IBS, Chronic Idiopathic Constipation Surged During Pandemic

Article Type
Changed
Thu, 07/10/2025 - 17:17

The prevalence of irritable bowel syndrome (IBS) and chronic idiopathic constipation among US adults rose significantly during the COVID-19 pandemic, with a near doubling of the national rate of IBS over 2 years, a study has found.

The uptick is probably due to not only the direct impact of SARS-CoV-2 infection on the gastrointestinal tract but also to the psychological stress associated with pandemic life, the study team said. 

“COVID infection itself can definitely cause gastrointestinal symptoms like diarrhea, nausea, and abdominal pain — and for some people, those symptoms can linger and lead to chronic conditions like IBS,” Christopher V. Almario, MD, MSHPM, lead author and gastroenterologist at Cedars-Sinai Medical Center, Los Angeles, California, told GI & Hepatology News

Dr. Christopher V. Almario



“But the stress of living through the pandemic — lockdowns, fear, isolation — also likely played a major role as well in the increased prevalence of digestive disorders. Both the infection itself and the psychological toll of the pandemic can disrupt the gut-brain axis and trigger chronic digestive disorders like IBS,” Almario said. 

The study was published in Neurogastroenterology & Motility.

 

Growing Burden of Gut Disorders 

Disorders of gut-brain interaction (DGBIs) are a heterogeneous group of conditions in which gastrointestinal symptoms occur without any detectable structural or biochemical abnormalities in the digestive tract. They include IBS, functional dyspepsia, and chronic idiopathic constipation, among others. 

DGBIs are highly prevalent. Research has shown that nearly 40% of people in the US meet Rome IV criteria for at least one DGBI. 

Almario and colleagues assessed trends in prevalence of these conditions during the COVID-19 pandemic. Starting in May 2020 through May 2022, they conducted a series of online surveys with more than 160,000 adults aged 18 or older using validated Rome IV diagnostic questionnaires. 

Results showed that during the pandemic, IBS prevalence rose from 6.1% in May 2020 to 11.0% by May 2022, an increase of 0.188% per month (adjusted P < .001). 

Chronic idiopathic constipation showed a smaller but statistically significant increase, from 6.0% to 6.4% (0.056% per month; adjusted P < .001). 

Within the IBS subtypes, mixed-type IBS showed the largest relative increase (0.085% per month), followed by IBS with constipation (0.041% per month) and IBS with diarrhea (0.037% per month). 

There were no significant changes in the prevalence of other DGBIs, such as functional bloating, functional diarrhea, or functional dyspepsia, during the study period. 

Almario told GI & Hepatology News only about 9% of those surveyed reported a positive COVID test at the time of the surveys, but that figure probably underrepresents actual infections, especially in the early months of the pandemic. “Most of the survey responses came in during the earlier phases of the pandemic, and the percentage reporting a positive test increased over time,” he explained. 

Almario also noted that this study did not directly compare digestive disorder rates between infected and uninfected individuals. However, a separate study by the Cedars-Sinai team currently undergoing peer review addresses that question more directly. “That study, along with several other studies, show that having COVID increases the risk of developing conditions like IBS and functional dyspepsia,” Almario said. 

Taken together, the findings “underscore the increasing healthcare and economic burden of DGBI in the post-pandemic era, emphasizing the need for targeted efforts to effectively diagnose and manage these complex conditions,” they wrote. 

“This will be especially challenging for healthcare systems to address, given the existing shortage of primary care physicians and gastroenterologists — clinicians who primarily manage individuals with DGBI,” they noted. 

Support for this study was received from Ironwood Pharmaceuticals and Salix Pharmaceuticals in the form of institutional research grants to Cedars-Sinai. Almario has consulted for Exact Sciences, Greenspace Labs, Owlstone Medical, Salix Pharmaceuticals, and Universal DX.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

The prevalence of irritable bowel syndrome (IBS) and chronic idiopathic constipation among US adults rose significantly during the COVID-19 pandemic, with a near doubling of the national rate of IBS over 2 years, a study has found.

The uptick is probably due to not only the direct impact of SARS-CoV-2 infection on the gastrointestinal tract but also to the psychological stress associated with pandemic life, the study team said. 

“COVID infection itself can definitely cause gastrointestinal symptoms like diarrhea, nausea, and abdominal pain — and for some people, those symptoms can linger and lead to chronic conditions like IBS,” Christopher V. Almario, MD, MSHPM, lead author and gastroenterologist at Cedars-Sinai Medical Center, Los Angeles, California, told GI & Hepatology News

Dr. Christopher V. Almario



“But the stress of living through the pandemic — lockdowns, fear, isolation — also likely played a major role as well in the increased prevalence of digestive disorders. Both the infection itself and the psychological toll of the pandemic can disrupt the gut-brain axis and trigger chronic digestive disorders like IBS,” Almario said. 

The study was published in Neurogastroenterology & Motility.

 

Growing Burden of Gut Disorders 

Disorders of gut-brain interaction (DGBIs) are a heterogeneous group of conditions in which gastrointestinal symptoms occur without any detectable structural or biochemical abnormalities in the digestive tract. They include IBS, functional dyspepsia, and chronic idiopathic constipation, among others. 

DGBIs are highly prevalent. Research has shown that nearly 40% of people in the US meet Rome IV criteria for at least one DGBI. 

Almario and colleagues assessed trends in prevalence of these conditions during the COVID-19 pandemic. Starting in May 2020 through May 2022, they conducted a series of online surveys with more than 160,000 adults aged 18 or older using validated Rome IV diagnostic questionnaires. 

Results showed that during the pandemic, IBS prevalence rose from 6.1% in May 2020 to 11.0% by May 2022, an increase of 0.188% per month (adjusted P < .001). 

Chronic idiopathic constipation showed a smaller but statistically significant increase, from 6.0% to 6.4% (0.056% per month; adjusted P < .001). 

Within the IBS subtypes, mixed-type IBS showed the largest relative increase (0.085% per month), followed by IBS with constipation (0.041% per month) and IBS with diarrhea (0.037% per month). 

There were no significant changes in the prevalence of other DGBIs, such as functional bloating, functional diarrhea, or functional dyspepsia, during the study period. 

Almario told GI & Hepatology News only about 9% of those surveyed reported a positive COVID test at the time of the surveys, but that figure probably underrepresents actual infections, especially in the early months of the pandemic. “Most of the survey responses came in during the earlier phases of the pandemic, and the percentage reporting a positive test increased over time,” he explained. 

Almario also noted that this study did not directly compare digestive disorder rates between infected and uninfected individuals. However, a separate study by the Cedars-Sinai team currently undergoing peer review addresses that question more directly. “That study, along with several other studies, show that having COVID increases the risk of developing conditions like IBS and functional dyspepsia,” Almario said. 

Taken together, the findings “underscore the increasing healthcare and economic burden of DGBI in the post-pandemic era, emphasizing the need for targeted efforts to effectively diagnose and manage these complex conditions,” they wrote. 

“This will be especially challenging for healthcare systems to address, given the existing shortage of primary care physicians and gastroenterologists — clinicians who primarily manage individuals with DGBI,” they noted. 

Support for this study was received from Ironwood Pharmaceuticals and Salix Pharmaceuticals in the form of institutional research grants to Cedars-Sinai. Almario has consulted for Exact Sciences, Greenspace Labs, Owlstone Medical, Salix Pharmaceuticals, and Universal DX.

A version of this article appeared on Medscape.com.

The prevalence of irritable bowel syndrome (IBS) and chronic idiopathic constipation among US adults rose significantly during the COVID-19 pandemic, with a near doubling of the national rate of IBS over 2 years, a study has found.

The uptick is probably due to not only the direct impact of SARS-CoV-2 infection on the gastrointestinal tract but also to the psychological stress associated with pandemic life, the study team said. 

“COVID infection itself can definitely cause gastrointestinal symptoms like diarrhea, nausea, and abdominal pain — and for some people, those symptoms can linger and lead to chronic conditions like IBS,” Christopher V. Almario, MD, MSHPM, lead author and gastroenterologist at Cedars-Sinai Medical Center, Los Angeles, California, told GI & Hepatology News

Dr. Christopher V. Almario



“But the stress of living through the pandemic — lockdowns, fear, isolation — also likely played a major role as well in the increased prevalence of digestive disorders. Both the infection itself and the psychological toll of the pandemic can disrupt the gut-brain axis and trigger chronic digestive disorders like IBS,” Almario said. 

The study was published in Neurogastroenterology & Motility.

 

Growing Burden of Gut Disorders 

Disorders of gut-brain interaction (DGBIs) are a heterogeneous group of conditions in which gastrointestinal symptoms occur without any detectable structural or biochemical abnormalities in the digestive tract. They include IBS, functional dyspepsia, and chronic idiopathic constipation, among others. 

DGBIs are highly prevalent. Research has shown that nearly 40% of people in the US meet Rome IV criteria for at least one DGBI. 

Almario and colleagues assessed trends in prevalence of these conditions during the COVID-19 pandemic. Starting in May 2020 through May 2022, they conducted a series of online surveys with more than 160,000 adults aged 18 or older using validated Rome IV diagnostic questionnaires. 

Results showed that during the pandemic, IBS prevalence rose from 6.1% in May 2020 to 11.0% by May 2022, an increase of 0.188% per month (adjusted P < .001). 

Chronic idiopathic constipation showed a smaller but statistically significant increase, from 6.0% to 6.4% (0.056% per month; adjusted P < .001). 

Within the IBS subtypes, mixed-type IBS showed the largest relative increase (0.085% per month), followed by IBS with constipation (0.041% per month) and IBS with diarrhea (0.037% per month). 

There were no significant changes in the prevalence of other DGBIs, such as functional bloating, functional diarrhea, or functional dyspepsia, during the study period. 

Almario told GI & Hepatology News only about 9% of those surveyed reported a positive COVID test at the time of the surveys, but that figure probably underrepresents actual infections, especially in the early months of the pandemic. “Most of the survey responses came in during the earlier phases of the pandemic, and the percentage reporting a positive test increased over time,” he explained. 

Almario also noted that this study did not directly compare digestive disorder rates between infected and uninfected individuals. However, a separate study by the Cedars-Sinai team currently undergoing peer review addresses that question more directly. “That study, along with several other studies, show that having COVID increases the risk of developing conditions like IBS and functional dyspepsia,” Almario said. 

Taken together, the findings “underscore the increasing healthcare and economic burden of DGBI in the post-pandemic era, emphasizing the need for targeted efforts to effectively diagnose and manage these complex conditions,” they wrote. 

“This will be especially challenging for healthcare systems to address, given the existing shortage of primary care physicians and gastroenterologists — clinicians who primarily manage individuals with DGBI,” they noted. 

Support for this study was received from Ironwood Pharmaceuticals and Salix Pharmaceuticals in the form of institutional research grants to Cedars-Sinai. Almario has consulted for Exact Sciences, Greenspace Labs, Owlstone Medical, Salix Pharmaceuticals, and Universal DX.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Thu, 07/10/2025 - 15:53
Un-Gate On Date
Thu, 07/10/2025 - 15:53
Use ProPublica
CFC Schedule Remove Status
Thu, 07/10/2025 - 15:53
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Thu, 07/10/2025 - 15:53

FDA Issues Early Alert for Medtronic pH-Monitoring Capsules

Article Type
Changed
Thu, 07/10/2025 - 15:42

The US Food and Drug Administration (FDA) has issued an early alert for three Medtronic pH-monitoring capsule devices. The notice follows two letters sent in June to customers by the devices’ manufacturer Medtronic and its subsidiary Given Imaging Inc., recommending that customers using certain Bravo CF Capsule Delivery Devices (lot numbers below) for esophageal pH monitoring be removed from all sites of use and sale.

All three of the capsule models listed below are thought to pose a potential risk because the capsules fail to attach to the esophagus’s mucosal wall or to detach from the delivery device as intended owing to a misapplication of adhesive during manufacture. The devices transmit pH data to a recorder attached to the waist of the patient, who interacts with the recorder to indicate symptoms, thereby allowing the physician to compare the symptoms with the occurrence of reflux episodes.

Risks associated with the devices include aspiration/inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

Medtronic has reported 33 serious injuries but no deaths associated with the devices.

