On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.^1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.^2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).^2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?¹

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.^1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.^2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).^2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?¹

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.^1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.^2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).^2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?¹

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

People living with HIV (PLWH) had a “mistimed circadian phase” and a shorter night’s sleep compared with HIV-negative individuals with a similar lifestyle, according to findings that suggest both a possible mechanism for increased comorbidities in PLWH and potential solutions.

“It is very well known that sleep problems are common in people living with HIV, and many different reasons for this have been proposed,” coauthor Malcolm von Schantz, PhD, professor of chronobiology at Northumbria University in Newcastle upon Tyne, England, said in an interview. “But the novelty of our findings is the observation of delayed circadian rhythms.”

The mistimed circadian phase in PLWH is linked to later sleep onset and earlier waking and has “important potential implications” for the health and well-being of PLWH, wrote senior author Karine Scheuermaier, MD, from the University of the Witwatersrand, in Johannesburg, South Africa, and coauthors.

Until now, research on sleep in HIV has focused primarily on its homeostatic components, such as sleep duration and staging, rather than on circadian-related aspects, they noted.

“If the lifestyle‐independent circadian misalignment observed in the current study is confirmed to be a constant feature of chronic HIV infection, then it may be a mediator both of poorer sleep health and of poorer physical health in PLWH, which could potentially be alleviated through light therapy or chronobiotic medication or supplements,” they suggested.
 

HIV endemic in study population

The study analyzed a random sample of 187 participants (36 with HIV and 151 without) in the HAALSI (Health and Ageing in Africa: A Longitudinal Study of an INDEPTH Community in South Africa) study, which is part of the Agincourt Health and Socio-demographic Surveillance System.

The study population ranged in age from 45 to 93 years, with an average age of 60.6 years in the HIV-positive group and 68.2 years in the HIV-negative group. Demographic data, Pittsburgh Sleep Quality Index score, and valid actigraphy (measured with an accelerometer for 14 consecutive days) were available for 172 participants (18% with HIV). A subgroup of 51 participants (22% with HIV) also had valid dim light melatonin onset (DLMO) data, a sensitive measure of the internal circadian clock. DLMO was measured for a minimum of 5 consecutive days with hourly saliva sampling between 5 p.m. and 11 p.m. while sitting in a dimly lit room.

In 36 participants (16% with HIV) with both valid actigraphy and DLMO data, circadian phase angle of entrainment was calculated by subtracting DLMO time from habitual sleep-onset time obtained from actigraphy.

After adjustment for age and sex, the study found a slightly later sleep onset (adjusted average delay of 10 minutes), earlier awakening (adjusted average advance of 10 minutes), and shorter sleep duration in PLWH compared with HIV-negative participants.

At the same time, melatonin production in PLWH started more than an hour later on average than in HIV-negative participants, “with half of the HIV+ group having an earlier habitual sleep onset than DLMO time” the authors wrote. In a subgroup of 36 participants with both valid actigraphy and DLMO data, the median circadian phase angle of entrainment was smaller in PLWH (–6 minutes vs. +1 hour 25 minutes in the HIV-negative group).

“Collectively, our data suggest that the sleep phase occurred earlier than what would be biologically optimal among the HIV+ participants,” they added.
 

Asynchrony between bedtime and circadian time

“Ideally, with this delayed timing of circadian phase, they should have delayed their sleep phase (sleep timing) by an equal amount to be sleeping at their optimal biological time,” Dr. Scheuermaier explained. “Their sleep onset was delayed by 12 minutes (statistically significant but biologically not that much) while their circadian phase was delayed by more than an hour.”

Possible consequences of a smaller phase angle of entrainment include difficulty in initiating and maintaining sleep, the authors wrote. “The shorter, potentially mistimed sleep relative to the endogenous circadian cycle observed in this study provides objectively measured evidence supporting the abundant previous subjective reports of poor sleep quality and insomnia in PLWH.”

They noted that a strength of their study is that participants were recruited from rural South Africa, where HIV prevalence is not confined to the so-called “high-risk” groups of gay men, other men who have sex with men, people who inject drugs, and sex workers.

“Behavioral factors associated with belonging to one or more of these groups would be strong potential confounders for studies of sleep and circadian phase,” they explained. “By contrast, in rural southern Africa, the epidemic has been less demographically discriminating ... There are no notable differences in lifestyle between the HIV– and HIV+ individuals in this study. The members of this aging population are mostly beyond retirement age, living quiet, rural lives supported by government remittances and subsistence farming.”
 

Direct evidence warrants further study

The study is “unique” in that it provides “the first direct evidence for potential circadian disturbances in PWLH,” agreed Peng Li, PhD, who was not involved in the study.

“The assessment of dim light melatonin onset in PLWH is a strength of the study; together with actigraphy-based sleep onset assessment, it provides a measure for the phase angle of entrainment,” said Dr. Li, who is research director of the medical biodynamics program, division of sleep and circadian disorders, Brigham and Women’s Hospital, Boston.

But actigraphy has limitations that affect the interpretation of the results, he told this news organization.

“Without the help of sleep diaries, low specificity in assessing sleep using actigraphy has been consistently reported,” he said. “The low specificity means a significant overestimation of sleep. This lowers the value of the reported sleep readouts and limits the validity of sleep onset estimation, especially considering that differences in sleep measures between the two groups are relatively small, compromising the clinical meaning.”

