Megan Brooks

Taking more steps per day is associated with a progressively lower risk of cardiovascular disease (CVD) among older adults – and the benefits accrue at well below the widely promoted threshold of 10,000 steps per day, new research shows.

Among adults aged 60 and older, those who took roughly 6,000 to 9,000 steps per day had a 40% to 50% lower risk of CVD, compared with peers logging just 2,000 steps per day.

“We hope this study will contribute evidence to future public health and clinical guidance on how many steps we need for health,” Amanda Paluch, PhD, with University of Massachusetts Amherst, told this news organization.

Getting in more steps per day can lower an individual’s risk for heart disease – but it’s not an “all or nothing” situation, Dr. Paluch said.

“The heart health benefits begin at lower than 10,000 steps per day. So, for the many adults that may find 10,000 steps a bit out of reach, it is important to promote that even small increases in steps can be beneficial for health,” Dr. Paluch said.

The study was published online in Circulation.
 

Attainable step goals

As part of the Steps for Health Collaborative, Dr. Paluch and colleagues examined the dose-response relationship between steps per day and CVD in a meta-analysis of eight prospective studies involving 20,152 adults (mean age 63, 52% women).

Steps were measured in each study using one of five different commercially available step-measuring devices. Adults aged 60 years and older took a median of 4,323 steps per day (interquartile range, 2,760-6,924), while younger adults walked a bit more (median 6,911 daily steps; IQR, 4,783-9,794).

During follow-up lasting an average of 6.2 years, a total of 1,523 CVD events were reported.

In the final adjusted model, for older adults, compared with those in quartile 1 who got the fewest steps per day (median 1,811), the risk of CVD was 20% lower in those in quartile 2, who got a median of 3,823 steps per day (hazard ratio, 0.80; 95% confidence interval, 0.69-0.93).

CVD risk was 38% lower in older adults in quartile 3 who got a median of 5,520 steps per day (HR, 0.62; 95% CI, 0.52-0.74) and 49% lower in those in quartile 4 who walked the most (a median of 9,259 steps per day; HR, 0.51; 95% CI, 0.41-0.63).

Restricting the analysis to individuals without known CVD at baseline showed similar results.

Among six studies that excluded adults with a history of CVD at baseline, compared with the lowest quartile, the HR for incident CVD events was 0.74 (95% CI, 0.60-0.91) in the second quartile, 0.60 (95% CI, 0.47-0.77) in the third quartile, and 0.55 (95% CI, 0.40-0.76) in the fourth quartile.

Despite the inverse association of steps with CVD in older adults, there was no association in younger adults. The researchers caution, however, that CVD is a disease of aging, and the follow-up period in these studies may not have been long enough to capture CVD incidence in younger adults.

Stepping rate (pace or cadence) was not associated with CVD risk beyond that of total steps per day. However, only four of the eight studies reported data on stepping rate, so this finding should be viewed as preliminary, Dr. Paluch and colleagues say.
 

Start small and go from there

Dr. Paluch said the take-home message from this study and numerous others is simple.

“Move more and sit less! Being physically active, by getting in your steps, is an important part of keeping your heart healthy,” she said in an interview.

For adults who are currently inactive, Dr. Paluch suggests finding small ways to get in a few more steps per day. “It does not need to be drastic changes. Consider a brief 5- to 10-minute walking break at lunch, taking the stairs, or playing a game of hide and seek with the grandchildren,” Dr. Paluch advised.

“For adults starting at 3,000 steps a day, set a goal of 4,000, and then 5,000. Each improvement can lead to better heart health,” Dr. Paluch said. “And for those who are already active, keep it up, as there are benefits with higher volumes of steps per day as well.”

Support for this research was provided by the Intergovernmental Personnel Act Agreement through the Centers for Disease Control and Prevention. The authors have reported no relevant financial relationships.

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

Taking more steps per day is associated with a progressively lower risk of cardiovascular disease (CVD) among older adults – and the benefits accrue at well below the widely promoted threshold of 10,000 steps per day, new research shows.

Among adults aged 60 and older, those who took roughly 6,000 to 9,000 steps per day had a 40% to 50% lower risk of CVD, compared with peers logging just 2,000 steps per day.

“We hope this study will contribute evidence to future public health and clinical guidance on how many steps we need for health,” Amanda Paluch, PhD, with University of Massachusetts Amherst, told this news organization.

Getting in more steps per day can lower an individual’s risk for heart disease – but it’s not an “all or nothing” situation, Dr. Paluch said.

“The heart health benefits begin at lower than 10,000 steps per day. So, for the many adults that may find 10,000 steps a bit out of reach, it is important to promote that even small increases in steps can be beneficial for health,” Dr. Paluch said.

The study was published online in Circulation.
 

Attainable step goals

As part of the Steps for Health Collaborative, Dr. Paluch and colleagues examined the dose-response relationship between steps per day and CVD in a meta-analysis of eight prospective studies involving 20,152 adults (mean age 63, 52% women).

Steps were measured in each study using one of five different commercially available step-measuring devices. Adults aged 60 years and older took a median of 4,323 steps per day (interquartile range, 2,760-6,924), while younger adults walked a bit more (median 6,911 daily steps; IQR, 4,783-9,794).

During follow-up lasting an average of 6.2 years, a total of 1,523 CVD events were reported.

In the final adjusted model, for older adults, compared with those in quartile 1 who got the fewest steps per day (median 1,811), the risk of CVD was 20% lower in those in quartile 2, who got a median of 3,823 steps per day (hazard ratio, 0.80; 95% confidence interval, 0.69-0.93).

