Journal of Clinical Outcomes Management

The incidence of metastatic prostate cancer shot up in the United States after the U.S. Preventive Services Task Force recommended against routinely screening men with the prostate-specific antigen (PSA), shows a report published online in JAMA Network Open.

It was a consequence that many experts in prostate cancer predicted at the time the recommendation was made – initially in 2008 against routine screening in men older than 75 years, then in all men in 2012.

The thinking was that the harms of screening all men – leading to unnecessary prostatectomies and other treatments in many men – outweighed the benefits of catching early high-risk disease in fewer men. Screening rates plummeted as a result.

But experts in prostate cancer warned that the move, while reducing overdiagnosis and overtreatment, would have the unfortunate consequence of underdiagnosis and, consequently, nondetection of the cases of prostate cancer that would spread. 

The new findings are the latest to suggest that this is, in fact, what happened, and echo similar findings previously reported by this news organization.  

For this study, investigators at the University of Southern California, Los Angeles, analyzed the incidence of metastatic prostate cancer (mPCa) in the Surveillance, Epidemiology, and End Results (SEER) database from 2004-2018, with 2018 being the latest data available.

SEER captures about 28% of the U.S. population and recorded almost 50,000 new mPCa cases over the period.

Among men 45-75 years old, the incidence of mPCa increased 41% from when USPSTF recommended against screening through 2018, which translated to an annual percentage change (APC) of 5.3%.

Among men 75 years and older, mPCa rates jumped 43% through 2018, an APC of 6.5%.

The researchers did not find an increase in deaths from prostate cancer, but given the 5-7 years median survival, it might be too early to tell.

“The observation of a rising incidence of mPCa in itself does not imply that screening practices should be changed. The overall risk versus benefit of PSA-based screening is extremely complex and must take into account various other factors that impact the overall health of the community,” say investigators, led by Mihir Desai, MD, a clinical urology professor at USC. 

However, screening practices have already changed. The USPSTF withdrew its objections to screening in 2018 and instead recommended personalized decisionmaking for men 55-69 years old, citing new evidence that screening prevents metastatic disease and reduces PCa mortality more than previously recognized, Richard Hoffman, MD, MPH, an internal medicine professor at the University of Iowa, Iowa City, said in an accompanying editorial.

The study’s trends in mPCa “might be transitory because the screening guidelines have” changed, Dr. Hoffman writes.

For now, clinicians should “consistently address screening with men who are healthy enough to benefit” from catching dangerous tumors early and engage them “in shared decisionmaking discussions to” strike the right balance between minimizing overdiagnosis and catching high-risk tumors before they spread, he said.

Easier said than done, but the field is advancing. Active surveillance, instead of surgery, for what seem to be low-risk tumors is one step in the right direction, Dr. Hoffman commented. 

No external funding was reported. Dr. Desai is a consultant for Procept Biorobotics and Auris Surgical. Dr. Hoffman reported royalties from UpToDate and fees from law firms as an expert witness on prostate cancer screening cases.

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

The incidence of metastatic prostate cancer shot up in the United States after the U.S. Preventive Services Task Force recommended against routinely screening men with the prostate-specific antigen (PSA), shows a report published online in JAMA Network Open.

It was a consequence that many experts in prostate cancer predicted at the time the recommendation was made – initially in 2008 against routine screening in men older than 75 years, then in all men in 2012.

The thinking was that the harms of screening all men – leading to unnecessary prostatectomies and other treatments in many men – outweighed the benefits of catching early high-risk disease in fewer men. Screening rates plummeted as a result.

But experts in prostate cancer warned that the move, while reducing overdiagnosis and overtreatment, would have the unfortunate consequence of underdiagnosis and, consequently, nondetection of the cases of prostate cancer that would spread. 

The new findings are the latest to suggest that this is, in fact, what happened, and echo similar findings previously reported by this news organization.  

For this study, investigators at the University of Southern California, Los Angeles, analyzed the incidence of metastatic prostate cancer (mPCa) in the Surveillance, Epidemiology, and End Results (SEER) database from 2004-2018, with 2018 being the latest data available.

SEER captures about 28% of the U.S. population and recorded almost 50,000 new mPCa cases over the period.

Among men 45-75 years old, the incidence of mPCa increased 41% from when USPSTF recommended against screening through 2018, which translated to an annual percentage change (APC) of 5.3%.

Among men 75 years and older, mPCa rates jumped 43% through 2018, an APC of 6.5%.

The researchers did not find an increase in deaths from prostate cancer, but given the 5-7 years median survival, it might be too early to tell.

“The observation of a rising incidence of mPCa in itself does not imply that screening practices should be changed. The overall risk versus benefit of PSA-based screening is extremely complex and must take into account various other factors that impact the overall health of the community,” say investigators, led by Mihir Desai, MD, a clinical urology professor at USC. 

However, screening practices have already changed. The USPSTF withdrew its objections to screening in 2018 and instead recommended personalized decisionmaking for men 55-69 years old, citing new evidence that screening prevents metastatic disease and reduces PCa mortality more than previously recognized, Richard Hoffman, MD, MPH, an internal medicine professor at the University of Iowa, Iowa City, said in an accompanying editorial.

The study’s trends in mPCa “might be transitory because the screening guidelines have” changed, Dr. Hoffman writes.

For now, clinicians should “consistently address screening with men who are healthy enough to benefit” from catching dangerous tumors early and engage them “in shared decisionmaking discussions to” strike the right balance between minimizing overdiagnosis and catching high-risk tumors before they spread, he said.

Easier said than done, but the field is advancing. Active surveillance, instead of surgery, for what seem to be low-risk tumors is one step in the right direction, Dr. Hoffman commented. 

No external funding was reported. Dr. Desai is a consultant for Procept Biorobotics and Auris Surgical. Dr. Hoffman reported royalties from UpToDate and fees from law firms as an expert witness on prostate cancer screening cases.

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

The incidence of metastatic prostate cancer shot up in the United States after the U.S. Preventive Services Task Force recommended against routinely screening men with the prostate-specific antigen (PSA), shows a report published online in JAMA Network Open.

It was a consequence that many experts in prostate cancer predicted at the time the recommendation was made – initially in 2008 against routine screening in men older than 75 years, then in all men in 2012.

The thinking was that the harms of screening all men – leading to unnecessary prostatectomies and other treatments in many men – outweighed the benefits of catching early high-risk disease in fewer men. Screening rates plummeted as a result.

But experts in prostate cancer warned that the move, while reducing overdiagnosis and overtreatment, would have the unfortunate consequence of underdiagnosis and, consequently, nondetection of the cases of prostate cancer that would spread. 

The new findings are the latest to suggest that this is, in fact, what happened, and echo similar findings previously reported by this news organization.  

For this study, investigators at the University of Southern California, Los Angeles, analyzed the incidence of metastatic prostate cancer (mPCa) in the Surveillance, Epidemiology, and End Results (SEER) database from 2004-2018, with 2018 being the latest data available.

SEER captures about 28% of the U.S. population and recorded almost 50,000 new mPCa cases over the period.

Among men 45-75 years old, the incidence of mPCa increased 41% from when USPSTF recommended against screening through 2018, which translated to an annual percentage change (APC) of 5.3%.

Among men 75 years and older, mPCa rates jumped 43% through 2018, an APC of 6.5%.

The researchers did not find an increase in deaths from prostate cancer, but given the 5-7 years median survival, it might be too early to tell.

“The observation of a rising incidence of mPCa in itself does not imply that screening practices should be changed. The overall risk versus benefit of PSA-based screening is extremely complex and must take into account various other factors that impact the overall health of the community,” say investigators, led by Mihir Desai, MD, a clinical urology professor at USC. 

