vulnerable to the serious side effects of these drugs (eg, cognitive impairment, falls, and frailty). The study was called Your Answers When Needing Sleep in New Brunswick (YAWNS NB).
Eligible participants were aged ≥ 65 years, lived in the community, and had taken benzodiazepine receptor agonists (BZRAs) for ≥ 3 nights per week for 3 or more months. Participants were randomly assigned to a control group or one of the two intervention groups. The YAWNS-1 intervention group (n = 195) received a mailed package containing a cover letter, a booklet outlining how to stop sleeping pills, a booklet on how to “get your sleep back,” and a companion website. The YAWNS-2 group (n = 193) received updated versions of the booklets used in a prior trial. The control group (n = 192) was assigned treatment as usual (TAU).
A greater proportion of YAWNS-1 participants discontinued BZRAs at 6 months (26.2%) and had dose reductions (20.4%), compared with YAWNS-2 participants (20.3% and 14.4%, respectively) and TAU participants (7.5% and 12.8%, respectively). The corresponding numbers needed to mail to achieve an additional discontinuation was 5.3 YAWNS-1 packages and 7.8 YAWNS-2 packages.
At 6 months, BZRA cessation was sustained a mean 13.6 weeks for YAWNS-1, 14.3 weeks for YAWNS-2, and 16.9 weeks for TAU.
Sleep measures also improved with YAWNS-1, compared with YAWNs-2 and TAU. Sleep onset latency was reduced by 26.1 minutes among YAWNS-1 participants, compared with YAWNS-2 (P < .001), and by 27.7 minutes, compared with TAU (P < .001). Wake after sleep onset increased by 4.1 minutes in YAWNS-1, 11.1 minutes in YAWNS-2, and 7.5 minutes in TAU.
Although all participants underwent rigorous assessment before inclusion, less than half of participants receiving either intervention (36% in YAWNS-1 and 43% in YAWNS-2) contacted their provider or pharmacist to discuss BZD dose reductions. This finding may have resulted partly from limited access because of the COVID-19 pandemic, according to the authors.
A Stepped-Care Model
The intervention is intended to help patients “change their approach from sleeping pills to a short-term CBTI course for long-term sleep benefits, and then speak to their provider,” said Dr. Gardner.
He pointed to a post-study follow-up of the study participants’ health providers, most of whom had moderate to extensive experience deprescribing BZRAs, which showed that 87.5%-100% fully or nearly fully agreed with or supported using the Sleepwell strategy and its content with older patients who rely on sedatives.
“Providers said that deprescribing is difficult, time-consuming, and often not a productive use of their time,” said Dr. Gardner. “I see insomnia as a health issue well set up for a stepped-care model. Self-help approaches are at the very bottom of that model and can help shift the initial burden to patients and out of the healthcare system.”
Poor uptake has prevented CBTI from demonstrating its potential, which is a challenge that Charles M. Morin, PhD, professor of psychology at Laval University in Quebec City, Quebec, Canada, attributes to two factors. “Clearly, there aren’t enough providers with this kind of expertise, and it’s not always covered by public health insurance, so people have to pay out of pocket to treat their insomnia,” he said.
“Overall, I think that this was a very nice study, well conducted, with an impressive sample size,” said Dr. Morin, who was not involved in the study. “The results are quite encouraging, telling us that even when older adults have used sleep medications for an average of 10 years, it’s still possible to reduce the medication. But this doesn’t happen alone. People need to be guided in doing that, not only to decrease medication use, but they also need an alternative,” he said.
Dr. Morin questioned how many patients agree to start with a low intensity. “Ideally, it should be a shared decision paradigm, where the physician or whoever sees the patient first presents the available options and explains the pluses and minuses of each. Some patients might choose medication because it’s a quick fix,” he said. “But some might want to do CBTI, even if it takes more work. The results are sustainable over time,” he added.
The study was jointly funded by the Public Health Agency of Canada and the government of New Brunswick as a Healthy Seniors Pilot Project. Dr. Gardner and Dr. Morin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Could British Columbia Eliminate Cervical Cancer by 2031?
To achieve this goal, the province will also need to reach historically underscreened, equity-seeking populations (ie, Black, indigenous, immigrant, LGBTQ, and disabled patients, and those with sexual trauma) through mailed self-screening HPV tests.
The adoption of both these strategies is essential, according to a modeling study that was published on June 3 in CMAJ, especially because the true impact of HPV vaccination has yet to be fully realized.
“In BC, we have a school-based program to increase vaccine coverage in boys and girls starting in grade 6,” study author Reka Pataky, PhD, a senior research health economist at the Canadian Centre for Applied Research in Cancer Control and BC Cancer in Vancouver, British Columbia, Canada, told this news organization. Dr. Pataky noted that this immunization program was launched in 2008 and that some of the initial cohorts haven›t yet reached the average age of diagnosis, which is between 30 and 59 years.
Three’s a Charm
The investigators undertook a modeling study to determine when and how BC might achieve the elimination of cervical cancer following a transition to HPV-based screening. Elimination was defined as an annual age-standardized incidence rate of < 4.0 per 100,000 women.
Modeling scenarios were developed using the Canadian Partnership Against Cancer’s priority targets, which include increasing HPV vaccination through school-based coverage from 70% to 90%, increasing the probability of ever receiving a screening test from 90% to 95%, increasing the rate of on-time screening from 70% to 90%, and improving follow-up to 95% for colposcopy (currently 88%) and HPV testing (currently 80%). Modeling simulated HPV transmission and the natural history of cervical cancer in the Canadian population and relied upon two reference scenarios: One using BC’s cytology-based screening at the time of analysis, and the other an HPV base-case scenario.
The researchers found that with the status quo (ie, cytology-based screening and no change to vaccination or screening participation rates), BC would not eliminate cervical cancer until 2045. Implementation of HPV-based screening at the current 70% participation rate would achieve elimination in 2034 and prevent 942 cases compared with cytology screening. Increasing the proportion of patients who were ever screened or increasing vaccination coverage would result in cervical cancer elimination by 2033. The time line would be shortened even further (to 2031) through a combination of three strategies (ie, improving recruitment, on-time screening, and follow-up compliance).
Low Incidence, Strained System
The incidence of cervical cancer in Canada is relatively low, accounting for 1.3% of all new female cancers and 1.1% of all female cancer deaths.