Additionally, he explained that it’s not clear whether sleep onset in the study participants was spontaneous or was “forced” to accommodate routines. “This is a limitation in field study as compared with in-lab studies,” he said.

Dr. Li also pointed to the small sample size and younger age of PLWH, suggesting the study might have benefited from a matched design. Finally, he said the study did not examine gender differences.

“In the general population, it is known that females usually have advanced circadian phase compared to males. ... More rigorous design and analyses based on sex/gender especially in this often-marginalized population are warranted to better inform HIV-specific or general clinical guidelines.”

The study was supported by the Academy of Medical Sciences. The authors did not mention any competing interests. Dr. Li reported grant support from the BrightFocus Foundation. The study is not directly related to this paper. He also receives grant support from the NIH through a Departmental Award, Harvard University Center for AIDS Research and a Pilot Project, HIV and Aging Research Consortium. The projects are on circadian disturbances and cognitive performance in PLWH.

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

People living with HIV (PLWH) had a “mistimed circadian phase” and a shorter night’s sleep compared with HIV-negative individuals with a similar lifestyle, according to findings that suggest both a possible mechanism for increased comorbidities in PLWH and potential solutions.

“It is very well known that sleep problems are common in people living with HIV, and many different reasons for this have been proposed,” coauthor Malcolm von Schantz, PhD, professor of chronobiology at Northumbria University in Newcastle upon Tyne, England, said in an interview. “But the novelty of our findings is the observation of delayed circadian rhythms.”

The mistimed circadian phase in PLWH is linked to later sleep onset and earlier waking and has “important potential implications” for the health and well-being of PLWH, wrote senior author Karine Scheuermaier, MD, from the University of the Witwatersrand, in Johannesburg, South Africa, and coauthors.

Until now, research on sleep in HIV has focused primarily on its homeostatic components, such as sleep duration and staging, rather than on circadian-related aspects, they noted.

“If the lifestyle‐independent circadian misalignment observed in the current study is confirmed to be a constant feature of chronic HIV infection, then it may be a mediator both of poorer sleep health and of poorer physical health in PLWH, which could potentially be alleviated through light therapy or chronobiotic medication or supplements,” they suggested.
 

HIV endemic in study population

The study analyzed a random sample of 187 participants (36 with HIV and 151 without) in the HAALSI (Health and Ageing in Africa: A Longitudinal Study of an INDEPTH Community in South Africa) study, which is part of the Agincourt Health and Socio-demographic Surveillance System.

The study population ranged in age from 45 to 93 years, with an average age of 60.6 years in the HIV-positive group and 68.2 years in the HIV-negative group. Demographic data, Pittsburgh Sleep Quality Index score, and valid actigraphy (measured with an accelerometer for 14 consecutive days) were available for 172 participants (18% with HIV). A subgroup of 51 participants (22% with HIV) also had valid dim light melatonin onset (DLMO) data, a sensitive measure of the internal circadian clock. DLMO was measured for a minimum of 5 consecutive days with hourly saliva sampling between 5 p.m. and 11 p.m. while sitting in a dimly lit room.

In 36 participants (16% with HIV) with both valid actigraphy and DLMO data, circadian phase angle of entrainment was calculated by subtracting DLMO time from habitual sleep-onset time obtained from actigraphy.

After adjustment for age and sex, the study found a slightly later sleep onset (adjusted average delay of 10 minutes), earlier awakening (adjusted average advance of 10 minutes), and shorter sleep duration in PLWH compared with HIV-negative participants.

At the same time, melatonin production in PLWH started more than an hour later on average than in HIV-negative participants, “with half of the HIV+ group having an earlier habitual sleep onset than DLMO time” the authors wrote. In a subgroup of 36 participants with both valid actigraphy and DLMO data, the median circadian phase angle of entrainment was smaller in PLWH (–6 minutes vs. +1 hour 25 minutes in the HIV-negative group).

“Collectively, our data suggest that the sleep phase occurred earlier than what would be biologically optimal among the HIV+ participants,” they added.
 

Asynchrony between bedtime and circadian time

“Ideally, with this delayed timing of circadian phase, they should have delayed their sleep phase (sleep timing) by an equal amount to be sleeping at their optimal biological time,” Dr. Scheuermaier explained. “Their sleep onset was delayed by 12 minutes (statistically significant but biologically not that much) while their circadian phase was delayed by more than an hour.”

Possible consequences of a smaller phase angle of entrainment include difficulty in initiating and maintaining sleep, the authors wrote. “The shorter, potentially mistimed sleep relative to the endogenous circadian cycle observed in this study provides objectively measured evidence supporting the abundant previous subjective reports of poor sleep quality and insomnia in PLWH.”

They noted that a strength of their study is that participants were recruited from rural South Africa, where HIV prevalence is not confined to the so-called “high-risk” groups of gay men, other men who have sex with men, people who inject drugs, and sex workers.

“Behavioral factors associated with belonging to one or more of these groups would be strong potential confounders for studies of sleep and circadian phase,” they explained. “By contrast, in rural southern Africa, the epidemic has been less demographically discriminating ... There are no notable differences in lifestyle between the HIV– and HIV+ individuals in this study. The members of this aging population are mostly beyond retirement age, living quiet, rural lives supported by government remittances and subsistence farming.”
 