The lot numbers of the three affected units, which should be identified and quarantined immediately are:

  • Bravo CF Capsule Delivery Device, 5-pk, Product Number FGS-0635, Unique Device Identifier-Device Identifier (UDI-DI) 07290101369707
  • Bravo CF Capsule Delivery Device 5-pk, FGS-0635, UDI-DI 10613994000009
  • Bravo CF Capsule Delivery Device 1-pk, FGS-0636, UDI-DI 07290101369714

These lot identifiers can be found on both the 5-pks’ FGS-0635 outer labels and on the 1-pk FGS-036 individual unit. Customers are advised to return all unused affected products to Medtronic for replacement or credit. In addition, they should pass on this notice to all those who need to be aware within their organizations or to any organizations to which the affected products have been distributed.

They are also advised to check the FDA recall website above for updates as it continues to review information about this potentially high-risk device issue. 

Healthcare professionals with concerns or reports of adverse events can contact Medtronic at 800-448-3644 or MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
 

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

The US Food and Drug Administration (FDA) has issued an early alert for three Medtronic pH-monitoring capsule devices. The notice follows two letters sent in June to customers by the devices’ manufacturer Medtronic and its subsidiary Given Imaging Inc., recommending that customers using certain Bravo CF Capsule Delivery Devices (lot numbers below) for esophageal pH monitoring be removed from all sites of use and sale.

All three of the capsule models listed below are thought to pose a potential risk because the capsules fail to attach to the esophagus’s mucosal wall or to detach from the delivery device as intended owing to a misapplication of adhesive during manufacture. The devices transmit pH data to a recorder attached to the waist of the patient, who interacts with the recorder to indicate symptoms, thereby allowing the physician to compare the symptoms with the occurrence of reflux episodes.

Risks associated with the devices include aspiration/inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

Medtronic has reported 33 serious injuries but no deaths associated with the devices.

The lot numbers of the three affected units, which should be identified and quarantined immediately are:

  • Bravo CF Capsule Delivery Device, 5-pk, Product Number FGS-0635, Unique Device Identifier-Device Identifier (UDI-DI) 07290101369707
  • Bravo CF Capsule Delivery Device 5-pk, FGS-0635, UDI-DI 10613994000009
  • Bravo CF Capsule Delivery Device 1-pk, FGS-0636, UDI-DI 07290101369714

These lot identifiers can be found on both the 5-pks’ FGS-0635 outer labels and on the 1-pk FGS-036 individual unit. Customers are advised to return all unused affected products to Medtronic for replacement or credit. In addition, they should pass on this notice to all those who need to be aware within their organizations or to any organizations to which the affected products have been distributed.

They are also advised to check the FDA recall website above for updates as it continues to review information about this potentially high-risk device issue. 

Healthcare professionals with concerns or reports of adverse events can contact Medtronic at 800-448-3644 or MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has issued an early alert for three Medtronic pH-monitoring capsule devices. The notice follows two letters sent in June to customers by the devices’ manufacturer Medtronic and its subsidiary Given Imaging Inc., recommending that customers using certain Bravo CF Capsule Delivery Devices (lot numbers below) for esophageal pH monitoring be removed from all sites of use and sale.

All three of the capsule models listed below are thought to pose a potential risk because the capsules fail to attach to the esophagus’s mucosal wall or to detach from the delivery device as intended owing to a misapplication of adhesive during manufacture. The devices transmit pH data to a recorder attached to the waist of the patient, who interacts with the recorder to indicate symptoms, thereby allowing the physician to compare the symptoms with the occurrence of reflux episodes.

Risks associated with the devices include aspiration/inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

Medtronic has reported 33 serious injuries but no deaths associated with the devices.

The lot numbers of the three affected units, which should be identified and quarantined immediately are:

  • Bravo CF Capsule Delivery Device, 5-pk, Product Number FGS-0635, Unique Device Identifier-Device Identifier (UDI-DI) 07290101369707
  • Bravo CF Capsule Delivery Device 5-pk, FGS-0635, UDI-DI 10613994000009
  • Bravo CF Capsule Delivery Device 1-pk, FGS-0636, UDI-DI 07290101369714

These lot identifiers can be found on both the 5-pks’ FGS-0635 outer labels and on the 1-pk FGS-036 individual unit. Customers are advised to return all unused affected products to Medtronic for replacement or credit. In addition, they should pass on this notice to all those who need to be aware within their organizations or to any organizations to which the affected products have been distributed.

They are also advised to check the FDA recall website above for updates as it continues to review information about this potentially high-risk device issue. 

Healthcare professionals with concerns or reports of adverse events can contact Medtronic at 800-448-3644 or MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
 

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Thu, 07/10/2025 - 15:33
Un-Gate On Date
Thu, 07/10/2025 - 15:33
Use ProPublica
CFC Schedule Remove Status
Thu, 07/10/2025 - 15:33
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Thu, 07/10/2025 - 15:33

How Common Meds Can Secretly Wreck Your Patients’ Microbiome

Article Type
Changed
Thu, 07/10/2025 - 09:31

Effective ways to combat harmful viruses, bacteria, fungi, and parasitic worms have driven major advances in medicine and contributed to a significant increase in human life expectancy over the past century. However, as knowledge about the role of these microorganisms in promoting and maintaining health deepens, there is a need for a new look at the impact of these treatments.

The list of drugs that can directly alter the gut microbiota is long. In addition to antibiotics, antivirals, antifungals, anthelmintics, proton pump inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), laxatives, oral antidiabetics, antidepressants, antipsychotics, statins, chemotherapeutics, and immunosuppressants can trigger dysbiosis.

2020 study published in Nature Communications, which analyzed the impact of common medications on the composition and metabolic function of the gut bacteria, showed that of the 41 classes of medications, researchers found that 19 were associated with changes in the microbiome, most notably antibiotics, proton pump inhibitors, laxatives, and metformin.

“There are still no protocols aimed at preserving the microbiota during pharmacological treatment. Future research should identify biomarkers of drug-induced dysbiosis and potentially adapt live biotherapeutics to counteract it,” said Maria Júlia Segantini, MD, a coloproctologist at the University of São Paulo, Brazil.

 

Known Facts

Antibiotics, antivirals, antifungals, and anthelmintics eliminate pathogens but can also disrupt the microbiota across the gut, skin, mouth, lungs, and genitourinary tract.

“This ecosystem is part of the innate immune system and helps to balance inflammation and homeostasis. Loss of microbial diversity alters interspecies interactions and changes nutrient availability, which can undermine the ability to fend off pathogens,” said Segantini, noting the role of microbiota in vitamin K and B-complex production.

“The microbiome may lose its ability to prevent pathogens from taking hold. This is due to the loss of microbial diversity, changes in interactions between species, and the availability of nutrients,” she added.

Antibiotics, as is well known, eliminate bacterial species indiscriminately, reduce the presence of beneficial bacteria in the gut, and, therefore, favor the growth of opportunistic pathogenic microorganisms. However, in addition to their direct effects on microorganisms, different medications can alter the intestinal microbiota through various mechanisms linked to their specific actions. Here are some examples:

Proton pump inhibitors: These can facilitate the translocation of bacteria from the mouth to the intestine and affect the metabolic functions of the intestinal microbiota. “In users of these medications, there may be an enrichment of pathways related to carbohydrate metabolism, such as glycolysis and pyruvate metabolism, indicating possible changes in intestinal metabolism,” Segantini explained.

NSAIDs: NSAIDs can modify the function and composition of the intestinal microbiota, favor the growth of pathogenic species, and reduce the diversity of preexisting bacteria by reducing the presence of beneficial commensal bacteria, such as Lactobacillus and Bifidobacterium. “This is due to changes in the permeability of the intestinal wall, due to the inhibition of prostaglandins that help maintain the integrity of the intestinal barrier, enteropathy induced by NSAIDs, and drug interactions,” said Segantini.

Laxatives: Accelerated intestinal transit using laxatives impairs the quality of the microbiota and alters bile acid. Osmotic agents, such as lactulose and polyethylene glycol, may decrease resistance to infection.

“Studies in animal models indicate that polyethylene glycol can increase the proportion of Bacteroides and reduce the abundance of Bacteroidales bacteria, with lasting repercussions on the intestinal microbiota. Stimulant laxatives, in addition to causing an acceleration of the evacuation flow, can lead to a decrease in the production of short-chain fatty acids, which are important for intestinal health,” Segantini explained.

Chemotherapeutics: Chemotherapeutic agents can significantly influence the intestinal microbiota and affect its composition, diversity, and functionality, which in turn can affect the efficacy of treatment and the occurrence of adverse effects. “5-fluorouracil led to a decrease in the abundance of beneficial anaerobic genera, such as Blautia, and an increase in opportunistic pathogens, such as Staphylococcus and Escherichia coli, during chemotherapy. In addition, it can lead to an increase in the abundance of Bacteroidetes and Proteobacteria while reducing Firmicutes and Actinobacteria. These changes can affect the function of the intestinal barrier and the immune response. Other problems related to chemotherapy-induced dysbiosis are the adverse effects themselves, such as diarrhea and mucositis,” said Segantini.

Statins: Animal studies suggest that treatment with statins, including atorvastatin, may alter the composition of the gut microbiota. “These changes include the reduction of beneficial bacteria, such as Akkermansia muciniphila, and the increase in intestinal pathogens, resulting in intestinal dysbiosis. The use of statins can affect the diversity of the intestinal microbiota, although the results vary according to the type of statin and the clinical context.”

“Statins can activate intestinal nuclear receptors, such as pregnane X receptors, which modulate the expression of genes involved in bile metabolism and the inflammatory response. This activation can contribute to changes in the intestinal microbiota and associated metabolic processes. Although statins play a fundamental role in reducing cardiovascular risk, their interactions with the intestinal microbiota can influence the efficacy of treatment and the profile of adverse effects,” said Segantini.

Immunosuppressants: The use of immunosuppressants, such as corticosteroids, tacrolimus, and mycophenolate, has been associated with changes in the composition of the intestinal microbiota. “Immunosuppressant-induced dysbiosis can compromise the intestinal barrier, increase permeability, and facilitate bacterial translocation. This can result in opportunistic infections by pathogens and post-transplant complications, such as graft rejection and post-transplant diabetes,” Segantini stated.

“Alteration of the gut microbiota by immunosuppressants may influence the host’s immune response. For example, tacrolimus has been associated with an increase in the abundance of AllobaculumBacteroides, and Lactobacillus, in addition to elevated levels of regulatory T cells in the colonic mucosa and circulation, suggesting a role in modulating gut immunity,” she said.

Antipsychotics: Antipsychotics can affect gut microbiota in several ways, influencing bacterial composition and diversity, which may contribute to adverse metabolic and gastrointestinal effects.

“Olanzapine, for example, has been shown in rodent studies to increase the abundance of Firmicutes and reduce that of Bacteroidetes, resulting in a higher Firmicutes/Bacteroidetes ratio, which is associated with weight gain and dyslipidemia,” said Segantini.

She stated that risperidone increased the abundance of Firmicutes and decreased that of Bacteroidetes in animal models, correlating with weight gain and reduced basal metabolic rate. “Fecal transfer from risperidone-treated mice to naive mice resulted in decreased metabolic rate, suggesting that the gut microbiota would mediate these effects.”

Treatment with aripiprazole increased microbial diversity and the abundance of ClostridiumPeptoclostridiumIntestinibacter, and Christensenellaceae, in addition to promoting increased intestinal permeability in animal models.

“Therefore, the use of these medications can lead to metabolic changes, such as weight gain, hyperglycemia, dyslipidemia, and hypertension. This is due to a decrease in the production of short-chain fatty acids, which are important for maintaining the integrity of the intestinal barrier. Another change frequently observed in clinical practice is constipation induced by these medications. This functional change can also generate changes in the intestinal microbiota,” she said.

Oral antidiabetic agents: Oral antidiabetic agents influence the intestinal microbiota in different ways, depending on the therapeutic class. However, not all drug interactions in the microbiome are harmful. Liraglutide, a GLP-1 receptor agonist, promotes the growth of beneficial bacteria associated with metabolism.

“Exenatide, another GLP-1 agonist, has varied effects and can increase both beneficial and inflammatory bacteria,” explained Álvaro Delgado, MD, a gastroenterologist at Hospital Alemão Oswaldo Cruz in São Paulo, Brazil.

“In humans, an increase in bacteria such as Faecalibacterium prausnitzii has been observed, with positive effects. However, more studies are needed to evaluate the clinical impacts,” he said, and that, in animal models, these changes caused by GLP-1 agonists are linked to metabolic changes, such as greater glucose tolerance.

