Men's Health

If the goal of a clinical encounter is to identify issues that adversely affect health, well-being, and life satisfaction, open-ended questions on sexual problems are essential, according to an expert who provided tips during a session presented by Current Psychiatry and the American Academy of Clinical Psychiatrists about how to begin a productive dialogue.

For identifying and treating the obstacles to sexual health, “the onus is on the provider,” said Anita H. Clayton, MD, chair of psychiatry and neurobehavioral sciences at the University of Virginia, Charlottesville.

In a poll published more than 20 years ago, 91% of men and 84% of women reported that a satisfying sex life is important, while 90% agreed that sexual difficulties cause emotional problems, said Dr. Clayton, who sees no reason to think that those percentages have changed. Yet, patients are traditionally reluctant to raise their concerns about sexual issues to a physician.

In the same poll, about 50% of the respondents characterized themselves as “very concerned” that a clinician would simply dismiss a sexual complaint or that there would be no treatment. Of the other respondents, 40% were somewhat concerned. Dr. Clayton assumes that those numbers are still valid and that they provide the rationale for asking routinely about sexual health, she said at the virtual meeting, presented by MedscapeLive.
 

Raising sexual health issues

“The clinician has to initiate the discussion and make it part of the routine examination,” said Dr. Clayton, also a professor of obstetrics and gynecology at the university. She indicated that unresolved sexual issues are a common and important but treatable problem, whether the underlying issue has a medical or psychological origin.

Yet, language is critical. Many physicians might have no difficulty discussing sexual problems, but patients often do. Dr. Clayton recommended developing strategies that might it easy if not seamless to elicit information about sexual health in the context of inquiring about other clinical issues.

“Use bridging statements,” Dr. Clayton suggested.

Bridging statements allow an easy transition into a discussion of sexual function from another clinical issue, Dr. Clayton said. As examples, she suggested moving to questions about sex from inquiries about conditions, such as diabetes, or medications, such as antidepressants, that are known to have an impact on sexual dysfunction.

Avoid yes-no questions.

To prompt a dialogue, Dr. Clayton advised against using yes-no questions that allow the patient to quickly dismiss the topic with a negative response. She tries to frame a question that requires a complete thought. In an inquiry addressed to a patient with diabetes, for example, she might first inform the patient that sexual issues are common with this disorder and then ask what types of sexual issues the patient is experiencing.

Once the topic is raised, a checklist approach is appropriate. Patients might be more or less willing to talk any one of the range of issues that influence sexual health, ranging from issues of desire and arousal to discomfort or pain. The door should be opened to a discussion of specific sexual organ function, such as ability to achieve an erection or adequate lubrication.

“Do not assume the patient is heterosexual,” Dr. Clayton cautioned.

It is reasonable and appropriate to bring up sexual health during the intake history. A discussion of sexual health can be initiated by simply posing the question: “Are you sexually active?” Importantly, Dr. Clayton strongly recommended a follow-up question when adults reply that they are not sexually active.

“If a patient is not sexually active, you should ask why,” Dr. Clayton said. The answer might involve a treatable condition.

In the ELIXIR study, which evaluated sexual function in patients with depression, more than twice as many patients reported impairments when asked by the physician than who volunteered this information spontaneously, according to Dr. Clayton, citing a study that found sexual issues in more than 70% of the 4,557 participants.

Prioritize choice of language.

Once sexual impairments are uncovered, clinicians will need to determine how to intervene, but Dr. Clayton recommended using clear and frank language to define the problem even if the language is tailored to the patient’s comfort level. Patients should be encouraged to recognize that there are solutions for most problems, but clinicians should recognize and respect cultural issues in directing patients toward solutions.

Dr. Clayton is not alone in recommending that patients be asked routinely about sexual health. Margot Savoy, MD, MPH, chair of family and community medicine, Temple University, Philadelphia, has also advocated for a proactive approach.

“Patients deserve whole-patient care that includes sexual health,” said Dr. Savoy, who was coauthor of a recent article that also outlined techniques for eliciting a sexual history.

She suggested that the need to inquire should not be considered age specific.

“Asking patients about their sexual history and concerns is a critical part of routine primary care across the lifespan,” she said.

“We also need to intentionally create a safe environment where it is as normal to talk about sexual questions or concerns as it is about how to care for a cold or manage a backache,” she added.

MedscapeLive and this news organization are owned by the same company. Dr. Clayton disclosed financial relationships with Acadia, Alkermes, Allergan, AMAG, Astellas, Fabre-Kramer, Janssen, Ovoca Bio, PureTech Health, Relmada, S1 Biopharma, Safe Therapeutics, Takeda, and WCG MedAd-vante-Prophase. Dr. Savoy reported no conflicts of interest.

If the goal of a clinical encounter is to identify issues that adversely affect health, well-being, and life satisfaction, open-ended questions on sexual problems are essential, according to an expert who provided tips during a session presented by Current Psychiatry and the American Academy of Clinical Psychiatrists about how to begin a productive dialogue.

For identifying and treating the obstacles to sexual health, “the onus is on the provider,” said Anita H. Clayton, MD, chair of psychiatry and neurobehavioral sciences at the University of Virginia, Charlottesville.

In a poll published more than 20 years ago, 91% of men and 84% of women reported that a satisfying sex life is important, while 90% agreed that sexual difficulties cause emotional problems, said Dr. Clayton, who sees no reason to think that those percentages have changed. Yet, patients are traditionally reluctant to raise their concerns about sexual issues to a physician.

In the same poll, about 50% of the respondents characterized themselves as “very concerned” that a clinician would simply dismiss a sexual complaint or that there would be no treatment. Of the other respondents, 40% were somewhat concerned. Dr. Clayton assumes that those numbers are still valid and that they provide the rationale for asking routinely about sexual health, she said at the virtual meeting, presented by MedscapeLive.
 

Raising sexual health issues

“The clinician has to initiate the discussion and make it part of the routine examination,” said Dr. Clayton, also a professor of obstetrics and gynecology at the university. She indicated that unresolved sexual issues are a common and important but treatable problem, whether the underlying issue has a medical or psychological origin.

Yet, language is critical. Many physicians might have no difficulty discussing sexual problems, but patients often do. Dr. Clayton recommended developing strategies that might it easy if not seamless to elicit information about sexual health in the context of inquiring about other clinical issues.

“Use bridging statements,” Dr. Clayton suggested.

Bridging statements allow an easy transition into a discussion of sexual function from another clinical issue, Dr. Clayton said. As examples, she suggested moving to questions about sex from inquiries about conditions, such as diabetes, or medications, such as antidepressants, that are known to have an impact on sexual dysfunction.

Avoid yes-no questions.

To prompt a dialogue, Dr. Clayton advised against using yes-no questions that allow the patient to quickly dismiss the topic with a negative response. She tries to frame a question that requires a complete thought. In an inquiry addressed to a patient with diabetes, for example, she might first inform the patient that sexual issues are common with this disorder and then ask what types of sexual issues the patient is experiencing.

Once the topic is raised, a checklist approach is appropriate. Patients might be more or less willing to talk any one of the range of issues that influence sexual health, ranging from issues of desire and arousal to discomfort or pain. The door should be opened to a discussion of specific sexual organ function, such as ability to achieve an erection or adequate lubrication.

“Do not assume the patient is heterosexual,” Dr. Clayton cautioned.

It is reasonable and appropriate to bring up sexual health during the intake history. A discussion of sexual health can be initiated by simply posing the question: “Are you sexually active?” Importantly, Dr. Clayton strongly recommended a follow-up question when adults reply that they are not sexually active.

“If a patient is not sexually active, you should ask why,” Dr. Clayton said. The answer might involve a treatable condition.

In the ELIXIR study, which evaluated sexual function in patients with depression, more than twice as many patients reported impairments when asked by the physician than who volunteered this information spontaneously, according to Dr. Clayton, citing a study that found sexual issues in more than 70% of the 4,557 participants.

Prioritize choice of language.

Once sexual impairments are uncovered, clinicians will need to determine how to intervene, but Dr. Clayton recommended using clear and frank language to define the problem even if the language is tailored to the patient’s comfort level. Patients should be encouraged to recognize that there are solutions for most problems, but clinicians should recognize and respect cultural issues in directing patients toward solutions.

Dr. Clayton is not alone in recommending that patients be asked routinely about sexual health. Margot Savoy, MD, MPH, chair of family and community medicine, Temple University, Philadelphia, has also advocated for a proactive approach.

“Patients deserve whole-patient care that includes sexual health,” said Dr. Savoy, who was coauthor of a recent article that also outlined techniques for eliciting a sexual history.

She suggested that the need to inquire should not be considered age specific.

“Asking patients about their sexual history and concerns is a critical part of routine primary care across the lifespan,” she said.

“We also need to intentionally create a safe environment where it is as normal to talk about sexual questions or concerns as it is about how to care for a cold or manage a backache,” she added.

MedscapeLive and this news organization are owned by the same company. Dr. Clayton disclosed financial relationships with Acadia, Alkermes, Allergan, AMAG, Astellas, Fabre-Kramer, Janssen, Ovoca Bio, PureTech Health, Relmada, S1 Biopharma, Safe Therapeutics, Takeda, and WCG MedAd-vante-Prophase. Dr. Savoy reported no conflicts of interest.

If the goal of a clinical encounter is to identify issues that adversely affect health, well-being, and life satisfaction, open-ended questions on sexual problems are essential, according to an expert who provided tips during a session presented by Current Psychiatry and the American Academy of Clinical Psychiatrists about how to begin a productive dialogue.

For identifying and treating the obstacles to sexual health, “the onus is on the provider,” said Anita H. Clayton, MD, chair of psychiatry and neurobehavioral sciences at the University of Virginia, Charlottesville.

In a poll published more than 20 years ago, 91% of men and 84% of women reported that a satisfying sex life is important, while 90% agreed that sexual difficulties cause emotional problems, said Dr. Clayton, who sees no reason to think that those percentages have changed. Yet, patients are traditionally reluctant to raise their concerns about sexual issues to a physician.

In the same poll, about 50% of the respondents characterized themselves as “very concerned” that a clinician would simply dismiss a sexual complaint or that there would be no treatment. Of the other respondents, 40% were somewhat concerned. Dr. Clayton assumes that those numbers are still valid and that they provide the rationale for asking routinely about sexual health, she said at the virtual meeting, presented by MedscapeLive.
 

Raising sexual health issues

“The clinician has to initiate the discussion and make it part of the routine examination,” said Dr. Clayton, also a professor of obstetrics and gynecology at the university. She indicated that unresolved sexual issues are a common and important but treatable problem, whether the underlying issue has a medical or psychological origin.

Yet, language is critical. Many physicians might have no difficulty discussing sexual problems, but patients often do. Dr. Clayton recommended developing strategies that might it easy if not seamless to elicit information about sexual health in the context of inquiring about other clinical issues.

“Use bridging statements,” Dr. Clayton suggested.

Bridging statements allow an easy transition into a discussion of sexual function from another clinical issue, Dr. Clayton said. As examples, she suggested moving to questions about sex from inquiries about conditions, such as diabetes, or medications, such as antidepressants, that are known to have an impact on sexual dysfunction.

Avoid yes-no questions.

To prompt a dialogue, Dr. Clayton advised against using yes-no questions that allow the patient to quickly dismiss the topic with a negative response. She tries to frame a question that requires a complete thought. In an inquiry addressed to a patient with diabetes, for example, she might first inform the patient that sexual issues are common with this disorder and then ask what types of sexual issues the patient is experiencing.

Once the topic is raised, a checklist approach is appropriate. Patients might be more or less willing to talk any one of the range of issues that influence sexual health, ranging from issues of desire and arousal to discomfort or pain. The door should be opened to a discussion of specific sexual organ function, such as ability to achieve an erection or adequate lubrication.

“Do not assume the patient is heterosexual,” Dr. Clayton cautioned.

It is reasonable and appropriate to bring up sexual health during the intake history. A discussion of sexual health can be initiated by simply posing the question: “Are you sexually active?” Importantly, Dr. Clayton strongly recommended a follow-up question when adults reply that they are not sexually active.

“If a patient is not sexually active, you should ask why,” Dr. Clayton said. The answer might involve a treatable condition.

In the ELIXIR study, which evaluated sexual function in patients with depression, more than twice as many patients reported impairments when asked by the physician than who volunteered this information spontaneously, according to Dr. Clayton, citing a study that found sexual issues in more than 70% of the 4,557 participants.

Prioritize choice of language.

Once sexual impairments are uncovered, clinicians will need to determine how to intervene, but Dr. Clayton recommended using clear and frank language to define the problem even if the language is tailored to the patient’s comfort level. Patients should be encouraged to recognize that there are solutions for most problems, but clinicians should recognize and respect cultural issues in directing patients toward solutions.

Dr. Clayton is not alone in recommending that patients be asked routinely about sexual health. Margot Savoy, MD, MPH, chair of family and community medicine, Temple University, Philadelphia, has also advocated for a proactive approach.

“Patients deserve whole-patient care that includes sexual health,” said Dr. Savoy, who was coauthor of a recent article that also outlined techniques for eliciting a sexual history.

