Commentary

As we enter into this new year, it is a good time to review the past few years of living through a pandemic and the impact this has had on the field of palliative care.

The health care system as a whole as well as palliative care teams, have been challenged by the ongoing COVID-19 pandemic.

According to the World Health Organization, “Palliative care is an approach that improves the quality of life of patients and their families who are facing the problems associated with life-threatening illness, by the prevention and relief of suffering through early identification, assessment and treatment of pain and other problems whether physical, psychosocial and spiritual.”¹ They identify a global need and recognize palliative care as a “human right to health and as a standard of care particularly for individuals living with a serious illness.¹ However, the WHO goes further to recognize palliative care as an essential part of the response team during crises and health emergencies like a pandemic, noting that a response team without palliative care is “medically deficient and ethically indefensible.”²

The need for palliative care in the United States is projected to grow significantly in the next decades.³ However, there has been insufficient staffing to meet these needs, even prior to the pandemic.⁴ The demand for palliative care reached further unprecedented levels during the pandemic as palliative care teams played an integral role and were well situated to support not only patients and families with COVID-19,⁵ but to also support the well-being of health care teams caring for COVID-19 patients.^6,7

A recent survey that was conducted by the Center to Advance Palliative Care among palliative care leadership captured the experiences of leading their teams through a pandemic. Below are the results of this survey, which highlighted important issues and developments to palliative care during the pandemic.⁶
 

Increasing need for palliative care

One of the main findings from the national survey of palliative care leaders corroborated that the demands for palliative care have increased significantly from 2020 through the pandemic.

As with many areas in the health care system, the pandemic has emphasized the strain and short staffing of the palliative care teams. In the survey, 61% of leaders reported that palliative care consults significantly increased from prepandemic levels. But only 26% of these leaders said they had the staffing support to meet these needs.
 

Value of palliative care

The value of palliative care along with understanding of the role of palliative care has been better recognized during the pandemic and has been evidenced by the increase in palliative care referrals from clinical providers, compared with prepandemic levels. In addition, data collected showed that earlier palliative care consultations reduced length of hospital stay, decreased ICU admissions, and improved patient, family, and provider satisfaction.

Well-being of the workforce

The pandemic has been a tremendously stressful time for the health care workforce that has undoubtedly led to burnout. A nationwide study of physicians,⁸ found that 61% of physicians experienced burnout. This is a significant increase from prepandemic levels with impacts on mental health (that is, anxiety, depression). This study did not include palliative care specialists, but the CAPC survey indicates a similar feeling of burnout. Because of this, some palliative care specialists have left the field altogether, or are leaving leadership positions because of burnout and exhaustion from the pandemic. This was featured as a concern among palliative care leaders, where 93% reported concern for the emotional well-being of the palliative care team.

Telehealth

A permanent operational change that has been well-utilized and implemented across multiple health care settings has been providing palliative care through telehealth. Prior to the pandemic, the baseline use of telehealth was less than 5% with the use now greater than 75% – a modality that is favored by both patients and clinicians. This has offered a broader scope of practice, reaching individuals who may have no other means, have limitations to accessing palliative care, or were in circumstances where patients required isolation during the pandemic. However, there are limitations to this platform, including in equity of access to devices and ease of use for those with limited exposure to technology.⁹

Barriers to implementation

Although the important role and value of palliative care has been well recognized, there have been barriers identified in a qualitative study of the integration of palliative care into COVID-19 action plans that are mentioned below.⁵

• Patients and families were identified as barriers to integration of palliative care if they were not open to palliative care referral, mainly because of misperceptions of palliative care as end-of-life care.
• Palliative care knowledge among providers was identified as another barrier to integration of palliative care. There are still misperceptions among providers that palliative care is end-of-life care and palliative care involvement is stigmatized as hastening death. In addition, some felt that COVID-19 was not a traditional “palliative diagnosis” thus were less likely to integrate palliative care into care plans.
• Lack of availability of a primary provider to conduct primary palliative care and lack of motivation “not to give up” were identified as other barriers. On the other hand, palliative care provider availability and accessibility to care teams affected the integration into COVID-19 care plans.
• COVID-19 itself was identified to be a barrier because of the uncertainty of illness trajectory and outcomes, which made it difficult for doctors to ascertain when to involve palliative care.
• Leadership and institution were important factors to consider in integration of palliative care into long-term care plans, which depended on leadership engagement and institutional culture.

Takeaways

The past few years have taught us a lot, but there is still much to learn. The COVID-19 pandemic has called attention to the challenges and barriers of health care delivery and has magnified the needs of the health care system including its infrastructure, preparedness, and staffing, including the field of palliative care. More work needs to be done, but leaders have taken steps to initiate national and international preparedness plans including the integration of palliative care, which has been identified as a vital role in any humanitarian crises.^10,11

Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle, in the division of geriatrics and gerontology. She has no conflicts related to the content of this article.

References

1. Palliative care. World Health Organization. Aug 5, 2020. https://www.who.int/news-room/fact-sheets/detail/palliative-care

2. World Health Organization. Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises: A WHO guide. Geneva: World Health Organization, 2018. https://apps.who.int/iris/handle/10665/274565.

3. Hughes MT, Smith TJ. The growth of palliative care in the United States. Annual Review Public Health. 2014;35:459-75.

4. Pastrana T et al. The impact of COVID-19 on palliative care workers across the world: A qualitative analysis of responses to open-ended questions. Palliative and Supportive Care. 2021:1-6.

5. Wentlandt K et al. Identifying barriers and facilitators to palliative care integration in the management of hospitalized patients with COVID-19: A qualitative study. Palliat Med. 2022;36(6):945-54.

6. Rogers M et al. Palliative care leadership during the pandemic: Results from a recent survey. Center to Advance Palliative Care. 2022 Sept 8. https://www.capc.org/blog/palliative-care-leadership-during-the-pandemic-results-from-a-recent-survey

7. Fogelman P. Reflections form a palliative care program leader two years into the pandemic. Center to Advance Palliative Care. 2023 Jan 15. https://www.capc.org/blog/reflections-from-a-palliative-care-program-leader-two-years-into-the-pandemic

8. 2021 survey of America’s physicians Covid-19 impact edition: A year later. The Physicians Foundation. 2021.

9. Caraceni A et al. Telemedicine for outpatient palliative care during Covid-19 pandemics: A longitudinal study. BMJ Supportive & Palliative Care. 2022;0:1-7.

10. Bausewein C et al. National strategy for palliative care of severely ill and dying people and their relatives in pandemics (PallPan) in Germany – study protocol of a mixed-methods project. BMC Palliative Care. 2022;21(10).

11. Powell RA et al. Palliative care in humanitarian crises: Always something to offer. The Lancet. 2017;389(10078):1498-9.

As we enter into this new year, it is a good time to review the past few years of living through a pandemic and the impact this has had on the field of palliative care.

The health care system as a whole as well as palliative care teams, have been challenged by the ongoing COVID-19 pandemic.

According to the World Health Organization, “Palliative care is an approach that improves the quality of life of patients and their families who are facing the problems associated with life-threatening illness, by the prevention and relief of suffering through early identification, assessment and treatment of pain and other problems whether physical, psychosocial and spiritual.”¹ They identify a global need and recognize palliative care as a “human right to health and as a standard of care particularly for individuals living with a serious illness.¹ However, the WHO goes further to recognize palliative care as an essential part of the response team during crises and health emergencies like a pandemic, noting that a response team without palliative care is “medically deficient and ethically indefensible.”²

The need for palliative care in the United States is projected to grow significantly in the next decades.³ However, there has been insufficient staffing to meet these needs, even prior to the pandemic.⁴ The demand for palliative care reached further unprecedented levels during the pandemic as palliative care teams played an integral role and were well situated to support not only patients and families with COVID-19,⁵ but to also support the well-being of health care teams caring for COVID-19 patients.^6,7

A recent survey that was conducted by the Center to Advance Palliative Care among palliative care leadership captured the experiences of leading their teams through a pandemic. Below are the results of this survey, which highlighted important issues and developments to palliative care during the pandemic.⁶
 

Increasing need for palliative care

One of the main findings from the national survey of palliative care leaders corroborated that the demands for palliative care have increased significantly from 2020 through the pandemic.

