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Buprenorphine One of Many Options For Pain Relief In Oldest Adults
Some degree of pain is inevitable in older individuals, and as people pass 80 years of age, the harms of medications used to control chronic pain increase. Pain-reducing medication use in this age group may cause inflammation, gastric bleeding, kidney damage, or constipation.
These risks may lead some clinicians to avoid aggressive pain treatment in their eldest patients, resulting in unnecessary suffering.
“Pain causes harm beyond just the physical suffering associated with it,” said Diane Meier, MD, a geriatrician and palliative care specialist at Mount Sinai Medicine in New York City who treats many people in their 80s and 90s.
Downstream effects of untreated pain could include a loss of mobility and isolation, Dr. Meier said. And, as these harms are mounting, some clinicians may avoid using an analgesic that could bring great relief: buprenorphine.
“People think about buprenorphine like they think about methadone,” Dr. Meier said, as something prescribed to treat substance use disorder. In reality, it is an effective analgesic in other situations.
Buprenorphine is better at treating chronic pain than other opioids that carry a higher addiction risk and often cause constipation in elderly patients. Buprenorphine is easier on the kidneys and has a lower addiction risk than opioids like oxycodone.
The transdermal patch form of buprenorphine (Butrans, PurduePharma) is changed weekly and starts at low doses.
“There’s an adage in geriatrics: start low and go slow,” said Jessica Merlin, MD, PhD, a palliative care and addiction medicine physician at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania.
Dr. Merlin recommends beginning elderly patients with chronic pain on a 10-microgram/hour dose of Butrans, among the lowest doses available. Physicians could monitor side effects, which will generally be mild, with the aim of never increasing the dose if pain is managed.
Nonpharmacologic Remedies, Drug Considerations
“Nonpharmacologic therapy is very underutilized,” Dr. Merlin said, even though multiple alternatives to medications can improve chronic pain symptoms at any age.
Cognitive-behavioral therapy or acceptance and commitment therapy can both help people reduce the impact of pain, Dr. Merlin said. And for people who can do so, physical therapy programs, yoga, or tai chi are all ways to strengthen the body’s defenses against pain, Dr. Merlin added.
Sometimes medication is necessary, however.
“You can’t get an older person to participate in rehab if they are in severe pain,” Dr. Meier said, adding that judicious use of medications should go hand in hand with nonpharmacologic treatment.
When medications are unavoidable, internist Douglas S. Paauw, MD, starts with topical injections at the site of the pain — a troublesome joint, for example — rather than systemic medications that affect multiple organs and the brain.
“We try not to flood their body with meds” for localized problems, Dr. Paauw said, whose goal when treating elderly patients with pain is to improve their daily functioning and quality of life.
Dr. Paauw works at the University of Washington in Seattle and treats people who are approaching 100 years old. As some of his patients have grown older, Dr. Paauw’s interest in effective pain management has grown; he thinks that all internists and family medicine physician need to know how to manage chronic pain in their eldest patients.
“Were you able to play with your grandkid? Were you able to go grocery shopping? Were you able to take a walk outside?” These are the kinds of improvements Dr. Paauw hopes to see in older patients, recognizing that the wear and tear of life — orthopedic stresses or healed fractures that cause lingering pain — make it impossible for many older people to be pain free.
Pain is often spread throughout the body rather than focusing at one point, which requires systemic medications if physical therapy and similar approaches have not reduced pain. Per American Geriatrics Society (AGS) guidelines, in this situation Dr. Paauw starts with acetaminophen (Tylenol) as the lowest-risk systemic pain treatment.
Dr. Pauuw often counsels older patients to begin with 2 grams/day of acetaminophen and then progress to 3 grams if the lower dose has manageable side effects, rather than the standard dose of 4 grams that he feels is geared toward younger patients.
When acetaminophen doesn’t reduce pain sufficiently, or aggravates inflammation, Dr. Paauw may use the nerve pain medication pregabalin, or the antidepressant duloxetine — especially if the pain appears to be neuropathic.
Tricyclic antidepressants used to be recommended for neuropathic pain in older adults, but are now on the AGS’s Beers Criteria of drugs to avoid in elderly patients due to risk of causing dizziness or cardiac stress. Dr. Paauw might still use a tricyclic, but only after a careful risk-benefit analysis.
Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Motrin) or naproxen (Aleve) could work in short bursts, Dr. Paauw said, although they may cause stomach bleeding or kidney damage in older patients.
This is why NSAIDs are not recommended by the AGS for chronic pain management. And opioids like oxycodone don’t work long at low doses, often leading to dose escalation and addiction.
“The American Geriatrics Society really puts opioids down at the bottom of the list,” Dr. Paauw said, to be used “judiciously and rarely.”
Opioids may interact with other drugs to increase risk of a fall, Dr. Meier added, making them inadvisable for older patients who live alone.
“That’s why knowing something about buprenorphine is so important,” Dr. Meier said.
Dr. Meier and Dr. Paauw are on the editorial board for Internal Medicine News. Dr. Merlin is a trainer for the Center to Advance Palliative Care, which Dr. Meier founded.
Some degree of pain is inevitable in older individuals, and as people pass 80 years of age, the harms of medications used to control chronic pain increase. Pain-reducing medication use in this age group may cause inflammation, gastric bleeding, kidney damage, or constipation.
These risks may lead some clinicians to avoid aggressive pain treatment in their eldest patients, resulting in unnecessary suffering.
“Pain causes harm beyond just the physical suffering associated with it,” said Diane Meier, MD, a geriatrician and palliative care specialist at Mount Sinai Medicine in New York City who treats many people in their 80s and 90s.
Downstream effects of untreated pain could include a loss of mobility and isolation, Dr. Meier said. And, as these harms are mounting, some clinicians may avoid using an analgesic that could bring great relief: buprenorphine.
“People think about buprenorphine like they think about methadone,” Dr. Meier said, as something prescribed to treat substance use disorder. In reality, it is an effective analgesic in other situations.
Buprenorphine is better at treating chronic pain than other opioids that carry a higher addiction risk and often cause constipation in elderly patients. Buprenorphine is easier on the kidneys and has a lower addiction risk than opioids like oxycodone.
The transdermal patch form of buprenorphine (Butrans, PurduePharma) is changed weekly and starts at low doses.
“There’s an adage in geriatrics: start low and go slow,” said Jessica Merlin, MD, PhD, a palliative care and addiction medicine physician at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania.
Dr. Merlin recommends beginning elderly patients with chronic pain on a 10-microgram/hour dose of Butrans, among the lowest doses available. Physicians could monitor side effects, which will generally be mild, with the aim of never increasing the dose if pain is managed.
Nonpharmacologic Remedies, Drug Considerations
“Nonpharmacologic therapy is very underutilized,” Dr. Merlin said, even though multiple alternatives to medications can improve chronic pain symptoms at any age.
Cognitive-behavioral therapy or acceptance and commitment therapy can both help people reduce the impact of pain, Dr. Merlin said. And for people who can do so, physical therapy programs, yoga, or tai chi are all ways to strengthen the body’s defenses against pain, Dr. Merlin added.
Sometimes medication is necessary, however.
“You can’t get an older person to participate in rehab if they are in severe pain,” Dr. Meier said, adding that judicious use of medications should go hand in hand with nonpharmacologic treatment.
When medications are unavoidable, internist Douglas S. Paauw, MD, starts with topical injections at the site of the pain — a troublesome joint, for example — rather than systemic medications that affect multiple organs and the brain.
“We try not to flood their body with meds” for localized problems, Dr. Paauw said, whose goal when treating elderly patients with pain is to improve their daily functioning and quality of life.
Dr. Paauw works at the University of Washington in Seattle and treats people who are approaching 100 years old. As some of his patients have grown older, Dr. Paauw’s interest in effective pain management has grown; he thinks that all internists and family medicine physician need to know how to manage chronic pain in their eldest patients.
“Were you able to play with your grandkid? Were you able to go grocery shopping? Were you able to take a walk outside?” These are the kinds of improvements Dr. Paauw hopes to see in older patients, recognizing that the wear and tear of life — orthopedic stresses or healed fractures that cause lingering pain — make it impossible for many older people to be pain free.
Pain is often spread throughout the body rather than focusing at one point, which requires systemic medications if physical therapy and similar approaches have not reduced pain. Per American Geriatrics Society (AGS) guidelines, in this situation Dr. Paauw starts with acetaminophen (Tylenol) as the lowest-risk systemic pain treatment.
Dr. Pauuw often counsels older patients to begin with 2 grams/day of acetaminophen and then progress to 3 grams if the lower dose has manageable side effects, rather than the standard dose of 4 grams that he feels is geared toward younger patients.
When acetaminophen doesn’t reduce pain sufficiently, or aggravates inflammation, Dr. Paauw may use the nerve pain medication pregabalin, or the antidepressant duloxetine — especially if the pain appears to be neuropathic.
Tricyclic antidepressants used to be recommended for neuropathic pain in older adults, but are now on the AGS’s Beers Criteria of drugs to avoid in elderly patients due to risk of causing dizziness or cardiac stress. Dr. Paauw might still use a tricyclic, but only after a careful risk-benefit analysis.
Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Motrin) or naproxen (Aleve) could work in short bursts, Dr. Paauw said, although they may cause stomach bleeding or kidney damage in older patients.
This is why NSAIDs are not recommended by the AGS for chronic pain management. And opioids like oxycodone don’t work long at low doses, often leading to dose escalation and addiction.
“The American Geriatrics Society really puts opioids down at the bottom of the list,” Dr. Paauw said, to be used “judiciously and rarely.”
Opioids may interact with other drugs to increase risk of a fall, Dr. Meier added, making them inadvisable for older patients who live alone.
“That’s why knowing something about buprenorphine is so important,” Dr. Meier said.
Dr. Meier and Dr. Paauw are on the editorial board for Internal Medicine News. Dr. Merlin is a trainer for the Center to Advance Palliative Care, which Dr. Meier founded.
Some degree of pain is inevitable in older individuals, and as people pass 80 years of age, the harms of medications used to control chronic pain increase. Pain-reducing medication use in this age group may cause inflammation, gastric bleeding, kidney damage, or constipation.
These risks may lead some clinicians to avoid aggressive pain treatment in their eldest patients, resulting in unnecessary suffering.
“Pain causes harm beyond just the physical suffering associated with it,” said Diane Meier, MD, a geriatrician and palliative care specialist at Mount Sinai Medicine in New York City who treats many people in their 80s and 90s.
Downstream effects of untreated pain could include a loss of mobility and isolation, Dr. Meier said. And, as these harms are mounting, some clinicians may avoid using an analgesic that could bring great relief: buprenorphine.
“People think about buprenorphine like they think about methadone,” Dr. Meier said, as something prescribed to treat substance use disorder. In reality, it is an effective analgesic in other situations.
Buprenorphine is better at treating chronic pain than other opioids that carry a higher addiction risk and often cause constipation in elderly patients. Buprenorphine is easier on the kidneys and has a lower addiction risk than opioids like oxycodone.
The transdermal patch form of buprenorphine (Butrans, PurduePharma) is changed weekly and starts at low doses.
“There’s an adage in geriatrics: start low and go slow,” said Jessica Merlin, MD, PhD, a palliative care and addiction medicine physician at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania.
Dr. Merlin recommends beginning elderly patients with chronic pain on a 10-microgram/hour dose of Butrans, among the lowest doses available. Physicians could monitor side effects, which will generally be mild, with the aim of never increasing the dose if pain is managed.
Nonpharmacologic Remedies, Drug Considerations
“Nonpharmacologic therapy is very underutilized,” Dr. Merlin said, even though multiple alternatives to medications can improve chronic pain symptoms at any age.
Cognitive-behavioral therapy or acceptance and commitment therapy can both help people reduce the impact of pain, Dr. Merlin said. And for people who can do so, physical therapy programs, yoga, or tai chi are all ways to strengthen the body’s defenses against pain, Dr. Merlin added.
Sometimes medication is necessary, however.
“You can’t get an older person to participate in rehab if they are in severe pain,” Dr. Meier said, adding that judicious use of medications should go hand in hand with nonpharmacologic treatment.
When medications are unavoidable, internist Douglas S. Paauw, MD, starts with topical injections at the site of the pain — a troublesome joint, for example — rather than systemic medications that affect multiple organs and the brain.
“We try not to flood their body with meds” for localized problems, Dr. Paauw said, whose goal when treating elderly patients with pain is to improve their daily functioning and quality of life.
Dr. Paauw works at the University of Washington in Seattle and treats people who are approaching 100 years old. As some of his patients have grown older, Dr. Paauw’s interest in effective pain management has grown; he thinks that all internists and family medicine physician need to know how to manage chronic pain in their eldest patients.
“Were you able to play with your grandkid? Were you able to go grocery shopping? Were you able to take a walk outside?” These are the kinds of improvements Dr. Paauw hopes to see in older patients, recognizing that the wear and tear of life — orthopedic stresses or healed fractures that cause lingering pain — make it impossible for many older people to be pain free.
Pain is often spread throughout the body rather than focusing at one point, which requires systemic medications if physical therapy and similar approaches have not reduced pain. Per American Geriatrics Society (AGS) guidelines, in this situation Dr. Paauw starts with acetaminophen (Tylenol) as the lowest-risk systemic pain treatment.