CVD risk was 38% lower in older adults in quartile 3 who got a median of 5,520 steps per day (HR, 0.62; 95% CI, 0.52-0.74) and 49% lower in those in quartile 4 who walked the most (a median of 9,259 steps per day; HR, 0.51; 95% CI, 0.41-0.63).

Restricting the analysis to individuals without known CVD at baseline showed similar results.

Among six studies that excluded adults with a history of CVD at baseline, compared with the lowest quartile, the HR for incident CVD events was 0.74 (95% CI, 0.60-0.91) in the second quartile, 0.60 (95% CI, 0.47-0.77) in the third quartile, and 0.55 (95% CI, 0.40-0.76) in the fourth quartile.

Despite the inverse association of steps with CVD in older adults, there was no association in younger adults. The researchers caution, however, that CVD is a disease of aging, and the follow-up period in these studies may not have been long enough to capture CVD incidence in younger adults.

Stepping rate (pace or cadence) was not associated with CVD risk beyond that of total steps per day. However, only four of the eight studies reported data on stepping rate, so this finding should be viewed as preliminary, Dr. Paluch and colleagues say.
 

Start small and go from there

Dr. Paluch said the take-home message from this study and numerous others is simple.

“Move more and sit less! Being physically active, by getting in your steps, is an important part of keeping your heart healthy,” she said in an interview.

For adults who are currently inactive, Dr. Paluch suggests finding small ways to get in a few more steps per day. “It does not need to be drastic changes. Consider a brief 5- to 10-minute walking break at lunch, taking the stairs, or playing a game of hide and seek with the grandchildren,” Dr. Paluch advised.

“For adults starting at 3,000 steps a day, set a goal of 4,000, and then 5,000. Each improvement can lead to better heart health,” Dr. Paluch said. “And for those who are already active, keep it up, as there are benefits with higher volumes of steps per day as well.”

Support for this research was provided by the Intergovernmental Personnel Act Agreement through the Centers for Disease Control and Prevention. The authors have reported no relevant financial relationships.

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

Taking more steps per day is associated with a progressively lower risk of cardiovascular disease (CVD) among older adults – and the benefits accrue at well below the widely promoted threshold of 10,000 steps per day, new research shows.

Among adults aged 60 and older, those who took roughly 6,000 to 9,000 steps per day had a 40% to 50% lower risk of CVD, compared with peers logging just 2,000 steps per day.

“We hope this study will contribute evidence to future public health and clinical guidance on how many steps we need for health,” Amanda Paluch, PhD, with University of Massachusetts Amherst, told this news organization.

Getting in more steps per day can lower an individual’s risk for heart disease – but it’s not an “all or nothing” situation, Dr. Paluch said.

“The heart health benefits begin at lower than 10,000 steps per day. So, for the many adults that may find 10,000 steps a bit out of reach, it is important to promote that even small increases in steps can be beneficial for health,” Dr. Paluch said.

The study was published online in Circulation.
 

Attainable step goals

As part of the Steps for Health Collaborative, Dr. Paluch and colleagues examined the dose-response relationship between steps per day and CVD in a meta-analysis of eight prospective studies involving 20,152 adults (mean age 63, 52% women).

Steps were measured in each study using one of five different commercially available step-measuring devices. Adults aged 60 years and older took a median of 4,323 steps per day (interquartile range, 2,760-6,924), while younger adults walked a bit more (median 6,911 daily steps; IQR, 4,783-9,794).

During follow-up lasting an average of 6.2 years, a total of 1,523 CVD events were reported.

In the final adjusted model, for older adults, compared with those in quartile 1 who got the fewest steps per day (median 1,811), the risk of CVD was 20% lower in those in quartile 2, who got a median of 3,823 steps per day (hazard ratio, 0.80; 95% confidence interval, 0.69-0.93).

CVD risk was 38% lower in older adults in quartile 3 who got a median of 5,520 steps per day (HR, 0.62; 95% CI, 0.52-0.74) and 49% lower in those in quartile 4 who walked the most (a median of 9,259 steps per day; HR, 0.51; 95% CI, 0.41-0.63).

Restricting the analysis to individuals without known CVD at baseline showed similar results.

Among six studies that excluded adults with a history of CVD at baseline, compared with the lowest quartile, the HR for incident CVD events was 0.74 (95% CI, 0.60-0.91) in the second quartile, 0.60 (95% CI, 0.47-0.77) in the third quartile, and 0.55 (95% CI, 0.40-0.76) in the fourth quartile.

Despite the inverse association of steps with CVD in older adults, there was no association in younger adults. The researchers caution, however, that CVD is a disease of aging, and the follow-up period in these studies may not have been long enough to capture CVD incidence in younger adults.

Stepping rate (pace or cadence) was not associated with CVD risk beyond that of total steps per day. However, only four of the eight studies reported data on stepping rate, so this finding should be viewed as preliminary, Dr. Paluch and colleagues say.
 

Start small and go from there

Dr. Paluch said the take-home message from this study and numerous others is simple.

“Move more and sit less! Being physically active, by getting in your steps, is an important part of keeping your heart healthy,” she said in an interview.

For adults who are currently inactive, Dr. Paluch suggests finding small ways to get in a few more steps per day. “It does not need to be drastic changes. Consider a brief 5- to 10-minute walking break at lunch, taking the stairs, or playing a game of hide and seek with the grandchildren,” Dr. Paluch advised.

“For adults starting at 3,000 steps a day, set a goal of 4,000, and then 5,000. Each improvement can lead to better heart health,” Dr. Paluch said. “And for those who are already active, keep it up, as there are benefits with higher volumes of steps per day as well.”