As with many areas in the health care system, the pandemic has emphasized the strain and short staffing of the palliative care teams. In the survey, 61% of leaders reported that palliative care consults significantly increased from prepandemic levels. But only 26% of these leaders said they had the staffing support to meet these needs.
 

Value of palliative care

The value of palliative care along with understanding of the role of palliative care has been better recognized during the pandemic and has been evidenced by the increase in palliative care referrals from clinical providers, compared with prepandemic levels. In addition, data collected showed that earlier palliative care consultations reduced length of hospital stay, decreased ICU admissions, and improved patient, family, and provider satisfaction.

Well-being of the workforce

The pandemic has been a tremendously stressful time for the health care workforce that has undoubtedly led to burnout. A nationwide study of physicians,⁸ found that 61% of physicians experienced burnout. This is a significant increase from prepandemic levels with impacts on mental health (that is, anxiety, depression). This study did not include palliative care specialists, but the CAPC survey indicates a similar feeling of burnout. Because of this, some palliative care specialists have left the field altogether, or are leaving leadership positions because of burnout and exhaustion from the pandemic. This was featured as a concern among palliative care leaders, where 93% reported concern for the emotional well-being of the palliative care team.

Telehealth

A permanent operational change that has been well-utilized and implemented across multiple health care settings has been providing palliative care through telehealth. Prior to the pandemic, the baseline use of telehealth was less than 5% with the use now greater than 75% – a modality that is favored by both patients and clinicians. This has offered a broader scope of practice, reaching individuals who may have no other means, have limitations to accessing palliative care, or were in circumstances where patients required isolation during the pandemic. However, there are limitations to this platform, including in equity of access to devices and ease of use for those with limited exposure to technology.⁹

Barriers to implementation

Although the important role and value of palliative care has been well recognized, there have been barriers identified in a qualitative study of the integration of palliative care into COVID-19 action plans that are mentioned below.⁵

• Patients and families were identified as barriers to integration of palliative care if they were not open to palliative care referral, mainly because of misperceptions of palliative care as end-of-life care.
• Palliative care knowledge among providers was identified as another barrier to integration of palliative care. There are still misperceptions among providers that palliative care is end-of-life care and palliative care involvement is stigmatized as hastening death. In addition, some felt that COVID-19 was not a traditional “palliative diagnosis” thus were less likely to integrate palliative care into care plans.
• Lack of availability of a primary provider to conduct primary palliative care and lack of motivation “not to give up” were identified as other barriers. On the other hand, palliative care provider availability and accessibility to care teams affected the integration into COVID-19 care plans.
• COVID-19 itself was identified to be a barrier because of the uncertainty of illness trajectory and outcomes, which made it difficult for doctors to ascertain when to involve palliative care.
• Leadership and institution were important factors to consider in integration of palliative care into long-term care plans, which depended on leadership engagement and institutional culture.

Takeaways

The past few years have taught us a lot, but there is still much to learn. The COVID-19 pandemic has called attention to the challenges and barriers of health care delivery and has magnified the needs of the health care system including its infrastructure, preparedness, and staffing, including the field of palliative care. More work needs to be done, but leaders have taken steps to initiate national and international preparedness plans including the integration of palliative care, which has been identified as a vital role in any humanitarian crises.^10,11

Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle, in the division of geriatrics and gerontology. She has no conflicts related to the content of this article.

References

1. Palliative care. World Health Organization. Aug 5, 2020. https://www.who.int/news-room/fact-sheets/detail/palliative-care

2. World Health Organization. Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises: A WHO guide. Geneva: World Health Organization, 2018. https://apps.who.int/iris/handle/10665/274565.

3. Hughes MT, Smith TJ. The growth of palliative care in the United States. Annual Review Public Health. 2014;35:459-75.

4. Pastrana T et al. The impact of COVID-19 on palliative care workers across the world: A qualitative analysis of responses to open-ended questions. Palliative and Supportive Care. 2021:1-6.

5. Wentlandt K et al. Identifying barriers and facilitators to palliative care integration in the management of hospitalized patients with COVID-19: A qualitative study. Palliat Med. 2022;36(6):945-54.

6. Rogers M et al. Palliative care leadership during the pandemic: Results from a recent survey. Center to Advance Palliative Care. 2022 Sept 8. https://www.capc.org/blog/palliative-care-leadership-during-the-pandemic-results-from-a-recent-survey

7. Fogelman P. Reflections form a palliative care program leader two years into the pandemic. Center to Advance Palliative Care. 2023 Jan 15. https://www.capc.org/blog/reflections-from-a-palliative-care-program-leader-two-years-into-the-pandemic

8. 2021 survey of America’s physicians Covid-19 impact edition: A year later. The Physicians Foundation. 2021.

9. Caraceni A et al. Telemedicine for outpatient palliative care during Covid-19 pandemics: A longitudinal study. BMJ Supportive & Palliative Care. 2022;0:1-7.

10. Bausewein C et al. National strategy for palliative care of severely ill and dying people and their relatives in pandemics (PallPan) in Germany – study protocol of a mixed-methods project. BMC Palliative Care. 2022;21(10).

11. Powell RA et al. Palliative care in humanitarian crises: Always something to offer. The Lancet. 2017;389(10078):1498-9.

As we enter into this new year, it is a good time to review the past few years of living through a pandemic and the impact this has had on the field of palliative care.

The health care system as a whole as well as palliative care teams, have been challenged by the ongoing COVID-19 pandemic.

According to the World Health Organization, “Palliative care is an approach that improves the quality of life of patients and their families who are facing the problems associated with life-threatening illness, by the prevention and relief of suffering through early identification, assessment and treatment of pain and other problems whether physical, psychosocial and spiritual.”¹ They identify a global need and recognize palliative care as a “human right to health and as a standard of care particularly for individuals living with a serious illness.¹ However, the WHO goes further to recognize palliative care as an essential part of the response team during crises and health emergencies like a pandemic, noting that a response team without palliative care is “medically deficient and ethically indefensible.”²

The need for palliative care in the United States is projected to grow significantly in the next decades.³ However, there has been insufficient staffing to meet these needs, even prior to the pandemic.⁴ The demand for palliative care reached further unprecedented levels during the pandemic as palliative care teams played an integral role and were well situated to support not only patients and families with COVID-19,⁵ but to also support the well-being of health care teams caring for COVID-19 patients.^6,7

A recent survey that was conducted by the Center to Advance Palliative Care among palliative care leadership captured the experiences of leading their teams through a pandemic. Below are the results of this survey, which highlighted important issues and developments to palliative care during the pandemic.⁶
 

Increasing need for palliative care

One of the main findings from the national survey of palliative care leaders corroborated that the demands for palliative care have increased significantly from 2020 through the pandemic.

As with many areas in the health care system, the pandemic has emphasized the strain and short staffing of the palliative care teams. In the survey, 61% of leaders reported that palliative care consults significantly increased from prepandemic levels. But only 26% of these leaders said they had the staffing support to meet these needs.
 

Value of palliative care

The value of palliative care along with understanding of the role of palliative care has been better recognized during the pandemic and has been evidenced by the increase in palliative care referrals from clinical providers, compared with prepandemic levels. In addition, data collected showed that earlier palliative care consultations reduced length of hospital stay, decreased ICU admissions, and improved patient, family, and provider satisfaction.

Well-being of the workforce

The pandemic has been a tremendously stressful time for the health care workforce that has undoubtedly led to burnout. A nationwide study of physicians,⁸ found that 61% of physicians experienced burnout. This is a significant increase from prepandemic levels with impacts on mental health (that is, anxiety, depression). This study did not include palliative care specialists, but the CAPC survey indicates a similar feeling of burnout. Because of this, some palliative care specialists have left the field altogether, or are leaving leadership positions because of burnout and exhaustion from the pandemic. This was featured as a concern among palliative care leaders, where 93% reported concern for the emotional well-being of the palliative care team.