However, screening practices have already changed. The USPSTF withdrew its objections to screening in 2018 and instead recommended personalized decisionmaking for men 55-69 years old, citing new evidence that screening prevents metastatic disease and reduces PCa mortality more than previously recognized, Richard Hoffman, MD, MPH, an internal medicine professor at the University of Iowa, Iowa City, said in an accompanying editorial.

The study’s trends in mPCa “might be transitory because the screening guidelines have” changed, Dr. Hoffman writes.

For now, clinicians should “consistently address screening with men who are healthy enough to benefit” from catching dangerous tumors early and engage them “in shared decisionmaking discussions to” strike the right balance between minimizing overdiagnosis and catching high-risk tumors before they spread, he said.

Easier said than done, but the field is advancing. Active surveillance, instead of surgery, for what seem to be low-risk tumors is one step in the right direction, Dr. Hoffman commented. 

No external funding was reported. Dr. Desai is a consultant for Procept Biorobotics and Auris Surgical. Dr. Hoffman reported royalties from UpToDate and fees from law firms as an expert witness on prostate cancer screening cases.

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

The global burden of thyroid cancer is substantial, and incidence rates are increasing in many developed countries, including the Unites States, concluded a new analysis based on 30 years of observational data.

“We report overall increases in the burden of thyroid cancer across the majority of EU15+ countries between 1990 and 2019, evidenced by plateaus in incidence rates and reductions in mortality and DALY [disability-adjusted life-years] rates,” the authors reported.

“However, in a number of countries, including the U.S., there are unfavorable increasing mortality and DALY trends over this time period ... [and] a better understanding of the trends in the disease burden of thyroid cancer may help to inform future health system planning,” they added.

The study was published online March 10, 2022, in JAMA Otolaryngology–Head & Neck Surgery.
 

Trends in thyroid cancer

For the analysis, James Schuster-Bruce, MBChB, from St. George’s University Hospital NHS Foundation Trust, London, and colleagues compared trends in thyroid cancer across 30 years of follow-up among 15 countries of the (pre-2004) European Union as well as those in the United States, Australia, Canada, and Norway (EU15+).

Data from the Global Burden of Disease study database were used to track these trends. “We extracted age-standardized incidence rates (ASIRs), age-standardized mortality rates (ASMRs), and DALYs for thyroid cancer from EU15+ countries between 1990 and 2019 using the dedicated GBD study results tool,” the investigators explained.

In 2019, ASIRs were highest in Italy at 6.36 per 100,000 population, followed by the United States at a rate of 5.59 per 100,000 population – although incidence rates of thyroid cancer have actually recently decreased in U.S. women, they noted.

“Thirteen of 19 countries showed an average annual percentage increase in ASIR across the study period,” the investigators added. Out of all the EU15+ countries, the average annual percentage change (AAPC) was the highest in Australia at 2.5 per 100,000 population and the United States at 1.2 per 100,000.

On the other hand, a largely plateauing trend in incidence rates across the majority of EU15+ nations has been observed since 1990, as reflected by incidence rates ranging from –0.8 to 0.8 per 100,000 in the most recent period, the researchers added. ASMRs ranged from a 0.40 per 100,000 in Greece to 0.57 per 100,000 in Luxembourg.

In the United States, the ASMR in 2019 was 0.43 per 100,000 population while the ASMR was the lowest in the United Kingdom in the same year at 0.38 per 100,000 population.

Australia, Denmark, and the United States were the only countries showing positive AAPC changes, the team observed. For example, in the most recent period to 2019, Denmark and Australia had reductions in ASMR trends, whereas in the United States, the trend was toward increasing ASMRs 

In 2019, the DALYs of the EU15+ nations ranged from 9.63 per 100,000 in the United Kingdom to 14.46 per 100,000 in Luxembourg. In the most recent period, a downward trend in DALYs was observed in Australia and Denmark while it plateaued in the United States.

“Overall, we identified improvements in thyroid cancer mortality and DALYs, but overall increases in thyroid cancer incidence in EU15+ countries over the past 3 decades,” the investigators commented.

It has been widely suggested that improvements in diagnostic techniques have contributed significantly to increasing incidence rates of thyroid cancer, but there is concern about overdiagnosis.  Newer diagnostic techniques detect significant numbers of slow-growing, subclinical papillary thyroid cancers that make up at least one quarter of all thyroid cancer subtypes, the authors pointed out.

“It has therefore been suggested that an increase in subclinical disease has inflated the data to look more substantial than the clinical reality,” the authors wrote. However, they insisted that overdiagnosis alone is unlikely to account entirely for increasing incidence trends in the current analysis.

Rather, their concern for countries with high incidence rates of thyroid cancer is the surveillance burden of disease that does not affect mortality. “Close observation of future time trends in thyroid cancer disease burden should be performed in the context of recent changes in international clinical practice guidelines, which have suggested more conservative diagnostic and management strategies,” the authors suggested.

“In the context of the more conservative treatment guidelines and reported increase in true disease, it is important to closely observe mortality and DALYs over the coming years to ensure optimum thyroid cancer management in these nations,” they added.

The study had no specific funding. Dr. Schuster-Bruce disclosed no relevant financial relationships.

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

The global burden of thyroid cancer is substantial, and incidence rates are increasing in many developed countries, including the Unites States, concluded a new analysis based on 30 years of observational data.

“We report overall increases in the burden of thyroid cancer across the majority of EU15+ countries between 1990 and 2019, evidenced by plateaus in incidence rates and reductions in mortality and DALY [disability-adjusted life-years] rates,” the authors reported.

“However, in a number of countries, including the U.S., there are unfavorable increasing mortality and DALY trends over this time period ... [and] a better understanding of the trends in the disease burden of thyroid cancer may help to inform future health system planning,” they added.

The study was published online March 10, 2022, in JAMA Otolaryngology–Head & Neck Surgery.
 

Trends in thyroid cancer

For the analysis, James Schuster-Bruce, MBChB, from St. George’s University Hospital NHS Foundation Trust, London, and colleagues compared trends in thyroid cancer across 30 years of follow-up among 15 countries of the (pre-2004) European Union as well as those in the United States, Australia, Canada, and Norway (EU15+).

Data from the Global Burden of Disease study database were used to track these trends. “We extracted age-standardized incidence rates (ASIRs), age-standardized mortality rates (ASMRs), and DALYs for thyroid cancer from EU15+ countries between 1990 and 2019 using the dedicated GBD study results tool,” the investigators explained.

In 2019, ASIRs were highest in Italy at 6.36 per 100,000 population, followed by the United States at a rate of 5.59 per 100,000 population – although incidence rates of thyroid cancer have actually recently decreased in U.S. women, they noted.

“Thirteen of 19 countries showed an average annual percentage increase in ASIR across the study period,” the investigators added. Out of all the EU15+ countries, the average annual percentage change (AAPC) was the highest in Australia at 2.5 per 100,000 population and the United States at 1.2 per 100,000.

On the other hand, a largely plateauing trend in incidence rates across the majority of EU15+ nations has been observed since 1990, as reflected by incidence rates ranging from –0.8 to 0.8 per 100,000 in the most recent period, the researchers added. ASMRs ranged from a 0.40 per 100,000 in Greece to 0.57 per 100,000 in Luxembourg.

In the United States, the ASMR in 2019 was 0.43 per 100,000 population while the ASMR was the lowest in the United Kingdom in the same year at 0.38 per 100,000 population.

Australia, Denmark, and the United States were the only countries showing positive AAPC changes, the team observed. For example, in the most recent period to 2019, Denmark and Australia had reductions in ASMR trends, whereas in the United States, the trend was toward increasing ASMRs 

In 2019, the DALYs of the EU15+ nations ranged from 9.63 per 100,000 in the United Kingdom to 14.46 per 100,000 in Luxembourg. In the most recent period, a downward trend in DALYs was observed in Australia and Denmark while it plateaued in the United States.