“The reason that we have such low rates is because we have organized screening programs,” explained Rachel Kupets, MD, associate professor of gynecologic oncology at the University of Toronto and Sunnybrook Hospital, Toronto. She was not involved in the study.
“We’re starting to see what happens when the system gets strained with lower participation rates. I am starting to see a lot more women with invasive cervical cancer. They’re younger, and their cancers are less curable and less treatable,” she said.
Difficulties with access, interest, and education have contributed to low cervical screening rates among equity-seeking populations, according to Dr. Pataky and Dr. Kupets.
“Self-screening is another tool that can incrementally benefit those folks who wouldn’t otherwise undergo screening or don’t want an invasive test,” said Dr. Kupets. It can also play an increasing role, while current access to primary care services in Canada is at an all-time low. Community outreach through centers, mobile coaches, and nursing stations might help ensure participation by at-risk populations. These measures also could boost follow-up for and education about positive results, said Dr. Kupets.
In a related editorial, Shannon Charlebois, MD, medical editor of CMAJ, and Sarah Kean, MD, assistant professor of gynecologic oncology at the University of Manitoba in Winnipeg, Manitoba, Canada, emphasized the need for mailed HPV self-screening kits to be paid for and integrated into provincial cervical cancer screening programs across Canada to support earlier cervical cancer detection and lower invasive cancer rates.
Dr. Pataky concurred. “There have been discussions about making the big transition from traditional cytology to implementing HPV self-screening,” she said. “We have really effective tools for preventing cervical cancer, and it’s important to not lose sight of that goal.”
The study was funded by the National Institutes of Health. Dr. Pataky and Dr. Kupets reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
To achieve this goal, the province will also need to reach historically underscreened, equity-seeking populations (ie, Black, indigenous, immigrant, LGBTQ, and disabled patients, and those with sexual trauma) through mailed self-screening HPV tests.
The adoption of both these strategies is essential, according to a modeling study that was published on June 3 in CMAJ, especially because the true impact of HPV vaccination has yet to be fully realized.
“In BC, we have a school-based program to increase vaccine coverage in boys and girls starting in grade 6,” study author Reka Pataky, PhD, a senior research health economist at the Canadian Centre for Applied Research in Cancer Control and BC Cancer in Vancouver, British Columbia, Canada, told this news organization. Dr. Pataky noted that this immunization program was launched in 2008 and that some of the initial cohorts haven›t yet reached the average age of diagnosis, which is between 30 and 59 years.
Three’s a Charm
The investigators undertook a modeling study to determine when and how BC might achieve the elimination of cervical cancer following a transition to HPV-based screening. Elimination was defined as an annual age-standardized incidence rate of < 4.0 per 100,000 women.
Modeling scenarios were developed using the Canadian Partnership Against Cancer’s priority targets, which include increasing HPV vaccination through school-based coverage from 70% to 90%, increasing the probability of ever receiving a screening test from 90% to 95%, increasing the rate of on-time screening from 70% to 90%, and improving follow-up to 95% for colposcopy (currently 88%) and HPV testing (currently 80%). Modeling simulated HPV transmission and the natural history of cervical cancer in the Canadian population and relied upon two reference scenarios: One using BC’s cytology-based screening at the time of analysis, and the other an HPV base-case scenario.
The researchers found that with the status quo (ie, cytology-based screening and no change to vaccination or screening participation rates), BC would not eliminate cervical cancer until 2045. Implementation of HPV-based screening at the current 70% participation rate would achieve elimination in 2034 and prevent 942 cases compared with cytology screening. Increasing the proportion of patients who were ever screened or increasing vaccination coverage would result in cervical cancer elimination by 2033. The time line would be shortened even further (to 2031) through a combination of three strategies (ie, improving recruitment, on-time screening, and follow-up compliance).
Low Incidence, Strained System
The incidence of cervical cancer in Canada is relatively low, accounting for 1.3% of all new female cancers and 1.1% of all female cancer deaths.
“The reason that we have such low rates is because we have organized screening programs,” explained Rachel Kupets, MD, associate professor of gynecologic oncology at the University of Toronto and Sunnybrook Hospital, Toronto. She was not involved in the study.
“We’re starting to see what happens when the system gets strained with lower participation rates. I am starting to see a lot more women with invasive cervical cancer. They’re younger, and their cancers are less curable and less treatable,” she said.
Difficulties with access, interest, and education have contributed to low cervical screening rates among equity-seeking populations, according to Dr. Pataky and Dr. Kupets.
“Self-screening is another tool that can incrementally benefit those folks who wouldn’t otherwise undergo screening or don’t want an invasive test,” said Dr. Kupets. It can also play an increasing role, while current access to primary care services in Canada is at an all-time low. Community outreach through centers, mobile coaches, and nursing stations might help ensure participation by at-risk populations. These measures also could boost follow-up for and education about positive results, said Dr. Kupets.
In a related editorial, Shannon Charlebois, MD, medical editor of CMAJ, and Sarah Kean, MD, assistant professor of gynecologic oncology at the University of Manitoba in Winnipeg, Manitoba, Canada, emphasized the need for mailed HPV self-screening kits to be paid for and integrated into provincial cervical cancer screening programs across Canada to support earlier cervical cancer detection and lower invasive cancer rates.
Dr. Pataky concurred. “There have been discussions about making the big transition from traditional cytology to implementing HPV self-screening,” she said. “We have really effective tools for preventing cervical cancer, and it’s important to not lose sight of that goal.”
The study was funded by the National Institutes of Health. Dr. Pataky and Dr. Kupets reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
To achieve this goal, the province will also need to reach historically underscreened, equity-seeking populations (ie, Black, indigenous, immigrant, LGBTQ, and disabled patients, and those with sexual trauma) through mailed self-screening HPV tests.
The adoption of both these strategies is essential, according to a modeling study that was published on June 3 in CMAJ, especially because the true impact of HPV vaccination has yet to be fully realized.
“In BC, we have a school-based program to increase vaccine coverage in boys and girls starting in grade 6,” study author Reka Pataky, PhD, a senior research health economist at the Canadian Centre for Applied Research in Cancer Control and BC Cancer in Vancouver, British Columbia, Canada, told this news organization. Dr. Pataky noted that this immunization program was launched in 2008 and that some of the initial cohorts haven›t yet reached the average age of diagnosis, which is between 30 and 59 years.