Telehealth

A permanent operational change that has been well-utilized and implemented across multiple health care settings has been providing palliative care through telehealth. Prior to the pandemic, the baseline use of telehealth was less than 5% with the use now greater than 75% – a modality that is favored by both patients and clinicians. This has offered a broader scope of practice, reaching individuals who may have no other means, have limitations to accessing palliative care, or were in circumstances where patients required isolation during the pandemic. However, there are limitations to this platform, including in equity of access to devices and ease of use for those with limited exposure to technology.⁹

Barriers to implementation

Although the important role and value of palliative care has been well recognized, there have been barriers identified in a qualitative study of the integration of palliative care into COVID-19 action plans that are mentioned below.⁵

• Patients and families were identified as barriers to integration of palliative care if they were not open to palliative care referral, mainly because of misperceptions of palliative care as end-of-life care.
• Palliative care knowledge among providers was identified as another barrier to integration of palliative care. There are still misperceptions among providers that palliative care is end-of-life care and palliative care involvement is stigmatized as hastening death. In addition, some felt that COVID-19 was not a traditional “palliative diagnosis” thus were less likely to integrate palliative care into care plans.
• Lack of availability of a primary provider to conduct primary palliative care and lack of motivation “not to give up” were identified as other barriers. On the other hand, palliative care provider availability and accessibility to care teams affected the integration into COVID-19 care plans.
• COVID-19 itself was identified to be a barrier because of the uncertainty of illness trajectory and outcomes, which made it difficult for doctors to ascertain when to involve palliative care.
• Leadership and institution were important factors to consider in integration of palliative care into long-term care plans, which depended on leadership engagement and institutional culture.

Takeaways

The past few years have taught us a lot, but there is still much to learn. The COVID-19 pandemic has called attention to the challenges and barriers of health care delivery and has magnified the needs of the health care system including its infrastructure, preparedness, and staffing, including the field of palliative care. More work needs to be done, but leaders have taken steps to initiate national and international preparedness plans including the integration of palliative care, which has been identified as a vital role in any humanitarian crises.^10,11

Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle, in the division of geriatrics and gerontology. She has no conflicts related to the content of this article.

References

1. Palliative care. World Health Organization. Aug 5, 2020. https://www.who.int/news-room/fact-sheets/detail/palliative-care

2. World Health Organization. Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises: A WHO guide. Geneva: World Health Organization, 2018. https://apps.who.int/iris/handle/10665/274565.

3. Hughes MT, Smith TJ. The growth of palliative care in the United States. Annual Review Public Health. 2014;35:459-75.

4. Pastrana T et al. The impact of COVID-19 on palliative care workers across the world: A qualitative analysis of responses to open-ended questions. Palliative and Supportive Care. 2021:1-6.

5. Wentlandt K et al. Identifying barriers and facilitators to palliative care integration in the management of hospitalized patients with COVID-19: A qualitative study. Palliat Med. 2022;36(6):945-54.

6. Rogers M et al. Palliative care leadership during the pandemic: Results from a recent survey. Center to Advance Palliative Care. 2022 Sept 8. https://www.capc.org/blog/palliative-care-leadership-during-the-pandemic-results-from-a-recent-survey

7. Fogelman P. Reflections form a palliative care program leader two years into the pandemic. Center to Advance Palliative Care. 2023 Jan 15. https://www.capc.org/blog/reflections-from-a-palliative-care-program-leader-two-years-into-the-pandemic

8. 2021 survey of America’s physicians Covid-19 impact edition: A year later. The Physicians Foundation. 2021.

9. Caraceni A et al. Telemedicine for outpatient palliative care during Covid-19 pandemics: A longitudinal study. BMJ Supportive & Palliative Care. 2022;0:1-7.

10. Bausewein C et al. National strategy for palliative care of severely ill and dying people and their relatives in pandemics (PallPan) in Germany – study protocol of a mixed-methods project. BMC Palliative Care. 2022;21(10).

11. Powell RA et al. Palliative care in humanitarian crises: Always something to offer. The Lancet. 2017;389(10078):1498-9.

This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today we are going to talk about the new Blood Pressure Targets in Adults With Hypertension: A Clinical Practice Guideline From the AAFP. There are very few things that we treat more often than hypertension, so you’d think the guidelines would have been clear a long time ago. Less than 10 years ago, in 2014, JNC 8 (Eighth Joint National Committee) recommended target blood pressure for individuals under 60 to be less than 140/90, and for those older than 60, less than 150/90.

Then, based primarily on the SPRINT trial (which included only people with or at significantly elevated risk for atherosclerotic cardiovascular disease), in 2017 the American Heart Association’s hypertension guidelines lowered the target BP to less than 130/80 for most individuals. It’s a little more nuanced than that, but most of us don’t remember the nuance. I’ve written about my reservations with that statement in the AHA’s journal, Circulation.

Now the American Academy of Family Physicians has updated its recommendations, and they recommend a BP less than 140/90. This is not a small change, as it often takes additional medication to achieve lower BP targets, and additional medicines lead to additional adverse effects. I’m going share with you some details from the new guideline, and then I’m going share my opinion about it.

The AAFP guideline applies to adults with hypertension, with or without cardiovascular disease. In the comprehensive literature review, the trials ran for an average of 3.7 years, and about 75% of the patients in the trials did not have preexisting cardiovascular disease.

The key to their recommendations is that target BPs lower than 140/90 did not show a statistically significant decrease in total mortality. In regard to serious adverse events, though, lower targets led to a nominal increase that didn’t reach statistical significance. Serious adverse events were defined as death or events that required hospitalization or resulted in significant disability. In regard to all other adverse events, including syncope and hypotension, there was a significant increase, with a relative risk of 1.44 (a 44% increase in adverse events). This reflected an absolute risk increase of 3%, compared with the standard target group (specifically 9.8% vs. 6.8%), with a number needed to harm of 33 over 3.7 years.

Another potential harm of low BP targets was the need for an average of one additional medicine to reach lower BP targets. One systematic review cited an eightfold higher withdrawal rate because of adverse events in the lower-target BP groups.

The AAFP guidelines said that, in the comprehensive review of the literature, while there was no difference in mortality or stroke with lower BP targets, a small additional benefit was observed in myocardial infarction – a 16% lower incidence, with a number needed to treat of 137 over 3.7 years.

So that’s the background. Let me now go over the specifics of the AAFP recommendations.

AAFP gives a strong recommendation for a standard BP target of less than 140/90. They go on to say – and grade this next statement as a weak recommendation – that, while treating to a lower BP target does not provide additional mortality benefit, a target BP of less than 135/85 can be considered to lower the risk for MI, noting that lower BP may increase harms. They state that the lower BP target could be considered based on patient preferences and values.

The AAFP guideline is incredibly helpful. The difference in the recommendations of two large societies – American Heart Association and AAFP — stems from two things. I believe that AHA focused on the composite endpoints in trials such as SPRINT, which included only high-risk patients, and the AAFP uses mortality as the driving endpoint in a broader group of patients that included both high- and lower-risk patients.

In addition, it appears that the two organizations weigh adverse events differently in coming to their conclusions. Clearly, we see more adverse events when aiming for a lower BP level, and in my experience, patients care a lot about adverse events.

Interestingly, the International Society of Hypertension recommends an “essential” BP target of less than 140/90 for most individuals, and for those under 65, they provide the option of an “optimal” BP of less than 130/80. Remember that for certain comorbidities there are also other guidelines out there. The American Diabetes Association this year revised its target BP to less than 130/80 for people with diabetes; for prevention of recurrent stroke, guidelines from the AHA/American Stroke Association in 2021 recommend BP less than 130/80, and the International Society for Hypertension as well as the AHA recommends a BP of less than 130/80 for those with established atherosclerotic cardiovascular disease.