“Overall, we identified improvements in thyroid cancer mortality and DALYs, but overall increases in thyroid cancer incidence in EU15+ countries over the past 3 decades,” the investigators commented.

It has been widely suggested that improvements in diagnostic techniques have contributed significantly to increasing incidence rates of thyroid cancer, but there is concern about overdiagnosis.  Newer diagnostic techniques detect significant numbers of slow-growing, subclinical papillary thyroid cancers that make up at least one quarter of all thyroid cancer subtypes, the authors pointed out.

“It has therefore been suggested that an increase in subclinical disease has inflated the data to look more substantial than the clinical reality,” the authors wrote. However, they insisted that overdiagnosis alone is unlikely to account entirely for increasing incidence trends in the current analysis.

Rather, their concern for countries with high incidence rates of thyroid cancer is the surveillance burden of disease that does not affect mortality. “Close observation of future time trends in thyroid cancer disease burden should be performed in the context of recent changes in international clinical practice guidelines, which have suggested more conservative diagnostic and management strategies,” the authors suggested.

“In the context of the more conservative treatment guidelines and reported increase in true disease, it is important to closely observe mortality and DALYs over the coming years to ensure optimum thyroid cancer management in these nations,” they added.

The study had no specific funding. Dr. Schuster-Bruce disclosed no relevant financial relationships.

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

The global burden of thyroid cancer is substantial, and incidence rates are increasing in many developed countries, including the Unites States, concluded a new analysis based on 30 years of observational data.

“We report overall increases in the burden of thyroid cancer across the majority of EU15+ countries between 1990 and 2019, evidenced by plateaus in incidence rates and reductions in mortality and DALY [disability-adjusted life-years] rates,” the authors reported.

“However, in a number of countries, including the U.S., there are unfavorable increasing mortality and DALY trends over this time period ... [and] a better understanding of the trends in the disease burden of thyroid cancer may help to inform future health system planning,” they added.

The study was published online March 10, 2022, in JAMA Otolaryngology–Head & Neck Surgery.
 

Trends in thyroid cancer

For the analysis, James Schuster-Bruce, MBChB, from St. George’s University Hospital NHS Foundation Trust, London, and colleagues compared trends in thyroid cancer across 30 years of follow-up among 15 countries of the (pre-2004) European Union as well as those in the United States, Australia, Canada, and Norway (EU15+).

Data from the Global Burden of Disease study database were used to track these trends. “We extracted age-standardized incidence rates (ASIRs), age-standardized mortality rates (ASMRs), and DALYs for thyroid cancer from EU15+ countries between 1990 and 2019 using the dedicated GBD study results tool,” the investigators explained.

In 2019, ASIRs were highest in Italy at 6.36 per 100,000 population, followed by the United States at a rate of 5.59 per 100,000 population – although incidence rates of thyroid cancer have actually recently decreased in U.S. women, they noted.

“Thirteen of 19 countries showed an average annual percentage increase in ASIR across the study period,” the investigators added. Out of all the EU15+ countries, the average annual percentage change (AAPC) was the highest in Australia at 2.5 per 100,000 population and the United States at 1.2 per 100,000.

On the other hand, a largely plateauing trend in incidence rates across the majority of EU15+ nations has been observed since 1990, as reflected by incidence rates ranging from –0.8 to 0.8 per 100,000 in the most recent period, the researchers added. ASMRs ranged from a 0.40 per 100,000 in Greece to 0.57 per 100,000 in Luxembourg.

In the United States, the ASMR in 2019 was 0.43 per 100,000 population while the ASMR was the lowest in the United Kingdom in the same year at 0.38 per 100,000 population.

Australia, Denmark, and the United States were the only countries showing positive AAPC changes, the team observed. For example, in the most recent period to 2019, Denmark and Australia had reductions in ASMR trends, whereas in the United States, the trend was toward increasing ASMRs 

In 2019, the DALYs of the EU15+ nations ranged from 9.63 per 100,000 in the United Kingdom to 14.46 per 100,000 in Luxembourg. In the most recent period, a downward trend in DALYs was observed in Australia and Denmark while it plateaued in the United States.

“Overall, we identified improvements in thyroid cancer mortality and DALYs, but overall increases in thyroid cancer incidence in EU15+ countries over the past 3 decades,” the investigators commented.

It has been widely suggested that improvements in diagnostic techniques have contributed significantly to increasing incidence rates of thyroid cancer, but there is concern about overdiagnosis.  Newer diagnostic techniques detect significant numbers of slow-growing, subclinical papillary thyroid cancers that make up at least one quarter of all thyroid cancer subtypes, the authors pointed out.

“It has therefore been suggested that an increase in subclinical disease has inflated the data to look more substantial than the clinical reality,” the authors wrote. However, they insisted that overdiagnosis alone is unlikely to account entirely for increasing incidence trends in the current analysis.

Rather, their concern for countries with high incidence rates of thyroid cancer is the surveillance burden of disease that does not affect mortality. “Close observation of future time trends in thyroid cancer disease burden should be performed in the context of recent changes in international clinical practice guidelines, which have suggested more conservative diagnostic and management strategies,” the authors suggested.

“In the context of the more conservative treatment guidelines and reported increase in true disease, it is important to closely observe mortality and DALYs over the coming years to ensure optimum thyroid cancer management in these nations,” they added.

The study had no specific funding. Dr. Schuster-Bruce disclosed no relevant financial relationships.

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

Cancer significantly raises a patient’s risk for cardiovascular morbidity and mortality, particularly within the first year after diagnosis and irrespective of cancer type, according to a population-based study.

The retrospective analysis, which included data from more than 200,000 patients with cancer, found that a new cancer diagnosis significantly increased the risk of cardiovascular (CV) death (hazard ratio [HR], 1.33) as well as other CV events, including stroke (HR, 1.44), heart failure (HR, 1.62) and pulmonary embolism (HR, 3.43).

From the results, the researchers concluded that a “new cancer diagnosis is independently associated with a significantly increased risk for cardiovascular death and nonfatal morbidity regardless of cancer site.”

The findings were published in the Journal of the American College of Cardiology: CardioOncology (2022 Mar;4[1]:85-94).

Patients with cancer and cancer survivors are known to have an increased risk for heart failure, but evidence on the risk for other CV outcomes remains less clear. In addition, the authors noted, many cancer therapies – including chest irradiation and chemotherapy – can increase a person’s risk of incident CV disease during treatment and after, but data on the long-term CV risk among cancer survivors conflict.

D. Ian Paterson, MD, of the University of Alberta, Edmonton, and coauthors wanted to clarify how a new cancer diagnosis at various sites and stages might affect a person’s risk for fatal and nonfatal CV events over the long term.

The current analysis included data from 224,016 patients with a new cancer diagnosis identified from an administrative database of more than 4.5 million adults residing in Alberta. The researcher identified 73,360 CV deaths and 470,481 nonfatal CV events between April 2007 and December 2018.

Comparing CV events in those with and in those without cancer, the authors found that patients with cancer had a 33% increased risk for CV mortality over the 12-year study follow-up, after adjusting for sociodemographic data and comorbidities (HR, 1.33; 95% confidence interval [CI], 1.29-1.37). Patients with cancer also had an increased risk for stroke (HR, 1.44), heart failure (HR, 1.62) and pulmonary embolism (HR, 3.43), though not myocardial infarction (HR, 1.01; 95% CI, 0.97 – 1.05), compared to those without cancer.

The extent of the risk varied somewhat by cancer stage, time from diagnosis, and cancer type.

A new cancer diagnosis put patients at a significantly higher risk of CV mortality, heart failure, stroke, or pulmonary embolism, regardless of the cancer site, but the risk of CV events was highest for patients with genitourinary, gastrointestinal, thoracic, nervous system, and hematologic malignancies. These patients accounted for more than half of the cancer cohort and more than 70% of the incident CV burden.