Three’s a Charm
The investigators undertook a modeling study to determine when and how BC might achieve the elimination of cervical cancer following a transition to HPV-based screening. Elimination was defined as an annual age-standardized incidence rate of < 4.0 per 100,000 women.
Modeling scenarios were developed using the Canadian Partnership Against Cancer’s priority targets, which include increasing HPV vaccination through school-based coverage from 70% to 90%, increasing the probability of ever receiving a screening test from 90% to 95%, increasing the rate of on-time screening from 70% to 90%, and improving follow-up to 95% for colposcopy (currently 88%) and HPV testing (currently 80%). Modeling simulated HPV transmission and the natural history of cervical cancer in the Canadian population and relied upon two reference scenarios: One using BC’s cytology-based screening at the time of analysis, and the other an HPV base-case scenario.
The researchers found that with the status quo (ie, cytology-based screening and no change to vaccination or screening participation rates), BC would not eliminate cervical cancer until 2045. Implementation of HPV-based screening at the current 70% participation rate would achieve elimination in 2034 and prevent 942 cases compared with cytology screening. Increasing the proportion of patients who were ever screened or increasing vaccination coverage would result in cervical cancer elimination by 2033. The time line would be shortened even further (to 2031) through a combination of three strategies (ie, improving recruitment, on-time screening, and follow-up compliance).
Low Incidence, Strained System
The incidence of cervical cancer in Canada is relatively low, accounting for 1.3% of all new female cancers and 1.1% of all female cancer deaths.
“The reason that we have such low rates is because we have organized screening programs,” explained Rachel Kupets, MD, associate professor of gynecologic oncology at the University of Toronto and Sunnybrook Hospital, Toronto. She was not involved in the study.
“We’re starting to see what happens when the system gets strained with lower participation rates. I am starting to see a lot more women with invasive cervical cancer. They’re younger, and their cancers are less curable and less treatable,” she said.
Difficulties with access, interest, and education have contributed to low cervical screening rates among equity-seeking populations, according to Dr. Pataky and Dr. Kupets.
“Self-screening is another tool that can incrementally benefit those folks who wouldn’t otherwise undergo screening or don’t want an invasive test,” said Dr. Kupets. It can also play an increasing role, while current access to primary care services in Canada is at an all-time low. Community outreach through centers, mobile coaches, and nursing stations might help ensure participation by at-risk populations. These measures also could boost follow-up for and education about positive results, said Dr. Kupets.
In a related editorial, Shannon Charlebois, MD, medical editor of CMAJ, and Sarah Kean, MD, assistant professor of gynecologic oncology at the University of Manitoba in Winnipeg, Manitoba, Canada, emphasized the need for mailed HPV self-screening kits to be paid for and integrated into provincial cervical cancer screening programs across Canada to support earlier cervical cancer detection and lower invasive cancer rates.
Dr. Pataky concurred. “There have been discussions about making the big transition from traditional cytology to implementing HPV self-screening,” she said. “We have really effective tools for preventing cervical cancer, and it’s important to not lose sight of that goal.”
The study was funded by the National Institutes of Health. Dr. Pataky and Dr. Kupets reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Will Your Next Prescription Be 20 Minutes of Nature a Day?
What if a walk in a green environment could reshape brains, recalibrate sense of time, and stave off mental health conditions? If the research trends are true, you might soon find yourself writing prescriptions of 20 minutes of nature per day.
In the wake of the pandemic, the British government allocated more than £5 million to pandemic recovery efforts that specifically involved green spaces. Since then, it has committed even more funding toward an expansive social prescribing program that connects patients to “link workers” who determine personal care needs and facilitate community and volunteer-based interventions. These can include group walking and volunteering to help out in community gardens or conservation efforts. Similar green programs can be found in Japan, where shinrin-yoku (forest bathing) was recently adopted as a national health strategy, and in the United States and Canada.
“Disconnection from nature is a major part of the health problems that we have on this planet,” said William Bird, a UK-based general practitioner, green prescriber, and CEO of Intelligent Health, which is geared toward building healthy, active, and connected communities. Dr. Bird received the prestigious Member of the Order of the British Empire (MBE) in 2010 for services related to physical activity and health.
“Our brains are designed to connect to nature ... and we haven’t lost that instinct,” he explained. “Once we are with birdsong and water flowing and greenery, cortisol levels drop, our central vagus nerve improves, our fight and flight [response] disappears, and we start to be more receptive to other people.”
Shifting Time Perception and Health
Ricardo A. Correia, PhD, a biologist and researcher at the University of Helsinki in Finland, said he believed that the mechanism for at least some of these outcomes might be differences in how time is perceived. In a perspective that appeared in March in People and Nature, Dr. Correia explored how the “services” that nature provides shift time perceptions and, in turn, regulate overall well-being.
“I reached the realization that there was some evidence for the shift in some of the dimensions that we use to make sense of time in urban vs natural environments,” he told this news organization.
Dr. Correia explained that human time perception facilitates understanding cause and effect, so we can act in a way that allows us to survive.
“Time perception in humans is really complex and multifaceted,” he said. “The way that we make sense of time is not directly attached to any sensory organ, but rather goes through a range of cognitive, emotional, and bodily processes, all of which vary from person to person.”
Dr. Correia pointed to evidence showing that time perception is shorter in urban environments and longer in natural ones. This, in turn, influences attention and attention restoration. “When we live in cities, we are exposed to similar sorts of demanding environments, increased time pressures, less time for oneself and for recreational purposes,” he said. “Ever-mounting pressure on daily demands plus processes we use to make sense of time, especially attention, means that we pay a cognitive toll.”
Dr. Correia posits that it might be possible to recalibrate time perception, but only by breaking the cycle of exposure.
“If we are always exposed to fast-paced lifestyles, we become attuned to them and get caught up in an endless loop.” This cycle can be broken, Dr. Correia explained, by increasing exposure to natural environments. This leads to positive emotions, a sense of being in the present, and a heightened sense of mindfulness, all of which help mitigate the physical and mental health outcomes commonly associated with time scarcity.
