Pam Harrison

ORLANDO – Hospitalization rates were higher in patients with advanced chronic kidney disease (CKD) treated with dialysis than those treated with conservative management, among those with an estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73m² and in most racial/ethnic groups, new research shows.

“Patients mostly start dialysis because of unpleasant symptoms that cause suffering, including high potassium levels and high levels of uremic toxins in the blood,” senior author Kamyar Kalantar-Zadeh, MD, PhD, MPH, told this news organization.

“Conservative management serves to address and manage these symptoms and levels of toxicities without dialysis, so conservative management is an alternative approach, and patients should always be given a choice between [the two],” stressed Dr. Kalantar-Zadeh, professor of medicine at the University of California, Irvine.

The results were presented during the annual meeting of the American Society of Nephrology.

“There has been growing recognition of the importance of conservative nondialytic management as an alternative patient-centered treatment strategy for advanced kidney disease. However, conservative management remains under-utilized in the United States, which may in part be due to uncertainties regarding which patients will most benefit from dialysis versus nondialytic treatment,” said first author Connie Rhee, MD, also of the University of California, Irvine.

“We hope that these findings and further research can help inform treatment options for patients, care partners, and providers in the shared decision-making process of conservative management versus dialysis,” added Dr. Rhee, in a press release from the American Society of Nephrology.

Asked for comment, Sarah Davison, MD, noted that part of the Society’s strategy is, in fact, to promote conservative kidney management (CKM) as a key component of integrated care for patients with kidney failure. Dr. Davison is professor of medicine and chair of the International Society Working Group for Kidney Supportive Care and Conservative Kidney Management.

“We’ve recognized for a long time that there are many patients for whom dialysis provides neither a survival advantage nor a quality of life advantage,” she told this news organization.

“These patients tend to be those who have multiple morbidities, who are more frail, and who tend to be older, and in fact, the patients can live as long, if not longer, with better symptom management and better quality of life by not being on dialysis,” she stressed.
 

Study details

In the study, using data from the Optum Labs Data Warehouse, patients with advanced CKD were categorized according to whether or not they received conservative management, defined as those who did not receive dialysis within 2 years of the index eGFR (first eGFR < 25 mL/min/1.73m²) versus receipt of dialysis parsed as late versus early dialysis transition (eGFR < 15 vs. ≥ 15 mL/min/1.73m² at dialysis initiation).

Hospitalization rates were compared between those treated with conservative management, compared with late or early dialysis.

“Among 309,188 advanced CKD patients who met eligibility [criteria], 55% of patients had greater than or equal to 1 hospitalization(s) within 2 years of the index eGFR,” the authors report. The most common causes of hospitalization among all patients were congestive heart failure, respiratory symptoms, or hypertension.

In most racial groups (non-Hispanic White, non-Hispanic Black, and Hispanic patients), patients on dialysis had higher hospitalization rates than those who received conservative management, and patients who started dialysis early (transitioned to dialysis at higher levels of kidney function) demonstrated the highest rates across all age groups, compared with those who started dialysis late (transitioned to dialysis at lower levels of kidney function) or were treated with conservative management.

Among Asian patients, those on dialysis also had higher hospitalization rates than those receiving conservative management, but patients who started dialysis late had higher rates than those on early dialysis, especially in older age groups, possibly because they were sicker, Dr. Kalantar-Zadeh suggested.
 

Conservative care has pros and cons, but Canada has embraced it

As Dr. Kalantar-Zadeh explained, conservative management has its pros and cons, compared with dialysis. “Conservative management requires that patients work with the multidisciplinary team including nephrologists, nutritionists, and others to try to manage CKD without dialysis, so it requires patient participation.”

On the other hand, dialysis is both easier and more lucrative than conservative management, at least for nephrologists, as they are well-trained in dialysis care, and it can be systematically applied. As to which patients with CKD might be optimal candidates for conservative management, Dr. Kalantar-Zadeh agreed this requires further study.

But he acknowledged that most nephrologists are not hugely supportive of conservative management because they are less well-trained in it, and it is more time-consuming. The one promising change is a new model introduced in 2022, a value-based kidney care model, that, if implemented, will be more incentivizing for nephrologists to offer conservative care more widely.

Dr. Davison meanwhile believes the “vast majority” of nephrologists based in Canada – as she is – are “highly supportive” of CKM as an important modality.

“The challenge, however, is that many nephrologists remain unsure as to how to best deliver or optimize all aspects of CKM, whether that is symptom management, advanced care planning, or how they must manage symptoms to align with a patient’s goals,” Dr. Davison explained.

“But it’s not that they do not believe in the value of CKM.”

Indeed, in her province, Alberta, nephrologists have been offering CKM for decades, and while they are currently standardizing care to make it easier to deliver, there is no financial incentive to offer dialysis over CKM.

“We are now seeing those elements of kidney supportive care as part of core competencies to manage any person with chronic illness, including CKD,” Dr. Davison said.

“So it’s absolutely doable, and contrary to one of the myths about CKM, it is not more time-consuming than dialysis – not when you know how to do it. You are just shifting your focus,” she emphasized.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Kalantar-Zadeh has reported receiving honoraria and medical directorship fees from Fresenius and DaVita. Dr. Davison has reported no relevant financial relationships.

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

ORLANDO – Hospitalization rates were higher in patients with advanced chronic kidney disease (CKD) treated with dialysis than those treated with conservative management, among those with an estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73m² and in most racial/ethnic groups, new research shows.

“Patients mostly start dialysis because of unpleasant symptoms that cause suffering, including high potassium levels and high levels of uremic toxins in the blood,” senior author Kamyar Kalantar-Zadeh, MD, PhD, MPH, told this news organization.

“Conservative management serves to address and manage these symptoms and levels of toxicities without dialysis, so conservative management is an alternative approach, and patients should always be given a choice between [the two],” stressed Dr. Kalantar-Zadeh, professor of medicine at the University of California, Irvine.

The results were presented during the annual meeting of the American Society of Nephrology.

“There has been growing recognition of the importance of conservative nondialytic management as an alternative patient-centered treatment strategy for advanced kidney disease. However, conservative management remains under-utilized in the United States, which may in part be due to uncertainties regarding which patients will most benefit from dialysis versus nondialytic treatment,” said first author Connie Rhee, MD, also of the University of California, Irvine.

“We hope that these findings and further research can help inform treatment options for patients, care partners, and providers in the shared decision-making process of conservative management versus dialysis,” added Dr. Rhee, in a press release from the American Society of Nephrology.

Asked for comment, Sarah Davison, MD, noted that part of the Society’s strategy is, in fact, to promote conservative kidney management (CKM) as a key component of integrated care for patients with kidney failure. Dr. Davison is professor of medicine and chair of the International Society Working Group for Kidney Supportive Care and Conservative Kidney Management.

“We’ve recognized for a long time that there are many patients for whom dialysis provides neither a survival advantage nor a quality of life advantage,” she told this news organization.

“These patients tend to be those who have multiple morbidities, who are more frail, and who tend to be older, and in fact, the patients can live as long, if not longer, with better symptom management and better quality of life by not being on dialysis,” she stressed.
 

Study details

In the study, using data from the Optum Labs Data Warehouse, patients with advanced CKD were categorized according to whether or not they received conservative management, defined as those who did not receive dialysis within 2 years of the index eGFR (first eGFR < 25 mL/min/1.73m²) versus receipt of dialysis parsed as late versus early dialysis transition (eGFR < 15 vs. ≥ 15 mL/min/1.73m² at dialysis initiation).

Hospitalization rates were compared between those treated with conservative management, compared with late or early dialysis.

“Among 309,188 advanced CKD patients who met eligibility [criteria], 55% of patients had greater than or equal to 1 hospitalization(s) within 2 years of the index eGFR,” the authors report. The most common causes of hospitalization among all patients were congestive heart failure, respiratory symptoms, or hypertension.

In most racial groups (non-Hispanic White, non-Hispanic Black, and Hispanic patients), patients on dialysis had higher hospitalization rates than those who received conservative management, and patients who started dialysis early (transitioned to dialysis at higher levels of kidney function) demonstrated the highest rates across all age groups, compared with those who started dialysis late (transitioned to dialysis at lower levels of kidney function) or were treated with conservative management.

Among Asian patients, those on dialysis also had higher hospitalization rates than those receiving conservative management, but patients who started dialysis late had higher rates than those on early dialysis, especially in older age groups, possibly because they were sicker, Dr. Kalantar-Zadeh suggested.
 

Conservative care has pros and cons, but Canada has embraced it

As Dr. Kalantar-Zadeh explained, conservative management has its pros and cons, compared with dialysis. “Conservative management requires that patients work with the multidisciplinary team including nephrologists, nutritionists, and others to try to manage CKD without dialysis, so it requires patient participation.”

On the other hand, dialysis is both easier and more lucrative than conservative management, at least for nephrologists, as they are well-trained in dialysis care, and it can be systematically applied. As to which patients with CKD might be optimal candidates for conservative management, Dr. Kalantar-Zadeh agreed this requires further study.

But he acknowledged that most nephrologists are not hugely supportive of conservative management because they are less well-trained in it, and it is more time-consuming. The one promising change is a new model introduced in 2022, a value-based kidney care model, that, if implemented, will be more incentivizing for nephrologists to offer conservative care more widely.

Dr. Davison meanwhile believes the “vast majority” of nephrologists based in Canada – as she is – are “highly supportive” of CKM as an important modality.

“The challenge, however, is that many nephrologists remain unsure as to how to best deliver or optimize all aspects of CKM, whether that is symptom management, advanced care planning, or how they must manage symptoms to align with a patient’s goals,” Dr. Davison explained.

“But it’s not that they do not believe in the value of CKM.”

Indeed, in her province, Alberta, nephrologists have been offering CKM for decades, and while they are currently standardizing care to make it easier to deliver, there is no financial incentive to offer dialysis over CKM.

“We are now seeing those elements of kidney supportive care as part of core competencies to manage any person with chronic illness, including CKD,” Dr. Davison said.