Patients with more advanced cancer were at the highest risk for poor CV outcomes, but even those with very early-stage disease faced an elevated risk.

The risk for CV events was greatest in the first year following a cancer diagnosis for all outcomes (HRs, 1.24-8.36) but remained significantly elevated for CV death, heart failure, and pulmonary embolism a decade later.

Overall, the authors concluded that “patients with cancer constitute a high-risk population for CV disease” over the long term and suggested that those with cancer “may benefit from comanagement that includes cardiologists as well as stroke and thrombosis specialists.”

In an accompanying editorial, Hiroshi Ohtsu of Juntendo University in Tokyo, and colleagues concluded that the work “has remarkable strengths” and important clinical implications. However, they said that additional steps may be warranted before translating these findings to clinical practice.

For example, the study is limited by its retrospective population-based design and the lack of data on cancer therapy as well as on several patient factors, including ethnicity, smoking, and physical activity.

The study authors agreed, noting that future work should evaluate how cancer therapies and other potential contributors to poor CV outcomes influence patients’ risk.

“Such work would potentially lead to better prediction of CV risk for patients with cancer and survivors and improved prevention and treatment strategies,” they wrote.

The study was supported by a foundation grant from the Canadian Institutes of Health Research. The authors have disclosed no relevant financial relationships. The editorial was supported in part by funding to individual authors from the Japan Society for the Promotion of Science/Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Agency for Medical Research and Development.

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

Cancer significantly raises a patient’s risk for cardiovascular morbidity and mortality, particularly within the first year after diagnosis and irrespective of cancer type, according to a population-based study.

The retrospective analysis, which included data from more than 200,000 patients with cancer, found that a new cancer diagnosis significantly increased the risk of cardiovascular (CV) death (hazard ratio [HR], 1.33) as well as other CV events, including stroke (HR, 1.44), heart failure (HR, 1.62) and pulmonary embolism (HR, 3.43).

From the results, the researchers concluded that a “new cancer diagnosis is independently associated with a significantly increased risk for cardiovascular death and nonfatal morbidity regardless of cancer site.”

The findings were published in the Journal of the American College of Cardiology: CardioOncology (2022 Mar;4[1]:85-94).

Patients with cancer and cancer survivors are known to have an increased risk for heart failure, but evidence on the risk for other CV outcomes remains less clear. In addition, the authors noted, many cancer therapies – including chest irradiation and chemotherapy – can increase a person’s risk of incident CV disease during treatment and after, but data on the long-term CV risk among cancer survivors conflict.

D. Ian Paterson, MD, of the University of Alberta, Edmonton, and coauthors wanted to clarify how a new cancer diagnosis at various sites and stages might affect a person’s risk for fatal and nonfatal CV events over the long term.

The current analysis included data from 224,016 patients with a new cancer diagnosis identified from an administrative database of more than 4.5 million adults residing in Alberta. The researcher identified 73,360 CV deaths and 470,481 nonfatal CV events between April 2007 and December 2018.

Comparing CV events in those with and in those without cancer, the authors found that patients with cancer had a 33% increased risk for CV mortality over the 12-year study follow-up, after adjusting for sociodemographic data and comorbidities (HR, 1.33; 95% confidence interval [CI], 1.29-1.37). Patients with cancer also had an increased risk for stroke (HR, 1.44), heart failure (HR, 1.62) and pulmonary embolism (HR, 3.43), though not myocardial infarction (HR, 1.01; 95% CI, 0.97 – 1.05), compared to those without cancer.

The extent of the risk varied somewhat by cancer stage, time from diagnosis, and cancer type.

A new cancer diagnosis put patients at a significantly higher risk of CV mortality, heart failure, stroke, or pulmonary embolism, regardless of the cancer site, but the risk of CV events was highest for patients with genitourinary, gastrointestinal, thoracic, nervous system, and hematologic malignancies. These patients accounted for more than half of the cancer cohort and more than 70% of the incident CV burden.

Patients with more advanced cancer were at the highest risk for poor CV outcomes, but even those with very early-stage disease faced an elevated risk.

The risk for CV events was greatest in the first year following a cancer diagnosis for all outcomes (HRs, 1.24-8.36) but remained significantly elevated for CV death, heart failure, and pulmonary embolism a decade later.

Overall, the authors concluded that “patients with cancer constitute a high-risk population for CV disease” over the long term and suggested that those with cancer “may benefit from comanagement that includes cardiologists as well as stroke and thrombosis specialists.”

In an accompanying editorial, Hiroshi Ohtsu of Juntendo University in Tokyo, and colleagues concluded that the work “has remarkable strengths” and important clinical implications. However, they said that additional steps may be warranted before translating these findings to clinical practice.

For example, the study is limited by its retrospective population-based design and the lack of data on cancer therapy as well as on several patient factors, including ethnicity, smoking, and physical activity.

The study authors agreed, noting that future work should evaluate how cancer therapies and other potential contributors to poor CV outcomes influence patients’ risk.

“Such work would potentially lead to better prediction of CV risk for patients with cancer and survivors and improved prevention and treatment strategies,” they wrote.

The study was supported by a foundation grant from the Canadian Institutes of Health Research. The authors have disclosed no relevant financial relationships. The editorial was supported in part by funding to individual authors from the Japan Society for the Promotion of Science/Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Agency for Medical Research and Development.

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

Cancer significantly raises a patient’s risk for cardiovascular morbidity and mortality, particularly within the first year after diagnosis and irrespective of cancer type, according to a population-based study.

The retrospective analysis, which included data from more than 200,000 patients with cancer, found that a new cancer diagnosis significantly increased the risk of cardiovascular (CV) death (hazard ratio [HR], 1.33) as well as other CV events, including stroke (HR, 1.44), heart failure (HR, 1.62) and pulmonary embolism (HR, 3.43).

From the results, the researchers concluded that a “new cancer diagnosis is independently associated with a significantly increased risk for cardiovascular death and nonfatal morbidity regardless of cancer site.”

The findings were published in the Journal of the American College of Cardiology: CardioOncology (2022 Mar;4[1]:85-94).

Patients with cancer and cancer survivors are known to have an increased risk for heart failure, but evidence on the risk for other CV outcomes remains less clear. In addition, the authors noted, many cancer therapies – including chest irradiation and chemotherapy – can increase a person’s risk of incident CV disease during treatment and after, but data on the long-term CV risk among cancer survivors conflict.

D. Ian Paterson, MD, of the University of Alberta, Edmonton, and coauthors wanted to clarify how a new cancer diagnosis at various sites and stages might affect a person’s risk for fatal and nonfatal CV events over the long term.

The current analysis included data from 224,016 patients with a new cancer diagnosis identified from an administrative database of more than 4.5 million adults residing in Alberta. The researcher identified 73,360 CV deaths and 470,481 nonfatal CV events between April 2007 and December 2018.

Comparing CV events in those with and in those without cancer, the authors found that patients with cancer had a 33% increased risk for CV mortality over the 12-year study follow-up, after adjusting for sociodemographic data and comorbidities (HR, 1.33; 95% confidence interval [CI], 1.29-1.37). Patients with cancer also had an increased risk for stroke (HR, 1.44), heart failure (HR, 1.62) and pulmonary embolism (HR, 3.43), though not myocardial infarction (HR, 1.01; 95% CI, 0.97 – 1.05), compared to those without cancer.

The extent of the risk varied somewhat by cancer stage, time from diagnosis, and cancer type.

A new cancer diagnosis put patients at a significantly higher risk of CV mortality, heart failure, stroke, or pulmonary embolism, regardless of the cancer site, but the risk of CV events was highest for patients with genitourinary, gastrointestinal, thoracic, nervous system, and hematologic malignancies. These patients accounted for more than half of the cancer cohort and more than 70% of the incident CV burden.

Patients with more advanced cancer were at the highest risk for poor CV outcomes, but even those with very early-stage disease faced an elevated risk.