Support for this research was provided by the Intergovernmental Personnel Act Agreement through the Centers for Disease Control and Prevention. The authors have reported no relevant financial relationships.

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

Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.

“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”

The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.

The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.

Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).

But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.

The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.

“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.

A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.

“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.

“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.

“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.

No commercial funding was received. The authors have disclosed no relevant financial relationships.

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

Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.

“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”

The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.

The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.

Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).

But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.

The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.

“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.

A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.

“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.

“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.

“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.

No commercial funding was received. The authors have disclosed no relevant financial relationships.

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

Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.

“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, England, told this news organization. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”

The joint opinion is from the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation. It was simultaneously published online in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.

The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Prof. Bowman said.

Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).

But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinders the ability to conduct trials swiftly and affordably, the authors point out.

The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.

“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Prof. Bowman told this news organization.

A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.

“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Prof. Bowman said.

“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Prof. Bowman acknowledged.

“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.

No commercial funding was received. The authors have disclosed no relevant financial relationships.

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

A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

• Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
• Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
• Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
• Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
• Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
• Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
• Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
• Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
• Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

• Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
• Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
• Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
• Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
• Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
• Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
• Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
• Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
• Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

• Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
• Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
• Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
• Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
• Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
• Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
• Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
• Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
• Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD). 

Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.

“The implication is that muscular strength and mobility influence brain health and can potentially be modified to improve outcomes in persons with Alzheimer’s,” study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.

The study was published online in the Journal of Alzheimer’s Disease.
 

Brain-body connection

The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”

They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.

The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).

Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.

“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.

The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
 

‘Use it or lose it’

The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure. 

In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.

The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.

However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.

“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.

“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.

This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.

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

A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD). 

Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.

“The implication is that muscular strength and mobility influence brain health and can potentially be modified to improve outcomes in persons with Alzheimer’s,” study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.

The study was published online in the Journal of Alzheimer’s Disease.
 

Brain-body connection

The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”

They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.

The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).

Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.

“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.

The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
 

‘Use it or lose it’

The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure. 

In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.

The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.

However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.

“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.

“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.

This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.

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

A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD). 

Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.

“The implication is that muscular strength and mobility influence brain health and can potentially be modified to improve outcomes in persons with Alzheimer’s,” study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.

The study was published online in the Journal of Alzheimer’s Disease.
 

Brain-body connection

The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”

They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.

The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).

Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.

“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.

The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
 

‘Use it or lose it’

The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure. 

In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.

The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.

However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.

“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.

“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.

This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.

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

Two conservative interventions are effective for treating acute and subacute spine pain, new research suggests.

Results from the SPINE CARE randomized controlled trial showed that 6-8 weeks of an individualized postural therapy (IPT) or a multidisciplinary biopsychosocial intervention known as ICE (identify, coordinate, and enhance) that includes physical therapy were associated with small but statistically significant reductions in pain-related disability at 3 months compared with usual care.

In addition, spine-related health care spending did not differ significantly between ICE and usual care. However, IPT significantly increased spending compared with usual care.

“We found that, compared to usual primary care, both interventions reduced pain-related disability at 3 months and that these changes were sustained and clinically meaningful at 12 months – long after the interventions were over,” lead author Niteesh K. Choudhry, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, told this news organization.

The findings were published online in JAMA.
 

Common complaint

Spine pain is defined as pain that occurs in the neck or back, the investigators noted. It “accounted for more health spending than any other health condition in the U.S. in 2016,” they added.

“Spine pain is an exceptionally common reason for patients to visit their primary care providers,” Dr. Choudhry said.

The SPINE CARE trial enrolled 2,971 adults (60% were women; mean age was 51 years) with back or neck pain that had lasted less than 12 weeks. All were randomly allocated to usual care (no intervention, n = 992) or to the ICE (n = 829) or IPT (n = 1150) interventions.

The ICE care model stratifies patients on the basis of their risk of progression from acute to chronic pain and addresses biopsychosocial contributors to pain. Low-risk patients received one physical therapy (PT) visit and one coaching call, while higher-risk patients received three PT visits, three coaching calls, and one e-consultation.

The IPT intervention, which was delivered in 8 weekly sessions, focuses on postural realignment. IPT also emphasizes self-efficacy and self-management, including daily exercises to improve postural control, coordination, and muscle balance.

Results at 3 months showed that both the ICE and IPT groups improved significantly more in Oswestry Disability Index (ODI) scores than in the usual care group (ICE, 31.2 to 15.4; IPT, 29.3 to 15.4; usual care, 28.9 to 19.5).

At 3 months, the absolute difference in ODI score vs. usual care was −5.8 for ICE (95% confidence interval [CI], −7.7 to −3.9; P < .001) and −4.3 for IPT (95% CI, −5.9 to −2.6; P < .001) for IPT.

Both interventions reduced resource utilization, such as diagnostic imaging, procedures, and specialist visits, Dr. Choudhry reported. “Because of this, both reduced spending unrelated to the interventions themselves,” he added.

When the intervention costs were included, ICE resulted in lower costs overall than those of usual care ($139 less), while overall spending for IPT was higher than for usual care (by $941).

“We tested the interventions in a way that was integrated into primary care, so implementing them in other practice settings should be quite straightforward,” Dr. Choudhry said.

He noted that the ICE model does not currently exist as a complete program – but its components, such as physical therapy or specialist e-consults, do. “And we think that our results justify exploring how to set this up more broadly,” he said.

Dr. Choudhry added that IPT was tested using a specific provider (Egoscue), “which has locations in a variety of places in the U.S. and internationally, and so should also be straightforward to integrate into routine practice.”

However, other important factors, such as insurance coverage, will need to be explored in the future, he said.
 

Confirmatory evidence?