Dr. Pauuw often counsels older patients to begin with 2 grams/day of acetaminophen and then progress to 3 grams if the lower dose has manageable side effects, rather than the standard dose of 4 grams that he feels is geared toward younger patients.
When acetaminophen doesn’t reduce pain sufficiently, or aggravates inflammation, Dr. Paauw may use the nerve pain medication pregabalin, or the antidepressant duloxetine — especially if the pain appears to be neuropathic.
Tricyclic antidepressants used to be recommended for neuropathic pain in older adults, but are now on the AGS’s Beers Criteria of drugs to avoid in elderly patients due to risk of causing dizziness or cardiac stress. Dr. Paauw might still use a tricyclic, but only after a careful risk-benefit analysis.
Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Motrin) or naproxen (Aleve) could work in short bursts, Dr. Paauw said, although they may cause stomach bleeding or kidney damage in older patients.
This is why NSAIDs are not recommended by the AGS for chronic pain management. And opioids like oxycodone don’t work long at low doses, often leading to dose escalation and addiction.
“The American Geriatrics Society really puts opioids down at the bottom of the list,” Dr. Paauw said, to be used “judiciously and rarely.”
Opioids may interact with other drugs to increase risk of a fall, Dr. Meier added, making them inadvisable for older patients who live alone.
“That’s why knowing something about buprenorphine is so important,” Dr. Meier said.
Dr. Meier and Dr. Paauw are on the editorial board for Internal Medicine News. Dr. Merlin is a trainer for the Center to Advance Palliative Care, which Dr. Meier founded.
Summer Is Not Over: Let's Talk About Recreational Water–Associated Illnesses
Recently I was in Wyoming. As I rode down the Snake River, the guide pointed out tree trunks that had been chewed on by beavers. Days later I joined a local friend for a hike to Taggart Lake. Upon reaching the end of the trail as I began to cast my eyes on the magnificent scenery, I could not help but notice several children, including toddlers, playing in the fresh warm water. The next thing out of my friend’s mouth was “You know there is Giardia in there.” Little did she know, she and the guide had just helped me select a topic for ID Consult.
Giardia, aka ”beaver fever,” was discussed in detail in this column as part of the differential of a diarrheal illness by Christopher J. Harrison, MD. However, it is the perfect time of year to revisit other recreational water–associated illnesses.
Infections acquired during recreational water activity can lead to illnesses involving the gastrointestinal tract, central nervous system, respiratory tract, skin, eyes, and ears. Pathogens, chemicals, and toxins are transmitted by ingestion, contact with contaminated water or a sick individual or animal, and inhalation of aerosols. The National Waterborne Disease and Outbreak Surveillance System (WBDOSS) collects data on waterborne disease and outbreaks associated with recreational water, drinking water, and environmental and undetermined exposures to water. All reporting to the Centers for Disease Control and Prevention (CDC) is voluntary. However, mandatory pathogen reporting requirements can vary by state. Ideally, once an agency has completed the outbreak investigation, the definitive cause and source will be determined, and interventions to prevent future outbreaks implemented.
Treated Versus Untreated Water
One useful way to help narrow the etiology of a patient’s symptoms is to consider those illnesses associated with treated water venues (e.g., pools, hot tubs, water parks) versus untreated water venues (e.g., rivers, lakes, oceans). Parents may forget to offer that information since they may not perceive a connection between water exposure and the illness, especially if they traveled within the US.
In 2021, the CDC reported results of data submitted between 2015 and 2019 from treated recreational water facilities. Of the 208 outbreaks, most (96%) were associated with public pools, hot tubs, or water playgrounds. These outbreaks resulted in at least 3,646 cases of illness, 286 hospitalizations, and 13 deaths. Overall infectious etiologies were the primary cause of illness. Of the 155 outbreaks with a confirmed etiology, Cryptosporidium was the causative pathogen in 49% of the outbreaks and accounted for 84% (2,492) of cases, while Legionella caused 42% of outbreaks, accounted for 13% (354) of cases, and was responsible for all 13 deaths. Slightly more than half (107 of 208) of the outbreaks started between June-August with Cryptosporidium accounting for 63 of the outbreaks during that period. A little more than one-third were associated with a hotel or resort. The majority of hotel recreational water–associated illnesses was associated with hot tubs. Of the 53 outbreaks without a confirmed etiology, 20 were suspected to have a chemical related etiology (excess chlorine, altered pool chemistry).
In contrast, there were 140 untreated recreational water outbreaks reported between 2000 and 2014 from 35 states and Guam involving 4,958 cases and 2 deaths. The etiology was confirmed for 103 (74%) outbreaks including 5 that had multiple etiologies and 8 due to toxins or chemicals; 7 of 8 toxins were from harmful algal blooms. Enteric pathogens were the etiology in 84% of outbreaks including: Norovirus (n = 1459), Shigella (n = 362) Avian schistosomes (n = 345), Cryptosporidium (n = 314) and Escherichia coli (n = 155).There were 24 cases of Giardia. The two deaths were due to Naegleria fowleri. The top 2 settings for these outbreaks were public parks (36%) and beaches (32%) with most outbreaks (n = 117) being associated with a lake /pond venue. Most outbreaks began between June and August.
The major differences between the two types of recreational water–associated illnesses are their most common settings and etiologies. With that in mind, let us briefly review the most common etiology from each venue.
Treated Water Venue: Cryptosporidiosis
Cryptosporidium is an oocyst-forming protozoa that causes a self-limited watery, nonbloody diarrhea which usually resolves within 10-14 days. Most patients have associated abdominal cramps, fever, and vomiting although infected persons can be asymptomatic. Infection in the immunocompromised potentially can lead to profuse and prolonged diarrhea. Oocysts are excreted in the feces of infected hosts and as little as 10 can cause infection. They can survive extreme environmental conditions in water and soil for several months and even survive up to 7 days in a properly chlorinated pool. Transmission occurs between humans via contaminated food and water or from infected animals. Oocysts have been isolated in raw or unpasteurized milk and apple cider. Incidence is highest in children 1 through 4 years of age.
Diagnosis today is usually via molecular methods (nucleic acid amplification tests, aka NAATs), due to their high sensitivity and specificity and is the preferred method. These tests can identify multiple gastrointestinal tract pathogens with a single assay. Diagnosis by microscopy or fecal immunoassay antigens are still available. Treatment is supportive in most cases. If needed, a 3-day course of nitazoxanide can be prescribed. Immunocompromised patients should be managed in consultation with an infectious disease specialist.
Untreated Water Venue: Norovirus
Norovirus is a viral illness characterized by the abrupt onset of vomiting and/or watery diarrhea, usually associated with nausea and abdominal cramps. Symptoms persist 24-72 hours, however they may be prolonged in the immunocompromised and persons at the extremes of the age spectrum. Norovirus has replaced rotavirus as the major cause of medically attended gastroenteritis. While a major cause of recreational water–associated illnesses, high attack rates also occur in semi closed communities including cruise ships, childcare centers, and schools. Transmission is fecal-oral, vomitus oral, person to person, by ingestion of contaminated food and water or touching contaminated surfaces with subsequent touching of the mouth. Asymptomatic viral shedding may occur, especially in children. Prolonged shedding (> 6 mos.) has been reported in immunocompromised hosts.
Molecular diagnosis with stool is utilized most often. Treatment is supportive.
Take Home Message
When evaluating your patients for an acute gastrointestinal illness, consider water-related activities and their potential for being the source. Encourage patients not to ignore posted advisories on beaches, to not swim if they have diarrhea, not to swallow the water they swim in and to minimize water entering their nose while swimming in warm freshwater. If you start seeing several patients with similar symptoms and/or etiology, consider contacting your local or state health department. It could be the beginning of an outbreak.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She has no relevant financial disclosures.
Suggested Readings
Graciaa DS et al. Outbreaks Associated with Untreated Recreational Water — United States, 2000–2014. MMWR Morb Mortal Wkly Rep. 2018 Jun 29;67(25):701-706. doi: 10.15585/mmwr.mm6725a1.
Hlavsa MC et al. Outbreaks Associated with Treated Recreational Water — United States, 2015–2019. MMWR Morb Mortal Wkly Rep. 2021;70:733–738. doi: 10.15585/mmwr.mm7020a1.
Kimberlin DW et al., eds. Red Book Report of the Committee on Infectious Diseases. 33rd ed. American Academy of Pediatrics. 2024. Cryptosporidiosis, p 338-40 and Norovirus, p 622-624.Waterborne Outbreaks Summary Reports. CDC. 2024 April 18.
Recently I was in Wyoming. As I rode down the Snake River, the guide pointed out tree trunks that had been chewed on by beavers. Days later I joined a local friend for a hike to Taggart Lake. Upon reaching the end of the trail as I began to cast my eyes on the magnificent scenery, I could not help but notice several children, including toddlers, playing in the fresh warm water. The next thing out of my friend’s mouth was “You know there is Giardia in there.” Little did she know, she and the guide had just helped me select a topic for ID Consult.
Giardia, aka ”beaver fever,” was discussed in detail in this column as part of the differential of a diarrheal illness by Christopher J. Harrison, MD. However, it is the perfect time of year to revisit other recreational water–associated illnesses.
Infections acquired during recreational water activity can lead to illnesses involving the gastrointestinal tract, central nervous system, respiratory tract, skin, eyes, and ears. Pathogens, chemicals, and toxins are transmitted by ingestion, contact with contaminated water or a sick individual or animal, and inhalation of aerosols. The National Waterborne Disease and Outbreak Surveillance System (WBDOSS) collects data on waterborne disease and outbreaks associated with recreational water, drinking water, and environmental and undetermined exposures to water. All reporting to the Centers for Disease Control and Prevention (CDC) is voluntary. However, mandatory pathogen reporting requirements can vary by state. Ideally, once an agency has completed the outbreak investigation, the definitive cause and source will be determined, and interventions to prevent future outbreaks implemented.
Treated Versus Untreated Water
One useful way to help narrow the etiology of a patient’s symptoms is to consider those illnesses associated with treated water venues (e.g., pools, hot tubs, water parks) versus untreated water venues (e.g., rivers, lakes, oceans). Parents may forget to offer that information since they may not perceive a connection between water exposure and the illness, especially if they traveled within the US.
In 2021, the CDC reported results of data submitted between 2015 and 2019 from treated recreational water facilities. Of the 208 outbreaks, most (96%) were associated with public pools, hot tubs, or water playgrounds. These outbreaks resulted in at least 3,646 cases of illness, 286 hospitalizations, and 13 deaths. Overall infectious etiologies were the primary cause of illness. Of the 155 outbreaks with a confirmed etiology, Cryptosporidium was the causative pathogen in 49% of the outbreaks and accounted for 84% (2,492) of cases, while Legionella caused 42% of outbreaks, accounted for 13% (354) of cases, and was responsible for all 13 deaths. Slightly more than half (107 of 208) of the outbreaks started between June-August with Cryptosporidium accounting for 63 of the outbreaks during that period. A little more than one-third were associated with a hotel or resort. The majority of hotel recreational water–associated illnesses was associated with hot tubs. Of the 53 outbreaks without a confirmed etiology, 20 were suspected to have a chemical related etiology (excess chlorine, altered pool chemistry).
In contrast, there were 140 untreated recreational water outbreaks reported between 2000 and 2014 from 35 states and Guam involving 4,958 cases and 2 deaths. The etiology was confirmed for 103 (74%) outbreaks including 5 that had multiple etiologies and 8 due to toxins or chemicals; 7 of 8 toxins were from harmful algal blooms. Enteric pathogens were the etiology in 84% of outbreaks including: Norovirus (n = 1459), Shigella (n = 362) Avian schistosomes (n = 345), Cryptosporidium (n = 314) and Escherichia coli (n = 155).There were 24 cases of Giardia. The two deaths were due to Naegleria fowleri. The top 2 settings for these outbreaks were public parks (36%) and beaches (32%) with most outbreaks (n = 117) being associated with a lake /pond venue. Most outbreaks began between June and August.
The major differences between the two types of recreational water–associated illnesses are their most common settings and etiologies. With that in mind, let us briefly review the most common etiology from each venue.
Treated Water Venue: Cryptosporidiosis
Cryptosporidium is an oocyst-forming protozoa that causes a self-limited watery, nonbloody diarrhea which usually resolves within 10-14 days. Most patients have associated abdominal cramps, fever, and vomiting although infected persons can be asymptomatic. Infection in the immunocompromised potentially can lead to profuse and prolonged diarrhea. Oocysts are excreted in the feces of infected hosts and as little as 10 can cause infection. They can survive extreme environmental conditions in water and soil for several months and even survive up to 7 days in a properly chlorinated pool. Transmission occurs between humans via contaminated food and water or from infected animals. Oocysts have been isolated in raw or unpasteurized milk and apple cider. Incidence is highest in children 1 through 4 years of age.
Diagnosis today is usually via molecular methods (nucleic acid amplification tests, aka NAATs), due to their high sensitivity and specificity and is the preferred method. These tests can identify multiple gastrointestinal tract pathogens with a single assay. Diagnosis by microscopy or fecal immunoassay antigens are still available. Treatment is supportive in most cases. If needed, a 3-day course of nitazoxanide can be prescribed. Immunocompromised patients should be managed in consultation with an infectious disease specialist.