She suggested that the need to inquire should not be considered age specific.

“Asking patients about their sexual history and concerns is a critical part of routine primary care across the lifespan,” she said.

“We also need to intentionally create a safe environment where it is as normal to talk about sexual questions or concerns as it is about how to care for a cold or manage a backache,” she added.

MedscapeLive and this news organization are owned by the same company. Dr. Clayton disclosed financial relationships with Acadia, Alkermes, Allergan, AMAG, Astellas, Fabre-Kramer, Janssen, Ovoca Bio, PureTech Health, Relmada, S1 Biopharma, Safe Therapeutics, Takeda, and WCG MedAd-vante-Prophase. Dr. Savoy reported no conflicts of interest.

Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.

Ronnie Kaufman/DigitalVision

The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.

After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.

Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.

”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
 

Meeting Mexican American men where they’re at

Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.

“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.

“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
 

Unmet needs for diabetes education

The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.

The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.

Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
 

Infusing diabetes self-management with car culture

The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.

This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.

The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:

In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.

The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).

The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).

Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
 

Rubber hits the road

Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.

In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.

The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.

The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.

By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.

Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.

Dr. Concha and coauthors reported no conflicts of interest related to the study.

Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.

Ronnie Kaufman/DigitalVision

The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.

After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.

Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.

”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
 

Meeting Mexican American men where they’re at

Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.

“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.

“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
 

Unmet needs for diabetes education

The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.

The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.

Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
 

Infusing diabetes self-management with car culture

The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.

This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.

The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:

In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.

The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).

The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).

Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
 

Rubber hits the road

Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.

In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.

The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.

The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.

By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.

Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.

Dr. Concha and coauthors reported no conflicts of interest related to the study.

Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.

Ronnie Kaufman/DigitalVision

The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.

After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.

Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.

”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
 

Meeting Mexican American men where they’re at

Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.

“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.

“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
 

Unmet needs for diabetes education

The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.

The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.

Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
 

Infusing diabetes self-management with car culture

The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.

This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.

The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:

In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.

The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).

The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).

Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
 

Rubber hits the road

Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.

In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.

The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.

The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.

By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.

Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.

Dr. Concha and coauthors reported no conflicts of interest related to the study.

Swelling of the heart appears to be a very rare side effect that primarily strikes young people after vaccination for COVID-19, a Centers for Disease Control and Prevention expert reported on June 10, detailing data on cases of myocarditis and pericarditis detected through a government safety system.

The side effect seems to be more common in teen boys and young men than in older adults and women and may occur in 16 cases for every 1 million people who got a second dose, said Tom Shimabukuro, MD, MPH, deputy director of the CDC’s Immunization Safety Office, who presented information on the cases at a meeting of an expert panel that advises the U.S. Food and Drug Administration on vaccines.

Telltale symptoms include chest pain, shortness of breath, and fever.

William Schaffner, MD, an infectious diseases specialist from Vanderbilt University, Nashville, Tenn., thinks certain characteristics are pointing toward a “rare, but real” signal. First, the events are clustering, occurring within days of vaccination. Second, they tend to be more common in males and younger people. Third, he says, the number of events is above the so-called “background rate” – the cases that could be expected in this age group even without vaccination.

“I don’t think we’re quite there yet. We haven’t tied a ribbon around it, but I think the data are trending in that direction,” he said.

The issue of myocarditis weighed heavily on the Vaccines and Related Biological Products Advisory Committee’s considerations of what kind and how much data might be needed to green light use of a vaccine for COVID in children. 

Because the rates of hospitalization for COVID are low in kids, some felt that the FDA should require at least a year of study of the vaccines in clinical trials, the amount of data typically required for full approval, instead of the 2 months currently required for emergency use authorization.  Others wondered whether the risks of vaccination – as low as they are – might outweigh the benefits in this age group.

“I don’t really see this as an emergency in children,” said committee member Michael Kurilla, MD, PhD, the director of clinical innovation at the National Institutes of Health. Dr. Kurilla, however, did say he thought having an expanded access program for children at high risk might make sense.

Most of the young adults who experienced myocarditis recovered quickly, though three needed intensive care and rehabilitation after their episodes. Among cases with known outcomes, 81% got better and 19% still have ongoing symptoms.
 

Adverse events reports

The data on myocarditis come from the Vaccine Adverse Events Reporting System, or VAERS, a database of health problems reported after vaccination. This reporting system, open to anyone, has benefits and limits. It gives the CDC and FDA the ability to rapidly detect potential safety issues, and it is large enough that it can detect rare events, something that’s beyond the power of even large clinical trials. 

But it is observational, so that there’s no way to know if problems reported were caused by the vaccines or a coincidence.

But because VAERS works on an honor system, it can also be spammed, and it carries the bias of the person who’s doing the reporting, from clinicians to average patients. For that reason, Dr. Shimabukuro said they are actively investigating and confirming each report they get. 

Out of more than 12 million doses administered to youth ages 16-24, the CDC says it has 275 reports of heart inflammation following vaccination in this age group. The CDC has analyzed a total 475 cases of myocarditis after vaccination in people under age 30 that were reported to VAERS.

The vaccines linked to the events are the mRNA vaccines made by Pfizer and Moderna. The only vaccines currently authorized for use in adolescents are made by Pfizer. Because the Pfizer vaccine was authorized for use in kids as young as 12 last month, there’s not yet enough data to draw conclusions about the risk of myocarditis in kids ages 12-15.

Younger age groups have only received about 9% of the total doses of the vaccine so far, but they represent about 50% of the myocarditis cases reported after vaccination. “We clearly have an imbalance there,” Dr. Shimabukuro said.

The number of events in this age group appears to be above the rate that would be expected for these age groups without vaccines in the picture, he said, explaining that the number of events are in line with similar adverse events seen in young people in Israel and reported by the Department of Defense. Israel found the incidence of myocarditis after vaccination was 50 cases per million for men ages 18-30.
 

More study needed

Another system tracking adverse events through hospitals, the Vaccine Safety Datalink, didn’t show reports of heart inflammation above numbers that are normally seen in the population, but it did show that inflammation was more likely after a second dose of the vaccine.

“Should this be included in informed consent?” asked Cody Meissner, MD, a pediatric infectious disease specialist at Tufts University, Boston, and a member of the FDA committee. 

“I think it’s hard to deny there seem to be some [events that seem] to be occurring in terms of myocarditis,” he said.

Dr. Meissner said later in the committee’s discussion that his own hospital had recently admitted a 12-year-old boy who developed heart swelling 2 days after the second dose of vaccine with a high level of troponin, an enzyme that indicates damage to the heart. His level was over 9. “A very high level,” Dr. Meissner said.

“Will there be scarring to the myocardium? Will there be a predisposition to arrhythmias later on? Will there be an early onset of heart failure? We think that’s unlikely, but [we] don’t know that,” he said.

The CDC has scheduled an emergency meeting next week to convene an expert panel on immunization practices to further review the events.

In addition to the information presented at the FDA’s meeting, doctors at Oregon Health & Science University, Portland, recently described seven cases in teens – all boys – who developed heart inflammation within 4 days of getting the second dose of the Pfizer vaccine.

The study was published June 10 in Pediatrics. All the boys were hospitalized and treated with anti-inflammatory medications including NSAIDs and steroids. Most were discharged within a few days and all recovered from their symptoms.

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

Swelling of the heart appears to be a very rare side effect that primarily strikes young people after vaccination for COVID-19, a Centers for Disease Control and Prevention expert reported on June 10, detailing data on cases of myocarditis and pericarditis detected through a government safety system.

The side effect seems to be more common in teen boys and young men than in older adults and women and may occur in 16 cases for every 1 million people who got a second dose, said Tom Shimabukuro, MD, MPH, deputy director of the CDC’s Immunization Safety Office, who presented information on the cases at a meeting of an expert panel that advises the U.S. Food and Drug Administration on vaccines.

Telltale symptoms include chest pain, shortness of breath, and fever.

William Schaffner, MD, an infectious diseases specialist from Vanderbilt University, Nashville, Tenn., thinks certain characteristics are pointing toward a “rare, but real” signal. First, the events are clustering, occurring within days of vaccination. Second, they tend to be more common in males and younger people. Third, he says, the number of events is above the so-called “background rate” – the cases that could be expected in this age group even without vaccination.

“I don’t think we’re quite there yet. We haven’t tied a ribbon around it, but I think the data are trending in that direction,” he said.

The issue of myocarditis weighed heavily on the Vaccines and Related Biological Products Advisory Committee’s considerations of what kind and how much data might be needed to green light use of a vaccine for COVID in children. 

Because the rates of hospitalization for COVID are low in kids, some felt that the FDA should require at least a year of study of the vaccines in clinical trials, the amount of data typically required for full approval, instead of the 2 months currently required for emergency use authorization.  Others wondered whether the risks of vaccination – as low as they are – might outweigh the benefits in this age group.

“I don’t really see this as an emergency in children,” said committee member Michael Kurilla, MD, PhD, the director of clinical innovation at the National Institutes of Health. Dr. Kurilla, however, did say he thought having an expanded access program for children at high risk might make sense.

Most of the young adults who experienced myocarditis recovered quickly, though three needed intensive care and rehabilitation after their episodes. Among cases with known outcomes, 81% got better and 19% still have ongoing symptoms.
 

Adverse events reports

The data on myocarditis come from the Vaccine Adverse Events Reporting System, or VAERS, a database of health problems reported after vaccination. This reporting system, open to anyone, has benefits and limits. It gives the CDC and FDA the ability to rapidly detect potential safety issues, and it is large enough that it can detect rare events, something that’s beyond the power of even large clinical trials. 

But it is observational, so that there’s no way to know if problems reported were caused by the vaccines or a coincidence.

But because VAERS works on an honor system, it can also be spammed, and it carries the bias of the person who’s doing the reporting, from clinicians to average patients. For that reason, Dr. Shimabukuro said they are actively investigating and confirming each report they get. 

Out of more than 12 million doses administered to youth ages 16-24, the CDC says it has 275 reports of heart inflammation following vaccination in this age group. The CDC has analyzed a total 475 cases of myocarditis after vaccination in people under age 30 that were reported to VAERS.

The vaccines linked to the events are the mRNA vaccines made by Pfizer and Moderna. The only vaccines currently authorized for use in adolescents are made by Pfizer. Because the Pfizer vaccine was authorized for use in kids as young as 12 last month, there’s not yet enough data to draw conclusions about the risk of myocarditis in kids ages 12-15.

Younger age groups have only received about 9% of the total doses of the vaccine so far, but they represent about 50% of the myocarditis cases reported after vaccination. “We clearly have an imbalance there,” Dr. Shimabukuro said.

The number of events in this age group appears to be above the rate that would be expected for these age groups without vaccines in the picture, he said, explaining that the number of events are in line with similar adverse events seen in young people in Israel and reported by the Department of Defense. Israel found the incidence of myocarditis after vaccination was 50 cases per million for men ages 18-30.
 

More study needed

Another system tracking adverse events through hospitals, the Vaccine Safety Datalink, didn’t show reports of heart inflammation above numbers that are normally seen in the population, but it did show that inflammation was more likely after a second dose of the vaccine.

“Should this be included in informed consent?” asked Cody Meissner, MD, a pediatric infectious disease specialist at Tufts University, Boston, and a member of the FDA committee. 

“I think it’s hard to deny there seem to be some [events that seem] to be occurring in terms of myocarditis,” he said.

Dr. Meissner said later in the committee’s discussion that his own hospital had recently admitted a 12-year-old boy who developed heart swelling 2 days after the second dose of vaccine with a high level of troponin, an enzyme that indicates damage to the heart. His level was over 9. “A very high level,” Dr. Meissner said.

“Will there be scarring to the myocardium? Will there be a predisposition to arrhythmias later on? Will there be an early onset of heart failure? We think that’s unlikely, but [we] don’t know that,” he said.

The CDC has scheduled an emergency meeting next week to convene an expert panel on immunization practices to further review the events.

In addition to the information presented at the FDA’s meeting, doctors at Oregon Health & Science University, Portland, recently described seven cases in teens – all boys – who developed heart inflammation within 4 days of getting the second dose of the Pfizer vaccine.

The study was published June 10 in Pediatrics. All the boys were hospitalized and treated with anti-inflammatory medications including NSAIDs and steroids. Most were discharged within a few days and all recovered from their symptoms.

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

Swelling of the heart appears to be a very rare side effect that primarily strikes young people after vaccination for COVID-19, a Centers for Disease Control and Prevention expert reported on June 10, detailing data on cases of myocarditis and pericarditis detected through a government safety system.

The side effect seems to be more common in teen boys and young men than in older adults and women and may occur in 16 cases for every 1 million people who got a second dose, said Tom Shimabukuro, MD, MPH, deputy director of the CDC’s Immunization Safety Office, who presented information on the cases at a meeting of an expert panel that advises the U.S. Food and Drug Administration on vaccines.

Telltale symptoms include chest pain, shortness of breath, and fever.

