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Snare Tip Soft Coagulation Leaves Clean Margins After Resection
according to a recent study.
Since STSC was faster to apply than APC and results in lower cost and plastic waste (because of APC requiring an additional catheter), STSC was the preferred option.
“The reduction in recurrence rate with thermal margin treatment is arguably the most important development in endoscopic mucosal resection in the past 2 decades,” said lead author Douglas Rex, MD, AGAF, a distinguished professor emeritus at the Indiana University School of Medicine and director of endoscopy at Indiana University Hospitals, both in Indianapolis.
“Margin thermal therapy with STSC should now be standard treatment after piecemeal EMR in the colorectum,” he said. “Before applying STSC, the endoscopist must ensure that the entire lesion is resected down to the submucosa. Then STSC should be aggressively applied to 100% of the margin.”
The study was published in Clinical Gastroenterology and Hepatology .
Comparing Treatments
Dr. Rex and colleagues performed a randomized three-arm trial in nine U.S. centers, comparing STSC with APC and no margin treatment in patients undergoing colorectal EMR of nonpedunculated lesions of 15 mm or greater.
All lesions underwent conventional injection and snare resection EMR using electrocautery, but the endoscopist chose the injection fluid and snare type and size. Areas with residual polyp that weren’t removable by snare resection because of flat shape or fibrosis were removed by hot or cold avulsion. After that, patients were randomized to one of the three arms.
Patients were scheduled for a follow-up appointment six months after the initial EMR. Any visible recurrence was resected using methods at the discretion of the endoscopist, and if no visible recurrence was present, EMR site biopsies were recommended.
Among 384 patients with 414 lesions, 308 patients with 328 lesions completed at least one follow-up appointment. The median interval to the first follow-up was 6.4 months, ranging from 2 to 37 months. The primary endpoint was the presence of recurrent or residual polyp at first follow-up.
The median polyp size was 25 mm, and 65 of the 414 polyps (15.7%) were 15-19 mm in size. Overall, 14.8% of lesions were resected en bloc, with no difference between the study arms.
The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% among control subjects with no margin treatment.
The odds of having a residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (odds ratio [OR] of 0.182 and 0.341, or P = .001 and P = .01, respectively). There wasn’t a significant difference in the odds of recurrence between STSC and APC (OR, 1.874).
In 259 lesions in 248 patients that were 20 mm or greater, the recurrence rates at first follow-up were 5.9% for STSC, 10.1% for APC, and 25.9% for the control group. In these lesions, STSC and APC remained associated with a lower risk of recurrence versus the control (OR, 0.18 and 0.323, respectively). The difference in recurrence rates between STSC and APC wasn’t significant.
Even still, STSC took less time to apply than APC, with a median time of 3.35 minutes vs 4.08 minutes.
The rates of adverse events were low, with no difference between the three arms. There were no immediate or delayed perforations in any arm, and the overall occurrence of delayed bleeding was low at 3.6%.
“I think STSC won the trial because it was numerically (though not statistically) superior to APC, was faster to apply, and using STSC results in lower cost and less plastic compared to APC,” Dr. Rex said.
Additional Considerations
Based on charges at the nine U.S. centers and a survey of two manufacturers, APC catheters typically cost $175-$275 each, the study authors wrote, noting that APC results in increased cost, plastic waste because of the catheter, and carbon emissions associated with its manufacture.
“What we’re seeing — now over several trials — is STSC appears to be the most effective method of treating the edges, and it’s inexpensive because it uses the same device used for snare resection, so there’s no incremental cost for the device,” said Michael Wallace, MD, professor of medicine and director of the digestive diseases research program at Mayo Clinic, Jacksonville, Florida.
Dr. Wallace, who wasn’t involved with this study, has researched thermal ablation after EMR, including both the margins and the base.
“The single most important message now is that patients shouldn’t be getting surgical resections for endoscopically treatable polyps,” he said. “We see many patients who are told they need to get surgery, but overwhelmingly, the data shows we can remove polyps without surgery.”
Dr. Rex and several authors declared fees and grants from numerous companies outside of this study. Dr. Wallace reported no relevant disclosures.
according to a recent study.
Since STSC was faster to apply than APC and results in lower cost and plastic waste (because of APC requiring an additional catheter), STSC was the preferred option.
“The reduction in recurrence rate with thermal margin treatment is arguably the most important development in endoscopic mucosal resection in the past 2 decades,” said lead author Douglas Rex, MD, AGAF, a distinguished professor emeritus at the Indiana University School of Medicine and director of endoscopy at Indiana University Hospitals, both in Indianapolis.
“Margin thermal therapy with STSC should now be standard treatment after piecemeal EMR in the colorectum,” he said. “Before applying STSC, the endoscopist must ensure that the entire lesion is resected down to the submucosa. Then STSC should be aggressively applied to 100% of the margin.”
The study was published in Clinical Gastroenterology and Hepatology .
Comparing Treatments
Dr. Rex and colleagues performed a randomized three-arm trial in nine U.S. centers, comparing STSC with APC and no margin treatment in patients undergoing colorectal EMR of nonpedunculated lesions of 15 mm or greater.
All lesions underwent conventional injection and snare resection EMR using electrocautery, but the endoscopist chose the injection fluid and snare type and size. Areas with residual polyp that weren’t removable by snare resection because of flat shape or fibrosis were removed by hot or cold avulsion. After that, patients were randomized to one of the three arms.
Patients were scheduled for a follow-up appointment six months after the initial EMR. Any visible recurrence was resected using methods at the discretion of the endoscopist, and if no visible recurrence was present, EMR site biopsies were recommended.
Among 384 patients with 414 lesions, 308 patients with 328 lesions completed at least one follow-up appointment. The median interval to the first follow-up was 6.4 months, ranging from 2 to 37 months. The primary endpoint was the presence of recurrent or residual polyp at first follow-up.
The median polyp size was 25 mm, and 65 of the 414 polyps (15.7%) were 15-19 mm in size. Overall, 14.8% of lesions were resected en bloc, with no difference between the study arms.
The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% among control subjects with no margin treatment.
The odds of having a residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (odds ratio [OR] of 0.182 and 0.341, or P = .001 and P = .01, respectively). There wasn’t a significant difference in the odds of recurrence between STSC and APC (OR, 1.874).
In 259 lesions in 248 patients that were 20 mm or greater, the recurrence rates at first follow-up were 5.9% for STSC, 10.1% for APC, and 25.9% for the control group. In these lesions, STSC and APC remained associated with a lower risk of recurrence versus the control (OR, 0.18 and 0.323, respectively). The difference in recurrence rates between STSC and APC wasn’t significant.
Even still, STSC took less time to apply than APC, with a median time of 3.35 minutes vs 4.08 minutes.
The rates of adverse events were low, with no difference between the three arms. There were no immediate or delayed perforations in any arm, and the overall occurrence of delayed bleeding was low at 3.6%.
“I think STSC won the trial because it was numerically (though not statistically) superior to APC, was faster to apply, and using STSC results in lower cost and less plastic compared to APC,” Dr. Rex said.
Additional Considerations
Based on charges at the nine U.S. centers and a survey of two manufacturers, APC catheters typically cost $175-$275 each, the study authors wrote, noting that APC results in increased cost, plastic waste because of the catheter, and carbon emissions associated with its manufacture.
“What we’re seeing — now over several trials — is STSC appears to be the most effective method of treating the edges, and it’s inexpensive because it uses the same device used for snare resection, so there’s no incremental cost for the device,” said Michael Wallace, MD, professor of medicine and director of the digestive diseases research program at Mayo Clinic, Jacksonville, Florida.
Dr. Wallace, who wasn’t involved with this study, has researched thermal ablation after EMR, including both the margins and the base.
“The single most important message now is that patients shouldn’t be getting surgical resections for endoscopically treatable polyps,” he said. “We see many patients who are told they need to get surgery, but overwhelmingly, the data shows we can remove polyps without surgery.”
Dr. Rex and several authors declared fees and grants from numerous companies outside of this study. Dr. Wallace reported no relevant disclosures.
according to a recent study.
Since STSC was faster to apply than APC and results in lower cost and plastic waste (because of APC requiring an additional catheter), STSC was the preferred option.
“The reduction in recurrence rate with thermal margin treatment is arguably the most important development in endoscopic mucosal resection in the past 2 decades,” said lead author Douglas Rex, MD, AGAF, a distinguished professor emeritus at the Indiana University School of Medicine and director of endoscopy at Indiana University Hospitals, both in Indianapolis.
“Margin thermal therapy with STSC should now be standard treatment after piecemeal EMR in the colorectum,” he said. “Before applying STSC, the endoscopist must ensure that the entire lesion is resected down to the submucosa. Then STSC should be aggressively applied to 100% of the margin.”
The study was published in Clinical Gastroenterology and Hepatology .
Comparing Treatments
Dr. Rex and colleagues performed a randomized three-arm trial in nine U.S. centers, comparing STSC with APC and no margin treatment in patients undergoing colorectal EMR of nonpedunculated lesions of 15 mm or greater.
All lesions underwent conventional injection and snare resection EMR using electrocautery, but the endoscopist chose the injection fluid and snare type and size. Areas with residual polyp that weren’t removable by snare resection because of flat shape or fibrosis were removed by hot or cold avulsion. After that, patients were randomized to one of the three arms.
Patients were scheduled for a follow-up appointment six months after the initial EMR. Any visible recurrence was resected using methods at the discretion of the endoscopist, and if no visible recurrence was present, EMR site biopsies were recommended.
Among 384 patients with 414 lesions, 308 patients with 328 lesions completed at least one follow-up appointment. The median interval to the first follow-up was 6.4 months, ranging from 2 to 37 months. The primary endpoint was the presence of recurrent or residual polyp at first follow-up.
The median polyp size was 25 mm, and 65 of the 414 polyps (15.7%) were 15-19 mm in size. Overall, 14.8% of lesions were resected en bloc, with no difference between the study arms.
The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% among control subjects with no margin treatment.
The odds of having a residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (odds ratio [OR] of 0.182 and 0.341, or P = .001 and P = .01, respectively). There wasn’t a significant difference in the odds of recurrence between STSC and APC (OR, 1.874).
In 259 lesions in 248 patients that were 20 mm or greater, the recurrence rates at first follow-up were 5.9% for STSC, 10.1% for APC, and 25.9% for the control group. In these lesions, STSC and APC remained associated with a lower risk of recurrence versus the control (OR, 0.18 and 0.323, respectively). The difference in recurrence rates between STSC and APC wasn’t significant.
Even still, STSC took less time to apply than APC, with a median time of 3.35 minutes vs 4.08 minutes.
The rates of adverse events were low, with no difference between the three arms. There were no immediate or delayed perforations in any arm, and the overall occurrence of delayed bleeding was low at 3.6%.
“I think STSC won the trial because it was numerically (though not statistically) superior to APC, was faster to apply, and using STSC results in lower cost and less plastic compared to APC,” Dr. Rex said.
Additional Considerations
Based on charges at the nine U.S. centers and a survey of two manufacturers, APC catheters typically cost $175-$275 each, the study authors wrote, noting that APC results in increased cost, plastic waste because of the catheter, and carbon emissions associated with its manufacture.
“What we’re seeing — now over several trials — is STSC appears to be the most effective method of treating the edges, and it’s inexpensive because it uses the same device used for snare resection, so there’s no incremental cost for the device,” said Michael Wallace, MD, professor of medicine and director of the digestive diseases research program at Mayo Clinic, Jacksonville, Florida.
Dr. Wallace, who wasn’t involved with this study, has researched thermal ablation after EMR, including both the margins and the base.
“The single most important message now is that patients shouldn’t be getting surgical resections for endoscopically treatable polyps,” he said. “We see many patients who are told they need to get surgery, but overwhelmingly, the data shows we can remove polyps without surgery.”
Dr. Rex and several authors declared fees and grants from numerous companies outside of this study. Dr. Wallace reported no relevant disclosures.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Gastroenterologists Can Play a Critical Role in Obesity Management
according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.
Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.
“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.
Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.
The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.
“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”
Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.
“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
Progress in Pharmacotherapy
In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.
Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.
In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.
Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.
Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
Efficacy of Endobariatrics
For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.
For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).
Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.
Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.
Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.
“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
Monitoring MASLD
Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.
The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.
Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.
“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”
Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.
In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.
“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
Considering the Community Perspective
Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.
Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.
“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”
The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:
- Asking if the patient is ready to talk
- Assessing for factors contributing to obesity
- Advising them of treatment options
- Agreeing on goals based on shared decision-making
- Assisting or Arranging the agreed-on plan.
During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.
During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.
Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.
“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”
according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.
Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.
“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.
Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.
The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.
“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”
Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.
“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
Progress in Pharmacotherapy
In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.
Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.
In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.
Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.
Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
Efficacy of Endobariatrics
For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.
For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).
Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.
Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.
Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.
“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
Monitoring MASLD
Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.
The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.
Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.
“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”
Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.
In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.
“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
Considering the Community Perspective
Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.
Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.
“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”
The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:
- Asking if the patient is ready to talk
- Assessing for factors contributing to obesity
- Advising them of treatment options
- Agreeing on goals based on shared decision-making
- Assisting or Arranging the agreed-on plan.
During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.
During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.
Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.
“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”
according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.
Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.
“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.
Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.
The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.
“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”
Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.
“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
Progress in Pharmacotherapy
In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.
Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.
In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.
Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.
Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
Efficacy of Endobariatrics
For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.
For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).
Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.
Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.
Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.
“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
Monitoring MASLD
Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.
The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.
Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.
“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”
Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.
In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.
“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
Considering the Community Perspective
Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.
Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.
“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”
The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:
- Asking if the patient is ready to talk
- Assessing for factors contributing to obesity
- Advising them of treatment options
- Agreeing on goals based on shared decision-making
- Assisting or Arranging the agreed-on plan.
