Why aren’t doctors managing pain during gynecologic procedures? 

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Fri, 11/03/2023 - 14:25

 

During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

 

 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

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During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

 

 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

 

During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

 

 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

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Can thermal biofeedback reduce pain and anxiety?

Article Type
Changed
Mon, 11/06/2023 - 19:30

 

TOPLINE:

A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.

METHODOLOGY:

  • Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
  • Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
  • Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.

TAKEAWAY:

  • Anxiety scores decreased by about 22% on average (P < .001).
  • Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
  • In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.

IN PRACTICE:

“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”

SOURCE:

Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.

LIMITATIONS:

The studies were open label and did not include control groups.

DISCLOSURES:

Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.

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

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TOPLINE:

A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.

METHODOLOGY:

  • Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
  • Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
  • Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.

TAKEAWAY:

  • Anxiety scores decreased by about 22% on average (P < .001).
  • Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
  • In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.

IN PRACTICE:

“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”

SOURCE:

Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.

LIMITATIONS:

The studies were open label and did not include control groups.

DISCLOSURES:

Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.

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

 

TOPLINE:

A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.

METHODOLOGY:

  • Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
  • Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
  • Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.

TAKEAWAY:

  • Anxiety scores decreased by about 22% on average (P < .001).
  • Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
  • In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.

IN PRACTICE:

“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”

SOURCE:

Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.

LIMITATIONS:

The studies were open label and did not include control groups.

DISCLOSURES:

Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.

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

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Childhood trauma linked to adult headache

Article Type
Changed
Tue, 10/31/2023 - 13:38

 

TOPLINE:

Childhood trauma increases the risk of developing a primary headache disorder in adulthood, with more early adverse experiences raising the risk even more, a new study found.

METHODOLOGY:

  • The meta-analysis included 28 observational studies with 154,739 persons in 19 countries that assessed the relationship between at least one adverse childhood experience (ACE) and primary headache (including migraine, tension-type headache, cluster headache, and chronic/severe headache) at age 21 years or older.
  • From each study, researchers extracted outcome point estimates and corresponding 95% confidence intervals, number of events in each group, and covariates included in the model. They subcategorized ACEs according to those involving threat (for example, physical, emotional, or sexual abuse) and deprivation (for example, neglect, household substance misuse).
  • For the primary analysis, the researchers calculated the odds ratios and hazard ratios of headache among persons with at least one ACE, compared with those with no ACEs.
  • They also tested an underlying biological theory that threat and deprivation ACEs may manifest differently in neurodevelopment, with distinct impacts on primary headaches.
  •  

TAKEAWAY:

  • The most commonly reported ACEs were physical abuse (77%), sexual abuse (73%), and exposure to family violence (38%).
  • Compared with having experienced no ACEs, experiencing at least one was associated with primary headaches (pooled OR, 1.48; 95% confidence interval, 1.36-1.61).
  • As the number of ACEs increased, the strength of the association with primary headaches increased in a dose-response relationship (P for trend < .0001).
  • Both threat and deprivation were independently associated with primary headaches; the pooled main effect was consistent for threat (OR, 1.46; 95% CI, 1.32-1.60) and for deprivation (OR, 1.35; 95% CI, 1.23-1.49), suggesting possible distinct pathways of early adversity.
  •  

IN PRACTICE:

Clinicians who treat primary headaches in adults “should routinely screen for ACEs, educate patients on the connection between ACEs and health, and provide referrals for treatment strategies,” the investigators write. Strategies such as trauma-informed or attachment-based therapy may help rewire parts of the brain that have been dysregulated, they add.

SOURCE:

The study was led by Claudia Sikorski, department of health research methods, evidence, and impact, McMaster University, Hamilton, Ont. It was published online in Neurology.

LIMITATIONS:

The findings reflect a conservative estimate of the true impact of ACEs on primary headaches, because ACEs are commonly underreported. The analysis could not statistically disentangle younger adults with developing brains (age 21-26 years) from older adults. Not all included studies adjusted for age and sex, which are known risk factors for headaches. The study did not explore the relationship between ACEs and primary headache disorders in childhood and adolescence. Owing to the inherent nature of studies investigating ACEs, causation cannot be inferred.

DISCLOSURES:

The authors report no targeted funding and no relevant conflicts of interest.

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

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TOPLINE:

Childhood trauma increases the risk of developing a primary headache disorder in adulthood, with more early adverse experiences raising the risk even more, a new study found.

METHODOLOGY:

  • The meta-analysis included 28 observational studies with 154,739 persons in 19 countries that assessed the relationship between at least one adverse childhood experience (ACE) and primary headache (including migraine, tension-type headache, cluster headache, and chronic/severe headache) at age 21 years or older.
  • From each study, researchers extracted outcome point estimates and corresponding 95% confidence intervals, number of events in each group, and covariates included in the model. They subcategorized ACEs according to those involving threat (for example, physical, emotional, or sexual abuse) and deprivation (for example, neglect, household substance misuse).
  • For the primary analysis, the researchers calculated the odds ratios and hazard ratios of headache among persons with at least one ACE, compared with those with no ACEs.
  • They also tested an underlying biological theory that threat and deprivation ACEs may manifest differently in neurodevelopment, with distinct impacts on primary headaches.
  •  

TAKEAWAY:

  • The most commonly reported ACEs were physical abuse (77%), sexual abuse (73%), and exposure to family violence (38%).
  • Compared with having experienced no ACEs, experiencing at least one was associated with primary headaches (pooled OR, 1.48; 95% confidence interval, 1.36-1.61).
  • As the number of ACEs increased, the strength of the association with primary headaches increased in a dose-response relationship (P for trend < .0001).
  • Both threat and deprivation were independently associated with primary headaches; the pooled main effect was consistent for threat (OR, 1.46; 95% CI, 1.32-1.60) and for deprivation (OR, 1.35; 95% CI, 1.23-1.49), suggesting possible distinct pathways of early adversity.
  •  

IN PRACTICE:

Clinicians who treat primary headaches in adults “should routinely screen for ACEs, educate patients on the connection between ACEs and health, and provide referrals for treatment strategies,” the investigators write. Strategies such as trauma-informed or attachment-based therapy may help rewire parts of the brain that have been dysregulated, they add.

SOURCE:

The study was led by Claudia Sikorski, department of health research methods, evidence, and impact, McMaster University, Hamilton, Ont. It was published online in Neurology.

LIMITATIONS:

The findings reflect a conservative estimate of the true impact of ACEs on primary headaches, because ACEs are commonly underreported. The analysis could not statistically disentangle younger adults with developing brains (age 21-26 years) from older adults. Not all included studies adjusted for age and sex, which are known risk factors for headaches. The study did not explore the relationship between ACEs and primary headache disorders in childhood and adolescence. Owing to the inherent nature of studies investigating ACEs, causation cannot be inferred.

DISCLOSURES:

The authors report no targeted funding and no relevant conflicts of interest.

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

 

TOPLINE:

Childhood trauma increases the risk of developing a primary headache disorder in adulthood, with more early adverse experiences raising the risk even more, a new study found.

METHODOLOGY:

  • The meta-analysis included 28 observational studies with 154,739 persons in 19 countries that assessed the relationship between at least one adverse childhood experience (ACE) and primary headache (including migraine, tension-type headache, cluster headache, and chronic/severe headache) at age 21 years or older.
  • From each study, researchers extracted outcome point estimates and corresponding 95% confidence intervals, number of events in each group, and covariates included in the model. They subcategorized ACEs according to those involving threat (for example, physical, emotional, or sexual abuse) and deprivation (for example, neglect, household substance misuse).
  • For the primary analysis, the researchers calculated the odds ratios and hazard ratios of headache among persons with at least one ACE, compared with those with no ACEs.
  • They also tested an underlying biological theory that threat and deprivation ACEs may manifest differently in neurodevelopment, with distinct impacts on primary headaches.
  •  

TAKEAWAY:

  • The most commonly reported ACEs were physical abuse (77%), sexual abuse (73%), and exposure to family violence (38%).
  • Compared with having experienced no ACEs, experiencing at least one was associated with primary headaches (pooled OR, 1.48; 95% confidence interval, 1.36-1.61).
  • As the number of ACEs increased, the strength of the association with primary headaches increased in a dose-response relationship (P for trend < .0001).
  • Both threat and deprivation were independently associated with primary headaches; the pooled main effect was consistent for threat (OR, 1.46; 95% CI, 1.32-1.60) and for deprivation (OR, 1.35; 95% CI, 1.23-1.49), suggesting possible distinct pathways of early adversity.
  •  

IN PRACTICE:

Clinicians who treat primary headaches in adults “should routinely screen for ACEs, educate patients on the connection between ACEs and health, and provide referrals for treatment strategies,” the investigators write. Strategies such as trauma-informed or attachment-based therapy may help rewire parts of the brain that have been dysregulated, they add.

SOURCE:

The study was led by Claudia Sikorski, department of health research methods, evidence, and impact, McMaster University, Hamilton, Ont. It was published online in Neurology.

LIMITATIONS:

The findings reflect a conservative estimate of the true impact of ACEs on primary headaches, because ACEs are commonly underreported. The analysis could not statistically disentangle younger adults with developing brains (age 21-26 years) from older adults. Not all included studies adjusted for age and sex, which are known risk factors for headaches. The study did not explore the relationship between ACEs and primary headache disorders in childhood and adolescence. Owing to the inherent nature of studies investigating ACEs, causation cannot be inferred.

DISCLOSURES:

The authors report no targeted funding and no relevant conflicts of interest.