Direct evidence warrants further study

The study is “unique” in that it provides “the first direct evidence for potential circadian disturbances in PWLH,” agreed Peng Li, PhD, who was not involved in the study.

“The assessment of dim light melatonin onset in PLWH is a strength of the study; together with actigraphy-based sleep onset assessment, it provides a measure for the phase angle of entrainment,” said Dr. Li, who is research director of the medical biodynamics program, division of sleep and circadian disorders, Brigham and Women’s Hospital, Boston.

But actigraphy has limitations that affect the interpretation of the results, he told this news organization.

“Without the help of sleep diaries, low specificity in assessing sleep using actigraphy has been consistently reported,” he said. “The low specificity means a significant overestimation of sleep. This lowers the value of the reported sleep readouts and limits the validity of sleep onset estimation, especially considering that differences in sleep measures between the two groups are relatively small, compromising the clinical meaning.”

Additionally, he explained that it’s not clear whether sleep onset in the study participants was spontaneous or was “forced” to accommodate routines. “This is a limitation in field study as compared with in-lab studies,” he said.

Dr. Li also pointed to the small sample size and younger age of PLWH, suggesting the study might have benefited from a matched design. Finally, he said the study did not examine gender differences.

“In the general population, it is known that females usually have advanced circadian phase compared to males. ... More rigorous design and analyses based on sex/gender especially in this often-marginalized population are warranted to better inform HIV-specific or general clinical guidelines.”

The study was supported by the Academy of Medical Sciences. The authors did not mention any competing interests. Dr. Li reported grant support from the BrightFocus Foundation. The study is not directly related to this paper. He also receives grant support from the NIH through a Departmental Award, Harvard University Center for AIDS Research and a Pilot Project, HIV and Aging Research Consortium. The projects are on circadian disturbances and cognitive performance in PLWH.

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

People living with HIV (PLWH) had a “mistimed circadian phase” and a shorter night’s sleep compared with HIV-negative individuals with a similar lifestyle, according to findings that suggest both a possible mechanism for increased comorbidities in PLWH and potential solutions.

“It is very well known that sleep problems are common in people living with HIV, and many different reasons for this have been proposed,” coauthor Malcolm von Schantz, PhD, professor of chronobiology at Northumbria University in Newcastle upon Tyne, England, said in an interview. “But the novelty of our findings is the observation of delayed circadian rhythms.”

The mistimed circadian phase in PLWH is linked to later sleep onset and earlier waking and has “important potential implications” for the health and well-being of PLWH, wrote senior author Karine Scheuermaier, MD, from the University of the Witwatersrand, in Johannesburg, South Africa, and coauthors.

Until now, research on sleep in HIV has focused primarily on its homeostatic components, such as sleep duration and staging, rather than on circadian-related aspects, they noted.

“If the lifestyle‐independent circadian misalignment observed in the current study is confirmed to be a constant feature of chronic HIV infection, then it may be a mediator both of poorer sleep health and of poorer physical health in PLWH, which could potentially be alleviated through light therapy or chronobiotic medication or supplements,” they suggested.
 

HIV endemic in study population

The study analyzed a random sample of 187 participants (36 with HIV and 151 without) in the HAALSI (Health and Ageing in Africa: A Longitudinal Study of an INDEPTH Community in South Africa) study, which is part of the Agincourt Health and Socio-demographic Surveillance System.

The study population ranged in age from 45 to 93 years, with an average age of 60.6 years in the HIV-positive group and 68.2 years in the HIV-negative group. Demographic data, Pittsburgh Sleep Quality Index score, and valid actigraphy (measured with an accelerometer for 14 consecutive days) were available for 172 participants (18% with HIV). A subgroup of 51 participants (22% with HIV) also had valid dim light melatonin onset (DLMO) data, a sensitive measure of the internal circadian clock. DLMO was measured for a minimum of 5 consecutive days with hourly saliva sampling between 5 p.m. and 11 p.m. while sitting in a dimly lit room.

In 36 participants (16% with HIV) with both valid actigraphy and DLMO data, circadian phase angle of entrainment was calculated by subtracting DLMO time from habitual sleep-onset time obtained from actigraphy.

After adjustment for age and sex, the study found a slightly later sleep onset (adjusted average delay of 10 minutes), earlier awakening (adjusted average advance of 10 minutes), and shorter sleep duration in PLWH compared with HIV-negative participants.

At the same time, melatonin production in PLWH started more than an hour later on average than in HIV-negative participants, “with half of the HIV+ group having an earlier habitual sleep onset than DLMO time” the authors wrote. In a subgroup of 36 participants with both valid actigraphy and DLMO data, the median circadian phase angle of entrainment was smaller in PLWH (–6 minutes vs. +1 hour 25 minutes in the HIV-negative group).

“Collectively, our data suggest that the sleep phase occurred earlier than what would be biologically optimal among the HIV+ participants,” they added.
 

Asynchrony between bedtime and circadian time

“Ideally, with this delayed timing of circadian phase, they should have delayed their sleep phase (sleep timing) by an equal amount to be sleeping at their optimal biological time,” Dr. Scheuermaier explained. “Their sleep onset was delayed by 12 minutes (statistically significant but biologically not that much) while their circadian phase was delayed by more than an hour.”