Brain-Mental Health Benefits
To date, there is quite a bit of research exploring the impacts of exposure to nature on the brain. For example, data have shown that adolescents raised exclusively in rural environments have a larger hippocampus and better spatial processing than children exclusively raised in cities. Other research demonstrated that spending just an hour in the forest led to a decline in amygdala activity in adults, whereas it remained stable after walking in an urban setting, underscoring the salutogenic effects on brain regions related to stress. There is also evidence from a 10-year longitudinal study of more than 2 million Welsh adults that highlights the value of proximity to green or blue (eg, lakes and rivers) spaces and common mental health conditions, with every additional 360 meters to the nearest green or blue space associated with 10% greater odds of anxiety and depression.
Dr. Bird said there has been a massive sea change in attitudes among general practitioners, who have come around to embracing the concept of nature as medicine. This shift among peers, who teased him in the 1990s about his green walking and conservation prescriptions, portends a bandwagon of epic proportions that could benefit patients. He said that he was especially hopeful that green prescriptions will become mainstream in certain conditions, especially those like depression and anxiety that are resistant to medication.
But Dr. Bird cautions that primary care professionals need to be mindful. “Patients need to know that it’s real science, otherwise they’ll think that they’re being pawned off or dismissed,” he said. “I try to put real evidence behind it and explain that there’s no contraindication. The main thing is to start where patients are, what they’re feeling, and what they need. Some people just don’t like nature,” he said.
A version of this article appeared on Medscape.com.
What if a walk in a green environment could reshape brains, recalibrate sense of time, and stave off mental health conditions? If the research trends are true, you might soon find yourself writing prescriptions of 20 minutes of nature per day.
In the wake of the pandemic, the British government allocated more than £5 million to pandemic recovery efforts that specifically involved green spaces. Since then, it has committed even more funding toward an expansive social prescribing program that connects patients to “link workers” who determine personal care needs and facilitate community and volunteer-based interventions. These can include group walking and volunteering to help out in community gardens or conservation efforts. Similar green programs can be found in Japan, where shinrin-yoku (forest bathing) was recently adopted as a national health strategy, and in the United States and Canada.
“Disconnection from nature is a major part of the health problems that we have on this planet,” said William Bird, a UK-based general practitioner, green prescriber, and CEO of Intelligent Health, which is geared toward building healthy, active, and connected communities. Dr. Bird received the prestigious Member of the Order of the British Empire (MBE) in 2010 for services related to physical activity and health.
“Our brains are designed to connect to nature ... and we haven’t lost that instinct,” he explained. “Once we are with birdsong and water flowing and greenery, cortisol levels drop, our central vagus nerve improves, our fight and flight [response] disappears, and we start to be more receptive to other people.”
Shifting Time Perception and Health
Ricardo A. Correia, PhD, a biologist and researcher at the University of Helsinki in Finland, said he believed that the mechanism for at least some of these outcomes might be differences in how time is perceived. In a perspective that appeared in March in People and Nature, Dr. Correia explored how the “services” that nature provides shift time perceptions and, in turn, regulate overall well-being.
“I reached the realization that there was some evidence for the shift in some of the dimensions that we use to make sense of time in urban vs natural environments,” he told this news organization.
Dr. Correia explained that human time perception facilitates understanding cause and effect, so we can act in a way that allows us to survive.
“Time perception in humans is really complex and multifaceted,” he said. “The way that we make sense of time is not directly attached to any sensory organ, but rather goes through a range of cognitive, emotional, and bodily processes, all of which vary from person to person.”
Dr. Correia pointed to evidence showing that time perception is shorter in urban environments and longer in natural ones. This, in turn, influences attention and attention restoration. “When we live in cities, we are exposed to similar sorts of demanding environments, increased time pressures, less time for oneself and for recreational purposes,” he said. “Ever-mounting pressure on daily demands plus processes we use to make sense of time, especially attention, means that we pay a cognitive toll.”
Dr. Correia posits that it might be possible to recalibrate time perception, but only by breaking the cycle of exposure.
“If we are always exposed to fast-paced lifestyles, we become attuned to them and get caught up in an endless loop.” This cycle can be broken, Dr. Correia explained, by increasing exposure to natural environments. This leads to positive emotions, a sense of being in the present, and a heightened sense of mindfulness, all of which help mitigate the physical and mental health outcomes commonly associated with time scarcity.
Brain-Mental Health Benefits
To date, there is quite a bit of research exploring the impacts of exposure to nature on the brain. For example, data have shown that adolescents raised exclusively in rural environments have a larger hippocampus and better spatial processing than children exclusively raised in cities. Other research demonstrated that spending just an hour in the forest led to a decline in amygdala activity in adults, whereas it remained stable after walking in an urban setting, underscoring the salutogenic effects on brain regions related to stress. There is also evidence from a 10-year longitudinal study of more than 2 million Welsh adults that highlights the value of proximity to green or blue (eg, lakes and rivers) spaces and common mental health conditions, with every additional 360 meters to the nearest green or blue space associated with 10% greater odds of anxiety and depression.
Dr. Bird said there has been a massive sea change in attitudes among general practitioners, who have come around to embracing the concept of nature as medicine. This shift among peers, who teased him in the 1990s about his green walking and conservation prescriptions, portends a bandwagon of epic proportions that could benefit patients. He said that he was especially hopeful that green prescriptions will become mainstream in certain conditions, especially those like depression and anxiety that are resistant to medication.
But Dr. Bird cautions that primary care professionals need to be mindful. “Patients need to know that it’s real science, otherwise they’ll think that they’re being pawned off or dismissed,” he said. “I try to put real evidence behind it and explain that there’s no contraindication. The main thing is to start where patients are, what they’re feeling, and what they need. Some people just don’t like nature,” he said.
A version of this article appeared on Medscape.com.
What if a walk in a green environment could reshape brains, recalibrate sense of time, and stave off mental health conditions? If the research trends are true, you might soon find yourself writing prescriptions of 20 minutes of nature per day.
In the wake of the pandemic, the British government allocated more than £5 million to pandemic recovery efforts that specifically involved green spaces. Since then, it has committed even more funding toward an expansive social prescribing program that connects patients to “link workers” who determine personal care needs and facilitate community and volunteer-based interventions. These can include group walking and volunteering to help out in community gardens or conservation efforts. Similar green programs can be found in Japan, where shinrin-yoku (forest bathing) was recently adopted as a national health strategy, and in the United States and Canada.