The risk for CV events was greatest in the first year following a cancer diagnosis for all outcomes (HRs, 1.24-8.36) but remained significantly elevated for CV death, heart failure, and pulmonary embolism a decade later.

Overall, the authors concluded that “patients with cancer constitute a high-risk population for CV disease” over the long term and suggested that those with cancer “may benefit from comanagement that includes cardiologists as well as stroke and thrombosis specialists.”

In an accompanying editorial, Hiroshi Ohtsu of Juntendo University in Tokyo, and colleagues concluded that the work “has remarkable strengths” and important clinical implications. However, they said that additional steps may be warranted before translating these findings to clinical practice.

For example, the study is limited by its retrospective population-based design and the lack of data on cancer therapy as well as on several patient factors, including ethnicity, smoking, and physical activity.

The study authors agreed, noting that future work should evaluate how cancer therapies and other potential contributors to poor CV outcomes influence patients’ risk.

“Such work would potentially lead to better prediction of CV risk for patients with cancer and survivors and improved prevention and treatment strategies,” they wrote.

The study was supported by a foundation grant from the Canadian Institutes of Health Research. The authors have disclosed no relevant financial relationships. The editorial was supported in part by funding to individual authors from the Japan Society for the Promotion of Science/Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Agency for Medical Research and Development.

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

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

Loss of vestibular function is a key contributor to a well-documented increased risk for falls in patients with Alzheimer’s disease (AD), new research confirms.

Falls are twice as common in patients with AD versu older individuals without the disorder and significantly increase the likelihood of institutionalization.

However, researchers recorded fewer falls in patients with a better functioning vestibular system, which detects head movements and plays a critical role in spatial orientation, posture, gait, and balance.

The results suggest that improving vestibular function with currently available therapies may prevent falls, something the researchers will investigate in a new clinical trial launching next month.

“One of the most dangerous and impactful symptoms in terms of function in patients with Alzheimer’s disease is their increased predisposition to falls,” study investigator Yuri Agrawal, MD, department of otolaryngology–head and neck surgery, Johns Hopkins University School of Medicine, Baltimore, said in an interview. “Alzheimer’s is the sixth leading cause of death in the U.S., and some people actually say that that high mortality rate is because of their predisposition to falls and the injuries that occur.”

The study was published online Feb. 14 in the Journal of Alzheimer’s Disease.
 

The ‘sixth hidden sense’

The vestibular system consists of three semicircular canals, which detect rotational head movement, and two otolith organs called the utricle and the saccule, which sense linear head movements and the orientation of the head with respect to gravity.

“We call the vestibular system the sixth hidden sense because it’s not a conscious perception like taste or smell,” Dr. Agrawal said. “It’s constantly providing input to our brain about where we are in space.”

Dr. Agrawal and colleagues previously reported that vestibular loss is twice as common in Alzheimer’s patients as in cognitively unimpaired age-matched controls. Now, they wanted to know if this sensory loss was associated with an increased risk for falls in this population.

The study included 48 patients age greater than or equal to 60 years with mild-to-moderate AD between 2018 and 2020. They also included an age-matched control group of healthy controls with no cognitive impairment.

Researchers assessed vestibular function at baseline by measuring semicircular canal and saccular function. One test required participants to wear goggles and complete a series of tests with their eyes open and closed while researchers recorded their eye movement with video-oculography. They also measured participants’ balance using the Berg Balance Scale.

Relative to matched controls, AD patients exhibited increased lateral instability when their eyes were open (P = .033) and closed (P = .042). Studies suggest that lateral stability declines more quickly with age and that instability with eyes closed is the single biggest predictor of incident falls in community-dwelling adults.

To determine if poor vestibular function increased fall risk in patients with AD, researchers followed the cohort for up to 2 years.

“We found that patients with vestibular loss at baseline were 50% more likely to fall, adjusting for other factors that could contribute to that,” Dr. Agrawal said.

Specifically, better semicircular canal function was significantly associated with lower likelihood of falls, even after adjusting for confounders (adjusted hazard ratio, 0.65; P = .009).
 

Can therapy help?

Commenting on the findings, James Burke, MD, PhD, professor of neurology at Duke University Medical Center, Durham, N.C., said that the finding that impaired vestibular function is associated with increased falls “significantly advances our understanding of the topic” and suggests that treating vestibular dysfunction could reduce falls in Alzheimer’s patients.

“Screening patients with Alzheimer’s disease for impaired vestibular function could lead to identification of individuals at high risk of falls and target those who would benefit from vestibular therapy,” he said.

Vestibular rehabilitation therapy is often used to treat a number of disorders related to vestibular function loss. There are also studies underway to measure the efficacy of a vestibular implant that works much like a cochlear implant.

While evaluation of vestibular function is currently not routinely included in AD care, studies such as these suggest it may be time to consider adding it to the standard of care, Jennifer Coto, PhD, assistant professor of otolaryngology at the University of Miami Miller School of Medicine, said in an interview.

“Best practice guidelines for management of Alzheimer’s patients should be revised to include routine vestibular evaluation and support from a multidisciplinary team that may address other crucial areas of functioning, particularly psychological functioning, sleep, and independence,” she said.

“Future research also needs to evaluate the effectiveness of vestibular therapy in patients with Alzheimer’s and the benefits of early identification and intervention for preventing recurrent falls.”

Dr. Agrawal is leading a 5-year, $3.5 million National Institute on Aging study that seeks to do just that. Enrollment in the study begins next month. Patients will complete an initial in-person screening, but the remainder of the study will be conducted virtually.

Therapies will be noninvasive, nonpharmaceutical, and performed in participants’ homes. If the therapy is successful at reducing falls, Dr. Agrawal said the virtual design would significantly broaden its potential patient reach.

The study was funded by the National Institute on Aging. Study authors’ disclosures are reported in the original article. Dr. Coto and Dr. Burke report no relevant financial relationships.

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

Loss of vestibular function is a key contributor to a well-documented increased risk for falls in patients with Alzheimer’s disease (AD), new research confirms.

Falls are twice as common in patients with AD versu older individuals without the disorder and significantly increase the likelihood of institutionalization.

However, researchers recorded fewer falls in patients with a better functioning vestibular system, which detects head movements and plays a critical role in spatial orientation, posture, gait, and balance.

The results suggest that improving vestibular function with currently available therapies may prevent falls, something the researchers will investigate in a new clinical trial launching next month.

“One of the most dangerous and impactful symptoms in terms of function in patients with Alzheimer’s disease is their increased predisposition to falls,” study investigator Yuri Agrawal, MD, department of otolaryngology–head and neck surgery, Johns Hopkins University School of Medicine, Baltimore, said in an interview. “Alzheimer’s is the sixth leading cause of death in the U.S., and some people actually say that that high mortality rate is because of their predisposition to falls and the injuries that occur.”

The study was published online Feb. 14 in the Journal of Alzheimer’s Disease.
 

The ‘sixth hidden sense’

The vestibular system consists of three semicircular canals, which detect rotational head movement, and two otolith organs called the utricle and the saccule, which sense linear head movements and the orientation of the head with respect to gravity.

“We call the vestibular system the sixth hidden sense because it’s not a conscious perception like taste or smell,” Dr. Agrawal said. “It’s constantly providing input to our brain about where we are in space.”

Dr. Agrawal and colleagues previously reported that vestibular loss is twice as common in Alzheimer’s patients as in cognitively unimpaired age-matched controls. Now, they wanted to know if this sensory loss was associated with an increased risk for falls in this population.

The study included 48 patients age greater than or equal to 60 years with mild-to-moderate AD between 2018 and 2020. They also included an age-matched control group of healthy controls with no cognitive impairment.

Researchers assessed vestibular function at baseline by measuring semicircular canal and saccular function. One test required participants to wear goggles and complete a series of tests with their eyes open and closed while researchers recorded their eye movement with video-oculography. They also measured participants’ balance using the Berg Balance Scale.