Possible consequences of a smaller phase angle of entrainment include difficulty in initiating and maintaining sleep, the authors wrote. “The shorter, potentially mistimed sleep relative to the endogenous circadian cycle observed in this study provides objectively measured evidence supporting the abundant previous subjective reports of poor sleep quality and insomnia in PLWH.”

They noted that a strength of their study is that participants were recruited from rural South Africa, where HIV prevalence is not confined to the so-called “high-risk” groups of gay men, other men who have sex with men, people who inject drugs, and sex workers.

“Behavioral factors associated with belonging to one or more of these groups would be strong potential confounders for studies of sleep and circadian phase,” they explained. “By contrast, in rural southern Africa, the epidemic has been less demographically discriminating ... There are no notable differences in lifestyle between the HIV– and HIV+ individuals in this study. The members of this aging population are mostly beyond retirement age, living quiet, rural lives supported by government remittances and subsistence farming.”
 

Direct evidence warrants further study

The study is “unique” in that it provides “the first direct evidence for potential circadian disturbances in PWLH,” agreed Peng Li, PhD, who was not involved in the study.

“The assessment of dim light melatonin onset in PLWH is a strength of the study; together with actigraphy-based sleep onset assessment, it provides a measure for the phase angle of entrainment,” said Dr. Li, who is research director of the medical biodynamics program, division of sleep and circadian disorders, Brigham and Women’s Hospital, Boston.

But actigraphy has limitations that affect the interpretation of the results, he told this news organization.

“Without the help of sleep diaries, low specificity in assessing sleep using actigraphy has been consistently reported,” he said. “The low specificity means a significant overestimation of sleep. This lowers the value of the reported sleep readouts and limits the validity of sleep onset estimation, especially considering that differences in sleep measures between the two groups are relatively small, compromising the clinical meaning.”

Additionally, he explained that it’s not clear whether sleep onset in the study participants was spontaneous or was “forced” to accommodate routines. “This is a limitation in field study as compared with in-lab studies,” he said.

Dr. Li also pointed to the small sample size and younger age of PLWH, suggesting the study might have benefited from a matched design. Finally, he said the study did not examine gender differences.

“In the general population, it is known that females usually have advanced circadian phase compared to males. ... More rigorous design and analyses based on sex/gender especially in this often-marginalized population are warranted to better inform HIV-specific or general clinical guidelines.”

The study was supported by the Academy of Medical Sciences. The authors did not mention any competing interests. Dr. Li reported grant support from the BrightFocus Foundation. The study is not directly related to this paper. He also receives grant support from the NIH through a Departmental Award, Harvard University Center for AIDS Research and a Pilot Project, HIV and Aging Research Consortium. The projects are on circadian disturbances and cognitive performance in PLWH.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

Patients with mild to moderate atopic dermatitis (AD) who were treated with topical brepocitinib had a significant improvement in their Eczema Area and Severity Index score at 6 weeks compared with a group that received vehicle, in a recently published study..

The investigators said that brepocitinib, an investigational dual tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) inhibitor, was effective and well tolerated in patients with mild to moderate AD based on improvements in multiple measures, including Eczema Area and Severity Index (EASI) total score and Investigator Global Assessment (IGA) responder rates. Brepocitinib also reduced pruritus symptoms as early as 2 days after the start of treatment, they noted.

“This study supports the further evaluation of topical brepocitinib as a novel treatment for mild to moderate AD,” Megan N. Landis, MD, of the department of medicine at the University of Louisville (Ky.) and colleagues wrote in the study published in the British Journal of Dermatology.

They evaluated brepocitinib in a phase 2b, double-blind, dose-ranging study where 292 patients were randomized to receive brepocitinib once daily (brepocitinib 0.1%, 0.3%, 1.0%, 3.0%) or twice daily (brepocitinib 0.3%, 1.0%), or vehicle for 6 weeks. At 6 weeks, the researchers assessed EASI total score as a primary outcome, an IGA score of 0 or 1 as a secondary outcome. The mean age of the patients was 40 years (range, 13-74), almost 60% were White, 17.5% were Black, and about 20% were Asian.

Compared with the corresponding once-daily vehicle group (least squares mean reduction of –44.4; 90% confidence interval, –57.3 to –31.6) and the twice-daily vehicle group (LSM, –47.6; 90% CI, –57.5 to –37.7) , the brepocitinib 1% once-daily group (LSM, –70.1; 90% CI, –82.1 to –58.0) and twice-daily group (LSM, –75.0; 90% CI, –83.8 to –66.2) had significant percentage reductions in EASI total score compared with baseline at 6 weeks. Patients in the other brepocitinib dose groups had nonsignificant reductions in EASI from baseline.

Regarding secondary outcomes, a significantly higher percentage of patients in five of the six active treatment groups achieved an IGA score of 0 or 1 and at least a 2-point reduction in IGA score in the once-daily brepocitinib 0.1% group (29.7%; 90% CI, 18.5%-43.3%), 0.3% group (33.3%; 90% CI, 21.3%-47.0%), 1.0% group (40.5%; 90% CI, 28.0%-54.4%), 3.0% group (44.4%; 90% CI, 30.2%-59.1%), and brepocitinib 0.3% twice-daily group (33.3%; 90% CI, 21.3%-47.0%) compared with the once-daily (10.8%; 90% CI, 4.8%-22.2%) and twice-daily (13.9%; 90% CI, 6.9%-25.4%) vehicle groups.

