Diana Swift

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

Cold snare endoscopic mucosal resection (EMR) may be a safe therapeutic option for selected large colorectal polyps, thanks to a safety profile superior to that of hot EMR.

In findings from Germany’s randomized controlled CHRONICLE trial, published in Gastroenterology , the cold technique almost eliminated major adverse events (AEs) — but at the cost of higher rates of recurrence and residual adenoma at first follow-up.

“The exact definition of the ideal lesions requires further research,” wrote investigators led by Ingo Steinbrück, MD, of the Department of Medicine and Gastroenterology at the Academic Teaching Hospital of the University of Freiburg, Freiburg im Breisgau, Germany. “Further studies have to confirm to what extent polyp size and histology can determine an individualized approach.”

Evangelisches Diakoniekrankenhaus Freiburg

The Study

From June 2021 to July 2023, the 19-center intention-to-treat analysis enrolled 363 patients (48.2% women) with a total of 396 polyps and randomly assigned those with polyps of ≥ 20 mm to cold (n = 193) or hot EMR (n = 203). The primary outcome was major AEs such as perforation or post-endoscopic bleeding.

Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001, odds ratio [OR], 0.12; 95% CI, 0.03-0.54).

Rates for perforation and post-endoscopic bleeding were significantly lower in the cold group, with 0 vs 8 (0% vs 3.9%, P = .007) perforations in the two groups, respectively, as well as 1.0% vs 4.4% (P = .040) for postprocedural bleeding.

Somewhat surprisingly, intraprocedural bleeding was also less common in the cold EMR group at 14% vs 23%.

Residual adenoma, however, was found more frequently in the cold group at 23.7% vs 13.8% (OR, 1.94; 95% CI,1.12-3.38; P = .020).

Commenting on the study but not involved in it, Seth Crockett, MD, MPH, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at Oregon Health & Science University in Portland, Oregon, called the CHRONICLE findings very important.

Oregon Health & Science University

Implications

This study has several implications, Dr. Crockett said. First, more research and innovation are needed to develop techniques to maximize complete resection during cold EMR and minimize residual polyp rates. “Ideally, this would involve other cold techniques so as not to offset the safety benefits of cold EMR,” he noted.

Second, patient selection is important, as cold EMR is likely more suitable for those with serrated lesions and for those in whom follow-up can be assured, he added. “For patients who have the largest polyps, particularly lesions of the laterally spreading tumor, nodular mixed type, and those who do not wish to participate in surveillance, hot EMR may be preferable, at least at this point.”

The authors agreed that new technical development that improves the outcomes and cost-effectiveness of cold snare polypectomy and combines its demonstrated safety with recurrence reduction is necessary, as are studies to identify optimal candidate lesions.

“The next step is to evaluate whether cold snare EMR with additional measures leads to a recurrence rate comparable to hot snare EMR with margin coagulation,” Dr. Steinbrück said. “If this is the case, cold snare resection may be the future treatment of choice for all large nonpedunculated polyps without suspected malignancy in the colorectum.”

This work was supported by the Gastroenterology Foundation, Küsnacht, Switzerland. Dr. Steinbrück reported lecture fees and travel grants from Olympus Medical, a polypectomy device maker, and Falk Pharma. Numerous coauthors disclosed financial relationships with pharmaceutical and medical device companies, including Olympus Medical. Dr. Crockett disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

Cold snare endoscopic mucosal resection (EMR) may be a safe therapeutic option for selected large colorectal polyps, thanks to a safety profile superior to that of hot EMR.

In findings from Germany’s randomized controlled CHRONICLE trial, published in Gastroenterology , the cold technique almost eliminated major adverse events (AEs) — but at the cost of higher rates of recurrence and residual adenoma at first follow-up.

“The exact definition of the ideal lesions requires further research,” wrote investigators led by Ingo Steinbrück, MD, of the Department of Medicine and Gastroenterology at the Academic Teaching Hospital of the University of Freiburg, Freiburg im Breisgau, Germany. “Further studies have to confirm to what extent polyp size and histology can determine an individualized approach.”

Evangelisches Diakoniekrankenhaus Freiburg

The Study

From June 2021 to July 2023, the 19-center intention-to-treat analysis enrolled 363 patients (48.2% women) with a total of 396 polyps and randomly assigned those with polyps of ≥ 20 mm to cold (n = 193) or hot EMR (n = 203). The primary outcome was major AEs such as perforation or post-endoscopic bleeding.

Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001, odds ratio [OR], 0.12; 95% CI, 0.03-0.54).

Rates for perforation and post-endoscopic bleeding were significantly lower in the cold group, with 0 vs 8 (0% vs 3.9%, P = .007) perforations in the two groups, respectively, as well as 1.0% vs 4.4% (P = .040) for postprocedural bleeding.

Somewhat surprisingly, intraprocedural bleeding was also less common in the cold EMR group at 14% vs 23%.

Residual adenoma, however, was found more frequently in the cold group at 23.7% vs 13.8% (OR, 1.94; 95% CI,1.12-3.38; P = .020).

Commenting on the study but not involved in it, Seth Crockett, MD, MPH, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at Oregon Health & Science University in Portland, Oregon, called the CHRONICLE findings very important.

Oregon Health & Science University

Implications

This study has several implications, Dr. Crockett said. First, more research and innovation are needed to develop techniques to maximize complete resection during cold EMR and minimize residual polyp rates. “Ideally, this would involve other cold techniques so as not to offset the safety benefits of cold EMR,” he noted.

Second, patient selection is important, as cold EMR is likely more suitable for those with serrated lesions and for those in whom follow-up can be assured, he added. “For patients who have the largest polyps, particularly lesions of the laterally spreading tumor, nodular mixed type, and those who do not wish to participate in surveillance, hot EMR may be preferable, at least at this point.”

The authors agreed that new technical development that improves the outcomes and cost-effectiveness of cold snare polypectomy and combines its demonstrated safety with recurrence reduction is necessary, as are studies to identify optimal candidate lesions.

“The next step is to evaluate whether cold snare EMR with additional measures leads to a recurrence rate comparable to hot snare EMR with margin coagulation,” Dr. Steinbrück said. “If this is the case, cold snare resection may be the future treatment of choice for all large nonpedunculated polyps without suspected malignancy in the colorectum.”

This work was supported by the Gastroenterology Foundation, Küsnacht, Switzerland. Dr. Steinbrück reported lecture fees and travel grants from Olympus Medical, a polypectomy device maker, and Falk Pharma. Numerous coauthors disclosed financial relationships with pharmaceutical and medical device companies, including Olympus Medical. Dr. Crockett disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

Cold snare endoscopic mucosal resection (EMR) may be a safe therapeutic option for selected large colorectal polyps, thanks to a safety profile superior to that of hot EMR.

In findings from Germany’s randomized controlled CHRONICLE trial, published in Gastroenterology , the cold technique almost eliminated major adverse events (AEs) — but at the cost of higher rates of recurrence and residual adenoma at first follow-up.

“The exact definition of the ideal lesions requires further research,” wrote investigators led by Ingo Steinbrück, MD, of the Department of Medicine and Gastroenterology at the Academic Teaching Hospital of the University of Freiburg, Freiburg im Breisgau, Germany. “Further studies have to confirm to what extent polyp size and histology can determine an individualized approach.”

Evangelisches Diakoniekrankenhaus Freiburg

The Study

From June 2021 to July 2023, the 19-center intention-to-treat analysis enrolled 363 patients (48.2% women) with a total of 396 polyps and randomly assigned those with polyps of ≥ 20 mm to cold (n = 193) or hot EMR (n = 203). The primary outcome was major AEs such as perforation or post-endoscopic bleeding.

Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001, odds ratio [OR], 0.12; 95% CI, 0.03-0.54).

Rates for perforation and post-endoscopic bleeding were significantly lower in the cold group, with 0 vs 8 (0% vs 3.9%, P = .007) perforations in the two groups, respectively, as well as 1.0% vs 4.4% (P = .040) for postprocedural bleeding.

Somewhat surprisingly, intraprocedural bleeding was also less common in the cold EMR group at 14% vs 23%.

Residual adenoma, however, was found more frequently in the cold group at 23.7% vs 13.8% (OR, 1.94; 95% CI,1.12-3.38; P = .020).

Commenting on the study but not involved in it, Seth Crockett, MD, MPH, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at Oregon Health & Science University in Portland, Oregon, called the CHRONICLE findings very important.

Oregon Health & Science University

Implications

This study has several implications, Dr. Crockett said. First, more research and innovation are needed to develop techniques to maximize complete resection during cold EMR and minimize residual polyp rates. “Ideally, this would involve other cold techniques so as not to offset the safety benefits of cold EMR,” he noted.

Second, patient selection is important, as cold EMR is likely more suitable for those with serrated lesions and for those in whom follow-up can be assured, he added. “For patients who have the largest polyps, particularly lesions of the laterally spreading tumor, nodular mixed type, and those who do not wish to participate in surveillance, hot EMR may be preferable, at least at this point.”

The authors agreed that new technical development that improves the outcomes and cost-effectiveness of cold snare polypectomy and combines its demonstrated safety with recurrence reduction is necessary, as are studies to identify optimal candidate lesions.

“The next step is to evaluate whether cold snare EMR with additional measures leads to a recurrence rate comparable to hot snare EMR with margin coagulation,” Dr. Steinbrück said. “If this is the case, cold snare resection may be the future treatment of choice for all large nonpedunculated polyps without suspected malignancy in the colorectum.”

This work was supported by the Gastroenterology Foundation, Küsnacht, Switzerland. Dr. Steinbrück reported lecture fees and travel grants from Olympus Medical, a polypectomy device maker, and Falk Pharma. Numerous coauthors disclosed financial relationships with pharmaceutical and medical device companies, including Olympus Medical. Dr. Crockett disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

Poorer physical function, not poorer bone mineral density (BMD), could be the principal reason for the increased fracture risk in older women with type 2 diabetes (T2D), according to a Swedish prospective observational study in JAMA Network Open.

The study was conducted in more than 3000 Swedish women by Mattias Lorentzon, MD, a professor of geriatric medicine at Gothenburg University, and chief physician at the Osteoporosis Clinic at Sahlgrenska University Hospital in Mölndal, and colleagues.

Study Details

A fractures study was performed in the Gothenburg area from March 2013 to May 2016 with follow-up of incident fracture data completed in March 2023. Data were collected from questionnaires and through examination of anthropometrics, physical function, and bone measurements using dual-energy x-ray absorptiometry and high-resolution peripheral computed tomography. A subsample underwent bone microindentation to assess BMSi.

Among the cohort’s 3008 women, ages 75-80 (mean, 77.8), 294 patients with T2D were compared with 2714 same-age unaffected women.

During a median follow-up of 7.3 years, 1071 incident fractures, 853 major osteoporotic fractures, and 232 hip fractures occurred. In models adjusted for age, BMI, clinical risk factors, and femoral neck BMD, T2D was associated with an increased risk of any fracture: hazard ratio (HR), 1.26; (95% CI, 1.04-1.54), and major osteoporotic fracture (HR, 1.25; 95% CI, 1.00-1.56).

Most fractures were due to falls, with the most common affected sites being the forearm, upper arm, spine, and hip, Dr. Lorentzon said.

Among the findings:

• In bone microarchitecture, women with T2D had higher BMD at all sites: total hip, 4.4% higher; femoral neck, 4.9% higher; and lumbar spine, 5.2% higher.
• At the tibia, the T2D group had 7.4% greater cortical area and 1.3% greater density, as well as 8.7% higher trabecular bone volume fraction.

“Our findings regarding BMD are consistent with previous publications showing higher BMD in individuals with T2D compared with those without diabetes,” Dr. Lorentzon said. A 2012 meta-analysis, for example, showed higher BMD levels in T2D patients. “Some smaller studies, however, have found worse bone microstructure and lower bone material strength in contrast to the results from our study,” Dr. Lorentzon said.

• There was no difference in BMSi, with a mean of 78 in both groups.
• The T2D group had lower performance on all physical function tests: a 9.7% lower grip strength, 9.9% slower gait speed, and 13.9% slower timed up-and-go time than women without diabetes.

“We found all parameters regarding physical function, such as muscle strength, balance, and performance, were much worse in women with diabetes than in those without,” Dr. Lorentzon said. “Dizziness could also be a contributor to the increased risk of falls, but this factor was not investigated in our study.”

Commenting on the study but not involved in it, Anthony J. Pick, MD, an endocrinologist at Northwestern Medicine Lake Forest Hospital in Lake Forest, Illinois, said sarcopenia is a common and often under-recognized problem in older adults and is especially prevalent in T2D, obesity, and heart failure. “I believe that ‘exercise is medicine’ is a key concept for metabolic and osteoporosis patients — and wellness and longevity in general — and I certainly hope studies like this drive awareness of the importance of engaging in strengthening exercises.”