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

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FDA warns of hidden ingredients in arthritis, pain products

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Changed
Mon, 10/30/2023 - 12:01

Certain products marketed for arthritis and pain management could contain hidden ingredients that could be harmful to consumers, according to a warning by the U.S. Food and Drug Administration.
 

Some of these products contain active ingredients found in anti-inflammatory prescription medication.

“These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the FDA said in a statement. “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers.”

Unlike prescription medication and over-the-counter drugs such as loratadine (Claritin) or acetaminophen (Tylenol), supplements do not need FDA approval before they can be sold. Only after a complaint is made or FDA testing reveals illegal or unsafe ingredients can the FDA get involved.

From August 2013 to September 2023, the FDA identified 22 arthritis and pain products with active ingredients not disclosed on the product label. The most common hidden ingredients detected in these supplements were prescription-only corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants, said Candy Tsourounis, PharmD, a professor in the department of clinical pharmacy at the University of California, San Francisco.

Kuka Flex Forte and Reumo Flex, both promoted for joint pain and arthritis, both contain the NSAID diclofenac. Tapee Tea, a product promoted for pain relief, contains dexamethasone and piroxicam. AK Forte, also sold for joint pain and arthritis, contains diclofenac, dexamethasone, and methocarbamol not disclosed on the label.

“It is interesting that these products have hidden ingredients that are used to reduce swelling and inflammation,” Dr. Tsourounis said. “I don’t know if this was intentional, but it seems suspicious that a product marketed to reduce joint pain and inflammation contains prescription-only ingredients that are used for this purpose.”

Certain products also contained antihistamines including cyproheptadine and chlorpheniramine.

These types of products are likely targeted toward underserved and immigrant communities, added Pieter Cohen, MD, a primary care physician and an assistant professor of medicine at Harvard Medical School, Boston, who studies dietary supplements. They might be sold in mom-and-pop shops or gas stations to individuals with limited access to health care or insurance, he noted.

The FDA warned that this list included “only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.”
 

Advising patients

Research suggests that most patients do not tell doctors about the supplements they are taking, and often, clinicians do not ask, said Dr. Cohen. “Most of the time it’s a total black box – we don’t know what’s going on,” he added.

He advised raising the subject of supplements in a very nonjudgmental way, particularly when treating patients in marginalized and immigrant communities. One approach he suggested was first mentioning that other patients in your care dealing with joint pain have bought remedies locally or have tried treatments that friends recommend. You can then ask a patient about their own use, framing it as a way to better help with treatment decisions.

Once a clinician understands what their patient is taking, they can then give advice and discuss if a product is safe to combine with prescription drugs, Dr. Cohen said. “If they come down too hard, I think the patients will just clam up and not talk about it anymore,” he said.

If a patient begins to experience side effects or gets sick, a clinician will already be informed of what their patient is taking and can ask that patient to bring the product or supplement in, so they can look over the product together, Dr. Cohen noted. Any side effects or other adverse events potentially related to the use of these products should then be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
 

 

 

Tips for safe shopping

To make sure supplements and other over-the-counter products are safe to use, Dr. Tsourounis recommends that consumers:

  • Buy products from well-known retailers like Target or large pharmacies like CVS or Walgreens.
  • Avoid buying products with labels in another language that you cannot read or products with no drug label.
  • Be cautious of buying products online or from other countries.
  • Look up suspicious products on the FDA’s health fraud database.
  • Be wary of any product that offers miracle cures or relies on personal testimonies without evidence.

In general, do not base purchasing decisions on any health claims on a product label because companies selling supplements making these claims “don’t have to have any clinical data to back them up,” Dr. Cohen said.

Dr. Cohen also recommends sticking with individual ingredients. “If you want echinacea, buy echinacea. Don’t buy a complicated mix that is supposed to be good for arthritis with 10 different botanical [ingredients]. That’s more likely to run [you] into trouble,” he said.

Last, Dr. Cohen recommended buying supplements that are certified by NSF International or United States Pharmacopeia, both respected third-party testing organizations. “If it has an NSF International or USP stamp, that gives us more certainty that what’s in the bottle is going to be what’s listed on label,” he said.

Dr. Tsourounis noted that if you are skeptical of a product, you can also try calling the manufacturer number on the product label.

“I always encourage people to call that number to see if somebody answers,” she said. “Sometimes, you can tell a lot about that company just by calling that number.”

Dr. Cohen has received research support from the Consumers Union and PEW Charitable Trusts and royalties from UpToDate. He has collaborated in research with NSF International. Dr. Tsourounis disclosed no relevant financial relationships.

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

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Certain products marketed for arthritis and pain management could contain hidden ingredients that could be harmful to consumers, according to a warning by the U.S. Food and Drug Administration.
 

Some of these products contain active ingredients found in anti-inflammatory prescription medication.

“These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the FDA said in a statement. “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers.”

Unlike prescription medication and over-the-counter drugs such as loratadine (Claritin) or acetaminophen (Tylenol), supplements do not need FDA approval before they can be sold. Only after a complaint is made or FDA testing reveals illegal or unsafe ingredients can the FDA get involved.

From August 2013 to September 2023, the FDA identified 22 arthritis and pain products with active ingredients not disclosed on the product label. The most common hidden ingredients detected in these supplements were prescription-only corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants, said Candy Tsourounis, PharmD, a professor in the department of clinical pharmacy at the University of California, San Francisco.

Kuka Flex Forte and Reumo Flex, both promoted for joint pain and arthritis, both contain the NSAID diclofenac. Tapee Tea, a product promoted for pain relief, contains dexamethasone and piroxicam. AK Forte, also sold for joint pain and arthritis, contains diclofenac, dexamethasone, and methocarbamol not disclosed on the label.

“It is interesting that these products have hidden ingredients that are used to reduce swelling and inflammation,” Dr. Tsourounis said. “I don’t know if this was intentional, but it seems suspicious that a product marketed to reduce joint pain and inflammation contains prescription-only ingredients that are used for this purpose.”

Certain products also contained antihistamines including cyproheptadine and chlorpheniramine.

These types of products are likely targeted toward underserved and immigrant communities, added Pieter Cohen, MD, a primary care physician and an assistant professor of medicine at Harvard Medical School, Boston, who studies dietary supplements. They might be sold in mom-and-pop shops or gas stations to individuals with limited access to health care or insurance, he noted.

The FDA warned that this list included “only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.”
 

Advising patients

Research suggests that most patients do not tell doctors about the supplements they are taking, and often, clinicians do not ask, said Dr. Cohen. “Most of the time it’s a total black box – we don’t know what’s going on,” he added.

He advised raising the subject of supplements in a very nonjudgmental way, particularly when treating patients in marginalized and immigrant communities. One approach he suggested was first mentioning that other patients in your care dealing with joint pain have bought remedies locally or have tried treatments that friends recommend. You can then ask a patient about their own use, framing it as a way to better help with treatment decisions.

Once a clinician understands what their patient is taking, they can then give advice and discuss if a product is safe to combine with prescription drugs, Dr. Cohen said. “If they come down too hard, I think the patients will just clam up and not talk about it anymore,” he said.

If a patient begins to experience side effects or gets sick, a clinician will already be informed of what their patient is taking and can ask that patient to bring the product or supplement in, so they can look over the product together, Dr. Cohen noted. Any side effects or other adverse events potentially related to the use of these products should then be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
 

 

 

Tips for safe shopping

To make sure supplements and other over-the-counter products are safe to use, Dr. Tsourounis recommends that consumers:

  • Buy products from well-known retailers like Target or large pharmacies like CVS or Walgreens.
  • Avoid buying products with labels in another language that you cannot read or products with no drug label.
  • Be cautious of buying products online or from other countries.
  • Look up suspicious products on the FDA’s health fraud database.
  • Be wary of any product that offers miracle cures or relies on personal testimonies without evidence.

In general, do not base purchasing decisions on any health claims on a product label because companies selling supplements making these claims “don’t have to have any clinical data to back them up,” Dr. Cohen said.

Dr. Cohen also recommends sticking with individual ingredients. “If you want echinacea, buy echinacea. Don’t buy a complicated mix that is supposed to be good for arthritis with 10 different botanical [ingredients]. That’s more likely to run [you] into trouble,” he said.

Last, Dr. Cohen recommended buying supplements that are certified by NSF International or United States Pharmacopeia, both respected third-party testing organizations. “If it has an NSF International or USP stamp, that gives us more certainty that what’s in the bottle is going to be what’s listed on label,” he said.

Dr. Tsourounis noted that if you are skeptical of a product, you can also try calling the manufacturer number on the product label.

“I always encourage people to call that number to see if somebody answers,” she said. “Sometimes, you can tell a lot about that company just by calling that number.”

Dr. Cohen has received research support from the Consumers Union and PEW Charitable Trusts and royalties from UpToDate. He has collaborated in research with NSF International. Dr. Tsourounis disclosed no relevant financial relationships.

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

Certain products marketed for arthritis and pain management could contain hidden ingredients that could be harmful to consumers, according to a warning by the U.S. Food and Drug Administration.
 

Some of these products contain active ingredients found in anti-inflammatory prescription medication.

“These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the FDA said in a statement. “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers.”

Unlike prescription medication and over-the-counter drugs such as loratadine (Claritin) or acetaminophen (Tylenol), supplements do not need FDA approval before they can be sold. Only after a complaint is made or FDA testing reveals illegal or unsafe ingredients can the FDA get involved.