“So it’s absolutely doable, and contrary to one of the myths about CKM, it is not more time-consuming than dialysis – not when you know how to do it. You are just shifting your focus,” she emphasized.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Kalantar-Zadeh has reported receiving honoraria and medical directorship fees from Fresenius and DaVita. Dr. Davison has reported no relevant financial relationships.

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

ORLANDO – Hospitalization rates were higher in patients with advanced chronic kidney disease (CKD) treated with dialysis than those treated with conservative management, among those with an estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73m² and in most racial/ethnic groups, new research shows.

“Patients mostly start dialysis because of unpleasant symptoms that cause suffering, including high potassium levels and high levels of uremic toxins in the blood,” senior author Kamyar Kalantar-Zadeh, MD, PhD, MPH, told this news organization.

“Conservative management serves to address and manage these symptoms and levels of toxicities without dialysis, so conservative management is an alternative approach, and patients should always be given a choice between [the two],” stressed Dr. Kalantar-Zadeh, professor of medicine at the University of California, Irvine.

The results were presented during the annual meeting of the American Society of Nephrology.

“There has been growing recognition of the importance of conservative nondialytic management as an alternative patient-centered treatment strategy for advanced kidney disease. However, conservative management remains under-utilized in the United States, which may in part be due to uncertainties regarding which patients will most benefit from dialysis versus nondialytic treatment,” said first author Connie Rhee, MD, also of the University of California, Irvine.

“We hope that these findings and further research can help inform treatment options for patients, care partners, and providers in the shared decision-making process of conservative management versus dialysis,” added Dr. Rhee, in a press release from the American Society of Nephrology.

Asked for comment, Sarah Davison, MD, noted that part of the Society’s strategy is, in fact, to promote conservative kidney management (CKM) as a key component of integrated care for patients with kidney failure. Dr. Davison is professor of medicine and chair of the International Society Working Group for Kidney Supportive Care and Conservative Kidney Management.

“We’ve recognized for a long time that there are many patients for whom dialysis provides neither a survival advantage nor a quality of life advantage,” she told this news organization.

“These patients tend to be those who have multiple morbidities, who are more frail, and who tend to be older, and in fact, the patients can live as long, if not longer, with better symptom management and better quality of life by not being on dialysis,” she stressed.
 

Study details

In the study, using data from the Optum Labs Data Warehouse, patients with advanced CKD were categorized according to whether or not they received conservative management, defined as those who did not receive dialysis within 2 years of the index eGFR (first eGFR < 25 mL/min/1.73m²) versus receipt of dialysis parsed as late versus early dialysis transition (eGFR < 15 vs. ≥ 15 mL/min/1.73m² at dialysis initiation).

Hospitalization rates were compared between those treated with conservative management, compared with late or early dialysis.

“Among 309,188 advanced CKD patients who met eligibility [criteria], 55% of patients had greater than or equal to 1 hospitalization(s) within 2 years of the index eGFR,” the authors report. The most common causes of hospitalization among all patients were congestive heart failure, respiratory symptoms, or hypertension.

In most racial groups (non-Hispanic White, non-Hispanic Black, and Hispanic patients), patients on dialysis had higher hospitalization rates than those who received conservative management, and patients who started dialysis early (transitioned to dialysis at higher levels of kidney function) demonstrated the highest rates across all age groups, compared with those who started dialysis late (transitioned to dialysis at lower levels of kidney function) or were treated with conservative management.

Among Asian patients, those on dialysis also had higher hospitalization rates than those receiving conservative management, but patients who started dialysis late had higher rates than those on early dialysis, especially in older age groups, possibly because they were sicker, Dr. Kalantar-Zadeh suggested.
 

Conservative care has pros and cons, but Canada has embraced it

As Dr. Kalantar-Zadeh explained, conservative management has its pros and cons, compared with dialysis. “Conservative management requires that patients work with the multidisciplinary team including nephrologists, nutritionists, and others to try to manage CKD without dialysis, so it requires patient participation.”

On the other hand, dialysis is both easier and more lucrative than conservative management, at least for nephrologists, as they are well-trained in dialysis care, and it can be systematically applied. As to which patients with CKD might be optimal candidates for conservative management, Dr. Kalantar-Zadeh agreed this requires further study.

But he acknowledged that most nephrologists are not hugely supportive of conservative management because they are less well-trained in it, and it is more time-consuming. The one promising change is a new model introduced in 2022, a value-based kidney care model, that, if implemented, will be more incentivizing for nephrologists to offer conservative care more widely.

Dr. Davison meanwhile believes the “vast majority” of nephrologists based in Canada – as she is – are “highly supportive” of CKM as an important modality.

“The challenge, however, is that many nephrologists remain unsure as to how to best deliver or optimize all aspects of CKM, whether that is symptom management, advanced care planning, or how they must manage symptoms to align with a patient’s goals,” Dr. Davison explained.

“But it’s not that they do not believe in the value of CKM.”

Indeed, in her province, Alberta, nephrologists have been offering CKM for decades, and while they are currently standardizing care to make it easier to deliver, there is no financial incentive to offer dialysis over CKM.

“We are now seeing those elements of kidney supportive care as part of core competencies to manage any person with chronic illness, including CKD,” Dr. Davison said.

“So it’s absolutely doable, and contrary to one of the myths about CKM, it is not more time-consuming than dialysis – not when you know how to do it. You are just shifting your focus,” she emphasized.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Kalantar-Zadeh has reported receiving honoraria and medical directorship fees from Fresenius and DaVita. Dr. Davison has reported no relevant financial relationships.

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

The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

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

The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

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

The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

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

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

yoga_woman_web.jpg

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

yoga_woman_web.jpg

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

yoga_woman_web.jpg

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

A weighted blanket of approximately 12% body weight used at bedtime prompted the release of higher concentrations of melatonin, as measured in the saliva, compared with a lighter blanket of only about 2.4% of body weight.

This suggests that weighted blankets may help promote sleep in patients suffering from insomnia, according to the results from the small, in-laboratory crossover study.

“Melatonin is produced by the pineal gland and plays an essential role in sleep timing,” lead author Elisa Meth, PhD student, Uppsala University, Sweden, and colleagues observe.

“Using a weighted blanket increased melatonin concentration in saliva by about 30%,” Ms. Meth added in a statement.

“Future studies should investigate whether the stimulatory effect on melatonin secretion remains when using a weighted blanket over more extended periods,” the researchers observe, and caution that “it is also unclear whether the observed increase in melatonin is therapeutically relevant.”

The study was published online in the Journal of Sleep Research.

Weighted blankets are commercially available at least in some countries in Scandinavia and Germany, as examples, and in general, they are sold for therapeutic purposes. And at least one study found that weighted blankets were an effective and safe intervention for insomnia in patients with major depressive disorder, bipolar disorder, generalized anxiety disorder, and attention deficit hyperactivity disorder and led to improvements in daytime symptoms and levels of activity.
 

Study done in healthy volunteers

The study involved a total of 26 healthy volunteers, 15 men and 11 women, none of whom had any sleep issues. “The day before the first testing session, the participants visited the laboratory for an adaptation night,” the authors observe. There were two experimental test nights, one in which the weighted blanket was used and the second during which the lighter blanket was used.

On the test nights, lights were dimmed between 9 PM and 11 PM and participants used a weighted blanket covering the extremities, abdomen, and chest 1 hour before and during 8 hours of sleep. As the authors explain, the filling of the weighted blanket consisted of honed glass pearls, combined with polyester wadding, which corresponded to 12.2% of participants’ body weight.

“Saliva was collected every 20 minutes between 22:00 and 23:00,” Ms. Meth and colleagues note. Participants’ subjective sleepiness was also assessed every 20 minutes using the Karolinska Sleepiness Scale both before the hour that lights were turned off and the next morning.

“Sleep duration in each experimental night was recorded with the OURA ring,” investigators explain.

The OURA ring is a commercial multisensor wearable device that measures physiological variables indicative of sleep. Investigators focused on total sleep duration as the primary outcome measure.

On average, salivary melatonin concentrations rose by about 5.8 pg/mL between 10 PM and 11 PM (P < .001), but the average increase in salivary melatonin concentrations was greater under weighted blanket conditions at 6.6 pg/mL, compared with 5.0 pg/mL during the lighter blanket session (P = .011).

Oxytocin in turn rose by about 315 pg/mL initially, but this rise was only transient, and over time, no significant difference in oxytocin levels was observed between the two blanket conditions. There were also no differences in cortisol levels or the activity of the sympathetic nervous system between the weighted and light blanket sessions.

Importantly, as well, no significant differences were seen in the level of sleepiness between participants when either blanket was used nor was there a significant difference in total sleep duration.

“Our study cannot identify the underlying mechanism for the observed stimulatory effects of the weighted blanket on melatonin,” the investigators caution.

However, one explanation could be that the pressure exerted by the weighted blanket activates cutaneous sensory afferent nerves, carrying information to the brain. The region where the sensory information is delivered stimulates oxytocinergic neurons that can promote calm and well-being and decrease fear, stress, and pain. In addition, these neurons also connect to the pineal gland to influence the release of melatonin, the authors explain.
 

Melatonin often viewed in the wrong context

Senior author Christian Benedict, PhD, associate professor of pharmacology, Uppsala University, Sweden, explained that some people think of melatonin in the wrong context.

In point of fact, “it’s not a sleep-promoting hormone. It prepares your body and brain for the biological night ... [and] sleep coincides with the biological night, but it’s not like you take melatonin and you have a very nice uninterrupted slumber – this is not true,” he told this news organization.

He also noted that certain groups respond to melatonin better than others. For example, children with attention deficit hyperactivity disorder may have some benefit from melatonin supplements, as may the elderly who can no longer produce sufficient amounts of melatonin and for whom supplements may help promote the timing of sleep.

However, the bottom line is that, even in those who do respond to melatonin supplements, they likely do so through a placebo effect that meta-analyses have shown plays a powerful role in promoting sleep. 

Dr. Benedict also stressed that just because the body makes melatonin, itself, does not mean that melatonin supplements are necessarily “safe.”

“We know melatonin has some impact on puberty – it may delay the onset of puberty – and we know that it can also impair blood glucose, so when people are eating and have a lot of melatonin on board, the melatonin will tell the pancreas to turn off insulin production, which can give rise to hyperglycemia,” he said.