Untreated Water Venue: Norovirus
Norovirus is a viral illness characterized by the abrupt onset of vomiting and/or watery diarrhea, usually associated with nausea and abdominal cramps. Symptoms persist 24-72 hours, however they may be prolonged in the immunocompromised and persons at the extremes of the age spectrum. Norovirus has replaced rotavirus as the major cause of medically attended gastroenteritis. While a major cause of recreational water–associated illnesses, high attack rates also occur in semi closed communities including cruise ships, childcare centers, and schools. Transmission is fecal-oral, vomitus oral, person to person, by ingestion of contaminated food and water or touching contaminated surfaces with subsequent touching of the mouth. Asymptomatic viral shedding may occur, especially in children. Prolonged shedding (> 6 mos.) has been reported in immunocompromised hosts.
Molecular diagnosis with stool is utilized most often. Treatment is supportive.
Take Home Message
When evaluating your patients for an acute gastrointestinal illness, consider water-related activities and their potential for being the source. Encourage patients not to ignore posted advisories on beaches, to not swim if they have diarrhea, not to swallow the water they swim in and to minimize water entering their nose while swimming in warm freshwater. If you start seeing several patients with similar symptoms and/or etiology, consider contacting your local or state health department. It could be the beginning of an outbreak.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She has no relevant financial disclosures.
Suggested Readings
Graciaa DS et al. Outbreaks Associated with Untreated Recreational Water — United States, 2000–2014. MMWR Morb Mortal Wkly Rep. 2018 Jun 29;67(25):701-706. doi: 10.15585/mmwr.mm6725a1.
Hlavsa MC et al. Outbreaks Associated with Treated Recreational Water — United States, 2015–2019. MMWR Morb Mortal Wkly Rep. 2021;70:733–738. doi: 10.15585/mmwr.mm7020a1.
Kimberlin DW et al., eds. Red Book Report of the Committee on Infectious Diseases. 33rd ed. American Academy of Pediatrics. 2024. Cryptosporidiosis, p 338-40 and Norovirus, p 622-624.Waterborne Outbreaks Summary Reports. CDC. 2024 April 18.
Recently I was in Wyoming. As I rode down the Snake River, the guide pointed out tree trunks that had been chewed on by beavers. Days later I joined a local friend for a hike to Taggart Lake. Upon reaching the end of the trail as I began to cast my eyes on the magnificent scenery, I could not help but notice several children, including toddlers, playing in the fresh warm water. The next thing out of my friend’s mouth was “You know there is Giardia in there.” Little did she know, she and the guide had just helped me select a topic for ID Consult.
Giardia, aka ”beaver fever,” was discussed in detail in this column as part of the differential of a diarrheal illness by Christopher J. Harrison, MD. However, it is the perfect time of year to revisit other recreational water–associated illnesses.
Infections acquired during recreational water activity can lead to illnesses involving the gastrointestinal tract, central nervous system, respiratory tract, skin, eyes, and ears. Pathogens, chemicals, and toxins are transmitted by ingestion, contact with contaminated water or a sick individual or animal, and inhalation of aerosols. The National Waterborne Disease and Outbreak Surveillance System (WBDOSS) collects data on waterborne disease and outbreaks associated with recreational water, drinking water, and environmental and undetermined exposures to water. All reporting to the Centers for Disease Control and Prevention (CDC) is voluntary. However, mandatory pathogen reporting requirements can vary by state. Ideally, once an agency has completed the outbreak investigation, the definitive cause and source will be determined, and interventions to prevent future outbreaks implemented.
Treated Versus Untreated Water
One useful way to help narrow the etiology of a patient’s symptoms is to consider those illnesses associated with treated water venues (e.g., pools, hot tubs, water parks) versus untreated water venues (e.g., rivers, lakes, oceans). Parents may forget to offer that information since they may not perceive a connection between water exposure and the illness, especially if they traveled within the US.
In 2021, the CDC reported results of data submitted between 2015 and 2019 from treated recreational water facilities. Of the 208 outbreaks, most (96%) were associated with public pools, hot tubs, or water playgrounds. These outbreaks resulted in at least 3,646 cases of illness, 286 hospitalizations, and 13 deaths. Overall infectious etiologies were the primary cause of illness. Of the 155 outbreaks with a confirmed etiology, Cryptosporidium was the causative pathogen in 49% of the outbreaks and accounted for 84% (2,492) of cases, while Legionella caused 42% of outbreaks, accounted for 13% (354) of cases, and was responsible for all 13 deaths. Slightly more than half (107 of 208) of the outbreaks started between June-August with Cryptosporidium accounting for 63 of the outbreaks during that period. A little more than one-third were associated with a hotel or resort. The majority of hotel recreational water–associated illnesses was associated with hot tubs. Of the 53 outbreaks without a confirmed etiology, 20 were suspected to have a chemical related etiology (excess chlorine, altered pool chemistry).
In contrast, there were 140 untreated recreational water outbreaks reported between 2000 and 2014 from 35 states and Guam involving 4,958 cases and 2 deaths. The etiology was confirmed for 103 (74%) outbreaks including 5 that had multiple etiologies and 8 due to toxins or chemicals; 7 of 8 toxins were from harmful algal blooms. Enteric pathogens were the etiology in 84% of outbreaks including: Norovirus (n = 1459), Shigella (n = 362) Avian schistosomes (n = 345), Cryptosporidium (n = 314) and Escherichia coli (n = 155).There were 24 cases of Giardia. The two deaths were due to Naegleria fowleri. The top 2 settings for these outbreaks were public parks (36%) and beaches (32%) with most outbreaks (n = 117) being associated with a lake /pond venue. Most outbreaks began between June and August.
The major differences between the two types of recreational water–associated illnesses are their most common settings and etiologies. With that in mind, let us briefly review the most common etiology from each venue.
Treated Water Venue: Cryptosporidiosis
Cryptosporidium is an oocyst-forming protozoa that causes a self-limited watery, nonbloody diarrhea which usually resolves within 10-14 days. Most patients have associated abdominal cramps, fever, and vomiting although infected persons can be asymptomatic. Infection in the immunocompromised potentially can lead to profuse and prolonged diarrhea. Oocysts are excreted in the feces of infected hosts and as little as 10 can cause infection. They can survive extreme environmental conditions in water and soil for several months and even survive up to 7 days in a properly chlorinated pool. Transmission occurs between humans via contaminated food and water or from infected animals. Oocysts have been isolated in raw or unpasteurized milk and apple cider. Incidence is highest in children 1 through 4 years of age.
Diagnosis today is usually via molecular methods (nucleic acid amplification tests, aka NAATs), due to their high sensitivity and specificity and is the preferred method. These tests can identify multiple gastrointestinal tract pathogens with a single assay. Diagnosis by microscopy or fecal immunoassay antigens are still available. Treatment is supportive in most cases. If needed, a 3-day course of nitazoxanide can be prescribed. Immunocompromised patients should be managed in consultation with an infectious disease specialist.
Untreated Water Venue: Norovirus
Norovirus is a viral illness characterized by the abrupt onset of vomiting and/or watery diarrhea, usually associated with nausea and abdominal cramps. Symptoms persist 24-72 hours, however they may be prolonged in the immunocompromised and persons at the extremes of the age spectrum. Norovirus has replaced rotavirus as the major cause of medically attended gastroenteritis. While a major cause of recreational water–associated illnesses, high attack rates also occur in semi closed communities including cruise ships, childcare centers, and schools. Transmission is fecal-oral, vomitus oral, person to person, by ingestion of contaminated food and water or touching contaminated surfaces with subsequent touching of the mouth. Asymptomatic viral shedding may occur, especially in children. Prolonged shedding (> 6 mos.) has been reported in immunocompromised hosts.
Molecular diagnosis with stool is utilized most often. Treatment is supportive.
Take Home Message
When evaluating your patients for an acute gastrointestinal illness, consider water-related activities and their potential for being the source. Encourage patients not to ignore posted advisories on beaches, to not swim if they have diarrhea, not to swallow the water they swim in and to minimize water entering their nose while swimming in warm freshwater. If you start seeing several patients with similar symptoms and/or etiology, consider contacting your local or state health department. It could be the beginning of an outbreak.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She has no relevant financial disclosures.
Suggested Readings
Graciaa DS et al. Outbreaks Associated with Untreated Recreational Water — United States, 2000–2014. MMWR Morb Mortal Wkly Rep. 2018 Jun 29;67(25):701-706. doi: 10.15585/mmwr.mm6725a1.
Hlavsa MC et al. Outbreaks Associated with Treated Recreational Water — United States, 2015–2019. MMWR Morb Mortal Wkly Rep. 2021;70:733–738. doi: 10.15585/mmwr.mm7020a1.
Kimberlin DW et al., eds. Red Book Report of the Committee on Infectious Diseases. 33rd ed. American Academy of Pediatrics. 2024. Cryptosporidiosis, p 338-40 and Norovirus, p 622-624.Waterborne Outbreaks Summary Reports. CDC. 2024 April 18.
Three AI Technologies Poised to Transform IBD Care
By now, it is widely accepted that artificial intelligence (AI) will reshape contemporary medicine. The question is simply when this hypothetical will become an everyday reality. For gastroenterologists involved in the management of inflammatory bowel disease (IBD), the waiting period may be ending.
AI “is the next step in clinical care,” Jacob Kurowski, MD, medical director of pediatric inflammatory bowel diseases at Cleveland Clinic Children’s in Cleveland, Ohio, said in an interview.
“In terms of technological breakthroughs, this is like going from some of the more rigid endoscopies to high-definition and white-light endoscopy or the upgrade from paper charts to the electronic medical record (EMR), but instead of making your life more difficult, it will actually make it a lot easier,” said Dr. Kurowski, who has researched and lectured on AI applications in IBD.
Simply put, “AI is when algorithms use data to simulate human intelligence,” said Seth A. Gross, MD, clinical chief in the Division of Gastroenterology and Hepatology at NYU Langone Health and a professor at NYU Grossman School of Medicine, New York City, who has studied the use of AI for polyp detection.
IBD is ideally served by AI because to diagnose and manage the disease, gastroenterologists must gather, analyze, and weave together a particularly heterogeneous mix of information — from blood tests and imaging to patient-reported symptoms and family history — often stored in different places or formats. And to ensure patient participation in their care plans, gastroenterologists also need to help them understand this complex disease.
Because of their potential to aid gastroenterologists with these tasks, three core AI technologies — some of which already have commercial applications — are likely to become foundational in clinical practice in the coming years: Image analysis and processing, natural language processing (NLP), and generative AI, according to experts familiar with AI research in IBD.
Image Analysis and Processing
One of AI’s most promising applications for IBD care is in medical image and video processing and analysis. Emerging AI tools convert the essential elements of medical images into mathematical features, which they then use to train and refine themselves. The ultimate goal is to provide fast, accurate, and granular results without inter- and intraobserver variation and human potential for bias.
Today’s techniques don’t quantify IBD very well because they’re qualitative and subjective, Ryan Stidham, MD, associate professor of gastroenterology and computational medicine and bioinformatics at the University of Michigan, Ann Arbor, and a leading researcher in AI applications in IBD, said in an interview.
“Even standardized scoring systems used by the US Food and Drug Administration and the European Medicines Agency to assess disease severity and measure therapeutic response are still pretty crude systems — not because of the gastroenterologists interpreting them, who are smart — but because it’s a very difficult task to quantify these features on imaging,” he said.
Another appeal of the technology in IBD care is that it has capabilities, including complex pattern recognition, beyond those of physicians.
“What we can’t do is things such as tediously measure every single ulcer, count how many different disease features are seen throughout the entire colon, where they are and how they’re spatially correlated, or what are their color patterns,” Dr. Stidham said. “We don’t have the time, feasibility, or, frankly, the energy and cognitive attention span to be able to do that for one patient, let alone every patient.”
AI-based disease activity assessments have yielded promising results across multiple imaging systems. The technology has advanced rapidly in the last decade and is beginning to demonstrate the ability to replicate near perfectly the endoscopic interpretation of human experts.
In separate studies, AI models had high levels of agreement with experienced reviewers on Mayo endoscopic scores and ulcerative colitis endoscopic index of severity scores, and they reduced the review time of pan-enteric capsule endoscopy among patients with suspected Crohn’s disease from a range of 26-39 minutes to 3.2 minutes per patient.
A report from the PiCaSSO study showed that an AI-guided system could distinguish remission/inflammation using histologic assessments of ulcerative colitis biopsies with an accuracy rate close to that of human reviewers.
In Crohn’s disease, research indicates that cross-sectional enterography imaging could potentially be made more precise with AI, providing hope that radiologists will be freed from this time-consuming task.
“As of today, several commercial companies are producing tools that can take an endoscopic image or a full-motion video and more or less give you a standardized score that would be akin to what an expert would give you on review of a colonoscopy,” Dr. Stidham said.
This is not to say there isn’t room for improvement.
“There’s probably still a bit of work to do when looking for the difference between inflammation and adenoma,” said Dr. Kurowski. “But it’s coming sooner rather than later.”
NLP
NLP — a subset of applied machine learning that essentially teaches computers to read — enables automated systems to go through existing digital information, including text like clinical notes, and extract, interpret, and quantify it in a fraction of the time required by clinicians.