From August 2013 to September 2023, the FDA identified 22 arthritis and pain products with active ingredients not disclosed on the product label. The most common hidden ingredients detected in these supplements were prescription-only corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants, said Candy Tsourounis, PharmD, a professor in the department of clinical pharmacy at the University of California, San Francisco.

Kuka Flex Forte and Reumo Flex, both promoted for joint pain and arthritis, both contain the NSAID diclofenac. Tapee Tea, a product promoted for pain relief, contains dexamethasone and piroxicam. AK Forte, also sold for joint pain and arthritis, contains diclofenac, dexamethasone, and methocarbamol not disclosed on the label.

“It is interesting that these products have hidden ingredients that are used to reduce swelling and inflammation,” Dr. Tsourounis said. “I don’t know if this was intentional, but it seems suspicious that a product marketed to reduce joint pain and inflammation contains prescription-only ingredients that are used for this purpose.”

Certain products also contained antihistamines including cyproheptadine and chlorpheniramine.

These types of products are likely targeted toward underserved and immigrant communities, added Pieter Cohen, MD, a primary care physician and an assistant professor of medicine at Harvard Medical School, Boston, who studies dietary supplements. They might be sold in mom-and-pop shops or gas stations to individuals with limited access to health care or insurance, he noted.

The FDA warned that this list included “only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.”
 

Advising patients

Research suggests that most patients do not tell doctors about the supplements they are taking, and often, clinicians do not ask, said Dr. Cohen. “Most of the time it’s a total black box – we don’t know what’s going on,” he added.

He advised raising the subject of supplements in a very nonjudgmental way, particularly when treating patients in marginalized and immigrant communities. One approach he suggested was first mentioning that other patients in your care dealing with joint pain have bought remedies locally or have tried treatments that friends recommend. You can then ask a patient about their own use, framing it as a way to better help with treatment decisions.

Once a clinician understands what their patient is taking, they can then give advice and discuss if a product is safe to combine with prescription drugs, Dr. Cohen said. “If they come down too hard, I think the patients will just clam up and not talk about it anymore,” he said.

If a patient begins to experience side effects or gets sick, a clinician will already be informed of what their patient is taking and can ask that patient to bring the product or supplement in, so they can look over the product together, Dr. Cohen noted. Any side effects or other adverse events potentially related to the use of these products should then be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
 

 

 

Tips for safe shopping

To make sure supplements and other over-the-counter products are safe to use, Dr. Tsourounis recommends that consumers:

  • Buy products from well-known retailers like Target or large pharmacies like CVS or Walgreens.
  • Avoid buying products with labels in another language that you cannot read or products with no drug label.
  • Be cautious of buying products online or from other countries.
  • Look up suspicious products on the FDA’s health fraud database.
  • Be wary of any product that offers miracle cures or relies on personal testimonies without evidence.

In general, do not base purchasing decisions on any health claims on a product label because companies selling supplements making these claims “don’t have to have any clinical data to back them up,” Dr. Cohen said.

Dr. Cohen also recommends sticking with individual ingredients. “If you want echinacea, buy echinacea. Don’t buy a complicated mix that is supposed to be good for arthritis with 10 different botanical [ingredients]. That’s more likely to run [you] into trouble,” he said.

Last, Dr. Cohen recommended buying supplements that are certified by NSF International or United States Pharmacopeia, both respected third-party testing organizations. “If it has an NSF International or USP stamp, that gives us more certainty that what’s in the bottle is going to be what’s listed on label,” he said.

Dr. Tsourounis noted that if you are skeptical of a product, you can also try calling the manufacturer number on the product label.

“I always encourage people to call that number to see if somebody answers,” she said. “Sometimes, you can tell a lot about that company just by calling that number.”

Dr. Cohen has received research support from the Consumers Union and PEW Charitable Trusts and royalties from UpToDate. He has collaborated in research with NSF International. Dr. Tsourounis disclosed no relevant financial relationships.

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

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Predictors of prescription opioid overdose

Article Type
Changed
Wed, 10/25/2023 - 16:52

A Canadian systematic review of 28 observational studies has identified 10 strong predictors of fatal and nonfatal prescription opioid overdose.

Published in CMAJ, the analysis found the risk of fatal and nonfatal opioid overdose was notably tied to such factors as high-dose and fentanyl prescriptions, multiple opioid prescribers or pharmacies, and several mental health issues. High-certainty evidence from 14 studies involving more than a million patients showed a linear dose-response relationship with opioid overdose.

“Our findings suggest that awareness of, and attention to, several patient and prescription characteristics may help reduce the risk of opioid overdose among people living with chronic pain,” wrote a research team led by Li Wang, PhD, a researcher at the Michael G. DeGroote Institute for Pain Research and Care and the department of anesthesia at McMaster University, Hamilton, Ont.
 

Predictors of fatal and nonfatal overdose

Reporting on studies of 103 possible predictors in a pooled cohort of almost 24 million patients, the review found moderate- to high-certainty evidence for large relative associations with the following 10 criteria:

  • A history of overdose (odds ratio, 5.85; 95% confidence interval, 3.78-9.04).
  • A higher opioid dosage (OR, 2.57; 95% CI, 2.08-3.18 per 90-mg increment).
  • Three or more prescribers (OR, 4.68; 95% CI, 3.57-6.12).
  • Four or more dispensing pharmacies (OR, 4.92; 95% CI, 4.35-5.57).
  • Prescription for fentanyl (OR, 2.80; 95% CI, 2.30-3.41).
  • Current substance use disorder (OR, 2.62; 95% CI, 2.09-3.27).
  • Any mental health diagnosis (OR, 2.12; 95% CI, 1.73-2.61).
  • Depression (OR, 2.22; 95% CI, 1.57-314).
  • Bipolar disorder (OR, 2.07; 95% CI, 1.77-2.41).
  • Pancreatitis (OR, 2.00; 95% CI,1.52-2.64).

Absolute risks in patients with the predictor ranged from 2 to 6 per 1,000 for fatal overdose and 4 to 12 per 1,000 for nonfatal overdose.

The authors noted that chronic pain affects 20% of the world’s population worldwide, and a 2021 meta-analysis of 60 observational studies revealed that opioids are prescribed for 27% of adults living with chronic pain, with a higher prevalence of prescribing in North America than in Europe.
 

International review

A total of 28 observational studies comprising 23,963,716 patients (52% female) with mean age of 52 years were enrolled. All used administrative databases. Twenty-four studies were conducted in the United States, three in Canada, and one in the United Kingdom. Twenty-one studies included only patients with noncancer chronic pain, while seven included patients with either cancer-related or noncancer chronic pain. Twenty-two studies accepted patients with previous or current substance use disorder and three excluded patients with comorbid substance use disorder. Twenty-three studies included patients with comorbid mental illness and five exclusively recruited veterans.

The median sample size was 43,885. As a limitation, 25 studies (89%) were at high risk of bias for at least one criterion, the authors acknowledged. Moderate-certainty evidence showed the pooled prevalence of fatal opioid overdose after prescription for chronic pain was 1.3 per 1,000 (95% CI, 0.6-2.3 per 1,000) for fatal overdose and 3.2 per 1,000 (95% CI, 2.0-4.7 per 1,000) for nonfatal overdose.

“Awareness of these predictors may facilitate shared decision-making regarding prescribing opioids for chronic pain and may inform harm-reduction strategies,” Dr. Wang and associates wrote.

This study was supported by a grant from Health Canada’s Substance Use and Addictions Program. Coauthor Dr. Corey Hayes was supported by Veterans Affairs Health Services Research and Development and the National Institute on Drug Abuse Clinical Trials Network. Dr. Jason Busse is supported by the Canadian Institutes of Health Research. Dr. David Juurlink has received travel support for presentations from the CIHR, Stanford University, and Texas Tech University Health Sciences Center.

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A Canadian systematic review of 28 observational studies has identified 10 strong predictors of fatal and nonfatal prescription opioid overdose.

Published in CMAJ, the analysis found the risk of fatal and nonfatal opioid overdose was notably tied to such factors as high-dose and fentanyl prescriptions, multiple opioid prescribers or pharmacies, and several mental health issues. High-certainty evidence from 14 studies involving more than a million patients showed a linear dose-response relationship with opioid overdose.

“Our findings suggest that awareness of, and attention to, several patient and prescription characteristics may help reduce the risk of opioid overdose among people living with chronic pain,” wrote a research team led by Li Wang, PhD, a researcher at the Michael G. DeGroote Institute for Pain Research and Care and the department of anesthesia at McMaster University, Hamilton, Ont.
 

Predictors of fatal and nonfatal overdose

Reporting on studies of 103 possible predictors in a pooled cohort of almost 24 million patients, the review found moderate- to high-certainty evidence for large relative associations with the following 10 criteria:

  • A history of overdose (odds ratio, 5.85; 95% confidence interval, 3.78-9.04).
  • A higher opioid dosage (OR, 2.57; 95% CI, 2.08-3.18 per 90-mg increment).
  • Three or more prescribers (OR, 4.68; 95% CI, 3.57-6.12).
  • Four or more dispensing pharmacies (OR, 4.92; 95% CI, 4.35-5.57).
  • Prescription for fentanyl (OR, 2.80; 95% CI, 2.30-3.41).
  • Current substance use disorder (OR, 2.62; 95% CI, 2.09-3.27).
  • Any mental health diagnosis (OR, 2.12; 95% CI, 1.73-2.61).
  • Depression (OR, 2.22; 95% CI, 1.57-314).
  • Bipolar disorder (OR, 2.07; 95% CI, 1.77-2.41).
  • Pancreatitis (OR, 2.00; 95% CI,1.52-2.64).