Poorer physical function, not poorer bone mineral density (BMD), could be the principal reason for the increased fracture risk in older women with type 2 diabetes (T2D), according to a Swedish prospective observational study in JAMA Network Open.

The study was conducted in more than 3000 Swedish women by Mattias Lorentzon, MD, a professor of geriatric medicine at Gothenburg University, and chief physician at the Osteoporosis Clinic at Sahlgrenska University Hospital in Mölndal, and colleagues.

Study Details

A fractures study was performed in the Gothenburg area from March 2013 to May 2016 with follow-up of incident fracture data completed in March 2023. Data were collected from questionnaires and through examination of anthropometrics, physical function, and bone measurements using dual-energy x-ray absorptiometry and high-resolution peripheral computed tomography. A subsample underwent bone microindentation to assess BMSi.

Among the cohort’s 3008 women, ages 75-80 (mean, 77.8), 294 patients with T2D were compared with 2714 same-age unaffected women.

During a median follow-up of 7.3 years, 1071 incident fractures, 853 major osteoporotic fractures, and 232 hip fractures occurred. In models adjusted for age, BMI, clinical risk factors, and femoral neck BMD, T2D was associated with an increased risk of any fracture: hazard ratio (HR), 1.26; (95% CI, 1.04-1.54), and major osteoporotic fracture (HR, 1.25; 95% CI, 1.00-1.56).

Most fractures were due to falls, with the most common affected sites being the forearm, upper arm, spine, and hip, Dr. Lorentzon said.

Among the findings:

• In bone microarchitecture, women with T2D had higher BMD at all sites: total hip, 4.4% higher; femoral neck, 4.9% higher; and lumbar spine, 5.2% higher.
• At the tibia, the T2D group had 7.4% greater cortical area and 1.3% greater density, as well as 8.7% higher trabecular bone volume fraction.

“Our findings regarding BMD are consistent with previous publications showing higher BMD in individuals with T2D compared with those without diabetes,” Dr. Lorentzon said. A 2012 meta-analysis, for example, showed higher BMD levels in T2D patients. “Some smaller studies, however, have found worse bone microstructure and lower bone material strength in contrast to the results from our study,” Dr. Lorentzon said.

• There was no difference in BMSi, with a mean of 78 in both groups.
• The T2D group had lower performance on all physical function tests: a 9.7% lower grip strength, 9.9% slower gait speed, and 13.9% slower timed up-and-go time than women without diabetes.

“We found all parameters regarding physical function, such as muscle strength, balance, and performance, were much worse in women with diabetes than in those without,” Dr. Lorentzon said. “Dizziness could also be a contributor to the increased risk of falls, but this factor was not investigated in our study.”

Commenting on the study but not involved in it, Anthony J. Pick, MD, an endocrinologist at Northwestern Medicine Lake Forest Hospital in Lake Forest, Illinois, said sarcopenia is a common and often under-recognized problem in older adults and is especially prevalent in T2D, obesity, and heart failure. “I believe that ‘exercise is medicine’ is a key concept for metabolic and osteoporosis patients — and wellness and longevity in general — and I certainly hope studies like this drive awareness of the importance of engaging in strengthening exercises.”

Poorer physical function, not poorer bone mineral density (BMD), could be the principal reason for the increased fracture risk in older women with type 2 diabetes (T2D), according to a Swedish prospective observational study in JAMA Network Open.

The study was conducted in more than 3000 Swedish women by Mattias Lorentzon, MD, a professor of geriatric medicine at Gothenburg University, and chief physician at the Osteoporosis Clinic at Sahlgrenska University Hospital in Mölndal, and colleagues.

Study Details

A fractures study was performed in the Gothenburg area from March 2013 to May 2016 with follow-up of incident fracture data completed in March 2023. Data were collected from questionnaires and through examination of anthropometrics, physical function, and bone measurements using dual-energy x-ray absorptiometry and high-resolution peripheral computed tomography. A subsample underwent bone microindentation to assess BMSi.

Among the cohort’s 3008 women, ages 75-80 (mean, 77.8), 294 patients with T2D were compared with 2714 same-age unaffected women.

During a median follow-up of 7.3 years, 1071 incident fractures, 853 major osteoporotic fractures, and 232 hip fractures occurred. In models adjusted for age, BMI, clinical risk factors, and femoral neck BMD, T2D was associated with an increased risk of any fracture: hazard ratio (HR), 1.26; (95% CI, 1.04-1.54), and major osteoporotic fracture (HR, 1.25; 95% CI, 1.00-1.56).

Most fractures were due to falls, with the most common affected sites being the forearm, upper arm, spine, and hip, Dr. Lorentzon said.

Among the findings:

• In bone microarchitecture, women with T2D had higher BMD at all sites: total hip, 4.4% higher; femoral neck, 4.9% higher; and lumbar spine, 5.2% higher.
• At the tibia, the T2D group had 7.4% greater cortical area and 1.3% greater density, as well as 8.7% higher trabecular bone volume fraction.

“Our findings regarding BMD are consistent with previous publications showing higher BMD in individuals with T2D compared with those without diabetes,” Dr. Lorentzon said. A 2012 meta-analysis, for example, showed higher BMD levels in T2D patients. “Some smaller studies, however, have found worse bone microstructure and lower bone material strength in contrast to the results from our study,” Dr. Lorentzon said.

• There was no difference in BMSi, with a mean of 78 in both groups.
• The T2D group had lower performance on all physical function tests: a 9.7% lower grip strength, 9.9% slower gait speed, and 13.9% slower timed up-and-go time than women without diabetes.

“We found all parameters regarding physical function, such as muscle strength, balance, and performance, were much worse in women with diabetes than in those without,” Dr. Lorentzon said. “Dizziness could also be a contributor to the increased risk of falls, but this factor was not investigated in our study.”

Commenting on the study but not involved in it, Anthony J. Pick, MD, an endocrinologist at Northwestern Medicine Lake Forest Hospital in Lake Forest, Illinois, said sarcopenia is a common and often under-recognized problem in older adults and is especially prevalent in T2D, obesity, and heart failure. “I believe that ‘exercise is medicine’ is a key concept for metabolic and osteoporosis patients — and wellness and longevity in general — and I certainly hope studies like this drive awareness of the importance of engaging in strengthening exercises.”

Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.

In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.

The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.

The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.

In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).

In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.

Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.

Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.

In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.

The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.

They called for more measures to mitigate the excess burden of PMADs.

This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.

Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.

In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.

The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.

The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.

In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).

In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.

Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.

Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.

In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.

The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.

They called for more measures to mitigate the excess burden of PMADs.

This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.

Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.

In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.

The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.

The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.

In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).

In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.

Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.

Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.

In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.

The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.

They called for more measures to mitigate the excess burden of PMADs.

This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.

Early-life and environmental exposures are more strongly linked to age at diagnosis of inflammatory bowel disease (IBD) than genetic factors, a large study of IBD patients reported.

Published in Clinical Gastroenterology and Hepatology , the study found that environment influences the onset of both ulcerative colitis (UC) and Crohn’s disease (CD), and exposures typical in Western society lower the age of diagnosis. These factors include birth in a developed nation, delivery by C-section, and more bathrooms in the home, according to Oriana M. Damas, MD, MSCTI, an associate professor of clinical medicine at the University of Miami Miller School of Medicine in Florida and colleagues.

courtesy University of Miami Health System

Environmental factors explained 21% of the variance in age of CD diagnosis and 39% of the variance in age of UC diagnosis. In models incorporating both genetic and environmental risk scores, the environment was the only significant factor associated with younger age of IBD diagnosis in all groups.

Several epidemiologic studies have examined environmental culprits in IBD, and others have examined genetic risk factors, Dr. Damas said in an interview. “But we had not seen any studies that examined the influence of both [of] these on age of IBD development.” Her group’s working hypothesis that environment would have a greater effect than genetics was borne out.

“Additionally, very few studies have examined the contribution of genetics or environmental factors in Hispanic individuals, and our study examined the contribution of these factors in this understudied population,” she added.

According to Dr. Damas, the findings’ most immediate clinical relevance is for counseling people with a family history of IBD. “I think it’s important for concerned patients to know that IBD is not solely genetic and that several environmental factors can shape disease risk to a greater extent than genetic predisposition,” she said

Westernization is increasingly considered a contributor to the global increase in IBD, which has been diagnosed in an estimated 2.39 million Americans . In genetically predisposed individuals, environmental culprits in developed countries are thought to negatively shape the intestinal microbiome’s composition into a less tolerant and more proinflammatory state, the authors noted. 

According to the “hygiene hypothesis,”  the oversanitization of life in the developed world is partly to blame. “A cleaner environment at home, part of the hygiene hypothesis, has been postulated as a theory to help explain the rise of autoimmune diseases in the 21st century and may play an important part in explaining our study findings,” the authors wrote.

Population-based studies have also pointed to antibiotics, nonsteroidal anti-inflammatory drugs, smoking, cesarean delivery, lack of breastfeeding, and nonexposure to farm animals as other risk factors for IBD. 
 

Study Details

To compare the effect of environmental vs genetic risk factors, the questionnaire-based study surveyed 2952 IBD patients from a tertiary care referral center — 58.9% with CD, 45.83% of Hispanic background, and 53.18% of non-Hispanic White (NHW) ethnicity. There were too few available Black and Asian patients to be included in the cohort. Data were collected from 2017 to 2022.

The mean age of patients was 39.71 years, and 34.14% were defined as born outside of the US mainland. Foreign-born patients were further characterized as from developed nations vs developing nations; 81.3% in this subgroup came from the latter. A detailed questionnaire probed 13 potential environmental factors from type of birth to domestic living conditions, medications, and smoking across several different age groups. Blood was drawn to genotype participants and to create a genetic risk score.

Early plastic water bottle use — which has been linked to inflammatory microplastics in the intestines — and residing in homes with more than one bathroom (and presumably less exposure to infections) were also associated with younger age at diagnosis. Susceptibility to environmental exposures was similar in Hispanic and NHW patients. 

“It was interesting to find an association between reported plastic water bottle use and younger age of IBD diagnosis,” said Dr. Damas. “Because this is a self-reported intake, we need more studies to confirm this. However, this finding falls in line with other recent studies showing a potential association between microplastics and disease states, including IBD. The next step is to measure for traces of environmental contaminants in human samples of patients with IBD.”

Unlike previous studies, this analysis did not find parasitic infections, pets, and antibiotics to be associated with age of IBD diagnosis. 

“This is an interesting and important study,” commented Ashwin Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, who was not involved in the study. “There are few environmental risk factor studies looking at non-White populations and to that end, this is a very large and well-done analysis looking at environmental factors among Hispanic patients with IBD.”

He added that, while most studies have just compared factors between cases and controls, “this is an interesting examination of the impact of such factors on age of onset.”

Dr. Ananthakrishnan stressed, however, that further work is needed to expand on these findings.” The addition of a control group would help determine how these factors actually modify disease risk. It is also intriguing that environmental factors more strongly predict age of onset than genetic risk. That only highlights the fact that IBD is in large part an environmentally influenced disease, suggesting there is exciting opportunity for environmental modification to address disease onset.”

courtesy Icahn School of Medicine

Offering another outsider’s perspective, Manasi Agrawal, MD, MS, an assistant professor of medicine at Icahn School of Medicine at Mount Sinai in New York City and not a participant in the study, agreed that the findings highlight the contribution of early life and childhood environmental factors to IBD risk relative to genetic variants. “The relative importance of the environment compared to genetic risk toward IBD, timing of exposure, and impact on age at IBD diagnosis is a novel and important finding. These data will help contextualize how we communicate disease risk and potential prevention approaches.”

She added that future research should measure various exposures, such as pollutants in preclinical biological samples. “Mechanistic data on their downstream effects are needed to understand IBD pathogenesis and develop prevention efforts.” 

According to the authors, theirs is the first study of its kind to examine the contribution of cumulative environmental factors, age-dependent exposures, and genetic predisposition to age of IBD diagnosis in a diverse IBD cohort.

The authors listed no specific funding for this study and had no conflicts of interest to declare. Dr. Ananthakrishnan and Dr. Agrawal had no relevant competing interests.

A version of this article appeared on Medscape.com.

Early-life and environmental exposures are more strongly linked to age at diagnosis of inflammatory bowel disease (IBD) than genetic factors, a large study of IBD patients reported.