Metformin has been linked to increased abundance of A muciniphila, a beneficial bacterium that degrades mucin and produces short-chain fatty acids. “These bacteria are associated with improved insulin sensitivity and reduced inflammation,” he said.

Segantini stated that studies in mice have shown that vildagliptin also plays a positive role in altering the composition of the intestinal microbiota, increasing the abundance of Lactobacillus and Roseburia, and reducing Oscillibacter. “This same beneficial effect is seen with the use of sitagliptin,” she said.

Studies in animal models have also indicated that empagliflozin and dapagliflozin increase the populations of short-chain fatty acid-producing bacteria, such as Bacteroides and Odoribacter, and reduce the populations of lipopolysaccharide-producing bacteria, such as Oscillibacter.

“There are still not many studies regarding the use of sulfonylureas on the intestinal microbiota, so their action on the microbiota is still controversial,” said Segantini.

Antivirals: Antiviral treatment can influence gut microbiota in complex ways, depending on the type of infection and medication used.

“Although many studies focus on the effects of viral infection on the microbiota, there is evidence that antiviral treatment can also restore the healthy composition of the microbiota, promoting additional benefits to gut and immune health,” said Segantini.

In mice with chronic hepatitis B, entecavir restored the alpha diversity of the gut microbiota, which was reduced due to infection. In addition, the recovery of beneficial bacteria, such as Akkermansia and Blautia, was observed, which was associated with the protection of the intestinal barrier and reduction of hepatic inflammation.

Studies have indicated that tenofovir may aid in the recovery of intestinal dysbiosis induced by chronic hepatitis B virus infection and promote the restoration of a healthy microbial composition.

“Specifically, an increase in Collinsella and Bifidobacterium, bacteria associated with the production of short-chain fatty acids and modulation of the immune response, was observed,” said Segantini.

The use of antiretrovirals, such as lopinavir and ritonavir, has been associated with changes in the composition of the intestinal microbiota in patients living with HIV.

“A decrease in Lachnospira, Butyricicoccus, Oscillospira, and Prevotella, bacteria that produce short-chain fatty acids that are important in intestinal health and in modulating the immune response, was observed.”

Antifungals: As a side effect, antifungals also eliminate commensal fungi, which “share intestinal niches with microbiota bacteria, balancing their immunological functions. When modified, they culminate in dysbiosis, worsening of inflammatory pathologies — such as colitis and allergic diseases — and can increase bacterial translocation,” said Segantini. 

For example, fluconazole reduces the abundance of Candida spp. while promoting the growth of fungi such as AspergillusWallemia, and Epicoccum.

“A relative increase in Firmicutes and Proteobacteria and a decrease in Bacteroidetes, Deferribacteres, Patescibacteria, and Tenericutes were also observed,” she explained.

Anthelmintics: These also affect the intestinal bacterial and fungal microbiota and alter the modulation of the immune response, in addition to having specific effects depending on the type of drug used.

 

Clinical Advice

Symptoms of dysbiosis include abdominal distension, flatulence, constipation or diarrhea, pain, fatigue, and mood swings. “The diagnosis is made based on the clinical picture, since tests such as small intestinal bacterial overgrowth, which indicate metabolites of bacteria associated with dysbiosis, specific stool tests, and microbiota mapping with GI-MAP [Gastrointestinal Microbial Assay Plus], for example, are expensive, difficult to access, and often inconclusive for diagnosis and for assessing the cause of the microbiota alteration,” explained Fernando Seefelder Flaquer, MD, a gastroenterologist at Albert Einstein Israelite Hospital in São Paulo.

When caused by medication, dysbiosis tends to be reversed naturally after discontinuation of the drug. “However, in medications with a high chance of altering the microbiota, probiotics can be used as prevention,” said Flaquer.

“To avoid problems, it is important to use antibiotics with caution and prefer, when possible, those with a reduced spectrum,” advised Delgado.

“Supplementation with probiotics and prebiotics can help maintain the balance of the microbiota, but it should be evaluated on a case-by-case basis, as its indications are still restricted at present.”

Currently, dysbiosis management relies on nutritional support and lifestyle modifications. “Physical exercise, management of psychological changes, and use of probiotics and prebiotics. In specific cases, individualized treatment may even require the administration of some types of antibiotics,” explained Segantini.

Although fecal microbiota transplantation (FMT) has been widely discussed and increasingly studied, it should still be approached with caution. While promising, FMT remains experimental for most conditions, and its use outside research settings should be carefully considered, particularly in patients who are immunocompromised or have compromised intestinal barriers.

“Currently, the treatment has stood out as promising for cases of recurrent Clostridioides difficile infection, being the only consolidated clinical indication,” said Segantini.

 

Science Hype

The interest in gut microbiome research has undoubtedly driven important scientific advances, but it also risks exaggeration. While the field holds enormous promise, much of the research remains in its early stages.

“The indiscriminate use of probiotics and reliance on microbiota analysis tests for personalized probiotic prescriptions are growing concerns,” Delgado warned. “We need to bridge the gap between basic science and clinical application. When that translation happens, it could revolutionize care for many diseases.”

Flaquer emphasized a broader issue: “There has been an overvaluation of dysbiosis and microbiota-focused treatments as cure-alls for a wide range of conditions — often subjective or lacking solid scientific correlation — such as depression, anxiety, fatigue, cancer, and even autism.”

With ongoing advances in microbiome research, understanding the impact of this complex ecosystem on human health has become essential across all medical specialties. In pediatrics, for instance, microbiota plays a critical role in immune and metabolic development, particularly in preventing conditions such as allergies and obesity.

In digestive surgery, preoperative use of probiotics has been shown to reduce complications and enhance postoperative recovery. Neurological research has highlighted the gut-brain axis as a potential factor in the development of neurodegenerative diseases. In gynecology, regulating the vaginal microbiota is key to preventing infections and complications during pregnancy.

“Given the connections between the microbiota and both intestinal and systemic diseases, every medical specialist should understand how it relates to the conditions they treat daily,” concluded Flaquer.

This story was translated from Medscape’s Portuguese edition.

Publications
Topics
Sections

Effective ways to combat harmful viruses, bacteria, fungi, and parasitic worms have driven major advances in medicine and contributed to a significant increase in human life expectancy over the past century. However, as knowledge about the role of these microorganisms in promoting and maintaining health deepens, there is a need for a new look at the impact of these treatments.

The list of drugs that can directly alter the gut microbiota is long. In addition to antibiotics, antivirals, antifungals, anthelmintics, proton pump inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), laxatives, oral antidiabetics, antidepressants, antipsychotics, statins, chemotherapeutics, and immunosuppressants can trigger dysbiosis.

2020 study published in Nature Communications, which analyzed the impact of common medications on the composition and metabolic function of the gut bacteria, showed that of the 41 classes of medications, researchers found that 19 were associated with changes in the microbiome, most notably antibiotics, proton pump inhibitors, laxatives, and metformin.

“There are still no protocols aimed at preserving the microbiota during pharmacological treatment. Future research should identify biomarkers of drug-induced dysbiosis and potentially adapt live biotherapeutics to counteract it,” said Maria Júlia Segantini, MD, a coloproctologist at the University of São Paulo, Brazil.

 

Known Facts

Antibiotics, antivirals, antifungals, and anthelmintics eliminate pathogens but can also disrupt the microbiota across the gut, skin, mouth, lungs, and genitourinary tract.

“This ecosystem is part of the innate immune system and helps to balance inflammation and homeostasis. Loss of microbial diversity alters interspecies interactions and changes nutrient availability, which can undermine the ability to fend off pathogens,” said Segantini, noting the role of microbiota in vitamin K and B-complex production.

“The microbiome may lose its ability to prevent pathogens from taking hold. This is due to the loss of microbial diversity, changes in interactions between species, and the availability of nutrients,” she added.

Antibiotics, as is well known, eliminate bacterial species indiscriminately, reduce the presence of beneficial bacteria in the gut, and, therefore, favor the growth of opportunistic pathogenic microorganisms. However, in addition to their direct effects on microorganisms, different medications can alter the intestinal microbiota through various mechanisms linked to their specific actions. Here are some examples:

Proton pump inhibitors: These can facilitate the translocation of bacteria from the mouth to the intestine and affect the metabolic functions of the intestinal microbiota. “In users of these medications, there may be an enrichment of pathways related to carbohydrate metabolism, such as glycolysis and pyruvate metabolism, indicating possible changes in intestinal metabolism,” Segantini explained.

NSAIDs: NSAIDs can modify the function and composition of the intestinal microbiota, favor the growth of pathogenic species, and reduce the diversity of preexisting bacteria by reducing the presence of beneficial commensal bacteria, such as Lactobacillus and Bifidobacterium. “This is due to changes in the permeability of the intestinal wall, due to the inhibition of prostaglandins that help maintain the integrity of the intestinal barrier, enteropathy induced by NSAIDs, and drug interactions,” said Segantini.

Laxatives: Accelerated intestinal transit using laxatives impairs the quality of the microbiota and alters bile acid. Osmotic agents, such as lactulose and polyethylene glycol, may decrease resistance to infection.

“Studies in animal models indicate that polyethylene glycol can increase the proportion of Bacteroides and reduce the abundance of Bacteroidales bacteria, with lasting repercussions on the intestinal microbiota. Stimulant laxatives, in addition to causing an acceleration of the evacuation flow, can lead to a decrease in the production of short-chain fatty acids, which are important for intestinal health,” Segantini explained.

Chemotherapeutics: Chemotherapeutic agents can significantly influence the intestinal microbiota and affect its composition, diversity, and functionality, which in turn can affect the efficacy of treatment and the occurrence of adverse effects. “5-fluorouracil led to a decrease in the abundance of beneficial anaerobic genera, such as Blautia, and an increase in opportunistic pathogens, such as Staphylococcus and Escherichia coli, during chemotherapy. In addition, it can lead to an increase in the abundance of Bacteroidetes and Proteobacteria while reducing Firmicutes and Actinobacteria. These changes can affect the function of the intestinal barrier and the immune response. Other problems related to chemotherapy-induced dysbiosis are the adverse effects themselves, such as diarrhea and mucositis,” said Segantini.

Statins: Animal studies suggest that treatment with statins, including atorvastatin, may alter the composition of the gut microbiota. “These changes include the reduction of beneficial bacteria, such as Akkermansia muciniphila, and the increase in intestinal pathogens, resulting in intestinal dysbiosis. The use of statins can affect the diversity of the intestinal microbiota, although the results vary according to the type of statin and the clinical context.”

“Statins can activate intestinal nuclear receptors, such as pregnane X receptors, which modulate the expression of genes involved in bile metabolism and the inflammatory response. This activation can contribute to changes in the intestinal microbiota and associated metabolic processes. Although statins play a fundamental role in reducing cardiovascular risk, their interactions with the intestinal microbiota can influence the efficacy of treatment and the profile of adverse effects,” said Segantini.

Immunosuppressants: The use of immunosuppressants, such as corticosteroids, tacrolimus, and mycophenolate, has been associated with changes in the composition of the intestinal microbiota. “Immunosuppressant-induced dysbiosis can compromise the intestinal barrier, increase permeability, and facilitate bacterial translocation. This can result in opportunistic infections by pathogens and post-transplant complications, such as graft rejection and post-transplant diabetes,” Segantini stated.

“Alteration of the gut microbiota by immunosuppressants may influence the host’s immune response. For example, tacrolimus has been associated with an increase in the abundance of AllobaculumBacteroides, and Lactobacillus, in addition to elevated levels of regulatory T cells in the colonic mucosa and circulation, suggesting a role in modulating gut immunity,” she said.

Antipsychotics: Antipsychotics can affect gut microbiota in several ways, influencing bacterial composition and diversity, which may contribute to adverse metabolic and gastrointestinal effects.

“Olanzapine, for example, has been shown in rodent studies to increase the abundance of Firmicutes and reduce that of Bacteroidetes, resulting in a higher Firmicutes/Bacteroidetes ratio, which is associated with weight gain and dyslipidemia,” said Segantini.

She stated that risperidone increased the abundance of Firmicutes and decreased that of Bacteroidetes in animal models, correlating with weight gain and reduced basal metabolic rate. “Fecal transfer from risperidone-treated mice to naive mice resulted in decreased metabolic rate, suggesting that the gut microbiota would mediate these effects.”