During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.
During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.
Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.
“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”
AGA Issues Guidance on Identifying, Treating Cyclic Vomiting Syndrome
, according to a new clinical practice update from the American Gastroenterological Association.
CVS affects up to 2% of U.S. adults and is more common in women, young adults, and those with a personal or family history of migraine headaches. However, most patients don’t receive a diagnosis or often experience years of delay in receiving effective treatment.
“A diagnosis is a powerful tool. Not only does it help patients make sense of debilitating symptoms, but it allows healthcare providers to create an effective treatment plan,” said author David J. Levinthal, MD, AGAF, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center.
The update was published online in Gastroenterology.
Understanding Cyclic Vomiting Syndrome
CVS is a chronic disorder of gut-brain interaction (DGBI), which is characterized by acute episodes of nausea and vomiting, separated by time without symptoms. Patients can usually identify a pattern of symptoms that show up during and between episodes.
CVS can vary, ranging from mild — with less than four episodes per year and lasting less than 2 days — to moderate-severe — with more than four episodes per year, lasting more than 2 days, and requiring at least one emergency department visit or hospitalization.
The disorder has four distinct phases — inter-episodic, prodromal, emetic, and recovery — that align with distinct treatment and management strategies. Between episodes, patients typically don’t experience repetitive vomiting but may experience symptoms such as mild nausea, indigestion, and occasional vomiting. Although CVS episodes can happen at any time, most tend to occur in the early morning.
For diagnosis, clinicians should consider CVS in adults presenting with episodic bouts of repetitive vomiting, following criteria established by the Rome Foundation. Rome IV criteria include acute-onset vomiting lasting less than 7 days, at least three discrete episodes in a year with two in the previous 6 months, and an absence of vomiting between episodes separated by at least 1 week of baseline health.
About 65% of patients with CVS experience prodromal symptoms, which last for about an hour before the onset of vomiting and may include panic, a sense of doom, and an inability to communicate effectively. During prodromal or emetic phases, patients have also reported fatigue, brain fog, restlessness, anxiety, headache, bowel urgency, abdominal pain, flushing, or shakiness.
As with migraines, CVS episodes may often be triggered by psychological and physiological factors, particularly stress. Episodes can stem from both negative stress, such as a death or relationship conflicts, as well as positive stress, such as birthdays and vacations. Other triggers include sleep deprivation, hormonal fluctuations linked to the menstrual cycle, travel, motion sickness, or acute infections.
Adult CVS is associated with several conditions, particularly mood disorders, including anxiety, depression, and panic disorder. Patients may also experience migraines, seizure disorders, or autonomic imbalances, such as postural orthostatic tachycardia syndrome, which may indicate pathophysiological mechanisms and routes for management.
The American Neurogastroenterology and Motility Society recommends testing to rule out similar or overlapping conditions, such as Addison’s disease, hypothyroidism, and hepatic porphyria. Diagnostic workup should include blood work, urinalysis, and one-time esophagogastroduodenoscopy or upper gastrointestinal imaging. Repeated imaging and gastric emptying scans should be avoided.
Providing Treatment and Prevention
For treatment, knowing the CVS phase is “essential,” the authors wrote. For instance, during the prodromal phase, abortive therapies can halt the transition to the emetic phase, and earlier intervention is associated with a higher probability of stopping an episode. The authors recommend intranasal sumatriptan, ondansetron, antihistamines, and sedatives.
During the emetic phase, supportive therapy can help terminate the episode. This may include continuing the abortive regimen and going to the emergency department for hydration and antiemetic medications. Patients may also find relief in a quiet, darker room in the emergency department, along with IV benzodiazepines, with the goal of inducing sedation.
During the recovery phase, patients should rest and focus on rehydration and nutrition to return to the well phase.
During the well or inter-episodic phase, patients can follow lifestyle measures to identify and avoid triggers, such as taking prophylactic medication (tricyclic antidepressants, anticonvulsants, and neurokinin-1 receptor antagonists such as aprepitant), reducing stress, and implementing a good sleep routine.
As part of patient education, clinicians can discuss the four phases and rehearse the actions to take to prevent or stop an episode.
“CVS has a significant impact on patients, families, and the healthcare system. The unpredictable and disruptive nature of episodes can result in reduced health-related quality of life, job loss precipitated by work absenteeism, and even divorce,” said Rosita Frazier, MD, a gastroenterologist at Mayo Clinic Arizona in Scottsdale who specializes in DGBI and CVS. Dr. Frazier, who wasn’t involved with the clinical practice update, has previously written about CVS diagnosis and management.
“Providing an individualized care plan for all patients could potentially address this problem and improve the physician-patient interaction,” she said. “Educational efforts to raise awareness among the medical community and increase both patient and provider engagement can optimize outcomes and are needed to address this critical problem.”
The authors received no specific funding for this update. Dr. Levinthal is a consultant for Takeda Pharmaceuticals and Mahana. Dr. Frazier reported no relevant financial disclosures.
, according to a new clinical practice update from the American Gastroenterological Association.
CVS affects up to 2% of U.S. adults and is more common in women, young adults, and those with a personal or family history of migraine headaches. However, most patients don’t receive a diagnosis or often experience years of delay in receiving effective treatment.
“A diagnosis is a powerful tool. Not only does it help patients make sense of debilitating symptoms, but it allows healthcare providers to create an effective treatment plan,” said author David J. Levinthal, MD, AGAF, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center.
The update was published online in Gastroenterology.
Understanding Cyclic Vomiting Syndrome
CVS is a chronic disorder of gut-brain interaction (DGBI), which is characterized by acute episodes of nausea and vomiting, separated by time without symptoms. Patients can usually identify a pattern of symptoms that show up during and between episodes.
CVS can vary, ranging from mild — with less than four episodes per year and lasting less than 2 days — to moderate-severe — with more than four episodes per year, lasting more than 2 days, and requiring at least one emergency department visit or hospitalization.
The disorder has four distinct phases — inter-episodic, prodromal, emetic, and recovery — that align with distinct treatment and management strategies. Between episodes, patients typically don’t experience repetitive vomiting but may experience symptoms such as mild nausea, indigestion, and occasional vomiting. Although CVS episodes can happen at any time, most tend to occur in the early morning.
For diagnosis, clinicians should consider CVS in adults presenting with episodic bouts of repetitive vomiting, following criteria established by the Rome Foundation. Rome IV criteria include acute-onset vomiting lasting less than 7 days, at least three discrete episodes in a year with two in the previous 6 months, and an absence of vomiting between episodes separated by at least 1 week of baseline health.
About 65% of patients with CVS experience prodromal symptoms, which last for about an hour before the onset of vomiting and may include panic, a sense of doom, and an inability to communicate effectively. During prodromal or emetic phases, patients have also reported fatigue, brain fog, restlessness, anxiety, headache, bowel urgency, abdominal pain, flushing, or shakiness.
As with migraines, CVS episodes may often be triggered by psychological and physiological factors, particularly stress. Episodes can stem from both negative stress, such as a death or relationship conflicts, as well as positive stress, such as birthdays and vacations. Other triggers include sleep deprivation, hormonal fluctuations linked to the menstrual cycle, travel, motion sickness, or acute infections.
Adult CVS is associated with several conditions, particularly mood disorders, including anxiety, depression, and panic disorder. Patients may also experience migraines, seizure disorders, or autonomic imbalances, such as postural orthostatic tachycardia syndrome, which may indicate pathophysiological mechanisms and routes for management.
The American Neurogastroenterology and Motility Society recommends testing to rule out similar or overlapping conditions, such as Addison’s disease, hypothyroidism, and hepatic porphyria. Diagnostic workup should include blood work, urinalysis, and one-time esophagogastroduodenoscopy or upper gastrointestinal imaging. Repeated imaging and gastric emptying scans should be avoided.
Providing Treatment and Prevention
For treatment, knowing the CVS phase is “essential,” the authors wrote. For instance, during the prodromal phase, abortive therapies can halt the transition to the emetic phase, and earlier intervention is associated with a higher probability of stopping an episode. The authors recommend intranasal sumatriptan, ondansetron, antihistamines, and sedatives.
During the emetic phase, supportive therapy can help terminate the episode. This may include continuing the abortive regimen and going to the emergency department for hydration and antiemetic medications. Patients may also find relief in a quiet, darker room in the emergency department, along with IV benzodiazepines, with the goal of inducing sedation.
During the recovery phase, patients should rest and focus on rehydration and nutrition to return to the well phase.
During the well or inter-episodic phase, patients can follow lifestyle measures to identify and avoid triggers, such as taking prophylactic medication (tricyclic antidepressants, anticonvulsants, and neurokinin-1 receptor antagonists such as aprepitant), reducing stress, and implementing a good sleep routine.
As part of patient education, clinicians can discuss the four phases and rehearse the actions to take to prevent or stop an episode.
“CVS has a significant impact on patients, families, and the healthcare system. The unpredictable and disruptive nature of episodes can result in reduced health-related quality of life, job loss precipitated by work absenteeism, and even divorce,” said Rosita Frazier, MD, a gastroenterologist at Mayo Clinic Arizona in Scottsdale who specializes in DGBI and CVS. Dr. Frazier, who wasn’t involved with the clinical practice update, has previously written about CVS diagnosis and management.
“Providing an individualized care plan for all patients could potentially address this problem and improve the physician-patient interaction,” she said. “Educational efforts to raise awareness among the medical community and increase both patient and provider engagement can optimize outcomes and are needed to address this critical problem.”
The authors received no specific funding for this update. Dr. Levinthal is a consultant for Takeda Pharmaceuticals and Mahana. Dr. Frazier reported no relevant financial disclosures.
, according to a new clinical practice update from the American Gastroenterological Association.
CVS affects up to 2% of U.S. adults and is more common in women, young adults, and those with a personal or family history of migraine headaches. However, most patients don’t receive a diagnosis or often experience years of delay in receiving effective treatment.
“A diagnosis is a powerful tool. Not only does it help patients make sense of debilitating symptoms, but it allows healthcare providers to create an effective treatment plan,” said author David J. Levinthal, MD, AGAF, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center.
The update was published online in Gastroenterology.
Understanding Cyclic Vomiting Syndrome
CVS is a chronic disorder of gut-brain interaction (DGBI), which is characterized by acute episodes of nausea and vomiting, separated by time without symptoms. Patients can usually identify a pattern of symptoms that show up during and between episodes.
CVS can vary, ranging from mild — with less than four episodes per year and lasting less than 2 days — to moderate-severe — with more than four episodes per year, lasting more than 2 days, and requiring at least one emergency department visit or hospitalization.
The disorder has four distinct phases — inter-episodic, prodromal, emetic, and recovery — that align with distinct treatment and management strategies. Between episodes, patients typically don’t experience repetitive vomiting but may experience symptoms such as mild nausea, indigestion, and occasional vomiting. Although CVS episodes can happen at any time, most tend to occur in the early morning.
For diagnosis, clinicians should consider CVS in adults presenting with episodic bouts of repetitive vomiting, following criteria established by the Rome Foundation. Rome IV criteria include acute-onset vomiting lasting less than 7 days, at least three discrete episodes in a year with two in the previous 6 months, and an absence of vomiting between episodes separated by at least 1 week of baseline health.
About 65% of patients with CVS experience prodromal symptoms, which last for about an hour before the onset of vomiting and may include panic, a sense of doom, and an inability to communicate effectively. During prodromal or emetic phases, patients have also reported fatigue, brain fog, restlessness, anxiety, headache, bowel urgency, abdominal pain, flushing, or shakiness.
As with migraines, CVS episodes may often be triggered by psychological and physiological factors, particularly stress. Episodes can stem from both negative stress, such as a death or relationship conflicts, as well as positive stress, such as birthdays and vacations. Other triggers include sleep deprivation, hormonal fluctuations linked to the menstrual cycle, travel, motion sickness, or acute infections.
Adult CVS is associated with several conditions, particularly mood disorders, including anxiety, depression, and panic disorder. Patients may also experience migraines, seizure disorders, or autonomic imbalances, such as postural orthostatic tachycardia syndrome, which may indicate pathophysiological mechanisms and routes for management.
The American Neurogastroenterology and Motility Society recommends testing to rule out similar or overlapping conditions, such as Addison’s disease, hypothyroidism, and hepatic porphyria. Diagnostic workup should include blood work, urinalysis, and one-time esophagogastroduodenoscopy or upper gastrointestinal imaging. Repeated imaging and gastric emptying scans should be avoided.
Providing Treatment and Prevention
For treatment, knowing the CVS phase is “essential,” the authors wrote. For instance, during the prodromal phase, abortive therapies can halt the transition to the emetic phase, and earlier intervention is associated with a higher probability of stopping an episode. The authors recommend intranasal sumatriptan, ondansetron, antihistamines, and sedatives.
During the emetic phase, supportive therapy can help terminate the episode. This may include continuing the abortive regimen and going to the emergency department for hydration and antiemetic medications. Patients may also find relief in a quiet, darker room in the emergency department, along with IV benzodiazepines, with the goal of inducing sedation.
During the recovery phase, patients should rest and focus on rehydration and nutrition to return to the well phase.
During the well or inter-episodic phase, patients can follow lifestyle measures to identify and avoid triggers, such as taking prophylactic medication (tricyclic antidepressants, anticonvulsants, and neurokinin-1 receptor antagonists such as aprepitant), reducing stress, and implementing a good sleep routine.
As part of patient education, clinicians can discuss the four phases and rehearse the actions to take to prevent or stop an episode.
“CVS has a significant impact on patients, families, and the healthcare system. The unpredictable and disruptive nature of episodes can result in reduced health-related quality of life, job loss precipitated by work absenteeism, and even divorce,” said Rosita Frazier, MD, a gastroenterologist at Mayo Clinic Arizona in Scottsdale who specializes in DGBI and CVS. Dr. Frazier, who wasn’t involved with the clinical practice update, has previously written about CVS diagnosis and management.