The study authors noted that 37.0% of patients overall experienced treatment-emergent adverse events (TEAEs), with most TEAEs occurring in the once-daily vehicle (48.6%), twice-daily vehicle (47.2%), and brepocitinib 0.1% (45.9%) groups. Adverse events were not considered dose dependent, and no group had any serious TEAEs or deaths.

Nasopharyngitis and worsening AD were the most common TEAEs reported, with about 8% of those in the vehicle groups experiencing worsening AD.

Brepocitinib is also currently being developed as a treatment for dermatomyositis, systemic lupus erythematosus, hidradenitis suppurativa, and noninfectious uveitis by Priovant Therapeutics, a company founded by Pfizer and Roivant Sciences.

In September 2021, the Food and Drug Administration approved topical ruxolitinib cream for the treatment of patients with mild to moderate atopic dermatitis aged 12 years and older, the first topical JAK inhibitor approved for AD.

This study was sponsored by Pfizer. The authors reported personal and institutional relationships in the form of investigator positions, fees, honoraria, research grants, employee positions, and holding stock or shares for a variety of pharmaceutical, life science, and biotechnology companies.

Patients with mild to moderate atopic dermatitis (AD) who were treated with topical brepocitinib had a significant improvement in their Eczema Area and Severity Index score at 6 weeks compared with a group that received vehicle, in a recently published study..

The investigators said that brepocitinib, an investigational dual tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) inhibitor, was effective and well tolerated in patients with mild to moderate AD based on improvements in multiple measures, including Eczema Area and Severity Index (EASI) total score and Investigator Global Assessment (IGA) responder rates. Brepocitinib also reduced pruritus symptoms as early as 2 days after the start of treatment, they noted.

“This study supports the further evaluation of topical brepocitinib as a novel treatment for mild to moderate AD,” Megan N. Landis, MD, of the department of medicine at the University of Louisville (Ky.) and colleagues wrote in the study published in the British Journal of Dermatology.

They evaluated brepocitinib in a phase 2b, double-blind, dose-ranging study where 292 patients were randomized to receive brepocitinib once daily (brepocitinib 0.1%, 0.3%, 1.0%, 3.0%) or twice daily (brepocitinib 0.3%, 1.0%), or vehicle for 6 weeks. At 6 weeks, the researchers assessed EASI total score as a primary outcome, an IGA score of 0 or 1 as a secondary outcome. The mean age of the patients was 40 years (range, 13-74), almost 60% were White, 17.5% were Black, and about 20% were Asian.

Compared with the corresponding once-daily vehicle group (least squares mean reduction of –44.4; 90% confidence interval, –57.3 to –31.6) and the twice-daily vehicle group (LSM, –47.6; 90% CI, –57.5 to –37.7) , the brepocitinib 1% once-daily group (LSM, –70.1; 90% CI, –82.1 to –58.0) and twice-daily group (LSM, –75.0; 90% CI, –83.8 to –66.2) had significant percentage reductions in EASI total score compared with baseline at 6 weeks. Patients in the other brepocitinib dose groups had nonsignificant reductions in EASI from baseline.

Regarding secondary outcomes, a significantly higher percentage of patients in five of the six active treatment groups achieved an IGA score of 0 or 1 and at least a 2-point reduction in IGA score in the once-daily brepocitinib 0.1% group (29.7%; 90% CI, 18.5%-43.3%), 0.3% group (33.3%; 90% CI, 21.3%-47.0%), 1.0% group (40.5%; 90% CI, 28.0%-54.4%), 3.0% group (44.4%; 90% CI, 30.2%-59.1%), and brepocitinib 0.3% twice-daily group (33.3%; 90% CI, 21.3%-47.0%) compared with the once-daily (10.8%; 90% CI, 4.8%-22.2%) and twice-daily (13.9%; 90% CI, 6.9%-25.4%) vehicle groups.

The study authors noted that 37.0% of patients overall experienced treatment-emergent adverse events (TEAEs), with most TEAEs occurring in the once-daily vehicle (48.6%), twice-daily vehicle (47.2%), and brepocitinib 0.1% (45.9%) groups. Adverse events were not considered dose dependent, and no group had any serious TEAEs or deaths.

Nasopharyngitis and worsening AD were the most common TEAEs reported, with about 8% of those in the vehicle groups experiencing worsening AD.

Brepocitinib is also currently being developed as a treatment for dermatomyositis, systemic lupus erythematosus, hidradenitis suppurativa, and noninfectious uveitis by Priovant Therapeutics, a company founded by Pfizer and Roivant Sciences.

In September 2021, the Food and Drug Administration approved topical ruxolitinib cream for the treatment of patients with mild to moderate atopic dermatitis aged 12 years and older, the first topical JAK inhibitor approved for AD.

This study was sponsored by Pfizer. The authors reported personal and institutional relationships in the form of investigator positions, fees, honoraria, research grants, employee positions, and holding stock or shares for a variety of pharmaceutical, life science, and biotechnology companies.

Patients with mild to moderate atopic dermatitis (AD) who were treated with topical brepocitinib had a significant improvement in their Eczema Area and Severity Index score at 6 weeks compared with a group that received vehicle, in a recently published study..

The investigators said that brepocitinib, an investigational dual tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) inhibitor, was effective and well tolerated in patients with mild to moderate AD based on improvements in multiple measures, including Eczema Area and Severity Index (EASI) total score and Investigator Global Assessment (IGA) responder rates. Brepocitinib also reduced pruritus symptoms as early as 2 days after the start of treatment, they noted.