Treatment with aripiprazole increased microbial diversity and the abundance of ClostridiumPeptoclostridiumIntestinibacter, and Christensenellaceae, in addition to promoting increased intestinal permeability in animal models.

“Therefore, the use of these medications can lead to metabolic changes, such as weight gain, hyperglycemia, dyslipidemia, and hypertension. This is due to a decrease in the production of short-chain fatty acids, which are important for maintaining the integrity of the intestinal barrier. Another change frequently observed in clinical practice is constipation induced by these medications. This functional change can also generate changes in the intestinal microbiota,” she said.

Oral antidiabetic agents: Oral antidiabetic agents influence the intestinal microbiota in different ways, depending on the therapeutic class. However, not all drug interactions in the microbiome are harmful. Liraglutide, a GLP-1 receptor agonist, promotes the growth of beneficial bacteria associated with metabolism.

“Exenatide, another GLP-1 agonist, has varied effects and can increase both beneficial and inflammatory bacteria,” explained Álvaro Delgado, MD, a gastroenterologist at Hospital Alemão Oswaldo Cruz in São Paulo, Brazil.

“In humans, an increase in bacteria such as Faecalibacterium prausnitzii has been observed, with positive effects. However, more studies are needed to evaluate the clinical impacts,” he said, and that, in animal models, these changes caused by GLP-1 agonists are linked to metabolic changes, such as greater glucose tolerance.

Metformin has been linked to increased abundance of A muciniphila, a beneficial bacterium that degrades mucin and produces short-chain fatty acids. “These bacteria are associated with improved insulin sensitivity and reduced inflammation,” he said.

Segantini stated that studies in mice have shown that vildagliptin also plays a positive role in altering the composition of the intestinal microbiota, increasing the abundance of Lactobacillus and Roseburia, and reducing Oscillibacter. “This same beneficial effect is seen with the use of sitagliptin,” she said.

Studies in animal models have also indicated that empagliflozin and dapagliflozin increase the populations of short-chain fatty acid-producing bacteria, such as Bacteroides and Odoribacter, and reduce the populations of lipopolysaccharide-producing bacteria, such as Oscillibacter.

“There are still not many studies regarding the use of sulfonylureas on the intestinal microbiota, so their action on the microbiota is still controversial,” said Segantini.

Antivirals: Antiviral treatment can influence gut microbiota in complex ways, depending on the type of infection and medication used.

“Although many studies focus on the effects of viral infection on the microbiota, there is evidence that antiviral treatment can also restore the healthy composition of the microbiota, promoting additional benefits to gut and immune health,” said Segantini.

In mice with chronic hepatitis B, entecavir restored the alpha diversity of the gut microbiota, which was reduced due to infection. In addition, the recovery of beneficial bacteria, such as Akkermansia and Blautia, was observed, which was associated with the protection of the intestinal barrier and reduction of hepatic inflammation.

Studies have indicated that tenofovir may aid in the recovery of intestinal dysbiosis induced by chronic hepatitis B virus infection and promote the restoration of a healthy microbial composition.

“Specifically, an increase in Collinsella and Bifidobacterium, bacteria associated with the production of short-chain fatty acids and modulation of the immune response, was observed,” said Segantini.

The use of antiretrovirals, such as lopinavir and ritonavir, has been associated with changes in the composition of the intestinal microbiota in patients living with HIV.

“A decrease in Lachnospira, Butyricicoccus, Oscillospira, and Prevotella, bacteria that produce short-chain fatty acids that are important in intestinal health and in modulating the immune response, was observed.”

Antifungals: As a side effect, antifungals also eliminate commensal fungi, which “share intestinal niches with microbiota bacteria, balancing their immunological functions. When modified, they culminate in dysbiosis, worsening of inflammatory pathologies — such as colitis and allergic diseases — and can increase bacterial translocation,” said Segantini. 

For example, fluconazole reduces the abundance of Candida spp. while promoting the growth of fungi such as AspergillusWallemia, and Epicoccum.

“A relative increase in Firmicutes and Proteobacteria and a decrease in Bacteroidetes, Deferribacteres, Patescibacteria, and Tenericutes were also observed,” she explained.

Anthelmintics: These also affect the intestinal bacterial and fungal microbiota and alter the modulation of the immune response, in addition to having specific effects depending on the type of drug used.

 

Clinical Advice

Symptoms of dysbiosis include abdominal distension, flatulence, constipation or diarrhea, pain, fatigue, and mood swings. “The diagnosis is made based on the clinical picture, since tests such as small intestinal bacterial overgrowth, which indicate metabolites of bacteria associated with dysbiosis, specific stool tests, and microbiota mapping with GI-MAP [Gastrointestinal Microbial Assay Plus], for example, are expensive, difficult to access, and often inconclusive for diagnosis and for assessing the cause of the microbiota alteration,” explained Fernando Seefelder Flaquer, MD, a gastroenterologist at Albert Einstein Israelite Hospital in São Paulo.

When caused by medication, dysbiosis tends to be reversed naturally after discontinuation of the drug. “However, in medications with a high chance of altering the microbiota, probiotics can be used as prevention,” said Flaquer.

“To avoid problems, it is important to use antibiotics with caution and prefer, when possible, those with a reduced spectrum,” advised Delgado.

“Supplementation with probiotics and prebiotics can help maintain the balance of the microbiota, but it should be evaluated on a case-by-case basis, as its indications are still restricted at present.”

Currently, dysbiosis management relies on nutritional support and lifestyle modifications. “Physical exercise, management of psychological changes, and use of probiotics and prebiotics. In specific cases, individualized treatment may even require the administration of some types of antibiotics,” explained Segantini.

Although fecal microbiota transplantation (FMT) has been widely discussed and increasingly studied, it should still be approached with caution. While promising, FMT remains experimental for most conditions, and its use outside research settings should be carefully considered, particularly in patients who are immunocompromised or have compromised intestinal barriers.

“Currently, the treatment has stood out as promising for cases of recurrent Clostridioides difficile infection, being the only consolidated clinical indication,” said Segantini.

 

Science Hype

The interest in gut microbiome research has undoubtedly driven important scientific advances, but it also risks exaggeration. While the field holds enormous promise, much of the research remains in its early stages.

“The indiscriminate use of probiotics and reliance on microbiota analysis tests for personalized probiotic prescriptions are growing concerns,” Delgado warned. “We need to bridge the gap between basic science and clinical application. When that translation happens, it could revolutionize care for many diseases.”

Flaquer emphasized a broader issue: “There has been an overvaluation of dysbiosis and microbiota-focused treatments as cure-alls for a wide range of conditions — often subjective or lacking solid scientific correlation — such as depression, anxiety, fatigue, cancer, and even autism.”

With ongoing advances in microbiome research, understanding the impact of this complex ecosystem on human health has become essential across all medical specialties. In pediatrics, for instance, microbiota plays a critical role in immune and metabolic development, particularly in preventing conditions such as allergies and obesity.

In digestive surgery, preoperative use of probiotics has been shown to reduce complications and enhance postoperative recovery. Neurological research has highlighted the gut-brain axis as a potential factor in the development of neurodegenerative diseases. In gynecology, regulating the vaginal microbiota is key to preventing infections and complications during pregnancy.

“Given the connections between the microbiota and both intestinal and systemic diseases, every medical specialist should understand how it relates to the conditions they treat daily,” concluded Flaquer.

This story was translated from Medscape’s Portuguese edition.

Effective ways to combat harmful viruses, bacteria, fungi, and parasitic worms have driven major advances in medicine and contributed to a significant increase in human life expectancy over the past century. However, as knowledge about the role of these microorganisms in promoting and maintaining health deepens, there is a need for a new look at the impact of these treatments.

The list of drugs that can directly alter the gut microbiota is long. In addition to antibiotics, antivirals, antifungals, anthelmintics, proton pump inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), laxatives, oral antidiabetics, antidepressants, antipsychotics, statins, chemotherapeutics, and immunosuppressants can trigger dysbiosis.

2020 study published in Nature Communications, which analyzed the impact of common medications on the composition and metabolic function of the gut bacteria, showed that of the 41 classes of medications, researchers found that 19 were associated with changes in the microbiome, most notably antibiotics, proton pump inhibitors, laxatives, and metformin.

“There are still no protocols aimed at preserving the microbiota during pharmacological treatment. Future research should identify biomarkers of drug-induced dysbiosis and potentially adapt live biotherapeutics to counteract it,” said Maria Júlia Segantini, MD, a coloproctologist at the University of São Paulo, Brazil.

 

Known Facts

Antibiotics, antivirals, antifungals, and anthelmintics eliminate pathogens but can also disrupt the microbiota across the gut, skin, mouth, lungs, and genitourinary tract.

“This ecosystem is part of the innate immune system and helps to balance inflammation and homeostasis. Loss of microbial diversity alters interspecies interactions and changes nutrient availability, which can undermine the ability to fend off pathogens,” said Segantini, noting the role of microbiota in vitamin K and B-complex production.

“The microbiome may lose its ability to prevent pathogens from taking hold. This is due to the loss of microbial diversity, changes in interactions between species, and the availability of nutrients,” she added.

Antibiotics, as is well known, eliminate bacterial species indiscriminately, reduce the presence of beneficial bacteria in the gut, and, therefore, favor the growth of opportunistic pathogenic microorganisms. However, in addition to their direct effects on microorganisms, different medications can alter the intestinal microbiota through various mechanisms linked to their specific actions. Here are some examples:

Proton pump inhibitors: These can facilitate the translocation of bacteria from the mouth to the intestine and affect the metabolic functions of the intestinal microbiota. “In users of these medications, there may be an enrichment of pathways related to carbohydrate metabolism, such as glycolysis and pyruvate metabolism, indicating possible changes in intestinal metabolism,” Segantini explained.

NSAIDs: NSAIDs can modify the function and composition of the intestinal microbiota, favor the growth of pathogenic species, and reduce the diversity of preexisting bacteria by reducing the presence of beneficial commensal bacteria, such as Lactobacillus and Bifidobacterium. “This is due to changes in the permeability of the intestinal wall, due to the inhibition of prostaglandins that help maintain the integrity of the intestinal barrier, enteropathy induced by NSAIDs, and drug interactions,” said Segantini.

Laxatives: Accelerated intestinal transit using laxatives impairs the quality of the microbiota and alters bile acid. Osmotic agents, such as lactulose and polyethylene glycol, may decrease resistance to infection.

“Studies in animal models indicate that polyethylene glycol can increase the proportion of Bacteroides and reduce the abundance of Bacteroidales bacteria, with lasting repercussions on the intestinal microbiota. Stimulant laxatives, in addition to causing an acceleration of the evacuation flow, can lead to a decrease in the production of short-chain fatty acids, which are important for intestinal health,” Segantini explained.

Chemotherapeutics: Chemotherapeutic agents can significantly influence the intestinal microbiota and affect its composition, diversity, and functionality, which in turn can affect the efficacy of treatment and the occurrence of adverse effects. “5-fluorouracil led to a decrease in the abundance of beneficial anaerobic genera, such as Blautia, and an increase in opportunistic pathogens, such as Staphylococcus and Escherichia coli, during chemotherapy. In addition, it can lead to an increase in the abundance of Bacteroidetes and Proteobacteria while reducing Firmicutes and Actinobacteria. These changes can affect the function of the intestinal barrier and the immune response. Other problems related to chemotherapy-induced dysbiosis are the adverse effects themselves, such as diarrhea and mucositis,” said Segantini.

Statins: Animal studies suggest that treatment with statins, including atorvastatin, may alter the composition of the gut microbiota. “These changes include the reduction of beneficial bacteria, such as Akkermansia muciniphila, and the increase in intestinal pathogens, resulting in intestinal dysbiosis. The use of statins can affect the diversity of the intestinal microbiota, although the results vary according to the type of statin and the clinical context.”

“Statins can activate intestinal nuclear receptors, such as pregnane X receptors, which modulate the expression of genes involved in bile metabolism and the inflammatory response. This activation can contribute to changes in the intestinal microbiota and associated metabolic processes. Although statins play a fundamental role in reducing cardiovascular risk, their interactions with the intestinal microbiota can influence the efficacy of treatment and the profile of adverse effects,” said Segantini.