“Providing an individualized care plan for all patients could potentially address this problem and improve the physician-patient interaction,” she said. “Educational efforts to raise awareness among the medical community and increase both patient and provider engagement can optimize outcomes and are needed to address this critical problem.”
The authors received no specific funding for this update. Dr. Levinthal is a consultant for Takeda Pharmaceuticals and Mahana. Dr. Frazier reported no relevant financial disclosures.
FROM GASTROENTEROLOGY
Risk Stratification May Work Well for FIT-Based CRC Screening in Elderly
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In particular, interval CRC risk can vary substantially based on the fecal hemoglobin (f-Hb) concentration in the patient’s last fecal immunochemical test (FIT), as well as the number of prior screening rounds.
“Less is known about what happens after the upper age limit has been reached and individuals are not invited to participate in more screening rounds. This is important as life expectancy is increasing, and it is increasingly important to consider the most efficient way of screening the elderly,” said lead author Brenda van Stigt, a PhD candidate focused on cancer screening at Erasmus University Medical Center in Rotterdam, the Netherlands.
In the Netherlands, adults between ages 55 and 75 are invited to participate in stool-based CRC screening every 2 years. Based on a fecal immunochemical testing (FIT) threshold of 47 μg Hb/g, those who test positive are referred to colonoscopy, and those who test negative are invited to participate again after a 2-year period.
FIT can play a major role in risk stratification, Ms. van Stigt noted, along with other factors that influence CRC risk, such as age, sex, and CRC screening history. Although this is documented for ages 55-75, she and colleagues wanted to know more about what happens after age 75.
Ms. Van Stigt and colleagues conducted a population-based study by analyzing Dutch national cancer registry data and FIT results around the final screening at age 75, looking at those who were diagnosed with CRC within 24 months of their last negative FIT. The researchers assessed interval CRC risk and cancer stage, accounting for sex, last f-Hb concentration, and the number of screening rounds.
Among 305,761 people with a complete 24-month follow-up after a negative FIT, 661 patients were diagnosed with interval CRC, indicating an overall interval CRC risk of 21.6 per 10,000 individuals with a negative FIT. There were no significant differences by sex.
However, there were differences by screening rounds, with those who had participated in three or four screening rounds having a lower risk than those who participated only once (HR, .49).
In addition, those with detectable f-Hb (>0 μg Hb/g) in their last screening round had a much higher interval CRC risk (HR, 4.87), at 65.8 per 10,000 negative FITs, compared with 13.8 per 10,000 among those without detectable f-Hb. Interval CRC risk also increased over time for those with detectable f-Hb.
About 15% of the total population had detectable f-Hb, whereas 46% of those with interval CRC had detectable f-Hb, Ms. van Stigt said, meaning that nearly half of patients who were diagnosed with interval CRC already had detectable f-Hb in their prior FIT.
In a survival analysis, there was no association between interval CRC risk and sex. However, those who participated in three or four screening rounds were half as likely to be diagnosed than those who participated once or twice, and those with detectable f-Hb were five times as likely to be diagnosed.
For late-stage CRC, there was no association with sex or the number of screening rounds. Detectable f-Hb was associated with not only a higher risk of interval CRC but also a late-stage diagnosis.
“These findings indicate that one uniform age to stop screening is suboptimal,” Ms. van Stigt said. “Personalized screening strategies should, therefore, also ideally incorporate a risk-stratified age to stop screening.”
The US Preventive Services Task Force recommends that clinicians personalize screening for ages 76-85, accounting for overall health, prior screening history, and patient preferences.
“But we have no clear guidance on how to quantify or weigh these factors. This interesting study highlights how one of these factors (prior screening history) and fecal hemoglobin level (an emerging factor) are powerful stratifiers of subsequent colorectal cancer risk,” said Sameer D. Saini, MD, AGAF, director and research investigator at the VA Ann Arbor Healthcare System’s Center for Clinical Management Research. Dr. Saini wasn’t involved with the study.
At the clinical level, Dr. Saini said, sophisticated modeling is needed to understand the interaction with competing risks and identify the optimal screening strategies for patients at varying levels of cancer risk and life expectancy. Models could also help to quantify the population benefits and cost-effectiveness of personalized screening.
“Finally, it is important to note that, in many health systems, access to quantitative FIT may be limited,” he said. “These data may be less informative if colonoscopy is the primary mode of screening.”
Ms. van Stigt and Dr. Saini reported no relevant disclosures.
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In particular, interval CRC risk can vary substantially based on the fecal hemoglobin (f-Hb) concentration in the patient’s last fecal immunochemical test (FIT), as well as the number of prior screening rounds.
“Less is known about what happens after the upper age limit has been reached and individuals are not invited to participate in more screening rounds. This is important as life expectancy is increasing, and it is increasingly important to consider the most efficient way of screening the elderly,” said lead author Brenda van Stigt, a PhD candidate focused on cancer screening at Erasmus University Medical Center in Rotterdam, the Netherlands.
In the Netherlands, adults between ages 55 and 75 are invited to participate in stool-based CRC screening every 2 years. Based on a fecal immunochemical testing (FIT) threshold of 47 μg Hb/g, those who test positive are referred to colonoscopy, and those who test negative are invited to participate again after a 2-year period.
FIT can play a major role in risk stratification, Ms. van Stigt noted, along with other factors that influence CRC risk, such as age, sex, and CRC screening history. Although this is documented for ages 55-75, she and colleagues wanted to know more about what happens after age 75.
Ms. Van Stigt and colleagues conducted a population-based study by analyzing Dutch national cancer registry data and FIT results around the final screening at age 75, looking at those who were diagnosed with CRC within 24 months of their last negative FIT. The researchers assessed interval CRC risk and cancer stage, accounting for sex, last f-Hb concentration, and the number of screening rounds.
Among 305,761 people with a complete 24-month follow-up after a negative FIT, 661 patients were diagnosed with interval CRC, indicating an overall interval CRC risk of 21.6 per 10,000 individuals with a negative FIT. There were no significant differences by sex.
However, there were differences by screening rounds, with those who had participated in three or four screening rounds having a lower risk than those who participated only once (HR, .49).
In addition, those with detectable f-Hb (>0 μg Hb/g) in their last screening round had a much higher interval CRC risk (HR, 4.87), at 65.8 per 10,000 negative FITs, compared with 13.8 per 10,000 among those without detectable f-Hb. Interval CRC risk also increased over time for those with detectable f-Hb.
About 15% of the total population had detectable f-Hb, whereas 46% of those with interval CRC had detectable f-Hb, Ms. van Stigt said, meaning that nearly half of patients who were diagnosed with interval CRC already had detectable f-Hb in their prior FIT.
In a survival analysis, there was no association between interval CRC risk and sex. However, those who participated in three or four screening rounds were half as likely to be diagnosed than those who participated once or twice, and those with detectable f-Hb were five times as likely to be diagnosed.
For late-stage CRC, there was no association with sex or the number of screening rounds. Detectable f-Hb was associated with not only a higher risk of interval CRC but also a late-stage diagnosis.
“These findings indicate that one uniform age to stop screening is suboptimal,” Ms. van Stigt said. “Personalized screening strategies should, therefore, also ideally incorporate a risk-stratified age to stop screening.”
The US Preventive Services Task Force recommends that clinicians personalize screening for ages 76-85, accounting for overall health, prior screening history, and patient preferences.
“But we have no clear guidance on how to quantify or weigh these factors. This interesting study highlights how one of these factors (prior screening history) and fecal hemoglobin level (an emerging factor) are powerful stratifiers of subsequent colorectal cancer risk,” said Sameer D. Saini, MD, AGAF, director and research investigator at the VA Ann Arbor Healthcare System’s Center for Clinical Management Research. Dr. Saini wasn’t involved with the study.
At the clinical level, Dr. Saini said, sophisticated modeling is needed to understand the interaction with competing risks and identify the optimal screening strategies for patients at varying levels of cancer risk and life expectancy. Models could also help to quantify the population benefits and cost-effectiveness of personalized screening.
“Finally, it is important to note that, in many health systems, access to quantitative FIT may be limited,” he said. “These data may be less informative if colonoscopy is the primary mode of screening.”
Ms. van Stigt and Dr. Saini reported no relevant disclosures.
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In particular, interval CRC risk can vary substantially based on the fecal hemoglobin (f-Hb) concentration in the patient’s last fecal immunochemical test (FIT), as well as the number of prior screening rounds.
“Less is known about what happens after the upper age limit has been reached and individuals are not invited to participate in more screening rounds. This is important as life expectancy is increasing, and it is increasingly important to consider the most efficient way of screening the elderly,” said lead author Brenda van Stigt, a PhD candidate focused on cancer screening at Erasmus University Medical Center in Rotterdam, the Netherlands.
In the Netherlands, adults between ages 55 and 75 are invited to participate in stool-based CRC screening every 2 years. Based on a fecal immunochemical testing (FIT) threshold of 47 μg Hb/g, those who test positive are referred to colonoscopy, and those who test negative are invited to participate again after a 2-year period.
FIT can play a major role in risk stratification, Ms. van Stigt noted, along with other factors that influence CRC risk, such as age, sex, and CRC screening history. Although this is documented for ages 55-75, she and colleagues wanted to know more about what happens after age 75.
Ms. Van Stigt and colleagues conducted a population-based study by analyzing Dutch national cancer registry data and FIT results around the final screening at age 75, looking at those who were diagnosed with CRC within 24 months of their last negative FIT. The researchers assessed interval CRC risk and cancer stage, accounting for sex, last f-Hb concentration, and the number of screening rounds.
Among 305,761 people with a complete 24-month follow-up after a negative FIT, 661 patients were diagnosed with interval CRC, indicating an overall interval CRC risk of 21.6 per 10,000 individuals with a negative FIT. There were no significant differences by sex.
However, there were differences by screening rounds, with those who had participated in three or four screening rounds having a lower risk than those who participated only once (HR, .49).
In addition, those with detectable f-Hb (>0 μg Hb/g) in their last screening round had a much higher interval CRC risk (HR, 4.87), at 65.8 per 10,000 negative FITs, compared with 13.8 per 10,000 among those without detectable f-Hb. Interval CRC risk also increased over time for those with detectable f-Hb.
About 15% of the total population had detectable f-Hb, whereas 46% of those with interval CRC had detectable f-Hb, Ms. van Stigt said, meaning that nearly half of patients who were diagnosed with interval CRC already had detectable f-Hb in their prior FIT.
In a survival analysis, there was no association between interval CRC risk and sex. However, those who participated in three or four screening rounds were half as likely to be diagnosed than those who participated once or twice, and those with detectable f-Hb were five times as likely to be diagnosed.
For late-stage CRC, there was no association with sex or the number of screening rounds. Detectable f-Hb was associated with not only a higher risk of interval CRC but also a late-stage diagnosis.
“These findings indicate that one uniform age to stop screening is suboptimal,” Ms. van Stigt said. “Personalized screening strategies should, therefore, also ideally incorporate a risk-stratified age to stop screening.”
The US Preventive Services Task Force recommends that clinicians personalize screening for ages 76-85, accounting for overall health, prior screening history, and patient preferences.
“But we have no clear guidance on how to quantify or weigh these factors. This interesting study highlights how one of these factors (prior screening history) and fecal hemoglobin level (an emerging factor) are powerful stratifiers of subsequent colorectal cancer risk,” said Sameer D. Saini, MD, AGAF, director and research investigator at the VA Ann Arbor Healthcare System’s Center for Clinical Management Research. Dr. Saini wasn’t involved with the study.
At the clinical level, Dr. Saini said, sophisticated modeling is needed to understand the interaction with competing risks and identify the optimal screening strategies for patients at varying levels of cancer risk and life expectancy. Models could also help to quantify the population benefits and cost-effectiveness of personalized screening.
“Finally, it is important to note that, in many health systems, access to quantitative FIT may be limited,” he said. “These data may be less informative if colonoscopy is the primary mode of screening.”
Ms. van Stigt and Dr. Saini reported no relevant disclosures.
FROM DDW 2024
Healthcare Workers Face Gender-Based Violence
Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.
An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.
“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.
“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”
The study was published online in PLOS Global Public Health.
Widespread and Severe
Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.
To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.
Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.
Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.
Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.
As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.
The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.
“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”
For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
Addressing Systemic Issues
In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.
“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.
Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”
Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.
In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.
But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.
“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.
“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”
The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.
An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.
“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.
“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”
The study was published online in PLOS Global Public Health.
Widespread and Severe
Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.
To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.
Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.
Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.
Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.
As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.
The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.
“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”
For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
Addressing Systemic Issues
In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.
“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.
Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”
Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.
In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.
But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.
“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.
“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”
The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.
An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.
“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.
“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”
The study was published online in PLOS Global Public Health.
Widespread and Severe
Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.
To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.
Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.
Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.
Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.
As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.
The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.
“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”
For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
Addressing Systemic Issues
In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.
“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.
Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”
Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.
In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.
But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.
“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.
“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”
The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women with Autoimmune Liver Diseases Still Face Increased CVD Risks
WASHINGTON – , according to a study presented at the annual Digestive Disease Week® (DDW).
In particular, women with autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC) appear to have higher risks than women without AIH or PBC. Those with primary sclerosing cholangitis (PSC) don’t seem to have increased risks.
“We know that cardiovascular disease remains the number one cause of death, but the mortality rate for women over the last decade has plateaued, whereas in men it’s actually declining due to interventions,” said lead author Rachel Redfield, MD, a transplant hepatology fellow at Thomas Jefferson University Hospital in Philadelphia.