To repeat, though, the main topic for today is that as a general target, the AAFP guidelines recommend a BP less than 140/90.

Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

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

*This article was updated on 2/7/2023.

This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today we are going to talk about the new Blood Pressure Targets in Adults With Hypertension: A Clinical Practice Guideline From the AAFP. There are very few things that we treat more often than hypertension, so you’d think the guidelines would have been clear a long time ago. Less than 10 years ago, in 2014, JNC 8 (Eighth Joint National Committee) recommended target blood pressure for individuals under 60 to be less than 140/90, and for those older than 60, less than 150/90.

Then, based primarily on the SPRINT trial (which included only people with or at significantly elevated risk for atherosclerotic cardiovascular disease), in 2017 the American Heart Association’s hypertension guidelines lowered the target BP to less than 130/80 for most individuals. It’s a little more nuanced than that, but most of us don’t remember the nuance. I’ve written about my reservations with that statement in the AHA’s journal, Circulation.

Now the American Academy of Family Physicians has updated its recommendations, and they recommend a BP less than 140/90. This is not a small change, as it often takes additional medication to achieve lower BP targets, and additional medicines lead to additional adverse effects. I’m going share with you some details from the new guideline, and then I’m going share my opinion about it.

The AAFP guideline applies to adults with hypertension, with or without cardiovascular disease. In the comprehensive literature review, the trials ran for an average of 3.7 years, and about 75% of the patients in the trials did not have preexisting cardiovascular disease.

The key to their recommendations is that target BPs lower than 140/90 did not show a statistically significant decrease in total mortality. In regard to serious adverse events, though, lower targets led to a nominal increase that didn’t reach statistical significance. Serious adverse events were defined as death or events that required hospitalization or resulted in significant disability. In regard to all other adverse events, including syncope and hypotension, there was a significant increase, with a relative risk of 1.44 (a 44% increase in adverse events). This reflected an absolute risk increase of 3%, compared with the standard target group (specifically 9.8% vs. 6.8%), with a number needed to harm of 33 over 3.7 years.

Another potential harm of low BP targets was the need for an average of one additional medicine to reach lower BP targets. One systematic review cited an eightfold higher withdrawal rate because of adverse events in the lower-target BP groups.

The AAFP guidelines said that, in the comprehensive review of the literature, while there was no difference in mortality or stroke with lower BP targets, a small additional benefit was observed in myocardial infarction – a 16% lower incidence, with a number needed to treat of 137 over 3.7 years.

So that’s the background. Let me now go over the specifics of the AAFP recommendations.

AAFP gives a strong recommendation for a standard BP target of less than 140/90. They go on to say – and grade this next statement as a weak recommendation – that, while treating to a lower BP target does not provide additional mortality benefit, a target BP of less than 135/85 can be considered to lower the risk for MI, noting that lower BP may increase harms. They state that the lower BP target could be considered based on patient preferences and values.

The AAFP guideline is incredibly helpful. The difference in the recommendations of two large societies – American Heart Association and AAFP — stems from two things. I believe that AHA focused on the composite endpoints in trials such as SPRINT, which included only high-risk patients, and the AAFP uses mortality as the driving endpoint in a broader group of patients that included both high- and lower-risk patients.

In addition, it appears that the two organizations weigh adverse events differently in coming to their conclusions. Clearly, we see more adverse events when aiming for a lower BP level, and in my experience, patients care a lot about adverse events.

Interestingly, the International Society of Hypertension recommends an “essential” BP target of less than 140/90 for most individuals, and for those under 65, they provide the option of an “optimal” BP of less than 130/80. Remember that for certain comorbidities there are also other guidelines out there. The American Diabetes Association this year revised its target BP to less than 130/80 for people with diabetes; for prevention of recurrent stroke, guidelines from the AHA/American Stroke Association in 2021 recommend BP less than 130/80, and the International Society for Hypertension as well as the AHA recommends a BP of less than 130/80 for those with established atherosclerotic cardiovascular disease.

To repeat, though, the main topic for today is that as a general target, the AAFP guidelines recommend a BP less than 140/90.

Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

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

*This article was updated on 2/7/2023.

This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today we are going to talk about the new Blood Pressure Targets in Adults With Hypertension: A Clinical Practice Guideline From the AAFP. There are very few things that we treat more often than hypertension, so you’d think the guidelines would have been clear a long time ago. Less than 10 years ago, in 2014, JNC 8 (Eighth Joint National Committee) recommended target blood pressure for individuals under 60 to be less than 140/90, and for those older than 60, less than 150/90.

Then, based primarily on the SPRINT trial (which included only people with or at significantly elevated risk for atherosclerotic cardiovascular disease), in 2017 the American Heart Association’s hypertension guidelines lowered the target BP to less than 130/80 for most individuals. It’s a little more nuanced than that, but most of us don’t remember the nuance. I’ve written about my reservations with that statement in the AHA’s journal, Circulation.

Now the American Academy of Family Physicians has updated its recommendations, and they recommend a BP less than 140/90. This is not a small change, as it often takes additional medication to achieve lower BP targets, and additional medicines lead to additional adverse effects. I’m going share with you some details from the new guideline, and then I’m going share my opinion about it.

The AAFP guideline applies to adults with hypertension, with or without cardiovascular disease. In the comprehensive literature review, the trials ran for an average of 3.7 years, and about 75% of the patients in the trials did not have preexisting cardiovascular disease.

The key to their recommendations is that target BPs lower than 140/90 did not show a statistically significant decrease in total mortality. In regard to serious adverse events, though, lower targets led to a nominal increase that didn’t reach statistical significance. Serious adverse events were defined as death or events that required hospitalization or resulted in significant disability. In regard to all other adverse events, including syncope and hypotension, there was a significant increase, with a relative risk of 1.44 (a 44% increase in adverse events). This reflected an absolute risk increase of 3%, compared with the standard target group (specifically 9.8% vs. 6.8%), with a number needed to harm of 33 over 3.7 years.

Another potential harm of low BP targets was the need for an average of one additional medicine to reach lower BP targets. One systematic review cited an eightfold higher withdrawal rate because of adverse events in the lower-target BP groups.

The AAFP guidelines said that, in the comprehensive review of the literature, while there was no difference in mortality or stroke with lower BP targets, a small additional benefit was observed in myocardial infarction – a 16% lower incidence, with a number needed to treat of 137 over 3.7 years.

So that’s the background. Let me now go over the specifics of the AAFP recommendations.

AAFP gives a strong recommendation for a standard BP target of less than 140/90. They go on to say – and grade this next statement as a weak recommendation – that, while treating to a lower BP target does not provide additional mortality benefit, a target BP of less than 135/85 can be considered to lower the risk for MI, noting that lower BP may increase harms. They state that the lower BP target could be considered based on patient preferences and values.

The AAFP guideline is incredibly helpful. The difference in the recommendations of two large societies – American Heart Association and AAFP — stems from two things. I believe that AHA focused on the composite endpoints in trials such as SPRINT, which included only high-risk patients, and the AAFP uses mortality as the driving endpoint in a broader group of patients that included both high- and lower-risk patients.

In addition, it appears that the two organizations weigh adverse events differently in coming to their conclusions. Clearly, we see more adverse events when aiming for a lower BP level, and in my experience, patients care a lot about adverse events.

Interestingly, the International Society of Hypertension recommends an “essential” BP target of less than 140/90 for most individuals, and for those under 65, they provide the option of an “optimal” BP of less than 130/80. Remember that for certain comorbidities there are also other guidelines out there. The American Diabetes Association this year revised its target BP to less than 130/80 for people with diabetes; for prevention of recurrent stroke, guidelines from the AHA/American Stroke Association in 2021 recommend BP less than 130/80, and the International Society for Hypertension as well as the AHA recommends a BP of less than 130/80 for those with established atherosclerotic cardiovascular disease.

To repeat, though, the main topic for today is that as a general target, the AAFP guidelines recommend a BP less than 140/90.

Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.

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

*This article was updated on 2/7/2023.