However, Dr. Benedict cautioned that weighted blankets don’t come cheap. A quick Google search brings up examples that cost upwards of $350. “MDs can say try one if you can afford these blankets, but perhaps people can use several less costly blankets,” he said. “But I definitely think if there are cheap options, why not?” he concluded.

Dr. Benedict has reported no relevant financial relationships.

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

A weighted blanket of approximately 12% body weight used at bedtime prompted the release of higher concentrations of melatonin, as measured in the saliva, compared with a lighter blanket of only about 2.4% of body weight.

This suggests that weighted blankets may help promote sleep in patients suffering from insomnia, according to the results from the small, in-laboratory crossover study.

“Melatonin is produced by the pineal gland and plays an essential role in sleep timing,” lead author Elisa Meth, PhD student, Uppsala University, Sweden, and colleagues observe.

“Using a weighted blanket increased melatonin concentration in saliva by about 30%,” Ms. Meth added in a statement.

“Future studies should investigate whether the stimulatory effect on melatonin secretion remains when using a weighted blanket over more extended periods,” the researchers observe, and caution that “it is also unclear whether the observed increase in melatonin is therapeutically relevant.”

The study was published online in the Journal of Sleep Research.

Weighted blankets are commercially available at least in some countries in Scandinavia and Germany, as examples, and in general, they are sold for therapeutic purposes. And at least one study found that weighted blankets were an effective and safe intervention for insomnia in patients with major depressive disorder, bipolar disorder, generalized anxiety disorder, and attention deficit hyperactivity disorder and led to improvements in daytime symptoms and levels of activity.
 

Study done in healthy volunteers

The study involved a total of 26 healthy volunteers, 15 men and 11 women, none of whom had any sleep issues. “The day before the first testing session, the participants visited the laboratory for an adaptation night,” the authors observe. There were two experimental test nights, one in which the weighted blanket was used and the second during which the lighter blanket was used.

On the test nights, lights were dimmed between 9 PM and 11 PM and participants used a weighted blanket covering the extremities, abdomen, and chest 1 hour before and during 8 hours of sleep. As the authors explain, the filling of the weighted blanket consisted of honed glass pearls, combined with polyester wadding, which corresponded to 12.2% of participants’ body weight.

“Saliva was collected every 20 minutes between 22:00 and 23:00,” Ms. Meth and colleagues note. Participants’ subjective sleepiness was also assessed every 20 minutes using the Karolinska Sleepiness Scale both before the hour that lights were turned off and the next morning.

“Sleep duration in each experimental night was recorded with the OURA ring,” investigators explain.

The OURA ring is a commercial multisensor wearable device that measures physiological variables indicative of sleep. Investigators focused on total sleep duration as the primary outcome measure.

On average, salivary melatonin concentrations rose by about 5.8 pg/mL between 10 PM and 11 PM (P < .001), but the average increase in salivary melatonin concentrations was greater under weighted blanket conditions at 6.6 pg/mL, compared with 5.0 pg/mL during the lighter blanket session (P = .011).

Oxytocin in turn rose by about 315 pg/mL initially, but this rise was only transient, and over time, no significant difference in oxytocin levels was observed between the two blanket conditions. There were also no differences in cortisol levels or the activity of the sympathetic nervous system between the weighted and light blanket sessions.

Importantly, as well, no significant differences were seen in the level of sleepiness between participants when either blanket was used nor was there a significant difference in total sleep duration.

“Our study cannot identify the underlying mechanism for the observed stimulatory effects of the weighted blanket on melatonin,” the investigators caution.

However, one explanation could be that the pressure exerted by the weighted blanket activates cutaneous sensory afferent nerves, carrying information to the brain. The region where the sensory information is delivered stimulates oxytocinergic neurons that can promote calm and well-being and decrease fear, stress, and pain. In addition, these neurons also connect to the pineal gland to influence the release of melatonin, the authors explain.
 

Melatonin often viewed in the wrong context

Senior author Christian Benedict, PhD, associate professor of pharmacology, Uppsala University, Sweden, explained that some people think of melatonin in the wrong context.

In point of fact, “it’s not a sleep-promoting hormone. It prepares your body and brain for the biological night ... [and] sleep coincides with the biological night, but it’s not like you take melatonin and you have a very nice uninterrupted slumber – this is not true,” he told this news organization.

He also noted that certain groups respond to melatonin better than others. For example, children with attention deficit hyperactivity disorder may have some benefit from melatonin supplements, as may the elderly who can no longer produce sufficient amounts of melatonin and for whom supplements may help promote the timing of sleep.

However, the bottom line is that, even in those who do respond to melatonin supplements, they likely do so through a placebo effect that meta-analyses have shown plays a powerful role in promoting sleep. 

Dr. Benedict also stressed that just because the body makes melatonin, itself, does not mean that melatonin supplements are necessarily “safe.”

“We know melatonin has some impact on puberty – it may delay the onset of puberty – and we know that it can also impair blood glucose, so when people are eating and have a lot of melatonin on board, the melatonin will tell the pancreas to turn off insulin production, which can give rise to hyperglycemia,” he said.

However, Dr. Benedict cautioned that weighted blankets don’t come cheap. A quick Google search brings up examples that cost upwards of $350. “MDs can say try one if you can afford these blankets, but perhaps people can use several less costly blankets,” he said. “But I definitely think if there are cheap options, why not?” he concluded.

Dr. Benedict has reported no relevant financial relationships.

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

A weighted blanket of approximately 12% body weight used at bedtime prompted the release of higher concentrations of melatonin, as measured in the saliva, compared with a lighter blanket of only about 2.4% of body weight.

This suggests that weighted blankets may help promote sleep in patients suffering from insomnia, according to the results from the small, in-laboratory crossover study.

“Melatonin is produced by the pineal gland and plays an essential role in sleep timing,” lead author Elisa Meth, PhD student, Uppsala University, Sweden, and colleagues observe.

“Using a weighted blanket increased melatonin concentration in saliva by about 30%,” Ms. Meth added in a statement.

“Future studies should investigate whether the stimulatory effect on melatonin secretion remains when using a weighted blanket over more extended periods,” the researchers observe, and caution that “it is also unclear whether the observed increase in melatonin is therapeutically relevant.”

The study was published online in the Journal of Sleep Research.

Weighted blankets are commercially available at least in some countries in Scandinavia and Germany, as examples, and in general, they are sold for therapeutic purposes. And at least one study found that weighted blankets were an effective and safe intervention for insomnia in patients with major depressive disorder, bipolar disorder, generalized anxiety disorder, and attention deficit hyperactivity disorder and led to improvements in daytime symptoms and levels of activity.
 

Study done in healthy volunteers

The study involved a total of 26 healthy volunteers, 15 men and 11 women, none of whom had any sleep issues. “The day before the first testing session, the participants visited the laboratory for an adaptation night,” the authors observe. There were two experimental test nights, one in which the weighted blanket was used and the second during which the lighter blanket was used.

On the test nights, lights were dimmed between 9 PM and 11 PM and participants used a weighted blanket covering the extremities, abdomen, and chest 1 hour before and during 8 hours of sleep. As the authors explain, the filling of the weighted blanket consisted of honed glass pearls, combined with polyester wadding, which corresponded to 12.2% of participants’ body weight.

“Saliva was collected every 20 minutes between 22:00 and 23:00,” Ms. Meth and colleagues note. Participants’ subjective sleepiness was also assessed every 20 minutes using the Karolinska Sleepiness Scale both before the hour that lights were turned off and the next morning.

“Sleep duration in each experimental night was recorded with the OURA ring,” investigators explain.

The OURA ring is a commercial multisensor wearable device that measures physiological variables indicative of sleep. Investigators focused on total sleep duration as the primary outcome measure.

On average, salivary melatonin concentrations rose by about 5.8 pg/mL between 10 PM and 11 PM (P < .001), but the average increase in salivary melatonin concentrations was greater under weighted blanket conditions at 6.6 pg/mL, compared with 5.0 pg/mL during the lighter blanket session (P = .011).

Oxytocin in turn rose by about 315 pg/mL initially, but this rise was only transient, and over time, no significant difference in oxytocin levels was observed between the two blanket conditions. There were also no differences in cortisol levels or the activity of the sympathetic nervous system between the weighted and light blanket sessions.

Importantly, as well, no significant differences were seen in the level of sleepiness between participants when either blanket was used nor was there a significant difference in total sleep duration.

“Our study cannot identify the underlying mechanism for the observed stimulatory effects of the weighted blanket on melatonin,” the investigators caution.

However, one explanation could be that the pressure exerted by the weighted blanket activates cutaneous sensory afferent nerves, carrying information to the brain. The region where the sensory information is delivered stimulates oxytocinergic neurons that can promote calm and well-being and decrease fear, stress, and pain. In addition, these neurons also connect to the pineal gland to influence the release of melatonin, the authors explain.
 

Melatonin often viewed in the wrong context

Senior author Christian Benedict, PhD, associate professor of pharmacology, Uppsala University, Sweden, explained that some people think of melatonin in the wrong context.

In point of fact, “it’s not a sleep-promoting hormone. It prepares your body and brain for the biological night ... [and] sleep coincides with the biological night, but it’s not like you take melatonin and you have a very nice uninterrupted slumber – this is not true,” he told this news organization.

He also noted that certain groups respond to melatonin better than others. For example, children with attention deficit hyperactivity disorder may have some benefit from melatonin supplements, as may the elderly who can no longer produce sufficient amounts of melatonin and for whom supplements may help promote the timing of sleep.

However, the bottom line is that, even in those who do respond to melatonin supplements, they likely do so through a placebo effect that meta-analyses have shown plays a powerful role in promoting sleep. 

Dr. Benedict also stressed that just because the body makes melatonin, itself, does not mean that melatonin supplements are necessarily “safe.”

“We know melatonin has some impact on puberty – it may delay the onset of puberty – and we know that it can also impair blood glucose, so when people are eating and have a lot of melatonin on board, the melatonin will tell the pancreas to turn off insulin production, which can give rise to hyperglycemia,” he said.