Immunosuppressants: The use of immunosuppressants, such as corticosteroids, tacrolimus, and mycophenolate, has been associated with changes in the composition of the intestinal microbiota. “Immunosuppressant-induced dysbiosis can compromise the intestinal barrier, increase permeability, and facilitate bacterial translocation. This can result in opportunistic infections by pathogens and post-transplant complications, such as graft rejection and post-transplant diabetes,” Segantini stated.

“Alteration of the gut microbiota by immunosuppressants may influence the host’s immune response. For example, tacrolimus has been associated with an increase in the abundance of AllobaculumBacteroides, and Lactobacillus, in addition to elevated levels of regulatory T cells in the colonic mucosa and circulation, suggesting a role in modulating gut immunity,” she said.

Antipsychotics: Antipsychotics can affect gut microbiota in several ways, influencing bacterial composition and diversity, which may contribute to adverse metabolic and gastrointestinal effects.

“Olanzapine, for example, has been shown in rodent studies to increase the abundance of Firmicutes and reduce that of Bacteroidetes, resulting in a higher Firmicutes/Bacteroidetes ratio, which is associated with weight gain and dyslipidemia,” said Segantini.

She stated that risperidone increased the abundance of Firmicutes and decreased that of Bacteroidetes in animal models, correlating with weight gain and reduced basal metabolic rate. “Fecal transfer from risperidone-treated mice to naive mice resulted in decreased metabolic rate, suggesting that the gut microbiota would mediate these effects.”

Treatment with aripiprazole increased microbial diversity and the abundance of ClostridiumPeptoclostridiumIntestinibacter, and Christensenellaceae, in addition to promoting increased intestinal permeability in animal models.

“Therefore, the use of these medications can lead to metabolic changes, such as weight gain, hyperglycemia, dyslipidemia, and hypertension. This is due to a decrease in the production of short-chain fatty acids, which are important for maintaining the integrity of the intestinal barrier. Another change frequently observed in clinical practice is constipation induced by these medications. This functional change can also generate changes in the intestinal microbiota,” she said.

Oral antidiabetic agents: Oral antidiabetic agents influence the intestinal microbiota in different ways, depending on the therapeutic class. However, not all drug interactions in the microbiome are harmful. Liraglutide, a GLP-1 receptor agonist, promotes the growth of beneficial bacteria associated with metabolism.

“Exenatide, another GLP-1 agonist, has varied effects and can increase both beneficial and inflammatory bacteria,” explained Álvaro Delgado, MD, a gastroenterologist at Hospital Alemão Oswaldo Cruz in São Paulo, Brazil.

“In humans, an increase in bacteria such as Faecalibacterium prausnitzii has been observed, with positive effects. However, more studies are needed to evaluate the clinical impacts,” he said, and that, in animal models, these changes caused by GLP-1 agonists are linked to metabolic changes, such as greater glucose tolerance.

Metformin has been linked to increased abundance of A muciniphila, a beneficial bacterium that degrades mucin and produces short-chain fatty acids. “These bacteria are associated with improved insulin sensitivity and reduced inflammation,” he said.

Segantini stated that studies in mice have shown that vildagliptin also plays a positive role in altering the composition of the intestinal microbiota, increasing the abundance of Lactobacillus and Roseburia, and reducing Oscillibacter. “This same beneficial effect is seen with the use of sitagliptin,” she said.

Studies in animal models have also indicated that empagliflozin and dapagliflozin increase the populations of short-chain fatty acid-producing bacteria, such as Bacteroides and Odoribacter, and reduce the populations of lipopolysaccharide-producing bacteria, such as Oscillibacter.

“There are still not many studies regarding the use of sulfonylureas on the intestinal microbiota, so their action on the microbiota is still controversial,” said Segantini.

Antivirals: Antiviral treatment can influence gut microbiota in complex ways, depending on the type of infection and medication used.

“Although many studies focus on the effects of viral infection on the microbiota, there is evidence that antiviral treatment can also restore the healthy composition of the microbiota, promoting additional benefits to gut and immune health,” said Segantini.

In mice with chronic hepatitis B, entecavir restored the alpha diversity of the gut microbiota, which was reduced due to infection. In addition, the recovery of beneficial bacteria, such as Akkermansia and Blautia, was observed, which was associated with the protection of the intestinal barrier and reduction of hepatic inflammation.

Studies have indicated that tenofovir may aid in the recovery of intestinal dysbiosis induced by chronic hepatitis B virus infection and promote the restoration of a healthy microbial composition.

“Specifically, an increase in Collinsella and Bifidobacterium, bacteria associated with the production of short-chain fatty acids and modulation of the immune response, was observed,” said Segantini.

The use of antiretrovirals, such as lopinavir and ritonavir, has been associated with changes in the composition of the intestinal microbiota in patients living with HIV.

“A decrease in Lachnospira, Butyricicoccus, Oscillospira, and Prevotella, bacteria that produce short-chain fatty acids that are important in intestinal health and in modulating the immune response, was observed.”

Antifungals: As a side effect, antifungals also eliminate commensal fungi, which “share intestinal niches with microbiota bacteria, balancing their immunological functions. When modified, they culminate in dysbiosis, worsening of inflammatory pathologies — such as colitis and allergic diseases — and can increase bacterial translocation,” said Segantini. 

For example, fluconazole reduces the abundance of Candida spp. while promoting the growth of fungi such as AspergillusWallemia, and Epicoccum.

“A relative increase in Firmicutes and Proteobacteria and a decrease in Bacteroidetes, Deferribacteres, Patescibacteria, and Tenericutes were also observed,” she explained.

Anthelmintics: These also affect the intestinal bacterial and fungal microbiota and alter the modulation of the immune response, in addition to having specific effects depending on the type of drug used.

 

Clinical Advice

Symptoms of dysbiosis include abdominal distension, flatulence, constipation or diarrhea, pain, fatigue, and mood swings. “The diagnosis is made based on the clinical picture, since tests such as small intestinal bacterial overgrowth, which indicate metabolites of bacteria associated with dysbiosis, specific stool tests, and microbiota mapping with GI-MAP [Gastrointestinal Microbial Assay Plus], for example, are expensive, difficult to access, and often inconclusive for diagnosis and for assessing the cause of the microbiota alteration,” explained Fernando Seefelder Flaquer, MD, a gastroenterologist at Albert Einstein Israelite Hospital in São Paulo.

When caused by medication, dysbiosis tends to be reversed naturally after discontinuation of the drug. “However, in medications with a high chance of altering the microbiota, probiotics can be used as prevention,” said Flaquer.

“To avoid problems, it is important to use antibiotics with caution and prefer, when possible, those with a reduced spectrum,” advised Delgado.

“Supplementation with probiotics and prebiotics can help maintain the balance of the microbiota, but it should be evaluated on a case-by-case basis, as its indications are still restricted at present.”

Currently, dysbiosis management relies on nutritional support and lifestyle modifications. “Physical exercise, management of psychological changes, and use of probiotics and prebiotics. In specific cases, individualized treatment may even require the administration of some types of antibiotics,” explained Segantini.

Although fecal microbiota transplantation (FMT) has been widely discussed and increasingly studied, it should still be approached with caution. While promising, FMT remains experimental for most conditions, and its use outside research settings should be carefully considered, particularly in patients who are immunocompromised or have compromised intestinal barriers.

“Currently, the treatment has stood out as promising for cases of recurrent Clostridioides difficile infection, being the only consolidated clinical indication,” said Segantini.

 

Science Hype

The interest in gut microbiome research has undoubtedly driven important scientific advances, but it also risks exaggeration. While the field holds enormous promise, much of the research remains in its early stages.

“The indiscriminate use of probiotics and reliance on microbiota analysis tests for personalized probiotic prescriptions are growing concerns,” Delgado warned. “We need to bridge the gap between basic science and clinical application. When that translation happens, it could revolutionize care for many diseases.”

Flaquer emphasized a broader issue: “There has been an overvaluation of dysbiosis and microbiota-focused treatments as cure-alls for a wide range of conditions — often subjective or lacking solid scientific correlation — such as depression, anxiety, fatigue, cancer, and even autism.”

With ongoing advances in microbiome research, understanding the impact of this complex ecosystem on human health has become essential across all medical specialties. In pediatrics, for instance, microbiota plays a critical role in immune and metabolic development, particularly in preventing conditions such as allergies and obesity.

In digestive surgery, preoperative use of probiotics has been shown to reduce complications and enhance postoperative recovery. Neurological research has highlighted the gut-brain axis as a potential factor in the development of neurodegenerative diseases. In gynecology, regulating the vaginal microbiota is key to preventing infections and complications during pregnancy.

“Given the connections between the microbiota and both intestinal and systemic diseases, every medical specialist should understand how it relates to the conditions they treat daily,” concluded Flaquer.

This story was translated from Medscape’s Portuguese edition.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Thu, 07/10/2025 - 09:29
Un-Gate On Date
Thu, 07/10/2025 - 09:29
Use ProPublica
CFC Schedule Remove Status
Thu, 07/10/2025 - 09:29
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Thu, 07/10/2025 - 09:29

Help Sustain GI Research

Article Type
Changed
Wed, 07/09/2025 - 16:52

Scientists are working hard to develop new treatments and therapies, and to discover cures to advance the field and better patient care. But they can’t do this without research funding.

A lack of funding can prevent talented individuals from pursuing a research career, thereby denying them the opportunity to conduct work that will ultimately benefit patients with critical needs.  

Donations to the AGA Research Foundation help support and fund investigators with a research grant in the field of gastroenterology and hepatology.

Treatment options for digestive diseases begin with rigorous research, but the limited funding available for physician-scientists to conduct research puts the field at risk of losing talented investigators.

As an AGA member, you have the power to make a difference. By increasing the number of talented women and men doing state-of-the-art research, you can help improve care for all patients suffering from digestive diseases.

Your gift to the AGA Research Foundation will catalyze discovery and career growth for a promising researcher in gastroenterology and hepatology. Please help us fund the next generation of GI researchers by donating today at https://foundation.gastro.org.







 

Publications
Topics
Sections

Scientists are working hard to develop new treatments and therapies, and to discover cures to advance the field and better patient care. But they can’t do this without research funding.

A lack of funding can prevent talented individuals from pursuing a research career, thereby denying them the opportunity to conduct work that will ultimately benefit patients with critical needs.  

Donations to the AGA Research Foundation help support and fund investigators with a research grant in the field of gastroenterology and hepatology.

Treatment options for digestive diseases begin with rigorous research, but the limited funding available for physician-scientists to conduct research puts the field at risk of losing talented investigators.

As an AGA member, you have the power to make a difference. By increasing the number of talented women and men doing state-of-the-art research, you can help improve care for all patients suffering from digestive diseases.

Your gift to the AGA Research Foundation will catalyze discovery and career growth for a promising researcher in gastroenterology and hepatology. Please help us fund the next generation of GI researchers by donating today at https://foundation.gastro.org.







 

Scientists are working hard to develop new treatments and therapies, and to discover cures to advance the field and better patient care. But they can’t do this without research funding.

A lack of funding can prevent talented individuals from pursuing a research career, thereby denying them the opportunity to conduct work that will ultimately benefit patients with critical needs.  

Donations to the AGA Research Foundation help support and fund investigators with a research grant in the field of gastroenterology and hepatology.

Treatment options for digestive diseases begin with rigorous research, but the limited funding available for physician-scientists to conduct research puts the field at risk of losing talented investigators.

As an AGA member, you have the power to make a difference. By increasing the number of talented women and men doing state-of-the-art research, you can help improve care for all patients suffering from digestive diseases.

Your gift to the AGA Research Foundation will catalyze discovery and career growth for a promising researcher in gastroenterology and hepatology. Please help us fund the next generation of GI researchers by donating today at https://foundation.gastro.org.







 

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 07/09/2025 - 14:23
Un-Gate On Date
Wed, 07/09/2025 - 14:23
Use ProPublica
CFC Schedule Remove Status
Wed, 07/09/2025 - 14:23
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Wed, 07/09/2025 - 14:23

State-Mandated ‘Gold Card’ Programs to Ease Prior Authorization Burdens Offer Little Relief, Experts Say

Article Type
Changed
Wed, 07/09/2025 - 09:46

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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

Publications
Topics
Sections

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 07/09/2025 - 09:45
Un-Gate On Date
Wed, 07/09/2025 - 09:45
Use ProPublica
CFC Schedule Remove Status
Wed, 07/09/2025 - 09:45
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Wed, 07/09/2025 - 09:45

Are Breast Cancer Survivors Vulnerable to Alzheimer’s Disease?