Published in Clinical Gastroenterology and Hepatology , the study found that environment influences the onset of both ulcerative colitis (UC) and Crohn’s disease (CD), and exposures typical in Western society lower the age of diagnosis. These factors include birth in a developed nation, delivery by C-section, and more bathrooms in the home, according to Oriana M. Damas, MD, MSCTI, an associate professor of clinical medicine at the University of Miami Miller School of Medicine in Florida and colleagues.

courtesy University of Miami Health System

Environmental factors explained 21% of the variance in age of CD diagnosis and 39% of the variance in age of UC diagnosis. In models incorporating both genetic and environmental risk scores, the environment was the only significant factor associated with younger age of IBD diagnosis in all groups.

Several epidemiologic studies have examined environmental culprits in IBD, and others have examined genetic risk factors, Dr. Damas said in an interview. “But we had not seen any studies that examined the influence of both [of] these on age of IBD development.” Her group’s working hypothesis that environment would have a greater effect than genetics was borne out.

“Additionally, very few studies have examined the contribution of genetics or environmental factors in Hispanic individuals, and our study examined the contribution of these factors in this understudied population,” she added.

According to Dr. Damas, the findings’ most immediate clinical relevance is for counseling people with a family history of IBD. “I think it’s important for concerned patients to know that IBD is not solely genetic and that several environmental factors can shape disease risk to a greater extent than genetic predisposition,” she said

Westernization is increasingly considered a contributor to the global increase in IBD, which has been diagnosed in an estimated 2.39 million Americans . In genetically predisposed individuals, environmental culprits in developed countries are thought to negatively shape the intestinal microbiome’s composition into a less tolerant and more proinflammatory state, the authors noted. 

According to the “hygiene hypothesis,”  the oversanitization of life in the developed world is partly to blame. “A cleaner environment at home, part of the hygiene hypothesis, has been postulated as a theory to help explain the rise of autoimmune diseases in the 21st century and may play an important part in explaining our study findings,” the authors wrote.

Population-based studies have also pointed to antibiotics, nonsteroidal anti-inflammatory drugs, smoking, cesarean delivery, lack of breastfeeding, and nonexposure to farm animals as other risk factors for IBD. 
 

Study Details

To compare the effect of environmental vs genetic risk factors, the questionnaire-based study surveyed 2952 IBD patients from a tertiary care referral center — 58.9% with CD, 45.83% of Hispanic background, and 53.18% of non-Hispanic White (NHW) ethnicity. There were too few available Black and Asian patients to be included in the cohort. Data were collected from 2017 to 2022.

The mean age of patients was 39.71 years, and 34.14% were defined as born outside of the US mainland. Foreign-born patients were further characterized as from developed nations vs developing nations; 81.3% in this subgroup came from the latter. A detailed questionnaire probed 13 potential environmental factors from type of birth to domestic living conditions, medications, and smoking across several different age groups. Blood was drawn to genotype participants and to create a genetic risk score.

Early plastic water bottle use — which has been linked to inflammatory microplastics in the intestines — and residing in homes with more than one bathroom (and presumably less exposure to infections) were also associated with younger age at diagnosis. Susceptibility to environmental exposures was similar in Hispanic and NHW patients. 

“It was interesting to find an association between reported plastic water bottle use and younger age of IBD diagnosis,” said Dr. Damas. “Because this is a self-reported intake, we need more studies to confirm this. However, this finding falls in line with other recent studies showing a potential association between microplastics and disease states, including IBD. The next step is to measure for traces of environmental contaminants in human samples of patients with IBD.”

Unlike previous studies, this analysis did not find parasitic infections, pets, and antibiotics to be associated with age of IBD diagnosis. 

“This is an interesting and important study,” commented Ashwin Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, who was not involved in the study. “There are few environmental risk factor studies looking at non-White populations and to that end, this is a very large and well-done analysis looking at environmental factors among Hispanic patients with IBD.”

He added that, while most studies have just compared factors between cases and controls, “this is an interesting examination of the impact of such factors on age of onset.”

Dr. Ananthakrishnan stressed, however, that further work is needed to expand on these findings.” The addition of a control group would help determine how these factors actually modify disease risk. It is also intriguing that environmental factors more strongly predict age of onset than genetic risk. That only highlights the fact that IBD is in large part an environmentally influenced disease, suggesting there is exciting opportunity for environmental modification to address disease onset.”

courtesy Icahn School of Medicine

Offering another outsider’s perspective, Manasi Agrawal, MD, MS, an assistant professor of medicine at Icahn School of Medicine at Mount Sinai in New York City and not a participant in the study, agreed that the findings highlight the contribution of early life and childhood environmental factors to IBD risk relative to genetic variants. “The relative importance of the environment compared to genetic risk toward IBD, timing of exposure, and impact on age at IBD diagnosis is a novel and important finding. These data will help contextualize how we communicate disease risk and potential prevention approaches.”

She added that future research should measure various exposures, such as pollutants in preclinical biological samples. “Mechanistic data on their downstream effects are needed to understand IBD pathogenesis and develop prevention efforts.” 

According to the authors, theirs is the first study of its kind to examine the contribution of cumulative environmental factors, age-dependent exposures, and genetic predisposition to age of IBD diagnosis in a diverse IBD cohort.

The authors listed no specific funding for this study and had no conflicts of interest to declare. Dr. Ananthakrishnan and Dr. Agrawal had no relevant competing interests.

A version of this article appeared on Medscape.com.

Early-life and environmental exposures are more strongly linked to age at diagnosis of inflammatory bowel disease (IBD) than genetic factors, a large study of IBD patients reported.

Published in Clinical Gastroenterology and Hepatology , the study found that environment influences the onset of both ulcerative colitis (UC) and Crohn’s disease (CD), and exposures typical in Western society lower the age of diagnosis. These factors include birth in a developed nation, delivery by C-section, and more bathrooms in the home, according to Oriana M. Damas, MD, MSCTI, an associate professor of clinical medicine at the University of Miami Miller School of Medicine in Florida and colleagues.

courtesy University of Miami Health System

Environmental factors explained 21% of the variance in age of CD diagnosis and 39% of the variance in age of UC diagnosis. In models incorporating both genetic and environmental risk scores, the environment was the only significant factor associated with younger age of IBD diagnosis in all groups.

Several epidemiologic studies have examined environmental culprits in IBD, and others have examined genetic risk factors, Dr. Damas said in an interview. “But we had not seen any studies that examined the influence of both [of] these on age of IBD development.” Her group’s working hypothesis that environment would have a greater effect than genetics was borne out.

“Additionally, very few studies have examined the contribution of genetics or environmental factors in Hispanic individuals, and our study examined the contribution of these factors in this understudied population,” she added.

According to Dr. Damas, the findings’ most immediate clinical relevance is for counseling people with a family history of IBD. “I think it’s important for concerned patients to know that IBD is not solely genetic and that several environmental factors can shape disease risk to a greater extent than genetic predisposition,” she said

Westernization is increasingly considered a contributor to the global increase in IBD, which has been diagnosed in an estimated 2.39 million Americans . In genetically predisposed individuals, environmental culprits in developed countries are thought to negatively shape the intestinal microbiome’s composition into a less tolerant and more proinflammatory state, the authors noted. 

According to the “hygiene hypothesis,”  the oversanitization of life in the developed world is partly to blame. “A cleaner environment at home, part of the hygiene hypothesis, has been postulated as a theory to help explain the rise of autoimmune diseases in the 21st century and may play an important part in explaining our study findings,” the authors wrote.

Population-based studies have also pointed to antibiotics, nonsteroidal anti-inflammatory drugs, smoking, cesarean delivery, lack of breastfeeding, and nonexposure to farm animals as other risk factors for IBD. 
 

Study Details

To compare the effect of environmental vs genetic risk factors, the questionnaire-based study surveyed 2952 IBD patients from a tertiary care referral center — 58.9% with CD, 45.83% of Hispanic background, and 53.18% of non-Hispanic White (NHW) ethnicity. There were too few available Black and Asian patients to be included in the cohort. Data were collected from 2017 to 2022.

The mean age of patients was 39.71 years, and 34.14% were defined as born outside of the US mainland. Foreign-born patients were further characterized as from developed nations vs developing nations; 81.3% in this subgroup came from the latter. A detailed questionnaire probed 13 potential environmental factors from type of birth to domestic living conditions, medications, and smoking across several different age groups. Blood was drawn to genotype participants and to create a genetic risk score.

Early plastic water bottle use — which has been linked to inflammatory microplastics in the intestines — and residing in homes with more than one bathroom (and presumably less exposure to infections) were also associated with younger age at diagnosis. Susceptibility to environmental exposures was similar in Hispanic and NHW patients. 

“It was interesting to find an association between reported plastic water bottle use and younger age of IBD diagnosis,” said Dr. Damas. “Because this is a self-reported intake, we need more studies to confirm this. However, this finding falls in line with other recent studies showing a potential association between microplastics and disease states, including IBD. The next step is to measure for traces of environmental contaminants in human samples of patients with IBD.”

Unlike previous studies, this analysis did not find parasitic infections, pets, and antibiotics to be associated with age of IBD diagnosis. 

“This is an interesting and important study,” commented Ashwin Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, who was not involved in the study. “There are few environmental risk factor studies looking at non-White populations and to that end, this is a very large and well-done analysis looking at environmental factors among Hispanic patients with IBD.”

He added that, while most studies have just compared factors between cases and controls, “this is an interesting examination of the impact of such factors on age of onset.”

Dr. Ananthakrishnan stressed, however, that further work is needed to expand on these findings.” The addition of a control group would help determine how these factors actually modify disease risk. It is also intriguing that environmental factors more strongly predict age of onset than genetic risk. That only highlights the fact that IBD is in large part an environmentally influenced disease, suggesting there is exciting opportunity for environmental modification to address disease onset.”

courtesy Icahn School of Medicine

Offering another outsider’s perspective, Manasi Agrawal, MD, MS, an assistant professor of medicine at Icahn School of Medicine at Mount Sinai in New York City and not a participant in the study, agreed that the findings highlight the contribution of early life and childhood environmental factors to IBD risk relative to genetic variants. “The relative importance of the environment compared to genetic risk toward IBD, timing of exposure, and impact on age at IBD diagnosis is a novel and important finding. These data will help contextualize how we communicate disease risk and potential prevention approaches.”

She added that future research should measure various exposures, such as pollutants in preclinical biological samples. “Mechanistic data on their downstream effects are needed to understand IBD pathogenesis and develop prevention efforts.” 

According to the authors, theirs is the first study of its kind to examine the contribution of cumulative environmental factors, age-dependent exposures, and genetic predisposition to age of IBD diagnosis in a diverse IBD cohort.

The authors listed no specific funding for this study and had no conflicts of interest to declare. Dr. Ananthakrishnan and Dr. Agrawal had no relevant competing interests.

A version of this article appeared on Medscape.com.

An estimated 25 million adult Americans experience temporary or chronic urinary incontinence.

Although urinary incontinence can occur in both women and men at any age, it is more common in women over age 50. According to Rise for Health, a national survey-based research study on bladder health, up to 40% of girls and women experience urinary problems and it may be as high as 50% or 60%.

“The main known predictors of urinary incontinence are age, obesity, diabetes, and pregnancy and childbirth,” said internist Joan M. Neuner MD, MPH, a professor of women’s health at Medical College of Wisconsin, Milwaukee.

courtesy Northwell Health

Other causes are urinary tract infections, pelvic surgery, and in men, of course, prostate problems. Medications such as antihypertensives and antidepressants can promote urinary incontinence. Inexplicably, smokers seem to be at higher risk. Childbearing is a prime reason women are at greater risk. “While C-section can be protective against many pelvic floor issues, vaginal delivery, particularly forceps assisted, increases the risk for urinary incontinence,” said Sarah Friedman, MD, director of the Division of Urogynecology at Staten Island University Hospital, New York City.

Urinary incontinence is underrecognized and undertreated in primary care and may not get enough emphasis in medical schools. Dr. Neuner recently coauthored a small pilot study on developing a primary care pathway to manage urinary incontinence. It suggested that a streamlined paradigm from identification and patient self-care through basic medical care and specialty referral might assist primary care providers as first-line providers in urinary incontinence.

courtesy Medical College of Wisconsin

Urinary incontinence’s impact on quality of life should not be underestimated. “It depends on severity, but people may limit their physical activities and social activities, including work, going out with friends, and sexual activity, which can in turn increase loneliness and depression,” Dr. Neuner said in an interview. “Incontinence products like pads and adult diapers are costly and often not covered by insurance.”

In fact, urinary incontinence costs US men and women more than $20 billion per year, mostly for management supplies such as pads and laundry.
 