Relative to matched controls, AD patients exhibited increased lateral instability when their eyes were open (P = .033) and closed (P = .042). Studies suggest that lateral stability declines more quickly with age and that instability with eyes closed is the single biggest predictor of incident falls in community-dwelling adults.

To determine if poor vestibular function increased fall risk in patients with AD, researchers followed the cohort for up to 2 years.

“We found that patients with vestibular loss at baseline were 50% more likely to fall, adjusting for other factors that could contribute to that,” Dr. Agrawal said.

Specifically, better semicircular canal function was significantly associated with lower likelihood of falls, even after adjusting for confounders (adjusted hazard ratio, 0.65; P = .009).
 

Can therapy help?

Commenting on the findings, James Burke, MD, PhD, professor of neurology at Duke University Medical Center, Durham, N.C., said that the finding that impaired vestibular function is associated with increased falls “significantly advances our understanding of the topic” and suggests that treating vestibular dysfunction could reduce falls in Alzheimer’s patients.

“Screening patients with Alzheimer’s disease for impaired vestibular function could lead to identification of individuals at high risk of falls and target those who would benefit from vestibular therapy,” he said.

Vestibular rehabilitation therapy is often used to treat a number of disorders related to vestibular function loss. There are also studies underway to measure the efficacy of a vestibular implant that works much like a cochlear implant.

While evaluation of vestibular function is currently not routinely included in AD care, studies such as these suggest it may be time to consider adding it to the standard of care, Jennifer Coto, PhD, assistant professor of otolaryngology at the University of Miami Miller School of Medicine, said in an interview.

“Best practice guidelines for management of Alzheimer’s patients should be revised to include routine vestibular evaluation and support from a multidisciplinary team that may address other crucial areas of functioning, particularly psychological functioning, sleep, and independence,” she said.

“Future research also needs to evaluate the effectiveness of vestibular therapy in patients with Alzheimer’s and the benefits of early identification and intervention for preventing recurrent falls.”

Dr. Agrawal is leading a 5-year, $3.5 million National Institute on Aging study that seeks to do just that. Enrollment in the study begins next month. Patients will complete an initial in-person screening, but the remainder of the study will be conducted virtually.

Therapies will be noninvasive, nonpharmaceutical, and performed in participants’ homes. If the therapy is successful at reducing falls, Dr. Agrawal said the virtual design would significantly broaden its potential patient reach.

The study was funded by the National Institute on Aging. Study authors’ disclosures are reported in the original article. Dr. Coto and Dr. Burke report no relevant financial relationships.

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

Loss of vestibular function is a key contributor to a well-documented increased risk for falls in patients with Alzheimer’s disease (AD), new research confirms.

Falls are twice as common in patients with AD versu older individuals without the disorder and significantly increase the likelihood of institutionalization.

However, researchers recorded fewer falls in patients with a better functioning vestibular system, which detects head movements and plays a critical role in spatial orientation, posture, gait, and balance.

The results suggest that improving vestibular function with currently available therapies may prevent falls, something the researchers will investigate in a new clinical trial launching next month.

“One of the most dangerous and impactful symptoms in terms of function in patients with Alzheimer’s disease is their increased predisposition to falls,” study investigator Yuri Agrawal, MD, department of otolaryngology–head and neck surgery, Johns Hopkins University School of Medicine, Baltimore, said in an interview. “Alzheimer’s is the sixth leading cause of death in the U.S., and some people actually say that that high mortality rate is because of their predisposition to falls and the injuries that occur.”

The study was published online Feb. 14 in the Journal of Alzheimer’s Disease.
 

The ‘sixth hidden sense’

The vestibular system consists of three semicircular canals, which detect rotational head movement, and two otolith organs called the utricle and the saccule, which sense linear head movements and the orientation of the head with respect to gravity.

“We call the vestibular system the sixth hidden sense because it’s not a conscious perception like taste or smell,” Dr. Agrawal said. “It’s constantly providing input to our brain about where we are in space.”

Dr. Agrawal and colleagues previously reported that vestibular loss is twice as common in Alzheimer’s patients as in cognitively unimpaired age-matched controls. Now, they wanted to know if this sensory loss was associated with an increased risk for falls in this population.

The study included 48 patients age greater than or equal to 60 years with mild-to-moderate AD between 2018 and 2020. They also included an age-matched control group of healthy controls with no cognitive impairment.

Researchers assessed vestibular function at baseline by measuring semicircular canal and saccular function. One test required participants to wear goggles and complete a series of tests with their eyes open and closed while researchers recorded their eye movement with video-oculography. They also measured participants’ balance using the Berg Balance Scale.

Relative to matched controls, AD patients exhibited increased lateral instability when their eyes were open (P = .033) and closed (P = .042). Studies suggest that lateral stability declines more quickly with age and that instability with eyes closed is the single biggest predictor of incident falls in community-dwelling adults.

To determine if poor vestibular function increased fall risk in patients with AD, researchers followed the cohort for up to 2 years.

“We found that patients with vestibular loss at baseline were 50% more likely to fall, adjusting for other factors that could contribute to that,” Dr. Agrawal said.

Specifically, better semicircular canal function was significantly associated with lower likelihood of falls, even after adjusting for confounders (adjusted hazard ratio, 0.65; P = .009).
 

Can therapy help?

Commenting on the findings, James Burke, MD, PhD, professor of neurology at Duke University Medical Center, Durham, N.C., said that the finding that impaired vestibular function is associated with increased falls “significantly advances our understanding of the topic” and suggests that treating vestibular dysfunction could reduce falls in Alzheimer’s patients.

“Screening patients with Alzheimer’s disease for impaired vestibular function could lead to identification of individuals at high risk of falls and target those who would benefit from vestibular therapy,” he said.

Vestibular rehabilitation therapy is often used to treat a number of disorders related to vestibular function loss. There are also studies underway to measure the efficacy of a vestibular implant that works much like a cochlear implant.

While evaluation of vestibular function is currently not routinely included in AD care, studies such as these suggest it may be time to consider adding it to the standard of care, Jennifer Coto, PhD, assistant professor of otolaryngology at the University of Miami Miller School of Medicine, said in an interview.

“Best practice guidelines for management of Alzheimer’s patients should be revised to include routine vestibular evaluation and support from a multidisciplinary team that may address other crucial areas of functioning, particularly psychological functioning, sleep, and independence,” she said.

“Future research also needs to evaluate the effectiveness of vestibular therapy in patients with Alzheimer’s and the benefits of early identification and intervention for preventing recurrent falls.”

Dr. Agrawal is leading a 5-year, $3.5 million National Institute on Aging study that seeks to do just that. Enrollment in the study begins next month. Patients will complete an initial in-person screening, but the remainder of the study will be conducted virtually.

Therapies will be noninvasive, nonpharmaceutical, and performed in participants’ homes. If the therapy is successful at reducing falls, Dr. Agrawal said the virtual design would significantly broaden its potential patient reach.

The study was funded by the National Institute on Aging. Study authors’ disclosures are reported in the original article. Dr. Coto and Dr. Burke report no relevant financial relationships.

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

Many older patients with advanced kidney disease who decide to forgo dialysis still survive for several years after making their decision and have a good quality of life until their final days, a new systematic review of cohort studies suggests.

“Our findings challenge the common misconception that the only alternative to dialysis for many patients with advanced chronic kidney disease is no care or death,” say Susan Wong, MD, of the Renal Dialysis Unit, Seattle, and colleagues in their review, published online March 14 in JAMA Network Open.

In an accompanying commentary, Christine Liu, MD, and Kurella Tamura, MD, MPH, note: “The decision to initiate dialysis or focus on active alleviation of symptoms, known as conservative care … is likely one of the consequential decisions [patients] will face.”