“This is likely because we don’t have adequate risk stratification, especially for women,” she said. “We know that immune-mediated diseases — such as rheumatoid arthritis and psoriasis — carry a higher risk of cardiovascular disease, but there’s not a lot of data on our autoimmune liver disease patients.”
Although being a female can offer protection against some CVD risks, the atherosclerotic cardiovascular disease (ASCVD) 10-year risk score calculator recommended by the American College of Cardiology doesn’t include chronic inflammatory diseases associated with increased CVD risk, including AILD.
Dr. Redfield and colleagues conducted a multicenter, retrospective cohort study of patients with AIH, PBC, and PSC from 1999-2019. Using TriNetX data, the researchers looked at women with AILD who also had diabetes mellitus, hypertension, and hyperlipidemia, as well as a control group of men and women with these same disorders, excluding those who used biologics, immune modulators, and steroids or had other autoimmune disorders.
The research team used 1:1 propensity-score matching for women in the study group and in the control group based on age, race, ethnicity, ASCVD risk factors, and tobacco use. Women in the study group and men in the control group were matched for age, race, ethnicity, and tobacco use.
The primary outcome was summative cardiovascular risk, including unstable angina, acute myocardial infarction, presence of coronary angioplasty implant, coronary artery bypass, percutaneous coronary intervention, and cerebral infarction.
Overall, women with AIH had a significantly higher cardiovascular risk compared to women without AIH, at 25.4% versus 20.6% (P = .0007).
Specifically, women with PBC had a significantly higher cardiovascular risk compared to women without PBC, at 27.05% versus 20.9% (P < .0001).
There wasn’t a significant difference in risk between women with and without PSC, at 27.5% versus 21.8% (P = .27).
When compared to men without disease, women with AIH didn’t have a statistically significant higher risk, at 25.3% versus 24.2% (P = .44). Similarly, there didn’t appear to be a significant difference between women with PBC and men without PBC, at 26.9% versus 25.9% (P = .52), or between women with PSC and men without PSC, at 27.7% versus 26.2% (P = .78).
Dr. Redfield and colleagues then compared the ASCVD-calculated risk versus database risk, finding that in each group of women with AILD — including AIH, PBC, and PSC — the ASCVD-calculated risk was around 11%, compared with database risk scores of 25% for AIH, 27% for PBC, and 28% for PSC. These database risks appeared similar to both the ASCVD and database risk percentages for men.
“So potentially there’s an oversight in women with any kind of inflammatory disease, but specifically here, autoimmune liver diseases,” she said. “We really need to enhance our risk assessment strategies to take into account their risk and optimize patient outcomes.”
Dr. Redfield noted the limitations with using TriNetX data, including coding consistency among providers and healthcare organizations, unknown patient follow-up dates, and the inability to capture various inflammatory disease phenotypes, such as autoimmune hepatitis with multiple flares, which may be associated with higher cardiovascular risks.
As an attendee of the DDW session, Kenneth Kelson, MD, a gastroenterologist with Fremont Medical Group and Washington Hospital Healthcare System in Fremont, California, noted the importance of investigating the effects of different types of statins in these patients. Although the research team looked at top-level differences among statin users, finding that women with AILD were more likely to be on a statin, they didn’t incorporate statin therapy in the propensity-score matching model.
“Lipid-soluble statins are known to cause more liver trouble, even though it’s pretty low,” Dr. Kelson said. “Whereas the water-soluble statins have a lower incidence of liver issues.”
Dr. Redfield and Dr. Kelson reported no relevant disclosures.
WASHINGTON – , according to a study presented at the annual Digestive Disease Week® (DDW).
In particular, women with autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC) appear to have higher risks than women without AIH or PBC. Those with primary sclerosing cholangitis (PSC) don’t seem to have increased risks.
“We know that cardiovascular disease remains the number one cause of death, but the mortality rate for women over the last decade has plateaued, whereas in men it’s actually declining due to interventions,” said lead author Rachel Redfield, MD, a transplant hepatology fellow at Thomas Jefferson University Hospital in Philadelphia.
“This is likely because we don’t have adequate risk stratification, especially for women,” she said. “We know that immune-mediated diseases — such as rheumatoid arthritis and psoriasis — carry a higher risk of cardiovascular disease, but there’s not a lot of data on our autoimmune liver disease patients.”
Although being a female can offer protection against some CVD risks, the atherosclerotic cardiovascular disease (ASCVD) 10-year risk score calculator recommended by the American College of Cardiology doesn’t include chronic inflammatory diseases associated with increased CVD risk, including AILD.
Dr. Redfield and colleagues conducted a multicenter, retrospective cohort study of patients with AIH, PBC, and PSC from 1999-2019. Using TriNetX data, the researchers looked at women with AILD who also had diabetes mellitus, hypertension, and hyperlipidemia, as well as a control group of men and women with these same disorders, excluding those who used biologics, immune modulators, and steroids or had other autoimmune disorders.
The research team used 1:1 propensity-score matching for women in the study group and in the control group based on age, race, ethnicity, ASCVD risk factors, and tobacco use. Women in the study group and men in the control group were matched for age, race, ethnicity, and tobacco use.
The primary outcome was summative cardiovascular risk, including unstable angina, acute myocardial infarction, presence of coronary angioplasty implant, coronary artery bypass, percutaneous coronary intervention, and cerebral infarction.
Overall, women with AIH had a significantly higher cardiovascular risk compared to women without AIH, at 25.4% versus 20.6% (P = .0007).
Specifically, women with PBC had a significantly higher cardiovascular risk compared to women without PBC, at 27.05% versus 20.9% (P < .0001).
There wasn’t a significant difference in risk between women with and without PSC, at 27.5% versus 21.8% (P = .27).
When compared to men without disease, women with AIH didn’t have a statistically significant higher risk, at 25.3% versus 24.2% (P = .44). Similarly, there didn’t appear to be a significant difference between women with PBC and men without PBC, at 26.9% versus 25.9% (P = .52), or between women with PSC and men without PSC, at 27.7% versus 26.2% (P = .78).
Dr. Redfield and colleagues then compared the ASCVD-calculated risk versus database risk, finding that in each group of women with AILD — including AIH, PBC, and PSC — the ASCVD-calculated risk was around 11%, compared with database risk scores of 25% for AIH, 27% for PBC, and 28% for PSC. These database risks appeared similar to both the ASCVD and database risk percentages for men.
“So potentially there’s an oversight in women with any kind of inflammatory disease, but specifically here, autoimmune liver diseases,” she said. “We really need to enhance our risk assessment strategies to take into account their risk and optimize patient outcomes.”
Dr. Redfield noted the limitations with using TriNetX data, including coding consistency among providers and healthcare organizations, unknown patient follow-up dates, and the inability to capture various inflammatory disease phenotypes, such as autoimmune hepatitis with multiple flares, which may be associated with higher cardiovascular risks.
As an attendee of the DDW session, Kenneth Kelson, MD, a gastroenterologist with Fremont Medical Group and Washington Hospital Healthcare System in Fremont, California, noted the importance of investigating the effects of different types of statins in these patients. Although the research team looked at top-level differences among statin users, finding that women with AILD were more likely to be on a statin, they didn’t incorporate statin therapy in the propensity-score matching model.
“Lipid-soluble statins are known to cause more liver trouble, even though it’s pretty low,” Dr. Kelson said. “Whereas the water-soluble statins have a lower incidence of liver issues.”
Dr. Redfield and Dr. Kelson reported no relevant disclosures.
WASHINGTON – , according to a study presented at the annual Digestive Disease Week® (DDW).
In particular, women with autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC) appear to have higher risks than women without AIH or PBC. Those with primary sclerosing cholangitis (PSC) don’t seem to have increased risks.
“We know that cardiovascular disease remains the number one cause of death, but the mortality rate for women over the last decade has plateaued, whereas in men it’s actually declining due to interventions,” said lead author Rachel Redfield, MD, a transplant hepatology fellow at Thomas Jefferson University Hospital in Philadelphia.
“This is likely because we don’t have adequate risk stratification, especially for women,” she said. “We know that immune-mediated diseases — such as rheumatoid arthritis and psoriasis — carry a higher risk of cardiovascular disease, but there’s not a lot of data on our autoimmune liver disease patients.”
Although being a female can offer protection against some CVD risks, the atherosclerotic cardiovascular disease (ASCVD) 10-year risk score calculator recommended by the American College of Cardiology doesn’t include chronic inflammatory diseases associated with increased CVD risk, including AILD.
Dr. Redfield and colleagues conducted a multicenter, retrospective cohort study of patients with AIH, PBC, and PSC from 1999-2019. Using TriNetX data, the researchers looked at women with AILD who also had diabetes mellitus, hypertension, and hyperlipidemia, as well as a control group of men and women with these same disorders, excluding those who used biologics, immune modulators, and steroids or had other autoimmune disorders.
The research team used 1:1 propensity-score matching for women in the study group and in the control group based on age, race, ethnicity, ASCVD risk factors, and tobacco use. Women in the study group and men in the control group were matched for age, race, ethnicity, and tobacco use.
The primary outcome was summative cardiovascular risk, including unstable angina, acute myocardial infarction, presence of coronary angioplasty implant, coronary artery bypass, percutaneous coronary intervention, and cerebral infarction.
Overall, women with AIH had a significantly higher cardiovascular risk compared to women without AIH, at 25.4% versus 20.6% (P = .0007).
Specifically, women with PBC had a significantly higher cardiovascular risk compared to women without PBC, at 27.05% versus 20.9% (P < .0001).
There wasn’t a significant difference in risk between women with and without PSC, at 27.5% versus 21.8% (P = .27).
When compared to men without disease, women with AIH didn’t have a statistically significant higher risk, at 25.3% versus 24.2% (P = .44). Similarly, there didn’t appear to be a significant difference between women with PBC and men without PBC, at 26.9% versus 25.9% (P = .52), or between women with PSC and men without PSC, at 27.7% versus 26.2% (P = .78).
Dr. Redfield and colleagues then compared the ASCVD-calculated risk versus database risk, finding that in each group of women with AILD — including AIH, PBC, and PSC — the ASCVD-calculated risk was around 11%, compared with database risk scores of 25% for AIH, 27% for PBC, and 28% for PSC. These database risks appeared similar to both the ASCVD and database risk percentages for men.
“So potentially there’s an oversight in women with any kind of inflammatory disease, but specifically here, autoimmune liver diseases,” she said. “We really need to enhance our risk assessment strategies to take into account their risk and optimize patient outcomes.”
Dr. Redfield noted the limitations with using TriNetX data, including coding consistency among providers and healthcare organizations, unknown patient follow-up dates, and the inability to capture various inflammatory disease phenotypes, such as autoimmune hepatitis with multiple flares, which may be associated with higher cardiovascular risks.
As an attendee of the DDW session, Kenneth Kelson, MD, a gastroenterologist with Fremont Medical Group and Washington Hospital Healthcare System in Fremont, California, noted the importance of investigating the effects of different types of statins in these patients. Although the research team looked at top-level differences among statin users, finding that women with AILD were more likely to be on a statin, they didn’t incorporate statin therapy in the propensity-score matching model.
“Lipid-soluble statins are known to cause more liver trouble, even though it’s pretty low,” Dr. Kelson said. “Whereas the water-soluble statins have a lower incidence of liver issues.”
Dr. Redfield and Dr. Kelson reported no relevant disclosures.
FROM DDW 2024
Emerging Evidence Supports Dietary Management of MASLD Through Gut-Liver Axis
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
For instance, patients with MASLD had lower intake of fiber and omega-3 fatty acids but higher consumption of added sugars and ultraprocessed foods, which correlated with the associated bacterial species and functional pathways.
“MASLD is an escalating concern globally, which highlights the need for innovative targets for disease prevention and management,” said lead author Georgina Williams, PhD, a postdoctoral researcher in diet and gastroenterology at the University of Newcastle, Australia.
“Therapeutic options often rely on lifestyle modifications, with a focus on weight loss,” she said. “Diet is considered a key component of disease management.”
Although calorie restriction with a 3%-5% fat loss is associated with hepatic benefits in MASLD, Dr. Williams noted, researchers have considered whole dietary patterns and the best fit for patients. Aspects of the Mediterranean diet may be effective, as reflected in recommendations from the American Association for the Study of Liver Disease (AASLD), which highlight dietary components such as limited carbohydrates and saturated fat, along with high fiber and unsaturated fats. The gut microbiome may be essential to consider as well, she said, given MASLD-associated differences in bile acid metabolism, inflammation, and ethanol production.
Dr. Williams and colleagues conducted a retrospective case-control study in an outpatient liver clinic to understand diet and dysbiosis in MASLD, looking at differences in diet, gut microbiota composition, and functional pathways in those with and without MASLD. The researchers investigated daily average intake, serum, and stool samples among 50 people (25 per group) matched for age and gender, comparing fibrosis-4, MASLD severity scores, macronutrients, micronutrients, food groups, metagenomic sequencing, and inflammatory markers such as interleukin (IL)-1ß, IL-6, tumor necrosis factor (TNF)-α, cytokeratin (CK)-18, and high-sensitivity C-reactive protein (hsCRP).
Dietary Characteristics
At baseline, the groups differed by ethnicity, prescription medication use, and body mass index (BMI), where the MASLD group had greater ethnic diversity, medication use, and BMI. In addition, the MASLD group had a zero to mild score of fibrosis.
Overall, energy intake didn’t differ significantly between the two groups. The control group had higher alcohol intake, likely since the MASLD group was recommended to reduce alcohol intake, though the difference was about 5 grams per day. The MASLD group also had less caffeine intake than the control group, as well as slightly lower protein intake, though the differences weren’t statistically significant.