“Disconnection from nature is a major part of the health problems that we have on this planet,” said William Bird, a UK-based general practitioner, green prescriber, and CEO of Intelligent Health, which is geared toward building healthy, active, and connected communities. Dr. Bird received the prestigious Member of the Order of the British Empire (MBE) in 2010 for services related to physical activity and health.
“Our brains are designed to connect to nature ... and we haven’t lost that instinct,” he explained. “Once we are with birdsong and water flowing and greenery, cortisol levels drop, our central vagus nerve improves, our fight and flight [response] disappears, and we start to be more receptive to other people.”
Shifting Time Perception and Health
Ricardo A. Correia, PhD, a biologist and researcher at the University of Helsinki in Finland, said he believed that the mechanism for at least some of these outcomes might be differences in how time is perceived. In a perspective that appeared in March in People and Nature, Dr. Correia explored how the “services” that nature provides shift time perceptions and, in turn, regulate overall well-being.
“I reached the realization that there was some evidence for the shift in some of the dimensions that we use to make sense of time in urban vs natural environments,” he told this news organization.
Dr. Correia explained that human time perception facilitates understanding cause and effect, so we can act in a way that allows us to survive.
“Time perception in humans is really complex and multifaceted,” he said. “The way that we make sense of time is not directly attached to any sensory organ, but rather goes through a range of cognitive, emotional, and bodily processes, all of which vary from person to person.”
Dr. Correia pointed to evidence showing that time perception is shorter in urban environments and longer in natural ones. This, in turn, influences attention and attention restoration. “When we live in cities, we are exposed to similar sorts of demanding environments, increased time pressures, less time for oneself and for recreational purposes,” he said. “Ever-mounting pressure on daily demands plus processes we use to make sense of time, especially attention, means that we pay a cognitive toll.”
Dr. Correia posits that it might be possible to recalibrate time perception, but only by breaking the cycle of exposure.
“If we are always exposed to fast-paced lifestyles, we become attuned to them and get caught up in an endless loop.” This cycle can be broken, Dr. Correia explained, by increasing exposure to natural environments. This leads to positive emotions, a sense of being in the present, and a heightened sense of mindfulness, all of which help mitigate the physical and mental health outcomes commonly associated with time scarcity.
Brain-Mental Health Benefits
To date, there is quite a bit of research exploring the impacts of exposure to nature on the brain. For example, data have shown that adolescents raised exclusively in rural environments have a larger hippocampus and better spatial processing than children exclusively raised in cities. Other research demonstrated that spending just an hour in the forest led to a decline in amygdala activity in adults, whereas it remained stable after walking in an urban setting, underscoring the salutogenic effects on brain regions related to stress. There is also evidence from a 10-year longitudinal study of more than 2 million Welsh adults that highlights the value of proximity to green or blue (eg, lakes and rivers) spaces and common mental health conditions, with every additional 360 meters to the nearest green or blue space associated with 10% greater odds of anxiety and depression.
Dr. Bird said there has been a massive sea change in attitudes among general practitioners, who have come around to embracing the concept of nature as medicine. This shift among peers, who teased him in the 1990s about his green walking and conservation prescriptions, portends a bandwagon of epic proportions that could benefit patients. He said that he was especially hopeful that green prescriptions will become mainstream in certain conditions, especially those like depression and anxiety that are resistant to medication.
But Dr. Bird cautions that primary care professionals need to be mindful. “Patients need to know that it’s real science, otherwise they’ll think that they’re being pawned off or dismissed,” he said. “I try to put real evidence behind it and explain that there’s no contraindication. The main thing is to start where patients are, what they’re feeling, and what they need. Some people just don’t like nature,” he said.
A version of this article appeared on Medscape.com.
Taking a new obesity drug and birth control pills? Be careful
For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.
So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.
On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. , making an unintended pregnancy more likely.
Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to.
“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”
When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response.
“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
It’s all in the gut
One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills.
Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy.
And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn.
“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
Unanticipated outcomes, extra prevention
Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks.
“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”
It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system.
What can women do to help ensure that they don’t become pregnant while using these drugs?
“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.”
Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”
Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”
“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.
Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue.
“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”
She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”
In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.
“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to.
Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah.
Clear conversations are key.
A version of this article first appeared on WebMD.com.
For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.
So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.
On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. , making an unintended pregnancy more likely.
Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to.
“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”
When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response.
“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
It’s all in the gut
One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills.
Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy.
And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn.
“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
Unanticipated outcomes, extra prevention
Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks.
“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”
It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system.
What can women do to help ensure that they don’t become pregnant while using these drugs?
“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.”
Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”
Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”
“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.
Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue.
“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”
She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”
In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.
“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to.
Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah.
Clear conversations are key.
A version of this article first appeared on WebMD.com.
For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.
So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.
On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. , making an unintended pregnancy more likely.
Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to.
“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”
When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response.
“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
It’s all in the gut
One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills.
Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy.
And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn.
“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
Unanticipated outcomes, extra prevention
Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks.
“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”
It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system.
What can women do to help ensure that they don’t become pregnant while using these drugs?
“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.”
Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”
Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”
“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.
Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue.
“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”
She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”
In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.
“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to.
Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah.
Clear conversations are key.
A version of this article first appeared on WebMD.com.
New guidelines for cannabis in chronic pain management released
New clinical practice guidelines for cannabis in chronic pain management have been released.
Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.
“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.
“But I would strongly argue that I would use cannabis-based medicine over opioids every time. Why would you use a high potency-high toxicity agent when there’s a low potency-low toxicity alternative?” he said.
The guidelines were published online in the journal Cannabis and Cannabinoid Research.
Examining the evidence
A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.
Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.
Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.
When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.
In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.
The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.
Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.
An effective alternative
Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.
“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”
Dr. Wallace said he found the guidelines’ dosing recommendations helpful.
“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”
While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.
Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.
“When we have an opportunity to use cannabinoids in place of opioids for our patients, I think that that’s a positive thing ... and a wise choice in terms of risk benefit,” Dr. Gilligan said.
On the other hand, he cautioned that “freely prescribing” cannabinoids for chronic pain in patients who aren’t on opioids is not good practice.