Article Type
Changed
Wed, 07/09/2025 - 09:42

Despite concerns about cognitive decline after cancer treatment, most breast cancer survivors show no increased risk of developing Alzheimer’s disease, and some may have a slightly lower risk than their cancer-free peers, according to a large retrospective study from Korea.

However, any apparent protective effect faded with time, the investigators reported online in JAMA Network Open.

Overall, this is “reassuring news for cancer survivors,” Tim Ahles, PhD, a psychologist with Memorial Sloan Kettering Cancer Center, New York City, who wasn’t involved in the study, told  this news organization.

“I get this question from patients a lot,” Ahles said. And based on these findings, “it doesn’t look like a history of breast cancer and breast cancer treatment increases your risk for Alzheimer’s disease.”

Breast cancer survivors often report cancer-related cognitive impairment, such as difficulties with concentration and memory, both during and after cancer treatment. But evidence surrounding patients’ risk for Alzheimer’s disease is mixed. One large study based in Sweden, for instance, reported a 35% increased risk for Alzheimer’s disease among patients diagnosed with breast cancer after the age of 65 years, but not among younger patients. A population-based study from Taiwan, however, found no increase in the risk for dementia overall compared with cancer-free individuals but did note a lower dementia risk in patients who had received tamoxifen.

To help clarify the evidence, investigators assessed Alzheimer’s disease risk in a large cohort of patients and explored the association by treatment type, age, and important risk factors.

Using the Korean National Health Insurance Service database, the researchers matched 70,701 patients who underwent breast cancer surgery between 2010 and 2016 with 180,360 cancer-free control individuals.

The mean age of breast cancer survivors was 53.1 years. Overall, 72% received radiotherapy. Cyclophosphamide (57%) and anthracycline (50%) were the most commonly used chemotherapies, and tamoxifen (47%) and aromatase inhibitors (30%) were the most commonly used endocrine therapies.

The primary outcome of this study was the incidence of newly diagnosed Alzheimer’s disease, which was defined on the basis of at least one prescription for medications to manage dementia associated with Alzheimer’s disease (donepezil, rivastigmine, galantamine, or memantine).

During a median follow-up of about 7 years, 1229 newly diagnosed Alzheimer’s disease cases were detected in breast cancer survivors and 3430 cases in control individuals — incidence rates of 2.45 and 2.63 per 1000 person-years, respectively.

This corresponded to an 8% lower risk for Alzheimer’s disease in breast cancer survivors compared with cancer-free control individuals at 6 months (subdistribution hazard ratio [SHR], 0.92; 95% CI, 0.86-0.98). The association was especially notable in survivors older than 65 years (SHR, 0.92; 95% CI, 0.85-0.99).

Looking at individual treatment modalities, only radiation therapy was associated with significantly lower risk for Alzheimer’s disease among breast cancer survivors (adjusted HR [aHR], 0.77).

Several risk factors were associated with a significantly higher risk for Alzheimer’s disease: current smoker vs never or ex-smokers (aHR, 2.04), diabetes (aHR, 1.58), and chronic kidney disease (aHR, 3.11). Notably, alcohol use, physical activity level, and hypertension were not associated with Alzheimer’s disease risk.

However, any potential protective effect may be short-lived. The reduced risk for Alzheimer’s disease was no longer significant at 1 year (SHR, 0.94; 95% CI, 0.87-1.01), 3 years (SHR, 0.97; 95% CI, 0.90-1.05), or 5 years (SHR, 0.98; 95% CI, 0.89-1.08).

Even so, breast cancer survivors can still feel reassured by the findings.

“Concerns about chemobrain and the long-term adverse effects of breast cancer treatment on cognition are common, but our findings suggest that this treatment does not directly lead to Alzheimer’s disease,” wrote the authors, led by Su-Min Jeong, MD, with Seoul National University College of Medicine, Seoul, South Korea.

Ahles agreed. The general takeaway from this study is that there is “no strong evidence that the cancer treatment is going to increase your risk for developing Alzheimer’s,” Ahles said. When patients ask about the risk for Alzheimer’s disease, “I can say, ‘Here’s yet another new study that supports the idea that there’s no increased risk.’”

He cautioned, however, that the study doesn’t address whether people with a genetic predisposition to Alzheimer’s might develop it sooner due to cancer treatment.

“Does the cancer treatment increase your probability or nudge you along? The study doesn’t answer that question,” Ahles said.

The study reported having no commercial funding. Jeong and Ahles reported having no relevant disclosures.

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

Publications
Topics
Sections

Despite concerns about cognitive decline after cancer treatment, most breast cancer survivors show no increased risk of developing Alzheimer’s disease, and some may have a slightly lower risk than their cancer-free peers, according to a large retrospective study from Korea.

However, any apparent protective effect faded with time, the investigators reported online in JAMA Network Open.

Overall, this is “reassuring news for cancer survivors,” Tim Ahles, PhD, a psychologist with Memorial Sloan Kettering Cancer Center, New York City, who wasn’t involved in the study, told  this news organization.

“I get this question from patients a lot,” Ahles said. And based on these findings, “it doesn’t look like a history of breast cancer and breast cancer treatment increases your risk for Alzheimer’s disease.”

Breast cancer survivors often report cancer-related cognitive impairment, such as difficulties with concentration and memory, both during and after cancer treatment. But evidence surrounding patients’ risk for Alzheimer’s disease is mixed. One large study based in Sweden, for instance, reported a 35% increased risk for Alzheimer’s disease among patients diagnosed with breast cancer after the age of 65 years, but not among younger patients. A population-based study from Taiwan, however, found no increase in the risk for dementia overall compared with cancer-free individuals but did note a lower dementia risk in patients who had received tamoxifen.

To help clarify the evidence, investigators assessed Alzheimer’s disease risk in a large cohort of patients and explored the association by treatment type, age, and important risk factors.

Using the Korean National Health Insurance Service database, the researchers matched 70,701 patients who underwent breast cancer surgery between 2010 and 2016 with 180,360 cancer-free control individuals.

The mean age of breast cancer survivors was 53.1 years. Overall, 72% received radiotherapy. Cyclophosphamide (57%) and anthracycline (50%) were the most commonly used chemotherapies, and tamoxifen (47%) and aromatase inhibitors (30%) were the most commonly used endocrine therapies.

The primary outcome of this study was the incidence of newly diagnosed Alzheimer’s disease, which was defined on the basis of at least one prescription for medications to manage dementia associated with Alzheimer’s disease (donepezil, rivastigmine, galantamine, or memantine).

During a median follow-up of about 7 years, 1229 newly diagnosed Alzheimer’s disease cases were detected in breast cancer survivors and 3430 cases in control individuals — incidence rates of 2.45 and 2.63 per 1000 person-years, respectively.

This corresponded to an 8% lower risk for Alzheimer’s disease in breast cancer survivors compared with cancer-free control individuals at 6 months (subdistribution hazard ratio [SHR], 0.92; 95% CI, 0.86-0.98). The association was especially notable in survivors older than 65 years (SHR, 0.92; 95% CI, 0.85-0.99).

Looking at individual treatment modalities, only radiation therapy was associated with significantly lower risk for Alzheimer’s disease among breast cancer survivors (adjusted HR [aHR], 0.77).

Several risk factors were associated with a significantly higher risk for Alzheimer’s disease: current smoker vs never or ex-smokers (aHR, 2.04), diabetes (aHR, 1.58), and chronic kidney disease (aHR, 3.11). Notably, alcohol use, physical activity level, and hypertension were not associated with Alzheimer’s disease risk.

However, any potential protective effect may be short-lived. The reduced risk for Alzheimer’s disease was no longer significant at 1 year (SHR, 0.94; 95% CI, 0.87-1.01), 3 years (SHR, 0.97; 95% CI, 0.90-1.05), or 5 years (SHR, 0.98; 95% CI, 0.89-1.08).

Even so, breast cancer survivors can still feel reassured by the findings.

“Concerns about chemobrain and the long-term adverse effects of breast cancer treatment on cognition are common, but our findings suggest that this treatment does not directly lead to Alzheimer’s disease,” wrote the authors, led by Su-Min Jeong, MD, with Seoul National University College of Medicine, Seoul, South Korea.

Ahles agreed. The general takeaway from this study is that there is “no strong evidence that the cancer treatment is going to increase your risk for developing Alzheimer’s,” Ahles said. When patients ask about the risk for Alzheimer’s disease, “I can say, ‘Here’s yet another new study that supports the idea that there’s no increased risk.’”

He cautioned, however, that the study doesn’t address whether people with a genetic predisposition to Alzheimer’s might develop it sooner due to cancer treatment.

“Does the cancer treatment increase your probability or nudge you along? The study doesn’t answer that question,” Ahles said.

The study reported having no commercial funding. Jeong and Ahles reported having no relevant disclosures.

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

Despite concerns about cognitive decline after cancer treatment, most breast cancer survivors show no increased risk of developing Alzheimer’s disease, and some may have a slightly lower risk than their cancer-free peers, according to a large retrospective study from Korea.

However, any apparent protective effect faded with time, the investigators reported online in JAMA Network Open.

Overall, this is “reassuring news for cancer survivors,” Tim Ahles, PhD, a psychologist with Memorial Sloan Kettering Cancer Center, New York City, who wasn’t involved in the study, told  this news organization.

“I get this question from patients a lot,” Ahles said. And based on these findings, “it doesn’t look like a history of breast cancer and breast cancer treatment increases your risk for Alzheimer’s disease.”

Breast cancer survivors often report cancer-related cognitive impairment, such as difficulties with concentration and memory, both during and after cancer treatment. But evidence surrounding patients’ risk for Alzheimer’s disease is mixed. One large study based in Sweden, for instance, reported a 35% increased risk for Alzheimer’s disease among patients diagnosed with breast cancer after the age of 65 years, but not among younger patients. A population-based study from Taiwan, however, found no increase in the risk for dementia overall compared with cancer-free individuals but did note a lower dementia risk in patients who had received tamoxifen.

To help clarify the evidence, investigators assessed Alzheimer’s disease risk in a large cohort of patients and explored the association by treatment type, age, and important risk factors.

Using the Korean National Health Insurance Service database, the researchers matched 70,701 patients who underwent breast cancer surgery between 2010 and 2016 with 180,360 cancer-free control individuals.

The mean age of breast cancer survivors was 53.1 years. Overall, 72% received radiotherapy. Cyclophosphamide (57%) and anthracycline (50%) were the most commonly used chemotherapies, and tamoxifen (47%) and aromatase inhibitors (30%) were the most commonly used endocrine therapies.

The primary outcome of this study was the incidence of newly diagnosed Alzheimer’s disease, which was defined on the basis of at least one prescription for medications to manage dementia associated with Alzheimer’s disease (donepezil, rivastigmine, galantamine, or memantine).

During a median follow-up of about 7 years, 1229 newly diagnosed Alzheimer’s disease cases were detected in breast cancer survivors and 3430 cases in control individuals — incidence rates of 2.45 and 2.63 per 1000 person-years, respectively.

This corresponded to an 8% lower risk for Alzheimer’s disease in breast cancer survivors compared with cancer-free control individuals at 6 months (subdistribution hazard ratio [SHR], 0.92; 95% CI, 0.86-0.98). The association was especially notable in survivors older than 65 years (SHR, 0.92; 95% CI, 0.85-0.99).

Looking at individual treatment modalities, only radiation therapy was associated with significantly lower risk for Alzheimer’s disease among breast cancer survivors (adjusted HR [aHR], 0.77).

Several risk factors were associated with a significantly higher risk for Alzheimer’s disease: current smoker vs never or ex-smokers (aHR, 2.04), diabetes (aHR, 1.58), and chronic kidney disease (aHR, 3.11). Notably, alcohol use, physical activity level, and hypertension were not associated with Alzheimer’s disease risk.

However, any potential protective effect may be short-lived. The reduced risk for Alzheimer’s disease was no longer significant at 1 year (SHR, 0.94; 95% CI, 0.87-1.01), 3 years (SHR, 0.97; 95% CI, 0.90-1.05), or 5 years (SHR, 0.98; 95% CI, 0.89-1.08).

Even so, breast cancer survivors can still feel reassured by the findings.

“Concerns about chemobrain and the long-term adverse effects of breast cancer treatment on cognition are common, but our findings suggest that this treatment does not directly lead to Alzheimer’s disease,” wrote the authors, led by Su-Min Jeong, MD, with Seoul National University College of Medicine, Seoul, South Korea.