In an accompanying editorial, Erin Krebs, MD, Minneapolis VA Health Care System, and colleagues, noted that past systematic reviews have concluded that exercise therapies are “generally effective” for chronic back and neck pain, which is usually defined as pain lasting more than 12 weeks, but not for acute pain, defined as pain lasting less than 4-6 weeks.

“The present trial contributes evidence for effectiveness of exercise therapy among patients with a current episode of less than 12 weeks, meaning not yet chronic, but not necessarily acute,” the editorialists wrote.

“Clinicians should more often recommend structured exercise programs for subacute back or neck pain, especially when the pain is recurrent,” they added.

The study was funded by unrestricted philanthropic gifts to Stanford (Calif.) University. Dr. Choudhry received grants from Stanford University during the conduct of the study.

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

Two conservative interventions are effective for treating acute and subacute spine pain, new research suggests.

Results from the SPINE CARE randomized controlled trial showed that 6-8 weeks of an individualized postural therapy (IPT) or a multidisciplinary biopsychosocial intervention known as ICE (identify, coordinate, and enhance) that includes physical therapy were associated with small but statistically significant reductions in pain-related disability at 3 months compared with usual care.

In addition, spine-related health care spending did not differ significantly between ICE and usual care. However, IPT significantly increased spending compared with usual care.

“We found that, compared to usual primary care, both interventions reduced pain-related disability at 3 months and that these changes were sustained and clinically meaningful at 12 months – long after the interventions were over,” lead author Niteesh K. Choudhry, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, told this news organization.

The findings were published online in JAMA.
 

Common complaint

Spine pain is defined as pain that occurs in the neck or back, the investigators noted. It “accounted for more health spending than any other health condition in the U.S. in 2016,” they added.

“Spine pain is an exceptionally common reason for patients to visit their primary care providers,” Dr. Choudhry said.

The SPINE CARE trial enrolled 2,971 adults (60% were women; mean age was 51 years) with back or neck pain that had lasted less than 12 weeks. All were randomly allocated to usual care (no intervention, n = 992) or to the ICE (n = 829) or IPT (n = 1150) interventions.

The ICE care model stratifies patients on the basis of their risk of progression from acute to chronic pain and addresses biopsychosocial contributors to pain. Low-risk patients received one physical therapy (PT) visit and one coaching call, while higher-risk patients received three PT visits, three coaching calls, and one e-consultation.

The IPT intervention, which was delivered in 8 weekly sessions, focuses on postural realignment. IPT also emphasizes self-efficacy and self-management, including daily exercises to improve postural control, coordination, and muscle balance.

Results at 3 months showed that both the ICE and IPT groups improved significantly more in Oswestry Disability Index (ODI) scores than in the usual care group (ICE, 31.2 to 15.4; IPT, 29.3 to 15.4; usual care, 28.9 to 19.5).

At 3 months, the absolute difference in ODI score vs. usual care was −5.8 for ICE (95% confidence interval [CI], −7.7 to −3.9; P < .001) and −4.3 for IPT (95% CI, −5.9 to −2.6; P < .001) for IPT.

Both interventions reduced resource utilization, such as diagnostic imaging, procedures, and specialist visits, Dr. Choudhry reported. “Because of this, both reduced spending unrelated to the interventions themselves,” he added.

When the intervention costs were included, ICE resulted in lower costs overall than those of usual care ($139 less), while overall spending for IPT was higher than for usual care (by $941).

“We tested the interventions in a way that was integrated into primary care, so implementing them in other practice settings should be quite straightforward,” Dr. Choudhry said.

He noted that the ICE model does not currently exist as a complete program – but its components, such as physical therapy or specialist e-consults, do. “And we think that our results justify exploring how to set this up more broadly,” he said.

Dr. Choudhry added that IPT was tested using a specific provider (Egoscue), “which has locations in a variety of places in the U.S. and internationally, and so should also be straightforward to integrate into routine practice.”

However, other important factors, such as insurance coverage, will need to be explored in the future, he said.
 

Confirmatory evidence?

In an accompanying editorial, Erin Krebs, MD, Minneapolis VA Health Care System, and colleagues, noted that past systematic reviews have concluded that exercise therapies are “generally effective” for chronic back and neck pain, which is usually defined as pain lasting more than 12 weeks, but not for acute pain, defined as pain lasting less than 4-6 weeks.

“The present trial contributes evidence for effectiveness of exercise therapy among patients with a current episode of less than 12 weeks, meaning not yet chronic, but not necessarily acute,” the editorialists wrote.

“Clinicians should more often recommend structured exercise programs for subacute back or neck pain, especially when the pain is recurrent,” they added.

The study was funded by unrestricted philanthropic gifts to Stanford (Calif.) University. Dr. Choudhry received grants from Stanford University during the conduct of the study.

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

Two conservative interventions are effective for treating acute and subacute spine pain, new research suggests.

Results from the SPINE CARE randomized controlled trial showed that 6-8 weeks of an individualized postural therapy (IPT) or a multidisciplinary biopsychosocial intervention known as ICE (identify, coordinate, and enhance) that includes physical therapy were associated with small but statistically significant reductions in pain-related disability at 3 months compared with usual care.

In addition, spine-related health care spending did not differ significantly between ICE and usual care. However, IPT significantly increased spending compared with usual care.

“We found that, compared to usual primary care, both interventions reduced pain-related disability at 3 months and that these changes were sustained and clinically meaningful at 12 months – long after the interventions were over,” lead author Niteesh K. Choudhry, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, told this news organization.

The findings were published online in JAMA.
 

Common complaint

Spine pain is defined as pain that occurs in the neck or back, the investigators noted. It “accounted for more health spending than any other health condition in the U.S. in 2016,” they added.