“We have to take seriously the potential adverse effects of [cannabis], including marijuana use disorder, interference with learning, memory impairment, and psychotic breakthroughs,” said Dr. Gilligan.
Given the current climate, it would appear that CBM is a long way from being endorsed by the Food and Drug Administration, but for clinicians interested in trying CBM for chronic pain patients, the guidelines may offer a roadmap for initiation and an alternative to prescribing opioids.
Dr. Bell, Dr. Gilligan, and Dr. Wallace report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New clinical practice guidelines for cannabis in chronic pain management have been released.
Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.
“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.
“But I would strongly argue that I would use cannabis-based medicine over opioids every time. Why would you use a high potency-high toxicity agent when there’s a low potency-low toxicity alternative?” he said.
The guidelines were published online in the journal Cannabis and Cannabinoid Research.
Examining the evidence
A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.
Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.
Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.
When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.
In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.
The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.
Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.
An effective alternative
Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.
“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”
Dr. Wallace said he found the guidelines’ dosing recommendations helpful.
“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”
While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.
Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.
“When we have an opportunity to use cannabinoids in place of opioids for our patients, I think that that’s a positive thing ... and a wise choice in terms of risk benefit,” Dr. Gilligan said.
On the other hand, he cautioned that “freely prescribing” cannabinoids for chronic pain in patients who aren’t on opioids is not good practice.
“We have to take seriously the potential adverse effects of [cannabis], including marijuana use disorder, interference with learning, memory impairment, and psychotic breakthroughs,” said Dr. Gilligan.
Given the current climate, it would appear that CBM is a long way from being endorsed by the Food and Drug Administration, but for clinicians interested in trying CBM for chronic pain patients, the guidelines may offer a roadmap for initiation and an alternative to prescribing opioids.
Dr. Bell, Dr. Gilligan, and Dr. Wallace report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New clinical practice guidelines for cannabis in chronic pain management have been released.
Developed by a group of Canadian researchers, clinicians, and patients, the guidelines note that cannabinoid-based medicines (CBM) may help clinicians offer an effective, less addictive, alternative to opioids in patients with chronic noncancer pain and comorbid conditions.
“We don’t recommend using CBM first line for anything pretty much because there are other alternatives that may be more effective and also offer fewer side effects,” lead guideline author Alan Bell, MD, assistant professor of family and community medicine at the University of Toronto, told this news organization.
“But I would strongly argue that I would use cannabis-based medicine over opioids every time. Why would you use a high potency-high toxicity agent when there’s a low potency-low toxicity alternative?” he said.
The guidelines were published online in the journal Cannabis and Cannabinoid Research.
Examining the evidence
A consistent criticism of CBM has been the lack of quality research supporting its therapeutic utility. To develop the current recommendations, the task force reviewed 47 pain management studies enrolling more than 11,000 patients. Almost half of the studies (n = 22) were randomized controlled trials (RCTs) and 12 of the 19 included systematic reviews focused solely on RCTs.
Overall, 38 of the 47 included studies demonstrated that CBM provided at least moderate benefits for chronic pain, resulting in a “strong” recommendation – mostly as an adjunct or replacement treatment in individuals living with chronic pain.
Overall, the guidelines place a high value on improving chronic pain and functionality, and addressing co-occurring conditions such as insomnia, anxiety and depression, mobility, and inflammation. They also provide practical dosing and formulation tips to support the use of CBM in the clinical setting.
When it comes to chronic pain, CBM is not a panacea. However, prior research suggests cannabinoids and opioids share several pharmacologic properties, including independent but possibly related mechanisms for antinociception, making them an intriguing combination.
In the current guidelines, all of the four studies specifically addressing combined opioids and vaporized cannabis flower demonstrated further pain reduction, reinforcing the conclusion that the benefits of CBM for improving pain control in patients taking opioids outweigh the risk of nonserious adverse events (AEs), such as dry mouth, dizziness, increased appetite, sedation, and concentration difficulties.
The recommendations also highlighted evidence demonstrating that a majority of participants were able to reduce use of routine pain medications with concomitant CBM/opioid administration, while simultaneously offering secondary benefits such as improved sleep, anxiety, and mood, as well as prevention of opioid tolerance and dose escalation.
Importantly, the guidelines offer an evidence-based algorithm with a clear framework for tapering patients off opioids, especially those who are on > 50 mg MED, which places them with a twofold greater risk for fatal overdose.
An effective alternative
Commenting on the new guidelines, Mark Wallace, MD, who has extensive experience researching and treating pain patients with medical cannabis, said the genesis of his interest in medical cannabis mirrors the guidelines’ focus.
“What got me interested in medical cannabis was trying to get patients off of opioids,” said Dr. Wallace, professor of anesthesiology and chief of the division of pain medicine in the department of anesthesiology at the University of California, San Diego. Dr. Wallace, who was not involved in the guidelines’ development study, said that he’s “titrated hundreds of patients off of opioids using cannabis.”
Dr. Wallace said he found the guidelines’ dosing recommendations helpful.
“If you stay within the 1- to 5-mg dosing range, the risks are so incredibly low, you’re not going to harm the patient.”
While there are patients who abuse cannabis and CBMs, Dr. Wallace noted that he has seen only one patient in the past 20 years who was overusing the medical cannabis. He added that his patient population does not use medical cannabis to get high and, in fact, wants to avoid doses that produce that effect at all costs.
Also commenting on the guidelines, Christopher Gilligan, MD, MBA, associate chief medical officer and a pain medicine physician at Brigham and Women’s Hospital in Boston, who was not involved in the guidelines’ development, points to the risks.
“When we have an opportunity to use cannabinoids in place of opioids for our patients, I think that that’s a positive thing ... and a wise choice in terms of risk benefit,” Dr. Gilligan said.
On the other hand, he cautioned that “freely prescribing” cannabinoids for chronic pain in patients who aren’t on opioids is not good practice.
“We have to take seriously the potential adverse effects of [cannabis], including marijuana use disorder, interference with learning, memory impairment, and psychotic breakthroughs,” said Dr. Gilligan.
Given the current climate, it would appear that CBM is a long way from being endorsed by the Food and Drug Administration, but for clinicians interested in trying CBM for chronic pain patients, the guidelines may offer a roadmap for initiation and an alternative to prescribing opioids.