Absolute risks in patients with the predictor ranged from 2 to 6 per 1,000 for fatal overdose and 4 to 12 per 1,000 for nonfatal overdose.

The authors noted that chronic pain affects 20% of the world’s population worldwide, and a 2021 meta-analysis of 60 observational studies revealed that opioids are prescribed for 27% of adults living with chronic pain, with a higher prevalence of prescribing in North America than in Europe.
 

International review

A total of 28 observational studies comprising 23,963,716 patients (52% female) with mean age of 52 years were enrolled. All used administrative databases. Twenty-four studies were conducted in the United States, three in Canada, and one in the United Kingdom. Twenty-one studies included only patients with noncancer chronic pain, while seven included patients with either cancer-related or noncancer chronic pain. Twenty-two studies accepted patients with previous or current substance use disorder and three excluded patients with comorbid substance use disorder. Twenty-three studies included patients with comorbid mental illness and five exclusively recruited veterans.

The median sample size was 43,885. As a limitation, 25 studies (89%) were at high risk of bias for at least one criterion, the authors acknowledged. Moderate-certainty evidence showed the pooled prevalence of fatal opioid overdose after prescription for chronic pain was 1.3 per 1,000 (95% CI, 0.6-2.3 per 1,000) for fatal overdose and 3.2 per 1,000 (95% CI, 2.0-4.7 per 1,000) for nonfatal overdose.

“Awareness of these predictors may facilitate shared decision-making regarding prescribing opioids for chronic pain and may inform harm-reduction strategies,” Dr. Wang and associates wrote.

This study was supported by a grant from Health Canada’s Substance Use and Addictions Program. Coauthor Dr. Corey Hayes was supported by Veterans Affairs Health Services Research and Development and the National Institute on Drug Abuse Clinical Trials Network. Dr. Jason Busse is supported by the Canadian Institutes of Health Research. Dr. David Juurlink has received travel support for presentations from the CIHR, Stanford University, and Texas Tech University Health Sciences Center.

A Canadian systematic review of 28 observational studies has identified 10 strong predictors of fatal and nonfatal prescription opioid overdose.

Published in CMAJ, the analysis found the risk of fatal and nonfatal opioid overdose was notably tied to such factors as high-dose and fentanyl prescriptions, multiple opioid prescribers or pharmacies, and several mental health issues. High-certainty evidence from 14 studies involving more than a million patients showed a linear dose-response relationship with opioid overdose.

“Our findings suggest that awareness of, and attention to, several patient and prescription characteristics may help reduce the risk of opioid overdose among people living with chronic pain,” wrote a research team led by Li Wang, PhD, a researcher at the Michael G. DeGroote Institute for Pain Research and Care and the department of anesthesia at McMaster University, Hamilton, Ont.
 

Predictors of fatal and nonfatal overdose

Reporting on studies of 103 possible predictors in a pooled cohort of almost 24 million patients, the review found moderate- to high-certainty evidence for large relative associations with the following 10 criteria:

  • A history of overdose (odds ratio, 5.85; 95% confidence interval, 3.78-9.04).
  • A higher opioid dosage (OR, 2.57; 95% CI, 2.08-3.18 per 90-mg increment).
  • Three or more prescribers (OR, 4.68; 95% CI, 3.57-6.12).
  • Four or more dispensing pharmacies (OR, 4.92; 95% CI, 4.35-5.57).
  • Prescription for fentanyl (OR, 2.80; 95% CI, 2.30-3.41).
  • Current substance use disorder (OR, 2.62; 95% CI, 2.09-3.27).
  • Any mental health diagnosis (OR, 2.12; 95% CI, 1.73-2.61).
  • Depression (OR, 2.22; 95% CI, 1.57-314).
  • Bipolar disorder (OR, 2.07; 95% CI, 1.77-2.41).
  • Pancreatitis (OR, 2.00; 95% CI,1.52-2.64).

Absolute risks in patients with the predictor ranged from 2 to 6 per 1,000 for fatal overdose and 4 to 12 per 1,000 for nonfatal overdose.

The authors noted that chronic pain affects 20% of the world’s population worldwide, and a 2021 meta-analysis of 60 observational studies revealed that opioids are prescribed for 27% of adults living with chronic pain, with a higher prevalence of prescribing in North America than in Europe.
 

International review

A total of 28 observational studies comprising 23,963,716 patients (52% female) with mean age of 52 years were enrolled. All used administrative databases. Twenty-four studies were conducted in the United States, three in Canada, and one in the United Kingdom. Twenty-one studies included only patients with noncancer chronic pain, while seven included patients with either cancer-related or noncancer chronic pain. Twenty-two studies accepted patients with previous or current substance use disorder and three excluded patients with comorbid substance use disorder. Twenty-three studies included patients with comorbid mental illness and five exclusively recruited veterans.

The median sample size was 43,885. As a limitation, 25 studies (89%) were at high risk of bias for at least one criterion, the authors acknowledged. Moderate-certainty evidence showed the pooled prevalence of fatal opioid overdose after prescription for chronic pain was 1.3 per 1,000 (95% CI, 0.6-2.3 per 1,000) for fatal overdose and 3.2 per 1,000 (95% CI, 2.0-4.7 per 1,000) for nonfatal overdose.

“Awareness of these predictors may facilitate shared decision-making regarding prescribing opioids for chronic pain and may inform harm-reduction strategies,” Dr. Wang and associates wrote.

This study was supported by a grant from Health Canada’s Substance Use and Addictions Program. Coauthor Dr. Corey Hayes was supported by Veterans Affairs Health Services Research and Development and the National Institute on Drug Abuse Clinical Trials Network. Dr. Jason Busse is supported by the Canadian Institutes of Health Research. Dr. David Juurlink has received travel support for presentations from the CIHR, Stanford University, and Texas Tech University Health Sciences Center.

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Antidepressants ‘don’t blunt’ semaglutide and weight loss

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Fri, 10/20/2023 - 15:32

Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m2, or ≥27 kg/m2 with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m2 with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

  • STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
  • STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
  • STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
  • STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

  • STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
  • STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
  • STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
  • STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

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Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m2, or ≥27 kg/m2 with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m2 with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

  • STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
  • STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
  • STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
  • STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

  • STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
  • STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
  • STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
  • STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m2, or ≥27 kg/m2 with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m2 with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

  • STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
  • STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
  • STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
  • STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

  • STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
  • STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
  • STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
  • STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

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Are migraine preventives underused in young adults?

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Thu, 11/09/2023 - 11:37

Prescribing patterns of preventive migraine medications for young adults do not appear to vary based on whether the provider is a pediatric or adult neurologist, but researchers say preventive medications may be underused for this group, according to recent research published in the journal Headache.

“Approximately two-fifths of young adults with migraine were prescribed preventive medications, and this did not differ between pediatric and adult neurologists,” Hannah F. J. Shapiro MD, of the department of neurology at the University of California, San Francisco, and the UCSF Benioff Children’s Hospitals, and colleagues wrote in their study. “This finding suggests that pediatric neurologists are providing comparable care to adult neurologists for young adults with migraine; however, this may represent the underuse of preventive medications in this patient population.”

Dr. Hannah F. J. Shapiro

Dr. Shapiro and colleagues conducted a retrospective study of 767 patients (mean age 20.3 years) at Mass General Brigham Hospital in Boston between 2017 and 2021 who received care from a pediatric or adult neurologist for episodic migraine. The majority of patients in the study were white (72.2%), non-Hispanic (82.1%) women (80.3%) with episodic migraine (72.8%), some of whom experienced a psychiatric comorbidity (12.7%), and had a 3.88 mean clinic visits for migraine. Researchers assessed prescription of migraine preventive medication as a primary outcome, with a secondary outcome of comparing the rate of migraine preventive prescriptions written by pediatric and adult neurologists.

Overall, 290 patients (37.8%) received care from a pediatric neurologist, and 131 of those 290 patients (45.2%) received preventive medications (95% confidence interval, 39.5%-51.0%). The remaining 477 patients received care from an adult neurologist; of these, 206 patients (43.2%) received preventive medications (95% CI, 39.0%-47.7%; P = .591). The most common preventive medication prescribed was topiramate, which was prescribed in 19.1% of cases by adult neurologists and 15.2% of cases by pediatric neurologists. Other preventive medications included tricyclic antidepressants such as amitriptyline and nortriptyline; pediatric neurologists prescribed amitriptyline more often than adult neurologists (14.5% vs. 5.5%; P <  .001), and adult neurologists prescribed nortriptyline more often than pediatric neurologists (12.8% vs. 2.4%; P < .001).

Dr. Shapiro and colleagues performed a mixed effects logistic regression analysis of potential confounders, and found no significant association between clinician specialty and use of preventive medication (adjusted odds ratio, 1.20; 95% CI, 0.62­-2.31), while factors such as female sex (aOR, 1.69; 95% CI, 1.07-2.66) and number of visits (aOR, 1.64; 95% CI, 1.49-1.80) carried associations with preventive medication use.

The finding that pediatric and adult neurologists use similar preventive medications is a positive one because “patients who continue care into adulthood with a pediatric neurologist should receive comparable care to the care they would receive with an adult neurologist,” Dr. Shapiro and colleagues said. “It is even more pertinent now for pediatric neurologists to have comfort prescribing preventive medication to young adults, as the newer calcitonin gene-related peptide (CGRP) pathway antagonists are currently only FDA approved for use in patients aged 18 years or older.”
 