Primary Care

While primary care practitioners are well positioned to manage urinary incontinence, the majority of patients remain untreated.

courtesy Corewell Health

The current stepwise approach should start with a knowledge of basic micturition physiology to identify the incontinence type before selecting treatment, said Khaled A. Imam, MD, CMD, a geriatrician at Corewell Health William Beaumont University Hospital in Royal Oak, Michigan. “More important, this working knowledge can prevent the prescription of an inappropriate treatment or drug, thus preventing many adverse effects,”

According to Dr. Imam, urinary incontinence occurs “because the outlet is open when it should be closed, the outlet is closed when it should be open, the detrusor fails to contract, or the detrusor contracts when it should not.”

There are five main types of incontinence: transient, detrusor overactivity (urge), stress, overflow, and functional. The primary care evaluation of urinary incontinence should include history taking, physical examination, post-voiding residual volume measurement, urinalysis, and urine culture, according to Dr. Imam. “The physical examination should include a urine stress test, abdominal examination, pelvic examination in female patients, rectal examination, and neurologic evaluation.”
 

Screening

“I am always careful before recommending additional screening that hasn’t been backed by a large screening study. Incontinence has not,” said Dr. Neuner. “However, at most preventive visits, PC [primary care] doctors do a review of systems that includes common symptoms. And so if a PC is currently asking a more generic question like ‘any problems with urine?’ I recommend they replace it with the more specific ‘during the last 3 months, have you leaked any urine, even a small amount?’ ”

courtesy Medical College of Wisconsin

Added Kathryn E. Flynn, PhD, a professor of medicine at Medical College of Wisconsin and Dr. Neuner’s coauthor on the primary care pilot study: “Routine screening for urinary incontinence in primary care makes a lot of sense because most older women visit a primary care provider regularly, but they often don’t want to bring the topic up to their provider. When providers routinely screen, it can reduce that barrier to disclosure.“
 

Treatment

For many women, DIY measures such as losing weight, restricting badder irritants such as caffeine or alcohol, scheduled or double voiding, and at-home Kegel exercises are not enough. Fortunately, treatment options are expanding.

“Nonpharmacologic interventions such as pelvic physical therapy can strengthen the pelvic floor muscles and improve incontinence as long as the muscle strength is maintained,” said Dr. Friedman. “Some procedural or surgical effects last long term and some are shorter acting and need to be repeated over time, but a medication’s effect on bladder function lasts only as long as you take it.”

Strengthening pelvic floor muscles. Solutions for stress incontinence – leakage during coughing, sneezing, lifting, or jumping – aim to hold the urethra closed in the face of increased pressure. “Strengthening the pelvic floor muscles can help hold the urethra closed, but many of us do not know how to contract our pelvic floor muscles correctly,” said Heidi Brown, MD, MAS, a clinician researcher at Kaiser Permanente Southern California and a urogynecologist at Kaiser Permanente San Diego Medical Center. “Working with a pelvic floor therapist is not an option for many busy people, so devices that can be used at home to help women confirm they’re contracting their muscles correctly and remind them to do their exercises are becoming more popular.”

courtesy Kaiser Permanente Southern California

These trainers include external thigh exercisers and vaginal Kegel balls or weights. Kegel chairs that electromagnetically stimulate pelvic muscle contractions are another option, if more expensive. Some deliver pelvic therapy in clinic sessions, but there are several portable versions for home use available online.

According to Dr. Neuner, “pelvic exercises can reduce incontinence by 50% or more. “Some women stay completely dry with them but many women will need help to do these and I usually recommend a referral to a pelvic floor physical therapist or someone with extensive experience.”

Drugs. Overactive bladder, or urge urinary incontinence, leads to leakage because the bladder muscle contracts strongly at inappropriate times. Anticholinergics/antimuscarinics such as oxybutynin (Oxytrol, Ditropan) have been used for decades to control these spasms by relaxing the bladder muscle. Because of recent concerns about their association with cognitive impairment after long-term use, these agents are now being used more cautiously, said Dr. Brown. “A newer class of medication, the beta-3-adrenergic agonists, has not been shown to have that association with cognitive impairment and this class is now being used more frequently to treat overactive bladder.”

This class includes the beta-3-adrenergic agonists vibegron (Gemtesa) and mirabegron (Myrbetriq), which a recent Japanese crossover study found to be comparably effective in women with overactive bladder.

“While they have fewer safety concerns, these newer agents can be costly or may require lots of insurance paperwork, and while I hope that will improve soon, it hasn’t yet,” said Dr. Neuner.

Another pharmacologic option is botulinum A toxin (Botox). Injected into the bladder, this neurotoxin can ease urgency and frequency by relaxing the bladder muscle, added Dr. Friedman.

In some cases combination pharmacotherapy may be advisable.

Surgery. Mid-urethral slings are still considered the preferred option for stress urinary incontinence because they are minimally invasive, safe, and very effective, said Dr. Brown. “Single-incisions slings are an emerging treatment for stress incontinence, because they require one incision instead of three, but their effectiveness has not been proven as robustly as that of the traditional mid-urethral slings,” Dr. Brown said.

Urethral bulking. Bulking can reduce incontinence caused by straining as in defecation by thickening the wall of the urethra. This procedure uses a needle to inject a filler material such as collagen. “These injections are gaining more popularity as research uncovers filler materials that are more durable and with fewer potential complications,” Dr. Brown said.

Neuromodulation. This technique works to reprogram communication between the nerves and the bladder. While conventional therapy worked by relaxing the bladder muscle itself, newer approaches target the nerve that controls the muscle. This can be done at home with gentle, acupuncture-like electric stimulation of the S3 sacral nerve.

“Traditional methods of stimulating the S3 nerve involved placing a needle in the ankle and delivering electrical stimulation via that needle in the doctor’s office, or placing a wire in the nerve near the spine and implanting a pacemaker to deliver electrical stimulation,” Dr. Brown explained. “There are now emerging therapies that implant a device in the ankle to allow electrical stimulation of the S3 nerve in the home, providing a minimally invasive option that does not require weekly trips to the office.”

InterStim is a neural pacemaker that is inserted into the fat of the buttocks and patient controlled by a small handheld external device.

Biofeedback is a technique works for some. A patch applied to the skin over the bladder and urethra area and connected to an external monitor allows patients to see the bladder muscle contracting and teaches them to control spasms and prevent leaks.

Dr. Neuner advises primary care doctors to connect with a local incontinence expert and refer patients to a specialist early on if their condition isn’t improving. “There are both surgical and nonsurgical treatments that only those specialists can give and that can be more effective if given before incontinence is severe — or before the patient has been so frustrated with other treatments that she doesn’t want to try anything else.”

When discussing potential outcomes with patients, Dr. Friedman’s advice is to explain that each management option has different success rates. “Patients need to know that urinary incontinence is a very common condition, but it is not a condition you need to live with. There are many treatments available, all with the goal of improving quality of life.”

The primary care pathway pilot study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Study authors Dr. Neuner and Dr. Flynn disclosed no relevant conflicts of interest. Dr. Friedman, Dr. Imam, and Dr. Brown disclosed no relevant conflicts of interest.

*Story was updated on August 7, 2024.

An estimated 25 million adult Americans experience temporary or chronic urinary incontinence.

Although urinary incontinence can occur in both women and men at any age, it is more common in women over age 50. According to Rise for Health, a national survey-based research study on bladder health, up to 40% of girls and women experience urinary problems and it may be as high as 50% or 60%.

“The main known predictors of urinary incontinence are age, obesity, diabetes, and pregnancy and childbirth,” said internist Joan M. Neuner MD, MPH, a professor of women’s health at Medical College of Wisconsin, Milwaukee.

courtesy Northwell Health

Other causes are urinary tract infections, pelvic surgery, and in men, of course, prostate problems. Medications such as antihypertensives and antidepressants can promote urinary incontinence. Inexplicably, smokers seem to be at higher risk. Childbearing is a prime reason women are at greater risk. “While C-section can be protective against many pelvic floor issues, vaginal delivery, particularly forceps assisted, increases the risk for urinary incontinence,” said Sarah Friedman, MD, director of the Division of Urogynecology at Staten Island University Hospital, New York City.

Urinary incontinence is underrecognized and undertreated in primary care and may not get enough emphasis in medical schools. Dr. Neuner recently coauthored a small pilot study on developing a primary care pathway to manage urinary incontinence. It suggested that a streamlined paradigm from identification and patient self-care through basic medical care and specialty referral might assist primary care providers as first-line providers in urinary incontinence.

courtesy Medical College of Wisconsin

Urinary incontinence’s impact on quality of life should not be underestimated. “It depends on severity, but people may limit their physical activities and social activities, including work, going out with friends, and sexual activity, which can in turn increase loneliness and depression,” Dr. Neuner said in an interview. “Incontinence products like pads and adult diapers are costly and often not covered by insurance.”

In fact, urinary incontinence costs US men and women more than $20 billion per year, mostly for management supplies such as pads and laundry.
 

Primary Care

While primary care practitioners are well positioned to manage urinary incontinence, the majority of patients remain untreated.

courtesy Corewell Health

The current stepwise approach should start with a knowledge of basic micturition physiology to identify the incontinence type before selecting treatment, said Khaled A. Imam, MD, CMD, a geriatrician at Corewell Health William Beaumont University Hospital in Royal Oak, Michigan. “More important, this working knowledge can prevent the prescription of an inappropriate treatment or drug, thus preventing many adverse effects,”

According to Dr. Imam, urinary incontinence occurs “because the outlet is open when it should be closed, the outlet is closed when it should be open, the detrusor fails to contract, or the detrusor contracts when it should not.”

There are five main types of incontinence: transient, detrusor overactivity (urge), stress, overflow, and functional. The primary care evaluation of urinary incontinence should include history taking, physical examination, post-voiding residual volume measurement, urinalysis, and urine culture, according to Dr. Imam. “The physical examination should include a urine stress test, abdominal examination, pelvic examination in female patients, rectal examination, and neurologic evaluation.”
 

Screening

“I am always careful before recommending additional screening that hasn’t been backed by a large screening study. Incontinence has not,” said Dr. Neuner. “However, at most preventive visits, PC [primary care] doctors do a review of systems that includes common symptoms. And so if a PC is currently asking a more generic question like ‘any problems with urine?’ I recommend they replace it with the more specific ‘during the last 3 months, have you leaked any urine, even a small amount?’ ”

courtesy Medical College of Wisconsin

Added Kathryn E. Flynn, PhD, a professor of medicine at Medical College of Wisconsin and Dr. Neuner’s coauthor on the primary care pilot study: “Routine screening for urinary incontinence in primary care makes a lot of sense because most older women visit a primary care provider regularly, but they often don’t want to bring the topic up to their provider. When providers routinely screen, it can reduce that barrier to disclosure.“
 

Treatment

For many women, DIY measures such as losing weight, restricting badder irritants such as caffeine or alcohol, scheduled or double voiding, and at-home Kegel exercises are not enough. Fortunately, treatment options are expanding.

“Nonpharmacologic interventions such as pelvic physical therapy can strengthen the pelvic floor muscles and improve incontinence as long as the muscle strength is maintained,” said Dr. Friedman. “Some procedural or surgical effects last long term and some are shorter acting and need to be repeated over time, but a medication’s effect on bladder function lasts only as long as you take it.”

Strengthening pelvic floor muscles. Solutions for stress incontinence – leakage during coughing, sneezing, lifting, or jumping – aim to hold the urethra closed in the face of increased pressure. “Strengthening the pelvic floor muscles can help hold the urethra closed, but many of us do not know how to contract our pelvic floor muscles correctly,” said Heidi Brown, MD, MAS, a clinician researcher at Kaiser Permanente Southern California and a urogynecologist at Kaiser Permanente San Diego Medical Center. “Working with a pelvic floor therapist is not an option for many busy people, so devices that can be used at home to help women confirm they’re contracting their muscles correctly and remind them to do their exercises are becoming more popular.”

courtesy Kaiser Permanente Southern California

These trainers include external thigh exercisers and vaginal Kegel balls or weights. Kegel chairs that electromagnetically stimulate pelvic muscle contractions are another option, if more expensive. Some deliver pelvic therapy in clinic sessions, but there are several portable versions for home use available online.

According to Dr. Neuner, “pelvic exercises can reduce incontinence by 50% or more. “Some women stay completely dry with them but many women will need help to do these and I usually recommend a referral to a pelvic floor physical therapist or someone with extensive experience.”

Drugs. Overactive bladder, or urge urinary incontinence, leads to leakage because the bladder muscle contracts strongly at inappropriate times. Anticholinergics/antimuscarinics such as oxybutynin (Oxytrol, Ditropan) have been used for decades to control these spasms by relaxing the bladder muscle. Because of recent concerns about their association with cognitive impairment after long-term use, these agents are now being used more cautiously, said Dr. Brown. “A newer class of medication, the beta-3-adrenergic agonists, has not been shown to have that association with cognitive impairment and this class is now being used more frequently to treat overactive bladder.”