Dr. Bell, Dr. Gilligan, and Dr. Wallace report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANNABIS AND CANNABINOID RESEARCH
HIV testing still suboptimal
from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.
Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?
“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.
The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.
“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.
“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
Conflicting priorities
Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.
These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.
But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.
This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.
“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.
Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.
“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”
Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
A fractured system
A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.
“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.
Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.
“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”
The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.
For patients, the ramifications are even greater.
“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.
“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.
“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”
Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.
Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?
“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.
The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.
“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.
“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
Conflicting priorities
Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.
These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.
But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.
This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.
“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.
Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.
“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”
Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
A fractured system
A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.
“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.
Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.
“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”
The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.
For patients, the ramifications are even greater.
“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.
“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.
“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”
Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.
Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?
“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.
The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.
“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.
“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
Conflicting priorities
Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.
These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.
But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.
This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.
“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.
Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.
“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”
Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
A fractured system
A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.
“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.
Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.
“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”
The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.
For patients, the ramifications are even greater.
“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.
“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.
“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”
Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Measles exposures in Kentucky have CDC on alert
The Centers for Disease Control and Prevention has issued a Health Alert Network (HAN) health advisory notifying clinicians and public health officials of a confirmed measles case in an individual who for 2 days (February 17-18) attended a large religious gathering that was attended by an estimated 20,000 people at Asbury University in Wilmore, Ky.
Given that large numbers of people might have been exposed to the attendee (who was not vaccinated) and that the individual had a history of recent international travel, the CDC has encouraged clinicians to be vigilant for patients presenting with symptoms that meet the measles case definition. A steady increase in measles cases from 49 in 2021 to 121 in 2022 in children who were not fully vaccinated – coupled with outbreaks in Ohio and Minnesota – underscores the potential gravity of the CDC advisory as well as the need to mitigate the risk of ongoing or secondary transmission.
Currently, little is known about the individual who contracted measles other than the fact that he is a resident of Jessamine County, Ky., according to a news release issued by the Kentucky Department of Public Health. It is the third confirmed case in Kentucky over the past 3 months. State and national health officials are concerned that the individual might have transmitted measles to attendees visiting from other states.
David Sugerman, MD, MPH, a medical officer in CDC’s division of viral diseases and lead for the measles, rubella, and cytomegalovirus team, noted that the timing of the alert coincides with the period in which persons who had had contact with the initial case patient might be expected to develop symptoms.
For clinicians, “It’s really about considering measles in any un- or undervaccinated patient that arrives at a clinic and recently traveled internationally,” Dr. Sugerman told this news organization. He explained that “when doctors are seeing patients, they’re not going to necessarily share that information off the bat when they present with fever or rash, or if their child has fever and rash, or that they traveled internationally. So, eliciting that history from the patient or their parents is really critical.”
The CDC recommends that measles be considered in anyone presenting with a febrile illness and symptoms that are clinically compatible with measles (that is, rash, cough, coryza, or conjunctivitis), as well as in patients who have recently traveled abroad, especially to countries with ongoing outbreaks, including India, Somalia, and Yemen.
“In general, if they’ve traveled internationally and they are undervaccinated, measles should be part of the differential diagnosis,” Sugerman said. He also emphasized the need to follow airborne isolation precautions in addition to general infection control measures.
Immediate triage is critical, especially since overcrowded waiting rooms might be filled with patients who are not yet eligible for vaccination or are not up to date or fully vaccinated.
“Measles is under airborne isolation criteria and precautions, and therefore, [patients] need to be placed as soon as possible into a negative pressure or airborne infection isolation room – and that should be a single room,” he explained. He noted, “In some settings, there may not be a negative pressure room, e.g., an outpatient pediatrics or family medicine office.”
Dr. Sugerman said that in these circumstances, patients should be placed in a room with masked health care providers who have received two doses of measles, mumps, and rubella (MMR) vaccine and that they should wear an N95 mask when entering the room and interviewing the patient.
Clinicians should follow CDC’s testing recommendations and collect a nasopharyngeal or throat swab or a urine specimen for PCR testing and a blood specimen for serology. In addition, they should immediately report cases to local and state public health authorities.
For all patients, it’s critical to be up to date on MMR vaccines, especially persons who are going to be traveling internationally. “We recommend that when they’ve got infants traveling with them who are 6-11 months of age, that they get a first dose (which we consider a zero dose), because they need a routine dose at 12-15 months, and then 4-6 years,” said Dr. Sugerman. He said that it’s safe for adults who are unsure of their status to receive an MMR dose as well.
Dr. Sugerman stressed that despite major strides, “we just don’t have enough coverage in all individuals in this country. Because people are traveling as often as they are, it can be imported. Until measles is eliminated globally, there’s going to be an ongoing risk of importation and potential spread amongst others in their household or community, especially amongst individuals who are not fully vaccinated and, in particular, amongst those who are unvaccinated,” he said.
Dr. Sugerman reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention has issued a Health Alert Network (HAN) health advisory notifying clinicians and public health officials of a confirmed measles case in an individual who for 2 days (February 17-18) attended a large religious gathering that was attended by an estimated 20,000 people at Asbury University in Wilmore, Ky.
Given that large numbers of people might have been exposed to the attendee (who was not vaccinated) and that the individual had a history of recent international travel, the CDC has encouraged clinicians to be vigilant for patients presenting with symptoms that meet the measles case definition. A steady increase in measles cases from 49 in 2021 to 121 in 2022 in children who were not fully vaccinated – coupled with outbreaks in Ohio and Minnesota – underscores the potential gravity of the CDC advisory as well as the need to mitigate the risk of ongoing or secondary transmission.
Currently, little is known about the individual who contracted measles other than the fact that he is a resident of Jessamine County, Ky., according to a news release issued by the Kentucky Department of Public Health. It is the third confirmed case in Kentucky over the past 3 months. State and national health officials are concerned that the individual might have transmitted measles to attendees visiting from other states.
David Sugerman, MD, MPH, a medical officer in CDC’s division of viral diseases and lead for the measles, rubella, and cytomegalovirus team, noted that the timing of the alert coincides with the period in which persons who had had contact with the initial case patient might be expected to develop symptoms.