One area this type of AI can help in IBD care is by automating EMR chart reviews. Currently, clinicians often must conduct time-consuming reviews to gather and read all the information they need to manage the care of patients with the disease.
Evidence suggests that this task takes a considerable toll. In a 2023 report, gastroenterologists cited hassles with EMRs and too much time spent at work among the main contributors to burnout.
NLP used on entire EMR systems could be used to improve overall IBD care.
“We have 30-40 years of EMRs available at our fingertips. These reams of clinical data are just sitting out there and provide a longitudinal narrative of what’s happened to every patient and the changes in their treatment course,” Dr. Stidham said.
Results from several studies involving NLP are promising. Automated chart review models enhanced with NLP have been shown to be better at identifying patients with Crohn’s disease or ulcerative colitis and at detecting and inferring the activity status of extraintestinal manifestations of IBD than models using only medical codes.
Additional examples of NLP applications that could save physicians’ time and energy in everyday practice include automatically generating clinical notes, summarizing patient interactions, and flagging important information for follow-up.
For time-strapped, overburdened clinicians, NLP may even restore the core aspects of care that first attracted them to the profession, Dr. Kurowski noted.
“It might actually be the next best step to get physicians away from the computer and back to being face to face with the patient, which I think is one of the biggest complaints of everybody in the modern EMR world in that we live in,” he said.
Generative AI
Patient education likely will be reshaped by emerging AI applications that can generate digital materials in a conversational tone. These generative AI tools, including advanced chatbots, are powered by large-language models, a type of machine learning that is trained on vast amounts of text data to understand and generate natural language.
This technology will be familiar to anyone who has interacted with OpenAI’s ChatGPT, which after getting a “prompt” — a question or request — from a user provides a conversational-sounding reply.
“Chatbots have been around for a while, but what’s new is that they now can understand and generate language that’s far more realistic,” Dr. Stidham said. “Plus, they can be trained on clinical scenarios so that it can put individual patients into context when having that digital, AI-powered conversation.”
In IBD, chatbots are being used to educate patients, for example, by answering their questions before they undergo colonoscopy. In a recent analysis, the best performer of three chatbots answered 91.4% of common precolonoscopy questions accurately. Other research determined that chatbot responses to colonoscopy questions were comparable with those provided by gastroenterologists.
Dr. Stidham and colleagues have seen the technology’s potential firsthand at the University of Michigan, where they’ve successfully deployed commercial chatbots to interact with patients prior to colonoscopy.
“It’s a force multiplier, in that these chatbots are essentially allowing us to expand our staff without bringing in more humans,” he said.
Despite fears that AI will threaten healthcare jobs, that isn’t an issue in today’s environment where “we can’t hire enough help,” Dr. Stidham said.
However, this technology isn’t fully ready for large-scale implementation, he added.
“ChatGPT may be ready for general medicine, but it’s not taking care of my gastroenterology patients (yet),” Dr. Stidham and coauthors wrote in a recent article. Among their concerns was the inability of ChatGPT versions 3 and 4 to pass the American College of Gastroenterology’s self-assessment test.
Preparing for the Future of AI
One proactive step is engaging with professional societies and initiatives aimed at guiding AI implementation.
One such initiative is the American Society for Gastrointestinal Endoscopy’s AI Task Force, which is led by Dr. Gross.
“The AI Task Force, which has recently evolved into an AI institute, believes in responsible AI,” Dr. Gross said. “The group highlights the importance of transparency and partnership with all key stakeholders to ensure that AI development and integration deliver improved care to GI patients.”
Dr. Kurowski, for one, believes that as AI gets even better at quantifying patient data, it will usher in the long-sought era of personalized care.
“I think it actually moves us into the realm of talking about a cure for certain people with IBD, for certain subtypes of the disease,” he said. “AI is going to be much more your friend and less of your foe than anything else you’ve seen in the modern era of medicine.”
A version of this article first appeared on Medscape.com.
By now, it is widely accepted that artificial intelligence (AI) will reshape contemporary medicine. The question is simply when this hypothetical will become an everyday reality. For gastroenterologists involved in the management of inflammatory bowel disease (IBD), the waiting period may be ending.
AI “is the next step in clinical care,” Jacob Kurowski, MD, medical director of pediatric inflammatory bowel diseases at Cleveland Clinic Children’s in Cleveland, Ohio, said in an interview.
“In terms of technological breakthroughs, this is like going from some of the more rigid endoscopies to high-definition and white-light endoscopy or the upgrade from paper charts to the electronic medical record (EMR), but instead of making your life more difficult, it will actually make it a lot easier,” said Dr. Kurowski, who has researched and lectured on AI applications in IBD.
Simply put, “AI is when algorithms use data to simulate human intelligence,” said Seth A. Gross, MD, clinical chief in the Division of Gastroenterology and Hepatology at NYU Langone Health and a professor at NYU Grossman School of Medicine, New York City, who has studied the use of AI for polyp detection.
IBD is ideally served by AI because to diagnose and manage the disease, gastroenterologists must gather, analyze, and weave together a particularly heterogeneous mix of information — from blood tests and imaging to patient-reported symptoms and family history — often stored in different places or formats. And to ensure patient participation in their care plans, gastroenterologists also need to help them understand this complex disease.
Because of their potential to aid gastroenterologists with these tasks, three core AI technologies — some of which already have commercial applications — are likely to become foundational in clinical practice in the coming years: Image analysis and processing, natural language processing (NLP), and generative AI, according to experts familiar with AI research in IBD.
Image Analysis and Processing
One of AI’s most promising applications for IBD care is in medical image and video processing and analysis. Emerging AI tools convert the essential elements of medical images into mathematical features, which they then use to train and refine themselves. The ultimate goal is to provide fast, accurate, and granular results without inter- and intraobserver variation and human potential for bias.
Today’s techniques don’t quantify IBD very well because they’re qualitative and subjective, Ryan Stidham, MD, associate professor of gastroenterology and computational medicine and bioinformatics at the University of Michigan, Ann Arbor, and a leading researcher in AI applications in IBD, said in an interview.
“Even standardized scoring systems used by the US Food and Drug Administration and the European Medicines Agency to assess disease severity and measure therapeutic response are still pretty crude systems — not because of the gastroenterologists interpreting them, who are smart — but because it’s a very difficult task to quantify these features on imaging,” he said.
Another appeal of the technology in IBD care is that it has capabilities, including complex pattern recognition, beyond those of physicians.
“What we can’t do is things such as tediously measure every single ulcer, count how many different disease features are seen throughout the entire colon, where they are and how they’re spatially correlated, or what are their color patterns,” Dr. Stidham said. “We don’t have the time, feasibility, or, frankly, the energy and cognitive attention span to be able to do that for one patient, let alone every patient.”
AI-based disease activity assessments have yielded promising results across multiple imaging systems. The technology has advanced rapidly in the last decade and is beginning to demonstrate the ability to replicate near perfectly the endoscopic interpretation of human experts.
In separate studies, AI models had high levels of agreement with experienced reviewers on Mayo endoscopic scores and ulcerative colitis endoscopic index of severity scores, and they reduced the review time of pan-enteric capsule endoscopy among patients with suspected Crohn’s disease from a range of 26-39 minutes to 3.2 minutes per patient.
A report from the PiCaSSO study showed that an AI-guided system could distinguish remission/inflammation using histologic assessments of ulcerative colitis biopsies with an accuracy rate close to that of human reviewers.
In Crohn’s disease, research indicates that cross-sectional enterography imaging could potentially be made more precise with AI, providing hope that radiologists will be freed from this time-consuming task.
“As of today, several commercial companies are producing tools that can take an endoscopic image or a full-motion video and more or less give you a standardized score that would be akin to what an expert would give you on review of a colonoscopy,” Dr. Stidham said.
This is not to say there isn’t room for improvement.
“There’s probably still a bit of work to do when looking for the difference between inflammation and adenoma,” said Dr. Kurowski. “But it’s coming sooner rather than later.”
NLP
NLP — a subset of applied machine learning that essentially teaches computers to read — enables automated systems to go through existing digital information, including text like clinical notes, and extract, interpret, and quantify it in a fraction of the time required by clinicians.
One area this type of AI can help in IBD care is by automating EMR chart reviews. Currently, clinicians often must conduct time-consuming reviews to gather and read all the information they need to manage the care of patients with the disease.
Evidence suggests that this task takes a considerable toll. In a 2023 report, gastroenterologists cited hassles with EMRs and too much time spent at work among the main contributors to burnout.
NLP used on entire EMR systems could be used to improve overall IBD care.
“We have 30-40 years of EMRs available at our fingertips. These reams of clinical data are just sitting out there and provide a longitudinal narrative of what’s happened to every patient and the changes in their treatment course,” Dr. Stidham said.
Results from several studies involving NLP are promising. Automated chart review models enhanced with NLP have been shown to be better at identifying patients with Crohn’s disease or ulcerative colitis and at detecting and inferring the activity status of extraintestinal manifestations of IBD than models using only medical codes.
Additional examples of NLP applications that could save physicians’ time and energy in everyday practice include automatically generating clinical notes, summarizing patient interactions, and flagging important information for follow-up.
For time-strapped, overburdened clinicians, NLP may even restore the core aspects of care that first attracted them to the profession, Dr. Kurowski noted.
“It might actually be the next best step to get physicians away from the computer and back to being face to face with the patient, which I think is one of the biggest complaints of everybody in the modern EMR world in that we live in,” he said.
Generative AI
Patient education likely will be reshaped by emerging AI applications that can generate digital materials in a conversational tone. These generative AI tools, including advanced chatbots, are powered by large-language models, a type of machine learning that is trained on vast amounts of text data to understand and generate natural language.
This technology will be familiar to anyone who has interacted with OpenAI’s ChatGPT, which after getting a “prompt” — a question or request — from a user provides a conversational-sounding reply.
“Chatbots have been around for a while, but what’s new is that they now can understand and generate language that’s far more realistic,” Dr. Stidham said. “Plus, they can be trained on clinical scenarios so that it can put individual patients into context when having that digital, AI-powered conversation.”
In IBD, chatbots are being used to educate patients, for example, by answering their questions before they undergo colonoscopy. In a recent analysis, the best performer of three chatbots answered 91.4% of common precolonoscopy questions accurately. Other research determined that chatbot responses to colonoscopy questions were comparable with those provided by gastroenterologists.
Dr. Stidham and colleagues have seen the technology’s potential firsthand at the University of Michigan, where they’ve successfully deployed commercial chatbots to interact with patients prior to colonoscopy.
“It’s a force multiplier, in that these chatbots are essentially allowing us to expand our staff without bringing in more humans,” he said.
Despite fears that AI will threaten healthcare jobs, that isn’t an issue in today’s environment where “we can’t hire enough help,” Dr. Stidham said.
However, this technology isn’t fully ready for large-scale implementation, he added.
“ChatGPT may be ready for general medicine, but it’s not taking care of my gastroenterology patients (yet),” Dr. Stidham and coauthors wrote in a recent article. Among their concerns was the inability of ChatGPT versions 3 and 4 to pass the American College of Gastroenterology’s self-assessment test.
Preparing for the Future of AI
One proactive step is engaging with professional societies and initiatives aimed at guiding AI implementation.
One such initiative is the American Society for Gastrointestinal Endoscopy’s AI Task Force, which is led by Dr. Gross.
“The AI Task Force, which has recently evolved into an AI institute, believes in responsible AI,” Dr. Gross said. “The group highlights the importance of transparency and partnership with all key stakeholders to ensure that AI development and integration deliver improved care to GI patients.”
Dr. Kurowski, for one, believes that as AI gets even better at quantifying patient data, it will usher in the long-sought era of personalized care.
“I think it actually moves us into the realm of talking about a cure for certain people with IBD, for certain subtypes of the disease,” he said. “AI is going to be much more your friend and less of your foe than anything else you’ve seen in the modern era of medicine.”
A version of this article first appeared on Medscape.com.
By now, it is widely accepted that artificial intelligence (AI) will reshape contemporary medicine. The question is simply when this hypothetical will become an everyday reality. For gastroenterologists involved in the management of inflammatory bowel disease (IBD), the waiting period may be ending.
AI “is the next step in clinical care,” Jacob Kurowski, MD, medical director of pediatric inflammatory bowel diseases at Cleveland Clinic Children’s in Cleveland, Ohio, said in an interview.
“In terms of technological breakthroughs, this is like going from some of the more rigid endoscopies to high-definition and white-light endoscopy or the upgrade from paper charts to the electronic medical record (EMR), but instead of making your life more difficult, it will actually make it a lot easier,” said Dr. Kurowski, who has researched and lectured on AI applications in IBD.
Simply put, “AI is when algorithms use data to simulate human intelligence,” said Seth A. Gross, MD, clinical chief in the Division of Gastroenterology and Hepatology at NYU Langone Health and a professor at NYU Grossman School of Medicine, New York City, who has studied the use of AI for polyp detection.
IBD is ideally served by AI because to diagnose and manage the disease, gastroenterologists must gather, analyze, and weave together a particularly heterogeneous mix of information — from blood tests and imaging to patient-reported symptoms and family history — often stored in different places or formats. And to ensure patient participation in their care plans, gastroenterologists also need to help them understand this complex disease.