While consumption of total carbohydrates didn’t differ significantly between the groups, participants with MASLD consumed more calories from carbohydrates than did the controls. The MASLD group consumed more calories from added and free sugars and didn’t meet recommendations for dietary fiber.
With particular food groups, participants with MASLD ate significantly fewer whole grains, red and orange fruits, and leafy green vegetables. When consuming fruit, those with MASLD were more likely to drink juice than eat whole fruit. These findings could be relevant when considering high sugar intake and low dietary fiber, Dr. Williams said.
With dietary fat, there were no differences in total fat between the groups, but the fat profiles differed. The control group was significantly more likely to consume omega-3 fatty acids, including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid (DHA). The MASLD group was less likely to consume seafood, nuts, seeds, avocado, and olive oil.
With inflammatory markers, hsCRP and CK-18 were increased in MASLD, while IL-1ß was increased in controls, which was consistently associated with higher alcohol intake among the control group. IL-6 and TNF-α didn’t differ between the groups.
Notably, dietary fats were most consistently associated with inflammatory markers, Dr. Williams said, with inflammation being positively associated with saturated fats and negatively associated with unsaturated fats.
Looking at microbiota, the alpha diversity was no different, but the beta diversity was across 162 taxa. Per bacterial species, there was an inverse relationship between MASLD and associations with unsaturated fat, as well as positive indicators of high sugar and fructose intake and low unsaturated fat and dietary fiber intake.
Beyond that, the functional pathways enriched in MASLD were associated with increased sugar and carbohydrates, reduced fiber, and reduced unsaturated fat. Lower butyrate production in MASLD was associated with low intake of nuts, seeds, and unsaturated fat.
In Clinical Practice
Dr. Williams suggested reinforcing AASLD guidelines and looking at diet quality, not just diet quantity. Although an energy deficit remains relevant in MASLD, macronutrient consumption matters across dietary fats, fibers, and sugars.
Future avenues for research include metabolomic pathways related to bile acids and fatty acids, she said, as well as disentangling metabolic syndrome from MASLD outcomes.
Session moderator Olivier Barbier, PhD, professor of pharmacy at Laval University in Quebec, Canada, asked about microbiome differences across countries. Dr. Williams noted the limitations in this study of looking at differences across geography and ethnicity, particularly in Australia, but said the species identified were consistent with those found in most literature globally.
In response to other questions after the presentation, Dr. Williams said supplements (such as omega-3 fatty acids) were included in total intake, and those taking prebiotics or probiotics were excluded from the study. In an upcoming clinical trial, she and colleagues plan to control for household microbiomes as well.
“The premise is that microbiomes are shared between households, so when you’re doing these sorts of large-scale clinical studies, if you’re going to look at the microbiome, then you should control for one of the major confounding variables,” said Mark Sundrud, PhD, professor of medicine at the Dartmouth Center for Digestive Health in Lebanon, New Hampshire. Dr. Sundrud, who wasn’t involved with this study, presented on the role of bile acids in mucosal immune cell function at DDW.
“We’ve done a collaborative study looking at microbiomes and bile acids in inflammatory bowel disease (IBD) patients versus controls,” which included consideration of households, he said. “We were able to see more intrinsic disease-specific changes.”
Dr. Williams declared no relevant disclosures. Dr. Sundrud has served as a scientific adviser to Sage Therapeutics.
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
For instance, patients with MASLD had lower intake of fiber and omega-3 fatty acids but higher consumption of added sugars and ultraprocessed foods, which correlated with the associated bacterial species and functional pathways.
“MASLD is an escalating concern globally, which highlights the need for innovative targets for disease prevention and management,” said lead author Georgina Williams, PhD, a postdoctoral researcher in diet and gastroenterology at the University of Newcastle, Australia.
“Therapeutic options often rely on lifestyle modifications, with a focus on weight loss,” she said. “Diet is considered a key component of disease management.”
Although calorie restriction with a 3%-5% fat loss is associated with hepatic benefits in MASLD, Dr. Williams noted, researchers have considered whole dietary patterns and the best fit for patients. Aspects of the Mediterranean diet may be effective, as reflected in recommendations from the American Association for the Study of Liver Disease (AASLD), which highlight dietary components such as limited carbohydrates and saturated fat, along with high fiber and unsaturated fats. The gut microbiome may be essential to consider as well, she said, given MASLD-associated differences in bile acid metabolism, inflammation, and ethanol production.
Dr. Williams and colleagues conducted a retrospective case-control study in an outpatient liver clinic to understand diet and dysbiosis in MASLD, looking at differences in diet, gut microbiota composition, and functional pathways in those with and without MASLD. The researchers investigated daily average intake, serum, and stool samples among 50 people (25 per group) matched for age and gender, comparing fibrosis-4, MASLD severity scores, macronutrients, micronutrients, food groups, metagenomic sequencing, and inflammatory markers such as interleukin (IL)-1ß, IL-6, tumor necrosis factor (TNF)-α, cytokeratin (CK)-18, and high-sensitivity C-reactive protein (hsCRP).
Dietary Characteristics
At baseline, the groups differed by ethnicity, prescription medication use, and body mass index (BMI), where the MASLD group had greater ethnic diversity, medication use, and BMI. In addition, the MASLD group had a zero to mild score of fibrosis.
Overall, energy intake didn’t differ significantly between the two groups. The control group had higher alcohol intake, likely since the MASLD group was recommended to reduce alcohol intake, though the difference was about 5 grams per day. The MASLD group also had less caffeine intake than the control group, as well as slightly lower protein intake, though the differences weren’t statistically significant.
While consumption of total carbohydrates didn’t differ significantly between the groups, participants with MASLD consumed more calories from carbohydrates than did the controls. The MASLD group consumed more calories from added and free sugars and didn’t meet recommendations for dietary fiber.
With particular food groups, participants with MASLD ate significantly fewer whole grains, red and orange fruits, and leafy green vegetables. When consuming fruit, those with MASLD were more likely to drink juice than eat whole fruit. These findings could be relevant when considering high sugar intake and low dietary fiber, Dr. Williams said.
With dietary fat, there were no differences in total fat between the groups, but the fat profiles differed. The control group was significantly more likely to consume omega-3 fatty acids, including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid (DHA). The MASLD group was less likely to consume seafood, nuts, seeds, avocado, and olive oil.
With inflammatory markers, hsCRP and CK-18 were increased in MASLD, while IL-1ß was increased in controls, which was consistently associated with higher alcohol intake among the control group. IL-6 and TNF-α didn’t differ between the groups.
Notably, dietary fats were most consistently associated with inflammatory markers, Dr. Williams said, with inflammation being positively associated with saturated fats and negatively associated with unsaturated fats.
Looking at microbiota, the alpha diversity was no different, but the beta diversity was across 162 taxa. Per bacterial species, there was an inverse relationship between MASLD and associations with unsaturated fat, as well as positive indicators of high sugar and fructose intake and low unsaturated fat and dietary fiber intake.
Beyond that, the functional pathways enriched in MASLD were associated with increased sugar and carbohydrates, reduced fiber, and reduced unsaturated fat. Lower butyrate production in MASLD was associated with low intake of nuts, seeds, and unsaturated fat.
In Clinical Practice
Dr. Williams suggested reinforcing AASLD guidelines and looking at diet quality, not just diet quantity. Although an energy deficit remains relevant in MASLD, macronutrient consumption matters across dietary fats, fibers, and sugars.
Future avenues for research include metabolomic pathways related to bile acids and fatty acids, she said, as well as disentangling metabolic syndrome from MASLD outcomes.
Session moderator Olivier Barbier, PhD, professor of pharmacy at Laval University in Quebec, Canada, asked about microbiome differences across countries. Dr. Williams noted the limitations in this study of looking at differences across geography and ethnicity, particularly in Australia, but said the species identified were consistent with those found in most literature globally.
In response to other questions after the presentation, Dr. Williams said supplements (such as omega-3 fatty acids) were included in total intake, and those taking prebiotics or probiotics were excluded from the study. In an upcoming clinical trial, she and colleagues plan to control for household microbiomes as well.
“The premise is that microbiomes are shared between households, so when you’re doing these sorts of large-scale clinical studies, if you’re going to look at the microbiome, then you should control for one of the major confounding variables,” said Mark Sundrud, PhD, professor of medicine at the Dartmouth Center for Digestive Health in Lebanon, New Hampshire. Dr. Sundrud, who wasn’t involved with this study, presented on the role of bile acids in mucosal immune cell function at DDW.
“We’ve done a collaborative study looking at microbiomes and bile acids in inflammatory bowel disease (IBD) patients versus controls,” which included consideration of households, he said. “We were able to see more intrinsic disease-specific changes.”
Dr. Williams declared no relevant disclosures. Dr. Sundrud has served as a scientific adviser to Sage Therapeutics.
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
For instance, patients with MASLD had lower intake of fiber and omega-3 fatty acids but higher consumption of added sugars and ultraprocessed foods, which correlated with the associated bacterial species and functional pathways.
“MASLD is an escalating concern globally, which highlights the need for innovative targets for disease prevention and management,” said lead author Georgina Williams, PhD, a postdoctoral researcher in diet and gastroenterology at the University of Newcastle, Australia.
“Therapeutic options often rely on lifestyle modifications, with a focus on weight loss,” she said. “Diet is considered a key component of disease management.”
Although calorie restriction with a 3%-5% fat loss is associated with hepatic benefits in MASLD, Dr. Williams noted, researchers have considered whole dietary patterns and the best fit for patients. Aspects of the Mediterranean diet may be effective, as reflected in recommendations from the American Association for the Study of Liver Disease (AASLD), which highlight dietary components such as limited carbohydrates and saturated fat, along with high fiber and unsaturated fats. The gut microbiome may be essential to consider as well, she said, given MASLD-associated differences in bile acid metabolism, inflammation, and ethanol production.
Dr. Williams and colleagues conducted a retrospective case-control study in an outpatient liver clinic to understand diet and dysbiosis in MASLD, looking at differences in diet, gut microbiota composition, and functional pathways in those with and without MASLD. The researchers investigated daily average intake, serum, and stool samples among 50 people (25 per group) matched for age and gender, comparing fibrosis-4, MASLD severity scores, macronutrients, micronutrients, food groups, metagenomic sequencing, and inflammatory markers such as interleukin (IL)-1ß, IL-6, tumor necrosis factor (TNF)-α, cytokeratin (CK)-18, and high-sensitivity C-reactive protein (hsCRP).
Dietary Characteristics
At baseline, the groups differed by ethnicity, prescription medication use, and body mass index (BMI), where the MASLD group had greater ethnic diversity, medication use, and BMI. In addition, the MASLD group had a zero to mild score of fibrosis.
Overall, energy intake didn’t differ significantly between the two groups. The control group had higher alcohol intake, likely since the MASLD group was recommended to reduce alcohol intake, though the difference was about 5 grams per day. The MASLD group also had less caffeine intake than the control group, as well as slightly lower protein intake, though the differences weren’t statistically significant.
While consumption of total carbohydrates didn’t differ significantly between the groups, participants with MASLD consumed more calories from carbohydrates than did the controls. The MASLD group consumed more calories from added and free sugars and didn’t meet recommendations for dietary fiber.
With particular food groups, participants with MASLD ate significantly fewer whole grains, red and orange fruits, and leafy green vegetables. When consuming fruit, those with MASLD were more likely to drink juice than eat whole fruit. These findings could be relevant when considering high sugar intake and low dietary fiber, Dr. Williams said.
With dietary fat, there were no differences in total fat between the groups, but the fat profiles differed. The control group was significantly more likely to consume omega-3 fatty acids, including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid (DHA). The MASLD group was less likely to consume seafood, nuts, seeds, avocado, and olive oil.
With inflammatory markers, hsCRP and CK-18 were increased in MASLD, while IL-1ß was increased in controls, which was consistently associated with higher alcohol intake among the control group. IL-6 and TNF-α didn’t differ between the groups.
Notably, dietary fats were most consistently associated with inflammatory markers, Dr. Williams said, with inflammation being positively associated with saturated fats and negatively associated with unsaturated fats.
Looking at microbiota, the alpha diversity was no different, but the beta diversity was across 162 taxa. Per bacterial species, there was an inverse relationship between MASLD and associations with unsaturated fat, as well as positive indicators of high sugar and fructose intake and low unsaturated fat and dietary fiber intake.
Beyond that, the functional pathways enriched in MASLD were associated with increased sugar and carbohydrates, reduced fiber, and reduced unsaturated fat. Lower butyrate production in MASLD was associated with low intake of nuts, seeds, and unsaturated fat.
In Clinical Practice
Dr. Williams suggested reinforcing AASLD guidelines and looking at diet quality, not just diet quantity. Although an energy deficit remains relevant in MASLD, macronutrient consumption matters across dietary fats, fibers, and sugars.
Future avenues for research include metabolomic pathways related to bile acids and fatty acids, she said, as well as disentangling metabolic syndrome from MASLD outcomes.
Session moderator Olivier Barbier, PhD, professor of pharmacy at Laval University in Quebec, Canada, asked about microbiome differences across countries. Dr. Williams noted the limitations in this study of looking at differences across geography and ethnicity, particularly in Australia, but said the species identified were consistent with those found in most literature globally.
In response to other questions after the presentation, Dr. Williams said supplements (such as omega-3 fatty acids) were included in total intake, and those taking prebiotics or probiotics were excluded from the study. In an upcoming clinical trial, she and colleagues plan to control for household microbiomes as well.
“The premise is that microbiomes are shared between households, so when you’re doing these sorts of large-scale clinical studies, if you’re going to look at the microbiome, then you should control for one of the major confounding variables,” said Mark Sundrud, PhD, professor of medicine at the Dartmouth Center for Digestive Health in Lebanon, New Hampshire. Dr. Sundrud, who wasn’t involved with this study, presented on the role of bile acids in mucosal immune cell function at DDW.