William Schaffner, MD, an infectious diseases specialist from Vanderbilt University, Nashville, Tenn., thinks certain characteristics are pointing toward a “rare, but real” signal. First, the events are clustering, occurring within days of vaccination. Second, they tend to be more common in males and younger people. Third, he says, the number of events is above the so-called “background rate” – the cases that could be expected in this age group even without vaccination.

“I don’t think we’re quite there yet. We haven’t tied a ribbon around it, but I think the data are trending in that direction,” he said.

The issue of myocarditis weighed heavily on the Vaccines and Related Biological Products Advisory Committee’s considerations of what kind and how much data might be needed to green light use of a vaccine for COVID in children. 

Because the rates of hospitalization for COVID are low in kids, some felt that the FDA should require at least a year of study of the vaccines in clinical trials, the amount of data typically required for full approval, instead of the 2 months currently required for emergency use authorization.  Others wondered whether the risks of vaccination – as low as they are – might outweigh the benefits in this age group.

“I don’t really see this as an emergency in children,” said committee member Michael Kurilla, MD, PhD, the director of clinical innovation at the National Institutes of Health. Dr. Kurilla, however, did say he thought having an expanded access program for children at high risk might make sense.

Most of the young adults who experienced myocarditis recovered quickly, though three needed intensive care and rehabilitation after their episodes. Among cases with known outcomes, 81% got better and 19% still have ongoing symptoms.
 

Adverse events reports

The data on myocarditis come from the Vaccine Adverse Events Reporting System, or VAERS, a database of health problems reported after vaccination. This reporting system, open to anyone, has benefits and limits. It gives the CDC and FDA the ability to rapidly detect potential safety issues, and it is large enough that it can detect rare events, something that’s beyond the power of even large clinical trials. 

But it is observational, so that there’s no way to know if problems reported were caused by the vaccines or a coincidence.

But because VAERS works on an honor system, it can also be spammed, and it carries the bias of the person who’s doing the reporting, from clinicians to average patients. For that reason, Dr. Shimabukuro said they are actively investigating and confirming each report they get. 

Out of more than 12 million doses administered to youth ages 16-24, the CDC says it has 275 reports of heart inflammation following vaccination in this age group. The CDC has analyzed a total 475 cases of myocarditis after vaccination in people under age 30 that were reported to VAERS.

The vaccines linked to the events are the mRNA vaccines made by Pfizer and Moderna. The only vaccines currently authorized for use in adolescents are made by Pfizer. Because the Pfizer vaccine was authorized for use in kids as young as 12 last month, there’s not yet enough data to draw conclusions about the risk of myocarditis in kids ages 12-15.

Younger age groups have only received about 9% of the total doses of the vaccine so far, but they represent about 50% of the myocarditis cases reported after vaccination. “We clearly have an imbalance there,” Dr. Shimabukuro said.

The number of events in this age group appears to be above the rate that would be expected for these age groups without vaccines in the picture, he said, explaining that the number of events are in line with similar adverse events seen in young people in Israel and reported by the Department of Defense. Israel found the incidence of myocarditis after vaccination was 50 cases per million for men ages 18-30.
 

More study needed

Another system tracking adverse events through hospitals, the Vaccine Safety Datalink, didn’t show reports of heart inflammation above numbers that are normally seen in the population, but it did show that inflammation was more likely after a second dose of the vaccine.

“Should this be included in informed consent?” asked Cody Meissner, MD, a pediatric infectious disease specialist at Tufts University, Boston, and a member of the FDA committee. 

“I think it’s hard to deny there seem to be some [events that seem] to be occurring in terms of myocarditis,” he said.

Dr. Meissner said later in the committee’s discussion that his own hospital had recently admitted a 12-year-old boy who developed heart swelling 2 days after the second dose of vaccine with a high level of troponin, an enzyme that indicates damage to the heart. His level was over 9. “A very high level,” Dr. Meissner said.

“Will there be scarring to the myocardium? Will there be a predisposition to arrhythmias later on? Will there be an early onset of heart failure? We think that’s unlikely, but [we] don’t know that,” he said.

The CDC has scheduled an emergency meeting next week to convene an expert panel on immunization practices to further review the events.

In addition to the information presented at the FDA’s meeting, doctors at Oregon Health & Science University, Portland, recently described seven cases in teens – all boys – who developed heart inflammation within 4 days of getting the second dose of the Pfizer vaccine.

The study was published June 10 in Pediatrics. All the boys were hospitalized and treated with anti-inflammatory medications including NSAIDs and steroids. Most were discharged within a few days and all recovered from their symptoms.

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

Study Overview

Objective. To determine the effectiveness of a person-centered intervention (comprising personalized and cocreated treatment plans to promote physical activity) for individuals with chronic widespread pain when delivered with digital eHealth support compared with standard telephone follow-up.

Design. Single-blinded multicenter randomized controlled trial.

Settings and participants. Participants with chronic widespread pain (CWP) who had participated in a pain management program from 2010–16 at 5 primary health care rehabilitation centers in 5 cities or towns in the western part of Sweden were invited to join the study between March 2018 and April 2019 via letter providing information about the intervention. The letter was followed by a phone call 1-2 weeks later to screen for inclusion and exclusion criteria and interest in participating. Additional participants were invited to participate via a newspaper advertisement in 1 of the 5 cities.

Inclusion criteria were Swedish-speaking persons aged 20–65 years with CWP (defined as having pain in both sides of the body, pain above and below the waist, and axial pain for at least 3 months). Exclusion criteria included having other severe somatic or psychiatric disorders, dominating causes of pain other than CWP, or other severe disease interfering with the ability to be physically active, pregnancy, not having access to a smartphone or a computer, inability to speak or understand Swedish, ongoing physiotherapy treatment, and already exercising regularly. Of 716 people initially assessed for eligibility, 425 completed telephone screening, and 139 were randomized (using block randomization) to either the intervention arm (n = 69) or the active control arm (n = 70). Due to the nature of the intervention, it was not possible to blind the participants or the physiotherapist to group allocation. All participants provided written informed consent.

The 2 groups underwent the same first individual meeting with a physiotherapist to cocreate a health plan with physical activities, and, if needed, stress management, based on each participant’s individual preferences, obstacles, goals, and resources. The difference between the groups was the type of follow-up support. Participants in the intervention group had 1 follow-up meeting with the physiotherapist a week after the initial meeting (to review and adjust the health plan as needed) and thereafter were supported through a digital e-health platform (accessed via the participant’s smartphone or computer) during the 6-month follow-up period. Participants were encouraged to access the platform once a week to answer questions regarding their health, and the extent to which they had been able to manage their health plan during the previous week. In addition, the participant and physiotherapist could communicate via the platform as needed. Participants in the active control group had 1 follow-up phone call with the physiotherapist 1 month after the initial meeting (similarly to review and adjust the health plan as needed), and no further contact or support from the physiotherapist during the 6-month follow-up period.

Measures and analysis. The primary outcome measure was pain intensity during the previous week assessed with a 0–100 subscale from the Fibromyalgia Impact Questionnaire (FIQ-pain). Secondary outcome measures included overall health status (via FIQ-total with 10 subscales), global fatigue (via FIQ-fatigue subscale), multidimensional fatigue (via Multidimensional Fatigue Inventory, a 20-item questionnaire rated on a 1-5 Likert scale), clinical manifestations of stress (via Stress and Crisis Inventory, a 35-item questionnaire rated on a 0-4 Likert scale), self-efficacy (via General Self-Efficacy Scale, a 10-item questionnaire rated on a 1-4 Likert scale), health-related quality of life (via Short Form 36, specifically the Physical Component Summary composite score), leisure-time physical activity (via Leisure Time Physical Activity Instrument), and physical function (via 1-min chair-stand test). Additional demographic data on age, pain localization, pharmacological treatment, tobacco use, country of birth, level of education, family status, economic status, work status, sick-leave, and disability pension were collected via a questionnaire.

Between-group differences for changes in outcomes from baseline to 6-month follow-up were calculated using the Mann–Whitney U test for continuous data, and Pearson’s χ² or Fisher’s exact test for categorical data. Significance level was set at 5% with no adjustment for multiple comparisons. All analyses were made according to intention-to-treat by originally assigned group; missing cases were not included in the analysis.

Main results. Participants consisted of primarily middle-age, middle income, educated (> 12 years of education) females, with > 60% of participants working at least part-time (between-group differences in baseline data and demographic data not detailed in the article). A total of 29 participants were lost to follow-up. In the intervention group, lost-to-follow up participants were older, performed fewer hours of physical activity, and had lower mental fatigue at baseline, compared with those who were lost to follow-up in the active control group.

In between-group analyses, there were no significant differences in the primary outcome (pain intensity) from baseline to 6-month follow-up. The only significant difference in secondary outcomes was seen in global fatigue – the active control group improved significantly compared with the intervention group (P = .004).

In the intervention group, 87% of participants used the digital platform. Among these users, 35% contacted the physiotherapist (75% of these communications were health- or study-related issues, 25% were issues with the digital platform), 33% were contacted by the physiotherapist (96% of these communications were about the health plan and physical activity), and 32% never had any contact with the physiotherapist. There was a significant difference in the primary outcome (pain intensity) from baseline to 6-month follow-up between platform users and non-users (P = .03, mean change [SD] 3.8 [19.66] mm vs –20.5 [6.36] mm, respectively).

Conclusion. No significant differences were found between the groups after 6 months (except for a significant decrease in global fatigue in the active control group compared with the intervention group). Further development of interventions to support persons with CWP to maintain regular physical activity is needed.

Commentary

Chronic widespread pain is a disorder characterized by diffuse body pain persisting for at least 3 months.^1-2 It has been associated with lost work productivity, mental ill health, and reduced quality of life. The development of clinically effective and cost-effective pain management strategies for CWP is challenging given the syndrome complexity and heterogenous symptomology. Thus, multimodal, multidisciplinary management is widely advocated, often a combination of education and self-management, with integration of physical, non-pharmacological and pharmacological treatments.^1-3 Of note, physical exercise and cognitive behavioral therapy are 2 non-pharmacological treatments that hold some promise based on available evidence.

The pervasiveness of technology in nearly all aspects of daily life has corresponded with the development of implementation of a wide range of technology-based interventions for health purposes.⁴ Examples of electronic health or eHealth modalities include internet-based, telephone supported, interactive voice-response, videoconferencing, mobile apps, and virtual reality. While the use of technology in chronic pain management interventions has increased in recent years, the literature is still limited, heterogenous, and provides limited evidence on the efficacy of eHealth/digital interventions, let alone which specific modalities are most effective.^4-9

This study adds to the literature as a randomized controlled trial evaluating the effectiveness of a person-centered intervention for individuals with CWP delivered with digital eHealth support compared with standard telephone follow-up. Results showed no significant difference in the primary outcome of pain intensity and nearly all secondary outcomes between the intervention group (supported by the digital platform) and the active control group (supported by a follow-up phone call). Further, intervention participants who did not use the platform improved significantly more in pain intensity than those who used the platform.

While these results imply that digital support does not contribute to improvements in the outcomes measured, it is important these findings are interpreted with caution given the limitations of the study design as well as limitations with the intervention itself. Importantly, while this study was designed as a randomized controlled trial, the authors indicated that it was not possible to blind the participants or the physiotherapist to group allocation, which may have impacted their behaviors while in the study. In addition, as the authors note, an intervention aimed at increasing physical activity should ideally include an objective measure of activity and this was lacking in this study. The use of an actigraphy device for example would have provided objective, continuous data on movement and could have helped assess an important outcome measure – whether participants reached their physical activity goals or had increased their overall physical activity. In the analysis, there was no adjustment for multiple comparisons or use of imputation methods to handle missing values. Further, it was unclear whether differences in baseline data were evaluated and taken into consideration in between-group analyses. Lastly, results are only attributable to the eHealth mode used in this study (digital web-based with limited mechanisms of behavior change and engagement built-in) and thus should not be generalized to all digital/eHealth interventions persons with CWP.

Applications for Clinical Practice

While the results of this study failed to demonstrate significant differences between a physical activity-promoting intervention for persons with CWP with digital follow-up vs telephone follow-up, it remains important to consider person-centered principles when offering CWP management support. In this spirit, clinicians should consider a management approach that takes into account the individual’s knowledge, resources, and barriers, and also actively involves the patient in treatment planning to enhance the patient’s self-efficacy to manage their health. In addition, individual preference for a specific (or combination of) eHealth/digital modality should be considered and used to guide a comprehensive management plan, as well as used as a complementary modality to face-to-face care/support.

Study Overview

Objective. To determine the effectiveness of a person-centered intervention (comprising personalized and cocreated treatment plans to promote physical activity) for individuals with chronic widespread pain when delivered with digital eHealth support compared with standard telephone follow-up.

Design. Single-blinded multicenter randomized controlled trial.

Settings and participants. Participants with chronic widespread pain (CWP) who had participated in a pain management program from 2010–16 at 5 primary health care rehabilitation centers in 5 cities or towns in the western part of Sweden were invited to join the study between March 2018 and April 2019 via letter providing information about the intervention. The letter was followed by a phone call 1-2 weeks later to screen for inclusion and exclusion criteria and interest in participating. Additional participants were invited to participate via a newspaper advertisement in 1 of the 5 cities.