However, Dr. Benedict cautioned that weighted blankets don’t come cheap. A quick Google search brings up examples that cost upwards of $350. “MDs can say try one if you can afford these blankets, but perhaps people can use several less costly blankets,” he said. “But I definitely think if there are cheap options, why not?” he concluded.

Dr. Benedict has reported no relevant financial relationships.

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

The antifibrotic pirfenidone (Esbriet) did not change the decline in forced vital capacity percentage (FVC%) from baseline of 10% or more or the risk of death compared with placebo in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). However, the drug appeared to slow the rate of decline in lung function, a phase 2 study indicated.

“This is the first randomized double-blind, placebo-controlled trial focused only on patients with RA-ILD,” observed Joshua Solomon, MD, National Jewish Health, Denver, and fellow TRAIL1 Network investigators.

“Although we did not meet our composite primary endpoint, key secondary endpoints showed a safe and beneficial effect of pirfenidone in patients with rheumatoid arthritis and evidence of fibrotic interstitial lung disease and the totality of the evidence suggests that pirfenidone is effective in the treatment of RA-ILD,” they suggest.

The study was published online in the Lancet Respiratory Medicine.


 

TRAIL1

The treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) was carried out in 34 academic centers specializing in ILD. Patients had RA and the presence of ILD on high-resolution CT scan and, where possible, lung biopsy. A total of 231 patients were randomly assigned to the pirfenidone group and the remainder to placebo. The mean age of patients was 66 (interquartile range (IQR, 61.0-74.0) in the pirfenidone group and 69.56 (IQR, 63.-74.5) among placebo controls.

Patients received pirfenidone at a dose of 2,403 mg per day, given in divided doses of three 267-mg tablets, three times a day, titrated to full dose over the course of 2 weeks. High-resolution CT scans were done at the beginning and the end of the study interval. Several disease-modifying antirheumatic drugs (DMARDS) were used for the treatment of RA but no differences were observed between treatment groups accounting for the DMARD classes.

“The primary endpoint was the incidence of the composite endpoint of a decline from baseline in [FVC%] of 10% or more or death during the 52-week treatment period,” Dr. Solomon and colleagues observed. The primary outcome was measured in the intent-to-treat (ITT) population.

Some 11% of patients in the active treatment group vs. 15% of patients in the placebo group met the composite primary endpoint, as investigators reported. For the secondary endpoint of the change in FVC over 52 weeks, patients treated with pirfenidone had a slow rate of decline in lung function compared with placebo patients as measured by estimated annual change in absolute FVC (–66 ml vs. –146 mL; P = .0082).

Moreover, in a post hoc analysis by CT pattern, the effect of the antifibrotic therapy on decline in FVC was more pronounced in those with usual interstitial pneumonia pattern on imaging compared with those with any pattern of ILD, the investigators observed. Indeed, approximately half of patients with the usual interstitial pneumonia in the pirfenidone group had a significantly smaller reduction in annual change in FVC at 52 weeks compared with over three-quarters of patients with usual interstitial pneumonia treated with placebo.

In contrast, the two groups were similar with regard to the decline in FVC% by 10% more or the frequency of progression. All-cause mortality rates were similar between the two groups. Adverse events thought to be related to treatment were more frequently reported in the pirfenidone group at 44% vs. 30% of placebo patients, the most frequent of which were nausea, fatigue, and diarrhea.

“These adverse events were generally grade 1 and were not clinically significant,” as the authors emphasized, although 24% of patients receiving pirfenidone discontinued treatment because of AEs vs. only 10% of placebo patients.

Limitations of the trial included early termination because of slow recruitment and the COVID-19 pandemic. This led to underpowering of the study.

Wrong endpoint?

In an accompanying editorial, Marco Sebastiani and Andreina Manfredi, MD, said that the choice of the primary outcome of an FVC decline from a baseline of 10% or more could have negatively influenced results because an FVC decline of 10% or more was probably too challenging to show a difference between the two groups. Indeed, the updated 2022 guidelines proposed a decline of 5% or more in FVC as a “significant threshold” for disease progression in patients with progressive pulmonary fibrosis, as the editorialists pointed out.

Nevertheless, the editorialists felt that the effect of pirfenidone on the decline in FVC seems to be significant, particularly when patients with usual interstitial pneumonia are considered. ”The magnitude of the effect of pirfenidone in patients with usual interstitial pneumonia-rheumatoid arthritis-interstitial lung disease and idiopathic pulmonary fibrosis [enrolled in a different study] was very similar,” they noted, “suggesting that a careful identification of usual interstitial pneumonia pattern at HRCT [high resolution CT] could be relevant in patients with RA-ILD. Moreover, given that pirfenidone did not modify its safety in these patients, the fact that pirfenidone can be safely used with DMARD therapy is important in clinical practice.

Dr. Solomon had no conflicts of interest to declare. Dr. Sebastiani disclosed ties with Bristol Myers Squibb, Pfizer, Boehringer-Ingelheim, Lilly, Amgen, Janssen, and Celltrion. Dr. Manfredi disclosed ties with Bristol Myers Squibb, Lilly, and Boehringer-Ingelheim. The study was funded by Genentech.

The antifibrotic pirfenidone (Esbriet) did not change the decline in forced vital capacity percentage (FVC%) from baseline of 10% or more or the risk of death compared with placebo in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). However, the drug appeared to slow the rate of decline in lung function, a phase 2 study indicated.

“This is the first randomized double-blind, placebo-controlled trial focused only on patients with RA-ILD,” observed Joshua Solomon, MD, National Jewish Health, Denver, and fellow TRAIL1 Network investigators.

“Although we did not meet our composite primary endpoint, key secondary endpoints showed a safe and beneficial effect of pirfenidone in patients with rheumatoid arthritis and evidence of fibrotic interstitial lung disease and the totality of the evidence suggests that pirfenidone is effective in the treatment of RA-ILD,” they suggest.

The study was published online in the Lancet Respiratory Medicine.


 

TRAIL1

The treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) was carried out in 34 academic centers specializing in ILD. Patients had RA and the presence of ILD on high-resolution CT scan and, where possible, lung biopsy. A total of 231 patients were randomly assigned to the pirfenidone group and the remainder to placebo. The mean age of patients was 66 (interquartile range (IQR, 61.0-74.0) in the pirfenidone group and 69.56 (IQR, 63.-74.5) among placebo controls.

Patients received pirfenidone at a dose of 2,403 mg per day, given in divided doses of three 267-mg tablets, three times a day, titrated to full dose over the course of 2 weeks. High-resolution CT scans were done at the beginning and the end of the study interval. Several disease-modifying antirheumatic drugs (DMARDS) were used for the treatment of RA but no differences were observed between treatment groups accounting for the DMARD classes.

“The primary endpoint was the incidence of the composite endpoint of a decline from baseline in [FVC%] of 10% or more or death during the 52-week treatment period,” Dr. Solomon and colleagues observed. The primary outcome was measured in the intent-to-treat (ITT) population.

Some 11% of patients in the active treatment group vs. 15% of patients in the placebo group met the composite primary endpoint, as investigators reported. For the secondary endpoint of the change in FVC over 52 weeks, patients treated with pirfenidone had a slow rate of decline in lung function compared with placebo patients as measured by estimated annual change in absolute FVC (–66 ml vs. –146 mL; P = .0082).

Moreover, in a post hoc analysis by CT pattern, the effect of the antifibrotic therapy on decline in FVC was more pronounced in those with usual interstitial pneumonia pattern on imaging compared with those with any pattern of ILD, the investigators observed. Indeed, approximately half of patients with the usual interstitial pneumonia in the pirfenidone group had a significantly smaller reduction in annual change in FVC at 52 weeks compared with over three-quarters of patients with usual interstitial pneumonia treated with placebo.

In contrast, the two groups were similar with regard to the decline in FVC% by 10% more or the frequency of progression. All-cause mortality rates were similar between the two groups. Adverse events thought to be related to treatment were more frequently reported in the pirfenidone group at 44% vs. 30% of placebo patients, the most frequent of which were nausea, fatigue, and diarrhea.

“These adverse events were generally grade 1 and were not clinically significant,” as the authors emphasized, although 24% of patients receiving pirfenidone discontinued treatment because of AEs vs. only 10% of placebo patients.

Limitations of the trial included early termination because of slow recruitment and the COVID-19 pandemic. This led to underpowering of the study.

Wrong endpoint?

In an accompanying editorial, Marco Sebastiani and Andreina Manfredi, MD, said that the choice of the primary outcome of an FVC decline from a baseline of 10% or more could have negatively influenced results because an FVC decline of 10% or more was probably too challenging to show a difference between the two groups. Indeed, the updated 2022 guidelines proposed a decline of 5% or more in FVC as a “significant threshold” for disease progression in patients with progressive pulmonary fibrosis, as the editorialists pointed out.

Nevertheless, the editorialists felt that the effect of pirfenidone on the decline in FVC seems to be significant, particularly when patients with usual interstitial pneumonia are considered. ”The magnitude of the effect of pirfenidone in patients with usual interstitial pneumonia-rheumatoid arthritis-interstitial lung disease and idiopathic pulmonary fibrosis [enrolled in a different study] was very similar,” they noted, “suggesting that a careful identification of usual interstitial pneumonia pattern at HRCT [high resolution CT] could be relevant in patients with RA-ILD. Moreover, given that pirfenidone did not modify its safety in these patients, the fact that pirfenidone can be safely used with DMARD therapy is important in clinical practice.

Dr. Solomon had no conflicts of interest to declare. Dr. Sebastiani disclosed ties with Bristol Myers Squibb, Pfizer, Boehringer-Ingelheim, Lilly, Amgen, Janssen, and Celltrion. Dr. Manfredi disclosed ties with Bristol Myers Squibb, Lilly, and Boehringer-Ingelheim. The study was funded by Genentech.

The antifibrotic pirfenidone (Esbriet) did not change the decline in forced vital capacity percentage (FVC%) from baseline of 10% or more or the risk of death compared with placebo in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). However, the drug appeared to slow the rate of decline in lung function, a phase 2 study indicated.

“This is the first randomized double-blind, placebo-controlled trial focused only on patients with RA-ILD,” observed Joshua Solomon, MD, National Jewish Health, Denver, and fellow TRAIL1 Network investigators.