To the Editor:

We read with interest the Cutis article by Dobkin et al¹ (Cutis. 2022;109:218-220) regarding guidelines for inpatient and emergency department dermatology consultations. We agree with the authors that dermatology training is lacking in other medical specialties, which makes it challenging for teams to assess the appropriateness of a dermatology consultation in the inpatient setting. Inpatient dermatology consultation can be utilized in a hospital system to aid in rapid and accurate diagnosis, avoid inappropriate therapies, and decrease length of stay² and readmission rates³ while providing education to the primary teams. This is precisely why in many instances the availability of inpatient dermatology consultation is so important because nondermatologists often are unable to determine whether a rash is life-threatening, benign, or something in between. From the perspective of dermatology hospitalists, there is room for improvement in the flowchart Dobkin et al¹ presented to guide inpatient dermatology consultation.

To have a productive relationship with our internal medicine, surgery, pediatrics, psychiatry, and other hospital-based colleagues, we must keep an open mind when a consultation is received. We feel that the flowchart proposed by Dobkin et al¹ presents too narrow a viewpoint on the utility of inpatient dermatology. It rests on assertions that other teams will be able to determine the appropriate dermatologic diagnosis without involving a dermatologist, which often is not the case.

We disagree with several recommendations in the flowchart, the first being the assertion that patients who are “hemodynamically unstable due to [a] nondermatologic problem (eg, intubated on pressors, febrile, and hypotensive)” are not appropriate for inpatient dermatology consultation.¹ Although dermatologists do not commonly encounter patients with critical illness in the outpatient clinic, dermatology consultation can be extremely helpful and even lifesaving in the inpatient setting. It is unrealistic to expect the primary teams to know whether cutaneous manifestations potentially could be related to the patient’s overall clinical picture. On the contrary, we would encourage the primary team in charge of a hemodynamically unstable patient to consult dermatology at the first sign of an unexplained rash. Take for example an acutely ill patient who develops retiform purpura. There are well-established dermatology guidelines for the workup of retiform purpura,⁴ including prompt biopsy and assessment of broad, potentially life-threatening differential diagnoses from calciphylaxis to angioinvasive fungal infection. In this scenario, the dermatology consultant may render the correct diagnosis and recommend immediate treatment that could be lifesaving.

Secondly, we do not agree with the recommendation that a patient in hospice care is not appropriate for inpatient dermatology consultation. Patients receiving hospice or palliative care have high rates of potentially symptomatic cutaneous diseases,⁵ including intertrigo and dermatitis—comprising stasis, seborrheic, and contact dermatitis.⁶ Although aggressive intervention for asymptomatic benign or malignant skin conditions may not be in line with their goals of care, an inpatient dermatology consultation can reduce symptoms and improve quality of life. This population also is one that is unlikely to be able to attend an outpatient dermatology clinic appointment and therefore are good candidates for inpatient consultation.

Lastly, we want to highlight the difference between a stable chronic dermatologic disease and an acute flare that may occur while a patient is hospitalized, regardless of whether it is the reason for admission. For example, a patient with psoriasis affecting limited body surface area who is hospitalized for a myocardial infarction is not appropriate for a dermatology consultation. However, if that same patient develops erythroderma while they are hospitalized for cardiac monitoring, it would certainly be appropriate for dermatology to be consulted. Additionally, there are times when a chronic skin disease is the reason for hospitalization; dermatology, although technically a consulting service, would be the primary decision-maker for the patient’s care in this situation. In these scenarios, it is important for the patient to be able to establish care for long-term outpatient management of their condition; however, it is prudent to involve dermatology while the patient is acutely hospitalized to guide their treatment plan until they are able to see a dermatologist after discharge.

In conclusion, we believe that hospital dermatology is a valuable tool that can be utilized in many different scenarios. Although there are certainly situations more appropriate for outpatient dermatology referral, we would caution against overly simplified algorithms that could discourage valuable inpatient dermatology consultations. It often is worth a conversation with your dermatology consultant (when available at an institution) to determine the best course of action for each patient. Additionally, we recognize the need for more formalized guidelines on when to pursue inpatient dermatology consultation. We are members of the Society of Dermatology Hospitalists and encourage readers to reference their website, which provides additional resources on inpatient dermatology (https://societydermatologyhospitalists.com/inpatient-dermatology-literature/).

 

 

Authors’ Response

We appreciate the letter in response to our commentary on the appropriateness of inpatient dermatology consultations. It is the continued refining and re-evaluation of concepts such as these that allow our field to grow and improve knowledge and patient care.

We sought to provide a nonpatronizing yet simple consultation flowchart that would help guide triage of patients in need or not in need of dermatologic evaluation by the inpatient teams. Understandably, the impressions of our flowchart have been variable based on different readers’ medical backgrounds and experiences. It is certainly possible that our flowchart lacked certain exceptions and oversimplified certain concepts, and we welcome further refining of this flowchart to better guide inpatient dermatology consultations.

We do, however, disagree that the primary team would not know whether a patient is intubated in the intensive care unit for a dermatology reason. If the patient is in such a status, it would be pertinent for the primary team to conduct a timely workup that could include consultations until a diagnosis is made. We were not implying that every dermatology consultation in the intensive care unit is unwarranted, especially if it can lead to a primary dermatologic diagnosis. We do believe that a thorough history could elicit an allergy or other chronic skin condition that could save resources and spending within a hospital. Likewise, psoriasis comes in many different presentations, and although we do not believe a consultation for chronic psoriatic plaques is appropriate in the hospital, it is absolutely appropriate for a patient who is erythrodermic from any cause.

Our flowchart was intended to be the first step to providing education on when consultations are appropriate, and further refinement will be necessary.

Hershel Dobkin, MD; Timothy Blackwell, BS; Robin Ashinoff, MD

Drs. Dobkin and Ashinoff are from Hackensack University Medical Center, New Jersey. Mr. Blackwell is from the Rowan University School of Osteopathic Medicine, Stratford, New Jersey.

The authors report no conflict of interest.

Correspondence: Hershel Dobkin, MD, Hackensack University Medical Center, 30 Prospect Ave, Hackensack, NJ 07601 ([email protected]).

To the Editor:

We read with interest the Cutis article by Dobkin et al¹ (Cutis. 2022;109:218-220) regarding guidelines for inpatient and emergency department dermatology consultations. We agree with the authors that dermatology training is lacking in other medical specialties, which makes it challenging for teams to assess the appropriateness of a dermatology consultation in the inpatient setting. Inpatient dermatology consultation can be utilized in a hospital system to aid in rapid and accurate diagnosis, avoid inappropriate therapies, and decrease length of stay² and readmission rates³ while providing education to the primary teams. This is precisely why in many instances the availability of inpatient dermatology consultation is so important because nondermatologists often are unable to determine whether a rash is life-threatening, benign, or something in between. From the perspective of dermatology hospitalists, there is room for improvement in the flowchart Dobkin et al¹ presented to guide inpatient dermatology consultation.

To have a productive relationship with our internal medicine, surgery, pediatrics, psychiatry, and other hospital-based colleagues, we must keep an open mind when a consultation is received. We feel that the flowchart proposed by Dobkin et al¹ presents too narrow a viewpoint on the utility of inpatient dermatology. It rests on assertions that other teams will be able to determine the appropriate dermatologic diagnosis without involving a dermatologist, which often is not the case.

We disagree with several recommendations in the flowchart, the first being the assertion that patients who are “hemodynamically unstable due to [a] nondermatologic problem (eg, intubated on pressors, febrile, and hypotensive)” are not appropriate for inpatient dermatology consultation.¹ Although dermatologists do not commonly encounter patients with critical illness in the outpatient clinic, dermatology consultation can be extremely helpful and even lifesaving in the inpatient setting. It is unrealistic to expect the primary teams to know whether cutaneous manifestations potentially could be related to the patient’s overall clinical picture. On the contrary, we would encourage the primary team in charge of a hemodynamically unstable patient to consult dermatology at the first sign of an unexplained rash. Take for example an acutely ill patient who develops retiform purpura. There are well-established dermatology guidelines for the workup of retiform purpura,⁴ including prompt biopsy and assessment of broad, potentially life-threatening differential diagnoses from calciphylaxis to angioinvasive fungal infection. In this scenario, the dermatology consultant may render the correct diagnosis and recommend immediate treatment that could be lifesaving.