“Spine pain is an exceptionally common reason for patients to visit their primary care providers,” Dr. Choudhry said.

The SPINE CARE trial enrolled 2,971 adults (60% were women; mean age was 51 years) with back or neck pain that had lasted less than 12 weeks. All were randomly allocated to usual care (no intervention, n = 992) or to the ICE (n = 829) or IPT (n = 1150) interventions.

The ICE care model stratifies patients on the basis of their risk of progression from acute to chronic pain and addresses biopsychosocial contributors to pain. Low-risk patients received one physical therapy (PT) visit and one coaching call, while higher-risk patients received three PT visits, three coaching calls, and one e-consultation.

The IPT intervention, which was delivered in 8 weekly sessions, focuses on postural realignment. IPT also emphasizes self-efficacy and self-management, including daily exercises to improve postural control, coordination, and muscle balance.

Results at 3 months showed that both the ICE and IPT groups improved significantly more in Oswestry Disability Index (ODI) scores than in the usual care group (ICE, 31.2 to 15.4; IPT, 29.3 to 15.4; usual care, 28.9 to 19.5).

At 3 months, the absolute difference in ODI score vs. usual care was −5.8 for ICE (95% confidence interval [CI], −7.7 to −3.9; P < .001) and −4.3 for IPT (95% CI, −5.9 to −2.6; P < .001) for IPT.

Both interventions reduced resource utilization, such as diagnostic imaging, procedures, and specialist visits, Dr. Choudhry reported. “Because of this, both reduced spending unrelated to the interventions themselves,” he added.

When the intervention costs were included, ICE resulted in lower costs overall than those of usual care ($139 less), while overall spending for IPT was higher than for usual care (by $941).

“We tested the interventions in a way that was integrated into primary care, so implementing them in other practice settings should be quite straightforward,” Dr. Choudhry said.

He noted that the ICE model does not currently exist as a complete program – but its components, such as physical therapy or specialist e-consults, do. “And we think that our results justify exploring how to set this up more broadly,” he said.

Dr. Choudhry added that IPT was tested using a specific provider (Egoscue), “which has locations in a variety of places in the U.S. and internationally, and so should also be straightforward to integrate into routine practice.”

However, other important factors, such as insurance coverage, will need to be explored in the future, he said.
 

Confirmatory evidence?

In an accompanying editorial, Erin Krebs, MD, Minneapolis VA Health Care System, and colleagues, noted that past systematic reviews have concluded that exercise therapies are “generally effective” for chronic back and neck pain, which is usually defined as pain lasting more than 12 weeks, but not for acute pain, defined as pain lasting less than 4-6 weeks.

“The present trial contributes evidence for effectiveness of exercise therapy among patients with a current episode of less than 12 weeks, meaning not yet chronic, but not necessarily acute,” the editorialists wrote.

“Clinicians should more often recommend structured exercise programs for subacute back or neck pain, especially when the pain is recurrent,” they added.

The study was funded by unrestricted philanthropic gifts to Stanford (Calif.) University. Dr. Choudhry received grants from Stanford University during the conduct of the study.

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

Lupin Pharmaceuticals is recalling four lots of quinapril tablets because of unacceptable levels of the nitrosamine impurity, N-nitroso-quinapril, a potential carcinogen.

Nitrosamines “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the company says in a recall notice posted on the Food and Drug Administration website.

Lupin says it “has received no reports of illness that appear to relate to this issue.”

Quinapril is an ACE inhibitor used to treat hypertension. Lupin stopped marketing quinapril tablets in September 2022.

The recalled product – quinapril tablets USP 20 mg and 40 mg – are packaged in 90-count bottles and were distributed nationwide to U.S. wholesalers, drug chains, mail order pharmacies, and supermarkets between March 15, 2021, and Sept. 1, 2022.

Lupin is notifying customers to immediately stop distribution of the recalled product and is arranging for the affected product lots to be returned to the company.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or healthcare professional for advice regarding an alternative treatment.

Questions regarding this recall should be directed to Inmar Rx Solutions at (877) 538-8445 Monday to Friday between 9:00 a.m. to 5:00 p.m. EST.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.

Pfizer recalled several lots of quinapril owing to the presence of the same impurity in March 2022and again in April.

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

Lupin Pharmaceuticals is recalling four lots of quinapril tablets because of unacceptable levels of the nitrosamine impurity, N-nitroso-quinapril, a potential carcinogen.

Nitrosamines “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the company says in a recall notice posted on the Food and Drug Administration website.

Lupin says it “has received no reports of illness that appear to relate to this issue.”

Quinapril is an ACE inhibitor used to treat hypertension. Lupin stopped marketing quinapril tablets in September 2022.

The recalled product – quinapril tablets USP 20 mg and 40 mg – are packaged in 90-count bottles and were distributed nationwide to U.S. wholesalers, drug chains, mail order pharmacies, and supermarkets between March 15, 2021, and Sept. 1, 2022.

Lupin is notifying customers to immediately stop distribution of the recalled product and is arranging for the affected product lots to be returned to the company.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or healthcare professional for advice regarding an alternative treatment.

Questions regarding this recall should be directed to Inmar Rx Solutions at (877) 538-8445 Monday to Friday between 9:00 a.m. to 5:00 p.m. EST.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.

Pfizer recalled several lots of quinapril owing to the presence of the same impurity in March 2022and again in April.

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

Lupin Pharmaceuticals is recalling four lots of quinapril tablets because of unacceptable levels of the nitrosamine impurity, N-nitroso-quinapril, a potential carcinogen.

Nitrosamines “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the company says in a recall notice posted on the Food and Drug Administration website.