This class includes the beta-3-adrenergic agonists vibegron (Gemtesa) and mirabegron (Myrbetriq), which a recent Japanese crossover study found to be comparably effective in women with overactive bladder.

“While they have fewer safety concerns, these newer agents can be costly or may require lots of insurance paperwork, and while I hope that will improve soon, it hasn’t yet,” said Dr. Neuner.

Another pharmacologic option is botulinum A toxin (Botox). Injected into the bladder, this neurotoxin can ease urgency and frequency by relaxing the bladder muscle, added Dr. Friedman.

In some cases combination pharmacotherapy may be advisable.

Surgery. Mid-urethral slings are still considered the preferred option for stress urinary incontinence because they are minimally invasive, safe, and very effective, said Dr. Brown. “Single-incisions slings are an emerging treatment for stress incontinence, because they require one incision instead of three, but their effectiveness has not been proven as robustly as that of the traditional mid-urethral slings,” Dr. Brown said.

Urethral bulking. Bulking can reduce incontinence caused by straining as in defecation by thickening the wall of the urethra. This procedure uses a needle to inject a filler material such as collagen. “These injections are gaining more popularity as research uncovers filler materials that are more durable and with fewer potential complications,” Dr. Brown said.

Neuromodulation. This technique works to reprogram communication between the nerves and the bladder. While conventional therapy worked by relaxing the bladder muscle itself, newer approaches target the nerve that controls the muscle. This can be done at home with gentle, acupuncture-like electric stimulation of the S3 sacral nerve.

“Traditional methods of stimulating the S3 nerve involved placing a needle in the ankle and delivering electrical stimulation via that needle in the doctor’s office, or placing a wire in the nerve near the spine and implanting a pacemaker to deliver electrical stimulation,” Dr. Brown explained. “There are now emerging therapies that implant a device in the ankle to allow electrical stimulation of the S3 nerve in the home, providing a minimally invasive option that does not require weekly trips to the office.”

InterStim is a neural pacemaker that is inserted into the fat of the buttocks and patient controlled by a small handheld external device.

Biofeedback is a technique works for some. A patch applied to the skin over the bladder and urethra area and connected to an external monitor allows patients to see the bladder muscle contracting and teaches them to control spasms and prevent leaks.

Dr. Neuner advises primary care doctors to connect with a local incontinence expert and refer patients to a specialist early on if their condition isn’t improving. “There are both surgical and nonsurgical treatments that only those specialists can give and that can be more effective if given before incontinence is severe — or before the patient has been so frustrated with other treatments that she doesn’t want to try anything else.”

When discussing potential outcomes with patients, Dr. Friedman’s advice is to explain that each management option has different success rates. “Patients need to know that urinary incontinence is a very common condition, but it is not a condition you need to live with. There are many treatments available, all with the goal of improving quality of life.”

The primary care pathway pilot study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Study authors Dr. Neuner and Dr. Flynn disclosed no relevant conflicts of interest. Dr. Friedman, Dr. Imam, and Dr. Brown disclosed no relevant conflicts of interest.

*Story was updated on August 7, 2024.

An estimated 25 million adult Americans experience temporary or chronic urinary incontinence.

Although urinary incontinence can occur in both women and men at any age, it is more common in women over age 50. According to Rise for Health, a national survey-based research study on bladder health, up to 40% of girls and women experience urinary problems and it may be as high as 50% or 60%.

“The main known predictors of urinary incontinence are age, obesity, diabetes, and pregnancy and childbirth,” said internist Joan M. Neuner MD, MPH, a professor of women’s health at Medical College of Wisconsin, Milwaukee.

courtesy Northwell Health

Other causes are urinary tract infections, pelvic surgery, and in men, of course, prostate problems. Medications such as antihypertensives and antidepressants can promote urinary incontinence. Inexplicably, smokers seem to be at higher risk. Childbearing is a prime reason women are at greater risk. “While C-section can be protective against many pelvic floor issues, vaginal delivery, particularly forceps assisted, increases the risk for urinary incontinence,” said Sarah Friedman, MD, director of the Division of Urogynecology at Staten Island University Hospital, New York City.

Urinary incontinence is underrecognized and undertreated in primary care and may not get enough emphasis in medical schools. Dr. Neuner recently coauthored a small pilot study on developing a primary care pathway to manage urinary incontinence. It suggested that a streamlined paradigm from identification and patient self-care through basic medical care and specialty referral might assist primary care providers as first-line providers in urinary incontinence.

courtesy Medical College of Wisconsin

Urinary incontinence’s impact on quality of life should not be underestimated. “It depends on severity, but people may limit their physical activities and social activities, including work, going out with friends, and sexual activity, which can in turn increase loneliness and depression,” Dr. Neuner said in an interview. “Incontinence products like pads and adult diapers are costly and often not covered by insurance.”

In fact, urinary incontinence costs US men and women more than $20 billion per year, mostly for management supplies such as pads and laundry.
 

Primary Care

While primary care practitioners are well positioned to manage urinary incontinence, the majority of patients remain untreated.

courtesy Corewell Health

The current stepwise approach should start with a knowledge of basic micturition physiology to identify the incontinence type before selecting treatment, said Khaled A. Imam, MD, CMD, a geriatrician at Corewell Health William Beaumont University Hospital in Royal Oak, Michigan. “More important, this working knowledge can prevent the prescription of an inappropriate treatment or drug, thus preventing many adverse effects,”

According to Dr. Imam, urinary incontinence occurs “because the outlet is open when it should be closed, the outlet is closed when it should be open, the detrusor fails to contract, or the detrusor contracts when it should not.”

There are five main types of incontinence: transient, detrusor overactivity (urge), stress, overflow, and functional. The primary care evaluation of urinary incontinence should include history taking, physical examination, post-voiding residual volume measurement, urinalysis, and urine culture, according to Dr. Imam. “The physical examination should include a urine stress test, abdominal examination, pelvic examination in female patients, rectal examination, and neurologic evaluation.”
 

Screening

“I am always careful before recommending additional screening that hasn’t been backed by a large screening study. Incontinence has not,” said Dr. Neuner. “However, at most preventive visits, PC [primary care] doctors do a review of systems that includes common symptoms. And so if a PC is currently asking a more generic question like ‘any problems with urine?’ I recommend they replace it with the more specific ‘during the last 3 months, have you leaked any urine, even a small amount?’ ”

courtesy Medical College of Wisconsin

Added Kathryn E. Flynn, PhD, a professor of medicine at Medical College of Wisconsin and Dr. Neuner’s coauthor on the primary care pilot study: “Routine screening for urinary incontinence in primary care makes a lot of sense because most older women visit a primary care provider regularly, but they often don’t want to bring the topic up to their provider. When providers routinely screen, it can reduce that barrier to disclosure.“
 

Treatment

For many women, DIY measures such as losing weight, restricting badder irritants such as caffeine or alcohol, scheduled or double voiding, and at-home Kegel exercises are not enough. Fortunately, treatment options are expanding.

“Nonpharmacologic interventions such as pelvic physical therapy can strengthen the pelvic floor muscles and improve incontinence as long as the muscle strength is maintained,” said Dr. Friedman. “Some procedural or surgical effects last long term and some are shorter acting and need to be repeated over time, but a medication’s effect on bladder function lasts only as long as you take it.”

Strengthening pelvic floor muscles. Solutions for stress incontinence – leakage during coughing, sneezing, lifting, or jumping – aim to hold the urethra closed in the face of increased pressure. “Strengthening the pelvic floor muscles can help hold the urethra closed, but many of us do not know how to contract our pelvic floor muscles correctly,” said Heidi Brown, MD, MAS, a clinician researcher at Kaiser Permanente Southern California and a urogynecologist at Kaiser Permanente San Diego Medical Center. “Working with a pelvic floor therapist is not an option for many busy people, so devices that can be used at home to help women confirm they’re contracting their muscles correctly and remind them to do their exercises are becoming more popular.”

courtesy Kaiser Permanente Southern California

These trainers include external thigh exercisers and vaginal Kegel balls or weights. Kegel chairs that electromagnetically stimulate pelvic muscle contractions are another option, if more expensive. Some deliver pelvic therapy in clinic sessions, but there are several portable versions for home use available online.

According to Dr. Neuner, “pelvic exercises can reduce incontinence by 50% or more. “Some women stay completely dry with them but many women will need help to do these and I usually recommend a referral to a pelvic floor physical therapist or someone with extensive experience.”

Drugs. Overactive bladder, or urge urinary incontinence, leads to leakage because the bladder muscle contracts strongly at inappropriate times. Anticholinergics/antimuscarinics such as oxybutynin (Oxytrol, Ditropan) have been used for decades to control these spasms by relaxing the bladder muscle. Because of recent concerns about their association with cognitive impairment after long-term use, these agents are now being used more cautiously, said Dr. Brown. “A newer class of medication, the beta-3-adrenergic agonists, has not been shown to have that association with cognitive impairment and this class is now being used more frequently to treat overactive bladder.”

This class includes the beta-3-adrenergic agonists vibegron (Gemtesa) and mirabegron (Myrbetriq), which a recent Japanese crossover study found to be comparably effective in women with overactive bladder.

“While they have fewer safety concerns, these newer agents can be costly or may require lots of insurance paperwork, and while I hope that will improve soon, it hasn’t yet,” said Dr. Neuner.

Another pharmacologic option is botulinum A toxin (Botox). Injected into the bladder, this neurotoxin can ease urgency and frequency by relaxing the bladder muscle, added Dr. Friedman.

In some cases combination pharmacotherapy may be advisable.

Surgery. Mid-urethral slings are still considered the preferred option for stress urinary incontinence because they are minimally invasive, safe, and very effective, said Dr. Brown. “Single-incisions slings are an emerging treatment for stress incontinence, because they require one incision instead of three, but their effectiveness has not been proven as robustly as that of the traditional mid-urethral slings,” Dr. Brown said.

Urethral bulking. Bulking can reduce incontinence caused by straining as in defecation by thickening the wall of the urethra. This procedure uses a needle to inject a filler material such as collagen. “These injections are gaining more popularity as research uncovers filler materials that are more durable and with fewer potential complications,” Dr. Brown said.

Neuromodulation. This technique works to reprogram communication between the nerves and the bladder. While conventional therapy worked by relaxing the bladder muscle itself, newer approaches target the nerve that controls the muscle. This can be done at home with gentle, acupuncture-like electric stimulation of the S3 sacral nerve.

“Traditional methods of stimulating the S3 nerve involved placing a needle in the ankle and delivering electrical stimulation via that needle in the doctor’s office, or placing a wire in the nerve near the spine and implanting a pacemaker to deliver electrical stimulation,” Dr. Brown explained. “There are now emerging therapies that implant a device in the ankle to allow electrical stimulation of the S3 nerve in the home, providing a minimally invasive option that does not require weekly trips to the office.”

InterStim is a neural pacemaker that is inserted into the fat of the buttocks and patient controlled by a small handheld external device.

Biofeedback is a technique works for some. A patch applied to the skin over the bladder and urethra area and connected to an external monitor allows patients to see the bladder muscle contracting and teaches them to control spasms and prevent leaks.

Dr. Neuner advises primary care doctors to connect with a local incontinence expert and refer patients to a specialist early on if their condition isn’t improving. “There are both surgical and nonsurgical treatments that only those specialists can give and that can be more effective if given before incontinence is severe — or before the patient has been so frustrated with other treatments that she doesn’t want to try anything else.”

When discussing potential outcomes with patients, Dr. Friedman’s advice is to explain that each management option has different success rates. “Patients need to know that urinary incontinence is a very common condition, but it is not a condition you need to live with. There are many treatments available, all with the goal of improving quality of life.”

The primary care pathway pilot study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Study authors Dr. Neuner and Dr. Flynn disclosed no relevant conflicts of interest. Dr. Friedman, Dr. Imam, and Dr. Brown disclosed no relevant conflicts of interest.

*Story was updated on August 7, 2024.

Ovarian cancer risk was higher in women with endometriosis overall and markedly increased in those with severe forms, a large population-based cohort study found.

The findings, published in JAMA, suggest these women may benefit from counseling on ovarian cancer risk and prevention and potentially from targeted screening, according to a group led by Mollie E. Barnard, ScD, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

While the absolute increase in number of cases was small, endometriosis patients overall had a more than fourfold higher risk for any type of ovarian cancer. Those with more severe forms, such as ovarian endometriomas or deep infiltrating endometriosis, had a nearly 10-fold higher risk of any type of ovarian cancer. In addition, those with more severe endometriosis had a 19-fold higher risk of type 1 (slow-growing) ovarian cancer and almost three times the risk of the more aggressive type 2.