“Although we did not meet our composite primary endpoint, key secondary endpoints showed a safe and beneficial effect of pirfenidone in patients with rheumatoid arthritis and evidence of fibrotic interstitial lung disease and the totality of the evidence suggests that pirfenidone is effective in the treatment of RA-ILD,” they suggest.

The study was published online in the Lancet Respiratory Medicine.


 

TRAIL1

The treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) was carried out in 34 academic centers specializing in ILD. Patients had RA and the presence of ILD on high-resolution CT scan and, where possible, lung biopsy. A total of 231 patients were randomly assigned to the pirfenidone group and the remainder to placebo. The mean age of patients was 66 (interquartile range (IQR, 61.0-74.0) in the pirfenidone group and 69.56 (IQR, 63.-74.5) among placebo controls.

Patients received pirfenidone at a dose of 2,403 mg per day, given in divided doses of three 267-mg tablets, three times a day, titrated to full dose over the course of 2 weeks. High-resolution CT scans were done at the beginning and the end of the study interval. Several disease-modifying antirheumatic drugs (DMARDS) were used for the treatment of RA but no differences were observed between treatment groups accounting for the DMARD classes.

“The primary endpoint was the incidence of the composite endpoint of a decline from baseline in [FVC%] of 10% or more or death during the 52-week treatment period,” Dr. Solomon and colleagues observed. The primary outcome was measured in the intent-to-treat (ITT) population.

Some 11% of patients in the active treatment group vs. 15% of patients in the placebo group met the composite primary endpoint, as investigators reported. For the secondary endpoint of the change in FVC over 52 weeks, patients treated with pirfenidone had a slow rate of decline in lung function compared with placebo patients as measured by estimated annual change in absolute FVC (–66 ml vs. –146 mL; P = .0082).

Moreover, in a post hoc analysis by CT pattern, the effect of the antifibrotic therapy on decline in FVC was more pronounced in those with usual interstitial pneumonia pattern on imaging compared with those with any pattern of ILD, the investigators observed. Indeed, approximately half of patients with the usual interstitial pneumonia in the pirfenidone group had a significantly smaller reduction in annual change in FVC at 52 weeks compared with over three-quarters of patients with usual interstitial pneumonia treated with placebo.

In contrast, the two groups were similar with regard to the decline in FVC% by 10% more or the frequency of progression. All-cause mortality rates were similar between the two groups. Adverse events thought to be related to treatment were more frequently reported in the pirfenidone group at 44% vs. 30% of placebo patients, the most frequent of which were nausea, fatigue, and diarrhea.

“These adverse events were generally grade 1 and were not clinically significant,” as the authors emphasized, although 24% of patients receiving pirfenidone discontinued treatment because of AEs vs. only 10% of placebo patients.

Limitations of the trial included early termination because of slow recruitment and the COVID-19 pandemic. This led to underpowering of the study.

Wrong endpoint?

In an accompanying editorial, Marco Sebastiani and Andreina Manfredi, MD, said that the choice of the primary outcome of an FVC decline from a baseline of 10% or more could have negatively influenced results because an FVC decline of 10% or more was probably too challenging to show a difference between the two groups. Indeed, the updated 2022 guidelines proposed a decline of 5% or more in FVC as a “significant threshold” for disease progression in patients with progressive pulmonary fibrosis, as the editorialists pointed out.

Nevertheless, the editorialists felt that the effect of pirfenidone on the decline in FVC seems to be significant, particularly when patients with usual interstitial pneumonia are considered. ”The magnitude of the effect of pirfenidone in patients with usual interstitial pneumonia-rheumatoid arthritis-interstitial lung disease and idiopathic pulmonary fibrosis [enrolled in a different study] was very similar,” they noted, “suggesting that a careful identification of usual interstitial pneumonia pattern at HRCT [high resolution CT] could be relevant in patients with RA-ILD. Moreover, given that pirfenidone did not modify its safety in these patients, the fact that pirfenidone can be safely used with DMARD therapy is important in clinical practice.

Dr. Solomon had no conflicts of interest to declare. Dr. Sebastiani disclosed ties with Bristol Myers Squibb, Pfizer, Boehringer-Ingelheim, Lilly, Amgen, Janssen, and Celltrion. Dr. Manfredi disclosed ties with Bristol Myers Squibb, Lilly, and Boehringer-Ingelheim. The study was funded by Genentech.

Patients with gastrointestinal esophageal reflux disease (GERD) have more than three times the risk of developing nontuberculous mycobacterial pulmonary disease (NTM-PD), compared with those without GERD, according to a population-based retrospective cohort study.

“GERD is a common comorbidity of nontuberculous mycobacterial pulmonary disease [but] whether GERD is associated with an increased risk of developing NTM-PD is unknown,” Hayoung Choi, MD, PhD, Hallym University, Seoul, Republic of Korea, and colleagues reported.

“Our study showed the relation between GERD and NTM infections, but preventing NTM is not simple,” Dr. Choi added in an email. “What needs to be understood is that GERD increases health care utilization in patients with NTM pulmonary disease; hence, clinicians who treat patients with NTM pulmonary disease need to be aware of the burden of GERD and treat the gastrointestinal illness simultaneously,” he added.

The study was published online in the journal CHEST.
 

Sample cohort

Data from the Korean National Health Insurance Service-National Sample Cohort between 2002 and 2015 were used to assess the impact of GERD on NTM-PD. The incidence and risk of NTM-PD were compared between 17,424 patients with GERD and 69,000 patients without GERD in a matched cohort. GERD was defined as patients having received more than 3 months of proton pump inhibitors (PPIs).

During a median follow-up of 5.1 years, the age- and sex-adjusted incidence of NTM-PD was significantly higher in the GERD cohort, at a rate of 34.8/100,000 person-years, than in the matched cohort, at a rate of only 10.5/100,000 person-years (P < .001), the authors reported.

As for risk factors for NTM-PD, being 60 years of age and older was associated with a 3.5-times higher risk of NTM-PD at an adjusted hazard ratio of 3.57 (95% confidence interval, 1.58-8.07), while bronchiectasis was associated with over an 18-times higher risk of NTM-PD in the GERD cohort at an adjusted HR of 18.69 (95% CI, 6.68-552.28). Those with GERD who developed NTM-PD had higher all-cause and respiratory disease–related emergency department visits or hospitalizations compared with patients with GERD who did not develop NTM-PD (P = .011), the investigators noted.

As the authors pointed out, the incidence of NTM-PD in the Korean population ranged from 6 to 19 cases/100,000 between 2008 and 2016; thus, the burden of incident NTM-PD associated with GERD appears to be considerable. As Dr. Choi explained, a combination of three factors influenced the development of NTM infections. The first is environmental, from water source, climate, or region; the second is patient influences, including such factors as immunodeficiency and comorbidities (including bronchiectasis); and the third is microbiological factors, including various NTM species.

Bile aspirating into the lung during GERD may be another possible pathway, as the authors suggested. Even if acid secretion is suppressed by PPI treatment in patients with GERD, NTM-PD may be induced or aggravated through mechanisms such as bile reflux. The fact that patients over the age of 60 were more prone to develop NTM-PD suggests that a decrease in gastric emptying and increased micro-aspiration or reflux associated with impaired swallowing (which are more common in elderly patients) may also be at play.

“Bronchiectasis is also a very well known risk factor for NTM pulmonary disease,” Dr. Choi emphasized. Thus, he recommends clinicians carefully observe clinical, radiological, and microbiological changes to detect NTM pulmonary disease when managing patients with bronchiectasis.

“The results of the present study have several potential clinical implications,” Dr. Choi and colleagues observed. First, NTM-PD should be suspected when new-onset worsening of respiratory symptoms develops during regular follow-up in patients with GERD. Second, because results indicate that older age and bronchiectasis significantly increase the risk of NTM-PD, “more active strategies (e.g., screening of symptoms and regular chest x-rays)” might be helpful in patients with GERD and these risk factors, the authors suggested. Because patients with GERD who developed NTM-PD had more respiratory disease–related ED visits and hospitalizations than those who did not develop NTM-PD, when GERD and NTM-PD are combined, clinicians should focus on the variations of respiratory symptoms, they suggested.

The authors cautioned, however, that because the study was one in a Korean population, studies in other countries and different ethnicities are needed before findings can be generalized.

More common than TB

Asked to comment on the findings, NTM-PD expert Theodore Marras, MD, clinician investigator, Krembil Research Institute, Toronto, noted that non-TB M-PD is about 10 times more common than TB and that could be an underestimate as there have been very large increases in the incidence of NTM-PD in recent years. “It’s an environmental germ – it’s in our water – and certain people are particularly susceptible to it, typically older age women who have underlying bronchiectasis,” Dr. Marras told this news organization. “And while there are ethnic differences in incidence rates between East Asian people and Black African people, immigration is not the main driver for the increase as far as we can tell,” he said.

He personally treats a lot of NTM-PD and he also believes that GERD is an important risk factor for all types of lung infections including NTM lung disease. “So without a doubt, I believe that GERD should be treated in patients with NTM-PD,” Dr. Marras emphasized. The big question is how to treat GERD, as there may be concerns with acid-suppressive agents such as proton pump inhibitors that “the reflux that comes back up may harbor more germs in it and if that reflux comes up high enough, we are at risk of aspirating some of that fluid into our lungs, especially when we’re asleep,” he said.

Some experts therefore argue in favor of using motility agents instead of PPIs. However, if Dr. Marras has a patient with heartburn, “you have to treat it,” he stressed. Similarly, if a patient has evidence of esophageal erosions, physicians need to treat those as well. However, if neither feature is present, “I tend to like the motility agents preferentially or use them in combination with a PPI,” Dr. Marras said.

Dr. Marras also thinks the study is encouraging physicians involved in treating these patients to think about controlling GERD both when they are treating patients and after they are treated to try to reduce recurrence.

The authors had no financial disclosures to make. Dr. Marras has given several talks on NTM lung disease, one sponsored by AstraZeneca and the other by Novartis.

Patients with gastrointestinal esophageal reflux disease (GERD) have more than three times the risk of developing nontuberculous mycobacterial pulmonary disease (NTM-PD), compared with those without GERD, according to a population-based retrospective cohort study.