“We’ve done a collaborative study looking at microbiomes and bile acids in inflammatory bowel disease (IBD) patients versus controls,” which included consideration of households, he said. “We were able to see more intrinsic disease-specific changes.”
Dr. Williams declared no relevant disclosures. Dr. Sundrud has served as a scientific adviser to Sage Therapeutics.
FROM DDW 2024
Mailed Outreach for CRC Screening Appeals Across Races and Ethnicities
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In a comparison of four outreach approaches, sending a FIT kit to people between the ages of 45 and 49 via mail garnered better response rates than opt-in strategies to participate in FIT, inviting them to undergo colonoscopy, or asking them to choose between FIT or colonoscopy. At the same time, when given a choice between colonoscopy and FIT, colonoscopy was preferred across all racial and ethnic groups.
“It is well known that colorectal cancer is the second-leading cause of cancer-related deaths in the United States. The good news is that for the past several decades, we’ve seen a decline in colorectal cancer incidence and mortality in ages 50 and above. However, there has been a recent rise in incidence and mortality in people younger than 50,” said lead author Rebecca Ekeanyanwu, a third-year medical student at Meharry Medical College School of Medicine in Nashville, Tennessee. She was awarded the 2024 AGA Institute Council Healthcare Disparities Research Award for the top oral presentation for research in racial and ethnic health care disparities.
CRC incidence, screening rates, and mortality also vary by race and ethnicity, with higher incidence and mortality rates seen among non-Hispanic Black patients, more late-stage diagnoses among Hispanic patients, and lower screening rates among Asian patients.
“There’s no formal guidance on how to screen the population under age 50,” she said. “With the disparities in race and ethnicity, it remains unclear what would be the best population health strategy to optimize colorectal screening participation in young minorities.”
Ms. Ekeanyanwu and colleagues conducted a subanalysis of a 2022 randomized controlled trial at the University of California, Los Angeles, that looked at screening strategies for average-risk patients between ages 45 and 49. The study population included patients who were assigned to a primary care provider in the UCLA Health system and had active electronic portal use and excluded those with a personal or family history of adenoma or CRC, history of IBD or gastrointestinal cancer, and a prior FIT or colonoscopy.
In this study, the research team focused on the completion of any CRC screening at 26 weeks, stratified by race and ethnicity. They included four outreach scenarios: FIT invitation, colonoscopy invitation, a choice between FIT or colonoscopy invitation, or a default mailed FIT kit, which served as the control and typically is sent to UCLA patients overdue for screening among ages 50 and older. The researchers sent letters via US Postal Service and the online patient portal, as well as two texts about CRC screening.
Among 20,509 patients, 8918 were White (43.5%), 2757 were Hispanic (13.4%), 2613 were Asian (12.7%), and 797 were Black (3.9%).
The overall screening participation rate was 18.6%, with the lowest percentage among Black participants at 16.7% and the highest among Asian participants at 23.8%. These numbers varied significantly from the 20% seen among both White and Hispanic participants.
The default mailed outreach approach had the highest uptake with higher screening rates, at 26.2% overall, and had the highest participation in each racial and ethnic group. The rates were 28.7% among White patients, 20.1% among Black patients, 27.5% among Hispanic patients, and 31% among Asian patients.
Participation was lowest among the colonoscopy invitation group — as well as for White (14.8%), Hispanic (16%), and Asian (19.3%) patients. Among Black patients, participation was lowest in the FIT invitation group (12.8%).
Notably, in the choice group, more participants chose colonoscopy above FIT — across all racial and ethnic groups — at 12.1% versus 5.6% overall. In addition, among both FIT groups, there was significant crossover to colonoscopy, with about 7%-14% among the racial and ethnic groups preferring colonoscopy.
Ms. Ekeanyanwu noted the study may be limited by variations in sample size by race and ethnicity, as well as the socioeconomic status of typical patients at UCLA, who tend to fall in middle class and affluent groups. Demographic and socioeconomic factors may play a part in patients’ decision to get screened, she noted.
Patient participation in the digital portal may affect response rates as well, said Benjamin Lebwohl, MD, AGAF, an associate professor of medicine and epidemiology at Columbia University Medical Center, New York, who moderated the DDW session titled Reducing the Burden of GI Cancers Through Early Interventions.
“At least at my institution, we have a large number of such patients [not on the digital portal] who tend to be of lower socioeconomic status and tend to be at higher risk of not getting screened,” Dr. Lebwohl said. It would be important to consider “those who might need this intervention the most.”
Ms. Ekeanyanwu declared no relevant disclosures.
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In a comparison of four outreach approaches, sending a FIT kit to people between the ages of 45 and 49 via mail garnered better response rates than opt-in strategies to participate in FIT, inviting them to undergo colonoscopy, or asking them to choose between FIT or colonoscopy. At the same time, when given a choice between colonoscopy and FIT, colonoscopy was preferred across all racial and ethnic groups.
“It is well known that colorectal cancer is the second-leading cause of cancer-related deaths in the United States. The good news is that for the past several decades, we’ve seen a decline in colorectal cancer incidence and mortality in ages 50 and above. However, there has been a recent rise in incidence and mortality in people younger than 50,” said lead author Rebecca Ekeanyanwu, a third-year medical student at Meharry Medical College School of Medicine in Nashville, Tennessee. She was awarded the 2024 AGA Institute Council Healthcare Disparities Research Award for the top oral presentation for research in racial and ethnic health care disparities.
CRC incidence, screening rates, and mortality also vary by race and ethnicity, with higher incidence and mortality rates seen among non-Hispanic Black patients, more late-stage diagnoses among Hispanic patients, and lower screening rates among Asian patients.
“There’s no formal guidance on how to screen the population under age 50,” she said. “With the disparities in race and ethnicity, it remains unclear what would be the best population health strategy to optimize colorectal screening participation in young minorities.”
Ms. Ekeanyanwu and colleagues conducted a subanalysis of a 2022 randomized controlled trial at the University of California, Los Angeles, that looked at screening strategies for average-risk patients between ages 45 and 49. The study population included patients who were assigned to a primary care provider in the UCLA Health system and had active electronic portal use and excluded those with a personal or family history of adenoma or CRC, history of IBD or gastrointestinal cancer, and a prior FIT or colonoscopy.
In this study, the research team focused on the completion of any CRC screening at 26 weeks, stratified by race and ethnicity. They included four outreach scenarios: FIT invitation, colonoscopy invitation, a choice between FIT or colonoscopy invitation, or a default mailed FIT kit, which served as the control and typically is sent to UCLA patients overdue for screening among ages 50 and older. The researchers sent letters via US Postal Service and the online patient portal, as well as two texts about CRC screening.
Among 20,509 patients, 8918 were White (43.5%), 2757 were Hispanic (13.4%), 2613 were Asian (12.7%), and 797 were Black (3.9%).
The overall screening participation rate was 18.6%, with the lowest percentage among Black participants at 16.7% and the highest among Asian participants at 23.8%. These numbers varied significantly from the 20% seen among both White and Hispanic participants.
The default mailed outreach approach had the highest uptake with higher screening rates, at 26.2% overall, and had the highest participation in each racial and ethnic group. The rates were 28.7% among White patients, 20.1% among Black patients, 27.5% among Hispanic patients, and 31% among Asian patients.
Participation was lowest among the colonoscopy invitation group — as well as for White (14.8%), Hispanic (16%), and Asian (19.3%) patients. Among Black patients, participation was lowest in the FIT invitation group (12.8%).
Notably, in the choice group, more participants chose colonoscopy above FIT — across all racial and ethnic groups — at 12.1% versus 5.6% overall. In addition, among both FIT groups, there was significant crossover to colonoscopy, with about 7%-14% among the racial and ethnic groups preferring colonoscopy.
Ms. Ekeanyanwu noted the study may be limited by variations in sample size by race and ethnicity, as well as the socioeconomic status of typical patients at UCLA, who tend to fall in middle class and affluent groups. Demographic and socioeconomic factors may play a part in patients’ decision to get screened, she noted.
Patient participation in the digital portal may affect response rates as well, said Benjamin Lebwohl, MD, AGAF, an associate professor of medicine and epidemiology at Columbia University Medical Center, New York, who moderated the DDW session titled Reducing the Burden of GI Cancers Through Early Interventions.
“At least at my institution, we have a large number of such patients [not on the digital portal] who tend to be of lower socioeconomic status and tend to be at higher risk of not getting screened,” Dr. Lebwohl said. It would be important to consider “those who might need this intervention the most.”
Ms. Ekeanyanwu declared no relevant disclosures.
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In a comparison of four outreach approaches, sending a FIT kit to people between the ages of 45 and 49 via mail garnered better response rates than opt-in strategies to participate in FIT, inviting them to undergo colonoscopy, or asking them to choose between FIT or colonoscopy. At the same time, when given a choice between colonoscopy and FIT, colonoscopy was preferred across all racial and ethnic groups.
“It is well known that colorectal cancer is the second-leading cause of cancer-related deaths in the United States. The good news is that for the past several decades, we’ve seen a decline in colorectal cancer incidence and mortality in ages 50 and above. However, there has been a recent rise in incidence and mortality in people younger than 50,” said lead author Rebecca Ekeanyanwu, a third-year medical student at Meharry Medical College School of Medicine in Nashville, Tennessee. She was awarded the 2024 AGA Institute Council Healthcare Disparities Research Award for the top oral presentation for research in racial and ethnic health care disparities.
CRC incidence, screening rates, and mortality also vary by race and ethnicity, with higher incidence and mortality rates seen among non-Hispanic Black patients, more late-stage diagnoses among Hispanic patients, and lower screening rates among Asian patients.
“There’s no formal guidance on how to screen the population under age 50,” she said. “With the disparities in race and ethnicity, it remains unclear what would be the best population health strategy to optimize colorectal screening participation in young minorities.”
Ms. Ekeanyanwu and colleagues conducted a subanalysis of a 2022 randomized controlled trial at the University of California, Los Angeles, that looked at screening strategies for average-risk patients between ages 45 and 49. The study population included patients who were assigned to a primary care provider in the UCLA Health system and had active electronic portal use and excluded those with a personal or family history of adenoma or CRC, history of IBD or gastrointestinal cancer, and a prior FIT or colonoscopy.
In this study, the research team focused on the completion of any CRC screening at 26 weeks, stratified by race and ethnicity. They included four outreach scenarios: FIT invitation, colonoscopy invitation, a choice between FIT or colonoscopy invitation, or a default mailed FIT kit, which served as the control and typically is sent to UCLA patients overdue for screening among ages 50 and older. The researchers sent letters via US Postal Service and the online patient portal, as well as two texts about CRC screening.
Among 20,509 patients, 8918 were White (43.5%), 2757 were Hispanic (13.4%), 2613 were Asian (12.7%), and 797 were Black (3.9%).
The overall screening participation rate was 18.6%, with the lowest percentage among Black participants at 16.7% and the highest among Asian participants at 23.8%. These numbers varied significantly from the 20% seen among both White and Hispanic participants.
The default mailed outreach approach had the highest uptake with higher screening rates, at 26.2% overall, and had the highest participation in each racial and ethnic group. The rates were 28.7% among White patients, 20.1% among Black patients, 27.5% among Hispanic patients, and 31% among Asian patients.
Participation was lowest among the colonoscopy invitation group — as well as for White (14.8%), Hispanic (16%), and Asian (19.3%) patients. Among Black patients, participation was lowest in the FIT invitation group (12.8%).
Notably, in the choice group, more participants chose colonoscopy above FIT — across all racial and ethnic groups — at 12.1% versus 5.6% overall. In addition, among both FIT groups, there was significant crossover to colonoscopy, with about 7%-14% among the racial and ethnic groups preferring colonoscopy.
Ms. Ekeanyanwu noted the study may be limited by variations in sample size by race and ethnicity, as well as the socioeconomic status of typical patients at UCLA, who tend to fall in middle class and affluent groups. Demographic and socioeconomic factors may play a part in patients’ decision to get screened, she noted.
Patient participation in the digital portal may affect response rates as well, said Benjamin Lebwohl, MD, AGAF, an associate professor of medicine and epidemiology at Columbia University Medical Center, New York, who moderated the DDW session titled Reducing the Burden of GI Cancers Through Early Interventions.
“At least at my institution, we have a large number of such patients [not on the digital portal] who tend to be of lower socioeconomic status and tend to be at higher risk of not getting screened,” Dr. Lebwohl said. It would be important to consider “those who might need this intervention the most.”
Ms. Ekeanyanwu declared no relevant disclosures.
FROM DDW 2024
In IBD Patients, Statin Use Associated with Lower Risk of Developing PSC
WASHINGTON — , according to a study presented at Digestive Disease Week® (DDW) 2024.
Statin use was associated with an 86% risk reduction, and only .09% of IBD patients who took statins developed PSC.
“We all take care of patients with liver disease, and we know what a significant burden PSC is. These patients have a significantly elevated risk of enhanced fibrosis and cirrhosis, multiple cancers, and cholangitis and sepsis,” said lead author Chiraag Kulkarni, MD, a gastroenterology fellow at Stanford (California) University Medical School.
“Despite this, we have to date no proven effective medical care for PSC,” he said. “However, over the last decade, there is growing evidence that statins may be beneficial in liver disease, and we see this evidence base stretching from basic science to clinical data.”
Dr. Kulkarni pointed to numerous studies that indicate statins may slow disease progression in steatotic liver disease, viral hepatitis, and cirrhosis. But could statins prevent the onset of PSC?
Because PSC incidence is low, Dr. Kulkarni and colleagues focused on a patient population with higher prevalence — those with IBD, who have an overall lifetime risk of 2% to 7%. The research team followed patients from the date of IBD diagnosis.