Secondly, we do not agree with the recommendation that a patient in hospice care is not appropriate for inpatient dermatology consultation. Patients receiving hospice or palliative care have high rates of potentially symptomatic cutaneous diseases,⁵ including intertrigo and dermatitis—comprising stasis, seborrheic, and contact dermatitis.⁶ Although aggressive intervention for asymptomatic benign or malignant skin conditions may not be in line with their goals of care, an inpatient dermatology consultation can reduce symptoms and improve quality of life. This population also is one that is unlikely to be able to attend an outpatient dermatology clinic appointment and therefore are good candidates for inpatient consultation.

Lastly, we want to highlight the difference between a stable chronic dermatologic disease and an acute flare that may occur while a patient is hospitalized, regardless of whether it is the reason for admission. For example, a patient with psoriasis affecting limited body surface area who is hospitalized for a myocardial infarction is not appropriate for a dermatology consultation. However, if that same patient develops erythroderma while they are hospitalized for cardiac monitoring, it would certainly be appropriate for dermatology to be consulted. Additionally, there are times when a chronic skin disease is the reason for hospitalization; dermatology, although technically a consulting service, would be the primary decision-maker for the patient’s care in this situation. In these scenarios, it is important for the patient to be able to establish care for long-term outpatient management of their condition; however, it is prudent to involve dermatology while the patient is acutely hospitalized to guide their treatment plan until they are able to see a dermatologist after discharge.

In conclusion, we believe that hospital dermatology is a valuable tool that can be utilized in many different scenarios. Although there are certainly situations more appropriate for outpatient dermatology referral, we would caution against overly simplified algorithms that could discourage valuable inpatient dermatology consultations. It often is worth a conversation with your dermatology consultant (when available at an institution) to determine the best course of action for each patient. Additionally, we recognize the need for more formalized guidelines on when to pursue inpatient dermatology consultation. We are members of the Society of Dermatology Hospitalists and encourage readers to reference their website, which provides additional resources on inpatient dermatology (https://societydermatologyhospitalists.com/inpatient-dermatology-literature/).

 

 

Authors’ Response

We appreciate the letter in response to our commentary on the appropriateness of inpatient dermatology consultations. It is the continued refining and re-evaluation of concepts such as these that allow our field to grow and improve knowledge and patient care.

We sought to provide a nonpatronizing yet simple consultation flowchart that would help guide triage of patients in need or not in need of dermatologic evaluation by the inpatient teams. Understandably, the impressions of our flowchart have been variable based on different readers’ medical backgrounds and experiences. It is certainly possible that our flowchart lacked certain exceptions and oversimplified certain concepts, and we welcome further refining of this flowchart to better guide inpatient dermatology consultations.

We do, however, disagree that the primary team would not know whether a patient is intubated in the intensive care unit for a dermatology reason. If the patient is in such a status, it would be pertinent for the primary team to conduct a timely workup that could include consultations until a diagnosis is made. We were not implying that every dermatology consultation in the intensive care unit is unwarranted, especially if it can lead to a primary dermatologic diagnosis. We do believe that a thorough history could elicit an allergy or other chronic skin condition that could save resources and spending within a hospital. Likewise, psoriasis comes in many different presentations, and although we do not believe a consultation for chronic psoriatic plaques is appropriate in the hospital, it is absolutely appropriate for a patient who is erythrodermic from any cause.

Our flowchart was intended to be the first step to providing education on when consultations are appropriate, and further refinement will be necessary.

Hershel Dobkin, MD; Timothy Blackwell, BS; Robin Ashinoff, MD

Drs. Dobkin and Ashinoff are from Hackensack University Medical Center, New Jersey. Mr. Blackwell is from the Rowan University School of Osteopathic Medicine, Stratford, New Jersey.

The authors report no conflict of interest.

Correspondence: Hershel Dobkin, MD, Hackensack University Medical Center, 30 Prospect Ave, Hackensack, NJ 07601 ([email protected]).

To the Editor:

We read with interest the Cutis article by Dobkin et al¹ (Cutis. 2022;109:218-220) regarding guidelines for inpatient and emergency department dermatology consultations. We agree with the authors that dermatology training is lacking in other medical specialties, which makes it challenging for teams to assess the appropriateness of a dermatology consultation in the inpatient setting. Inpatient dermatology consultation can be utilized in a hospital system to aid in rapid and accurate diagnosis, avoid inappropriate therapies, and decrease length of stay² and readmission rates³ while providing education to the primary teams. This is precisely why in many instances the availability of inpatient dermatology consultation is so important because nondermatologists often are unable to determine whether a rash is life-threatening, benign, or something in between. From the perspective of dermatology hospitalists, there is room for improvement in the flowchart Dobkin et al¹ presented to guide inpatient dermatology consultation.

To have a productive relationship with our internal medicine, surgery, pediatrics, psychiatry, and other hospital-based colleagues, we must keep an open mind when a consultation is received. We feel that the flowchart proposed by Dobkin et al¹ presents too narrow a viewpoint on the utility of inpatient dermatology. It rests on assertions that other teams will be able to determine the appropriate dermatologic diagnosis without involving a dermatologist, which often is not the case.

We disagree with several recommendations in the flowchart, the first being the assertion that patients who are “hemodynamically unstable due to [a] nondermatologic problem (eg, intubated on pressors, febrile, and hypotensive)” are not appropriate for inpatient dermatology consultation.¹ Although dermatologists do not commonly encounter patients with critical illness in the outpatient clinic, dermatology consultation can be extremely helpful and even lifesaving in the inpatient setting. It is unrealistic to expect the primary teams to know whether cutaneous manifestations potentially could be related to the patient’s overall clinical picture. On the contrary, we would encourage the primary team in charge of a hemodynamically unstable patient to consult dermatology at the first sign of an unexplained rash. Take for example an acutely ill patient who develops retiform purpura. There are well-established dermatology guidelines for the workup of retiform purpura,⁴ including prompt biopsy and assessment of broad, potentially life-threatening differential diagnoses from calciphylaxis to angioinvasive fungal infection. In this scenario, the dermatology consultant may render the correct diagnosis and recommend immediate treatment that could be lifesaving.

Secondly, we do not agree with the recommendation that a patient in hospice care is not appropriate for inpatient dermatology consultation. Patients receiving hospice or palliative care have high rates of potentially symptomatic cutaneous diseases,⁵ including intertrigo and dermatitis—comprising stasis, seborrheic, and contact dermatitis.⁶ Although aggressive intervention for asymptomatic benign or malignant skin conditions may not be in line with their goals of care, an inpatient dermatology consultation can reduce symptoms and improve quality of life. This population also is one that is unlikely to be able to attend an outpatient dermatology clinic appointment and therefore are good candidates for inpatient consultation.

Lastly, we want to highlight the difference between a stable chronic dermatologic disease and an acute flare that may occur while a patient is hospitalized, regardless of whether it is the reason for admission. For example, a patient with psoriasis affecting limited body surface area who is hospitalized for a myocardial infarction is not appropriate for a dermatology consultation. However, if that same patient develops erythroderma while they are hospitalized for cardiac monitoring, it would certainly be appropriate for dermatology to be consulted. Additionally, there are times when a chronic skin disease is the reason for hospitalization; dermatology, although technically a consulting service, would be the primary decision-maker for the patient’s care in this situation. In these scenarios, it is important for the patient to be able to establish care for long-term outpatient management of their condition; however, it is prudent to involve dermatology while the patient is acutely hospitalized to guide their treatment plan until they are able to see a dermatologist after discharge.