“GERD is a common comorbidity of nontuberculous mycobacterial pulmonary disease [but] whether GERD is associated with an increased risk of developing NTM-PD is unknown,” Hayoung Choi, MD, PhD, Hallym University, Seoul, Republic of Korea, and colleagues reported.

“Our study showed the relation between GERD and NTM infections, but preventing NTM is not simple,” Dr. Choi added in an email. “What needs to be understood is that GERD increases health care utilization in patients with NTM pulmonary disease; hence, clinicians who treat patients with NTM pulmonary disease need to be aware of the burden of GERD and treat the gastrointestinal illness simultaneously,” he added.

The study was published online in the journal CHEST.
 

Sample cohort

Data from the Korean National Health Insurance Service-National Sample Cohort between 2002 and 2015 were used to assess the impact of GERD on NTM-PD. The incidence and risk of NTM-PD were compared between 17,424 patients with GERD and 69,000 patients without GERD in a matched cohort. GERD was defined as patients having received more than 3 months of proton pump inhibitors (PPIs).

During a median follow-up of 5.1 years, the age- and sex-adjusted incidence of NTM-PD was significantly higher in the GERD cohort, at a rate of 34.8/100,000 person-years, than in the matched cohort, at a rate of only 10.5/100,000 person-years (P < .001), the authors reported.

As for risk factors for NTM-PD, being 60 years of age and older was associated with a 3.5-times higher risk of NTM-PD at an adjusted hazard ratio of 3.57 (95% confidence interval, 1.58-8.07), while bronchiectasis was associated with over an 18-times higher risk of NTM-PD in the GERD cohort at an adjusted HR of 18.69 (95% CI, 6.68-552.28). Those with GERD who developed NTM-PD had higher all-cause and respiratory disease–related emergency department visits or hospitalizations compared with patients with GERD who did not develop NTM-PD (P = .011), the investigators noted.

As the authors pointed out, the incidence of NTM-PD in the Korean population ranged from 6 to 19 cases/100,000 between 2008 and 2016; thus, the burden of incident NTM-PD associated with GERD appears to be considerable. As Dr. Choi explained, a combination of three factors influenced the development of NTM infections. The first is environmental, from water source, climate, or region; the second is patient influences, including such factors as immunodeficiency and comorbidities (including bronchiectasis); and the third is microbiological factors, including various NTM species.

Bile aspirating into the lung during GERD may be another possible pathway, as the authors suggested. Even if acid secretion is suppressed by PPI treatment in patients with GERD, NTM-PD may be induced or aggravated through mechanisms such as bile reflux. The fact that patients over the age of 60 were more prone to develop NTM-PD suggests that a decrease in gastric emptying and increased micro-aspiration or reflux associated with impaired swallowing (which are more common in elderly patients) may also be at play.

“Bronchiectasis is also a very well known risk factor for NTM pulmonary disease,” Dr. Choi emphasized. Thus, he recommends clinicians carefully observe clinical, radiological, and microbiological changes to detect NTM pulmonary disease when managing patients with bronchiectasis.

“The results of the present study have several potential clinical implications,” Dr. Choi and colleagues observed. First, NTM-PD should be suspected when new-onset worsening of respiratory symptoms develops during regular follow-up in patients with GERD. Second, because results indicate that older age and bronchiectasis significantly increase the risk of NTM-PD, “more active strategies (e.g., screening of symptoms and regular chest x-rays)” might be helpful in patients with GERD and these risk factors, the authors suggested. Because patients with GERD who developed NTM-PD had more respiratory disease–related ED visits and hospitalizations than those who did not develop NTM-PD, when GERD and NTM-PD are combined, clinicians should focus on the variations of respiratory symptoms, they suggested.

The authors cautioned, however, that because the study was one in a Korean population, studies in other countries and different ethnicities are needed before findings can be generalized.

More common than TB

Asked to comment on the findings, NTM-PD expert Theodore Marras, MD, clinician investigator, Krembil Research Institute, Toronto, noted that non-TB M-PD is about 10 times more common than TB and that could be an underestimate as there have been very large increases in the incidence of NTM-PD in recent years. “It’s an environmental germ – it’s in our water – and certain people are particularly susceptible to it, typically older age women who have underlying bronchiectasis,” Dr. Marras told this news organization. “And while there are ethnic differences in incidence rates between East Asian people and Black African people, immigration is not the main driver for the increase as far as we can tell,” he said.

He personally treats a lot of NTM-PD and he also believes that GERD is an important risk factor for all types of lung infections including NTM lung disease. “So without a doubt, I believe that GERD should be treated in patients with NTM-PD,” Dr. Marras emphasized. The big question is how to treat GERD, as there may be concerns with acid-suppressive agents such as proton pump inhibitors that “the reflux that comes back up may harbor more germs in it and if that reflux comes up high enough, we are at risk of aspirating some of that fluid into our lungs, especially when we’re asleep,” he said.

Some experts therefore argue in favor of using motility agents instead of PPIs. However, if Dr. Marras has a patient with heartburn, “you have to treat it,” he stressed. Similarly, if a patient has evidence of esophageal erosions, physicians need to treat those as well. However, if neither feature is present, “I tend to like the motility agents preferentially or use them in combination with a PPI,” Dr. Marras said.

Dr. Marras also thinks the study is encouraging physicians involved in treating these patients to think about controlling GERD both when they are treating patients and after they are treated to try to reduce recurrence.

The authors had no financial disclosures to make. Dr. Marras has given several talks on NTM lung disease, one sponsored by AstraZeneca and the other by Novartis.

Patients with gastrointestinal esophageal reflux disease (GERD) have more than three times the risk of developing nontuberculous mycobacterial pulmonary disease (NTM-PD), compared with those without GERD, according to a population-based retrospective cohort study.

“GERD is a common comorbidity of nontuberculous mycobacterial pulmonary disease [but] whether GERD is associated with an increased risk of developing NTM-PD is unknown,” Hayoung Choi, MD, PhD, Hallym University, Seoul, Republic of Korea, and colleagues reported.

“Our study showed the relation between GERD and NTM infections, but preventing NTM is not simple,” Dr. Choi added in an email. “What needs to be understood is that GERD increases health care utilization in patients with NTM pulmonary disease; hence, clinicians who treat patients with NTM pulmonary disease need to be aware of the burden of GERD and treat the gastrointestinal illness simultaneously,” he added.

The study was published online in the journal CHEST.
 

Sample cohort

Data from the Korean National Health Insurance Service-National Sample Cohort between 2002 and 2015 were used to assess the impact of GERD on NTM-PD. The incidence and risk of NTM-PD were compared between 17,424 patients with GERD and 69,000 patients without GERD in a matched cohort. GERD was defined as patients having received more than 3 months of proton pump inhibitors (PPIs).

During a median follow-up of 5.1 years, the age- and sex-adjusted incidence of NTM-PD was significantly higher in the GERD cohort, at a rate of 34.8/100,000 person-years, than in the matched cohort, at a rate of only 10.5/100,000 person-years (P < .001), the authors reported.

As for risk factors for NTM-PD, being 60 years of age and older was associated with a 3.5-times higher risk of NTM-PD at an adjusted hazard ratio of 3.57 (95% confidence interval, 1.58-8.07), while bronchiectasis was associated with over an 18-times higher risk of NTM-PD in the GERD cohort at an adjusted HR of 18.69 (95% CI, 6.68-552.28). Those with GERD who developed NTM-PD had higher all-cause and respiratory disease–related emergency department visits or hospitalizations compared with patients with GERD who did not develop NTM-PD (P = .011), the investigators noted.

As the authors pointed out, the incidence of NTM-PD in the Korean population ranged from 6 to 19 cases/100,000 between 2008 and 2016; thus, the burden of incident NTM-PD associated with GERD appears to be considerable. As Dr. Choi explained, a combination of three factors influenced the development of NTM infections. The first is environmental, from water source, climate, or region; the second is patient influences, including such factors as immunodeficiency and comorbidities (including bronchiectasis); and the third is microbiological factors, including various NTM species.

Bile aspirating into the lung during GERD may be another possible pathway, as the authors suggested. Even if acid secretion is suppressed by PPI treatment in patients with GERD, NTM-PD may be induced or aggravated through mechanisms such as bile reflux. The fact that patients over the age of 60 were more prone to develop NTM-PD suggests that a decrease in gastric emptying and increased micro-aspiration or reflux associated with impaired swallowing (which are more common in elderly patients) may also be at play.

“Bronchiectasis is also a very well known risk factor for NTM pulmonary disease,” Dr. Choi emphasized. Thus, he recommends clinicians carefully observe clinical, radiological, and microbiological changes to detect NTM pulmonary disease when managing patients with bronchiectasis.

“The results of the present study have several potential clinical implications,” Dr. Choi and colleagues observed. First, NTM-PD should be suspected when new-onset worsening of respiratory symptoms develops during regular follow-up in patients with GERD. Second, because results indicate that older age and bronchiectasis significantly increase the risk of NTM-PD, “more active strategies (e.g., screening of symptoms and regular chest x-rays)” might be helpful in patients with GERD and these risk factors, the authors suggested. Because patients with GERD who developed NTM-PD had more respiratory disease–related ED visits and hospitalizations than those who did not develop NTM-PD, when GERD and NTM-PD are combined, clinicians should focus on the variations of respiratory symptoms, they suggested.

The authors cautioned, however, that because the study was one in a Korean population, studies in other countries and different ethnicities are needed before findings can be generalized.

More common than TB

Asked to comment on the findings, NTM-PD expert Theodore Marras, MD, clinician investigator, Krembil Research Institute, Toronto, noted that non-TB M-PD is about 10 times more common than TB and that could be an underestimate as there have been very large increases in the incidence of NTM-PD in recent years. “It’s an environmental germ – it’s in our water – and certain people are particularly susceptible to it, typically older age women who have underlying bronchiectasis,” Dr. Marras told this news organization. “And while there are ethnic differences in incidence rates between East Asian people and Black African people, immigration is not the main driver for the increase as far as we can tell,” he said.