“This study supports the further evaluation of topical brepocitinib as a novel treatment for mild to moderate AD,” Megan N. Landis, MD, of the department of medicine at the University of Louisville (Ky.) and colleagues wrote in the study published in the British Journal of Dermatology.

They evaluated brepocitinib in a phase 2b, double-blind, dose-ranging study where 292 patients were randomized to receive brepocitinib once daily (brepocitinib 0.1%, 0.3%, 1.0%, 3.0%) or twice daily (brepocitinib 0.3%, 1.0%), or vehicle for 6 weeks. At 6 weeks, the researchers assessed EASI total score as a primary outcome, an IGA score of 0 or 1 as a secondary outcome. The mean age of the patients was 40 years (range, 13-74), almost 60% were White, 17.5% were Black, and about 20% were Asian.

Compared with the corresponding once-daily vehicle group (least squares mean reduction of –44.4; 90% confidence interval, –57.3 to –31.6) and the twice-daily vehicle group (LSM, –47.6; 90% CI, –57.5 to –37.7) , the brepocitinib 1% once-daily group (LSM, –70.1; 90% CI, –82.1 to –58.0) and twice-daily group (LSM, –75.0; 90% CI, –83.8 to –66.2) had significant percentage reductions in EASI total score compared with baseline at 6 weeks. Patients in the other brepocitinib dose groups had nonsignificant reductions in EASI from baseline.

Regarding secondary outcomes, a significantly higher percentage of patients in five of the six active treatment groups achieved an IGA score of 0 or 1 and at least a 2-point reduction in IGA score in the once-daily brepocitinib 0.1% group (29.7%; 90% CI, 18.5%-43.3%), 0.3% group (33.3%; 90% CI, 21.3%-47.0%), 1.0% group (40.5%; 90% CI, 28.0%-54.4%), 3.0% group (44.4%; 90% CI, 30.2%-59.1%), and brepocitinib 0.3% twice-daily group (33.3%; 90% CI, 21.3%-47.0%) compared with the once-daily (10.8%; 90% CI, 4.8%-22.2%) and twice-daily (13.9%; 90% CI, 6.9%-25.4%) vehicle groups.

The study authors noted that 37.0% of patients overall experienced treatment-emergent adverse events (TEAEs), with most TEAEs occurring in the once-daily vehicle (48.6%), twice-daily vehicle (47.2%), and brepocitinib 0.1% (45.9%) groups. Adverse events were not considered dose dependent, and no group had any serious TEAEs or deaths.

Nasopharyngitis and worsening AD were the most common TEAEs reported, with about 8% of those in the vehicle groups experiencing worsening AD.

Brepocitinib is also currently being developed as a treatment for dermatomyositis, systemic lupus erythematosus, hidradenitis suppurativa, and noninfectious uveitis by Priovant Therapeutics, a company founded by Pfizer and Roivant Sciences.

In September 2021, the Food and Drug Administration approved topical ruxolitinib cream for the treatment of patients with mild to moderate atopic dermatitis aged 12 years and older, the first topical JAK inhibitor approved for AD.

This study was sponsored by Pfizer. The authors reported personal and institutional relationships in the form of investigator positions, fees, honoraria, research grants, employee positions, and holding stock or shares for a variety of pharmaceutical, life science, and biotechnology companies.

Nearly 1 in 7 U.S. adults reported bloating symptoms in the past week, yet most didn’t seek help from a gastroenterologist or other health care professional, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.

The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.

“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.

Results of the survey are published online in Clinical Gastroenterology and Hepatology.
 

Common problem, incompletely understood

To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.

Altogether, 12,324 (14%) respondents reported bloating in the past week.

The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.

The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.

Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.

Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
 

Suffering in silence?

Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.

About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.

“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.

Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.

A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.

Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.

Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.

“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.

“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.

Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.

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

Nearly 1 in 7 U.S. adults reported bloating symptoms in the past week, yet most didn’t seek help from a gastroenterologist or other health care professional, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.

The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.

“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.

Results of the survey are published online in Clinical Gastroenterology and Hepatology.
 

Common problem, incompletely understood

To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.

Altogether, 12,324 (14%) respondents reported bloating in the past week.

The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.

The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.

Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.

Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
 

Suffering in silence?

Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.

About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.

“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.

Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.

A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.

Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.

Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.

“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.

“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.

Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.

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

Nearly 1 in 7 U.S. adults reported bloating symptoms in the past week, yet most didn’t seek help from a gastroenterologist or other health care professional, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.

The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.

“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.

Results of the survey are published online in Clinical Gastroenterology and Hepatology.
 

Common problem, incompletely understood

To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.

Altogether, 12,324 (14%) respondents reported bloating in the past week.

The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.

The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.

Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.

Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
 

Suffering in silence?

Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.

About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.

“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.

Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.

A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.

Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.

Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.

“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.

“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.

Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.

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

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

---

Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

---

Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

---

Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

The combination of nivolumab and vidutolimod led to a high rate of pathologic complete response and pathologic major response in a phase 2 trial of patients with stage 3 resectable melanoma. The result led researchers to call for a future study comparing the regimen against a suitable control group.