Among 33,813 patients with IBD in a national dataset from 2018 onward, 8813 used statins. Statin users tended to be older than non–statin users.
Overall, 181 patients developed new onset PSC during a median follow-up of about 45 months after initial IBD diagnosis. Only eight statin users (.09%) developed PSC, compared with 173 patients (.69%) in the control group.
In a propensity score-matched analysis, statin therapy was associated with a significantly lower risk of developing PSC (HR .14, P < .001). The associated E-value was 5.5, which suggested a robust finding and unlikely to be due to non-visible confounding.
The findings were consistent across secondary and sensitivity analyses, including by age, duration of statin use, and type of statin. For instance, for patients under age 50 where PSC is more likely to occur, statins were associated with a 90% reduction in PSC risk.
“We take away two things from this. First, it’s suggested that a protective effect occurs at ages where PSC is most likely to occur,” Dr. Kulkarni said. “Second, in combination with our propensity score-matched analysis, the results we are observing are not due to a survival bias, where the patients who survive to an age where statins are prescribed simply have a biologically different predilection for developing PSC.”
Statins also protected against PSC in both ulcerative colitis (HR .21) and Crohn’s disease (HR .15), as well as both women (HR .16) and men (HR .22).
Given the uncertainty about the optimal duration of statin therapy for a protective effect, Dr. Kulkarni and colleagues looked at a lag time of 12 months. They found statins were associated with an 84% risk reduction (HR .16), which was similar to the primary analysis.
The study was limited by the inability to capture dosage data or medication adherence. The findings raised several questions, Dr. Kulkarni said, such as the underlying mechanisms and clinical implications. For instance, the underlying mechanisms appear to be related to the pleiotropic effect of statins, modulation of gut inflammation, and alterations in bile acid profiles.
“This is really fascinating and interesting. I wonder about this as a primary prevention strategy in those who have normal cholesterol. Could this work or not?” said Gyongyi Szabo, MD, AGAF, chief academic officer at Beth Israel Deaconess Medical Center, Boston, who was a moderator for the Liver & Biliary Section Distinguished Abstract Plenary Session.
Dr. Kulkarni noted that these findings wouldn’t change clinical practice alone, but based on existing literature around statin hesitancy among patients with cardiovascular disease, the risk reduction for PSC could provide another reason to encourage patients to take them.
“To move this to a place where you can actually think about primary prevention, I think the biological mechanisms need to be teased out a little bit more,” Dr. Kulkarni said. “Then I think you probably still need to identify a higher-risk group than IBD alone.”
Dr. Kulkarni declared no disclosures.
WASHINGTON — , according to a study presented at Digestive Disease Week® (DDW) 2024.
Statin use was associated with an 86% risk reduction, and only .09% of IBD patients who took statins developed PSC.
“We all take care of patients with liver disease, and we know what a significant burden PSC is. These patients have a significantly elevated risk of enhanced fibrosis and cirrhosis, multiple cancers, and cholangitis and sepsis,” said lead author Chiraag Kulkarni, MD, a gastroenterology fellow at Stanford (California) University Medical School.
“Despite this, we have to date no proven effective medical care for PSC,” he said. “However, over the last decade, there is growing evidence that statins may be beneficial in liver disease, and we see this evidence base stretching from basic science to clinical data.”
Dr. Kulkarni pointed to numerous studies that indicate statins may slow disease progression in steatotic liver disease, viral hepatitis, and cirrhosis. But could statins prevent the onset of PSC?
Because PSC incidence is low, Dr. Kulkarni and colleagues focused on a patient population with higher prevalence — those with IBD, who have an overall lifetime risk of 2% to 7%. The research team followed patients from the date of IBD diagnosis.
Among 33,813 patients with IBD in a national dataset from 2018 onward, 8813 used statins. Statin users tended to be older than non–statin users.
Overall, 181 patients developed new onset PSC during a median follow-up of about 45 months after initial IBD diagnosis. Only eight statin users (.09%) developed PSC, compared with 173 patients (.69%) in the control group.
In a propensity score-matched analysis, statin therapy was associated with a significantly lower risk of developing PSC (HR .14, P < .001). The associated E-value was 5.5, which suggested a robust finding and unlikely to be due to non-visible confounding.
The findings were consistent across secondary and sensitivity analyses, including by age, duration of statin use, and type of statin. For instance, for patients under age 50 where PSC is more likely to occur, statins were associated with a 90% reduction in PSC risk.
“We take away two things from this. First, it’s suggested that a protective effect occurs at ages where PSC is most likely to occur,” Dr. Kulkarni said. “Second, in combination with our propensity score-matched analysis, the results we are observing are not due to a survival bias, where the patients who survive to an age where statins are prescribed simply have a biologically different predilection for developing PSC.”
Statins also protected against PSC in both ulcerative colitis (HR .21) and Crohn’s disease (HR .15), as well as both women (HR .16) and men (HR .22).
Given the uncertainty about the optimal duration of statin therapy for a protective effect, Dr. Kulkarni and colleagues looked at a lag time of 12 months. They found statins were associated with an 84% risk reduction (HR .16), which was similar to the primary analysis.
The study was limited by the inability to capture dosage data or medication adherence. The findings raised several questions, Dr. Kulkarni said, such as the underlying mechanisms and clinical implications. For instance, the underlying mechanisms appear to be related to the pleiotropic effect of statins, modulation of gut inflammation, and alterations in bile acid profiles.
“This is really fascinating and interesting. I wonder about this as a primary prevention strategy in those who have normal cholesterol. Could this work or not?” said Gyongyi Szabo, MD, AGAF, chief academic officer at Beth Israel Deaconess Medical Center, Boston, who was a moderator for the Liver & Biliary Section Distinguished Abstract Plenary Session.
Dr. Kulkarni noted that these findings wouldn’t change clinical practice alone, but based on existing literature around statin hesitancy among patients with cardiovascular disease, the risk reduction for PSC could provide another reason to encourage patients to take them.
“To move this to a place where you can actually think about primary prevention, I think the biological mechanisms need to be teased out a little bit more,” Dr. Kulkarni said. “Then I think you probably still need to identify a higher-risk group than IBD alone.”
Dr. Kulkarni declared no disclosures.
WASHINGTON — , according to a study presented at Digestive Disease Week® (DDW) 2024.
Statin use was associated with an 86% risk reduction, and only .09% of IBD patients who took statins developed PSC.
“We all take care of patients with liver disease, and we know what a significant burden PSC is. These patients have a significantly elevated risk of enhanced fibrosis and cirrhosis, multiple cancers, and cholangitis and sepsis,” said lead author Chiraag Kulkarni, MD, a gastroenterology fellow at Stanford (California) University Medical School.
“Despite this, we have to date no proven effective medical care for PSC,” he said. “However, over the last decade, there is growing evidence that statins may be beneficial in liver disease, and we see this evidence base stretching from basic science to clinical data.”
Dr. Kulkarni pointed to numerous studies that indicate statins may slow disease progression in steatotic liver disease, viral hepatitis, and cirrhosis. But could statins prevent the onset of PSC?
Because PSC incidence is low, Dr. Kulkarni and colleagues focused on a patient population with higher prevalence — those with IBD, who have an overall lifetime risk of 2% to 7%. The research team followed patients from the date of IBD diagnosis.
Among 33,813 patients with IBD in a national dataset from 2018 onward, 8813 used statins. Statin users tended to be older than non–statin users.
Overall, 181 patients developed new onset PSC during a median follow-up of about 45 months after initial IBD diagnosis. Only eight statin users (.09%) developed PSC, compared with 173 patients (.69%) in the control group.
In a propensity score-matched analysis, statin therapy was associated with a significantly lower risk of developing PSC (HR .14, P < .001). The associated E-value was 5.5, which suggested a robust finding and unlikely to be due to non-visible confounding.
The findings were consistent across secondary and sensitivity analyses, including by age, duration of statin use, and type of statin. For instance, for patients under age 50 where PSC is more likely to occur, statins were associated with a 90% reduction in PSC risk.
“We take away two things from this. First, it’s suggested that a protective effect occurs at ages where PSC is most likely to occur,” Dr. Kulkarni said. “Second, in combination with our propensity score-matched analysis, the results we are observing are not due to a survival bias, where the patients who survive to an age where statins are prescribed simply have a biologically different predilection for developing PSC.”
Statins also protected against PSC in both ulcerative colitis (HR .21) and Crohn’s disease (HR .15), as well as both women (HR .16) and men (HR .22).
Given the uncertainty about the optimal duration of statin therapy for a protective effect, Dr. Kulkarni and colleagues looked at a lag time of 12 months. They found statins were associated with an 84% risk reduction (HR .16), which was similar to the primary analysis.
The study was limited by the inability to capture dosage data or medication adherence. The findings raised several questions, Dr. Kulkarni said, such as the underlying mechanisms and clinical implications. For instance, the underlying mechanisms appear to be related to the pleiotropic effect of statins, modulation of gut inflammation, and alterations in bile acid profiles.
“This is really fascinating and interesting. I wonder about this as a primary prevention strategy in those who have normal cholesterol. Could this work or not?” said Gyongyi Szabo, MD, AGAF, chief academic officer at Beth Israel Deaconess Medical Center, Boston, who was a moderator for the Liver & Biliary Section Distinguished Abstract Plenary Session.
Dr. Kulkarni noted that these findings wouldn’t change clinical practice alone, but based on existing literature around statin hesitancy among patients with cardiovascular disease, the risk reduction for PSC could provide another reason to encourage patients to take them.
“To move this to a place where you can actually think about primary prevention, I think the biological mechanisms need to be teased out a little bit more,” Dr. Kulkarni said. “Then I think you probably still need to identify a higher-risk group than IBD alone.”
Dr. Kulkarni declared no disclosures.
FROM DDW 2024
Low-FODMAP, Low-Carb Diets May Beat Medical Treatment for IBS
According to a new study, evidence was found that these dietary interventions were more efficacious at 4 weeks, suggesting their potential as first-line treatments.
“IBS is a disorder that may have different underlying causes, and it can manifest in different ways among patients. It is also likely that the most effective treatment option can differ in patients,” said lead author Sanna Nybacka, RD, PhD, a postdoctoral researcher in molecular and clinical medicine at the University of Gothenburg’s Sahlgrenska Academy, Gothenburg, Sweden.
“Up to 80% of patients with IBS report that their symptoms are exacerbated by dietary factors, and dietary modifications are considered a promising avenue for alleviating IBS symptoms,” she said. “However, as not all patients respond to dietary modifications, we need studies comparing the effectiveness of dietary vs pharmacological treatments in IBS to better understand which patients are more likely to benefit from which treatment.”
The study was published online in The Lancet Gastroenterology and Hepatology.
Treatment Comparison
Dr. Nybacka and colleagues conducted a single-blind randomized controlled trial at a specialized outpatient clinic at Sahlgrenska University Hospital in Gothenburg, Sweden, between January 2017 and September 2021. They included adults with moderate to severe IBS, which was defined as ≥ 175 points on the IBS Severity Scoring System (IBS-SSS), and who had no other serious diseases or food allergies.
The participants were assigned 1:1:1 to receive a low-FODMAP diet plus traditional dietary advice (50% carbohydrates, 33% fat, 17% protein), a fiber-optimized diet with low carbohydrates and high protein and fat (10% carbohydrates, 67% fat, 23% protein), or optimized medical treatment based on predominant IBS symptoms. Participants were masked to the names of the diets, but the pharmacological treatment was open-label.
After 4 weeks, participants were unmasked and encouraged to continue their diets.
During 6 months of follow-up, those in the low-FODMAP group were instructed on how to reintroduce FODMAPs, and those in the pharmacological treatment group were offered personalized diet counseling and to continue their medication.
Among 1104 participants assessed for eligibility, 304 were randomly assigned. However, 10 participants did not receive their intervention after randomization, so only 294 participants were included in the modified intention-to-treat population: 96 in the low-FODMAP group, 97 in the low-carbohydrate group, and 101 in the optimized medical treatment group. Overall, 82% were women, and the mean age was 38 years.
Following the 4-week intervention, 73 of 96 participants (76%) in the low-FODMAP group, 69 of 97 participants (71%) in the low-carbohydrate group, and 59 of 101 participants (58%) in the optimized medical treatment group had a reduction of ≥ 50 points in the IBS-SSS compared with baseline.
A stricter score reduction of ≥ 100 points was observed in 61% of the low-FODMAP group, 58% of the low-carbohydrate group, and 39% of the optimized medical treatment group.
In both the low-FODMAP group and the low-carbohydrate group, 95% of participants completed the 4-week intervention compared with 90% among the pharmacological group. Two people in each group said adverse events prompted their discontinuation, and five in the medical treatment group stopped prematurely due to side effects. No serious adverse events or treatment-related deaths occurred.
“We were surprised by the effectiveness of the fiber-optimized low-carbohydrate diet, which demonstrated comparable efficacy to the combined low-FODMAP and traditional IBS diet,” Dr. Nybacka said. “While previous knowledge suggested that high-fat intake could worsen symptoms in some individuals, the synergy with low-carbohydrate intake appeared to render the diet more tolerable for these patients.”
The authors noted that since all three treatment options showed significant and clinically meaningful efficacy, patient preference, ease of implementation, compliance, cost-effectiveness, and long-term effects, including those on nutritional status and gut microbiota, should be considered in personalized plans.
Future Practice Considerations
Dr. Nybacka and colleagues recommended additional trials before implementing the low-carbohydrate diet in clinical practice. “Worse blood lipid levels among some participants in the low-carbohydrate group point to an area for caution,” she said.
The research team also plans to evaluate changes in microbiota composition and metabolomic profiles among participants to further understand factors associated with positive treatment outcomes.