He personally treats a lot of NTM-PD and he also believes that GERD is an important risk factor for all types of lung infections including NTM lung disease. “So without a doubt, I believe that GERD should be treated in patients with NTM-PD,” Dr. Marras emphasized. The big question is how to treat GERD, as there may be concerns with acid-suppressive agents such as proton pump inhibitors that “the reflux that comes back up may harbor more germs in it and if that reflux comes up high enough, we are at risk of aspirating some of that fluid into our lungs, especially when we’re asleep,” he said.

Some experts therefore argue in favor of using motility agents instead of PPIs. However, if Dr. Marras has a patient with heartburn, “you have to treat it,” he stressed. Similarly, if a patient has evidence of esophageal erosions, physicians need to treat those as well. However, if neither feature is present, “I tend to like the motility agents preferentially or use them in combination with a PPI,” Dr. Marras said.

Dr. Marras also thinks the study is encouraging physicians involved in treating these patients to think about controlling GERD both when they are treating patients and after they are treated to try to reduce recurrence.

The authors had no financial disclosures to make. Dr. Marras has given several talks on NTM lung disease, one sponsored by AstraZeneca and the other by Novartis.

Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.

“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.

“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.

Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.

The study was published online in Regional Anesthesia and Pain.

The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.

In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.

This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.

The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).

Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.

The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).

There was a big difference in the results for all-cause mortality.

Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.

A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.

In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.

In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.

The authors disclosed no relevant financial relationships.

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

Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.

“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.

“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.

Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.

The study was published online in Regional Anesthesia and Pain.

The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.

In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.

This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.

The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).

Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.

The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).

There was a big difference in the results for all-cause mortality.

Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.

A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.

In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.

In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.

The authors disclosed no relevant financial relationships.

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

Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.

“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.

“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.

Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.

The study was published online in Regional Anesthesia and Pain.

The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.

In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.

This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.

The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).

Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.

The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).

There was a big difference in the results for all-cause mortality.

Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.

A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.

In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.

In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.

The authors disclosed no relevant financial relationships.

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

New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.

However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.

“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.

“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.

The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.

The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.

The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.

The median follow-up for both age groups was roughly 7 years.

“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.

When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.

AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).

The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.

The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.

Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.

The authors have no conflicts of interest to report.

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

New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.

However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.

“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.

“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.

The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.

The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.

The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.

The median follow-up for both age groups was roughly 7 years.

“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.

When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.

AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).

The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.

The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.

Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.

The authors have no conflicts of interest to report.

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

New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.

However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.

“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.

“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.

The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.

The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.

The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.

The median follow-up for both age groups was roughly 7 years.

“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.

When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.

AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).

The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.

The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.

Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.

The authors have no conflicts of interest to report.

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

A home-based strength training program does not improve dyspnea in patients with chronic obstructive lung disease (COPD), but it does improve some functional capacity and helps patients feel better, a 12-month long HOMEX exercise program shows. 

“Home-based programs became increasingly popular in the last years and complement traditional center-based inpatient and outpatient PR (pulmonary rehabilitation),” Anja Frei, PhD, University of Zurich, Switzerland, and colleagues reported.

“Our study showed that the HOMEX strength training program had no effect on dyspnea after 12 months in persons with COPD who completed PR, [but] the program improved functional exercise capacity ... and many participants reported having perceived positive effects that they attributed to the training,” investigators add.

The study was published online  in the journal CHEST.
 

Intervention or controls

A total of 123 patients (mean age, 67 years) with COPD were randomly assigned to the intervention group or to the control group. The mean forced expiratory volume in 1 second (FEV1) was 39.3% of predicted. Three-quarters of participants had severe or very severe COPD.

A total of 104 patients completed the 12-month study. “The primary outcome was change in dyspnea (Chronic Respiratory Questionnaire, CRQ) from baseline to 12 months,” investigators note. Secondary outcomes included change in exercise capacity as assessed by the 1-minute-sit-to-stand test (1-min-STST); the 6-minute walk test (6MWT); health-related quality of life, exacerbations, and symptoms.

The HOMEX program was a structured, home-based strength training program developed for patients with COPD that could be done following the pulmonary rehabilitation program, with the intention of maintaining the training benefits gained during pulmonary rehabilitation.

“We deliberately focused on the strength component of exercise training due to the fact that skeletal muscle dysfunction is prevalent in COPD and [is] associated with lower daily physical activity and poor prognosis,” the authors explain. Patients had completed pulmonary rehabilitation no longer than 1 month prior to starting the training program. The program required a chair and a set of resistance bands and consisted of trunk, upper limb, and lower limb exercises done at different intensity levels.

Participants were instructed to do the exercises 6 days per week for about 20 minutes per day over the 12-month study interval. The dyspnea score dropped from 4.65 to 4.42 from baseline to 12 months in the intervention group, compared with a drop from 4.61 to 4.06 in the control group, the investigators reported. “There was no evidence for a difference between the two groups in change in the 6MWT distance after 12 months ... but moderate evidence for a between-group difference in the change of repetitions in the 1-min-STST favoring the IG (intervention group),” they also noted, at an adjusted mean difference of 2.6 (95% confidence interval, 0.22-5.03, P = .033).

In all other outcomes, no differences were observed between the two groups. Importantly, 70% of participants carried on with the HOMEX training program until study endpoint and at least 79% of them persevered for at least 10 months. Based on results from a satisfaction survey, 81% of participants randomly assigned to the intervention group indicated that they “liked” or “very much liked” participating in the program, and 79% of them reported that they experienced positive effects that they felt were attributed to the training.

“The program was safe and the majority of the multimorbid and severely ill study participants adhered to the training during the study year,” the authors write. And while the program had no effect on functional exercise capacity as measured by the 6MWT, it did improve the strength and intramuscular coordination of the lower leg muscles because the program had repetitive sit-to-stand exercises as a component of the training. “Adherence to this long-term training program was surprisingly high,” the authors say. “It was well accepted by COPD patients and may facilitate continued training at home.”

One limitation of the study was that some participants did not travel to the rehabilitation clinic for a follow-up assessment.

The authors reported no relevant financial relationships.

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

A home-based strength training program does not improve dyspnea in patients with chronic obstructive lung disease (COPD), but it does improve some functional capacity and helps patients feel better, a 12-month long HOMEX exercise program shows. 

“Home-based programs became increasingly popular in the last years and complement traditional center-based inpatient and outpatient PR (pulmonary rehabilitation),” Anja Frei, PhD, University of Zurich, Switzerland, and colleagues reported.

“Our study showed that the HOMEX strength training program had no effect on dyspnea after 12 months in persons with COPD who completed PR, [but] the program improved functional exercise capacity ... and many participants reported having perceived positive effects that they attributed to the training,” investigators add.

The study was published online  in the journal CHEST.
 

Intervention or controls

A total of 123 patients (mean age, 67 years) with COPD were randomly assigned to the intervention group or to the control group. The mean forced expiratory volume in 1 second (FEV1) was 39.3% of predicted. Three-quarters of participants had severe or very severe COPD.

A total of 104 patients completed the 12-month study. “The primary outcome was change in dyspnea (Chronic Respiratory Questionnaire, CRQ) from baseline to 12 months,” investigators note. Secondary outcomes included change in exercise capacity as assessed by the 1-minute-sit-to-stand test (1-min-STST); the 6-minute walk test (6MWT); health-related quality of life, exacerbations, and symptoms.

The HOMEX program was a structured, home-based strength training program developed for patients with COPD that could be done following the pulmonary rehabilitation program, with the intention of maintaining the training benefits gained during pulmonary rehabilitation.

“We deliberately focused on the strength component of exercise training due to the fact that skeletal muscle dysfunction is prevalent in COPD and [is] associated with lower daily physical activity and poor prognosis,” the authors explain. Patients had completed pulmonary rehabilitation no longer than 1 month prior to starting the training program. The program required a chair and a set of resistance bands and consisted of trunk, upper limb, and lower limb exercises done at different intensity levels.

Participants were instructed to do the exercises 6 days per week for about 20 minutes per day over the 12-month study interval. The dyspnea score dropped from 4.65 to 4.42 from baseline to 12 months in the intervention group, compared with a drop from 4.61 to 4.06 in the control group, the investigators reported. “There was no evidence for a difference between the two groups in change in the 6MWT distance after 12 months ... but moderate evidence for a between-group difference in the change of repetitions in the 1-min-STST favoring the IG (intervention group),” they also noted, at an adjusted mean difference of 2.6 (95% confidence interval, 0.22-5.03, P = .033).

In all other outcomes, no differences were observed between the two groups. Importantly, 70% of participants carried on with the HOMEX training program until study endpoint and at least 79% of them persevered for at least 10 months. Based on results from a satisfaction survey, 81% of participants randomly assigned to the intervention group indicated that they “liked” or “very much liked” participating in the program, and 79% of them reported that they experienced positive effects that they felt were attributed to the training.

“The program was safe and the majority of the multimorbid and severely ill study participants adhered to the training during the study year,” the authors write. And while the program had no effect on functional exercise capacity as measured by the 6MWT, it did improve the strength and intramuscular coordination of the lower leg muscles because the program had repetitive sit-to-stand exercises as a component of the training. “Adherence to this long-term training program was surprisingly high,” the authors say. “It was well accepted by COPD patients and may facilitate continued training at home.”

One limitation of the study was that some participants did not travel to the rehabilitation clinic for a follow-up assessment.

The authors reported no relevant financial relationships.

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

A home-based strength training program does not improve dyspnea in patients with chronic obstructive lung disease (COPD), but it does improve some functional capacity and helps patients feel better, a 12-month long HOMEX exercise program shows. 

“Home-based programs became increasingly popular in the last years and complement traditional center-based inpatient and outpatient PR (pulmonary rehabilitation),” Anja Frei, PhD, University of Zurich, Switzerland, and colleagues reported.

“Our study showed that the HOMEX strength training program had no effect on dyspnea after 12 months in persons with COPD who completed PR, [but] the program improved functional exercise capacity ... and many participants reported having perceived positive effects that they attributed to the training,” investigators add.

The study was published online  in the journal CHEST.
 

Intervention or controls

A total of 123 patients (mean age, 67 years) with COPD were randomly assigned to the intervention group or to the control group. The mean forced expiratory volume in 1 second (FEV1) was 39.3% of predicted. Three-quarters of participants had severe or very severe COPD.