In conclusion, we believe that hospital dermatology is a valuable tool that can be utilized in many different scenarios. Although there are certainly situations more appropriate for outpatient dermatology referral, we would caution against overly simplified algorithms that could discourage valuable inpatient dermatology consultations. It often is worth a conversation with your dermatology consultant (when available at an institution) to determine the best course of action for each patient. Additionally, we recognize the need for more formalized guidelines on when to pursue inpatient dermatology consultation. We are members of the Society of Dermatology Hospitalists and encourage readers to reference their website, which provides additional resources on inpatient dermatology (https://societydermatologyhospitalists.com/inpatient-dermatology-literature/).

 

 

Authors’ Response

We appreciate the letter in response to our commentary on the appropriateness of inpatient dermatology consultations. It is the continued refining and re-evaluation of concepts such as these that allow our field to grow and improve knowledge and patient care.

We sought to provide a nonpatronizing yet simple consultation flowchart that would help guide triage of patients in need or not in need of dermatologic evaluation by the inpatient teams. Understandably, the impressions of our flowchart have been variable based on different readers’ medical backgrounds and experiences. It is certainly possible that our flowchart lacked certain exceptions and oversimplified certain concepts, and we welcome further refining of this flowchart to better guide inpatient dermatology consultations.

We do, however, disagree that the primary team would not know whether a patient is intubated in the intensive care unit for a dermatology reason. If the patient is in such a status, it would be pertinent for the primary team to conduct a timely workup that could include consultations until a diagnosis is made. We were not implying that every dermatology consultation in the intensive care unit is unwarranted, especially if it can lead to a primary dermatologic diagnosis. We do believe that a thorough history could elicit an allergy or other chronic skin condition that could save resources and spending within a hospital. Likewise, psoriasis comes in many different presentations, and although we do not believe a consultation for chronic psoriatic plaques is appropriate in the hospital, it is absolutely appropriate for a patient who is erythrodermic from any cause.

Our flowchart was intended to be the first step to providing education on when consultations are appropriate, and further refinement will be necessary.

Hershel Dobkin, MD; Timothy Blackwell, BS; Robin Ashinoff, MD

Drs. Dobkin and Ashinoff are from Hackensack University Medical Center, New Jersey. Mr. Blackwell is from the Rowan University School of Osteopathic Medicine, Stratford, New Jersey.

The authors report no conflict of interest.

Correspondence: Hershel Dobkin, MD, Hackensack University Medical Center, 30 Prospect Ave, Hackensack, NJ 07601 ([email protected]).

Psychiatric electroceutical interventions (PEIs) – including Food and Drug Administration–approved therapies like electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), as well as experimental interventions such as deep brain stimulation (DBS) and adaptive brain implants (ABI) – offer therapeutic promise for patients suffering with major depressive disorder (MDD). Yet there remain many open questions regarding their use, even in cases where their safety and effectiveness is well established.

Our research aims to better understand how different stakeholder groups view these interventions. We conducted a series of interviews with psychiatrists, patients with MDD, and members of the public to more fully comprehend these groups’ perceptions of barriers to using these therapies.¹ They raised concerns about limitations to access posed by the limited geographic availability of these treatments, their cost, and lack of insurance coverage. In addition, each stakeholder group cited lack of knowledge about PEIs as a perceived barrier to their wider implementation in depression care.

Michigan State University

Our participants recognized there are significant geographic limitations to accessing PEIs, as many of these treatments are available only in large, well-resourced cities. This is especially true for DBS and ABIs as they remain investigational, require neurosurgery, and currently are offered only during clinical research trials. However, even for established therapies like ECT and rTMS, access often remains limited to larger treatment centers. Further, training on the proper implementation and use of these modalities is limited in the United States. Current requirements from the Accreditation Council for Graduate Medical Education state only that psychiatry residents demonstrate knowledge of these therapies and their indications, falling short of requiring first-hand experience in referring or administering them.²

Michigan State University

Our participants also perceived the cost of these therapies as a significant barrier affecting a large proportion of patients who could potentially benefit from them. Another frequently mentioned barrier is the lack of insurance coverage for existing PEIs, particularly rTMS. Even when insurance covers treatment with an approved PEI (for example, ECT, rTMS), there may be a requirement to have tried and failed multiple antidepressant medications first. These insurance requirements may contribute to a lack of general clarity about when these treatments should be used. The psychiatrists we interviewed, for example, were almost evenly split between believing that ECT and/or rTMS should be offered earlier in the course of therapy and believing that they should be reserved only for patients with treatment-resistant depression.

Michigan State University

Further, some psychiatrists we interviewed stated that they wanted more information about the appropriate use of these treatments. This is unsurprising, as the available guidelines for the approved electroceutical treatments are outdated. Although the American Psychiatric Association Task Force is due to publish updated guidelines for ECT, it has been more than 20 years since the current guidelines were published.³ More recent guidelines, such as those issued in 2016 by the Canadian Network for Mood and Anxiety Treatments cite studies that were even then several years old.⁴ For rTMS, newer guidelines are available, but they have not yet been revised to include recent developments such as the SAINT protocol.^5,6

While useful, clinical guidelines do not provide all of the information psychiatrists require for clinical decision-making. They are only as good as the evidence available and to the extent that they include all of the considerations important to psychiatrists and the specific patients they are treating.^7,8 We asked the psychiatrists in our interviews what practical information they would like to see included in treatment guidelines. They offered a range of suggestions: better guidance about which patients would be most likely to benefit, when to offer the treatments, and how to combine these therapies with other interventions.

Pennsylvania State University

For the experimental PEIs (DBS and ABIs), similar questions and concerns arise. In the current research context, psychiatrists may not be aware of which patients are good candidates for referral to clinical trials. If these therapies are approved, similar questions about patient selection and place in treatment (for example, first line, second line, etc.) remain.⁹

Finally, each of our participant groups believed that patients and the public lack adequate knowledge about electroceutical interventions, and they emphasized the importance of giving potential patients sufficient information to enable them to provide valid informed consent. This is important in the case of the approved electroceutical therapies (ECT and rTMS), in part because of the potential for decision-making to be influenced unduly by misinformation and controversy – especially given that the media’s depiction of these interventions might influence patients’ willingness to receive helpful therapies such as ECT.¹⁰

Our interviews were used to inform the development of a national survey of these four stakeholder groups, which will provide further information about perceived barriers to accessing PEIs.

Dr. Bluhm is associate professor of philosophy at Michigan State University, East Lansing. Dr. Achtyes is director of the division of psychiatry and behavioral medicine at Michigan State University, Grand Rapids. Dr. McCright is chair of the department of sociology at Michigan State University. Dr. Cabrera is Dorothy Foehr Huck and J. Lloyd Huck Chair in Neuroethics at the Huck Institutes of the Life Sciences, Penn State University, University Park.

References

1. Cabrera LY et al. Psychiatry Res. 2022 Jul;313:114612. doi: 10.1016/j.psychres.2022.114612.

2. Accreditation Council for Graduate Medical Education. Psychiatry – Program Requirements and FAQs. https://www.acgme.org/specialties/psychiatry/program-requirements-and-faqs-and-applications/

3. American Psychiatric Association. The Practice of Electroconvulsive Therapy, Second Edition: Recommendations for Treatment, Training, and Privileging. 2001.

4. Miley RV et al. Can J Psychiatry. 2016 Sep;61(9):561-75. doi: 10.1177/0706743716660033.

5. Perera T et al. Brain Stimul. 2016 May-Jun;9(3):336-46. doi: 10.1016/j.brs.2016.03.010.

6. Cole EJ et al. Am J Psychiatry. 2020 Aug 1;177(8):716-26. doi: 10.1176/appi.ajp.2019.19070720.

7. Gabriel FC et al. PLoS One. 2020 Apr 21;15(4):e0231700. doi: 10.1371/journal.pone.0231700.

8. Woolf SH et al. BMJ. 1999 Feb 20;318(7182):527-30. doi: 10.1136/bmj.318.7182.527.

9. Widge AS et al. Biol Psychiatry. 2016 Feb 15;79(4):e9-10. doi: 10.1016/j.biopsych.2015.06.005.

10. Sienaert P. Brain Stimul. 2016 Nov-Dec;9(6):882-91. doi: 10.1016/j.brs.2016.07.005.

Psychiatric electroceutical interventions (PEIs) – including Food and Drug Administration–approved therapies like electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), as well as experimental interventions such as deep brain stimulation (DBS) and adaptive brain implants (ABI) – offer therapeutic promise for patients suffering with major depressive disorder (MDD). Yet there remain many open questions regarding their use, even in cases where their safety and effectiveness is well established.