Because of their potential to aid gastroenterologists with these tasks, three core AI technologies — some of which already have commercial applications — are likely to become foundational in clinical practice in the coming years: Image analysis and processing, natural language processing (NLP), and generative AI, according to experts familiar with AI research in IBD.
Image Analysis and Processing
One of AI’s most promising applications for IBD care is in medical image and video processing and analysis. Emerging AI tools convert the essential elements of medical images into mathematical features, which they then use to train and refine themselves. The ultimate goal is to provide fast, accurate, and granular results without inter- and intraobserver variation and human potential for bias.
Today’s techniques don’t quantify IBD very well because they’re qualitative and subjective, Ryan Stidham, MD, associate professor of gastroenterology and computational medicine and bioinformatics at the University of Michigan, Ann Arbor, and a leading researcher in AI applications in IBD, said in an interview.
“Even standardized scoring systems used by the US Food and Drug Administration and the European Medicines Agency to assess disease severity and measure therapeutic response are still pretty crude systems — not because of the gastroenterologists interpreting them, who are smart — but because it’s a very difficult task to quantify these features on imaging,” he said.
Another appeal of the technology in IBD care is that it has capabilities, including complex pattern recognition, beyond those of physicians.
“What we can’t do is things such as tediously measure every single ulcer, count how many different disease features are seen throughout the entire colon, where they are and how they’re spatially correlated, or what are their color patterns,” Dr. Stidham said. “We don’t have the time, feasibility, or, frankly, the energy and cognitive attention span to be able to do that for one patient, let alone every patient.”
AI-based disease activity assessments have yielded promising results across multiple imaging systems. The technology has advanced rapidly in the last decade and is beginning to demonstrate the ability to replicate near perfectly the endoscopic interpretation of human experts.
In separate studies, AI models had high levels of agreement with experienced reviewers on Mayo endoscopic scores and ulcerative colitis endoscopic index of severity scores, and they reduced the review time of pan-enteric capsule endoscopy among patients with suspected Crohn’s disease from a range of 26-39 minutes to 3.2 minutes per patient.
A report from the PiCaSSO study showed that an AI-guided system could distinguish remission/inflammation using histologic assessments of ulcerative colitis biopsies with an accuracy rate close to that of human reviewers.
In Crohn’s disease, research indicates that cross-sectional enterography imaging could potentially be made more precise with AI, providing hope that radiologists will be freed from this time-consuming task.
“As of today, several commercial companies are producing tools that can take an endoscopic image or a full-motion video and more or less give you a standardized score that would be akin to what an expert would give you on review of a colonoscopy,” Dr. Stidham said.
This is not to say there isn’t room for improvement.
“There’s probably still a bit of work to do when looking for the difference between inflammation and adenoma,” said Dr. Kurowski. “But it’s coming sooner rather than later.”
NLP
NLP — a subset of applied machine learning that essentially teaches computers to read — enables automated systems to go through existing digital information, including text like clinical notes, and extract, interpret, and quantify it in a fraction of the time required by clinicians.
One area this type of AI can help in IBD care is by automating EMR chart reviews. Currently, clinicians often must conduct time-consuming reviews to gather and read all the information they need to manage the care of patients with the disease.
Evidence suggests that this task takes a considerable toll. In a 2023 report, gastroenterologists cited hassles with EMRs and too much time spent at work among the main contributors to burnout.
NLP used on entire EMR systems could be used to improve overall IBD care.
“We have 30-40 years of EMRs available at our fingertips. These reams of clinical data are just sitting out there and provide a longitudinal narrative of what’s happened to every patient and the changes in their treatment course,” Dr. Stidham said.
Results from several studies involving NLP are promising. Automated chart review models enhanced with NLP have been shown to be better at identifying patients with Crohn’s disease or ulcerative colitis and at detecting and inferring the activity status of extraintestinal manifestations of IBD than models using only medical codes.
Additional examples of NLP applications that could save physicians’ time and energy in everyday practice include automatically generating clinical notes, summarizing patient interactions, and flagging important information for follow-up.
For time-strapped, overburdened clinicians, NLP may even restore the core aspects of care that first attracted them to the profession, Dr. Kurowski noted.
“It might actually be the next best step to get physicians away from the computer and back to being face to face with the patient, which I think is one of the biggest complaints of everybody in the modern EMR world in that we live in,” he said.
Generative AI
Patient education likely will be reshaped by emerging AI applications that can generate digital materials in a conversational tone. These generative AI tools, including advanced chatbots, are powered by large-language models, a type of machine learning that is trained on vast amounts of text data to understand and generate natural language.
This technology will be familiar to anyone who has interacted with OpenAI’s ChatGPT, which after getting a “prompt” — a question or request — from a user provides a conversational-sounding reply.
“Chatbots have been around for a while, but what’s new is that they now can understand and generate language that’s far more realistic,” Dr. Stidham said. “Plus, they can be trained on clinical scenarios so that it can put individual patients into context when having that digital, AI-powered conversation.”
In IBD, chatbots are being used to educate patients, for example, by answering their questions before they undergo colonoscopy. In a recent analysis, the best performer of three chatbots answered 91.4% of common precolonoscopy questions accurately. Other research determined that chatbot responses to colonoscopy questions were comparable with those provided by gastroenterologists.
Dr. Stidham and colleagues have seen the technology’s potential firsthand at the University of Michigan, where they’ve successfully deployed commercial chatbots to interact with patients prior to colonoscopy.
“It’s a force multiplier, in that these chatbots are essentially allowing us to expand our staff without bringing in more humans,” he said.
Despite fears that AI will threaten healthcare jobs, that isn’t an issue in today’s environment where “we can’t hire enough help,” Dr. Stidham said.
However, this technology isn’t fully ready for large-scale implementation, he added.
“ChatGPT may be ready for general medicine, but it’s not taking care of my gastroenterology patients (yet),” Dr. Stidham and coauthors wrote in a recent article. Among their concerns was the inability of ChatGPT versions 3 and 4 to pass the American College of Gastroenterology’s self-assessment test.
Preparing for the Future of AI
One proactive step is engaging with professional societies and initiatives aimed at guiding AI implementation.
One such initiative is the American Society for Gastrointestinal Endoscopy’s AI Task Force, which is led by Dr. Gross.
“The AI Task Force, which has recently evolved into an AI institute, believes in responsible AI,” Dr. Gross said. “The group highlights the importance of transparency and partnership with all key stakeholders to ensure that AI development and integration deliver improved care to GI patients.”
Dr. Kurowski, for one, believes that as AI gets even better at quantifying patient data, it will usher in the long-sought era of personalized care.
“I think it actually moves us into the realm of talking about a cure for certain people with IBD, for certain subtypes of the disease,” he said. “AI is going to be much more your friend and less of your foe than anything else you’ve seen in the modern era of medicine.”
A version of this article first appeared on Medscape.com.
A Fitbit for the Gut May Aid in Detection of GI Disorders
, new research revealed.
Traditional methods for locating, measuring, and monitoring gasses associated with such disorders as irritable bowel syndrome, inflammatory bowel disease, food intolerances, and gastric cancers are often invasive and typically require hospital-based procedures.
This experimental system, developed by a team at the University of Southern California’s Viterbi School of Engineering, Los Angeles, represents “a significant step forward in ingestible technology,” according to principal investigator Yasser Khan, PhD, and colleagues.
The novel ingestible could someday serve as a “Fitbit for the gut” and aid in early disease detection, Dr. Khan said.
The team’s work was published online in Cell Reports Physical Science.
Real-Time Tracking
While wearables with sensors are a promising way to monitor body functions, the ability to track ingestible devices once they are inside the body has been limited.
To solve this problem, the researchers developed a system that includes a wearable coil (placed on a T-shirt for this study) and an ingestible pill with a 3D-printed shell made from a biocompatible resin.
The pill is equipped with a gas-permeable membrane, an optical gas-sensing membrane, an optical filter, and a printed circuit board that houses its electronic components. The gas sensor can detect oxygen in the 0%-20% range and ammonia in the 0-100 ppm concentration range.
The researchers developed various algorithms and conducted experiments to test the system’s ability to decode the pill’s location in a human gut model and in an ex vivo animal intestine. To simulate the in vivo environment, they tested the system in an agar phantom solution, which enabled them to track the pill’s movement.
So, how does it work?
Simply put, once the patient ingests the pill, a phone application connects to the pill over Bluetooth and sends a command to initiate the target gas and magnetic field measurements.
Next, the wearable coil generates a magnetic field, which is captured by a magnetic sensor on the pill, enabling the pill’s location to be decoded in real time.
Then, using optical absorption spectroscopy with a light-emitting diode, a photodiode, and the pill’s gas-sensing membrane, gasses such as oxygen and ammonia can be measured and mapped in 3D while the pill is in the gut.
Notably, elevated levels of ammonia, which is produced by Helicobacter pylori, could serve as a signal for peptic ulcers, gastric cancer, or irritable bowel syndrome, Dr. Khan said.
“The ingestible system with the wearable coil is both compact and practical, offering a clear path for application in human health,” he said. The work also could “empower patients to conveniently assess their GI gas profiles from home and manage their digestive health.”
The next step is to test the wearable in animal models to assess, among other factors, whether the gas-sensing system “will operate properly in biological tissue and whether clogging or coating with GI liquids and food particles causes sensor fouling and affects the measurement accuracy,” Dr. Khan and colleagues noted.
Dr. Khan acknowledges support from USC Viterbi School of Engineering. A provisional patent application has been filed based on the technology described in this work. During the preparation of this work, the authors used ChatGPT to check for grammatical errors in the writing. After using this tool, the authors reviewed and edited the content as needed and take full responsibility for the content of the publication.
A version of this article first appeared on Medscape.com.
, new research revealed.
Traditional methods for locating, measuring, and monitoring gasses associated with such disorders as irritable bowel syndrome, inflammatory bowel disease, food intolerances, and gastric cancers are often invasive and typically require hospital-based procedures.
This experimental system, developed by a team at the University of Southern California’s Viterbi School of Engineering, Los Angeles, represents “a significant step forward in ingestible technology,” according to principal investigator Yasser Khan, PhD, and colleagues.
The novel ingestible could someday serve as a “Fitbit for the gut” and aid in early disease detection, Dr. Khan said.
The team’s work was published online in Cell Reports Physical Science.
Real-Time Tracking
While wearables with sensors are a promising way to monitor body functions, the ability to track ingestible devices once they are inside the body has been limited.
To solve this problem, the researchers developed a system that includes a wearable coil (placed on a T-shirt for this study) and an ingestible pill with a 3D-printed shell made from a biocompatible resin.
The pill is equipped with a gas-permeable membrane, an optical gas-sensing membrane, an optical filter, and a printed circuit board that houses its electronic components. The gas sensor can detect oxygen in the 0%-20% range and ammonia in the 0-100 ppm concentration range.
The researchers developed various algorithms and conducted experiments to test the system’s ability to decode the pill’s location in a human gut model and in an ex vivo animal intestine. To simulate the in vivo environment, they tested the system in an agar phantom solution, which enabled them to track the pill’s movement.
So, how does it work?
Simply put, once the patient ingests the pill, a phone application connects to the pill over Bluetooth and sends a command to initiate the target gas and magnetic field measurements.
Next, the wearable coil generates a magnetic field, which is captured by a magnetic sensor on the pill, enabling the pill’s location to be decoded in real time.
Then, using optical absorption spectroscopy with a light-emitting diode, a photodiode, and the pill’s gas-sensing membrane, gasses such as oxygen and ammonia can be measured and mapped in 3D while the pill is in the gut.
Notably, elevated levels of ammonia, which is produced by Helicobacter pylori, could serve as a signal for peptic ulcers, gastric cancer, or irritable bowel syndrome, Dr. Khan said.
“The ingestible system with the wearable coil is both compact and practical, offering a clear path for application in human health,” he said. The work also could “empower patients to conveniently assess their GI gas profiles from home and manage their digestive health.”
The next step is to test the wearable in animal models to assess, among other factors, whether the gas-sensing system “will operate properly in biological tissue and whether clogging or coating with GI liquids and food particles causes sensor fouling and affects the measurement accuracy,” Dr. Khan and colleagues noted.
Dr. Khan acknowledges support from USC Viterbi School of Engineering. A provisional patent application has been filed based on the technology described in this work. During the preparation of this work, the authors used ChatGPT to check for grammatical errors in the writing. After using this tool, the authors reviewed and edited the content as needed and take full responsibility for the content of the publication.
A version of this article first appeared on Medscape.com.
, new research revealed.
Traditional methods for locating, measuring, and monitoring gasses associated with such disorders as irritable bowel syndrome, inflammatory bowel disease, food intolerances, and gastric cancers are often invasive and typically require hospital-based procedures.
This experimental system, developed by a team at the University of Southern California’s Viterbi School of Engineering, Los Angeles, represents “a significant step forward in ingestible technology,” according to principal investigator Yasser Khan, PhD, and colleagues.
The novel ingestible could someday serve as a “Fitbit for the gut” and aid in early disease detection, Dr. Khan said.
The team’s work was published online in Cell Reports Physical Science.
Real-Time Tracking
While wearables with sensors are a promising way to monitor body functions, the ability to track ingestible devices once they are inside the body has been limited.