For clinicians, “It’s really about considering measles in any un- or undervaccinated patient that arrives at a clinic and recently traveled internationally,” Dr. Sugerman told this news organization. He explained that “when doctors are seeing patients, they’re not going to necessarily share that information off the bat when they present with fever or rash, or if their child has fever and rash, or that they traveled internationally. So, eliciting that history from the patient or their parents is really critical.”
The CDC recommends that measles be considered in anyone presenting with a febrile illness and symptoms that are clinically compatible with measles (that is, rash, cough, coryza, or conjunctivitis), as well as in patients who have recently traveled abroad, especially to countries with ongoing outbreaks, including India, Somalia, and Yemen.
“In general, if they’ve traveled internationally and they are undervaccinated, measles should be part of the differential diagnosis,” Sugerman said. He also emphasized the need to follow airborne isolation precautions in addition to general infection control measures.
Immediate triage is critical, especially since overcrowded waiting rooms might be filled with patients who are not yet eligible for vaccination or are not up to date or fully vaccinated.
“Measles is under airborne isolation criteria and precautions, and therefore, [patients] need to be placed as soon as possible into a negative pressure or airborne infection isolation room – and that should be a single room,” he explained. He noted, “In some settings, there may not be a negative pressure room, e.g., an outpatient pediatrics or family medicine office.”
Dr. Sugerman said that in these circumstances, patients should be placed in a room with masked health care providers who have received two doses of measles, mumps, and rubella (MMR) vaccine and that they should wear an N95 mask when entering the room and interviewing the patient.
Clinicians should follow CDC’s testing recommendations and collect a nasopharyngeal or throat swab or a urine specimen for PCR testing and a blood specimen for serology. In addition, they should immediately report cases to local and state public health authorities.
For all patients, it’s critical to be up to date on MMR vaccines, especially persons who are going to be traveling internationally. “We recommend that when they’ve got infants traveling with them who are 6-11 months of age, that they get a first dose (which we consider a zero dose), because they need a routine dose at 12-15 months, and then 4-6 years,” said Dr. Sugerman. He said that it’s safe for adults who are unsure of their status to receive an MMR dose as well.
Dr. Sugerman stressed that despite major strides, “we just don’t have enough coverage in all individuals in this country. Because people are traveling as often as they are, it can be imported. Until measles is eliminated globally, there’s going to be an ongoing risk of importation and potential spread amongst others in their household or community, especially amongst individuals who are not fully vaccinated and, in particular, amongst those who are unvaccinated,” he said.
Dr. Sugerman reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention has issued a Health Alert Network (HAN) health advisory notifying clinicians and public health officials of a confirmed measles case in an individual who for 2 days (February 17-18) attended a large religious gathering that was attended by an estimated 20,000 people at Asbury University in Wilmore, Ky.
Given that large numbers of people might have been exposed to the attendee (who was not vaccinated) and that the individual had a history of recent international travel, the CDC has encouraged clinicians to be vigilant for patients presenting with symptoms that meet the measles case definition. A steady increase in measles cases from 49 in 2021 to 121 in 2022 in children who were not fully vaccinated – coupled with outbreaks in Ohio and Minnesota – underscores the potential gravity of the CDC advisory as well as the need to mitigate the risk of ongoing or secondary transmission.
Currently, little is known about the individual who contracted measles other than the fact that he is a resident of Jessamine County, Ky., according to a news release issued by the Kentucky Department of Public Health. It is the third confirmed case in Kentucky over the past 3 months. State and national health officials are concerned that the individual might have transmitted measles to attendees visiting from other states.
David Sugerman, MD, MPH, a medical officer in CDC’s division of viral diseases and lead for the measles, rubella, and cytomegalovirus team, noted that the timing of the alert coincides with the period in which persons who had had contact with the initial case patient might be expected to develop symptoms.
For clinicians, “It’s really about considering measles in any un- or undervaccinated patient that arrives at a clinic and recently traveled internationally,” Dr. Sugerman told this news organization. He explained that “when doctors are seeing patients, they’re not going to necessarily share that information off the bat when they present with fever or rash, or if their child has fever and rash, or that they traveled internationally. So, eliciting that history from the patient or their parents is really critical.”
The CDC recommends that measles be considered in anyone presenting with a febrile illness and symptoms that are clinically compatible with measles (that is, rash, cough, coryza, or conjunctivitis), as well as in patients who have recently traveled abroad, especially to countries with ongoing outbreaks, including India, Somalia, and Yemen.
“In general, if they’ve traveled internationally and they are undervaccinated, measles should be part of the differential diagnosis,” Sugerman said. He also emphasized the need to follow airborne isolation precautions in addition to general infection control measures.
Immediate triage is critical, especially since overcrowded waiting rooms might be filled with patients who are not yet eligible for vaccination or are not up to date or fully vaccinated.
“Measles is under airborne isolation criteria and precautions, and therefore, [patients] need to be placed as soon as possible into a negative pressure or airborne infection isolation room – and that should be a single room,” he explained. He noted, “In some settings, there may not be a negative pressure room, e.g., an outpatient pediatrics or family medicine office.”
Dr. Sugerman said that in these circumstances, patients should be placed in a room with masked health care providers who have received two doses of measles, mumps, and rubella (MMR) vaccine and that they should wear an N95 mask when entering the room and interviewing the patient.
Clinicians should follow CDC’s testing recommendations and collect a nasopharyngeal or throat swab or a urine specimen for PCR testing and a blood specimen for serology. In addition, they should immediately report cases to local and state public health authorities.
For all patients, it’s critical to be up to date on MMR vaccines, especially persons who are going to be traveling internationally. “We recommend that when they’ve got infants traveling with them who are 6-11 months of age, that they get a first dose (which we consider a zero dose), because they need a routine dose at 12-15 months, and then 4-6 years,” said Dr. Sugerman. He said that it’s safe for adults who are unsure of their status to receive an MMR dose as well.
Dr. Sugerman stressed that despite major strides, “we just don’t have enough coverage in all individuals in this country. Because people are traveling as often as they are, it can be imported. Until measles is eliminated globally, there’s going to be an ongoing risk of importation and potential spread amongst others in their household or community, especially amongst individuals who are not fully vaccinated and, in particular, amongst those who are unvaccinated,” he said.
Dr. Sugerman reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.