Inclusion criteria were Swedish-speaking persons aged 20–65 years with CWP (defined as having pain in both sides of the body, pain above and below the waist, and axial pain for at least 3 months). Exclusion criteria included having other severe somatic or psychiatric disorders, dominating causes of pain other than CWP, or other severe disease interfering with the ability to be physically active, pregnancy, not having access to a smartphone or a computer, inability to speak or understand Swedish, ongoing physiotherapy treatment, and already exercising regularly. Of 716 people initially assessed for eligibility, 425 completed telephone screening, and 139 were randomized (using block randomization) to either the intervention arm (n = 69) or the active control arm (n = 70). Due to the nature of the intervention, it was not possible to blind the participants or the physiotherapist to group allocation. All participants provided written informed consent.

The 2 groups underwent the same first individual meeting with a physiotherapist to cocreate a health plan with physical activities, and, if needed, stress management, based on each participant’s individual preferences, obstacles, goals, and resources. The difference between the groups was the type of follow-up support. Participants in the intervention group had 1 follow-up meeting with the physiotherapist a week after the initial meeting (to review and adjust the health plan as needed) and thereafter were supported through a digital e-health platform (accessed via the participant’s smartphone or computer) during the 6-month follow-up period. Participants were encouraged to access the platform once a week to answer questions regarding their health, and the extent to which they had been able to manage their health plan during the previous week. In addition, the participant and physiotherapist could communicate via the platform as needed. Participants in the active control group had 1 follow-up phone call with the physiotherapist 1 month after the initial meeting (similarly to review and adjust the health plan as needed), and no further contact or support from the physiotherapist during the 6-month follow-up period.

Measures and analysis. The primary outcome measure was pain intensity during the previous week assessed with a 0–100 subscale from the Fibromyalgia Impact Questionnaire (FIQ-pain). Secondary outcome measures included overall health status (via FIQ-total with 10 subscales), global fatigue (via FIQ-fatigue subscale), multidimensional fatigue (via Multidimensional Fatigue Inventory, a 20-item questionnaire rated on a 1-5 Likert scale), clinical manifestations of stress (via Stress and Crisis Inventory, a 35-item questionnaire rated on a 0-4 Likert scale), self-efficacy (via General Self-Efficacy Scale, a 10-item questionnaire rated on a 1-4 Likert scale), health-related quality of life (via Short Form 36, specifically the Physical Component Summary composite score), leisure-time physical activity (via Leisure Time Physical Activity Instrument), and physical function (via 1-min chair-stand test). Additional demographic data on age, pain localization, pharmacological treatment, tobacco use, country of birth, level of education, family status, economic status, work status, sick-leave, and disability pension were collected via a questionnaire.

Between-group differences for changes in outcomes from baseline to 6-month follow-up were calculated using the Mann–Whitney U test for continuous data, and Pearson’s χ² or Fisher’s exact test for categorical data. Significance level was set at 5% with no adjustment for multiple comparisons. All analyses were made according to intention-to-treat by originally assigned group; missing cases were not included in the analysis.

Main results. Participants consisted of primarily middle-age, middle income, educated (> 12 years of education) females, with > 60% of participants working at least part-time (between-group differences in baseline data and demographic data not detailed in the article). A total of 29 participants were lost to follow-up. In the intervention group, lost-to-follow up participants were older, performed fewer hours of physical activity, and had lower mental fatigue at baseline, compared with those who were lost to follow-up in the active control group.

In between-group analyses, there were no significant differences in the primary outcome (pain intensity) from baseline to 6-month follow-up. The only significant difference in secondary outcomes was seen in global fatigue – the active control group improved significantly compared with the intervention group (P = .004).

In the intervention group, 87% of participants used the digital platform. Among these users, 35% contacted the physiotherapist (75% of these communications were health- or study-related issues, 25% were issues with the digital platform), 33% were contacted by the physiotherapist (96% of these communications were about the health plan and physical activity), and 32% never had any contact with the physiotherapist. There was a significant difference in the primary outcome (pain intensity) from baseline to 6-month follow-up between platform users and non-users (P = .03, mean change [SD] 3.8 [19.66] mm vs –20.5 [6.36] mm, respectively).

Conclusion. No significant differences were found between the groups after 6 months (except for a significant decrease in global fatigue in the active control group compared with the intervention group). Further development of interventions to support persons with CWP to maintain regular physical activity is needed.

Commentary

Chronic widespread pain is a disorder characterized by diffuse body pain persisting for at least 3 months.^1-2 It has been associated with lost work productivity, mental ill health, and reduced quality of life. The development of clinically effective and cost-effective pain management strategies for CWP is challenging given the syndrome complexity and heterogenous symptomology. Thus, multimodal, multidisciplinary management is widely advocated, often a combination of education and self-management, with integration of physical, non-pharmacological and pharmacological treatments.^1-3 Of note, physical exercise and cognitive behavioral therapy are 2 non-pharmacological treatments that hold some promise based on available evidence.

The pervasiveness of technology in nearly all aspects of daily life has corresponded with the development of implementation of a wide range of technology-based interventions for health purposes.⁴ Examples of electronic health or eHealth modalities include internet-based, telephone supported, interactive voice-response, videoconferencing, mobile apps, and virtual reality. While the use of technology in chronic pain management interventions has increased in recent years, the literature is still limited, heterogenous, and provides limited evidence on the efficacy of eHealth/digital interventions, let alone which specific modalities are most effective.^4-9

This study adds to the literature as a randomized controlled trial evaluating the effectiveness of a person-centered intervention for individuals with CWP delivered with digital eHealth support compared with standard telephone follow-up. Results showed no significant difference in the primary outcome of pain intensity and nearly all secondary outcomes between the intervention group (supported by the digital platform) and the active control group (supported by a follow-up phone call). Further, intervention participants who did not use the platform improved significantly more in pain intensity than those who used the platform.

While these results imply that digital support does not contribute to improvements in the outcomes measured, it is important these findings are interpreted with caution given the limitations of the study design as well as limitations with the intervention itself. Importantly, while this study was designed as a randomized controlled trial, the authors indicated that it was not possible to blind the participants or the physiotherapist to group allocation, which may have impacted their behaviors while in the study. In addition, as the authors note, an intervention aimed at increasing physical activity should ideally include an objective measure of activity and this was lacking in this study. The use of an actigraphy device for example would have provided objective, continuous data on movement and could have helped assess an important outcome measure – whether participants reached their physical activity goals or had increased their overall physical activity. In the analysis, there was no adjustment for multiple comparisons or use of imputation methods to handle missing values. Further, it was unclear whether differences in baseline data were evaluated and taken into consideration in between-group analyses. Lastly, results are only attributable to the eHealth mode used in this study (digital web-based with limited mechanisms of behavior change and engagement built-in) and thus should not be generalized to all digital/eHealth interventions persons with CWP.

Applications for Clinical Practice

While the results of this study failed to demonstrate significant differences between a physical activity-promoting intervention for persons with CWP with digital follow-up vs telephone follow-up, it remains important to consider person-centered principles when offering CWP management support. In this spirit, clinicians should consider a management approach that takes into account the individual’s knowledge, resources, and barriers, and also actively involves the patient in treatment planning to enhance the patient’s self-efficacy to manage their health. In addition, individual preference for a specific (or combination of) eHealth/digital modality should be considered and used to guide a comprehensive management plan, as well as used as a complementary modality to face-to-face care/support.

Study Overview

Objective. To determine the effectiveness of a person-centered intervention (comprising personalized and cocreated treatment plans to promote physical activity) for individuals with chronic widespread pain when delivered with digital eHealth support compared with standard telephone follow-up.

Design. Single-blinded multicenter randomized controlled trial.

Settings and participants. Participants with chronic widespread pain (CWP) who had participated in a pain management program from 2010–16 at 5 primary health care rehabilitation centers in 5 cities or towns in the western part of Sweden were invited to join the study between March 2018 and April 2019 via letter providing information about the intervention. The letter was followed by a phone call 1-2 weeks later to screen for inclusion and exclusion criteria and interest in participating. Additional participants were invited to participate via a newspaper advertisement in 1 of the 5 cities.

Inclusion criteria were Swedish-speaking persons aged 20–65 years with CWP (defined as having pain in both sides of the body, pain above and below the waist, and axial pain for at least 3 months). Exclusion criteria included having other severe somatic or psychiatric disorders, dominating causes of pain other than CWP, or other severe disease interfering with the ability to be physically active, pregnancy, not having access to a smartphone or a computer, inability to speak or understand Swedish, ongoing physiotherapy treatment, and already exercising regularly. Of 716 people initially assessed for eligibility, 425 completed telephone screening, and 139 were randomized (using block randomization) to either the intervention arm (n = 69) or the active control arm (n = 70). Due to the nature of the intervention, it was not possible to blind the participants or the physiotherapist to group allocation. All participants provided written informed consent.

The 2 groups underwent the same first individual meeting with a physiotherapist to cocreate a health plan with physical activities, and, if needed, stress management, based on each participant’s individual preferences, obstacles, goals, and resources. The difference between the groups was the type of follow-up support. Participants in the intervention group had 1 follow-up meeting with the physiotherapist a week after the initial meeting (to review and adjust the health plan as needed) and thereafter were supported through a digital e-health platform (accessed via the participant’s smartphone or computer) during the 6-month follow-up period. Participants were encouraged to access the platform once a week to answer questions regarding their health, and the extent to which they had been able to manage their health plan during the previous week. In addition, the participant and physiotherapist could communicate via the platform as needed. Participants in the active control group had 1 follow-up phone call with the physiotherapist 1 month after the initial meeting (similarly to review and adjust the health plan as needed), and no further contact or support from the physiotherapist during the 6-month follow-up period.

Measures and analysis. The primary outcome measure was pain intensity during the previous week assessed with a 0–100 subscale from the Fibromyalgia Impact Questionnaire (FIQ-pain). Secondary outcome measures included overall health status (via FIQ-total with 10 subscales), global fatigue (via FIQ-fatigue subscale), multidimensional fatigue (via Multidimensional Fatigue Inventory, a 20-item questionnaire rated on a 1-5 Likert scale), clinical manifestations of stress (via Stress and Crisis Inventory, a 35-item questionnaire rated on a 0-4 Likert scale), self-efficacy (via General Self-Efficacy Scale, a 10-item questionnaire rated on a 1-4 Likert scale), health-related quality of life (via Short Form 36, specifically the Physical Component Summary composite score), leisure-time physical activity (via Leisure Time Physical Activity Instrument), and physical function (via 1-min chair-stand test). Additional demographic data on age, pain localization, pharmacological treatment, tobacco use, country of birth, level of education, family status, economic status, work status, sick-leave, and disability pension were collected via a questionnaire.

Between-group differences for changes in outcomes from baseline to 6-month follow-up were calculated using the Mann–Whitney U test for continuous data, and Pearson’s χ² or Fisher’s exact test for categorical data. Significance level was set at 5% with no adjustment for multiple comparisons. All analyses were made according to intention-to-treat by originally assigned group; missing cases were not included in the analysis.

Main results. Participants consisted of primarily middle-age, middle income, educated (> 12 years of education) females, with > 60% of participants working at least part-time (between-group differences in baseline data and demographic data not detailed in the article). A total of 29 participants were lost to follow-up. In the intervention group, lost-to-follow up participants were older, performed fewer hours of physical activity, and had lower mental fatigue at baseline, compared with those who were lost to follow-up in the active control group.

In between-group analyses, there were no significant differences in the primary outcome (pain intensity) from baseline to 6-month follow-up. The only significant difference in secondary outcomes was seen in global fatigue – the active control group improved significantly compared with the intervention group (P = .004).

In the intervention group, 87% of participants used the digital platform. Among these users, 35% contacted the physiotherapist (75% of these communications were health- or study-related issues, 25% were issues with the digital platform), 33% were contacted by the physiotherapist (96% of these communications were about the health plan and physical activity), and 32% never had any contact with the physiotherapist. There was a significant difference in the primary outcome (pain intensity) from baseline to 6-month follow-up between platform users and non-users (P = .03, mean change [SD] 3.8 [19.66] mm vs –20.5 [6.36] mm, respectively).

Conclusion. No significant differences were found between the groups after 6 months (except for a significant decrease in global fatigue in the active control group compared with the intervention group). Further development of interventions to support persons with CWP to maintain regular physical activity is needed.

Commentary

Chronic widespread pain is a disorder characterized by diffuse body pain persisting for at least 3 months.^1-2 It has been associated with lost work productivity, mental ill health, and reduced quality of life. The development of clinically effective and cost-effective pain management strategies for CWP is challenging given the syndrome complexity and heterogenous symptomology. Thus, multimodal, multidisciplinary management is widely advocated, often a combination of education and self-management, with integration of physical, non-pharmacological and pharmacological treatments.^1-3 Of note, physical exercise and cognitive behavioral therapy are 2 non-pharmacological treatments that hold some promise based on available evidence.