To solve this problem, the researchers developed a system that includes a wearable coil (placed on a T-shirt for this study) and an ingestible pill with a 3D-printed shell made from a biocompatible resin.
The pill is equipped with a gas-permeable membrane, an optical gas-sensing membrane, an optical filter, and a printed circuit board that houses its electronic components. The gas sensor can detect oxygen in the 0%-20% range and ammonia in the 0-100 ppm concentration range.
The researchers developed various algorithms and conducted experiments to test the system’s ability to decode the pill’s location in a human gut model and in an ex vivo animal intestine. To simulate the in vivo environment, they tested the system in an agar phantom solution, which enabled them to track the pill’s movement.
So, how does it work?
Simply put, once the patient ingests the pill, a phone application connects to the pill over Bluetooth and sends a command to initiate the target gas and magnetic field measurements.
Next, the wearable coil generates a magnetic field, which is captured by a magnetic sensor on the pill, enabling the pill’s location to be decoded in real time.
Then, using optical absorption spectroscopy with a light-emitting diode, a photodiode, and the pill’s gas-sensing membrane, gasses such as oxygen and ammonia can be measured and mapped in 3D while the pill is in the gut.
Notably, elevated levels of ammonia, which is produced by Helicobacter pylori, could serve as a signal for peptic ulcers, gastric cancer, or irritable bowel syndrome, Dr. Khan said.
“The ingestible system with the wearable coil is both compact and practical, offering a clear path for application in human health,” he said. The work also could “empower patients to conveniently assess their GI gas profiles from home and manage their digestive health.”
The next step is to test the wearable in animal models to assess, among other factors, whether the gas-sensing system “will operate properly in biological tissue and whether clogging or coating with GI liquids and food particles causes sensor fouling and affects the measurement accuracy,” Dr. Khan and colleagues noted.
Dr. Khan acknowledges support from USC Viterbi School of Engineering. A provisional patent application has been filed based on the technology described in this work. During the preparation of this work, the authors used ChatGPT to check for grammatical errors in the writing. After using this tool, the authors reviewed and edited the content as needed and take full responsibility for the content of the publication.
A version of this article first appeared on Medscape.com.
FROM CELL REPORTS PHYSICAL SCIENCE
Few Women Know Uterine Fibroid Risk, Treatment Options
Most women (72%) are not aware they are at risk for developing uterine fibroids, though up to 77% of women will develop them in their lifetime, results of a new survey indicate.
Data from The Harris Poll, conducted on behalf of the Society of Interventional Radiology, also found that 17% of women mistakenly think a hysterectomy is the only treatment option, including more than one in four women (27%) who are between the ages of 18 and 34. Results were shared in a press release. The survey included 1,122 US women, some who have been diagnosed with uterine fibroids.
Fibroids may not cause symptoms for some, but some women may have heavy, prolonged, debilitating bleeding. Some women experience pelvic pain, a diminished sex life, and declining energy. However, the growths do not spread to other body regions and typically are not dangerous.
Hysterectomy Is Only One Option
Among the women in the survey who had been diagnosed with fibroids, 53% were presented the option of hysterectomy and 20% were told about other, less-invasive options, including over-the-counter NSAIDs (19%); uterine fibroid embolization (UFE) (17%); oral contraceptives (17%); and endometrial ablation (17%).
“Women need to be informed about the complete range of options available for treating their uterine fibroids, not just the surgical options as is most commonly done by gynecologists,” John C. Lipman, MD, founder and medical director of the Atlanta Fibroid Center in Smyrna, Georgia, said in the press release.
The survey also found that:
- More than half of women ages 18-34 (56%) and women ages 35-44 (51%) were either not familiar with uterine fibroids or never heard of them.
- Awareness was particularly low among Hispanic women, as 50% of Hispanic women say they’ve never heard of or aren’t familiar with the condition, compared with 37% of Black women who answered that way.
- More than one third (36%) of Black women and 22% of Hispanic women mistakenly think they are not at risk for developing fibroids, yet research has shown that uterine fibroids are three times more common in Black women and two times more common in Hispanic women than in White women.
For this study, the full sample data is accurate to within +/– 3.2 percentage points using a 95% confidence level. The data are part of the report “The Fibroid Fix: What Women Need to Know,” published on July 9 by the Society of Interventional Radiology.
Linda Fan, MD, chief of gynecology at Yale University in New Haven, Connecticut, said she is not surprised by those numbers. She says many patients are referred to her department who have not been given the full array of medical options for their fibroids or have not had thorough discussions with their providers, such as whether they want to preserve their fertility, or how they feel about an incision, undergoing anesthesia, or having their uterus removed.
Sometimes the hysterectomy choice is clear, she said — for instance, if there are indications of the rare cancer leiomyosarcoma, or if a postmenopausal woman has rapid growth of fibroids or heavy bleeding. Fibroids should not start growing after menopause, she said.
Additional options include radiofrequency ablation, performed while a patient is under anesthesia, by laparoscopy or hysteroscopy. The procedure uses ultrasound to watch a probe as it shrinks the fibroids with heat.
Currently, if a woman wants large fibroids removed and wants to keep her fertility options open, Dr. Fan says, myomectomy or medication are best “because we have the most information or data on (those options).”
When treating patients who don’t prioritize fertility, she said, UFE is a good option that doesn’t need incisions or anesthesia. But patients sometimes require a lot of pain medication afterward, Dr. Fan said. With radiofrequency ablation, specifically the Acessa and Sonata procedures, she said, “patients don’t experience a lot of pain after the procedure because the shrinking happens when they’re asleep under anesthesia.”
Uterine Fibroid Embolization a Nonsurgical Option
The report describes how UFE works but the Harris Poll showed that 60% of women who have heard of UFE did not hear about it first from a healthcare provider.
“UFE is a nonsurgical treatment, performed by interventional radiologists, that has been proven to significantly reduce heavy menstrual bleeding, relieve uterine pain, and improve energy levels,” the authors write. “Through a tiny incision in the wrist or thigh, a catheter is guided via imaging to the vessels leading to the fibroids. Through this catheter, small clear particles are injected to block the blood flow leading to the fibroids causing them to shrink and disappear.”
After UFE, most women leave the hospital the day of or the day after treatment, according to the report authors, who add that many patients also report they can resume normal activity in about 2 weeks, more quickly than with surgical treatments.
In some cases, watchful waiting will be the best option, the report notes, and that may require repeated checkups and scans.
Dr. Lipman is an adviser on The Fibroid Fix report.
Most women (72%) are not aware they are at risk for developing uterine fibroids, though up to 77% of women will develop them in their lifetime, results of a new survey indicate.
Data from The Harris Poll, conducted on behalf of the Society of Interventional Radiology, also found that 17% of women mistakenly think a hysterectomy is the only treatment option, including more than one in four women (27%) who are between the ages of 18 and 34. Results were shared in a press release. The survey included 1,122 US women, some who have been diagnosed with uterine fibroids.
Fibroids may not cause symptoms for some, but some women may have heavy, prolonged, debilitating bleeding. Some women experience pelvic pain, a diminished sex life, and declining energy. However, the growths do not spread to other body regions and typically are not dangerous.
Hysterectomy Is Only One Option
Among the women in the survey who had been diagnosed with fibroids, 53% were presented the option of hysterectomy and 20% were told about other, less-invasive options, including over-the-counter NSAIDs (19%); uterine fibroid embolization (UFE) (17%); oral contraceptives (17%); and endometrial ablation (17%).
“Women need to be informed about the complete range of options available for treating their uterine fibroids, not just the surgical options as is most commonly done by gynecologists,” John C. Lipman, MD, founder and medical director of the Atlanta Fibroid Center in Smyrna, Georgia, said in the press release.
The survey also found that:
- More than half of women ages 18-34 (56%) and women ages 35-44 (51%) were either not familiar with uterine fibroids or never heard of them.
- Awareness was particularly low among Hispanic women, as 50% of Hispanic women say they’ve never heard of or aren’t familiar with the condition, compared with 37% of Black women who answered that way.
- More than one third (36%) of Black women and 22% of Hispanic women mistakenly think they are not at risk for developing fibroids, yet research has shown that uterine fibroids are three times more common in Black women and two times more common in Hispanic women than in White women.
For this study, the full sample data is accurate to within +/– 3.2 percentage points using a 95% confidence level. The data are part of the report “The Fibroid Fix: What Women Need to Know,” published on July 9 by the Society of Interventional Radiology.
Linda Fan, MD, chief of gynecology at Yale University in New Haven, Connecticut, said she is not surprised by those numbers. She says many patients are referred to her department who have not been given the full array of medical options for their fibroids or have not had thorough discussions with their providers, such as whether they want to preserve their fertility, or how they feel about an incision, undergoing anesthesia, or having their uterus removed.
Sometimes the hysterectomy choice is clear, she said — for instance, if there are indications of the rare cancer leiomyosarcoma, or if a postmenopausal woman has rapid growth of fibroids or heavy bleeding. Fibroids should not start growing after menopause, she said.
Additional options include radiofrequency ablation, performed while a patient is under anesthesia, by laparoscopy or hysteroscopy. The procedure uses ultrasound to watch a probe as it shrinks the fibroids with heat.
Currently, if a woman wants large fibroids removed and wants to keep her fertility options open, Dr. Fan says, myomectomy or medication are best “because we have the most information or data on (those options).”
When treating patients who don’t prioritize fertility, she said, UFE is a good option that doesn’t need incisions or anesthesia. But patients sometimes require a lot of pain medication afterward, Dr. Fan said. With radiofrequency ablation, specifically the Acessa and Sonata procedures, she said, “patients don’t experience a lot of pain after the procedure because the shrinking happens when they’re asleep under anesthesia.”
Uterine Fibroid Embolization a Nonsurgical Option
The report describes how UFE works but the Harris Poll showed that 60% of women who have heard of UFE did not hear about it first from a healthcare provider.
“UFE is a nonsurgical treatment, performed by interventional radiologists, that has been proven to significantly reduce heavy menstrual bleeding, relieve uterine pain, and improve energy levels,” the authors write. “Through a tiny incision in the wrist or thigh, a catheter is guided via imaging to the vessels leading to the fibroids. Through this catheter, small clear particles are injected to block the blood flow leading to the fibroids causing them to shrink and disappear.”
After UFE, most women leave the hospital the day of or the day after treatment, according to the report authors, who add that many patients also report they can resume normal activity in about 2 weeks, more quickly than with surgical treatments.
In some cases, watchful waiting will be the best option, the report notes, and that may require repeated checkups and scans.
Dr. Lipman is an adviser on The Fibroid Fix report.
Most women (72%) are not aware they are at risk for developing uterine fibroids, though up to 77% of women will develop them in their lifetime, results of a new survey indicate.
Data from The Harris Poll, conducted on behalf of the Society of Interventional Radiology, also found that 17% of women mistakenly think a hysterectomy is the only treatment option, including more than one in four women (27%) who are between the ages of 18 and 34. Results were shared in a press release. The survey included 1,122 US women, some who have been diagnosed with uterine fibroids.
Fibroids may not cause symptoms for some, but some women may have heavy, prolonged, debilitating bleeding. Some women experience pelvic pain, a diminished sex life, and declining energy. However, the growths do not spread to other body regions and typically are not dangerous.
Hysterectomy Is Only One Option
Among the women in the survey who had been diagnosed with fibroids, 53% were presented the option of hysterectomy and 20% were told about other, less-invasive options, including over-the-counter NSAIDs (19%); uterine fibroid embolization (UFE) (17%); oral contraceptives (17%); and endometrial ablation (17%).
“Women need to be informed about the complete range of options available for treating their uterine fibroids, not just the surgical options as is most commonly done by gynecologists,” John C. Lipman, MD, founder and medical director of the Atlanta Fibroid Center in Smyrna, Georgia, said in the press release.
The survey also found that:
- More than half of women ages 18-34 (56%) and women ages 35-44 (51%) were either not familiar with uterine fibroids or never heard of them.
- Awareness was particularly low among Hispanic women, as 50% of Hispanic women say they’ve never heard of or aren’t familiar with the condition, compared with 37% of Black women who answered that way.
- More than one third (36%) of Black women and 22% of Hispanic women mistakenly think they are not at risk for developing fibroids, yet research has shown that uterine fibroids are three times more common in Black women and two times more common in Hispanic women than in White women.
For this study, the full sample data is accurate to within +/– 3.2 percentage points using a 95% confidence level. The data are part of the report “The Fibroid Fix: What Women Need to Know,” published on July 9 by the Society of Interventional Radiology.
Linda Fan, MD, chief of gynecology at Yale University in New Haven, Connecticut, said she is not surprised by those numbers. She says many patients are referred to her department who have not been given the full array of medical options for their fibroids or have not had thorough discussions with their providers, such as whether they want to preserve their fertility, or how they feel about an incision, undergoing anesthesia, or having their uterus removed.
Sometimes the hysterectomy choice is clear, she said — for instance, if there are indications of the rare cancer leiomyosarcoma, or if a postmenopausal woman has rapid growth of fibroids or heavy bleeding. Fibroids should not start growing after menopause, she said.
Additional options include radiofrequency ablation, performed while a patient is under anesthesia, by laparoscopy or hysteroscopy. The procedure uses ultrasound to watch a probe as it shrinks the fibroids with heat.