“We were very excited to see the ability of intratumoral vidutolimod to augment T-cell infiltrate. (Pathologic) response was associated with a dense infiltrate of CD8 T cells. We were also able to demonstrate for what I think may be the first time, that intratumoral CpG resulted in clear evidence of CD303+ plasmacytoid dendritic cells [pDCs],” said Diwakar Davar, MD, assistant professor of medicine at the University of Pittsburgh, during a presentation of the results at the annual meeting of the Society for Immunotherapy of Cancer. He noted that pDCs represent a very rare cell population, less than 0.4% of circulating peripheral blood mononuclear cells, and tend to be found in lymph nodes.

The current standard of care for stage 3 melanoma is up-front surgery followed by adjuvant therapy – anti–PD-1 therapy for patients with wild-type or BRAF-mutant cancers, and targeted therapy with BRAF/MEK inhibitors in patients with BRAF mutations. However, preclinical studies suggest that neoadjuvant immunotherapy could lead to a stronger antitumor T-cell response than adjuvant immunotherapy.

Vidutolimod targets the toll-like receptor 9 (TLR-9) endosomal receptor found in B cells and pDC cells. The formulation is a virus-like particle (VLP) that contains unmethylated cytosine guanine–rich oligonucleotides (CpG ODN). Bacterial and viral genomes tend to be enriched in CpG ODN, and this acts as a TLR-9 agonist. TLR-9 activation in turn triggers an interferon response, and this may help overcome PD-1 blockade resistance in metastatic melanoma.

The researchers conducted a nonrandomized, open-label trial that included 30 patients with stage 3 melanoma (14 women; median age, 61 years). Patients received neoadjuvant nivolumab and vidutolimod for 8 weeks, then were evaluated for surgery. Patients continued both drugs in the adjuvant setting for 48 weeks. 47% experienced complete pathologic response, 10% a major pathologic response, and 10% a partial pathologic response.

Analysis of resected samples revealed clear evidence of an immune response, Dr. Davar said during a press conference held in advance of the meeting. “Pathologic response was associated with compelling evidence of immune activation both peripherally and within the tumor, with clear evidence of pDC infiltrate and pDC activation – something that has not previously been seen in human specimens.”

The study regimen appeared safe, with no dose-limiting toxicities or grade 4 or 5 adverse events. He noted that the regimen is now being tested in the phase 2 ECOG-ACRIN trial.

The results are “very exciting,” said Pamela Ohashi, PhD, who commented on the study during the press conference. The virus-like nature of vidutolimod may be an important element of the therapy. “I think scientifically we would have predicted that the VLP carrying the CPG would be very good at activating the CD8 cells, which in fact is what you’re seeing. So I think it’s very exciting and has lots of potential for future combinations,” said Dr. Ohashi, who is director of the tumor immunotherapy program at the Princess Margaret Cancer Centre, Toronto.

The study was funded by Checkmate Pharmaceuticals. Dr. Davar has financial relationships with Checkmate Pharmaceuticals and Regeneron, which has acquired Checkmate Pharmaceuticals.

The combination of nivolumab and vidutolimod led to a high rate of pathologic complete response and pathologic major response in a phase 2 trial of patients with stage 3 resectable melanoma. The result led researchers to call for a future study comparing the regimen against a suitable control group.

“We were very excited to see the ability of intratumoral vidutolimod to augment T-cell infiltrate. (Pathologic) response was associated with a dense infiltrate of CD8 T cells. We were also able to demonstrate for what I think may be the first time, that intratumoral CpG resulted in clear evidence of CD303+ plasmacytoid dendritic cells [pDCs],” said Diwakar Davar, MD, assistant professor of medicine at the University of Pittsburgh, during a presentation of the results at the annual meeting of the Society for Immunotherapy of Cancer. He noted that pDCs represent a very rare cell population, less than 0.4% of circulating peripheral blood mononuclear cells, and tend to be found in lymph nodes.

The current standard of care for stage 3 melanoma is up-front surgery followed by adjuvant therapy – anti–PD-1 therapy for patients with wild-type or BRAF-mutant cancers, and targeted therapy with BRAF/MEK inhibitors in patients with BRAF mutations. However, preclinical studies suggest that neoadjuvant immunotherapy could lead to a stronger antitumor T-cell response than adjuvant immunotherapy.

Vidutolimod targets the toll-like receptor 9 (TLR-9) endosomal receptor found in B cells and pDC cells. The formulation is a virus-like particle (VLP) that contains unmethylated cytosine guanine–rich oligonucleotides (CpG ODN). Bacterial and viral genomes tend to be enriched in CpG ODN, and this acts as a TLR-9 agonist. TLR-9 activation in turn triggers an interferon response, and this may help overcome PD-1 blockade resistance in metastatic melanoma.

The researchers conducted a nonrandomized, open-label trial that included 30 patients with stage 3 melanoma (14 women; median age, 61 years). Patients received neoadjuvant nivolumab and vidutolimod for 8 weeks, then were evaluated for surgery. Patients continued both drugs in the adjuvant setting for 48 weeks. 47% experienced complete pathologic response, 10% a major pathologic response, and 10% a partial pathologic response.

Analysis of resected samples revealed clear evidence of an immune response, Dr. Davar said during a press conference held in advance of the meeting. “Pathologic response was associated with compelling evidence of immune activation both peripherally and within the tumor, with clear evidence of pDC infiltrate and pDC activation – something that has not previously been seen in human specimens.”