Lupin says it “has received no reports of illness that appear to relate to this issue.”

Quinapril is an ACE inhibitor used to treat hypertension. Lupin stopped marketing quinapril tablets in September 2022.

The recalled product – quinapril tablets USP 20 mg and 40 mg – are packaged in 90-count bottles and were distributed nationwide to U.S. wholesalers, drug chains, mail order pharmacies, and supermarkets between March 15, 2021, and Sept. 1, 2022.

Lupin is notifying customers to immediately stop distribution of the recalled product and is arranging for the affected product lots to be returned to the company.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or healthcare professional for advice regarding an alternative treatment.

Questions regarding this recall should be directed to Inmar Rx Solutions at (877) 538-8445 Monday to Friday between 9:00 a.m. to 5:00 p.m. EST.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.

Pfizer recalled several lots of quinapril owing to the presence of the same impurity in March 2022and again in April.

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

A gastroenterologist affiliated with the Cleveland Clinic was recently arrested and charged with multiple felonies.

According to Cleveland Municipal Court records, Omar Massoud, MD, PhD, of Westlake, Ohio, has been charged with three counts of kidnapping, all first-degree felonies, and three counts of gross sexual imposition, all third-degree felonies.

The assaults are alleged to have happened during liver examinations on March 25, Nov. 11, and Nov. 28, 2022 at Cleveland Clinic’s main campus located at 9500 Euclid Avenue.

No further details were provided.

Dr. Massoud is the former chief of hepatology at the Cleveland Clinic.

In a statement, the Cleveland Clinic said it “immediately reported the accusations to the appropriate law enforcement agencies and are fully cooperating with the investigations.”

“Following a thorough internal investigation,” Dr. Massoud was fired, the Cleveland Clinic said.

“Cleveland Clinic is strongly committed to protecting the rights and safety of our patients, visitors, and caregivers from any type of inappropriate behavior. We care deeply about patient safety and any form of misconduct is not tolerated,” the statement said.

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

A gastroenterologist affiliated with the Cleveland Clinic was recently arrested and charged with multiple felonies.

According to Cleveland Municipal Court records, Omar Massoud, MD, PhD, of Westlake, Ohio, has been charged with three counts of kidnapping, all first-degree felonies, and three counts of gross sexual imposition, all third-degree felonies.

The assaults are alleged to have happened during liver examinations on March 25, Nov. 11, and Nov. 28, 2022 at Cleveland Clinic’s main campus located at 9500 Euclid Avenue.

No further details were provided.

Dr. Massoud is the former chief of hepatology at the Cleveland Clinic.

In a statement, the Cleveland Clinic said it “immediately reported the accusations to the appropriate law enforcement agencies and are fully cooperating with the investigations.”

“Following a thorough internal investigation,” Dr. Massoud was fired, the Cleveland Clinic said.

“Cleveland Clinic is strongly committed to protecting the rights and safety of our patients, visitors, and caregivers from any type of inappropriate behavior. We care deeply about patient safety and any form of misconduct is not tolerated,” the statement said.

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

A gastroenterologist affiliated with the Cleveland Clinic was recently arrested and charged with multiple felonies.

According to Cleveland Municipal Court records, Omar Massoud, MD, PhD, of Westlake, Ohio, has been charged with three counts of kidnapping, all first-degree felonies, and three counts of gross sexual imposition, all third-degree felonies.

The assaults are alleged to have happened during liver examinations on March 25, Nov. 11, and Nov. 28, 2022 at Cleveland Clinic’s main campus located at 9500 Euclid Avenue.

No further details were provided.

Dr. Massoud is the former chief of hepatology at the Cleveland Clinic.

In a statement, the Cleveland Clinic said it “immediately reported the accusations to the appropriate law enforcement agencies and are fully cooperating with the investigations.”

“Following a thorough internal investigation,” Dr. Massoud was fired, the Cleveland Clinic said.

“Cleveland Clinic is strongly committed to protecting the rights and safety of our patients, visitors, and caregivers from any type of inappropriate behavior. We care deeply about patient safety and any form of misconduct is not tolerated,” the statement said.

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

Problematic alcohol use by physicians appears to be increasing, new research shows. However, good data on exactly how common this is and on salient risk factors are lacking.
 

In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.

However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.

“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.

The findings were published online in JAMA Network Open.
 

Serious concern

The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.

Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.

To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.

In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.

“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.

Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.

The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
 

True prevalence unknown

“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.

The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.

True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.

They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.

The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.

The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.

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

Problematic alcohol use by physicians appears to be increasing, new research shows. However, good data on exactly how common this is and on salient risk factors are lacking.
 

In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.

However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.

“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.

The findings were published online in JAMA Network Open.
 

Serious concern

The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.

Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.

To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.

In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.

“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.

Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.

The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
 

True prevalence unknown

“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.

The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.

True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.

They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.

The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.

The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.

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

Problematic alcohol use by physicians appears to be increasing, new research shows. However, good data on exactly how common this is and on salient risk factors are lacking.
 

In a systematic literature review, investigators found the prevalence of self-reported problematic alcohol use varied widely, but could affect up to one third of physicians.

However, all studies were survey-based and self-reported, and definitions of problematic alcohol use were mixed, with inconsistent reporting on differences across sex, age, physician specialty, and career stage.

“Key epidemiologic information of the prevalence of problematic alcohol use in physicians and associated risk factors are unknown, hampering the ability to identify high-risk individuals for targeted interventions,” Manish Sood, MD, University of Ottawa, and colleagues wrote.

The findings were published online in JAMA Network Open.
 