The pervasiveness of technology in nearly all aspects of daily life has corresponded with the development of implementation of a wide range of technology-based interventions for health purposes.⁴ Examples of electronic health or eHealth modalities include internet-based, telephone supported, interactive voice-response, videoconferencing, mobile apps, and virtual reality. While the use of technology in chronic pain management interventions has increased in recent years, the literature is still limited, heterogenous, and provides limited evidence on the efficacy of eHealth/digital interventions, let alone which specific modalities are most effective.^4-9

This study adds to the literature as a randomized controlled trial evaluating the effectiveness of a person-centered intervention for individuals with CWP delivered with digital eHealth support compared with standard telephone follow-up. Results showed no significant difference in the primary outcome of pain intensity and nearly all secondary outcomes between the intervention group (supported by the digital platform) and the active control group (supported by a follow-up phone call). Further, intervention participants who did not use the platform improved significantly more in pain intensity than those who used the platform.

While these results imply that digital support does not contribute to improvements in the outcomes measured, it is important these findings are interpreted with caution given the limitations of the study design as well as limitations with the intervention itself. Importantly, while this study was designed as a randomized controlled trial, the authors indicated that it was not possible to blind the participants or the physiotherapist to group allocation, which may have impacted their behaviors while in the study. In addition, as the authors note, an intervention aimed at increasing physical activity should ideally include an objective measure of activity and this was lacking in this study. The use of an actigraphy device for example would have provided objective, continuous data on movement and could have helped assess an important outcome measure – whether participants reached their physical activity goals or had increased their overall physical activity. In the analysis, there was no adjustment for multiple comparisons or use of imputation methods to handle missing values. Further, it was unclear whether differences in baseline data were evaluated and taken into consideration in between-group analyses. Lastly, results are only attributable to the eHealth mode used in this study (digital web-based with limited mechanisms of behavior change and engagement built-in) and thus should not be generalized to all digital/eHealth interventions persons with CWP.

Applications for Clinical Practice

While the results of this study failed to demonstrate significant differences between a physical activity-promoting intervention for persons with CWP with digital follow-up vs telephone follow-up, it remains important to consider person-centered principles when offering CWP management support. In this spirit, clinicians should consider a management approach that takes into account the individual’s knowledge, resources, and barriers, and also actively involves the patient in treatment planning to enhance the patient’s self-efficacy to manage their health. In addition, individual preference for a specific (or combination of) eHealth/digital modality should be considered and used to guide a comprehensive management plan, as well as used as a complementary modality to face-to-face care/support.

With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.

The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.¹ (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.

The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.² (Em, 2018).

Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.^1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.

Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.³ Studies demonstrate that MENT suppresses sperm production.¹

Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 10⁶/mL. Studies measured gonadal concentrations after 4 weeks.¹ Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.⁴

Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.

Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.

References

1. Long J E et al. Clin Chem. 2019;65(1):153-60.

2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.

3. Sundaram K et al. Ann Med. 1993;25(2):199-205.

4. Anawalt BD et al. Andrology. 2019;7(6):878-87.

With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.

The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.¹ (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.

The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.² (Em, 2018).

Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.^1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.

Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.³ Studies demonstrate that MENT suppresses sperm production.¹

Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 10⁶/mL. Studies measured gonadal concentrations after 4 weeks.¹ Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.⁴

Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.

Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.

References

1. Long J E et al. Clin Chem. 2019;65(1):153-60.

2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.

3. Sundaram K et al. Ann Med. 1993;25(2):199-205.

4. Anawalt BD et al. Andrology. 2019;7(6):878-87.

With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.

The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.¹ (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.

The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.² (Em, 2018).

Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.^1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.

Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.³ Studies demonstrate that MENT suppresses sperm production.¹

Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 10⁶/mL. Studies measured gonadal concentrations after 4 weeks.¹ Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.⁴

Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.

Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.

References

1. Long J E et al. Clin Chem. 2019;65(1):153-60.

2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.

3. Sundaram K et al. Ann Med. 1993;25(2):199-205.

4. Anawalt BD et al. Andrology. 2019;7(6):878-87.

Low-fat diets appear to decrease testosterone levels in men, but further randomized, controlled trials are needed to confirm this effect, the authors of a meta-analysis of six small intervention studies concluded.

A total of 206 healthy men with normal testosterone received a high-fat diet followed by a low-fat diet (or vice versa), and their mean total testosterone levels were 10%-15% lower (but still in the normal range) during the low-fat diet.

The study by registered nutritionist Joseph Whittaker, MSc, University of Worcester (England), and statistician Kexin Wu, MSc, University of Warwick, Coventry, England, was published online in the Journal of Steroid Biochemistry and Molecular Biology.

“I think our results are consistent and fairly strong, but they are not strong enough to give blanket recommendations,” Mr. Whittaker said in an interview.

However, “if somebody has low testosterone, particularly borderline, they could try increasing their fat intake, maybe on a Mediterranean diet,” he said, and see if that works to increase their testosterone by 60 ng/dL, the weighted mean difference in total testosterone levels between the low-fat versus high-fat diet interventions in this meta-analysis.

“A Mediterranean diet is a good way to increase ‘healthy fats,’ mono- and polyunsaturated fatty acids, which will likely decrease cardiovascular disease risk, and boost testosterone at the same time,” Mr. Whittaker noted.

Olive oil has been shown to boost testosterone more than butter, and it also reduces CVD, he continued. Nuts are high in “healthy fats” and consistently decrease CVD and mortality and may boost testosterone. Other sources of “good fat” in a healthy diet include avocado, and red meat and poultry in moderation.

“It is controversial, but our results also indicate that foods with saturated fatty acids may boost testosterone,” he added, noting however that such foods are also associated with an increase in cholesterol.
 

Is waning testosterone explained by leaner diet?

Men need healthy testosterone levels for good physical performance, mental health, and sexual health, and low levels are associated with a higher risk of heart disease, diabetes, and Alzheimer’s disease, according to a statement about this research issued by the University of Worcester.

Although testosterone levels do decline with advancing age, there has also been an additional age-independent and persistent decline in testosterone levels that began roughly after nutrition guidelines began recommending a lower-fat diet in 1965.

Fat consumption dropped from 45% of the diet in 1965 to 35% of the diet in 1991, and stayed around that lower level through to 2011.

However, it is not clear if this decrease in dietary fat intake might explain part of the concurrent decline in men’s testosterone levels.

Mr. Whittaker and Mr. Wu conducted a systematic literature review and identified six crossover intervention studies that compared testosterone levels during low-fat versus high-fat diets – Dorgan 1996, Wang 2005, Hamalainen 1984, Hill 1980, Reed 1987, and Hill 1979 – and then they combined these studies in a meta-analysis.

Five studies each enrolled 6-43 healthy men from North America, the United Kingdom, and Scandinavia, and the sixth study (Hill 1980) enrolled 34 healthy men from North America and 39 farm laborers from South Africa.

Overall, on average, the men were aged 34-54 years and slightly overweight (a mean body mass index of roughly 27 kg/m²) with normal testosterone (i.e., >300 ng/dL, based on the 2018 American Urological Association guidelines criteria).

Most men received a high-fat diet (40% of calories from fat) first, followed by a low-fat diet (on average 20% of calories from fat; range, 7%-25%), but the subgroup of men from South Africa received the low-fat diet first.

To put this into context, U.K. guidelines recommend a fat intake of less than 35% of daily calories, and U.S. guidelines recommend a fat intake of 20%-35% of daily calories.

The low-and high-fat interventions ranged from 2 to 10 weeks.  
 

Lowest testosterone levels with low-fat vegetarian diets

Overall, on average, the men’s total testosterone was 475 mg/dL when they were consuming a low-fat diet and 532 mg/dL when they were consuming a high-fat diet.

However, the South African men had higher testosterone levels when they consumed a low-fat diet. This suggests that “men with European ancestry may experience a greater decrease in testosterone in response to a low-fat diet,” the researchers wrote.

The decrease in total testosterone in the low-fat versus high-fat diet was largest (26%) in the two studies of men who consumed a vegetarian diet (Hill 1979 and Hill 1980). These diets may have been low in zinc, since a marginal zinc deficiency has been shown to decrease total testosterone, Mr. Whittaker and Mr. Wu speculated.

The meta-analysis also showed that levels of free testosterone, urinary testosterone, and dihydrotestosterone declined during the low-fat diet, whereas levels of luteinizing hormone or sex hormone binding globulin were similar with both diets.
 

Men with low testosterone and overweight, obesity

What nutritional advice should practitioners give to men who have low testosterone and overweight/obesity?

“If you are very overweight, losing weight is going to dramatically improve your testosterone,” Mr. Whittaker said.

However, proponents of various diets are often in stark disagreement about the merits of a low-fat versus low-carbohydrate diet to lose weight.

“In general,” he continued, “the literature shows low-carb (high-fat) diets are better for weight loss [although many will disagree with that statement].”

Although nutrition guidelines have stressed the importance of limiting fat intake, fat in the diet is also associated with lower triglyceride levels and blood pressure and higher HDL cholesterol levels, and now in this study, higher testosterone levels.
 

More research needed

The researchers acknowledge study limitations: The meta-analysis included just a few small studies with heterogeneous designs and findings, and there was possible bias from confounding variables.

“Ideally, we would like to see a few more studies to confirm our results,” Mr. Whittaker said in the statement. “However, these studies may never come; normally researchers want to find new results, not replicate old ones. In the meantime, men with low testosterone would be wise to avoid low-fat diets.”

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors disclosed no relevant financial relationships.

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

Low-fat diets appear to decrease testosterone levels in men, but further randomized, controlled trials are needed to confirm this effect, the authors of a meta-analysis of six small intervention studies concluded.

A total of 206 healthy men with normal testosterone received a high-fat diet followed by a low-fat diet (or vice versa), and their mean total testosterone levels were 10%-15% lower (but still in the normal range) during the low-fat diet.

The study by registered nutritionist Joseph Whittaker, MSc, University of Worcester (England), and statistician Kexin Wu, MSc, University of Warwick, Coventry, England, was published online in the Journal of Steroid Biochemistry and Molecular Biology.

“I think our results are consistent and fairly strong, but they are not strong enough to give blanket recommendations,” Mr. Whittaker said in an interview.

However, “if somebody has low testosterone, particularly borderline, they could try increasing their fat intake, maybe on a Mediterranean diet,” he said, and see if that works to increase their testosterone by 60 ng/dL, the weighted mean difference in total testosterone levels between the low-fat versus high-fat diet interventions in this meta-analysis.

“A Mediterranean diet is a good way to increase ‘healthy fats,’ mono- and polyunsaturated fatty acids, which will likely decrease cardiovascular disease risk, and boost testosterone at the same time,” Mr. Whittaker noted.

Olive oil has been shown to boost testosterone more than butter, and it also reduces CVD, he continued. Nuts are high in “healthy fats” and consistently decrease CVD and mortality and may boost testosterone. Other sources of “good fat” in a healthy diet include avocado, and red meat and poultry in moderation.

“It is controversial, but our results also indicate that foods with saturated fatty acids may boost testosterone,” he added, noting however that such foods are also associated with an increase in cholesterol.
 

Is waning testosterone explained by leaner diet?

Men need healthy testosterone levels for good physical performance, mental health, and sexual health, and low levels are associated with a higher risk of heart disease, diabetes, and Alzheimer’s disease, according to a statement about this research issued by the University of Worcester.

Although testosterone levels do decline with advancing age, there has also been an additional age-independent and persistent decline in testosterone levels that began roughly after nutrition guidelines began recommending a lower-fat diet in 1965.

Fat consumption dropped from 45% of the diet in 1965 to 35% of the diet in 1991, and stayed around that lower level through to 2011.

However, it is not clear if this decrease in dietary fat intake might explain part of the concurrent decline in men’s testosterone levels.

Mr. Whittaker and Mr. Wu conducted a systematic literature review and identified six crossover intervention studies that compared testosterone levels during low-fat versus high-fat diets – Dorgan 1996, Wang 2005, Hamalainen 1984, Hill 1980, Reed 1987, and Hill 1979 – and then they combined these studies in a meta-analysis.

Five studies each enrolled 6-43 healthy men from North America, the United Kingdom, and Scandinavia, and the sixth study (Hill 1980) enrolled 34 healthy men from North America and 39 farm laborers from South Africa.

Overall, on average, the men were aged 34-54 years and slightly overweight (a mean body mass index of roughly 27 kg/m²) with normal testosterone (i.e., >300 ng/dL, based on the 2018 American Urological Association guidelines criteria).

Most men received a high-fat diet (40% of calories from fat) first, followed by a low-fat diet (on average 20% of calories from fat; range, 7%-25%), but the subgroup of men from South Africa received the low-fat diet first.

To put this into context, U.K. guidelines recommend a fat intake of less than 35% of daily calories, and U.S. guidelines recommend a fat intake of 20%-35% of daily calories.

The low-and high-fat interventions ranged from 2 to 10 weeks.  
 

Lowest testosterone levels with low-fat vegetarian diets

Overall, on average, the men’s total testosterone was 475 mg/dL when they were consuming a low-fat diet and 532 mg/dL when they were consuming a high-fat diet.