A total of 104 patients completed the 12-month study. “The primary outcome was change in dyspnea (Chronic Respiratory Questionnaire, CRQ) from baseline to 12 months,” investigators note. Secondary outcomes included change in exercise capacity as assessed by the 1-minute-sit-to-stand test (1-min-STST); the 6-minute walk test (6MWT); health-related quality of life, exacerbations, and symptoms.

The HOMEX program was a structured, home-based strength training program developed for patients with COPD that could be done following the pulmonary rehabilitation program, with the intention of maintaining the training benefits gained during pulmonary rehabilitation.

“We deliberately focused on the strength component of exercise training due to the fact that skeletal muscle dysfunction is prevalent in COPD and [is] associated with lower daily physical activity and poor prognosis,” the authors explain. Patients had completed pulmonary rehabilitation no longer than 1 month prior to starting the training program. The program required a chair and a set of resistance bands and consisted of trunk, upper limb, and lower limb exercises done at different intensity levels.

Participants were instructed to do the exercises 6 days per week for about 20 minutes per day over the 12-month study interval. The dyspnea score dropped from 4.65 to 4.42 from baseline to 12 months in the intervention group, compared with a drop from 4.61 to 4.06 in the control group, the investigators reported. “There was no evidence for a difference between the two groups in change in the 6MWT distance after 12 months ... but moderate evidence for a between-group difference in the change of repetitions in the 1-min-STST favoring the IG (intervention group),” they also noted, at an adjusted mean difference of 2.6 (95% confidence interval, 0.22-5.03, P = .033).

In all other outcomes, no differences were observed between the two groups. Importantly, 70% of participants carried on with the HOMEX training program until study endpoint and at least 79% of them persevered for at least 10 months. Based on results from a satisfaction survey, 81% of participants randomly assigned to the intervention group indicated that they “liked” or “very much liked” participating in the program, and 79% of them reported that they experienced positive effects that they felt were attributed to the training.

“The program was safe and the majority of the multimorbid and severely ill study participants adhered to the training during the study year,” the authors write. And while the program had no effect on functional exercise capacity as measured by the 6MWT, it did improve the strength and intramuscular coordination of the lower leg muscles because the program had repetitive sit-to-stand exercises as a component of the training. “Adherence to this long-term training program was surprisingly high,” the authors say. “It was well accepted by COPD patients and may facilitate continued training at home.”

One limitation of the study was that some participants did not travel to the rehabilitation clinic for a follow-up assessment.

The authors reported no relevant financial relationships.

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

Despite significant disruptions to the health care system and employment early in the COVID-19 pandemic, the uninsured rate among cancer survivors remained stable in 2020, new research indicates.

In addition, the prevalence of unhealthy behaviors, including smoking and poor sleep habits, appeared to decline among cancer survivors as well as adults who had no history of cancer during this period.

“Our findings suggest that the pandemic may have motivated people to adopt certain healthier behaviors,” Xuesong Han, PhD, American Cancer Society, Atlanta, said in a statement. In addition, policies implemented in response to the pandemic regarding insurance coverage, unemployment benefits, and financial assistance “may have contributed to the observed positive changes.”

Dr. Han and colleagues noted that “to the best of our knowledge, our study provides the first nationally representative estimates of the effects of the first year of the COVID-19 pandemic on cancer survivors in the United States.”

The study was published online in Cancer.

Given the considerable upheaval caused by the COVID-19 pandemic, Dr. Han and colleagues wanted to explore how cancer survivors, in particular, were affected during the first year.

The analysis included 57,132 cancer survivors and 1,044,585 adults without cancer who were involved in the Behavioral Risk Factor Surveillance System.

The researchers found that the unemployment rate in 2020 increased by 43% among cancer survivors and by 57% among adults without a cancer history compared with the previous 2 years.

However, the rate of uninsured cancer survivors aged 18-64 years remained relatively stable in 2020 at 8%, compared with 8.8% in 2017-2019.

Notably, the prevalence of insufficient sleep decreased among cancer survivors (43% to 39%), as did smoking (22% to 19%). Among adults without a history of cancer, there was a decline in insufficient sleep (37% to 34.3%) and smoking (16% to 15%). The prevalence of binge drinking decreased among adults with and those without a history of cancer as well.

Obesity rates, however, increased during the first year of the pandemic among cancer survivors (36.5% to 40%) as well as among those with no cancer history (30.8% to 32.7%). In addition, more adults without a cancer history reported an increase in mental distress in 2020 compared with before the COVID-19 pandemic.

The authors suggest that some of the positive trends observed could be explained, in part, by increased enrollment in the Affordable Care Act and by the Families First Coronavirus Response Act, which increased the federal government’s share of Medicaid costs and prevented states from terminating Medicaid coverage during the pandemic.

“These provisions likely compensated for the loss in employer-sponsored insurance,” the authors noted.

But, they added, “as policies related to the public health emergency expire, ongoing monitoring of long-term effects of the COVID-19 pandemic on cancer survivorship is warranted.”

Dr. Han has received a grant from AstraZeneca outside of the current study.

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

Despite significant disruptions to the health care system and employment early in the COVID-19 pandemic, the uninsured rate among cancer survivors remained stable in 2020, new research indicates.

In addition, the prevalence of unhealthy behaviors, including smoking and poor sleep habits, appeared to decline among cancer survivors as well as adults who had no history of cancer during this period.

“Our findings suggest that the pandemic may have motivated people to adopt certain healthier behaviors,” Xuesong Han, PhD, American Cancer Society, Atlanta, said in a statement. In addition, policies implemented in response to the pandemic regarding insurance coverage, unemployment benefits, and financial assistance “may have contributed to the observed positive changes.”

Dr. Han and colleagues noted that “to the best of our knowledge, our study provides the first nationally representative estimates of the effects of the first year of the COVID-19 pandemic on cancer survivors in the United States.”

The study was published online in Cancer.

Given the considerable upheaval caused by the COVID-19 pandemic, Dr. Han and colleagues wanted to explore how cancer survivors, in particular, were affected during the first year.

The analysis included 57,132 cancer survivors and 1,044,585 adults without cancer who were involved in the Behavioral Risk Factor Surveillance System.

The researchers found that the unemployment rate in 2020 increased by 43% among cancer survivors and by 57% among adults without a cancer history compared with the previous 2 years.

However, the rate of uninsured cancer survivors aged 18-64 years remained relatively stable in 2020 at 8%, compared with 8.8% in 2017-2019.

Notably, the prevalence of insufficient sleep decreased among cancer survivors (43% to 39%), as did smoking (22% to 19%). Among adults without a history of cancer, there was a decline in insufficient sleep (37% to 34.3%) and smoking (16% to 15%). The prevalence of binge drinking decreased among adults with and those without a history of cancer as well.

Obesity rates, however, increased during the first year of the pandemic among cancer survivors (36.5% to 40%) as well as among those with no cancer history (30.8% to 32.7%). In addition, more adults without a cancer history reported an increase in mental distress in 2020 compared with before the COVID-19 pandemic.

The authors suggest that some of the positive trends observed could be explained, in part, by increased enrollment in the Affordable Care Act and by the Families First Coronavirus Response Act, which increased the federal government’s share of Medicaid costs and prevented states from terminating Medicaid coverage during the pandemic.

“These provisions likely compensated for the loss in employer-sponsored insurance,” the authors noted.

But, they added, “as policies related to the public health emergency expire, ongoing monitoring of long-term effects of the COVID-19 pandemic on cancer survivorship is warranted.”

Dr. Han has received a grant from AstraZeneca outside of the current study.

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

Despite significant disruptions to the health care system and employment early in the COVID-19 pandemic, the uninsured rate among cancer survivors remained stable in 2020, new research indicates.

In addition, the prevalence of unhealthy behaviors, including smoking and poor sleep habits, appeared to decline among cancer survivors as well as adults who had no history of cancer during this period.

“Our findings suggest that the pandemic may have motivated people to adopt certain healthier behaviors,” Xuesong Han, PhD, American Cancer Society, Atlanta, said in a statement. In addition, policies implemented in response to the pandemic regarding insurance coverage, unemployment benefits, and financial assistance “may have contributed to the observed positive changes.”

Dr. Han and colleagues noted that “to the best of our knowledge, our study provides the first nationally representative estimates of the effects of the first year of the COVID-19 pandemic on cancer survivors in the United States.”

The study was published online in Cancer.

Given the considerable upheaval caused by the COVID-19 pandemic, Dr. Han and colleagues wanted to explore how cancer survivors, in particular, were affected during the first year.

The analysis included 57,132 cancer survivors and 1,044,585 adults without cancer who were involved in the Behavioral Risk Factor Surveillance System.

The researchers found that the unemployment rate in 2020 increased by 43% among cancer survivors and by 57% among adults without a cancer history compared with the previous 2 years.

However, the rate of uninsured cancer survivors aged 18-64 years remained relatively stable in 2020 at 8%, compared with 8.8% in 2017-2019.

Notably, the prevalence of insufficient sleep decreased among cancer survivors (43% to 39%), as did smoking (22% to 19%). Among adults without a history of cancer, there was a decline in insufficient sleep (37% to 34.3%) and smoking (16% to 15%). The prevalence of binge drinking decreased among adults with and those without a history of cancer as well.

Obesity rates, however, increased during the first year of the pandemic among cancer survivors (36.5% to 40%) as well as among those with no cancer history (30.8% to 32.7%). In addition, more adults without a cancer history reported an increase in mental distress in 2020 compared with before the COVID-19 pandemic.

The authors suggest that some of the positive trends observed could be explained, in part, by increased enrollment in the Affordable Care Act and by the Families First Coronavirus Response Act, which increased the federal government’s share of Medicaid costs and prevented states from terminating Medicaid coverage during the pandemic.

“These provisions likely compensated for the loss in employer-sponsored insurance,” the authors noted.

But, they added, “as policies related to the public health emergency expire, ongoing monitoring of long-term effects of the COVID-19 pandemic on cancer survivorship is warranted.”

Dr. Han has received a grant from AstraZeneca outside of the current study.

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