“Approximately two thirds of patients with IBS report that certain foods trigger symptoms of IBS, which is why many patients are interested in exploring dietary interventions for their symptoms,” said Brian Lacy, MD, professor of medicine and program director of the GI fellowship program at the Mayo Clinic in Jacksonville, Florida. “One of the most commonly employed diets for the treatment of IBS is the low-FODMAP diet.”
Dr. Lacy, who wasn’t involved with this study, co-authored the 2021 American College of Gastroenterology clinical guideline for the management of IBS.
He and his colleagues recommended a limited trial of a low-FODMAP diet to improve symptoms, as well as targeted use of medications for IBS subtypes with constipation or diarrhea and gut-directed psychotherapy for overall IBS symptoms.
“However, there are problems with the low-FODMAP diet, as it can be difficult to institute, it can be fairly restrictive, and long-term use has the potential to lead to micronutrient deficiencies,” he said. “Importantly, large studies comparing dietary interventions directly to medical therapies are absent, which led to the study by Nybacka and colleagues.”
Dr. Lacy noted several limitations, including the single-center focus, short-term intervention, and variety of therapies used among the medical arm of the study. In addition, some therapies available in the United States aren’t available in Europe, so the varying approaches to medical management in the former may lead to different results. At the same time, he said, the study is important and will be widely discussed among patients and clinicians.
“I think it will likely stand the test of time,” Dr. Lacy said. “An easy-to-use diet with common sense advice that improves symptoms will likely eventually translate into first-line therapy for IBS patients.”
The study was funded by grants from the Healthcare Board Region Västra Götaland, Swedish Research Council, Swedish Research Council for Health, Working Life and Welfare, and AFA Insurance; the ALF agreement between the Swedish government and county councils; Wilhelm and Martina Lundgren Science Foundation; Skandia; Dietary Science Foundation; and Nanna Swartz Foundation. Several authors declared grants, consulting fees, and advisory board roles with various pharmaceutical companies. Dr. Lacy reported no relevant disclosures.
A version of this article appeared on Medscape.com.
According to a new study, evidence was found that these dietary interventions were more efficacious at 4 weeks, suggesting their potential as first-line treatments.
“IBS is a disorder that may have different underlying causes, and it can manifest in different ways among patients. It is also likely that the most effective treatment option can differ in patients,” said lead author Sanna Nybacka, RD, PhD, a postdoctoral researcher in molecular and clinical medicine at the University of Gothenburg’s Sahlgrenska Academy, Gothenburg, Sweden.
“Up to 80% of patients with IBS report that their symptoms are exacerbated by dietary factors, and dietary modifications are considered a promising avenue for alleviating IBS symptoms,” she said. “However, as not all patients respond to dietary modifications, we need studies comparing the effectiveness of dietary vs pharmacological treatments in IBS to better understand which patients are more likely to benefit from which treatment.”
The study was published online in The Lancet Gastroenterology and Hepatology.
Treatment Comparison
Dr. Nybacka and colleagues conducted a single-blind randomized controlled trial at a specialized outpatient clinic at Sahlgrenska University Hospital in Gothenburg, Sweden, between January 2017 and September 2021. They included adults with moderate to severe IBS, which was defined as ≥ 175 points on the IBS Severity Scoring System (IBS-SSS), and who had no other serious diseases or food allergies.
The participants were assigned 1:1:1 to receive a low-FODMAP diet plus traditional dietary advice (50% carbohydrates, 33% fat, 17% protein), a fiber-optimized diet with low carbohydrates and high protein and fat (10% carbohydrates, 67% fat, 23% protein), or optimized medical treatment based on predominant IBS symptoms. Participants were masked to the names of the diets, but the pharmacological treatment was open-label.
After 4 weeks, participants were unmasked and encouraged to continue their diets.
During 6 months of follow-up, those in the low-FODMAP group were instructed on how to reintroduce FODMAPs, and those in the pharmacological treatment group were offered personalized diet counseling and to continue their medication.
Among 1104 participants assessed for eligibility, 304 were randomly assigned. However, 10 participants did not receive their intervention after randomization, so only 294 participants were included in the modified intention-to-treat population: 96 in the low-FODMAP group, 97 in the low-carbohydrate group, and 101 in the optimized medical treatment group. Overall, 82% were women, and the mean age was 38 years.
Following the 4-week intervention, 73 of 96 participants (76%) in the low-FODMAP group, 69 of 97 participants (71%) in the low-carbohydrate group, and 59 of 101 participants (58%) in the optimized medical treatment group had a reduction of ≥ 50 points in the IBS-SSS compared with baseline.
A stricter score reduction of ≥ 100 points was observed in 61% of the low-FODMAP group, 58% of the low-carbohydrate group, and 39% of the optimized medical treatment group.
In both the low-FODMAP group and the low-carbohydrate group, 95% of participants completed the 4-week intervention compared with 90% among the pharmacological group. Two people in each group said adverse events prompted their discontinuation, and five in the medical treatment group stopped prematurely due to side effects. No serious adverse events or treatment-related deaths occurred.
“We were surprised by the effectiveness of the fiber-optimized low-carbohydrate diet, which demonstrated comparable efficacy to the combined low-FODMAP and traditional IBS diet,” Dr. Nybacka said. “While previous knowledge suggested that high-fat intake could worsen symptoms in some individuals, the synergy with low-carbohydrate intake appeared to render the diet more tolerable for these patients.”
The authors noted that since all three treatment options showed significant and clinically meaningful efficacy, patient preference, ease of implementation, compliance, cost-effectiveness, and long-term effects, including those on nutritional status and gut microbiota, should be considered in personalized plans.
Future Practice Considerations
Dr. Nybacka and colleagues recommended additional trials before implementing the low-carbohydrate diet in clinical practice. “Worse blood lipid levels among some participants in the low-carbohydrate group point to an area for caution,” she said.
The research team also plans to evaluate changes in microbiota composition and metabolomic profiles among participants to further understand factors associated with positive treatment outcomes.
“Approximately two thirds of patients with IBS report that certain foods trigger symptoms of IBS, which is why many patients are interested in exploring dietary interventions for their symptoms,” said Brian Lacy, MD, professor of medicine and program director of the GI fellowship program at the Mayo Clinic in Jacksonville, Florida. “One of the most commonly employed diets for the treatment of IBS is the low-FODMAP diet.”
Dr. Lacy, who wasn’t involved with this study, co-authored the 2021 American College of Gastroenterology clinical guideline for the management of IBS.
He and his colleagues recommended a limited trial of a low-FODMAP diet to improve symptoms, as well as targeted use of medications for IBS subtypes with constipation or diarrhea and gut-directed psychotherapy for overall IBS symptoms.
“However, there are problems with the low-FODMAP diet, as it can be difficult to institute, it can be fairly restrictive, and long-term use has the potential to lead to micronutrient deficiencies,” he said. “Importantly, large studies comparing dietary interventions directly to medical therapies are absent, which led to the study by Nybacka and colleagues.”
Dr. Lacy noted several limitations, including the single-center focus, short-term intervention, and variety of therapies used among the medical arm of the study. In addition, some therapies available in the United States aren’t available in Europe, so the varying approaches to medical management in the former may lead to different results. At the same time, he said, the study is important and will be widely discussed among patients and clinicians.
“I think it will likely stand the test of time,” Dr. Lacy said. “An easy-to-use diet with common sense advice that improves symptoms will likely eventually translate into first-line therapy for IBS patients.”
The study was funded by grants from the Healthcare Board Region Västra Götaland, Swedish Research Council, Swedish Research Council for Health, Working Life and Welfare, and AFA Insurance; the ALF agreement between the Swedish government and county councils; Wilhelm and Martina Lundgren Science Foundation; Skandia; Dietary Science Foundation; and Nanna Swartz Foundation. Several authors declared grants, consulting fees, and advisory board roles with various pharmaceutical companies. Dr. Lacy reported no relevant disclosures.
A version of this article appeared on Medscape.com.
According to a new study, evidence was found that these dietary interventions were more efficacious at 4 weeks, suggesting their potential as first-line treatments.
“IBS is a disorder that may have different underlying causes, and it can manifest in different ways among patients. It is also likely that the most effective treatment option can differ in patients,” said lead author Sanna Nybacka, RD, PhD, a postdoctoral researcher in molecular and clinical medicine at the University of Gothenburg’s Sahlgrenska Academy, Gothenburg, Sweden.
“Up to 80% of patients with IBS report that their symptoms are exacerbated by dietary factors, and dietary modifications are considered a promising avenue for alleviating IBS symptoms,” she said. “However, as not all patients respond to dietary modifications, we need studies comparing the effectiveness of dietary vs pharmacological treatments in IBS to better understand which patients are more likely to benefit from which treatment.”
The study was published online in The Lancet Gastroenterology and Hepatology.
Treatment Comparison
Dr. Nybacka and colleagues conducted a single-blind randomized controlled trial at a specialized outpatient clinic at Sahlgrenska University Hospital in Gothenburg, Sweden, between January 2017 and September 2021. They included adults with moderate to severe IBS, which was defined as ≥ 175 points on the IBS Severity Scoring System (IBS-SSS), and who had no other serious diseases or food allergies.
The participants were assigned 1:1:1 to receive a low-FODMAP diet plus traditional dietary advice (50% carbohydrates, 33% fat, 17% protein), a fiber-optimized diet with low carbohydrates and high protein and fat (10% carbohydrates, 67% fat, 23% protein), or optimized medical treatment based on predominant IBS symptoms. Participants were masked to the names of the diets, but the pharmacological treatment was open-label.
After 4 weeks, participants were unmasked and encouraged to continue their diets.
During 6 months of follow-up, those in the low-FODMAP group were instructed on how to reintroduce FODMAPs, and those in the pharmacological treatment group were offered personalized diet counseling and to continue their medication.
Among 1104 participants assessed for eligibility, 304 were randomly assigned. However, 10 participants did not receive their intervention after randomization, so only 294 participants were included in the modified intention-to-treat population: 96 in the low-FODMAP group, 97 in the low-carbohydrate group, and 101 in the optimized medical treatment group. Overall, 82% were women, and the mean age was 38 years.
Following the 4-week intervention, 73 of 96 participants (76%) in the low-FODMAP group, 69 of 97 participants (71%) in the low-carbohydrate group, and 59 of 101 participants (58%) in the optimized medical treatment group had a reduction of ≥ 50 points in the IBS-SSS compared with baseline.
A stricter score reduction of ≥ 100 points was observed in 61% of the low-FODMAP group, 58% of the low-carbohydrate group, and 39% of the optimized medical treatment group.
In both the low-FODMAP group and the low-carbohydrate group, 95% of participants completed the 4-week intervention compared with 90% among the pharmacological group. Two people in each group said adverse events prompted their discontinuation, and five in the medical treatment group stopped prematurely due to side effects. No serious adverse events or treatment-related deaths occurred.
“We were surprised by the effectiveness of the fiber-optimized low-carbohydrate diet, which demonstrated comparable efficacy to the combined low-FODMAP and traditional IBS diet,” Dr. Nybacka said. “While previous knowledge suggested that high-fat intake could worsen symptoms in some individuals, the synergy with low-carbohydrate intake appeared to render the diet more tolerable for these patients.”
The authors noted that since all three treatment options showed significant and clinically meaningful efficacy, patient preference, ease of implementation, compliance, cost-effectiveness, and long-term effects, including those on nutritional status and gut microbiota, should be considered in personalized plans.
Future Practice Considerations
Dr. Nybacka and colleagues recommended additional trials before implementing the low-carbohydrate diet in clinical practice. “Worse blood lipid levels among some participants in the low-carbohydrate group point to an area for caution,” she said.
The research team also plans to evaluate changes in microbiota composition and metabolomic profiles among participants to further understand factors associated with positive treatment outcomes.
“Approximately two thirds of patients with IBS report that certain foods trigger symptoms of IBS, which is why many patients are interested in exploring dietary interventions for their symptoms,” said Brian Lacy, MD, professor of medicine and program director of the GI fellowship program at the Mayo Clinic in Jacksonville, Florida. “One of the most commonly employed diets for the treatment of IBS is the low-FODMAP diet.”
Dr. Lacy, who wasn’t involved with this study, co-authored the 2021 American College of Gastroenterology clinical guideline for the management of IBS.
He and his colleagues recommended a limited trial of a low-FODMAP diet to improve symptoms, as well as targeted use of medications for IBS subtypes with constipation or diarrhea and gut-directed psychotherapy for overall IBS symptoms.
“However, there are problems with the low-FODMAP diet, as it can be difficult to institute, it can be fairly restrictive, and long-term use has the potential to lead to micronutrient deficiencies,” he said. “Importantly, large studies comparing dietary interventions directly to medical therapies are absent, which led to the study by Nybacka and colleagues.”
Dr. Lacy noted several limitations, including the single-center focus, short-term intervention, and variety of therapies used among the medical arm of the study. In addition, some therapies available in the United States aren’t available in Europe, so the varying approaches to medical management in the former may lead to different results. At the same time, he said, the study is important and will be widely discussed among patients and clinicians.
“I think it will likely stand the test of time,” Dr. Lacy said. “An easy-to-use diet with common sense advice that improves symptoms will likely eventually translate into first-line therapy for IBS patients.”
The study was funded by grants from the Healthcare Board Region Västra Götaland, Swedish Research Council, Swedish Research Council for Health, Working Life and Welfare, and AFA Insurance; the ALF agreement between the Swedish government and county councils; Wilhelm and Martina Lundgren Science Foundation; Skandia; Dietary Science Foundation; and Nanna Swartz Foundation. Several authors declared grants, consulting fees, and advisory board roles with various pharmaceutical companies. Dr. Lacy reported no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM THE LANCET GASTROENTEROLOGY AND HEPATOLOGY