However, the South African men had higher testosterone levels when they consumed a low-fat diet. This suggests that “men with European ancestry may experience a greater decrease in testosterone in response to a low-fat diet,” the researchers wrote.

The decrease in total testosterone in the low-fat versus high-fat diet was largest (26%) in the two studies of men who consumed a vegetarian diet (Hill 1979 and Hill 1980). These diets may have been low in zinc, since a marginal zinc deficiency has been shown to decrease total testosterone, Mr. Whittaker and Mr. Wu speculated.

The meta-analysis also showed that levels of free testosterone, urinary testosterone, and dihydrotestosterone declined during the low-fat diet, whereas levels of luteinizing hormone or sex hormone binding globulin were similar with both diets.
 

Men with low testosterone and overweight, obesity

What nutritional advice should practitioners give to men who have low testosterone and overweight/obesity?

“If you are very overweight, losing weight is going to dramatically improve your testosterone,” Mr. Whittaker said.

However, proponents of various diets are often in stark disagreement about the merits of a low-fat versus low-carbohydrate diet to lose weight.

“In general,” he continued, “the literature shows low-carb (high-fat) diets are better for weight loss [although many will disagree with that statement].”

Although nutrition guidelines have stressed the importance of limiting fat intake, fat in the diet is also associated with lower triglyceride levels and blood pressure and higher HDL cholesterol levels, and now in this study, higher testosterone levels.
 

More research needed

The researchers acknowledge study limitations: The meta-analysis included just a few small studies with heterogeneous designs and findings, and there was possible bias from confounding variables.

“Ideally, we would like to see a few more studies to confirm our results,” Mr. Whittaker said in the statement. “However, these studies may never come; normally researchers want to find new results, not replicate old ones. In the meantime, men with low testosterone would be wise to avoid low-fat diets.”

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors disclosed no relevant financial relationships.

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

Low-fat diets appear to decrease testosterone levels in men, but further randomized, controlled trials are needed to confirm this effect, the authors of a meta-analysis of six small intervention studies concluded.

A total of 206 healthy men with normal testosterone received a high-fat diet followed by a low-fat diet (or vice versa), and their mean total testosterone levels were 10%-15% lower (but still in the normal range) during the low-fat diet.

The study by registered nutritionist Joseph Whittaker, MSc, University of Worcester (England), and statistician Kexin Wu, MSc, University of Warwick, Coventry, England, was published online in the Journal of Steroid Biochemistry and Molecular Biology.

“I think our results are consistent and fairly strong, but they are not strong enough to give blanket recommendations,” Mr. Whittaker said in an interview.

However, “if somebody has low testosterone, particularly borderline, they could try increasing their fat intake, maybe on a Mediterranean diet,” he said, and see if that works to increase their testosterone by 60 ng/dL, the weighted mean difference in total testosterone levels between the low-fat versus high-fat diet interventions in this meta-analysis.

“A Mediterranean diet is a good way to increase ‘healthy fats,’ mono- and polyunsaturated fatty acids, which will likely decrease cardiovascular disease risk, and boost testosterone at the same time,” Mr. Whittaker noted.

Olive oil has been shown to boost testosterone more than butter, and it also reduces CVD, he continued. Nuts are high in “healthy fats” and consistently decrease CVD and mortality and may boost testosterone. Other sources of “good fat” in a healthy diet include avocado, and red meat and poultry in moderation.

“It is controversial, but our results also indicate that foods with saturated fatty acids may boost testosterone,” he added, noting however that such foods are also associated with an increase in cholesterol.
 

Is waning testosterone explained by leaner diet?

Men need healthy testosterone levels for good physical performance, mental health, and sexual health, and low levels are associated with a higher risk of heart disease, diabetes, and Alzheimer’s disease, according to a statement about this research issued by the University of Worcester.

Although testosterone levels do decline with advancing age, there has also been an additional age-independent and persistent decline in testosterone levels that began roughly after nutrition guidelines began recommending a lower-fat diet in 1965.

Fat consumption dropped from 45% of the diet in 1965 to 35% of the diet in 1991, and stayed around that lower level through to 2011.

However, it is not clear if this decrease in dietary fat intake might explain part of the concurrent decline in men’s testosterone levels.

Mr. Whittaker and Mr. Wu conducted a systematic literature review and identified six crossover intervention studies that compared testosterone levels during low-fat versus high-fat diets – Dorgan 1996, Wang 2005, Hamalainen 1984, Hill 1980, Reed 1987, and Hill 1979 – and then they combined these studies in a meta-analysis.

Five studies each enrolled 6-43 healthy men from North America, the United Kingdom, and Scandinavia, and the sixth study (Hill 1980) enrolled 34 healthy men from North America and 39 farm laborers from South Africa.

Overall, on average, the men were aged 34-54 years and slightly overweight (a mean body mass index of roughly 27 kg/m²) with normal testosterone (i.e., >300 ng/dL, based on the 2018 American Urological Association guidelines criteria).

Most men received a high-fat diet (40% of calories from fat) first, followed by a low-fat diet (on average 20% of calories from fat; range, 7%-25%), but the subgroup of men from South Africa received the low-fat diet first.

To put this into context, U.K. guidelines recommend a fat intake of less than 35% of daily calories, and U.S. guidelines recommend a fat intake of 20%-35% of daily calories.

The low-and high-fat interventions ranged from 2 to 10 weeks.  
 

Lowest testosterone levels with low-fat vegetarian diets

Overall, on average, the men’s total testosterone was 475 mg/dL when they were consuming a low-fat diet and 532 mg/dL when they were consuming a high-fat diet.

However, the South African men had higher testosterone levels when they consumed a low-fat diet. This suggests that “men with European ancestry may experience a greater decrease in testosterone in response to a low-fat diet,” the researchers wrote.

The decrease in total testosterone in the low-fat versus high-fat diet was largest (26%) in the two studies of men who consumed a vegetarian diet (Hill 1979 and Hill 1980). These diets may have been low in zinc, since a marginal zinc deficiency has been shown to decrease total testosterone, Mr. Whittaker and Mr. Wu speculated.

The meta-analysis also showed that levels of free testosterone, urinary testosterone, and dihydrotestosterone declined during the low-fat diet, whereas levels of luteinizing hormone or sex hormone binding globulin were similar with both diets.
 

Men with low testosterone and overweight, obesity

What nutritional advice should practitioners give to men who have low testosterone and overweight/obesity?

“If you are very overweight, losing weight is going to dramatically improve your testosterone,” Mr. Whittaker said.

However, proponents of various diets are often in stark disagreement about the merits of a low-fat versus low-carbohydrate diet to lose weight.

“In general,” he continued, “the literature shows low-carb (high-fat) diets are better for weight loss [although many will disagree with that statement].”

Although nutrition guidelines have stressed the importance of limiting fat intake, fat in the diet is also associated with lower triglyceride levels and blood pressure and higher HDL cholesterol levels, and now in this study, higher testosterone levels.
 

More research needed

The researchers acknowledge study limitations: The meta-analysis included just a few small studies with heterogeneous designs and findings, and there was possible bias from confounding variables.

“Ideally, we would like to see a few more studies to confirm our results,” Mr. Whittaker said in the statement. “However, these studies may never come; normally researchers want to find new results, not replicate old ones. In the meantime, men with low testosterone would be wise to avoid low-fat diets.”

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors disclosed no relevant financial relationships.

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

Adhering to a healthy lifestyle may offset the heightened risk of lethal prostate cancer in patients with adverse genetic risk factors, according to results of a large U.S. study.

In men at the highest risk of dying from prostate cancer, having the highest healthy lifestyle scores cut the risk of fatal disease in half, said study author Anna Plym, PhD, of Brigham and Women’s Hospital and Harvard School of Public Health, both in Boston. She presented these findings at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract 822).

Dr. Plym noted that about 58% of the variability in prostate cancer risk is accounted for by genetic factors, with common single-nucleotide polymorphisms (SNPs) accounting for a substantial proportion of prostate cancer susceptibility.

A recent study showed that a polygenic risk score (PRS) derived by combining information from 269 SNPs was “highly predictive” of prostate cancer, Dr. Plym said. There was a 10-fold gradient in disease risk between the lowest and highest genetic risk deciles, and the pattern was consistent across ethnic groups.

In addition, Dr. Plym noted, previous studies have suggested that a healthy lifestyle reduces lethal prostate cancer risk.

What has remained unclear is whether the risk for both developing prostate cancer and experiencing progression to lethal disease can be offset by adherence to a healthy lifestyle.

To investigate, Dr. Plym and colleagues used the 269-SNP PRS to quantify the genetic risk of prostate cancer in 10,443 men enrolled in the Health Professionals Follow-up Study. The men were divided into quartiles according to genetic risk.

The investigators also classified the men using a validated lifestyle score. For this score, one point was given for each of the following: not currently smoking or having quit 10 or more years ago, body mass index under 30 kg/m², high vigorous physical activity, high intake of tomatoes and fatty fish, and low intake of processed meat. Patients with 1-2 points were considered the least healthy, those with 3 points were moderately healthy, and those with 4-6 points were the most healthy.

The outcomes assessed were overall prostate cancer and lethal prostate cancer (i.e., metastatic disease or prostate cancer–specific death).
 

No overall benefit of healthy lifestyle

At a median follow-up of 18 years, 2,111 cases of prostate cancer were observed. And at a median follow-up of 22 years, 238 lethal prostate cancer events occurred.

Men in the highest genetic risk quartile were five times more likely to develop prostate cancer (hazard ratio, 5.39; 95% confidence interval, 4.59-6.34) and three times more likely to develop lethal prostate cancer (HR, 3.43; 95% CI, 2.29-5.14), when compared with men in the lowest genetic risk quartile.

Adherence to a healthy lifestyle did not decrease the risk of prostate cancer overall (HR, 1.01; 95% CI, 0.84-1.22), nor did it affect men in the lower genetic risk quartiles.

However, healthy lifestyle did appear to affect men in the highest genetic risk quartile. Men with the highest healthy lifestyle scores had roughly half the risk of lethal prostate cancer, compared to men with the lowest lifestyle scores (3% vs. 6%).
 

A counterbalance to genetic risk

Dr. Plym observed that the rate of lethal disease in men with the best lifestyle scores matched the rate for the study population as a whole (3%), suggesting that healthy lifestyle may counterbalance high genetic risk.

She added that previous research has confirmed physical activity as a protective factor, but more study is needed to shed light on the relative benefit of the healthy lifestyle components.

In addition, further research is necessary to explain why the benefit was limited to lethal prostate cancer risk in men with the highest genetic risk.

Dr. Plym speculated that the genetic variants contributing to a high PRS may also be the variants that have the strongest interaction with lifestyle factors. For men with a genetic predisposition to prostate cancer, she added, these findings underscore the potential value of surveillance.

“Our findings add to current evidence suggesting that men with a high genetic risk may benefit from a targeted prostate cancer screening program, aiming at detecting a potentially lethal prostate cancer while it is still curable,” she said.

Charles Swanton, MBPhD, of the Francis Crick Institute and UCL Cancer Institute in London, raised the possibility that competing risk issues could be at play.

If a healthy lifestyle leads to longer life, he asked, does that make it more likely that patients will live long enough to die from their prostate cancer because they are not dying from cardiovascular disease, complications of diabetes, etc.? In that case, is the healthy lifestyle really affecting prostate cancer at all?

Dr. Plym responded that, among those in the highest genetic risk group with an unhealthy lifestyle, the increased risk for prostate cancer exceeded the risk for other illnesses.

This study was funded by the DiNovi Family Foundation, the National Cancer Institute, the William Casey Foundation, the Swedish Society for Medical Research, and the Prostate Cancer Foundation. Dr. Plym declared no conflicts of interest. Dr. Swanton disclosed relationships with numerous companies, including Pfizer, Novartis, and GlaxoSmithKline.

Adhering to a healthy lifestyle may offset the heightened risk of lethal prostate cancer in patients with adverse genetic risk factors, according to results of a large U.S. study.

In men at the highest risk of dying from prostate cancer, having the highest healthy lifestyle scores cut the risk of fatal disease in half, said study author Anna Plym, PhD, of Brigham and Women’s Hospital and Harvard School of Public Health, both in Boston. She presented these findings at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract 822).

Dr. Plym noted that about 58% of the variability in prostate cancer risk is accounted for by genetic factors, with common single-nucleotide polymorphisms (SNPs) accounting for a substantial proportion of prostate cancer susceptibility.

A recent study showed that a polygenic risk score (PRS) derived by combining information from 269 SNPs was “highly predictive” of prostate cancer, Dr. Plym said. There was a 10-fold gradient in disease risk between the lowest and highest genetic risk deciles, and the pattern was consistent across ethnic groups.

In addition, Dr. Plym noted, previous studies have suggested that a healthy lifestyle reduces lethal prostate cancer risk.

What has remained unclear is whether the risk for both developing prostate cancer and experiencing progression to lethal disease can be offset by adherence to a healthy lifestyle.

To investigate, Dr. Plym and colleagues used the 269-SNP PRS to quantify the genetic risk of prostate cancer in 10,443 men enrolled in the Health Professionals Follow-up Study. The men were divided into quartiles according to genetic risk.