“[But] in reality, dialysis is viewed as the default treatment for kidney failure, and the option to forgo dialysis treatment is often not explicitly discussed,” they add.

“We believe it is time to broaden the scope of kidney replacement therapy registries to include persons who receive conservative treatment of kidney failure … and we need to address the conservative care information gap so that lack of awareness is no longer a barrier to informed decision-making,” Dr. Liu and Dr. Tamura, both from Stanford (Calif.) University, note.

The work by Dr. Wong and colleagues “dispels the notion that conservative care for kidney failure means a grim and near-immediate death. The study advances the idea that a conservative care approach can provide time and sustain quality of life to support patients’ life goals,” they emphasize.
 

Conservative care assessed in 41 studies

The review included 41 studies involving 5,102 patients with a mean age ranging from 60 to 87 years conducted in the United Kingdom, Europe, and Asia.

Median survival of cohorts ranged from 1 to 41 months as measured from a baseline mean estimated glomerular filtration rate (eGFR) ranging from 7 to 19 mL/min/1.73m².

Younger patients between 70 and 79 years of age had a median survival of 7 to 41 months, the authors note, while cohorts consisting of patients 80 years of age and older had a median survival of 1 to 37 months despite overlapping ranges of baseline mean eGFRs.

During an observation period of 8-24 months, mental well-being improved, and physical well-being and overall quality of life were largely stable until late in the course of illness.

“Ten studies … provided information on the use of health care resources during follow-up,” the researchers say. Patients generally experienced one to two hospital admissions, 6-16 in-hospital days, seven to eight clinic visits, and two emergency department visits per person-year. Use of acute care services was “therefore common,” they note.

Not all studies provided information about end-of-life care, but those that did reported rates of hospice enrollment that ranged from 20% to 76%; hospitalization rates during the final month of life from 57% to 76%; in-hospital death rates of 27%-68%, and in-home death rates ranging from 12% to 71%.

This indicates substantial disparity in access to supportive care near the end of life across cohorts, the authors observe.

Nevertheless, “Most patients survived several years after the decision to forgo dialysis was made,” they stress.

“These findings not only suggest that conservative kidney management may be a viable and positive therapeutic alternative to dialysis, they also highlight the strengths of its multidisciplinary approach to care and aggressive symptom management.”

“Collectively, our findings demonstrate the need to implement systematic and unified research methods for conservative kidney management and to develop models of care and the care infrastructure to advance practice and outcomes of conservative kidney management,” they conclude.

Dr. Wong has no financial ties to industry. Dr. Tamura has reported receiving personal fees from the American Federation for Aging Research.

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

Many older patients with advanced kidney disease who decide to forgo dialysis still survive for several years after making their decision and have a good quality of life until their final days, a new systematic review of cohort studies suggests.

“Our findings challenge the common misconception that the only alternative to dialysis for many patients with advanced chronic kidney disease is no care or death,” say Susan Wong, MD, of the Renal Dialysis Unit, Seattle, and colleagues in their review, published online March 14 in JAMA Network Open.

In an accompanying commentary, Christine Liu, MD, and Kurella Tamura, MD, MPH, note: “The decision to initiate dialysis or focus on active alleviation of symptoms, known as conservative care … is likely one of the consequential decisions [patients] will face.”

“[But] in reality, dialysis is viewed as the default treatment for kidney failure, and the option to forgo dialysis treatment is often not explicitly discussed,” they add.

“We believe it is time to broaden the scope of kidney replacement therapy registries to include persons who receive conservative treatment of kidney failure … and we need to address the conservative care information gap so that lack of awareness is no longer a barrier to informed decision-making,” Dr. Liu and Dr. Tamura, both from Stanford (Calif.) University, note.

The work by Dr. Wong and colleagues “dispels the notion that conservative care for kidney failure means a grim and near-immediate death. The study advances the idea that a conservative care approach can provide time and sustain quality of life to support patients’ life goals,” they emphasize.
 

Conservative care assessed in 41 studies

The review included 41 studies involving 5,102 patients with a mean age ranging from 60 to 87 years conducted in the United Kingdom, Europe, and Asia.

Median survival of cohorts ranged from 1 to 41 months as measured from a baseline mean estimated glomerular filtration rate (eGFR) ranging from 7 to 19 mL/min/1.73m².

Younger patients between 70 and 79 years of age had a median survival of 7 to 41 months, the authors note, while cohorts consisting of patients 80 years of age and older had a median survival of 1 to 37 months despite overlapping ranges of baseline mean eGFRs.

During an observation period of 8-24 months, mental well-being improved, and physical well-being and overall quality of life were largely stable until late in the course of illness.

“Ten studies … provided information on the use of health care resources during follow-up,” the researchers say. Patients generally experienced one to two hospital admissions, 6-16 in-hospital days, seven to eight clinic visits, and two emergency department visits per person-year. Use of acute care services was “therefore common,” they note.

Not all studies provided information about end-of-life care, but those that did reported rates of hospice enrollment that ranged from 20% to 76%; hospitalization rates during the final month of life from 57% to 76%; in-hospital death rates of 27%-68%, and in-home death rates ranging from 12% to 71%.

This indicates substantial disparity in access to supportive care near the end of life across cohorts, the authors observe.

Nevertheless, “Most patients survived several years after the decision to forgo dialysis was made,” they stress.

“These findings not only suggest that conservative kidney management may be a viable and positive therapeutic alternative to dialysis, they also highlight the strengths of its multidisciplinary approach to care and aggressive symptom management.”

“Collectively, our findings demonstrate the need to implement systematic and unified research methods for conservative kidney management and to develop models of care and the care infrastructure to advance practice and outcomes of conservative kidney management,” they conclude.

Dr. Wong has no financial ties to industry. Dr. Tamura has reported receiving personal fees from the American Federation for Aging Research.

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

Many older patients with advanced kidney disease who decide to forgo dialysis still survive for several years after making their decision and have a good quality of life until their final days, a new systematic review of cohort studies suggests.

“Our findings challenge the common misconception that the only alternative to dialysis for many patients with advanced chronic kidney disease is no care or death,” say Susan Wong, MD, of the Renal Dialysis Unit, Seattle, and colleagues in their review, published online March 14 in JAMA Network Open.

In an accompanying commentary, Christine Liu, MD, and Kurella Tamura, MD, MPH, note: “The decision to initiate dialysis or focus on active alleviation of symptoms, known as conservative care … is likely one of the consequential decisions [patients] will face.”

“[But] in reality, dialysis is viewed as the default treatment for kidney failure, and the option to forgo dialysis treatment is often not explicitly discussed,” they add.

“We believe it is time to broaden the scope of kidney replacement therapy registries to include persons who receive conservative treatment of kidney failure … and we need to address the conservative care information gap so that lack of awareness is no longer a barrier to informed decision-making,” Dr. Liu and Dr. Tamura, both from Stanford (Calif.) University, note.

The work by Dr. Wong and colleagues “dispels the notion that conservative care for kidney failure means a grim and near-immediate death. The study advances the idea that a conservative care approach can provide time and sustain quality of life to support patients’ life goals,” they emphasize.
 

Conservative care assessed in 41 studies

The review included 41 studies involving 5,102 patients with a mean age ranging from 60 to 87 years conducted in the United Kingdom, Europe, and Asia.

Median survival of cohorts ranged from 1 to 41 months as measured from a baseline mean estimated glomerular filtration rate (eGFR) ranging from 7 to 19 mL/min/1.73m².

Younger patients between 70 and 79 years of age had a median survival of 7 to 41 months, the authors note, while cohorts consisting of patients 80 years of age and older had a median survival of 1 to 37 months despite overlapping ranges of baseline mean eGFRs.

During an observation period of 8-24 months, mental well-being improved, and physical well-being and overall quality of life were largely stable until late in the course of illness.