Ahles agreed. The general takeaway from this study is that there is “no strong evidence that the cancer treatment is going to increase your risk for developing Alzheimer’s,” Ahles said. When patients ask about the risk for Alzheimer’s disease, “I can say, ‘Here’s yet another new study that supports the idea that there’s no increased risk.’”

He cautioned, however, that the study doesn’t address whether people with a genetic predisposition to Alzheimer’s might develop it sooner due to cancer treatment.

“Does the cancer treatment increase your probability or nudge you along? The study doesn’t answer that question,” Ahles said.

The study reported having no commercial funding. Jeong and Ahles reported having no relevant disclosures.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 07/09/2025 - 09:41
Un-Gate On Date
Wed, 07/09/2025 - 09:41
Use ProPublica
CFC Schedule Remove Status
Wed, 07/09/2025 - 09:41
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Wed, 07/09/2025 - 09:41

Paclitaxel Matches Cisplatin HIPEC in Ovarian Cancer

Article Type
Changed
Wed, 07/09/2025 - 09:38

TOPLINE:

Patients with advanced ovarian cancer undergoing interval cytoreductive surgery who received paclitaxel-based hyperthermic intraperitoneal chemotherapy (HIPEC) during surgery appeared to have comparable overall survival and disease-free survival rates to those who received cisplatin-based HIPEC.

METHODOLOGY:

  • Although the use of HIPEC remains controversial, cisplatin-based HIPEC during cytoreductive surgery may benefit patients with advanced ovarian cancer; however, there is less evidence for paclitaxel-based HIPEC, typically used in patients who are frail or intolerant to platinum agents.
  • To compare the two regimens, researchers analyzed data from the National Registry of Peritoneal Carcinomatosis, which included 846 patients (mean age, 59 years) who underwent interval cytoreductive surgery with either cisplatin-based HIPEC (n = 325) or paclitaxel-based HIPEC (n = 521). After propensity score matching, there were 199 patients per group (total = 398).
  • HIPEC was administered post-surgery with cisplatin (75-100 mg/m2 for 90 minutes) or paclitaxel (120 mg/m2 for 60 minutes), both at 42-43 °C.

TAKEAWAY:

  • Using cisplatin as the reference group, the median overall survival was not significantly different between the two options (hazard ratio [HR], 0.74; P = .16); however, the median overall survival was 82 months in the paclitaxel group vs 58 months in the cisplatin group.
  • Disease-free survival was also not significantly different between the 2 groups, with a median of 20 months in the cisplatin group and 21 months in the paclitaxel groups (HR, 0.95; 95% CI, 0.72-1.25; P = .70).
  • Overall survival was comparable during the first 20 months of follow-up and disease-free survival was equivalent during the first 15 months of follow-up, based on a predefined equivalence margin of 0.1.
  • Paclitaxel-based HIPEC was not associated with increased morbidity (odds ratio, 1.32; P = .06).

IN PRACTICE:

“Our study suggests that cisplatin and paclitaxel are two safe and effective drugs to be used for HIPEC in [interval cytoreductive surgery] for advanced ovarian cancer. As cisplatin is the preferred drug according to strong evidence, paclitaxel could be a valuable alternative for patients with any contraindication to cisplatin, with similar oncological and perioperative outcomes,” the authors wrote.

SOURCE:

This study, led by Salud González Sánchez, MD, Reina Sofía University Hospital in Córdoba, Spain, was published online in JAMA Network Open.

LIMITATIONS:

The retrospective design of this study limited causal inference. The BRCA mutation status was not captured in the national registry. Additionally, the matching procedure resulted in a moderate sample size, which could have led to residual confounding.

DISCLOSURES:

The authors did not declare any funding information and reported no relevant conflicts of interest.

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.

Publications
Topics
Sections

TOPLINE:

Patients with advanced ovarian cancer undergoing interval cytoreductive surgery who received paclitaxel-based hyperthermic intraperitoneal chemotherapy (HIPEC) during surgery appeared to have comparable overall survival and disease-free survival rates to those who received cisplatin-based HIPEC.

METHODOLOGY:

  • Although the use of HIPEC remains controversial, cisplatin-based HIPEC during cytoreductive surgery may benefit patients with advanced ovarian cancer; however, there is less evidence for paclitaxel-based HIPEC, typically used in patients who are frail or intolerant to platinum agents.
  • To compare the two regimens, researchers analyzed data from the National Registry of Peritoneal Carcinomatosis, which included 846 patients (mean age, 59 years) who underwent interval cytoreductive surgery with either cisplatin-based HIPEC (n = 325) or paclitaxel-based HIPEC (n = 521). After propensity score matching, there were 199 patients per group (total = 398).
  • HIPEC was administered post-surgery with cisplatin (75-100 mg/m2 for 90 minutes) or paclitaxel (120 mg/m2 for 60 minutes), both at 42-43 °C.

TAKEAWAY:

  • Using cisplatin as the reference group, the median overall survival was not significantly different between the two options (hazard ratio [HR], 0.74; P = .16); however, the median overall survival was 82 months in the paclitaxel group vs 58 months in the cisplatin group.
  • Disease-free survival was also not significantly different between the 2 groups, with a median of 20 months in the cisplatin group and 21 months in the paclitaxel groups (HR, 0.95; 95% CI, 0.72-1.25; P = .70).
  • Overall survival was comparable during the first 20 months of follow-up and disease-free survival was equivalent during the first 15 months of follow-up, based on a predefined equivalence margin of 0.1.
  • Paclitaxel-based HIPEC was not associated with increased morbidity (odds ratio, 1.32; P = .06).

IN PRACTICE:

“Our study suggests that cisplatin and paclitaxel are two safe and effective drugs to be used for HIPEC in [interval cytoreductive surgery] for advanced ovarian cancer. As cisplatin is the preferred drug according to strong evidence, paclitaxel could be a valuable alternative for patients with any contraindication to cisplatin, with similar oncological and perioperative outcomes,” the authors wrote.

SOURCE:

This study, led by Salud González Sánchez, MD, Reina Sofía University Hospital in Córdoba, Spain, was published online in JAMA Network Open.

LIMITATIONS:

The retrospective design of this study limited causal inference. The BRCA mutation status was not captured in the national registry. Additionally, the matching procedure resulted in a moderate sample size, which could have led to residual confounding.

DISCLOSURES:

The authors did not declare any funding information and reported no relevant conflicts of interest.

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:

Patients with advanced ovarian cancer undergoing interval cytoreductive surgery who received paclitaxel-based hyperthermic intraperitoneal chemotherapy (HIPEC) during surgery appeared to have comparable overall survival and disease-free survival rates to those who received cisplatin-based HIPEC.

METHODOLOGY:

  • Although the use of HIPEC remains controversial, cisplatin-based HIPEC during cytoreductive surgery may benefit patients with advanced ovarian cancer; however, there is less evidence for paclitaxel-based HIPEC, typically used in patients who are frail or intolerant to platinum agents.
  • To compare the two regimens, researchers analyzed data from the National Registry of Peritoneal Carcinomatosis, which included 846 patients (mean age, 59 years) who underwent interval cytoreductive surgery with either cisplatin-based HIPEC (n = 325) or paclitaxel-based HIPEC (n = 521). After propensity score matching, there were 199 patients per group (total = 398).
  • HIPEC was administered post-surgery with cisplatin (75-100 mg/m2 for 90 minutes) or paclitaxel (120 mg/m2 for 60 minutes), both at 42-43 °C.

TAKEAWAY:

  • Using cisplatin as the reference group, the median overall survival was not significantly different between the two options (hazard ratio [HR], 0.74; P = .16); however, the median overall survival was 82 months in the paclitaxel group vs 58 months in the cisplatin group.
  • Disease-free survival was also not significantly different between the 2 groups, with a median of 20 months in the cisplatin group and 21 months in the paclitaxel groups (HR, 0.95; 95% CI, 0.72-1.25; P = .70).
  • Overall survival was comparable during the first 20 months of follow-up and disease-free survival was equivalent during the first 15 months of follow-up, based on a predefined equivalence margin of 0.1.
  • Paclitaxel-based HIPEC was not associated with increased morbidity (odds ratio, 1.32; P = .06).

IN PRACTICE:

“Our study suggests that cisplatin and paclitaxel are two safe and effective drugs to be used for HIPEC in [interval cytoreductive surgery] for advanced ovarian cancer. As cisplatin is the preferred drug according to strong evidence, paclitaxel could be a valuable alternative for patients with any contraindication to cisplatin, with similar oncological and perioperative outcomes,” the authors wrote.

SOURCE:

This study, led by Salud González Sánchez, MD, Reina Sofía University Hospital in Córdoba, Spain, was published online in JAMA Network Open.

LIMITATIONS:

The retrospective design of this study limited causal inference. The BRCA mutation status was not captured in the national registry. Additionally, the matching procedure resulted in a moderate sample size, which could have led to residual confounding.

DISCLOSURES:

The authors did not declare any funding information and reported no relevant conflicts of interest.

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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 07/09/2025 - 09:36
Un-Gate On Date
Wed, 07/09/2025 - 09:36
Use ProPublica
CFC Schedule Remove Status
Wed, 07/09/2025 - 09:36
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Wed, 07/09/2025 - 09:36

VA To Lose 30K Positions Via Attrition, No RIFs Planned

Article Type
Changed
Thu, 07/24/2025 - 13:13

The initial plan to reduce the US Department of Veterans Affairs (VA) workforce by 15%—roughly 83,000 employees—has been revised. The VA announced that it expected to reduce its workforce by 30,000 positions through normal attrition, early retirements, and resignations by the end of fiscal year 2025, “eliminating the need for a large-scale reduction-in-force.” Most of the positions will not be replaced due to the federal hiring freeze, which has been extended for 3 months.

“Since March, we’ve been conducting a holistic review of the department centered on reducing bureaucracy and improving services to Veterans,” VA Secretary Doug Collins said in a press release. “A department-wide RIF is off the table, but that doesn’t mean we’re done improving VA.”

About 17,000 VA employees have left their jobs as of June 1. From now and Sept. 30, the department expects another reduction of nearly 12,000. Pete Kasperowicz, a VA spokesperson, said there would not be any reductions beyond the 30,000 planned.

The VA says it has multiple safeguards in place to ensure the reductions do not impact veteran care or benefits. All VA mission-critical positions are exempt from the voluntary early retirement authority and deferred resignation program, and > 350,000 positions are exempt from the federal hiring freeze. 

The release noted several other improvements regarding VA performance in 2025, among them that the disability claims backlog has been reduced by 30% and a record 2 million disability claims have been processed by June. More than 60,000 VA employees have also returned to the office, according to the release.

“As a result of our efforts, VA is headed in the right direction – both in terms of staff levels and customer service,” Collins said. “Our review has resulted in a host of new ideas for better serving Veterans that we will continue to pursue.” 

Publications
Topics
Sections

The initial plan to reduce the US Department of Veterans Affairs (VA) workforce by 15%—roughly 83,000 employees—has been revised. The VA announced that it expected to reduce its workforce by 30,000 positions through normal attrition, early retirements, and resignations by the end of fiscal year 2025, “eliminating the need for a large-scale reduction-in-force.” Most of the positions will not be replaced due to the federal hiring freeze, which has been extended for 3 months.

“Since March, we’ve been conducting a holistic review of the department centered on reducing bureaucracy and improving services to Veterans,” VA Secretary Doug Collins said in a press release. “A department-wide RIF is off the table, but that doesn’t mean we’re done improving VA.”

About 17,000 VA employees have left their jobs as of June 1. From now and Sept. 30, the department expects another reduction of nearly 12,000. Pete Kasperowicz, a VA spokesperson, said there would not be any reductions beyond the 30,000 planned.

The VA says it has multiple safeguards in place to ensure the reductions do not impact veteran care or benefits. All VA mission-critical positions are exempt from the voluntary early retirement authority and deferred resignation program, and > 350,000 positions are exempt from the federal hiring freeze. 

The release noted several other improvements regarding VA performance in 2025, among them that the disability claims backlog has been reduced by 30% and a record 2 million disability claims have been processed by June. More than 60,000 VA employees have also returned to the office, according to the release.

“As a result of our efforts, VA is headed in the right direction – both in terms of staff levels and customer service,” Collins said. “Our review has resulted in a host of new ideas for better serving Veterans that we will continue to pursue.” 