The investigators also classified the men using a validated lifestyle score. For this score, one point was given for each of the following: not currently smoking or having quit 10 or more years ago, body mass index under 30 kg/m², high vigorous physical activity, high intake of tomatoes and fatty fish, and low intake of processed meat. Patients with 1-2 points were considered the least healthy, those with 3 points were moderately healthy, and those with 4-6 points were the most healthy.

The outcomes assessed were overall prostate cancer and lethal prostate cancer (i.e., metastatic disease or prostate cancer–specific death).
 

No overall benefit of healthy lifestyle

At a median follow-up of 18 years, 2,111 cases of prostate cancer were observed. And at a median follow-up of 22 years, 238 lethal prostate cancer events occurred.

Men in the highest genetic risk quartile were five times more likely to develop prostate cancer (hazard ratio, 5.39; 95% confidence interval, 4.59-6.34) and three times more likely to develop lethal prostate cancer (HR, 3.43; 95% CI, 2.29-5.14), when compared with men in the lowest genetic risk quartile.

Adherence to a healthy lifestyle did not decrease the risk of prostate cancer overall (HR, 1.01; 95% CI, 0.84-1.22), nor did it affect men in the lower genetic risk quartiles.

However, healthy lifestyle did appear to affect men in the highest genetic risk quartile. Men with the highest healthy lifestyle scores had roughly half the risk of lethal prostate cancer, compared to men with the lowest lifestyle scores (3% vs. 6%).
 

A counterbalance to genetic risk

Dr. Plym observed that the rate of lethal disease in men with the best lifestyle scores matched the rate for the study population as a whole (3%), suggesting that healthy lifestyle may counterbalance high genetic risk.

She added that previous research has confirmed physical activity as a protective factor, but more study is needed to shed light on the relative benefit of the healthy lifestyle components.

In addition, further research is necessary to explain why the benefit was limited to lethal prostate cancer risk in men with the highest genetic risk.

Dr. Plym speculated that the genetic variants contributing to a high PRS may also be the variants that have the strongest interaction with lifestyle factors. For men with a genetic predisposition to prostate cancer, she added, these findings underscore the potential value of surveillance.

“Our findings add to current evidence suggesting that men with a high genetic risk may benefit from a targeted prostate cancer screening program, aiming at detecting a potentially lethal prostate cancer while it is still curable,” she said.

Charles Swanton, MBPhD, of the Francis Crick Institute and UCL Cancer Institute in London, raised the possibility that competing risk issues could be at play.

If a healthy lifestyle leads to longer life, he asked, does that make it more likely that patients will live long enough to die from their prostate cancer because they are not dying from cardiovascular disease, complications of diabetes, etc.? In that case, is the healthy lifestyle really affecting prostate cancer at all?

Dr. Plym responded that, among those in the highest genetic risk group with an unhealthy lifestyle, the increased risk for prostate cancer exceeded the risk for other illnesses.

This study was funded by the DiNovi Family Foundation, the National Cancer Institute, the William Casey Foundation, the Swedish Society for Medical Research, and the Prostate Cancer Foundation. Dr. Plym declared no conflicts of interest. Dr. Swanton disclosed relationships with numerous companies, including Pfizer, Novartis, and GlaxoSmithKline.

Adhering to a healthy lifestyle may offset the heightened risk of lethal prostate cancer in patients with adverse genetic risk factors, according to results of a large U.S. study.

In men at the highest risk of dying from prostate cancer, having the highest healthy lifestyle scores cut the risk of fatal disease in half, said study author Anna Plym, PhD, of Brigham and Women’s Hospital and Harvard School of Public Health, both in Boston. She presented these findings at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract 822).

Dr. Plym noted that about 58% of the variability in prostate cancer risk is accounted for by genetic factors, with common single-nucleotide polymorphisms (SNPs) accounting for a substantial proportion of prostate cancer susceptibility.

A recent study showed that a polygenic risk score (PRS) derived by combining information from 269 SNPs was “highly predictive” of prostate cancer, Dr. Plym said. There was a 10-fold gradient in disease risk between the lowest and highest genetic risk deciles, and the pattern was consistent across ethnic groups.

In addition, Dr. Plym noted, previous studies have suggested that a healthy lifestyle reduces lethal prostate cancer risk.

What has remained unclear is whether the risk for both developing prostate cancer and experiencing progression to lethal disease can be offset by adherence to a healthy lifestyle.

To investigate, Dr. Plym and colleagues used the 269-SNP PRS to quantify the genetic risk of prostate cancer in 10,443 men enrolled in the Health Professionals Follow-up Study. The men were divided into quartiles according to genetic risk.

The investigators also classified the men using a validated lifestyle score. For this score, one point was given for each of the following: not currently smoking or having quit 10 or more years ago, body mass index under 30 kg/m², high vigorous physical activity, high intake of tomatoes and fatty fish, and low intake of processed meat. Patients with 1-2 points were considered the least healthy, those with 3 points were moderately healthy, and those with 4-6 points were the most healthy.

The outcomes assessed were overall prostate cancer and lethal prostate cancer (i.e., metastatic disease or prostate cancer–specific death).
 

No overall benefit of healthy lifestyle

At a median follow-up of 18 years, 2,111 cases of prostate cancer were observed. And at a median follow-up of 22 years, 238 lethal prostate cancer events occurred.

Men in the highest genetic risk quartile were five times more likely to develop prostate cancer (hazard ratio, 5.39; 95% confidence interval, 4.59-6.34) and three times more likely to develop lethal prostate cancer (HR, 3.43; 95% CI, 2.29-5.14), when compared with men in the lowest genetic risk quartile.

Adherence to a healthy lifestyle did not decrease the risk of prostate cancer overall (HR, 1.01; 95% CI, 0.84-1.22), nor did it affect men in the lower genetic risk quartiles.

However, healthy lifestyle did appear to affect men in the highest genetic risk quartile. Men with the highest healthy lifestyle scores had roughly half the risk of lethal prostate cancer, compared to men with the lowest lifestyle scores (3% vs. 6%).
 

A counterbalance to genetic risk

Dr. Plym observed that the rate of lethal disease in men with the best lifestyle scores matched the rate for the study population as a whole (3%), suggesting that healthy lifestyle may counterbalance high genetic risk.

She added that previous research has confirmed physical activity as a protective factor, but more study is needed to shed light on the relative benefit of the healthy lifestyle components.

In addition, further research is necessary to explain why the benefit was limited to lethal prostate cancer risk in men with the highest genetic risk.

Dr. Plym speculated that the genetic variants contributing to a high PRS may also be the variants that have the strongest interaction with lifestyle factors. For men with a genetic predisposition to prostate cancer, she added, these findings underscore the potential value of surveillance.

“Our findings add to current evidence suggesting that men with a high genetic risk may benefit from a targeted prostate cancer screening program, aiming at detecting a potentially lethal prostate cancer while it is still curable,” she said.

Charles Swanton, MBPhD, of the Francis Crick Institute and UCL Cancer Institute in London, raised the possibility that competing risk issues could be at play.

If a healthy lifestyle leads to longer life, he asked, does that make it more likely that patients will live long enough to die from their prostate cancer because they are not dying from cardiovascular disease, complications of diabetes, etc.? In that case, is the healthy lifestyle really affecting prostate cancer at all?

Dr. Plym responded that, among those in the highest genetic risk group with an unhealthy lifestyle, the increased risk for prostate cancer exceeded the risk for other illnesses.

This study was funded by the DiNovi Family Foundation, the National Cancer Institute, the William Casey Foundation, the Swedish Society for Medical Research, and the Prostate Cancer Foundation. Dr. Plym declared no conflicts of interest. Dr. Swanton disclosed relationships with numerous companies, including Pfizer, Novartis, and GlaxoSmithKline.

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

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

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

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

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

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

COVID-19 increases the risk of developing erectile dysfunction (ED) by nearly sixfold, according to data from the first study to investigate the association between ED and COVID-19 in young men in a real-life setting.

The preliminary data also indicated that ED is a marker of increased susceptibility to SARS-CoV-2 infection. Men with ED are more than five times more likely to have COVID-19 (odds ratio, 5.27).

For men with a history of COVID-19, the odds ratio of developing ED was 5.66. The strength of the association remained after adjusting for factors considered to affect ED.

The study, which was led by Emmanuele A. Jannini, MD, professor of endocrinology and medical sexology, University of Rome Tor Vergata, was published on March 20 in Andrology.
 

‘Mask up to keep it up’

ED can be both a short-term and a long-term complication of COVID-19, Dr. Jannini suggests.

“When offered, men should have the COVID vaccination. It also gives a whole new meaning to wearing the mask – mask up to keep it up,” he said. “It could possibly have the added benefit of preventing sexual dysfunction.”

He points out that older age, diabetes, high body mass index, and smoking increase the risk of contracting COVID-19.

“These are the same as risk factors for ED. Results of our study agree with the pathophysiological mechanisms linking ED, endothelial dysfunction, and COVID-19. Basically, endothelial dysfunction is common in both conditions [COVID-10 and ED].

“We would like to find some sort of biomarker of endothelial dysfunction post COVID, because it seems that there are many sequelae that coexist for a long time after infection,” added Dr. Jannini. “Asking a patient if they have ED after COVID might provide a measure of systemic wellness.”

Allan Pacey, MD, professor of andrology at the University of Sheffield (England), welcomed the research, noting, “This seems to be a well-conducted study. However, at the moment, the relationship is just a correlation, and it might be that some of the comorbidities that increased the men’s chances of getting a significant COVID-19 infection may have also independently increased their chances of erectile dysfunction.

“But the authors offer a plausible mechanism by which COVID-19 may impact directly on erectile function,” agrees Dr. Pacey. However, “There’s more work to be done,” he said. “I’d also argue it’s a good reason for men to wear a mask, practice social distancing, and take the vaccine when it’s offered to them.”

Urologist John Mulhall, MD, from Memorial Sloan Kettering Cancer Center, New York, remarked, “It was a highly preliminary study, but the data are suggestive of a potential link between COVID-19 infection and ED.

“However, it raises enough questions such that further large, more long-term analyses are required to define causation. Future studies assessing testosterone levels and erectile hemodynamics will be needed to provide definite evidence of a causative link,» he stressed.
 

Erectile problems a ‘hallmark’ of systemic endothelial dysfunction

Prior research has suggested that asymptomatic COVID-19 could be associated with subclinical microvascular involvement with long-term cardiovascular effects.

“Indeed, COVID-19 is by all means an endothelial disease, in which systemic manifestations ... can potentially be due to alterations in the endothelial thrombotic/fibrinolytic balance,” emphasized Dr. Jannini. “In addition, endothelial cells express many of the cofactors used by SARS-CoV-2 to invade host cells.

“Erectile dysfunction has often been considered a hallmark of endothelial dysfunction, and as such, a potential association between ED and COVID-19 has also been postulated and underpinned the investigation in this study,” he explained.

The study was predicated on the fact that ED is often considered a clinical marker of impaired overall health status, which often features cardiovascular events at an early age. It aimed to investigate the bidirectional relationship between COVID-19 and ED. It asked whether ED could be a risk factor for contracting COVID-19 and whether having COVID-19 predisposes to developing ED.

“This would possibly suggest that men with ED, due to the underlying conditions which impair erectile response, could also be more susceptible to contracting COVID-19,” said Dr. Jannini.

Data were drawn from the Sex@COVID online survey, which was conducted from April 7 to May 4, 2020, in Italy. The survey included 6,821 participants aged 18 years or older (4,177 women; 2,644 men; mean age, 32.83 ± 11.24 years). Participants were stratified on the basis of marital status and sexual activity during lockdown. From these participants, 985 sexually active men were identified, among whom 25 (2.54%) reported having tested positive for COVID-19. These persons were matched with 75 COVID-19–negative men using propensity score matching in a 1:3 ratio.

The researchers used standardized psychometric tools to measure the effects of lockdown and social distancing on the intrapsychic, relational, and sexual health of the participants.

Erectile function was measured with the International Index of Erectile Function or the Sexual Health Inventory for Men, which are often used in clinical settings. In light of the two-way interaction between sexual activity and psychological well-being, results were adjusted for any influence of anxiety and depression, which were measured with recognized scales for use in patients with a history of COVID-19.

Results showed that the prevalence of ED was significantly higher among men who self-reported a history of COVID-19, compared with a matching COVID-negative population (28% vs. 9.33%; P = .027).

After adjusting for variables that are considered to have a bearing on the development of ED, such as psychological status, age, and BMI, the odds ratio for developing ED after having had COVID-19 was 5.66 (95% confidence interval, 1.50-24.01).

Similarly, after adjusting for age and BMI, men with ED were more likely to have COVID‐19 (OR, 5.27; 95% CI, 1.49-20.09).

The authors note that persons who experience “a sudden onset or worsening of ED might also consider precautionary quarantine or nasopharyngeal swab, as COVID‐19 might act as a potential initiating trigger for the onset of erectile impairment, or an aggravating factor for its progression to more severe forms.”