 

 

Roadblocks may prevent adoption

M. Cristina Victorio, MD, a pediatric neurologist and director of the headache program at Akron (Ohio) Children’s, said in an interview that the study is well-designed, but the results cannot be generalized as the study is retrospective, was conducted at a single institution, and data about nutraceuticals and drug-free neuromodulation devices were excluded from the analysis.

Dr. M. Cristina Victorio

Another aspect of the study to consider is that episodic migraine, defined as between 0 and 14 migraine days per month, comprised most of the diagnoses in this study, while preventive medication is usually considered in patients with migraines occurring at least 6 days per month. “[I]f migraine is only once every other month or once a month, preventive treatment may not be recommended,” she said.

There is also the element of patient preference, which is “difficult to obtain” in a retrospective study, she noted.

Citing the authors’ comments about pediatric neurologists’ comfortability prescribing preventive medications, including CGRP antagonists, Dr. Victorio said she offers CGRP antagonists to “young adult patients who have failed at least two of the guideline-recommended preventive medications.”

However, pediatric neurologists may encounter roadblocks to prescribing these medications. “A big challenge is access, as it requires prior authorization as well as writing a letter of appeal or medical necessity, which can be a nuisance for clinicians who are already inundated with clinical responsibilities,” she said.
 

More education is needed

“As a pediatric headache specialist and knowing the results of this study, my colleagues and I have a role in educating all clinicians as well as trainees on headache management to improve and provide optimal care for young adult patients with migraine,” Dr. Victorio said.

In her experience, more clinic visits usually mean a need for preventative medication, and psychiatric morbidities are common. “I differ in the sense that as a headache specialist I am comfortable offering various preventive treatment options when indicated, so I do not believe I am underutilizing,” she said.

Dr. Victorio said she prescribes topiramate, amitriptyline, and propranolol as migraine preventatives for adolescents and young adults, but recommends cyproheptadine for younger children “due to lesser side effects, tolerability, and convenience of formulation (both liquid and tablet forms are available), which can be challenging for younger children who are unable to swallow pills.”

“Cognizant that there are patients who are reluctant to take daily prescription medication and that consideration for preventive treatment includes patient’s preference, I include the use of nutraceuticals and drug-free neuromodulation devices when discussing preventive treatment options,” she added, noting that children and adolescents “[m]ore often than not” prefer nutraceuticals like magnesium and vitamin B2.

“I think the bottom line is that all clinicians managing young adults with migraine should know when to consider starting preventive migraine medication,” Dr. Victorio said. “Not offering preventive treatment to young adults specifically for those who have frequent migraine attacks, or those who have severe migraine despite adequate acute treatment, or those with significant adverse reactions to acute medications will only put these patients at risk to progression to chronic migraine (meaning having migraine more often than not – at least 15 days per month), and increases headache-related disability and reduces quality of life.”

The authors report no relevant financial disclosures. This study was supported by Harvard University and an award from the National Institutes of Health. Dr. Victorio reports being on the advisory board for Theranica Bio-electronics, has received honorarium serving as an author of the Merck Manual, and is involved in industry-sponsored clinical trials through Akron Children’s Hospital.

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Prescribing patterns of preventive migraine medications for young adults do not appear to vary based on whether the provider is a pediatric or adult neurologist, but researchers say preventive medications may be underused for this group, according to recent research published in the journal Headache.

“Approximately two-fifths of young adults with migraine were prescribed preventive medications, and this did not differ between pediatric and adult neurologists,” Hannah F. J. Shapiro MD, of the department of neurology at the University of California, San Francisco, and the UCSF Benioff Children’s Hospitals, and colleagues wrote in their study. “This finding suggests that pediatric neurologists are providing comparable care to adult neurologists for young adults with migraine; however, this may represent the underuse of preventive medications in this patient population.”

Dr. Hannah F. J. Shapiro

Dr. Shapiro and colleagues conducted a retrospective study of 767 patients (mean age 20.3 years) at Mass General Brigham Hospital in Boston between 2017 and 2021 who received care from a pediatric or adult neurologist for episodic migraine. The majority of patients in the study were white (72.2%), non-Hispanic (82.1%) women (80.3%) with episodic migraine (72.8%), some of whom experienced a psychiatric comorbidity (12.7%), and had a 3.88 mean clinic visits for migraine. Researchers assessed prescription of migraine preventive medication as a primary outcome, with a secondary outcome of comparing the rate of migraine preventive prescriptions written by pediatric and adult neurologists.

Overall, 290 patients (37.8%) received care from a pediatric neurologist, and 131 of those 290 patients (45.2%) received preventive medications (95% confidence interval, 39.5%-51.0%). The remaining 477 patients received care from an adult neurologist; of these, 206 patients (43.2%) received preventive medications (95% CI, 39.0%-47.7%; P = .591). The most common preventive medication prescribed was topiramate, which was prescribed in 19.1% of cases by adult neurologists and 15.2% of cases by pediatric neurologists. Other preventive medications included tricyclic antidepressants such as amitriptyline and nortriptyline; pediatric neurologists prescribed amitriptyline more often than adult neurologists (14.5% vs. 5.5%; P <  .001), and adult neurologists prescribed nortriptyline more often than pediatric neurologists (12.8% vs. 2.4%; P < .001).

Dr. Shapiro and colleagues performed a mixed effects logistic regression analysis of potential confounders, and found no significant association between clinician specialty and use of preventive medication (adjusted odds ratio, 1.20; 95% CI, 0.62­-2.31), while factors such as female sex (aOR, 1.69; 95% CI, 1.07-2.66) and number of visits (aOR, 1.64; 95% CI, 1.49-1.80) carried associations with preventive medication use.

The finding that pediatric and adult neurologists use similar preventive medications is a positive one because “patients who continue care into adulthood with a pediatric neurologist should receive comparable care to the care they would receive with an adult neurologist,” Dr. Shapiro and colleagues said. “It is even more pertinent now for pediatric neurologists to have comfort prescribing preventive medication to young adults, as the newer calcitonin gene-related peptide (CGRP) pathway antagonists are currently only FDA approved for use in patients aged 18 years or older.”
 

 

 

Roadblocks may prevent adoption

M. Cristina Victorio, MD, a pediatric neurologist and director of the headache program at Akron (Ohio) Children’s, said in an interview that the study is well-designed, but the results cannot be generalized as the study is retrospective, was conducted at a single institution, and data about nutraceuticals and drug-free neuromodulation devices were excluded from the analysis.

Dr. M. Cristina Victorio

Another aspect of the study to consider is that episodic migraine, defined as between 0 and 14 migraine days per month, comprised most of the diagnoses in this study, while preventive medication is usually considered in patients with migraines occurring at least 6 days per month. “[I]f migraine is only once every other month or once a month, preventive treatment may not be recommended,” she said.

There is also the element of patient preference, which is “difficult to obtain” in a retrospective study, she noted.

Citing the authors’ comments about pediatric neurologists’ comfortability prescribing preventive medications, including CGRP antagonists, Dr. Victorio said she offers CGRP antagonists to “young adult patients who have failed at least two of the guideline-recommended preventive medications.”

However, pediatric neurologists may encounter roadblocks to prescribing these medications. “A big challenge is access, as it requires prior authorization as well as writing a letter of appeal or medical necessity, which can be a nuisance for clinicians who are already inundated with clinical responsibilities,” she said.
 

More education is needed

“As a pediatric headache specialist and knowing the results of this study, my colleagues and I have a role in educating all clinicians as well as trainees on headache management to improve and provide optimal care for young adult patients with migraine,” Dr. Victorio said.

In her experience, more clinic visits usually mean a need for preventative medication, and psychiatric morbidities are common. “I differ in the sense that as a headache specialist I am comfortable offering various preventive treatment options when indicated, so I do not believe I am underutilizing,” she said.

Dr. Victorio said she prescribes topiramate, amitriptyline, and propranolol as migraine preventatives for adolescents and young adults, but recommends cyproheptadine for younger children “due to lesser side effects, tolerability, and convenience of formulation (both liquid and tablet forms are available), which can be challenging for younger children who are unable to swallow pills.”

“Cognizant that there are patients who are reluctant to take daily prescription medication and that consideration for preventive treatment includes patient’s preference, I include the use of nutraceuticals and drug-free neuromodulation devices when discussing preventive treatment options,” she added, noting that children and adolescents “[m]ore often than not” prefer nutraceuticals like magnesium and vitamin B2.

“I think the bottom line is that all clinicians managing young adults with migraine should know when to consider starting preventive migraine medication,” Dr. Victorio said. “Not offering preventive treatment to young adults specifically for those who have frequent migraine attacks, or those who have severe migraine despite adequate acute treatment, or those with significant adverse reactions to acute medications will only put these patients at risk to progression to chronic migraine (meaning having migraine more often than not – at least 15 days per month), and increases headache-related disability and reduces quality of life.”

The authors report no relevant financial disclosures. This study was supported by Harvard University and an award from the National Institutes of Health. Dr. Victorio reports being on the advisory board for Theranica Bio-electronics, has received honorarium serving as an author of the Merck Manual, and is involved in industry-sponsored clinical trials through Akron Children’s Hospital.

Prescribing patterns of preventive migraine medications for young adults do not appear to vary based on whether the provider is a pediatric or adult neurologist, but researchers say preventive medications may be underused for this group, according to recent research published in the journal Headache.