Serious concern

The researchers noted that physicians are at a higher risk for burnout and mental health conditions, including depression and anxiety, than the general population, which could contribute to problematic drinking.

Problematic drinking among physicians poses a “serious concern” to their health and ability to provide care, the investigators wrote. Understanding the extent and characteristics of the issue is important to guide interventions.

To better characterize problematic drinking among physicians, the investigators reviewed 31 studies from 2006 to 2020 involving 51,680 residents, fellows, or staff physicians in 17 countries.

In the studies, problematic alcohol use was measured by a validated tool: the Alcohol Use Disorders Identification Test, AUDIT Version C (AUDIT-C), or the Cut down, Annoyed, Guilty, and Eye-opener (CAGE) questionnaire.

“Problematic alcohol use” included hazardous, potentially hazardous, risky, at-risk, harmful, problematic, or heavy drinking or alcohol use, as well as alcohol misuse, alcohol dependence, and alcohol use more than low-risk guidelines and alcohol use disorder.

Results showed problematic alcohol use “varied widely” regardless of measurement method used. The rate was 0%-34% with AUDIT, 9%-35% with AUDIT-C, and 4%-22% with CAGE.

The data also showed an increase in reported problematic alcohol use over time, rising from 16.3% between 2006 and 2010 to 26.8% between 2017 and 2020.
 

True prevalence unknown

“It remains unknown whether this increase is indeed accurate or whether it is due to increased transparency by physicians in self-reporting problematic alcohol use because of a changing culture of medicine,” the investigators wrote.

The data suggest that problematic alcohol use is more common in male than female physicians; but no firm conclusions can be drawn from the data on how problematic alcohol use varies based on physician age, sex, specialty, and career stage, the researchers noted.

True prevalence of problematic alcohol use among physicians remains unknown – and identifying this type of behavior is difficult, they pointed out.

They added that physicians with problematic use may be “high functioning,” making identifying potential impairment a challenge. Also, societal stigma and fear of reprisal from professional colleges for reporting or seeking care for problematic alcohol use may encourage physicians with alcohol problems to keep their problems hidden.

The researchers noted that future population-based studies with longitudinal designs or using health administrative data could help identify the prevalence of and salient risk factors for problematic alcohol use in physicians.

The study was supported by the Canadian Medical Association. The authors reported no relevant disclosures.

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

The Alzheimer’s Association has filed a formal request with the Centers for Medicare & Medicaid Services that it provide full and unrestricted coverage for Alzheimer’s disease (AD) treatments approved by the U.S. Food and Drug Administration.

In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.

The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.

Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.

The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.

The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.

“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
 

‘No time to waste’

“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.

“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.

The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.

“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.

“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.

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

The Alzheimer’s Association has filed a formal request with the Centers for Medicare & Medicaid Services that it provide full and unrestricted coverage for Alzheimer’s disease (AD) treatments approved by the U.S. Food and Drug Administration.

In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.

The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.

Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.

The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.

The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.

“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
 

‘No time to waste’

“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.

“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.

The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.

“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.

“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.

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

The Alzheimer’s Association has filed a formal request with the Centers for Medicare & Medicaid Services that it provide full and unrestricted coverage for Alzheimer’s disease (AD) treatments approved by the U.S. Food and Drug Administration.

In a letter addressed to CMS administrator Chiquita Brooks-LaSure, MPP, the association has asked the agency to remove the requirements for “coverage with evidence development” in its national coverage determination for FDA-approved anti-amyloid monoclonal antibodies.

The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the basis of data available at the time.

Since then, new data from the CLARITY AD trial “clearly demonstrate a meaningful clinical benefit” from the investigational anti-amyloid agent lecanemab (Eisai/Biogen), Robert Egge, chief public policy officer for the Alzheimer’s Association, told this news organization.

The CLARITY AD results were published in the New England Journal of Medicine. Lecanemab is currently under accelerated review at the FDA.

The Alzheimer’s Association’s letter to the CMS includes a joint statement signed by more than 200 AD researchers and experts. All agree that the lecanemab results represent “significant new evidence” that necessitates reconsidering the restrictions on anti-amyloid agents.

“CMS has said it would look at new evidence, and now that evidence is here. We believe CMS recognizes this evidence for lecanemab is stronger than that for many treatments Medicare routinely covers,” Mr. Egge said.
 

‘No time to waste’

“With the timing of accelerated approvals for both lecanemab and donanemab in the next few months, the Alzheimer’s Association wants to ensure, if approved, that patients can access these treatments,” Mr. Egge noted.

“Because revisions to National Coverage Determinations can be a lengthy process, CMS needs to act quickly to minimize delays. People living with Alzheimer’s disease don’t have time to waste,” he added.

The Alzheimer’s Association estimates that every day, more than 2,000 individuals aged 65 or older may transition from mild dementia due to AD to a more advanced stage of the disease in which they may no longer be eligible for lecanemab and the other anti-amyloid agents currently being tested.

“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, president and incoming chief executive officer for the Alzheimer’s Association, noted in a news release.

“The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable,” Dr. Pike said.

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

Fecal microbiota transplantation (FMT) does not appear to contribute to weight loss for patients who undergo bariatric surgery, according to results of a randomized controlled trial.

The small study by Perttu Lahtinen, MD, with Päijät-Häme Central Hospital in Lahti, Finland, and colleagues was published online in JAMA Network Open.

Bariatric surgery remains the most effective strategy for treating severe obesity. Yet some patients achieve only minimal weight loss or regain weight after surgery, the researchers noted.

There is much interest in the gut microbiota as a potential target for the treatment of obesity. FMT from a lean donor has shown promise in treating obesity in mouse models (Science. 2013 Sep 6. doi: 10.1126/science.1241214).