“Given the rarity of ovarian cancer, the excess risk was relatively small, with 10-20 additional cases per 10,000 women. Nevertheless, women with endometriosis, notably the more severe subtypes, may be an important population for targeted cancer screening and prevention studies,” said corresponding author Karen C. Schliep, PhD, MSPH, associate professor in the university’s Division of Public Health.

Prior studies have shown modest associations between endometriosis and ovarian cancer, Dr. Schliep said in an interview. A 2021 systematic review and meta-analysis found endometriosis conferred nearly double the risk of ovarian cancer, although associations varied by ovarian cancer histotype. Few studies have been large enough to assess associations between endometriosis types — including superficial or peritoneal endometriosis vs ovarian endometriomas or deep infiltrating endometriosis and ovarian cancer histotypes such as low-grade serous, endometrioid, clear cell, and mucinous carcinomas (type 1), and the most aggressive and lethal form, high-grade serous type 2, she said in an interview. “Our large health administrative database of over 11 million individuals with linked electronic health and cancer registry data allowed us to answer this as yet poorly studied research question.”
 

Study Details

Drawing on Utah electronic health records from 1992 to 2019, the investigators matched 78,893 women with endometriosis in a 1:5 ratio to unaffected women. Cases were categorized as superficial endometriosis, ovarian endometriomas, deep infiltrating endometriosis, or other, and the types of endometriosis were matched to ovarian cancer histotypes.

The mean age of patients at first endometriosis diagnosis was 36 and the mean follow-up was 12 years. Compared with controls, endometriosis patients were more likely to be nulliparous (31% vs 24%) and to have had a hysterectomy (39% vs 6%) during follow-up.

There were 596 reported cases of ovarian cancer in the cohort. Those with incident endometriosis were 4.2 times more likely to develop ovarian cancer (95% CI, 3.59-4.91), 7.48 times more likely to develop type 1 ovarian cancer (95% CI, 5.80-9.65), and 2.70 times more likely to develop type 2 ovarian cancer (95% CI, 2.09-3.49) compared with those without endometriosis.

The magnitudes of these associations varied by endometriosis subtype. Individuals diagnosed with deep infiltrating endometriosis and/or ovarian endometriomas had 9.66 times the risk of ovarian cancer vs individuals without endometriosis (95% CI, 7.77-12.00). “Women with, compared to without, more severe endometriosis had a 19-fold higher risk of type 1 ovarian cancer, including endometrioid, clear cell, mucinous, and low-grade serous,” Dr. Schliep said, with associated risk highest for malignant subtypes such as clear cell and endometrioid carcinoma (adjusted hazard ratios, 11.15 and 7.96, respectively.

According to Dr. Schliep, physicians should encourage endometriosis patients to be aware of but not worry about ovarian cancer risk because the likelihood of developing it remains low. For their part, patients can reduce their risk of cancer through a balanced diet with low intake of alcohol, regular exercise, a healthy weight, and abstention from smoking.

Her message for researchers is as follows: “We need more studies that explore how different types of endometriosis impact different types of ovarian cancer risk. These studies will guide improved ovarian cancer screening and prevention strategies among women with severe endometriosis, with or without other important ovarian cancer risk factors such as BRCA 1/2 variations.”

An accompanying editorial called the Utah study “eloquent” and noted its distinguishing contribution of observing associations between subtypes of endometriosis with overall risk for ovarian cancer as well as histologic subtypes of epithelial ovarian cancer.

Nevertheless, Michael T. McHale, MD, of the Department of Obstetrics, Gynecology, and Reproductive Sciences at Moores Cancer Center, UC San Diego Health, University of California, expressed some methodological concerns. Although the authors attempted to control for key confounders, he noted, the dataset could not provide details on the medical management of endometriosis, such as oral contraceptives or gonadotropin-releasing hormone agonists. “Additionally, there is a possibility that women in the control cohort could have had undiagnosed endometriosis,” he wrote.

Furthermore, making clinical recommendations from these reported observations, particularly with respect to deep infiltrating endometriosis, would require a clear and consistent definition of this type in the dataset over the entire study interval from 1992 to 2019 and for the state of Utah, which the authors did not provide.

“Despite this potential challenge, the increased risk associated with deep infiltrating and/or ovarian endometriosis was clearly significant,” Dr. McHale wrote.

And although the absolute number of ovarian cancers is limited, in his view, the increased risk is sufficiently significant to advise women who have completed childbearing or have alternative fertility options to consider “more definitive surgery.”

This study was supported by multiple not-for-profit agencies, including the National Cancer Institute, the University of Utah, the National Center for Research Resources, the Utah Department of Health and Human Services, the Utah Cancer Registry, the US Centers for Disease Control and Prevention, the Huntsman Cancer Foundation, the National Institutes of Health, and Doris Duke Foundation. Dr. Barnard reported grants from the National Cancer Institute during the conduct of the study and personal fees from Epi Excellence LLC outside the submitted work. Other coauthors reported similar funding from nonprofit agencies or private research organizations. Dr Schliep disclosed no competing interests. Dr McHale reported educational consulting for Eisai Training outside the submitted work.

Ovarian cancer risk was higher in women with endometriosis overall and markedly increased in those with severe forms, a large population-based cohort study found.

The findings, published in JAMA, suggest these women may benefit from counseling on ovarian cancer risk and prevention and potentially from targeted screening, according to a group led by Mollie E. Barnard, ScD, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

While the absolute increase in number of cases was small, endometriosis patients overall had a more than fourfold higher risk for any type of ovarian cancer. Those with more severe forms, such as ovarian endometriomas or deep infiltrating endometriosis, had a nearly 10-fold higher risk of any type of ovarian cancer. In addition, those with more severe endometriosis had a 19-fold higher risk of type 1 (slow-growing) ovarian cancer and almost three times the risk of the more aggressive type 2.

“Given the rarity of ovarian cancer, the excess risk was relatively small, with 10-20 additional cases per 10,000 women. Nevertheless, women with endometriosis, notably the more severe subtypes, may be an important population for targeted cancer screening and prevention studies,” said corresponding author Karen C. Schliep, PhD, MSPH, associate professor in the university’s Division of Public Health.

Prior studies have shown modest associations between endometriosis and ovarian cancer, Dr. Schliep said in an interview. A 2021 systematic review and meta-analysis found endometriosis conferred nearly double the risk of ovarian cancer, although associations varied by ovarian cancer histotype. Few studies have been large enough to assess associations between endometriosis types — including superficial or peritoneal endometriosis vs ovarian endometriomas or deep infiltrating endometriosis and ovarian cancer histotypes such as low-grade serous, endometrioid, clear cell, and mucinous carcinomas (type 1), and the most aggressive and lethal form, high-grade serous type 2, she said in an interview. “Our large health administrative database of over 11 million individuals with linked electronic health and cancer registry data allowed us to answer this as yet poorly studied research question.”
 

Study Details

Drawing on Utah electronic health records from 1992 to 2019, the investigators matched 78,893 women with endometriosis in a 1:5 ratio to unaffected women. Cases were categorized as superficial endometriosis, ovarian endometriomas, deep infiltrating endometriosis, or other, and the types of endometriosis were matched to ovarian cancer histotypes.

The mean age of patients at first endometriosis diagnosis was 36 and the mean follow-up was 12 years. Compared with controls, endometriosis patients were more likely to be nulliparous (31% vs 24%) and to have had a hysterectomy (39% vs 6%) during follow-up.

There were 596 reported cases of ovarian cancer in the cohort. Those with incident endometriosis were 4.2 times more likely to develop ovarian cancer (95% CI, 3.59-4.91), 7.48 times more likely to develop type 1 ovarian cancer (95% CI, 5.80-9.65), and 2.70 times more likely to develop type 2 ovarian cancer (95% CI, 2.09-3.49) compared with those without endometriosis.

The magnitudes of these associations varied by endometriosis subtype. Individuals diagnosed with deep infiltrating endometriosis and/or ovarian endometriomas had 9.66 times the risk of ovarian cancer vs individuals without endometriosis (95% CI, 7.77-12.00). “Women with, compared to without, more severe endometriosis had a 19-fold higher risk of type 1 ovarian cancer, including endometrioid, clear cell, mucinous, and low-grade serous,” Dr. Schliep said, with associated risk highest for malignant subtypes such as clear cell and endometrioid carcinoma (adjusted hazard ratios, 11.15 and 7.96, respectively.

According to Dr. Schliep, physicians should encourage endometriosis patients to be aware of but not worry about ovarian cancer risk because the likelihood of developing it remains low. For their part, patients can reduce their risk of cancer through a balanced diet with low intake of alcohol, regular exercise, a healthy weight, and abstention from smoking.

Her message for researchers is as follows: “We need more studies that explore how different types of endometriosis impact different types of ovarian cancer risk. These studies will guide improved ovarian cancer screening and prevention strategies among women with severe endometriosis, with or without other important ovarian cancer risk factors such as BRCA 1/2 variations.”

An accompanying editorial called the Utah study “eloquent” and noted its distinguishing contribution of observing associations between subtypes of endometriosis with overall risk for ovarian cancer as well as histologic subtypes of epithelial ovarian cancer.

Nevertheless, Michael T. McHale, MD, of the Department of Obstetrics, Gynecology, and Reproductive Sciences at Moores Cancer Center, UC San Diego Health, University of California, expressed some methodological concerns. Although the authors attempted to control for key confounders, he noted, the dataset could not provide details on the medical management of endometriosis, such as oral contraceptives or gonadotropin-releasing hormone agonists. “Additionally, there is a possibility that women in the control cohort could have had undiagnosed endometriosis,” he wrote.

Furthermore, making clinical recommendations from these reported observations, particularly with respect to deep infiltrating endometriosis, would require a clear and consistent definition of this type in the dataset over the entire study interval from 1992 to 2019 and for the state of Utah, which the authors did not provide.

“Despite this potential challenge, the increased risk associated with deep infiltrating and/or ovarian endometriosis was clearly significant,” Dr. McHale wrote.

And although the absolute number of ovarian cancers is limited, in his view, the increased risk is sufficiently significant to advise women who have completed childbearing or have alternative fertility options to consider “more definitive surgery.”

This study was supported by multiple not-for-profit agencies, including the National Cancer Institute, the University of Utah, the National Center for Research Resources, the Utah Department of Health and Human Services, the Utah Cancer Registry, the US Centers for Disease Control and Prevention, the Huntsman Cancer Foundation, the National Institutes of Health, and Doris Duke Foundation. Dr. Barnard reported grants from the National Cancer Institute during the conduct of the study and personal fees from Epi Excellence LLC outside the submitted work. Other coauthors reported similar funding from nonprofit agencies or private research organizations. Dr Schliep disclosed no competing interests. Dr McHale reported educational consulting for Eisai Training outside the submitted work.

Ovarian cancer risk was higher in women with endometriosis overall and markedly increased in those with severe forms, a large population-based cohort study found.

The findings, published in JAMA, suggest these women may benefit from counseling on ovarian cancer risk and prevention and potentially from targeted screening, according to a group led by Mollie E. Barnard, ScD, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

While the absolute increase in number of cases was small, endometriosis patients overall had a more than fourfold higher risk for any type of ovarian cancer. Those with more severe forms, such as ovarian endometriomas or deep infiltrating endometriosis, had a nearly 10-fold higher risk of any type of ovarian cancer. In addition, those with more severe endometriosis had a 19-fold higher risk of type 1 (slow-growing) ovarian cancer and almost three times the risk of the more aggressive type 2.

“Given the rarity of ovarian cancer, the excess risk was relatively small, with 10-20 additional cases per 10,000 women. Nevertheless, women with endometriosis, notably the more severe subtypes, may be an important population for targeted cancer screening and prevention studies,” said corresponding author Karen C. Schliep, PhD, MSPH, associate professor in the university’s Division of Public Health.

Prior studies have shown modest associations between endometriosis and ovarian cancer, Dr. Schliep said in an interview. A 2021 systematic review and meta-analysis found endometriosis conferred nearly double the risk of ovarian cancer, although associations varied by ovarian cancer histotype. Few studies have been large enough to assess associations between endometriosis types — including superficial or peritoneal endometriosis vs ovarian endometriomas or deep infiltrating endometriosis and ovarian cancer histotypes such as low-grade serous, endometrioid, clear cell, and mucinous carcinomas (type 1), and the most aggressive and lethal form, high-grade serous type 2, she said in an interview. “Our large health administrative database of over 11 million individuals with linked electronic health and cancer registry data allowed us to answer this as yet poorly studied research question.”
 

Study Details

Drawing on Utah electronic health records from 1992 to 2019, the investigators matched 78,893 women with endometriosis in a 1:5 ratio to unaffected women. Cases were categorized as superficial endometriosis, ovarian endometriomas, deep infiltrating endometriosis, or other, and the types of endometriosis were matched to ovarian cancer histotypes.