“Approximately two-fifths of young adults with migraine were prescribed preventive medications, and this did not differ between pediatric and adult neurologists,” Hannah F. J. Shapiro MD, of the department of neurology at the University of California, San Francisco, and the UCSF Benioff Children’s Hospitals, and colleagues wrote in their study. “This finding suggests that pediatric neurologists are providing comparable care to adult neurologists for young adults with migraine; however, this may represent the underuse of preventive medications in this patient population.”

Dr. Hannah F. J. Shapiro

Dr. Shapiro and colleagues conducted a retrospective study of 767 patients (mean age 20.3 years) at Mass General Brigham Hospital in Boston between 2017 and 2021 who received care from a pediatric or adult neurologist for episodic migraine. The majority of patients in the study were white (72.2%), non-Hispanic (82.1%) women (80.3%) with episodic migraine (72.8%), some of whom experienced a psychiatric comorbidity (12.7%), and had a 3.88 mean clinic visits for migraine. Researchers assessed prescription of migraine preventive medication as a primary outcome, with a secondary outcome of comparing the rate of migraine preventive prescriptions written by pediatric and adult neurologists.

Overall, 290 patients (37.8%) received care from a pediatric neurologist, and 131 of those 290 patients (45.2%) received preventive medications (95% confidence interval, 39.5%-51.0%). The remaining 477 patients received care from an adult neurologist; of these, 206 patients (43.2%) received preventive medications (95% CI, 39.0%-47.7%; P = .591). The most common preventive medication prescribed was topiramate, which was prescribed in 19.1% of cases by adult neurologists and 15.2% of cases by pediatric neurologists. Other preventive medications included tricyclic antidepressants such as amitriptyline and nortriptyline; pediatric neurologists prescribed amitriptyline more often than adult neurologists (14.5% vs. 5.5%; P <  .001), and adult neurologists prescribed nortriptyline more often than pediatric neurologists (12.8% vs. 2.4%; P < .001).

Dr. Shapiro and colleagues performed a mixed effects logistic regression analysis of potential confounders, and found no significant association between clinician specialty and use of preventive medication (adjusted odds ratio, 1.20; 95% CI, 0.62­-2.31), while factors such as female sex (aOR, 1.69; 95% CI, 1.07-2.66) and number of visits (aOR, 1.64; 95% CI, 1.49-1.80) carried associations with preventive medication use.

The finding that pediatric and adult neurologists use similar preventive medications is a positive one because “patients who continue care into adulthood with a pediatric neurologist should receive comparable care to the care they would receive with an adult neurologist,” Dr. Shapiro and colleagues said. “It is even more pertinent now for pediatric neurologists to have comfort prescribing preventive medication to young adults, as the newer calcitonin gene-related peptide (CGRP) pathway antagonists are currently only FDA approved for use in patients aged 18 years or older.”
 

 

 

Roadblocks may prevent adoption

M. Cristina Victorio, MD, a pediatric neurologist and director of the headache program at Akron (Ohio) Children’s, said in an interview that the study is well-designed, but the results cannot be generalized as the study is retrospective, was conducted at a single institution, and data about nutraceuticals and drug-free neuromodulation devices were excluded from the analysis.

Dr. M. Cristina Victorio

Another aspect of the study to consider is that episodic migraine, defined as between 0 and 14 migraine days per month, comprised most of the diagnoses in this study, while preventive medication is usually considered in patients with migraines occurring at least 6 days per month. “[I]f migraine is only once every other month or once a month, preventive treatment may not be recommended,” she said.

There is also the element of patient preference, which is “difficult to obtain” in a retrospective study, she noted.

Citing the authors’ comments about pediatric neurologists’ comfortability prescribing preventive medications, including CGRP antagonists, Dr. Victorio said she offers CGRP antagonists to “young adult patients who have failed at least two of the guideline-recommended preventive medications.”

However, pediatric neurologists may encounter roadblocks to prescribing these medications. “A big challenge is access, as it requires prior authorization as well as writing a letter of appeal or medical necessity, which can be a nuisance for clinicians who are already inundated with clinical responsibilities,” she said.
 

More education is needed

“As a pediatric headache specialist and knowing the results of this study, my colleagues and I have a role in educating all clinicians as well as trainees on headache management to improve and provide optimal care for young adult patients with migraine,” Dr. Victorio said.

In her experience, more clinic visits usually mean a need for preventative medication, and psychiatric morbidities are common. “I differ in the sense that as a headache specialist I am comfortable offering various preventive treatment options when indicated, so I do not believe I am underutilizing,” she said.

Dr. Victorio said she prescribes topiramate, amitriptyline, and propranolol as migraine preventatives for adolescents and young adults, but recommends cyproheptadine for younger children “due to lesser side effects, tolerability, and convenience of formulation (both liquid and tablet forms are available), which can be challenging for younger children who are unable to swallow pills.”

“Cognizant that there are patients who are reluctant to take daily prescription medication and that consideration for preventive treatment includes patient’s preference, I include the use of nutraceuticals and drug-free neuromodulation devices when discussing preventive treatment options,” she added, noting that children and adolescents “[m]ore often than not” prefer nutraceuticals like magnesium and vitamin B2.

“I think the bottom line is that all clinicians managing young adults with migraine should know when to consider starting preventive migraine medication,” Dr. Victorio said. “Not offering preventive treatment to young adults specifically for those who have frequent migraine attacks, or those who have severe migraine despite adequate acute treatment, or those with significant adverse reactions to acute medications will only put these patients at risk to progression to chronic migraine (meaning having migraine more often than not – at least 15 days per month), and increases headache-related disability and reduces quality of life.”

The authors report no relevant financial disclosures. This study was supported by Harvard University and an award from the National Institutes of Health. Dr. Victorio reports being on the advisory board for Theranica Bio-electronics, has received honorarium serving as an author of the Merck Manual, and is involved in industry-sponsored clinical trials through Akron Children’s Hospital.

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CBT linked to reduced pain, less catastrophizing in fibromyalgia

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Changed
Tue, 10/03/2023 - 11:42

 

TOPLINE:

In patients with fibromyalgia, cognitive behavior therapy (CBT) can reduce pain through its effect on pain-related catastrophizing, which involves intensified cognitive and emotional responses to things like intrusive thoughts, a new study suggests.

METHODOLOGY:

  • The study included 98 female patients with fibromyalgia (FM), mean age about 42 years, who underwent a baseline neuroimaging assessment and were randomly assigned to CBT (where patients learned to identify negative thoughts and use cognitive restructuring to diminish pain-related distress) or a matched educational intervention (where patients learned about fibromyalgia and chronic pain); both groups had eight weekly individual 60- to 75-minute visits.
  • The primary outcome was the pain interference subscale of the Brief Pain Inventory (BPI); secondary outcomes included the BPI pain severity subscale, the Fibromyalgia Impact Questionnaire–Revised (FIQR), and the Pain Catastrophizing Scale (PCS), which includes subscales of rumination, magnification, and helplessness.
  • Researchers used functional magnetic resonance imaging (fMRI)-adapted task to investigate the neural circuitry supporting pain catastrophizing.

TAKEAWAY:

  • After controlling for baseline values, BPI pain interference scores were significantly reduced, with a larger reduction in the CBT group, compared with the education group (P = .03), which was also the case for FIQR scores (P = .05) and pain catastrophizing (P = .04).
  • There were larger reductions in pain-related symptomatology in the CBT group, but they did not reach statistical significance.
  • Following CBT treatment, the study showed reduced connectivity between regions of the brain associated with self-awareness, pain, and emotional processing.

IN PRACTICE:

The results “highlight the important role of targeting pain catastrophizing with psychotherapy, particularly for patients reporting high levels of catastrophizing cognitions” write the authors, adding that altered network connectivity identified by the study “may emerge as a valuable biomarker of catastrophizing-related cognitive and affective processes.”

SOURCE:

The study was carried out by Jeungchan Lee, PhD, department of radiology, center for biomedical imaging, Massachusetts General Hospital, Boston, and the Discovery Center for Recovery from Chronic Pain, Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, and colleagues. It was published in Arthritis & Rheumatology.

LIMITATIONS:

Findings were limited to female participants. CBT for chronic pain includes different therapeutic modules, and the study can’t draw definitive conclusions regarding which CBT skills were most beneficial to patients in reducing catastrophizing. Baseline symptom severity was higher for the CBT group, which may complicate interpretation of the findings.

DISCLOSURES:

The study received support from the National Institutes of Health: National Center for Complementary and Integrative Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Center for Research Resources. The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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TOPLINE:

In patients with fibromyalgia, cognitive behavior therapy (CBT) can reduce pain through its effect on pain-related catastrophizing, which involves intensified cognitive and emotional responses to things like intrusive thoughts, a new study suggests.

METHODOLOGY:

  • The study included 98 female patients with fibromyalgia (FM), mean age about 42 years, who underwent a baseline neuroimaging assessment and were randomly assigned to CBT (where patients learned to identify negative thoughts and use cognitive restructuring to diminish pain-related distress) or a matched educational intervention (where patients learned about fibromyalgia and chronic pain); both groups had eight weekly individual 60- to 75-minute visits.
  • The primary outcome was the pain interference subscale of the Brief Pain Inventory (BPI); secondary outcomes included the BPI pain severity subscale, the Fibromyalgia Impact Questionnaire–Revised (FIQR), and the Pain Catastrophizing Scale (PCS), which includes subscales of rumination, magnification, and helplessness.
  • Researchers used functional magnetic resonance imaging (fMRI)-adapted task to investigate the neural circuitry supporting pain catastrophizing.