Currently, if a woman wants large fibroids removed and wants to keep her fertility options open, Dr. Fan says, myomectomy or medication are best “because we have the most information or data on (those options).”
When treating patients who don’t prioritize fertility, she said, UFE is a good option that doesn’t need incisions or anesthesia. But patients sometimes require a lot of pain medication afterward, Dr. Fan said. With radiofrequency ablation, specifically the Acessa and Sonata procedures, she said, “patients don’t experience a lot of pain after the procedure because the shrinking happens when they’re asleep under anesthesia.”
Uterine Fibroid Embolization a Nonsurgical Option
The report describes how UFE works but the Harris Poll showed that 60% of women who have heard of UFE did not hear about it first from a healthcare provider.
“UFE is a nonsurgical treatment, performed by interventional radiologists, that has been proven to significantly reduce heavy menstrual bleeding, relieve uterine pain, and improve energy levels,” the authors write. “Through a tiny incision in the wrist or thigh, a catheter is guided via imaging to the vessels leading to the fibroids. Through this catheter, small clear particles are injected to block the blood flow leading to the fibroids causing them to shrink and disappear.”
After UFE, most women leave the hospital the day of or the day after treatment, according to the report authors, who add that many patients also report they can resume normal activity in about 2 weeks, more quickly than with surgical treatments.
In some cases, watchful waiting will be the best option, the report notes, and that may require repeated checkups and scans.
Dr. Lipman is an adviser on The Fibroid Fix report.
Expanding Use of GLP-1 RAs for Weight Management
To discuss issues related to counseling patients about weight loss with glucagon-like peptide 1 receptor agonists (GLP-1 RAs), I recently posted a case from my own practice. This was a 44-year-old woman with hyperlipidemia, hypertension, and obesity who wanted to try to lose weight with a GLP-1 RA, having been unsuccessful in maintaining a normal weight with lifestyle change alone.
I am very happy to see a high number of favorable responses to this article, and I also recognize that it was very focused on GLP-1 RA therapy while not addressing the multivariate treatment of obesity.
A healthy lifestyle remains foundational for the management of obesity, and clinicians should guide patients to make constructive choices regarding their diet, physical activity, mental health, and sleep. However, like for our patient introduced in that article, lifestyle changes are rarely sufficient to obtain a goal of sustained weight loss that promotes better health outcomes. A meta-analysis of clinical trials testing lifestyle interventions to lose weight among adults with overweight and obesity found that the relative reduction in body weight in the intervention vs control cohorts was −3.63 kg at 1 year and −2.45 kg at 3 years. More intensive programs with at least 28 interventions per year were associated with slightly more weight loss than less intensive programs.
That is why clinicians and patients have been reaching for effective pharmacotherapy to create better outcomes among adults with obesity. In a national survey of 1479 US adults, 12% reported having used a GLP-1 RA. Diabetes was the most common indication (43%), followed by heart disease (26%) and overweight/obesity (22%).
The high cost of GLP-1 RA therapy was a major barrier to even wider use. Some 54% of participants said that it was difficult to afford GLP-1 RA therapy, and an additional 22% found it very difficult to pay for the drugs. Having health insurance did not alter these figures substantially.
While cost and access remain some of the greatest challenges with the use of GLP-1 RAs, there is hope for change there. In March 2024, the US Food and Drug Administration approved semaglutide to reduce the risk for cardiovascular events among patients with overweight and obesity and existing cardiovascular disease. It appears that Medicare will cover semaglutide for that indication, which bucks a trend of more than 20 years during which Medicare Part D would not cover pharmacotherapy for weight loss.
There is bipartisan support in the US Congress to further increase coverage of GLP-1 RAs for obesity, which makes sense. GLP-1 RAs are associated with greater average weight loss than either lifestyle interventions alone or that associated with previous anti-obesity medications. While there are no safety data for these drugs stretching back for 50 or 100 years, clinicians should bear in mind that exenatide was approved for the management of type 2 diabetes in 2005. So, we are approaching two decades of practical experience with these drugs, and it appears clear that the benefits of GLP-1 RAs outweigh any known harms. For the right patient, and with the right kind of guidance by clinicians, GLP-1 RA therapy can have a profound effect on individual and public health.
Dr. Vega, health sciences clinical professor, Family Medicine, University of California, Irvine, disclosed ties with McNeil Pharmaceuticals.
A version of this article first appeared on Medscape.com.
To discuss issues related to counseling patients about weight loss with glucagon-like peptide 1 receptor agonists (GLP-1 RAs), I recently posted a case from my own practice. This was a 44-year-old woman with hyperlipidemia, hypertension, and obesity who wanted to try to lose weight with a GLP-1 RA, having been unsuccessful in maintaining a normal weight with lifestyle change alone.
I am very happy to see a high number of favorable responses to this article, and I also recognize that it was very focused on GLP-1 RA therapy while not addressing the multivariate treatment of obesity.
A healthy lifestyle remains foundational for the management of obesity, and clinicians should guide patients to make constructive choices regarding their diet, physical activity, mental health, and sleep. However, like for our patient introduced in that article, lifestyle changes are rarely sufficient to obtain a goal of sustained weight loss that promotes better health outcomes. A meta-analysis of clinical trials testing lifestyle interventions to lose weight among adults with overweight and obesity found that the relative reduction in body weight in the intervention vs control cohorts was −3.63 kg at 1 year and −2.45 kg at 3 years. More intensive programs with at least 28 interventions per year were associated with slightly more weight loss than less intensive programs.
That is why clinicians and patients have been reaching for effective pharmacotherapy to create better outcomes among adults with obesity. In a national survey of 1479 US adults, 12% reported having used a GLP-1 RA. Diabetes was the most common indication (43%), followed by heart disease (26%) and overweight/obesity (22%).
The high cost of GLP-1 RA therapy was a major barrier to even wider use. Some 54% of participants said that it was difficult to afford GLP-1 RA therapy, and an additional 22% found it very difficult to pay for the drugs. Having health insurance did not alter these figures substantially.
While cost and access remain some of the greatest challenges with the use of GLP-1 RAs, there is hope for change there. In March 2024, the US Food and Drug Administration approved semaglutide to reduce the risk for cardiovascular events among patients with overweight and obesity and existing cardiovascular disease. It appears that Medicare will cover semaglutide for that indication, which bucks a trend of more than 20 years during which Medicare Part D would not cover pharmacotherapy for weight loss.
There is bipartisan support in the US Congress to further increase coverage of GLP-1 RAs for obesity, which makes sense. GLP-1 RAs are associated with greater average weight loss than either lifestyle interventions alone or that associated with previous anti-obesity medications. While there are no safety data for these drugs stretching back for 50 or 100 years, clinicians should bear in mind that exenatide was approved for the management of type 2 diabetes in 2005. So, we are approaching two decades of practical experience with these drugs, and it appears clear that the benefits of GLP-1 RAs outweigh any known harms. For the right patient, and with the right kind of guidance by clinicians, GLP-1 RA therapy can have a profound effect on individual and public health.
Dr. Vega, health sciences clinical professor, Family Medicine, University of California, Irvine, disclosed ties with McNeil Pharmaceuticals.
A version of this article first appeared on Medscape.com.
To discuss issues related to counseling patients about weight loss with glucagon-like peptide 1 receptor agonists (GLP-1 RAs), I recently posted a case from my own practice. This was a 44-year-old woman with hyperlipidemia, hypertension, and obesity who wanted to try to lose weight with a GLP-1 RA, having been unsuccessful in maintaining a normal weight with lifestyle change alone.
I am very happy to see a high number of favorable responses to this article, and I also recognize that it was very focused on GLP-1 RA therapy while not addressing the multivariate treatment of obesity.
A healthy lifestyle remains foundational for the management of obesity, and clinicians should guide patients to make constructive choices regarding their diet, physical activity, mental health, and sleep. However, like for our patient introduced in that article, lifestyle changes are rarely sufficient to obtain a goal of sustained weight loss that promotes better health outcomes. A meta-analysis of clinical trials testing lifestyle interventions to lose weight among adults with overweight and obesity found that the relative reduction in body weight in the intervention vs control cohorts was −3.63 kg at 1 year and −2.45 kg at 3 years. More intensive programs with at least 28 interventions per year were associated with slightly more weight loss than less intensive programs.
That is why clinicians and patients have been reaching for effective pharmacotherapy to create better outcomes among adults with obesity. In a national survey of 1479 US adults, 12% reported having used a GLP-1 RA. Diabetes was the most common indication (43%), followed by heart disease (26%) and overweight/obesity (22%).
The high cost of GLP-1 RA therapy was a major barrier to even wider use. Some 54% of participants said that it was difficult to afford GLP-1 RA therapy, and an additional 22% found it very difficult to pay for the drugs. Having health insurance did not alter these figures substantially.
While cost and access remain some of the greatest challenges with the use of GLP-1 RAs, there is hope for change there. In March 2024, the US Food and Drug Administration approved semaglutide to reduce the risk for cardiovascular events among patients with overweight and obesity and existing cardiovascular disease. It appears that Medicare will cover semaglutide for that indication, which bucks a trend of more than 20 years during which Medicare Part D would not cover pharmacotherapy for weight loss.
There is bipartisan support in the US Congress to further increase coverage of GLP-1 RAs for obesity, which makes sense. GLP-1 RAs are associated with greater average weight loss than either lifestyle interventions alone or that associated with previous anti-obesity medications. While there are no safety data for these drugs stretching back for 50 or 100 years, clinicians should bear in mind that exenatide was approved for the management of type 2 diabetes in 2005. So, we are approaching two decades of practical experience with these drugs, and it appears clear that the benefits of GLP-1 RAs outweigh any known harms. For the right patient, and with the right kind of guidance by clinicians, GLP-1 RA therapy can have a profound effect on individual and public health.
Dr. Vega, health sciences clinical professor, Family Medicine, University of California, Irvine, disclosed ties with McNeil Pharmaceuticals.
A version of this article first appeared on Medscape.com.
A Second-line Option for Previously Treated Radioiodine-Refractory Differentiated Thyroid Cancer (DTC)
In this special supplement to Federal Practitioner, Dr. Jameel Muzaffar, MD shares insights into a second-line treatment option for previously treated radioiodine-refractory differentiated thyroid cancer (DTC), along with an exploratory analysis of BRAF mutation status. It discusses the challenges associated with metastatic DTC and the significance of understanding factors like BRAF mutation status in treatment decisions. Additionally, it highlights the efficacy and safety profiles of the treatment option.
CA-3326
In this special supplement to Federal Practitioner, Dr. Jameel Muzaffar, MD shares insights into a second-line treatment option for previously treated radioiodine-refractory differentiated thyroid cancer (DTC), along with an exploratory analysis of BRAF mutation status. It discusses the challenges associated with metastatic DTC and the significance of understanding factors like BRAF mutation status in treatment decisions. Additionally, it highlights the efficacy and safety profiles of the treatment option.
CA-3326
In this special supplement to Federal Practitioner, Dr. Jameel Muzaffar, MD shares insights into a second-line treatment option for previously treated radioiodine-refractory differentiated thyroid cancer (DTC), along with an exploratory analysis of BRAF mutation status. It discusses the challenges associated with metastatic DTC and the significance of understanding factors like BRAF mutation status in treatment decisions. Additionally, it highlights the efficacy and safety profiles of the treatment option.
CA-3326
Lower Edoxaban Dose Cuts Bleeding Risk in Elderly Atrial Fibrillation Patients
TOPLINE:
Lowering the dose of edoxaban to 30 mg in patients 80 years of age and older with atrial fibrillation (AF) reduces major bleeding events without increasing ischemic events.
METHODOLOGY:
- Researchers conducted a parallel design, double-blind clinical trial of 21,105 patients with AF.
- Nearly 3000 patients aged 80 years and older were included in the secondary analysis, focusing on edoxaban, 60 mg vs 30 mg, and edoxaban 30 mg vs warfarin.
- The primary outcome was a composite of death, stroke or systemic embolism, and major bleeding, with secondary outcomes including ischemic stroke and all-cause death.
- People were excluded from the study if they had moderate or severe mitral stenosis, a mechanical heart valve, a high risk for bleeding, or were on antiplatelet drugs.
TAKEAWAY:
- Participants without dose-reduction criteria who received edoxaban 30 mg had lower rates of major bleeding than those who received 60 mg (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03).
- Rates of major gastrointestinal hemorrhage were higher with edoxaban 60 mg than with 30 mg (HR, 2.24; 95% CI, 1.29-3.90; P = .004).
- People who took edoxaban 30 mg had a 17% lower risk for all-cause death than those who received warfarin (HR, 0.83; 95% CI, 0.70-1.00; P = .046).
- In a little over 2400 participants with or without dose-reduction criteria, those receiving edoxaban 30 mg had the lower risk for major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001) and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046); risk for stroke or systemic embolism was comparable between the two drugs.
IN PRACTICE:
“These data suggest that lower-dose anticoagulants, such as edoxaban, 30 mg once daily, may be considered in all patients 80 years and older with AF irrespective of dose-reduction criteria,” the study authors wrote.