“Ten studies … provided information on the use of health care resources during follow-up,” the researchers say. Patients generally experienced one to two hospital admissions, 6-16 in-hospital days, seven to eight clinic visits, and two emergency department visits per person-year. Use of acute care services was “therefore common,” they note.

Not all studies provided information about end-of-life care, but those that did reported rates of hospice enrollment that ranged from 20% to 76%; hospitalization rates during the final month of life from 57% to 76%; in-hospital death rates of 27%-68%, and in-home death rates ranging from 12% to 71%.

This indicates substantial disparity in access to supportive care near the end of life across cohorts, the authors observe.

Nevertheless, “Most patients survived several years after the decision to forgo dialysis was made,” they stress.

“These findings not only suggest that conservative kidney management may be a viable and positive therapeutic alternative to dialysis, they also highlight the strengths of its multidisciplinary approach to care and aggressive symptom management.”

“Collectively, our findings demonstrate the need to implement systematic and unified research methods for conservative kidney management and to develop models of care and the care infrastructure to advance practice and outcomes of conservative kidney management,” they conclude.

Dr. Wong has no financial ties to industry. Dr. Tamura has reported receiving personal fees from the American Federation for Aging Research.

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

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

It’s no secret that heavy drinking is linked to potential health problems, from liver damage to a higher risk of cancer. But most people probably wouldn’t think a nightcap every evening is much of a health threat.

Now, new evidence published in Nature Communications suggests even one drink a day is linked to detectable changes in the brain, though it’s not clear whether the alcohol is causing the differences.

Previous research has found that people with alcohol use disorder have structural changes in their brains, compared with healthy people’s brains, such as reduced gray-matter and white-matter volume.

But those findings were in people with a history of heavy drinking, defined by the National Institute on Alcohol Abuse and Alcoholism as more than four drinks a day for men and more than three drinks a day for women.

The national dietary guidelines from the U.S. Department of Health & Human Services advise drinking no more than two standard drinks for men and one drink for women each day. A standard drink in the United States is 12 ounces of beer, 5 ounces of wine, or 1½ ounce of liquor.

But could even this modest amount of alcohol make a difference to our brains?

Researchers examined functional MRI brain scans from 36,678 healthy adults, aged 40-69 years, in the United Kingdom and compared those findings with their weekly alcohol consumption, adjusting for differences in age, sex, height, social and economic status, and country of residence, among other things.

In line with past studies, the researchers found that, as a person drank more alcohol, their gray-matter and white-matter volume decreased, getting worse the more drinks they had in a week.

But the researchers also noted that they could tell the difference between brain images of people who never drank alcohol and those who had just one or two drinks a day.

Going from 1 unit of alcohol to 2 – which in the United Kingdom means a full pint of beer or standard glass of wine – was linked to changes similar to 2 years of aging in the brain.

Other than comparing the changes with aging, it’s not yet clear what the findings mean until the scientists do more research, including looking at the genes of the people who took part in the study.

The study also has several drawbacks. The people who were studied are all middle-aged Europeans, so findings might be different in younger people or those with different ancestries. People also self-reported how much alcohol they drank for the past year, which they might not remember correctly or which might be different from previous years, including past years of heavy drinking.

And since the researchers compared drinking habits with brain imaging at one point in time, it’s not possible to say whether alcohol is actually causing the brain differences they saw.

Still, the findings raise the question of whether national guidelines should be revisited, and whether it’s better to cut that evening drink to a half-glass of wine instead.

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

It’s no secret that heavy drinking is linked to potential health problems, from liver damage to a higher risk of cancer. But most people probably wouldn’t think a nightcap every evening is much of a health threat.

Now, new evidence published in Nature Communications suggests even one drink a day is linked to detectable changes in the brain, though it’s not clear whether the alcohol is causing the differences.

Previous research has found that people with alcohol use disorder have structural changes in their brains, compared with healthy people’s brains, such as reduced gray-matter and white-matter volume.

But those findings were in people with a history of heavy drinking, defined by the National Institute on Alcohol Abuse and Alcoholism as more than four drinks a day for men and more than three drinks a day for women.

The national dietary guidelines from the U.S. Department of Health & Human Services advise drinking no more than two standard drinks for men and one drink for women each day. A standard drink in the United States is 12 ounces of beer, 5 ounces of wine, or 1½ ounce of liquor.

But could even this modest amount of alcohol make a difference to our brains?

Researchers examined functional MRI brain scans from 36,678 healthy adults, aged 40-69 years, in the United Kingdom and compared those findings with their weekly alcohol consumption, adjusting for differences in age, sex, height, social and economic status, and country of residence, among other things.

In line with past studies, the researchers found that, as a person drank more alcohol, their gray-matter and white-matter volume decreased, getting worse the more drinks they had in a week.

But the researchers also noted that they could tell the difference between brain images of people who never drank alcohol and those who had just one or two drinks a day.

Going from 1 unit of alcohol to 2 – which in the United Kingdom means a full pint of beer or standard glass of wine – was linked to changes similar to 2 years of aging in the brain.

Other than comparing the changes with aging, it’s not yet clear what the findings mean until the scientists do more research, including looking at the genes of the people who took part in the study.

The study also has several drawbacks. The people who were studied are all middle-aged Europeans, so findings might be different in younger people or those with different ancestries. People also self-reported how much alcohol they drank for the past year, which they might not remember correctly or which might be different from previous years, including past years of heavy drinking.

And since the researchers compared drinking habits with brain imaging at one point in time, it’s not possible to say whether alcohol is actually causing the brain differences they saw.

Still, the findings raise the question of whether national guidelines should be revisited, and whether it’s better to cut that evening drink to a half-glass of wine instead.

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

It’s no secret that heavy drinking is linked to potential health problems, from liver damage to a higher risk of cancer. But most people probably wouldn’t think a nightcap every evening is much of a health threat.

Now, new evidence published in Nature Communications suggests even one drink a day is linked to detectable changes in the brain, though it’s not clear whether the alcohol is causing the differences.

Previous research has found that people with alcohol use disorder have structural changes in their brains, compared with healthy people’s brains, such as reduced gray-matter and white-matter volume.

But those findings were in people with a history of heavy drinking, defined by the National Institute on Alcohol Abuse and Alcoholism as more than four drinks a day for men and more than three drinks a day for women.

The national dietary guidelines from the U.S. Department of Health & Human Services advise drinking no more than two standard drinks for men and one drink for women each day. A standard drink in the United States is 12 ounces of beer, 5 ounces of wine, or 1½ ounce of liquor.

But could even this modest amount of alcohol make a difference to our brains?

Researchers examined functional MRI brain scans from 36,678 healthy adults, aged 40-69 years, in the United Kingdom and compared those findings with their weekly alcohol consumption, adjusting for differences in age, sex, height, social and economic status, and country of residence, among other things.

In line with past studies, the researchers found that, as a person drank more alcohol, their gray-matter and white-matter volume decreased, getting worse the more drinks they had in a week.

But the researchers also noted that they could tell the difference between brain images of people who never drank alcohol and those who had just one or two drinks a day.

Going from 1 unit of alcohol to 2 – which in the United Kingdom means a full pint of beer or standard glass of wine – was linked to changes similar to 2 years of aging in the brain.

Other than comparing the changes with aging, it’s not yet clear what the findings mean until the scientists do more research, including looking at the genes of the people who took part in the study.

The study also has several drawbacks. The people who were studied are all middle-aged Europeans, so findings might be different in younger people or those with different ancestries. People also self-reported how much alcohol they drank for the past year, which they might not remember correctly or which might be different from previous years, including past years of heavy drinking.

And since the researchers compared drinking habits with brain imaging at one point in time, it’s not possible to say whether alcohol is actually causing the brain differences they saw.

Still, the findings raise the question of whether national guidelines should be revisited, and whether it’s better to cut that evening drink to a half-glass of wine instead.

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

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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