The initial plan to reduce the US Department of Veterans Affairs (VA) workforce by 15%—roughly 83,000 employees—has been revised. The VA announced that it expected to reduce its workforce by 30,000 positions through normal attrition, early retirements, and resignations by the end of fiscal year 2025, “eliminating the need for a large-scale reduction-in-force.” Most of the positions will not be replaced due to the federal hiring freeze, which has been extended for 3 months.

“Since March, we’ve been conducting a holistic review of the department centered on reducing bureaucracy and improving services to Veterans,” VA Secretary Doug Collins said in a press release. “A department-wide RIF is off the table, but that doesn’t mean we’re done improving VA.”

About 17,000 VA employees have left their jobs as of June 1. From now and Sept. 30, the department expects another reduction of nearly 12,000. Pete Kasperowicz, a VA spokesperson, said there would not be any reductions beyond the 30,000 planned.

The VA says it has multiple safeguards in place to ensure the reductions do not impact veteran care or benefits. All VA mission-critical positions are exempt from the voluntary early retirement authority and deferred resignation program, and > 350,000 positions are exempt from the federal hiring freeze. 

The release noted several other improvements regarding VA performance in 2025, among them that the disability claims backlog has been reduced by 30% and a record 2 million disability claims have been processed by June. More than 60,000 VA employees have also returned to the office, according to the release.

“As a result of our efforts, VA is headed in the right direction – both in terms of staff levels and customer service,” Collins said. “Our review has resulted in a host of new ideas for better serving Veterans that we will continue to pursue.” 

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 07/09/2025 - 09:42
Un-Gate On Date
Wed, 07/09/2025 - 09:42
Use ProPublica
CFC Schedule Remove Status
Wed, 07/09/2025 - 09:42
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Wed, 07/09/2025 - 09:42

Dementia Risk May Follow a Geographic Pattern

Article Type
Changed
Tue, 07/08/2025 - 09:22

TOPLINE:

Dementia incidence varied significantly by US region in a new study, with the Southeast showing a 25% higher risk and the Northwest and Rocky Mountains each showing a 23% higher risk compared to the Mid-Atlantic. Investigators said the findings highlight the need for a geographically tailored approach to address dementia risk factors and diagnostic services.

METHODOLOGY:

  • Researchers conducted a cohort study using data from the US Veterans Health Administration for more than 1.2 million older adults without dementia (mean age, 73.9 years; 98%% men) from 1999 to 2021. The average follow-up was 12.6 years.
  • Ten geographical regions across the US were defined using the CDC National Center for Chronic Disease Prevention and Health Promotion definition.
  • The diagnosis of dementia was made using International Classification of Diseases, Ninth and Tenth Revision codes from inpatient and outpatient visits.

TAKEAWAY:

  • Dementia incidence rates per 1000 person-years were lowest in the Mid-Atlantic (11.2; 95% CI, 11.1-11.4) and highest in the Southeast (14.0; 95% CI, 13.8-14.2).
  • After adjusting for demographics, compared with the Mid-Atlantic region, dementia incidence was highest in the Southeast (rate ratio [RR], 1.25), followed by the Northwest and Rocky Mountains (RR for both, 1.23), South (RR, 1.18), Southwest (RR, 1.13), and Midwest and South Atlantic (RR for both, 1.12). The Great Lakes and Northeast regions had < a 10% difference in incidence.
  • Results remained consistent after adjusting for rurality and cardiovascular comorbidities, and after accounting for competing risk for death.

IN PRACTICE:

“This study provides valuable insights into the regional variation in dementia incidence among US veterans in that we observed more than 20% greater incidence in several regions compared with the Mid-Atlantic region,” the investigators wrote. 

“By identifying areas with the highest incidence rates, resources can be better allocated and targeted interventions designed to mitigate the impact of dementia on vulnerable populations,” they added.

SOURCE:

This study was led by Christina S. Dintica, PhD, University of California, San Francisco. It was published online on June 9 in JAMA Neurology.

LIMITATIONS:

This study population was limited to US veterans, limiting the generalizability of the findings. Education level was defined using educational attainment rates in the participants’ zip codes rather than individual data. Additionally, because residential history was limited to a single location per participant, migration patterns could not be tracked. 

DISCLOSURES:

This study was supported by grants from the Alzheimer’s Association, the National Institute on Aging, and the Department of Defense. One author reported serving on data and safety monitoring boards for studies sponsored by the National Institutes of Health, as well as holding advisory board membership and receiving personal fees from industry. Full details are listed in the original article. The other four investigators reported no relevant financial conflicts.

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.

Publications
Topics
Sections

TOPLINE:

Dementia incidence varied significantly by US region in a new study, with the Southeast showing a 25% higher risk and the Northwest and Rocky Mountains each showing a 23% higher risk compared to the Mid-Atlantic. Investigators said the findings highlight the need for a geographically tailored approach to address dementia risk factors and diagnostic services.

METHODOLOGY:

  • Researchers conducted a cohort study using data from the US Veterans Health Administration for more than 1.2 million older adults without dementia (mean age, 73.9 years; 98%% men) from 1999 to 2021. The average follow-up was 12.6 years.
  • Ten geographical regions across the US were defined using the CDC National Center for Chronic Disease Prevention and Health Promotion definition.
  • The diagnosis of dementia was made using International Classification of Diseases, Ninth and Tenth Revision codes from inpatient and outpatient visits.

TAKEAWAY:

  • Dementia incidence rates per 1000 person-years were lowest in the Mid-Atlantic (11.2; 95% CI, 11.1-11.4) and highest in the Southeast (14.0; 95% CI, 13.8-14.2).
  • After adjusting for demographics, compared with the Mid-Atlantic region, dementia incidence was highest in the Southeast (rate ratio [RR], 1.25), followed by the Northwest and Rocky Mountains (RR for both, 1.23), South (RR, 1.18), Southwest (RR, 1.13), and Midwest and South Atlantic (RR for both, 1.12). The Great Lakes and Northeast regions had < a 10% difference in incidence.
  • Results remained consistent after adjusting for rurality and cardiovascular comorbidities, and after accounting for competing risk for death.

IN PRACTICE:

“This study provides valuable insights into the regional variation in dementia incidence among US veterans in that we observed more than 20% greater incidence in several regions compared with the Mid-Atlantic region,” the investigators wrote. 

“By identifying areas with the highest incidence rates, resources can be better allocated and targeted interventions designed to mitigate the impact of dementia on vulnerable populations,” they added.

SOURCE:

This study was led by Christina S. Dintica, PhD, University of California, San Francisco. It was published online on June 9 in JAMA Neurology.

LIMITATIONS:

This study population was limited to US veterans, limiting the generalizability of the findings. Education level was defined using educational attainment rates in the participants’ zip codes rather than individual data. Additionally, because residential history was limited to a single location per participant, migration patterns could not be tracked. 

DISCLOSURES:

This study was supported by grants from the Alzheimer’s Association, the National Institute on Aging, and the Department of Defense. One author reported serving on data and safety monitoring boards for studies sponsored by the National Institutes of Health, as well as holding advisory board membership and receiving personal fees from industry. Full details are listed in the original article. The other four investigators reported no relevant financial conflicts.

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:

Dementia incidence varied significantly by US region in a new study, with the Southeast showing a 25% higher risk and the Northwest and Rocky Mountains each showing a 23% higher risk compared to the Mid-Atlantic. Investigators said the findings highlight the need for a geographically tailored approach to address dementia risk factors and diagnostic services.

METHODOLOGY:

  • Researchers conducted a cohort study using data from the US Veterans Health Administration for more than 1.2 million older adults without dementia (mean age, 73.9 years; 98%% men) from 1999 to 2021. The average follow-up was 12.6 years.
  • Ten geographical regions across the US were defined using the CDC National Center for Chronic Disease Prevention and Health Promotion definition.
  • The diagnosis of dementia was made using International Classification of Diseases, Ninth and Tenth Revision codes from inpatient and outpatient visits.

TAKEAWAY:

  • Dementia incidence rates per 1000 person-years were lowest in the Mid-Atlantic (11.2; 95% CI, 11.1-11.4) and highest in the Southeast (14.0; 95% CI, 13.8-14.2).
  • After adjusting for demographics, compared with the Mid-Atlantic region, dementia incidence was highest in the Southeast (rate ratio [RR], 1.25), followed by the Northwest and Rocky Mountains (RR for both, 1.23), South (RR, 1.18), Southwest (RR, 1.13), and Midwest and South Atlantic (RR for both, 1.12). The Great Lakes and Northeast regions had < a 10% difference in incidence.
  • Results remained consistent after adjusting for rurality and cardiovascular comorbidities, and after accounting for competing risk for death.

IN PRACTICE:

“This study provides valuable insights into the regional variation in dementia incidence among US veterans in that we observed more than 20% greater incidence in several regions compared with the Mid-Atlantic region,” the investigators wrote. 

“By identifying areas with the highest incidence rates, resources can be better allocated and targeted interventions designed to mitigate the impact of dementia on vulnerable populations,” they added.

SOURCE:

This study was led by Christina S. Dintica, PhD, University of California, San Francisco. It was published online on June 9 in JAMA Neurology.

LIMITATIONS:

This study population was limited to US veterans, limiting the generalizability of the findings. Education level was defined using educational attainment rates in the participants’ zip codes rather than individual data. Additionally, because residential history was limited to a single location per participant, migration patterns could not be tracked. 

DISCLOSURES:

This study was supported by grants from the Alzheimer’s Association, the National Institute on Aging, and the Department of Defense. One author reported serving on data and safety monitoring boards for studies sponsored by the National Institutes of Health, as well as holding advisory board membership and receiving personal fees from industry. Full details are listed in the original article. The other four investigators reported no relevant financial conflicts.

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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Tue, 07/08/2025 - 09:21
Un-Gate On Date
Tue, 07/08/2025 - 09:21
Use ProPublica
CFC Schedule Remove Status
Tue, 07/08/2025 - 09:21
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Tue, 07/08/2025 - 09:21

Sclerosing Mesenteritis: What GIs Need to Know About This Rare Disease

Article Type
Changed
Mon, 07/07/2025 - 11:55

AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.

Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.

“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.

The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”

As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.

No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.

“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”

Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.

Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.

The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.

 

Medical Therapy

Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.

Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.

Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”

Dr. Stephen B. Hanauer



Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”

In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.” 

Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.

Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”

This guidance was supported by the AGA. Worthington reported renumeration from TriCity Surgery Center, Prescott, Ariz. Hanauer had no conflicts of interest relevant to their comments.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.

Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.

“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.

The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”

As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.

No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.

“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”

Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.

Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.

The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.

 

Medical Therapy

Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.

Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.

Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”

Dr. Stephen B. Hanauer



Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”

In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.” 

Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.

Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”

This guidance was supported by the AGA. Worthington reported renumeration from TriCity Surgery Center, Prescott, Ariz. Hanauer had no conflicts of interest relevant to their comments.

A version of this article appeared on Medscape.com.

AGA has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor.

Led by Mark T. Worthington, MD, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it.

“CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,” Worthington told GI & Hepatology News. “We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.” Metabolic syndrome and associated conditions increase the risk for SM, as does aging.

The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. “For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,” Worthington said. “A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.”

As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response.

No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin’s lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis.

“There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn’t,” said Worthington. “Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.”

Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race.

Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted.

The update allows room for differences in clinical judgment. “For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient’s findings, and no one should feel locked in by these recommendations,” Worthington said.

 

Medical Therapy

Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however.

Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass.

Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, AGAF, a professor of medicine at Northwestern Medicine in Chicago, said, “The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.” He stressed that the recommendations are pragmatic rather than evidence-based “as there are no controlled trials and the presentation is heterogeneous.”

Dr. Stephen B. Hanauer



Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. “Hence, all of the treatments are empiric without biological or imaging endpoints.”

In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. “As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.” 

Worthington and colleagues agreed that treatment protocols have developed empirically. “Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,” they wrote.

Currently, said Worthington, the biggest gaps remain in treatment. “Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.”

This guidance was supported by the AGA. Worthington reported renumeration from TriCity Surgery Center, Prescott, Ariz. Hanauer had no conflicts of interest relevant to their comments.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Mon, 07/07/2025 - 10:37
Un-Gate On Date
Mon, 07/07/2025 - 10:37
Use ProPublica
CFC Schedule Remove Status
Mon, 07/07/2025 - 10:37
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Mon, 07/07/2025 - 10:37