SOURCE:
The study was led by André Zimerman, MD, PhD, of Brigham and Women’s Hospital and the Department of Medicine at Harvard Medical School in Boston. It was published online in JAMA Cardiology. The study was funded by Daiichi Sankyo for the TIMI Study Group.
LIMITATIONS:
The study did not adjust for multiple comparisons, increasing the risk for type I and type II errors. Additionally, the trial participants may represent a more compliant subset of the target population, which could influence the results.
DISCLOSURES:
Various authors reported receiving grants, consultant fees, and consulting fees from AstraZeneca, Merck, Novartis, Amgen, Boehringer Ingelheim/Lilly, and Cardurion Pharmaceuticals, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Lowering the dose of edoxaban to 30 mg in patients 80 years of age and older with atrial fibrillation (AF) reduces major bleeding events without increasing ischemic events.
METHODOLOGY:
- Researchers conducted a parallel design, double-blind clinical trial of 21,105 patients with AF.
- Nearly 3000 patients aged 80 years and older were included in the secondary analysis, focusing on edoxaban, 60 mg vs 30 mg, and edoxaban 30 mg vs warfarin.
- The primary outcome was a composite of death, stroke or systemic embolism, and major bleeding, with secondary outcomes including ischemic stroke and all-cause death.
- People were excluded from the study if they had moderate or severe mitral stenosis, a mechanical heart valve, a high risk for bleeding, or were on antiplatelet drugs.
TAKEAWAY:
- Participants without dose-reduction criteria who received edoxaban 30 mg had lower rates of major bleeding than those who received 60 mg (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03).
- Rates of major gastrointestinal hemorrhage were higher with edoxaban 60 mg than with 30 mg (HR, 2.24; 95% CI, 1.29-3.90; P = .004).
- People who took edoxaban 30 mg had a 17% lower risk for all-cause death than those who received warfarin (HR, 0.83; 95% CI, 0.70-1.00; P = .046).
- In a little over 2400 participants with or without dose-reduction criteria, those receiving edoxaban 30 mg had the lower risk for major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001) and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046); risk for stroke or systemic embolism was comparable between the two drugs.
IN PRACTICE:
“These data suggest that lower-dose anticoagulants, such as edoxaban, 30 mg once daily, may be considered in all patients 80 years and older with AF irrespective of dose-reduction criteria,” the study authors wrote.
SOURCE:
The study was led by André Zimerman, MD, PhD, of Brigham and Women’s Hospital and the Department of Medicine at Harvard Medical School in Boston. It was published online in JAMA Cardiology. The study was funded by Daiichi Sankyo for the TIMI Study Group.
LIMITATIONS:
The study did not adjust for multiple comparisons, increasing the risk for type I and type II errors. Additionally, the trial participants may represent a more compliant subset of the target population, which could influence the results.
DISCLOSURES:
Various authors reported receiving grants, consultant fees, and consulting fees from AstraZeneca, Merck, Novartis, Amgen, Boehringer Ingelheim/Lilly, and Cardurion Pharmaceuticals, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Lowering the dose of edoxaban to 30 mg in patients 80 years of age and older with atrial fibrillation (AF) reduces major bleeding events without increasing ischemic events.
METHODOLOGY:
- Researchers conducted a parallel design, double-blind clinical trial of 21,105 patients with AF.
- Nearly 3000 patients aged 80 years and older were included in the secondary analysis, focusing on edoxaban, 60 mg vs 30 mg, and edoxaban 30 mg vs warfarin.
- The primary outcome was a composite of death, stroke or systemic embolism, and major bleeding, with secondary outcomes including ischemic stroke and all-cause death.
- People were excluded from the study if they had moderate or severe mitral stenosis, a mechanical heart valve, a high risk for bleeding, or were on antiplatelet drugs.
TAKEAWAY:
- Participants without dose-reduction criteria who received edoxaban 30 mg had lower rates of major bleeding than those who received 60 mg (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03).
- Rates of major gastrointestinal hemorrhage were higher with edoxaban 60 mg than with 30 mg (HR, 2.24; 95% CI, 1.29-3.90; P = .004).
- People who took edoxaban 30 mg had a 17% lower risk for all-cause death than those who received warfarin (HR, 0.83; 95% CI, 0.70-1.00; P = .046).
- In a little over 2400 participants with or without dose-reduction criteria, those receiving edoxaban 30 mg had the lower risk for major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001) and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046); risk for stroke or systemic embolism was comparable between the two drugs.
IN PRACTICE:
“These data suggest that lower-dose anticoagulants, such as edoxaban, 30 mg once daily, may be considered in all patients 80 years and older with AF irrespective of dose-reduction criteria,” the study authors wrote.
SOURCE:
The study was led by André Zimerman, MD, PhD, of Brigham and Women’s Hospital and the Department of Medicine at Harvard Medical School in Boston. It was published online in JAMA Cardiology. The study was funded by Daiichi Sankyo for the TIMI Study Group.
LIMITATIONS:
The study did not adjust for multiple comparisons, increasing the risk for type I and type II errors. Additionally, the trial participants may represent a more compliant subset of the target population, which could influence the results.
DISCLOSURES:
Various authors reported receiving grants, consultant fees, and consulting fees from AstraZeneca, Merck, Novartis, Amgen, Boehringer Ingelheim/Lilly, and Cardurion Pharmaceuticals, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
‘Double-Expresser’ DLBCL: Tucidinostat Improved R-CHOP Outcomes
At the annual meeting of the American Society of Clinical Oncology (ASCO), they announced that combining the histone deacetylase inhibitor tucidinostat with standard R-CHOP chemotherapy in previously untreated “double-expresser” patients improved complete response and event-free survival (EFS) rates over R-CHOP alone.
The trial, dubbed DEB, is the first phase 3 investigation to confirm the benefit of combination treatment with an epigenetic agent for such patients, lead investigator and study presenter Weili Zhao, MD, PhD, a hematologist at the Shanghai Institute of Hematology, told her audience.
“Tucidinostat plus R-CHOP could be a new frontline treatment option in this patient population,” Dr. Zhao said.
However, the agent is not available in the United States, at least for now. It is approved in China for peripheral T-cell lymphoma (PTCL) and HER2-negative breast cancer and in Japan for PTCL and adult T-cell leukemia/lymphoma.
Dr. Zhao said that tucidinostat was also conditionally approved for DLBCL in China recently, based on the strength of the DEB results.
Study discussant Peter Riedell, MD, a hematologist at the University of Chicago, Illinois, was cautious on several points.
First, there’s been no overall survival benefit in the trial, but follow-up so far has been short, at a median of 13.9 months, and Dr. Zhao reported interim, not final, results.
Dr. Riedell also noted that there were more grade 3 or worse adverse events, particularly hematologic side effects, hypokalemia, and pneumonia, with tucidinostat add-on in DEB.
Other outstanding questions include the applicability of the findings to non-Chinese patients and the effect of adding tucidinostat to another common DLCBL chemotherapy regimen, pola-R-CHP, which is being increasingly used in the United States for higher-risk disease, which includes double-expressers of the MYC and BCLC oncogenes.
DEB equally randomized 423 patients at 40 centers in China to either six cycles of R-CHOP with tucidinostat 20 μg twice weekly or R-CHOP with placebo. Complete responders went on to either tucidinostat or placebo maintenance treatment for up to 24 weeks. Subjects had an International Prognostic Index score of at least 2.
Out of a total of 152 EFS events, 64 (30.3%) were in the tucidinostat group and 88 (41.5%) were in the placebo group; 24-month EFS was 58.9% with tucidinostat and 46.2% with R-CHOP alone (hazard ratio, 0.68; P = .018).
Meanwhile, the complete response rate with tucidinostat was 73.0% versus 61.8% (P = .014).
Although there were more higher-grade adverse events in the experimental arm, most patients were able to tolerate and complete the planned treatment cycles.
The study was funded by tucidinostat maker Chipscreen Biosciences. Dr. Zhao reported no disclosures. Dr. Riedell disclosed ties with numerous companies, including BeiGene (a partner of Chipscreen) and Novartis.
At the annual meeting of the American Society of Clinical Oncology (ASCO), they announced that combining the histone deacetylase inhibitor tucidinostat with standard R-CHOP chemotherapy in previously untreated “double-expresser” patients improved complete response and event-free survival (EFS) rates over R-CHOP alone.
The trial, dubbed DEB, is the first phase 3 investigation to confirm the benefit of combination treatment with an epigenetic agent for such patients, lead investigator and study presenter Weili Zhao, MD, PhD, a hematologist at the Shanghai Institute of Hematology, told her audience.
“Tucidinostat plus R-CHOP could be a new frontline treatment option in this patient population,” Dr. Zhao said.
However, the agent is not available in the United States, at least for now. It is approved in China for peripheral T-cell lymphoma (PTCL) and HER2-negative breast cancer and in Japan for PTCL and adult T-cell leukemia/lymphoma.
Dr. Zhao said that tucidinostat was also conditionally approved for DLBCL in China recently, based on the strength of the DEB results.
Study discussant Peter Riedell, MD, a hematologist at the University of Chicago, Illinois, was cautious on several points.
First, there’s been no overall survival benefit in the trial, but follow-up so far has been short, at a median of 13.9 months, and Dr. Zhao reported interim, not final, results.
Dr. Riedell also noted that there were more grade 3 or worse adverse events, particularly hematologic side effects, hypokalemia, and pneumonia, with tucidinostat add-on in DEB.
Other outstanding questions include the applicability of the findings to non-Chinese patients and the effect of adding tucidinostat to another common DLCBL chemotherapy regimen, pola-R-CHP, which is being increasingly used in the United States for higher-risk disease, which includes double-expressers of the MYC and BCLC oncogenes.
DEB equally randomized 423 patients at 40 centers in China to either six cycles of R-CHOP with tucidinostat 20 μg twice weekly or R-CHOP with placebo. Complete responders went on to either tucidinostat or placebo maintenance treatment for up to 24 weeks. Subjects had an International Prognostic Index score of at least 2.
Out of a total of 152 EFS events, 64 (30.3%) were in the tucidinostat group and 88 (41.5%) were in the placebo group; 24-month EFS was 58.9% with tucidinostat and 46.2% with R-CHOP alone (hazard ratio, 0.68; P = .018).
Meanwhile, the complete response rate with tucidinostat was 73.0% versus 61.8% (P = .014).
Although there were more higher-grade adverse events in the experimental arm, most patients were able to tolerate and complete the planned treatment cycles.
The study was funded by tucidinostat maker Chipscreen Biosciences. Dr. Zhao reported no disclosures. Dr. Riedell disclosed ties with numerous companies, including BeiGene (a partner of Chipscreen) and Novartis.
At the annual meeting of the American Society of Clinical Oncology (ASCO), they announced that combining the histone deacetylase inhibitor tucidinostat with standard R-CHOP chemotherapy in previously untreated “double-expresser” patients improved complete response and event-free survival (EFS) rates over R-CHOP alone.
The trial, dubbed DEB, is the first phase 3 investigation to confirm the benefit of combination treatment with an epigenetic agent for such patients, lead investigator and study presenter Weili Zhao, MD, PhD, a hematologist at the Shanghai Institute of Hematology, told her audience.
“Tucidinostat plus R-CHOP could be a new frontline treatment option in this patient population,” Dr. Zhao said.
However, the agent is not available in the United States, at least for now. It is approved in China for peripheral T-cell lymphoma (PTCL) and HER2-negative breast cancer and in Japan for PTCL and adult T-cell leukemia/lymphoma.
Dr. Zhao said that tucidinostat was also conditionally approved for DLBCL in China recently, based on the strength of the DEB results.
Study discussant Peter Riedell, MD, a hematologist at the University of Chicago, Illinois, was cautious on several points.
First, there’s been no overall survival benefit in the trial, but follow-up so far has been short, at a median of 13.9 months, and Dr. Zhao reported interim, not final, results.
Dr. Riedell also noted that there were more grade 3 or worse adverse events, particularly hematologic side effects, hypokalemia, and pneumonia, with tucidinostat add-on in DEB.
Other outstanding questions include the applicability of the findings to non-Chinese patients and the effect of adding tucidinostat to another common DLCBL chemotherapy regimen, pola-R-CHP, which is being increasingly used in the United States for higher-risk disease, which includes double-expressers of the MYC and BCLC oncogenes.
DEB equally randomized 423 patients at 40 centers in China to either six cycles of R-CHOP with tucidinostat 20 μg twice weekly or R-CHOP with placebo. Complete responders went on to either tucidinostat or placebo maintenance treatment for up to 24 weeks. Subjects had an International Prognostic Index score of at least 2.
Out of a total of 152 EFS events, 64 (30.3%) were in the tucidinostat group and 88 (41.5%) were in the placebo group; 24-month EFS was 58.9% with tucidinostat and 46.2% with R-CHOP alone (hazard ratio, 0.68; P = .018).
Meanwhile, the complete response rate with tucidinostat was 73.0% versus 61.8% (P = .014).
Although there were more higher-grade adverse events in the experimental arm, most patients were able to tolerate and complete the planned treatment cycles.
The study was funded by tucidinostat maker Chipscreen Biosciences. Dr. Zhao reported no disclosures. Dr. Riedell disclosed ties with numerous companies, including BeiGene (a partner of Chipscreen) and Novartis.
FROM ASCO 2024