Similarly, patients who have ED “should consider their erectile impairment as a sign of possible underlying conditions that could increase the likelihood of suffering from COVID‐19,” they write.

Dr. Mulhall highlighted several limitations of the study, including its retrospective nature, recall bias associated with the use of online questionnaires, and the inclusion of COVID‐19 diagnoses that were based on the response to the survey rather than on testing with nasopharyngeal swabs. In addition, comorbidity data were incomplete, and there was no indication of duration after COVID-19 infection, the severity of COVID-19, or the severity of ED.

The authors have disclosed no relevant financial relationships. Dr. Pacey is chairman of the advisory committee of the U.K. National External Quality Assurance Schemes in Andrology, editor-in-chief of Human Fertility, trustee of the Progress Educational Trust, and trustee of the British Fertility Society (all unpaid). Dr. Mulhall has disclosed no relevant financial relationships.

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

COVID-19 increases the risk of developing erectile dysfunction (ED) by nearly sixfold, according to data from the first study to investigate the association between ED and COVID-19 in young men in a real-life setting.

The preliminary data also indicated that ED is a marker of increased susceptibility to SARS-CoV-2 infection. Men with ED are more than five times more likely to have COVID-19 (odds ratio, 5.27).

For men with a history of COVID-19, the odds ratio of developing ED was 5.66. The strength of the association remained after adjusting for factors considered to affect ED.

The study, which was led by Emmanuele A. Jannini, MD, professor of endocrinology and medical sexology, University of Rome Tor Vergata, was published on March 20 in Andrology.
 

‘Mask up to keep it up’

ED can be both a short-term and a long-term complication of COVID-19, Dr. Jannini suggests.

“When offered, men should have the COVID vaccination. It also gives a whole new meaning to wearing the mask – mask up to keep it up,” he said. “It could possibly have the added benefit of preventing sexual dysfunction.”

He points out that older age, diabetes, high body mass index, and smoking increase the risk of contracting COVID-19.

“These are the same as risk factors for ED. Results of our study agree with the pathophysiological mechanisms linking ED, endothelial dysfunction, and COVID-19. Basically, endothelial dysfunction is common in both conditions [COVID-10 and ED].

“We would like to find some sort of biomarker of endothelial dysfunction post COVID, because it seems that there are many sequelae that coexist for a long time after infection,” added Dr. Jannini. “Asking a patient if they have ED after COVID might provide a measure of systemic wellness.”

Allan Pacey, MD, professor of andrology at the University of Sheffield (England), welcomed the research, noting, “This seems to be a well-conducted study. However, at the moment, the relationship is just a correlation, and it might be that some of the comorbidities that increased the men’s chances of getting a significant COVID-19 infection may have also independently increased their chances of erectile dysfunction.

“But the authors offer a plausible mechanism by which COVID-19 may impact directly on erectile function,” agrees Dr. Pacey. However, “There’s more work to be done,” he said. “I’d also argue it’s a good reason for men to wear a mask, practice social distancing, and take the vaccine when it’s offered to them.”

Urologist John Mulhall, MD, from Memorial Sloan Kettering Cancer Center, New York, remarked, “It was a highly preliminary study, but the data are suggestive of a potential link between COVID-19 infection and ED.

“However, it raises enough questions such that further large, more long-term analyses are required to define causation. Future studies assessing testosterone levels and erectile hemodynamics will be needed to provide definite evidence of a causative link,» he stressed.
 

Erectile problems a ‘hallmark’ of systemic endothelial dysfunction

Prior research has suggested that asymptomatic COVID-19 could be associated with subclinical microvascular involvement with long-term cardiovascular effects.

“Indeed, COVID-19 is by all means an endothelial disease, in which systemic manifestations ... can potentially be due to alterations in the endothelial thrombotic/fibrinolytic balance,” emphasized Dr. Jannini. “In addition, endothelial cells express many of the cofactors used by SARS-CoV-2 to invade host cells.

“Erectile dysfunction has often been considered a hallmark of endothelial dysfunction, and as such, a potential association between ED and COVID-19 has also been postulated and underpinned the investigation in this study,” he explained.

The study was predicated on the fact that ED is often considered a clinical marker of impaired overall health status, which often features cardiovascular events at an early age. It aimed to investigate the bidirectional relationship between COVID-19 and ED. It asked whether ED could be a risk factor for contracting COVID-19 and whether having COVID-19 predisposes to developing ED.

“This would possibly suggest that men with ED, due to the underlying conditions which impair erectile response, could also be more susceptible to contracting COVID-19,” said Dr. Jannini.

Data were drawn from the Sex@COVID online survey, which was conducted from April 7 to May 4, 2020, in Italy. The survey included 6,821 participants aged 18 years or older (4,177 women; 2,644 men; mean age, 32.83 ± 11.24 years). Participants were stratified on the basis of marital status and sexual activity during lockdown. From these participants, 985 sexually active men were identified, among whom 25 (2.54%) reported having tested positive for COVID-19. These persons were matched with 75 COVID-19–negative men using propensity score matching in a 1:3 ratio.

The researchers used standardized psychometric tools to measure the effects of lockdown and social distancing on the intrapsychic, relational, and sexual health of the participants.

Erectile function was measured with the International Index of Erectile Function or the Sexual Health Inventory for Men, which are often used in clinical settings. In light of the two-way interaction between sexual activity and psychological well-being, results were adjusted for any influence of anxiety and depression, which were measured with recognized scales for use in patients with a history of COVID-19.

Results showed that the prevalence of ED was significantly higher among men who self-reported a history of COVID-19, compared with a matching COVID-negative population (28% vs. 9.33%; P = .027).

After adjusting for variables that are considered to have a bearing on the development of ED, such as psychological status, age, and BMI, the odds ratio for developing ED after having had COVID-19 was 5.66 (95% confidence interval, 1.50-24.01).

Similarly, after adjusting for age and BMI, men with ED were more likely to have COVID‐19 (OR, 5.27; 95% CI, 1.49-20.09).

The authors note that persons who experience “a sudden onset or worsening of ED might also consider precautionary quarantine or nasopharyngeal swab, as COVID‐19 might act as a potential initiating trigger for the onset of erectile impairment, or an aggravating factor for its progression to more severe forms.”

Similarly, patients who have ED “should consider their erectile impairment as a sign of possible underlying conditions that could increase the likelihood of suffering from COVID‐19,” they write.

Dr. Mulhall highlighted several limitations of the study, including its retrospective nature, recall bias associated with the use of online questionnaires, and the inclusion of COVID‐19 diagnoses that were based on the response to the survey rather than on testing with nasopharyngeal swabs. In addition, comorbidity data were incomplete, and there was no indication of duration after COVID-19 infection, the severity of COVID-19, or the severity of ED.

The authors have disclosed no relevant financial relationships. Dr. Pacey is chairman of the advisory committee of the U.K. National External Quality Assurance Schemes in Andrology, editor-in-chief of Human Fertility, trustee of the Progress Educational Trust, and trustee of the British Fertility Society (all unpaid). Dr. Mulhall has disclosed no relevant financial relationships.

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

COVID-19 increases the risk of developing erectile dysfunction (ED) by nearly sixfold, according to data from the first study to investigate the association between ED and COVID-19 in young men in a real-life setting.

The preliminary data also indicated that ED is a marker of increased susceptibility to SARS-CoV-2 infection. Men with ED are more than five times more likely to have COVID-19 (odds ratio, 5.27).

For men with a history of COVID-19, the odds ratio of developing ED was 5.66. The strength of the association remained after adjusting for factors considered to affect ED.

The study, which was led by Emmanuele A. Jannini, MD, professor of endocrinology and medical sexology, University of Rome Tor Vergata, was published on March 20 in Andrology.
 

‘Mask up to keep it up’

ED can be both a short-term and a long-term complication of COVID-19, Dr. Jannini suggests.

“When offered, men should have the COVID vaccination. It also gives a whole new meaning to wearing the mask – mask up to keep it up,” he said. “It could possibly have the added benefit of preventing sexual dysfunction.”

He points out that older age, diabetes, high body mass index, and smoking increase the risk of contracting COVID-19.

“These are the same as risk factors for ED. Results of our study agree with the pathophysiological mechanisms linking ED, endothelial dysfunction, and COVID-19. Basically, endothelial dysfunction is common in both conditions [COVID-10 and ED].

“We would like to find some sort of biomarker of endothelial dysfunction post COVID, because it seems that there are many sequelae that coexist for a long time after infection,” added Dr. Jannini. “Asking a patient if they have ED after COVID might provide a measure of systemic wellness.”

Allan Pacey, MD, professor of andrology at the University of Sheffield (England), welcomed the research, noting, “This seems to be a well-conducted study. However, at the moment, the relationship is just a correlation, and it might be that some of the comorbidities that increased the men’s chances of getting a significant COVID-19 infection may have also independently increased their chances of erectile dysfunction.

“But the authors offer a plausible mechanism by which COVID-19 may impact directly on erectile function,” agrees Dr. Pacey. However, “There’s more work to be done,” he said. “I’d also argue it’s a good reason for men to wear a mask, practice social distancing, and take the vaccine when it’s offered to them.”

Urologist John Mulhall, MD, from Memorial Sloan Kettering Cancer Center, New York, remarked, “It was a highly preliminary study, but the data are suggestive of a potential link between COVID-19 infection and ED.

“However, it raises enough questions such that further large, more long-term analyses are required to define causation. Future studies assessing testosterone levels and erectile hemodynamics will be needed to provide definite evidence of a causative link,» he stressed.
 

Erectile problems a ‘hallmark’ of systemic endothelial dysfunction

Prior research has suggested that asymptomatic COVID-19 could be associated with subclinical microvascular involvement with long-term cardiovascular effects.

“Indeed, COVID-19 is by all means an endothelial disease, in which systemic manifestations ... can potentially be due to alterations in the endothelial thrombotic/fibrinolytic balance,” emphasized Dr. Jannini. “In addition, endothelial cells express many of the cofactors used by SARS-CoV-2 to invade host cells.

“Erectile dysfunction has often been considered a hallmark of endothelial dysfunction, and as such, a potential association between ED and COVID-19 has also been postulated and underpinned the investigation in this study,” he explained.

The study was predicated on the fact that ED is often considered a clinical marker of impaired overall health status, which often features cardiovascular events at an early age. It aimed to investigate the bidirectional relationship between COVID-19 and ED. It asked whether ED could be a risk factor for contracting COVID-19 and whether having COVID-19 predisposes to developing ED.

“This would possibly suggest that men with ED, due to the underlying conditions which impair erectile response, could also be more susceptible to contracting COVID-19,” said Dr. Jannini.

Data were drawn from the Sex@COVID online survey, which was conducted from April 7 to May 4, 2020, in Italy. The survey included 6,821 participants aged 18 years or older (4,177 women; 2,644 men; mean age, 32.83 ± 11.24 years). Participants were stratified on the basis of marital status and sexual activity during lockdown. From these participants, 985 sexually active men were identified, among whom 25 (2.54%) reported having tested positive for COVID-19. These persons were matched with 75 COVID-19–negative men using propensity score matching in a 1:3 ratio.

The researchers used standardized psychometric tools to measure the effects of lockdown and social distancing on the intrapsychic, relational, and sexual health of the participants.

Erectile function was measured with the International Index of Erectile Function or the Sexual Health Inventory for Men, which are often used in clinical settings. In light of the two-way interaction between sexual activity and psychological well-being, results were adjusted for any influence of anxiety and depression, which were measured with recognized scales for use in patients with a history of COVID-19.

Results showed that the prevalence of ED was significantly higher among men who self-reported a history of COVID-19, compared with a matching COVID-negative population (28% vs. 9.33%; P = .027).

After adjusting for variables that are considered to have a bearing on the development of ED, such as psychological status, age, and BMI, the odds ratio for developing ED after having had COVID-19 was 5.66 (95% confidence interval, 1.50-24.01).

Similarly, after adjusting for age and BMI, men with ED were more likely to have COVID‐19 (OR, 5.27; 95% CI, 1.49-20.09).

The authors note that persons who experience “a sudden onset or worsening of ED might also consider precautionary quarantine or nasopharyngeal swab, as COVID‐19 might act as a potential initiating trigger for the onset of erectile impairment, or an aggravating factor for its progression to more severe forms.”

Similarly, patients who have ED “should consider their erectile impairment as a sign of possible underlying conditions that could increase the likelihood of suffering from COVID‐19,” they write.

Dr. Mulhall highlighted several limitations of the study, including its retrospective nature, recall bias associated with the use of online questionnaires, and the inclusion of COVID‐19 diagnoses that were based on the response to the survey rather than on testing with nasopharyngeal swabs. In addition, comorbidity data were incomplete, and there was no indication of duration after COVID-19 infection, the severity of COVID-19, or the severity of ED.

The authors have disclosed no relevant financial relationships. Dr. Pacey is chairman of the advisory committee of the U.K. National External Quality Assurance Schemes in Andrology, editor-in-chief of Human Fertility, trustee of the Progress Educational Trust, and trustee of the British Fertility Society (all unpaid). Dr. Mulhall has disclosed no relevant financial relationships.

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