The Finnish trial, however, does not support that conclusion.

The study included 41 adults (71% women; mean age, 48.7 years) with severe obesity (mean body mass index, 42.5 kg/m²). Twenty-one received FMT from a lean donor, and 20 received FMT from their own feces (autologous placebo). FMT was administered by gastroscopy into the duodenum 6 months before laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. All patients also consumed a very-low-calorie diet approximately 4 weeks before the surgery.

Bariatric surgery led to equal weight reductions for both groups, but there was no additive benefit in terms of weight loss with FMT.

Six months after the administration of FMT, and before the surgery was performed, the percentage of total weight loss, the main outcome, was 4.8% (P < .001) in the FMT group and 4.6% (P = .006) in the placebo group. There was no statistically significant difference between the groups (absolute difference, 0.2%).

At 18 months (12 months after surgery), the percentage of total weight loss was 25.3% (P < .001) in the FMT group and 25.2% (P < .001) in the placebo group – an absolute difference of 0.1%.

The researchers said the main limitation of their study is the small number of patients. Because there were few patients, the study may be inadequate to show possible minor effects of FMT on weight; it’s unclear whether a much larger sample size would have yielded any differences between the groups.

Nonetheless, the study suggests that FMT does not affect weight loss for patients who undergo bariatric surgery, the researchers said.

The study was supported by governmental research grants and the Sigrid Juselius Foundation. The authors disclosed no relevant financial relationships.

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

Fecal microbiota transplantation (FMT) does not appear to contribute to weight loss for patients who undergo bariatric surgery, according to results of a randomized controlled trial.

The small study by Perttu Lahtinen, MD, with Päijät-Häme Central Hospital in Lahti, Finland, and colleagues was published online in JAMA Network Open.

Bariatric surgery remains the most effective strategy for treating severe obesity. Yet some patients achieve only minimal weight loss or regain weight after surgery, the researchers noted.

There is much interest in the gut microbiota as a potential target for the treatment of obesity. FMT from a lean donor has shown promise in treating obesity in mouse models (Science. 2013 Sep 6. doi: 10.1126/science.1241214).

The Finnish trial, however, does not support that conclusion.

The study included 41 adults (71% women; mean age, 48.7 years) with severe obesity (mean body mass index, 42.5 kg/m²). Twenty-one received FMT from a lean donor, and 20 received FMT from their own feces (autologous placebo). FMT was administered by gastroscopy into the duodenum 6 months before laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. All patients also consumed a very-low-calorie diet approximately 4 weeks before the surgery.

Bariatric surgery led to equal weight reductions for both groups, but there was no additive benefit in terms of weight loss with FMT.

Six months after the administration of FMT, and before the surgery was performed, the percentage of total weight loss, the main outcome, was 4.8% (P < .001) in the FMT group and 4.6% (P = .006) in the placebo group. There was no statistically significant difference between the groups (absolute difference, 0.2%).

At 18 months (12 months after surgery), the percentage of total weight loss was 25.3% (P < .001) in the FMT group and 25.2% (P < .001) in the placebo group – an absolute difference of 0.1%.

The researchers said the main limitation of their study is the small number of patients. Because there were few patients, the study may be inadequate to show possible minor effects of FMT on weight; it’s unclear whether a much larger sample size would have yielded any differences between the groups.

Nonetheless, the study suggests that FMT does not affect weight loss for patients who undergo bariatric surgery, the researchers said.

The study was supported by governmental research grants and the Sigrid Juselius Foundation. The authors disclosed no relevant financial relationships.

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

Fecal microbiota transplantation (FMT) does not appear to contribute to weight loss for patients who undergo bariatric surgery, according to results of a randomized controlled trial.

The small study by Perttu Lahtinen, MD, with Päijät-Häme Central Hospital in Lahti, Finland, and colleagues was published online in JAMA Network Open.

Bariatric surgery remains the most effective strategy for treating severe obesity. Yet some patients achieve only minimal weight loss or regain weight after surgery, the researchers noted.

There is much interest in the gut microbiota as a potential target for the treatment of obesity. FMT from a lean donor has shown promise in treating obesity in mouse models (Science. 2013 Sep 6. doi: 10.1126/science.1241214).

The Finnish trial, however, does not support that conclusion.

The study included 41 adults (71% women; mean age, 48.7 years) with severe obesity (mean body mass index, 42.5 kg/m²). Twenty-one received FMT from a lean donor, and 20 received FMT from their own feces (autologous placebo). FMT was administered by gastroscopy into the duodenum 6 months before laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. All patients also consumed a very-low-calorie diet approximately 4 weeks before the surgery.

Bariatric surgery led to equal weight reductions for both groups, but there was no additive benefit in terms of weight loss with FMT.

Six months after the administration of FMT, and before the surgery was performed, the percentage of total weight loss, the main outcome, was 4.8% (P < .001) in the FMT group and 4.6% (P = .006) in the placebo group. There was no statistically significant difference between the groups (absolute difference, 0.2%).

At 18 months (12 months after surgery), the percentage of total weight loss was 25.3% (P < .001) in the FMT group and 25.2% (P < .001) in the placebo group – an absolute difference of 0.1%.

The researchers said the main limitation of their study is the small number of patients. Because there were few patients, the study may be inadequate to show possible minor effects of FMT on weight; it’s unclear whether a much larger sample size would have yielded any differences between the groups.

Nonetheless, the study suggests that FMT does not affect weight loss for patients who undergo bariatric surgery, the researchers said.

The study was supported by governmental research grants and the Sigrid Juselius Foundation. The authors disclosed no relevant financial relationships.

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