The mean age of patients at first endometriosis diagnosis was 36 and the mean follow-up was 12 years. Compared with controls, endometriosis patients were more likely to be nulliparous (31% vs 24%) and to have had a hysterectomy (39% vs 6%) during follow-up.

There were 596 reported cases of ovarian cancer in the cohort. Those with incident endometriosis were 4.2 times more likely to develop ovarian cancer (95% CI, 3.59-4.91), 7.48 times more likely to develop type 1 ovarian cancer (95% CI, 5.80-9.65), and 2.70 times more likely to develop type 2 ovarian cancer (95% CI, 2.09-3.49) compared with those without endometriosis.

The magnitudes of these associations varied by endometriosis subtype. Individuals diagnosed with deep infiltrating endometriosis and/or ovarian endometriomas had 9.66 times the risk of ovarian cancer vs individuals without endometriosis (95% CI, 7.77-12.00). “Women with, compared to without, more severe endometriosis had a 19-fold higher risk of type 1 ovarian cancer, including endometrioid, clear cell, mucinous, and low-grade serous,” Dr. Schliep said, with associated risk highest for malignant subtypes such as clear cell and endometrioid carcinoma (adjusted hazard ratios, 11.15 and 7.96, respectively.

According to Dr. Schliep, physicians should encourage endometriosis patients to be aware of but not worry about ovarian cancer risk because the likelihood of developing it remains low. For their part, patients can reduce their risk of cancer through a balanced diet with low intake of alcohol, regular exercise, a healthy weight, and abstention from smoking.

Her message for researchers is as follows: “We need more studies that explore how different types of endometriosis impact different types of ovarian cancer risk. These studies will guide improved ovarian cancer screening and prevention strategies among women with severe endometriosis, with or without other important ovarian cancer risk factors such as BRCA 1/2 variations.”

An accompanying editorial called the Utah study “eloquent” and noted its distinguishing contribution of observing associations between subtypes of endometriosis with overall risk for ovarian cancer as well as histologic subtypes of epithelial ovarian cancer.

Nevertheless, Michael T. McHale, MD, of the Department of Obstetrics, Gynecology, and Reproductive Sciences at Moores Cancer Center, UC San Diego Health, University of California, expressed some methodological concerns. Although the authors attempted to control for key confounders, he noted, the dataset could not provide details on the medical management of endometriosis, such as oral contraceptives or gonadotropin-releasing hormone agonists. “Additionally, there is a possibility that women in the control cohort could have had undiagnosed endometriosis,” he wrote.

Furthermore, making clinical recommendations from these reported observations, particularly with respect to deep infiltrating endometriosis, would require a clear and consistent definition of this type in the dataset over the entire study interval from 1992 to 2019 and for the state of Utah, which the authors did not provide.

“Despite this potential challenge, the increased risk associated with deep infiltrating and/or ovarian endometriosis was clearly significant,” Dr. McHale wrote.

And although the absolute number of ovarian cancers is limited, in his view, the increased risk is sufficiently significant to advise women who have completed childbearing or have alternative fertility options to consider “more definitive surgery.”

This study was supported by multiple not-for-profit agencies, including the National Cancer Institute, the University of Utah, the National Center for Research Resources, the Utah Department of Health and Human Services, the Utah Cancer Registry, the US Centers for Disease Control and Prevention, the Huntsman Cancer Foundation, the National Institutes of Health, and Doris Duke Foundation. Dr. Barnard reported grants from the National Cancer Institute during the conduct of the study and personal fees from Epi Excellence LLC outside the submitted work. Other coauthors reported similar funding from nonprofit agencies or private research organizations. Dr Schliep disclosed no competing interests. Dr McHale reported educational consulting for Eisai Training outside the submitted work.

The effectiveness of massage therapy for a range of painful adult health conditions remains uncertain. Despite hundreds of randomized clinical trials and dozens of systematic reviews, few studies have offered conclusions based on more than low-certainty evidence, a systematic review in JAMA Network Open has shown (doi: 10.1001/jamanetworkopen.2024.22259).

Some moderate-certainty evidence, however, suggested massage therapy may alleviate pain related to such conditions as low-back problems, labor, and breast cancer surgery, concluded a group led by Selene Mak, PhD, MPH, program manager in the Evidence Synthesis Program at the Veterans Health Administration Greater Los Angeles Healthcare System in Los Angeles, California.

“More high-quality randomized clinical trials are needed to provide a stronger evidence base to assess the effect of massage therapy on pain,” Dr. Mak and colleagues wrote.

The review updates a previous Veterans Affairs evidence map covering reviews of massage therapy for pain published through 2018.

To categorize the evidence base for decision-making by policymakers and practitioners, the VA requested an updated evidence map of reviews to answer the question: “What is the certainty of evidence in systematic reviews of massage therapy for pain?”
 

The Analysis

The current review included studies published from 2018 to 2023 with formal ratings of evidence quality or certainty, excluding other nonpharmacologic techniques such as sports massage therapy, osteopathy, dry cupping, dry needling, and internal massage therapy, and self-administered techniques such as foam rolling.

Of 129 systematic reviews, only 41 formally rated evidence quality, and 17 were evidence-mapped for pain across 13 health states: cancer, back, neck and mechanical neck issues, fibromyalgia, labor, myofascial, palliative care need, plantar fasciitis, postoperative, post breast cancer surgery, and post cesarean/postpartum.

The investigators found no conclusions based on a high certainty of evidence, while seven based conclusions on moderate-certainty evidence. All remaining conclusions were rated as having low- or very-low-certainty evidence.

The priority, they added, should be studies comparing massage therapy with other recommended, accepted, and active therapies for pain and should have sufficiently long follow-up to allow any nonspecific outcomes to dissipate, At least 6 months’ follow-up has been suggested for studies of chronic pain.

While massage therapy is considered safe, in patients with central sensitizations more aggressive treatments may cause a flare of myofascial pain.

This study was funded by the Department of Veterans Affairs Health Services Research and Development. The authors had no conflicts of interest to disclose.

The effectiveness of massage therapy for a range of painful adult health conditions remains uncertain. Despite hundreds of randomized clinical trials and dozens of systematic reviews, few studies have offered conclusions based on more than low-certainty evidence, a systematic review in JAMA Network Open has shown (doi: 10.1001/jamanetworkopen.2024.22259).

Some moderate-certainty evidence, however, suggested massage therapy may alleviate pain related to such conditions as low-back problems, labor, and breast cancer surgery, concluded a group led by Selene Mak, PhD, MPH, program manager in the Evidence Synthesis Program at the Veterans Health Administration Greater Los Angeles Healthcare System in Los Angeles, California.

“More high-quality randomized clinical trials are needed to provide a stronger evidence base to assess the effect of massage therapy on pain,” Dr. Mak and colleagues wrote.

The review updates a previous Veterans Affairs evidence map covering reviews of massage therapy for pain published through 2018.

To categorize the evidence base for decision-making by policymakers and practitioners, the VA requested an updated evidence map of reviews to answer the question: “What is the certainty of evidence in systematic reviews of massage therapy for pain?”
 

The Analysis

The current review included studies published from 2018 to 2023 with formal ratings of evidence quality or certainty, excluding other nonpharmacologic techniques such as sports massage therapy, osteopathy, dry cupping, dry needling, and internal massage therapy, and self-administered techniques such as foam rolling.

Of 129 systematic reviews, only 41 formally rated evidence quality, and 17 were evidence-mapped for pain across 13 health states: cancer, back, neck and mechanical neck issues, fibromyalgia, labor, myofascial, palliative care need, plantar fasciitis, postoperative, post breast cancer surgery, and post cesarean/postpartum.

The investigators found no conclusions based on a high certainty of evidence, while seven based conclusions on moderate-certainty evidence. All remaining conclusions were rated as having low- or very-low-certainty evidence.

The priority, they added, should be studies comparing massage therapy with other recommended, accepted, and active therapies for pain and should have sufficiently long follow-up to allow any nonspecific outcomes to dissipate, At least 6 months’ follow-up has been suggested for studies of chronic pain.

While massage therapy is considered safe, in patients with central sensitizations more aggressive treatments may cause a flare of myofascial pain.

This study was funded by the Department of Veterans Affairs Health Services Research and Development. The authors had no conflicts of interest to disclose.

The effectiveness of massage therapy for a range of painful adult health conditions remains uncertain. Despite hundreds of randomized clinical trials and dozens of systematic reviews, few studies have offered conclusions based on more than low-certainty evidence, a systematic review in JAMA Network Open has shown (doi: 10.1001/jamanetworkopen.2024.22259).

Some moderate-certainty evidence, however, suggested massage therapy may alleviate pain related to such conditions as low-back problems, labor, and breast cancer surgery, concluded a group led by Selene Mak, PhD, MPH, program manager in the Evidence Synthesis Program at the Veterans Health Administration Greater Los Angeles Healthcare System in Los Angeles, California.

“More high-quality randomized clinical trials are needed to provide a stronger evidence base to assess the effect of massage therapy on pain,” Dr. Mak and colleagues wrote.

The review updates a previous Veterans Affairs evidence map covering reviews of massage therapy for pain published through 2018.

To categorize the evidence base for decision-making by policymakers and practitioners, the VA requested an updated evidence map of reviews to answer the question: “What is the certainty of evidence in systematic reviews of massage therapy for pain?”
 

The Analysis

The current review included studies published from 2018 to 2023 with formal ratings of evidence quality or certainty, excluding other nonpharmacologic techniques such as sports massage therapy, osteopathy, dry cupping, dry needling, and internal massage therapy, and self-administered techniques such as foam rolling.

Of 129 systematic reviews, only 41 formally rated evidence quality, and 17 were evidence-mapped for pain across 13 health states: cancer, back, neck and mechanical neck issues, fibromyalgia, labor, myofascial, palliative care need, plantar fasciitis, postoperative, post breast cancer surgery, and post cesarean/postpartum.

The investigators found no conclusions based on a high certainty of evidence, while seven based conclusions on moderate-certainty evidence. All remaining conclusions were rated as having low- or very-low-certainty evidence.

The priority, they added, should be studies comparing massage therapy with other recommended, accepted, and active therapies for pain and should have sufficiently long follow-up to allow any nonspecific outcomes to dissipate, At least 6 months’ follow-up has been suggested for studies of chronic pain.

While massage therapy is considered safe, in patients with central sensitizations more aggressive treatments may cause a flare of myofascial pain.

This study was funded by the Department of Veterans Affairs Health Services Research and Development. The authors had no conflicts of interest to disclose.

The combination of the antiviral bulevirtide (Hepcludex) plus pegylated interferon alfa-2a was superior to bulevirtide monotherapy for chronic hepatitis delta (HDV) infection, a multinational phase 2b open-label study in Europe found.

The combination resulted in higher rates of HDV RNA suppression levels at 24 weeks after end of treatment, especially at a higher, 10-mg dose of bulevirtide, according to researchers led by Tarik Asselah, MD. PhD, a professor of medicine and hepatology at Hôpital Beaujon, APHP, Clichy, France, and the University of Paris.

“This response appeared to be maintained from 24-48 weeks after the end of treatment — a finding that supports the concept that sustained undetectable HDV RNA for at least 1 year after treatment is possible in patients with chronic hepatitis D who have been treated with a finite duration of therapy of at least 96 weeks, including 48 weeks of peginterferon alfa-2a therapy,” the investigators wrote in The New England Journal of Medicine.

“As of today, there is no approved treatment for chronic HDV infection in the United States. Pegylated interferon alfa-2a, which is not approved for treatment of HDV, is the only option recommended by US treatment guidelines,” said study corresponding author Fabien Zoulim, MD, PhD, a hepatologist at the Lyon Hepatology Institute and a professor of medicine at the University of Lyon in France, in comments to GI & Hepatology News. “Bulevirtide 2 mg is approved for treating chronic HDV and compensated liver disease, and both bulevirtide and peginterferon are recommended options by the European treatment guidelines.”

The study found that most patients with undetectable HDV RNA levels during treatment-free follow-up showed no reduction in HepB surface antigen (HBsAg), suggesting an undetectable HDV RNA level can be achieved and sustained without HBsAg loss, the authors wrote.

While very small numbers in the combo groups and the higher-dose bulevirtide arm cleared HBsAg, “the study was not powered to evaluate the HBsAg response,” Dr. Zoulim said.

HDV is a defective virus that requires HBsAg for assembly and propagation, the authors noted. It affects as many as 20 million persons worldwide, and as the most severe form of chronic viral hepatitis, is associated with 2-6 times the risk of hepatocellular carcinoma and 2-3 times the risk of death associated with HBV monoinfection.