TAKEAWAY:

  • After controlling for baseline values, BPI pain interference scores were significantly reduced, with a larger reduction in the CBT group, compared with the education group (P = .03), which was also the case for FIQR scores (P = .05) and pain catastrophizing (P = .04).
  • There were larger reductions in pain-related symptomatology in the CBT group, but they did not reach statistical significance.
  • Following CBT treatment, the study showed reduced connectivity between regions of the brain associated with self-awareness, pain, and emotional processing.

IN PRACTICE:

The results “highlight the important role of targeting pain catastrophizing with psychotherapy, particularly for patients reporting high levels of catastrophizing cognitions” write the authors, adding that altered network connectivity identified by the study “may emerge as a valuable biomarker of catastrophizing-related cognitive and affective processes.”

SOURCE:

The study was carried out by Jeungchan Lee, PhD, department of radiology, center for biomedical imaging, Massachusetts General Hospital, Boston, and the Discovery Center for Recovery from Chronic Pain, Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, and colleagues. It was published in Arthritis & Rheumatology.

LIMITATIONS:

Findings were limited to female participants. CBT for chronic pain includes different therapeutic modules, and the study can’t draw definitive conclusions regarding which CBT skills were most beneficial to patients in reducing catastrophizing. Baseline symptom severity was higher for the CBT group, which may complicate interpretation of the findings.

DISCLOSURES:

The study received support from the National Institutes of Health: National Center for Complementary and Integrative Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Center for Research Resources. The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

 

TOPLINE:

In patients with fibromyalgia, cognitive behavior therapy (CBT) can reduce pain through its effect on pain-related catastrophizing, which involves intensified cognitive and emotional responses to things like intrusive thoughts, a new study suggests.

METHODOLOGY:

  • The study included 98 female patients with fibromyalgia (FM), mean age about 42 years, who underwent a baseline neuroimaging assessment and were randomly assigned to CBT (where patients learned to identify negative thoughts and use cognitive restructuring to diminish pain-related distress) or a matched educational intervention (where patients learned about fibromyalgia and chronic pain); both groups had eight weekly individual 60- to 75-minute visits.
  • The primary outcome was the pain interference subscale of the Brief Pain Inventory (BPI); secondary outcomes included the BPI pain severity subscale, the Fibromyalgia Impact Questionnaire–Revised (FIQR), and the Pain Catastrophizing Scale (PCS), which includes subscales of rumination, magnification, and helplessness.
  • Researchers used functional magnetic resonance imaging (fMRI)-adapted task to investigate the neural circuitry supporting pain catastrophizing.

TAKEAWAY:

  • After controlling for baseline values, BPI pain interference scores were significantly reduced, with a larger reduction in the CBT group, compared with the education group (P = .03), which was also the case for FIQR scores (P = .05) and pain catastrophizing (P = .04).
  • There were larger reductions in pain-related symptomatology in the CBT group, but they did not reach statistical significance.
  • Following CBT treatment, the study showed reduced connectivity between regions of the brain associated with self-awareness, pain, and emotional processing.

IN PRACTICE:

The results “highlight the important role of targeting pain catastrophizing with psychotherapy, particularly for patients reporting high levels of catastrophizing cognitions” write the authors, adding that altered network connectivity identified by the study “may emerge as a valuable biomarker of catastrophizing-related cognitive and affective processes.”

SOURCE:

The study was carried out by Jeungchan Lee, PhD, department of radiology, center for biomedical imaging, Massachusetts General Hospital, Boston, and the Discovery Center for Recovery from Chronic Pain, Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, and colleagues. It was published in Arthritis & Rheumatology.

LIMITATIONS:

Findings were limited to female participants. CBT for chronic pain includes different therapeutic modules, and the study can’t draw definitive conclusions regarding which CBT skills were most beneficial to patients in reducing catastrophizing. Baseline symptom severity was higher for the CBT group, which may complicate interpretation of the findings.

DISCLOSURES:

The study received support from the National Institutes of Health: National Center for Complementary and Integrative Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Center for Research Resources. The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Navigating chronic cough in primary care

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Tue, 09/12/2023 - 06:40

Chronic cough took center stage at the European Respiratory Society Congress session titled “Conditions We Are Just Dealing With the Tip of the Iceberg in Primary Care: Frequently Mismanaged Conditions in Primary Health Care.”

“When it comes to chronic cough, general practitioners often feel lost,” Miguel Román Rodríguez, family doctor and an associate professor of family medicine at the University of the Balearic Islands, Palma, Mallorca, Spain, and one of the chairs of the session, said to this news organization.

“GPs are central in diagnosing conditions like chronic cough. We bring something that the specialists don’t bring: the knowledge of the context, of the family, the longitudinal history,” echoed the second chair of the session, Hilary Pinnock, family physician and professor of primary care respiratory medicine at the University of Edinburgh.
 

Understanding the multifaceted nature of chronic cough

Imran Satia, an assistant professor at McMaster University, Hamilton, Ont., guided attendees at the Milan, Italy, meeting through a comprehensive exploration of chronic cough. The first issue he addressed was the definition of the condition, emphasizing that it is defined by its duration, with chronic cough typically lasting for more than 8 weeks. Prof. Satia pointed out common associations of chronic cough, including asthma, nasal disease, and reflux disease.

Delving into epidemiology, he cited a meta-analysis indicating a global prevalence of approximately 10% in the adult population, with significant regional variability: from 18.1% in Australia to 2.3% in Africa. Notably, the Canadian Longitudinal Study on Aging found an overall prevalence of 16% at baseline. “The most common risk factor was smoke, but even in nonsmokers the prevalence reached 10%,” Prof. Satia added, highlighting that it increased with age and changed depending on location. “The most common associated comorbidities were heart failure and hypertension, but also conditions related to chronic pain, mood, and anxiety,” he explained.

Mental health was identified as a crucial factor in chronic cough, with psychological distress and depressive symptoms emerging as risk factors for developing chronic cough over the next 3 years, contributing to a 20% increased risk.
 

Effective management strategies

Prof. Satia proposed the use of algorithms to aid in the management of patients with chronic cough in primary care. He introduced a Canadian algorithm that offers specific recommendations for both primary and secondary care.

The algorithm’s primary care assessment, step 1, includes a comprehensive evaluation of the cough history (duration, severity, triggers, nature, location); cardiorespiratory, gastrointestinal, and nasal symptoms; and use of angiotensin-converting enzyme inhibitors and smoking status. Essential diagnostic tests, such as chest radiography (to check for structural disease), complete blood cell count, and spirometry (with or without bronchodilator reversibility), were emphasized. Urgent referral criteria encompassed symptoms like hemoptysis, weight loss, fever, or abnormal chest radiography findings.

“When checking for cough history, GPs should always consider factors like the presence of dry or productive cough, mental health, presence of chronic pain, stroke, and swallowing,” said Prof. Satia, stressing the importance of documenting the impact of chronic cough on quality of life, work life, social life, and family life. “This is something that doctors sometimes do not ask about. They may think that these are not major problems, but acknowledging their importance can help the patient,” he added.

Step 2 of the algorithm focuses on treatment options tailored to specific diagnoses, such as asthma or chronic obstructive pulmonary disease. Prof. Satia urged caution, emphasizing that treatment should only be initiated when evidence of these conditions is present. Additionally, he encouraged early consideration of cough hypersensitivity syndrome when patients exhibit coughing in response to low levels of mechanical stimulation.
 

 

 

Current treatments and future prospects

Prof. Satia presented an overview of existing treatments for chronic cough, outlining their respective advantages and disadvantages. For instance, speech therapy is a patient-led approach with no side effects but entails challenges related to access, costs, and patient motivation. On the other hand, low-dose morphine offers rapid relief but is associated with issues like nausea, stigma, and constipation.

Looking ahead, Prof. Satia shared the results of COUGH-1 and COUGH-2, pivotal phase 3 trials evaluating the oral, peripherally acting P2X3-receptor antagonist gefapixant. This drug, currently approved in Switzerland and Japan, demonstrated a significant reduction in cough frequency, compared with placebo, with rapid and sustained effects. “The estimated relative reduction for 45 mg was 18.45% in COUGH-1 (12 weeks) and 14.64% in COUGH-2 (24 weeks). Of note, cough reduction is very quick and sustained with gefapixant, but a 40% reduction is observed in the placebo arm,” commented Prof. Satia.

Experts unanimously stressed the importance for specialists and GPs of effective communication in managing chronic cough, involving both patients and their families.

“As GPs, we are crucial to manage the common problems, but we are also crucial to spot the needle in the haystack: this is extremely difficult and challenging, and we need support from our colleagues,” Dr. Pinnock concluded.

Prof. Satia reported funding from Merck MSD, AstraZeneca, and GSK; consulting fees from Merck MSD, Genentech, and Respiplus; and speaker fees from AstraZeneca, GSK, and Merck MSD.

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

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Chronic cough took center stage at the European Respiratory Society Congress session titled “Conditions We Are Just Dealing With the Tip of the Iceberg in Primary Care: Frequently Mismanaged Conditions in Primary Health Care.”

“When it comes to chronic cough, general practitioners often feel lost,” Miguel Román Rodríguez, family doctor and an associate professor of family medicine at the University of the Balearic Islands, Palma, Mallorca, Spain, and one of the chairs of the session, said to this news organization.

“GPs are central in diagnosing conditions like chronic cough. We bring something that the specialists don’t bring: the knowledge of the context, of the family, the longitudinal history,” echoed the second chair of the session, Hilary Pinnock, family physician and professor of primary care respiratory medicine at the University of Edinburgh.
 