The study regimen appeared safe, with no dose-limiting toxicities or grade 4 or 5 adverse events. He noted that the regimen is now being tested in the phase 2 ECOG-ACRIN trial.

The results are “very exciting,” said Pamela Ohashi, PhD, who commented on the study during the press conference. The virus-like nature of vidutolimod may be an important element of the therapy. “I think scientifically we would have predicted that the VLP carrying the CPG would be very good at activating the CD8 cells, which in fact is what you’re seeing. So I think it’s very exciting and has lots of potential for future combinations,” said Dr. Ohashi, who is director of the tumor immunotherapy program at the Princess Margaret Cancer Centre, Toronto.

The study was funded by Checkmate Pharmaceuticals. Dr. Davar has financial relationships with Checkmate Pharmaceuticals and Regeneron, which has acquired Checkmate Pharmaceuticals.

The combination of nivolumab and vidutolimod led to a high rate of pathologic complete response and pathologic major response in a phase 2 trial of patients with stage 3 resectable melanoma. The result led researchers to call for a future study comparing the regimen against a suitable control group.

“We were very excited to see the ability of intratumoral vidutolimod to augment T-cell infiltrate. (Pathologic) response was associated with a dense infiltrate of CD8 T cells. We were also able to demonstrate for what I think may be the first time, that intratumoral CpG resulted in clear evidence of CD303+ plasmacytoid dendritic cells [pDCs],” said Diwakar Davar, MD, assistant professor of medicine at the University of Pittsburgh, during a presentation of the results at the annual meeting of the Society for Immunotherapy of Cancer. He noted that pDCs represent a very rare cell population, less than 0.4% of circulating peripheral blood mononuclear cells, and tend to be found in lymph nodes.

The current standard of care for stage 3 melanoma is up-front surgery followed by adjuvant therapy – anti–PD-1 therapy for patients with wild-type or BRAF-mutant cancers, and targeted therapy with BRAF/MEK inhibitors in patients with BRAF mutations. However, preclinical studies suggest that neoadjuvant immunotherapy could lead to a stronger antitumor T-cell response than adjuvant immunotherapy.

Vidutolimod targets the toll-like receptor 9 (TLR-9) endosomal receptor found in B cells and pDC cells. The formulation is a virus-like particle (VLP) that contains unmethylated cytosine guanine–rich oligonucleotides (CpG ODN). Bacterial and viral genomes tend to be enriched in CpG ODN, and this acts as a TLR-9 agonist. TLR-9 activation in turn triggers an interferon response, and this may help overcome PD-1 blockade resistance in metastatic melanoma.

The researchers conducted a nonrandomized, open-label trial that included 30 patients with stage 3 melanoma (14 women; median age, 61 years). Patients received neoadjuvant nivolumab and vidutolimod for 8 weeks, then were evaluated for surgery. Patients continued both drugs in the adjuvant setting for 48 weeks. 47% experienced complete pathologic response, 10% a major pathologic response, and 10% a partial pathologic response.

Analysis of resected samples revealed clear evidence of an immune response, Dr. Davar said during a press conference held in advance of the meeting. “Pathologic response was associated with compelling evidence of immune activation both peripherally and within the tumor, with clear evidence of pDC infiltrate and pDC activation – something that has not previously been seen in human specimens.”

The study regimen appeared safe, with no dose-limiting toxicities or grade 4 or 5 adverse events. He noted that the regimen is now being tested in the phase 2 ECOG-ACRIN trial.

The results are “very exciting,” said Pamela Ohashi, PhD, who commented on the study during the press conference. The virus-like nature of vidutolimod may be an important element of the therapy. “I think scientifically we would have predicted that the VLP carrying the CPG would be very good at activating the CD8 cells, which in fact is what you’re seeing. So I think it’s very exciting and has lots of potential for future combinations,” said Dr. Ohashi, who is director of the tumor immunotherapy program at the Princess Margaret Cancer Centre, Toronto.

The study was funded by Checkmate Pharmaceuticals. Dr. Davar has financial relationships with Checkmate Pharmaceuticals and Regeneron, which has acquired Checkmate Pharmaceuticals.

NASHVILLE, TENN. – Supported by several cases series, a large cohort analysis has associated exposure to probiotics in the intensive care unit with a measurable increase in bacteremia and bacteremia-related mortality due to organisms in these preparations, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).

According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.

“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.

The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.

For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).

“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.

These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.

“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.

“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.

To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.

“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.

The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.

“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.

This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).

Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.

“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.

“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.

Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.

Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).

The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.

For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”

She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”

Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.

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

NASHVILLE, TENN. – Supported by several cases series, a large cohort analysis has associated exposure to probiotics in the intensive care unit with a measurable increase in bacteremia and bacteremia-related mortality due to organisms in these preparations, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).

According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.

“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.

The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.

For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).

“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.

These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.

“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.

“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.

To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.

“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.

The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.

“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.

This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).

Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.

“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.

“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.

Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.

Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).

The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.

For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”

She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”

Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.

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

NASHVILLE, TENN. – Supported by several cases series, a large cohort analysis has associated exposure to probiotics in the intensive care unit with a measurable increase in bacteremia and bacteremia-related mortality due to organisms in these preparations, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).

According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.

“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.

The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.

For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).

“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.

These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.

“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.

“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.

To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.

“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.

The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.

“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.

This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).

Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.

“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.

“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.

Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.

Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).

The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.

For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”

She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”

Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.

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