Though not common in the United States, it affects an estimated 10 to 20 million people worldwide (J Hepatol. 2020 Apr. doi: 10.1016/j.jhep.2020.04.008). One US database study found HepD in 4.6% of patients with HepB infection.

Commenting on the study but not a participant in it, Ahmet O. Gurakar, MD, AGAF, a professor of medicine in the sections of gastroenterology and hepatology at Johns Hopkins School of Medicine in Baltimore, Maryland, said the study findings look promising for the future treatment of HepD, but cautioned that it will be “a slow process to get approval for combination therapy with bulevirtide since the FDA has previously said it needs to see more studies. The findings need to be confirmed in larger groups, but it’s difficult to recruit enough patients in the United States for a trial since hepatitis D is not common in this country — it’s more common in the Mediterranean basin Eastern European populations.”

The Trial

The investigators randomly assigned 174, largely male, patients ages 18-65 (mean, about 41) years to receive one of four treatments:

• Pegylated interferon alfa-2a alone at 180 μg per week) for 48 weeks (n = 24).
• Bulevirtide at a daily dose of 2 mg plus peginterferon alfa-2a at 180 μg per week for 48 weeks, followed by the same daily dose of bulevirtide for 48 weeks (n = 50).
• Bulevirtide at 10 mg plus peginterferon alfa-2a at 180 μg per week for 48 weeks, followed by the same daily dose of bulevirtide for 48 weeks (n = 50).
• Bulevirtide at a daily dose of 10 mg alone for 96 weeks (n = 50).

All were followed for 48 weeks after treatment. The primary comparison was between the 10-mg bulevirtide plus peginterferon alfa-2a group and the 10-mg bulevirtide monotherapy group.

At 24 weeks post-treatment, HDV RNA was undetectable in 17% of patients in the peginterferon alfa-2a group. In the other arms, HDV RNA was undetectable in 32% in the 2-mg bulevirtide plus peginterferon alfa-2a group, in 46% of the 10-mg bulevirtide plus peginterferon alfa-2a group, and in 12% of the 10-mg bulevirtide group.

For the primary comparison, the between-group difference was 34 percentage points (95% confidence interval, 15-50; P < .001).

At 48 weeks after the end of treatment, HDV RNA was undetectable in 25% in the peginterferon alfa-2a group, 26% in the 2-mg bulevirtide plus peginterferon alfa-2a group, 46% in the 10-mg bulevirtide plus peginterferon alfa-2a group, and 12% in the 10-mg bulevirtide group.

Also calling the findings promising, Anna Lok, MBBS, MD, AGAF, a gastroenterologist at the University of Michigan, Ann Arbor, said that, “Given that the European Medicines Agency’s approval is for bulevirtide alone at 2 mg, results of this study should prompt reassessment whether bulevirtide should be used in combination with pegylated interferon in patients with no contraindications, and if 10 mg is more appropriate than a 2-mg dose.”

The combination of the antiviral bulevirtide (Hepcludex) plus pegylated interferon alfa-2a was superior to bulevirtide monotherapy for chronic hepatitis delta (HDV) infection, a multinational phase 2b open-label study in Europe found.

The combination resulted in higher rates of HDV RNA suppression levels at 24 weeks after end of treatment, especially at a higher, 10-mg dose of bulevirtide, according to researchers led by Tarik Asselah, MD. PhD, a professor of medicine and hepatology at Hôpital Beaujon, APHP, Clichy, France, and the University of Paris.

“This response appeared to be maintained from 24-48 weeks after the end of treatment — a finding that supports the concept that sustained undetectable HDV RNA for at least 1 year after treatment is possible in patients with chronic hepatitis D who have been treated with a finite duration of therapy of at least 96 weeks, including 48 weeks of peginterferon alfa-2a therapy,” the investigators wrote in The New England Journal of Medicine.

“As of today, there is no approved treatment for chronic HDV infection in the United States. Pegylated interferon alfa-2a, which is not approved for treatment of HDV, is the only option recommended by US treatment guidelines,” said study corresponding author Fabien Zoulim, MD, PhD, a hepatologist at the Lyon Hepatology Institute and a professor of medicine at the University of Lyon in France, in comments to GI & Hepatology News. “Bulevirtide 2 mg is approved for treating chronic HDV and compensated liver disease, and both bulevirtide and peginterferon are recommended options by the European treatment guidelines.”

The study found that most patients with undetectable HDV RNA levels during treatment-free follow-up showed no reduction in HepB surface antigen (HBsAg), suggesting an undetectable HDV RNA level can be achieved and sustained without HBsAg loss, the authors wrote.

While very small numbers in the combo groups and the higher-dose bulevirtide arm cleared HBsAg, “the study was not powered to evaluate the HBsAg response,” Dr. Zoulim said.

HDV is a defective virus that requires HBsAg for assembly and propagation, the authors noted. It affects as many as 20 million persons worldwide, and as the most severe form of chronic viral hepatitis, is associated with 2-6 times the risk of hepatocellular carcinoma and 2-3 times the risk of death associated with HBV monoinfection.

Though not common in the United States, it affects an estimated 10 to 20 million people worldwide (J Hepatol. 2020 Apr. doi: 10.1016/j.jhep.2020.04.008). One US database study found HepD in 4.6% of patients with HepB infection.

Commenting on the study but not a participant in it, Ahmet O. Gurakar, MD, AGAF, a professor of medicine in the sections of gastroenterology and hepatology at Johns Hopkins School of Medicine in Baltimore, Maryland, said the study findings look promising for the future treatment of HepD, but cautioned that it will be “a slow process to get approval for combination therapy with bulevirtide since the FDA has previously said it needs to see more studies. The findings need to be confirmed in larger groups, but it’s difficult to recruit enough patients in the United States for a trial since hepatitis D is not common in this country — it’s more common in the Mediterranean basin Eastern European populations.”

The Trial

The investigators randomly assigned 174, largely male, patients ages 18-65 (mean, about 41) years to receive one of four treatments:

• Pegylated interferon alfa-2a alone at 180 μg per week) for 48 weeks (n = 24).
• Bulevirtide at a daily dose of 2 mg plus peginterferon alfa-2a at 180 μg per week for 48 weeks, followed by the same daily dose of bulevirtide for 48 weeks (n = 50).
• Bulevirtide at 10 mg plus peginterferon alfa-2a at 180 μg per week for 48 weeks, followed by the same daily dose of bulevirtide for 48 weeks (n = 50).
• Bulevirtide at a daily dose of 10 mg alone for 96 weeks (n = 50).

All were followed for 48 weeks after treatment. The primary comparison was between the 10-mg bulevirtide plus peginterferon alfa-2a group and the 10-mg bulevirtide monotherapy group.

At 24 weeks post-treatment, HDV RNA was undetectable in 17% of patients in the peginterferon alfa-2a group. In the other arms, HDV RNA was undetectable in 32% in the 2-mg bulevirtide plus peginterferon alfa-2a group, in 46% of the 10-mg bulevirtide plus peginterferon alfa-2a group, and in 12% of the 10-mg bulevirtide group.

For the primary comparison, the between-group difference was 34 percentage points (95% confidence interval, 15-50; P < .001).

At 48 weeks after the end of treatment, HDV RNA was undetectable in 25% in the peginterferon alfa-2a group, 26% in the 2-mg bulevirtide plus peginterferon alfa-2a group, 46% in the 10-mg bulevirtide plus peginterferon alfa-2a group, and 12% in the 10-mg bulevirtide group.

Also calling the findings promising, Anna Lok, MBBS, MD, AGAF, a gastroenterologist at the University of Michigan, Ann Arbor, said that, “Given that the European Medicines Agency’s approval is for bulevirtide alone at 2 mg, results of this study should prompt reassessment whether bulevirtide should be used in combination with pegylated interferon in patients with no contraindications, and if 10 mg is more appropriate than a 2-mg dose.”

The combination of the antiviral bulevirtide (Hepcludex) plus pegylated interferon alfa-2a was superior to bulevirtide monotherapy for chronic hepatitis delta (HDV) infection, a multinational phase 2b open-label study in Europe found.

The combination resulted in higher rates of HDV RNA suppression levels at 24 weeks after end of treatment, especially at a higher, 10-mg dose of bulevirtide, according to researchers led by Tarik Asselah, MD. PhD, a professor of medicine and hepatology at Hôpital Beaujon, APHP, Clichy, France, and the University of Paris.

“This response appeared to be maintained from 24-48 weeks after the end of treatment — a finding that supports the concept that sustained undetectable HDV RNA for at least 1 year after treatment is possible in patients with chronic hepatitis D who have been treated with a finite duration of therapy of at least 96 weeks, including 48 weeks of peginterferon alfa-2a therapy,” the investigators wrote in The New England Journal of Medicine.

“As of today, there is no approved treatment for chronic HDV infection in the United States. Pegylated interferon alfa-2a, which is not approved for treatment of HDV, is the only option recommended by US treatment guidelines,” said study corresponding author Fabien Zoulim, MD, PhD, a hepatologist at the Lyon Hepatology Institute and a professor of medicine at the University of Lyon in France, in comments to GI & Hepatology News. “Bulevirtide 2 mg is approved for treating chronic HDV and compensated liver disease, and both bulevirtide and peginterferon are recommended options by the European treatment guidelines.”

The study found that most patients with undetectable HDV RNA levels during treatment-free follow-up showed no reduction in HepB surface antigen (HBsAg), suggesting an undetectable HDV RNA level can be achieved and sustained without HBsAg loss, the authors wrote.

While very small numbers in the combo groups and the higher-dose bulevirtide arm cleared HBsAg, “the study was not powered to evaluate the HBsAg response,” Dr. Zoulim said.

HDV is a defective virus that requires HBsAg for assembly and propagation, the authors noted. It affects as many as 20 million persons worldwide, and as the most severe form of chronic viral hepatitis, is associated with 2-6 times the risk of hepatocellular carcinoma and 2-3 times the risk of death associated with HBV monoinfection.

Though not common in the United States, it affects an estimated 10 to 20 million people worldwide (J Hepatol. 2020 Apr. doi: 10.1016/j.jhep.2020.04.008). One US database study found HepD in 4.6% of patients with HepB infection.

Commenting on the study but not a participant in it, Ahmet O. Gurakar, MD, AGAF, a professor of medicine in the sections of gastroenterology and hepatology at Johns Hopkins School of Medicine in Baltimore, Maryland, said the study findings look promising for the future treatment of HepD, but cautioned that it will be “a slow process to get approval for combination therapy with bulevirtide since the FDA has previously said it needs to see more studies. The findings need to be confirmed in larger groups, but it’s difficult to recruit enough patients in the United States for a trial since hepatitis D is not common in this country — it’s more common in the Mediterranean basin Eastern European populations.”

The Trial

The investigators randomly assigned 174, largely male, patients ages 18-65 (mean, about 41) years to receive one of four treatments:

• Pegylated interferon alfa-2a alone at 180 μg per week) for 48 weeks (n = 24).
• Bulevirtide at a daily dose of 2 mg plus peginterferon alfa-2a at 180 μg per week for 48 weeks, followed by the same daily dose of bulevirtide for 48 weeks (n = 50).
• Bulevirtide at 10 mg plus peginterferon alfa-2a at 180 μg per week for 48 weeks, followed by the same daily dose of bulevirtide for 48 weeks (n = 50).
• Bulevirtide at a daily dose of 10 mg alone for 96 weeks (n = 50).

All were followed for 48 weeks after treatment. The primary comparison was between the 10-mg bulevirtide plus peginterferon alfa-2a group and the 10-mg bulevirtide monotherapy group.

At 24 weeks post-treatment, HDV RNA was undetectable in 17% of patients in the peginterferon alfa-2a group. In the other arms, HDV RNA was undetectable in 32% in the 2-mg bulevirtide plus peginterferon alfa-2a group, in 46% of the 10-mg bulevirtide plus peginterferon alfa-2a group, and in 12% of the 10-mg bulevirtide group.

For the primary comparison, the between-group difference was 34 percentage points (95% confidence interval, 15-50; P < .001).

At 48 weeks after the end of treatment, HDV RNA was undetectable in 25% in the peginterferon alfa-2a group, 26% in the 2-mg bulevirtide plus peginterferon alfa-2a group, 46% in the 10-mg bulevirtide plus peginterferon alfa-2a group, and 12% in the 10-mg bulevirtide group.

Also calling the findings promising, Anna Lok, MBBS, MD, AGAF, a gastroenterologist at the University of Michigan, Ann Arbor, said that, “Given that the European Medicines Agency’s approval is for bulevirtide alone at 2 mg, results of this study should prompt reassessment whether bulevirtide should be used in combination with pegylated interferon in patients with no contraindications, and if 10 mg is more appropriate than a 2-mg dose.”