Understanding the multifaceted nature of chronic cough

Imran Satia, an assistant professor at McMaster University, Hamilton, Ont., guided attendees at the Milan, Italy, meeting through a comprehensive exploration of chronic cough. The first issue he addressed was the definition of the condition, emphasizing that it is defined by its duration, with chronic cough typically lasting for more than 8 weeks. Prof. Satia pointed out common associations of chronic cough, including asthma, nasal disease, and reflux disease.

Delving into epidemiology, he cited a meta-analysis indicating a global prevalence of approximately 10% in the adult population, with significant regional variability: from 18.1% in Australia to 2.3% in Africa. Notably, the Canadian Longitudinal Study on Aging found an overall prevalence of 16% at baseline. “The most common risk factor was smoke, but even in nonsmokers the prevalence reached 10%,” Prof. Satia added, highlighting that it increased with age and changed depending on location. “The most common associated comorbidities were heart failure and hypertension, but also conditions related to chronic pain, mood, and anxiety,” he explained.

Mental health was identified as a crucial factor in chronic cough, with psychological distress and depressive symptoms emerging as risk factors for developing chronic cough over the next 3 years, contributing to a 20% increased risk.
 

Effective management strategies

Prof. Satia proposed the use of algorithms to aid in the management of patients with chronic cough in primary care. He introduced a Canadian algorithm that offers specific recommendations for both primary and secondary care.

The algorithm’s primary care assessment, step 1, includes a comprehensive evaluation of the cough history (duration, severity, triggers, nature, location); cardiorespiratory, gastrointestinal, and nasal symptoms; and use of angiotensin-converting enzyme inhibitors and smoking status. Essential diagnostic tests, such as chest radiography (to check for structural disease), complete blood cell count, and spirometry (with or without bronchodilator reversibility), were emphasized. Urgent referral criteria encompassed symptoms like hemoptysis, weight loss, fever, or abnormal chest radiography findings.

“When checking for cough history, GPs should always consider factors like the presence of dry or productive cough, mental health, presence of chronic pain, stroke, and swallowing,” said Prof. Satia, stressing the importance of documenting the impact of chronic cough on quality of life, work life, social life, and family life. “This is something that doctors sometimes do not ask about. They may think that these are not major problems, but acknowledging their importance can help the patient,” he added.

Step 2 of the algorithm focuses on treatment options tailored to specific diagnoses, such as asthma or chronic obstructive pulmonary disease. Prof. Satia urged caution, emphasizing that treatment should only be initiated when evidence of these conditions is present. Additionally, he encouraged early consideration of cough hypersensitivity syndrome when patients exhibit coughing in response to low levels of mechanical stimulation.
 

 

 

Current treatments and future prospects

Prof. Satia presented an overview of existing treatments for chronic cough, outlining their respective advantages and disadvantages. For instance, speech therapy is a patient-led approach with no side effects but entails challenges related to access, costs, and patient motivation. On the other hand, low-dose morphine offers rapid relief but is associated with issues like nausea, stigma, and constipation.

Looking ahead, Prof. Satia shared the results of COUGH-1 and COUGH-2, pivotal phase 3 trials evaluating the oral, peripherally acting P2X3-receptor antagonist gefapixant. This drug, currently approved in Switzerland and Japan, demonstrated a significant reduction in cough frequency, compared with placebo, with rapid and sustained effects. “The estimated relative reduction for 45 mg was 18.45% in COUGH-1 (12 weeks) and 14.64% in COUGH-2 (24 weeks). Of note, cough reduction is very quick and sustained with gefapixant, but a 40% reduction is observed in the placebo arm,” commented Prof. Satia.

Experts unanimously stressed the importance for specialists and GPs of effective communication in managing chronic cough, involving both patients and their families.

“As GPs, we are crucial to manage the common problems, but we are also crucial to spot the needle in the haystack: this is extremely difficult and challenging, and we need support from our colleagues,” Dr. Pinnock concluded.

Prof. Satia reported funding from Merck MSD, AstraZeneca, and GSK; consulting fees from Merck MSD, Genentech, and Respiplus; and speaker fees from AstraZeneca, GSK, and Merck MSD.

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

Chronic cough took center stage at the European Respiratory Society Congress session titled “Conditions We Are Just Dealing With the Tip of the Iceberg in Primary Care: Frequently Mismanaged Conditions in Primary Health Care.”

“When it comes to chronic cough, general practitioners often feel lost,” Miguel Román Rodríguez, family doctor and an associate professor of family medicine at the University of the Balearic Islands, Palma, Mallorca, Spain, and one of the chairs of the session, said to this news organization.

“GPs are central in diagnosing conditions like chronic cough. We bring something that the specialists don’t bring: the knowledge of the context, of the family, the longitudinal history,” echoed the second chair of the session, Hilary Pinnock, family physician and professor of primary care respiratory medicine at the University of Edinburgh.
 

Understanding the multifaceted nature of chronic cough

Imran Satia, an assistant professor at McMaster University, Hamilton, Ont., guided attendees at the Milan, Italy, meeting through a comprehensive exploration of chronic cough. The first issue he addressed was the definition of the condition, emphasizing that it is defined by its duration, with chronic cough typically lasting for more than 8 weeks. Prof. Satia pointed out common associations of chronic cough, including asthma, nasal disease, and reflux disease.

Delving into epidemiology, he cited a meta-analysis indicating a global prevalence of approximately 10% in the adult population, with significant regional variability: from 18.1% in Australia to 2.3% in Africa. Notably, the Canadian Longitudinal Study on Aging found an overall prevalence of 16% at baseline. “The most common risk factor was smoke, but even in nonsmokers the prevalence reached 10%,” Prof. Satia added, highlighting that it increased with age and changed depending on location. “The most common associated comorbidities were heart failure and hypertension, but also conditions related to chronic pain, mood, and anxiety,” he explained.

Mental health was identified as a crucial factor in chronic cough, with psychological distress and depressive symptoms emerging as risk factors for developing chronic cough over the next 3 years, contributing to a 20% increased risk.
 

Effective management strategies

Prof. Satia proposed the use of algorithms to aid in the management of patients with chronic cough in primary care. He introduced a Canadian algorithm that offers specific recommendations for both primary and secondary care.

The algorithm’s primary care assessment, step 1, includes a comprehensive evaluation of the cough history (duration, severity, triggers, nature, location); cardiorespiratory, gastrointestinal, and nasal symptoms; and use of angiotensin-converting enzyme inhibitors and smoking status. Essential diagnostic tests, such as chest radiography (to check for structural disease), complete blood cell count, and spirometry (with or without bronchodilator reversibility), were emphasized. Urgent referral criteria encompassed symptoms like hemoptysis, weight loss, fever, or abnormal chest radiography findings.

“When checking for cough history, GPs should always consider factors like the presence of dry or productive cough, mental health, presence of chronic pain, stroke, and swallowing,” said Prof. Satia, stressing the importance of documenting the impact of chronic cough on quality of life, work life, social life, and family life. “This is something that doctors sometimes do not ask about. They may think that these are not major problems, but acknowledging their importance can help the patient,” he added.

Step 2 of the algorithm focuses on treatment options tailored to specific diagnoses, such as asthma or chronic obstructive pulmonary disease. Prof. Satia urged caution, emphasizing that treatment should only be initiated when evidence of these conditions is present. Additionally, he encouraged early consideration of cough hypersensitivity syndrome when patients exhibit coughing in response to low levels of mechanical stimulation.
 

 

 

Current treatments and future prospects

Prof. Satia presented an overview of existing treatments for chronic cough, outlining their respective advantages and disadvantages. For instance, speech therapy is a patient-led approach with no side effects but entails challenges related to access, costs, and patient motivation. On the other hand, low-dose morphine offers rapid relief but is associated with issues like nausea, stigma, and constipation.

Looking ahead, Prof. Satia shared the results of COUGH-1 and COUGH-2, pivotal phase 3 trials evaluating the oral, peripherally acting P2X3-receptor antagonist gefapixant. This drug, currently approved in Switzerland and Japan, demonstrated a significant reduction in cough frequency, compared with placebo, with rapid and sustained effects. “The estimated relative reduction for 45 mg was 18.45% in COUGH-1 (12 weeks) and 14.64% in COUGH-2 (24 weeks). Of note, cough reduction is very quick and sustained with gefapixant, but a 40% reduction is observed in the placebo arm,” commented Prof. Satia.

Experts unanimously stressed the importance for specialists and GPs of effective communication in managing chronic cough, involving both patients and their families.

“As GPs, we are crucial to manage the common problems, but we are also crucial to spot the needle in the haystack: this is extremely difficult and challenging, and we need support from our colleagues,” Dr. Pinnock concluded.

Prof. Satia reported funding from Merck MSD, AstraZeneca, and GSK; consulting fees from Merck MSD, Genentech, and Respiplus; and speaker fees from AstraZeneca, GSK, and Merck MSD.

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

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New guideline for managing toothache in children

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Fri, 09/08/2023 - 11:22

Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.

The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.

Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.

Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”

Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.

Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.

If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.

“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.

The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.

The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.

The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.

“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.

“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”

2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.

The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.

The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.

The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.

A version of this article appeared on Medscape.com.

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Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.

The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.

Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.

Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”

Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.

Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.

If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.

“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.

The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.

The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.

The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.

“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.

“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”

2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.

The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.

The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.

The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.

A version of this article appeared on Medscape.com.

Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.

The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.

Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.

Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”

Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.

Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.

If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.

“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.

The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.

The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.

The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.

“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.

“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”

2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.

The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.

The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.

The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.

A version of this article appeared on Medscape.com.

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