Our research aims to better understand how different stakeholder groups view these interventions. We conducted a series of interviews with psychiatrists, patients with MDD, and members of the public to more fully comprehend these groups’ perceptions of barriers to using these therapies.¹ They raised concerns about limitations to access posed by the limited geographic availability of these treatments, their cost, and lack of insurance coverage. In addition, each stakeholder group cited lack of knowledge about PEIs as a perceived barrier to their wider implementation in depression care.

Michigan State University

Our participants recognized there are significant geographic limitations to accessing PEIs, as many of these treatments are available only in large, well-resourced cities. This is especially true for DBS and ABIs as they remain investigational, require neurosurgery, and currently are offered only during clinical research trials. However, even for established therapies like ECT and rTMS, access often remains limited to larger treatment centers. Further, training on the proper implementation and use of these modalities is limited in the United States. Current requirements from the Accreditation Council for Graduate Medical Education state only that psychiatry residents demonstrate knowledge of these therapies and their indications, falling short of requiring first-hand experience in referring or administering them.²

Michigan State University

Our participants also perceived the cost of these therapies as a significant barrier affecting a large proportion of patients who could potentially benefit from them. Another frequently mentioned barrier is the lack of insurance coverage for existing PEIs, particularly rTMS. Even when insurance covers treatment with an approved PEI (for example, ECT, rTMS), there may be a requirement to have tried and failed multiple antidepressant medications first. These insurance requirements may contribute to a lack of general clarity about when these treatments should be used. The psychiatrists we interviewed, for example, were almost evenly split between believing that ECT and/or rTMS should be offered earlier in the course of therapy and believing that they should be reserved only for patients with treatment-resistant depression.

Michigan State University

Further, some psychiatrists we interviewed stated that they wanted more information about the appropriate use of these treatments. This is unsurprising, as the available guidelines for the approved electroceutical treatments are outdated. Although the American Psychiatric Association Task Force is due to publish updated guidelines for ECT, it has been more than 20 years since the current guidelines were published.³ More recent guidelines, such as those issued in 2016 by the Canadian Network for Mood and Anxiety Treatments cite studies that were even then several years old.⁴ For rTMS, newer guidelines are available, but they have not yet been revised to include recent developments such as the SAINT protocol.^5,6

While useful, clinical guidelines do not provide all of the information psychiatrists require for clinical decision-making. They are only as good as the evidence available and to the extent that they include all of the considerations important to psychiatrists and the specific patients they are treating.^7,8 We asked the psychiatrists in our interviews what practical information they would like to see included in treatment guidelines. They offered a range of suggestions: better guidance about which patients would be most likely to benefit, when to offer the treatments, and how to combine these therapies with other interventions.

Pennsylvania State University

For the experimental PEIs (DBS and ABIs), similar questions and concerns arise. In the current research context, psychiatrists may not be aware of which patients are good candidates for referral to clinical trials. If these therapies are approved, similar questions about patient selection and place in treatment (for example, first line, second line, etc.) remain.⁹

Finally, each of our participant groups believed that patients and the public lack adequate knowledge about electroceutical interventions, and they emphasized the importance of giving potential patients sufficient information to enable them to provide valid informed consent. This is important in the case of the approved electroceutical therapies (ECT and rTMS), in part because of the potential for decision-making to be influenced unduly by misinformation and controversy – especially given that the media’s depiction of these interventions might influence patients’ willingness to receive helpful therapies such as ECT.¹⁰

Our interviews were used to inform the development of a national survey of these four stakeholder groups, which will provide further information about perceived barriers to accessing PEIs.

Dr. Bluhm is associate professor of philosophy at Michigan State University, East Lansing. Dr. Achtyes is director of the division of psychiatry and behavioral medicine at Michigan State University, Grand Rapids. Dr. McCright is chair of the department of sociology at Michigan State University. Dr. Cabrera is Dorothy Foehr Huck and J. Lloyd Huck Chair in Neuroethics at the Huck Institutes of the Life Sciences, Penn State University, University Park.

References

1. Cabrera LY et al. Psychiatry Res. 2022 Jul;313:114612. doi: 10.1016/j.psychres.2022.114612.

2. Accreditation Council for Graduate Medical Education. Psychiatry – Program Requirements and FAQs. https://www.acgme.org/specialties/psychiatry/program-requirements-and-faqs-and-applications/

3. American Psychiatric Association. The Practice of Electroconvulsive Therapy, Second Edition: Recommendations for Treatment, Training, and Privileging. 2001.

4. Miley RV et al. Can J Psychiatry. 2016 Sep;61(9):561-75. doi: 10.1177/0706743716660033.

5. Perera T et al. Brain Stimul. 2016 May-Jun;9(3):336-46. doi: 10.1016/j.brs.2016.03.010.

6. Cole EJ et al. Am J Psychiatry. 2020 Aug 1;177(8):716-26. doi: 10.1176/appi.ajp.2019.19070720.

7. Gabriel FC et al. PLoS One. 2020 Apr 21;15(4):e0231700. doi: 10.1371/journal.pone.0231700.

8. Woolf SH et al. BMJ. 1999 Feb 20;318(7182):527-30. doi: 10.1136/bmj.318.7182.527.

9. Widge AS et al. Biol Psychiatry. 2016 Feb 15;79(4):e9-10. doi: 10.1016/j.biopsych.2015.06.005.

10. Sienaert P. Brain Stimul. 2016 Nov-Dec;9(6):882-91. doi: 10.1016/j.brs.2016.07.005.

Psychiatric electroceutical interventions (PEIs) – including Food and Drug Administration–approved therapies like electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), as well as experimental interventions such as deep brain stimulation (DBS) and adaptive brain implants (ABI) – offer therapeutic promise for patients suffering with major depressive disorder (MDD). Yet there remain many open questions regarding their use, even in cases where their safety and effectiveness is well established.

Our research aims to better understand how different stakeholder groups view these interventions. We conducted a series of interviews with psychiatrists, patients with MDD, and members of the public to more fully comprehend these groups’ perceptions of barriers to using these therapies.¹ They raised concerns about limitations to access posed by the limited geographic availability of these treatments, their cost, and lack of insurance coverage. In addition, each stakeholder group cited lack of knowledge about PEIs as a perceived barrier to their wider implementation in depression care.

Michigan State University

Our participants recognized there are significant geographic limitations to accessing PEIs, as many of these treatments are available only in large, well-resourced cities. This is especially true for DBS and ABIs as they remain investigational, require neurosurgery, and currently are offered only during clinical research trials. However, even for established therapies like ECT and rTMS, access often remains limited to larger treatment centers. Further, training on the proper implementation and use of these modalities is limited in the United States. Current requirements from the Accreditation Council for Graduate Medical Education state only that psychiatry residents demonstrate knowledge of these therapies and their indications, falling short of requiring first-hand experience in referring or administering them.²

Michigan State University

Our participants also perceived the cost of these therapies as a significant barrier affecting a large proportion of patients who could potentially benefit from them. Another frequently mentioned barrier is the lack of insurance coverage for existing PEIs, particularly rTMS. Even when insurance covers treatment with an approved PEI (for example, ECT, rTMS), there may be a requirement to have tried and failed multiple antidepressant medications first. These insurance requirements may contribute to a lack of general clarity about when these treatments should be used. The psychiatrists we interviewed, for example, were almost evenly split between believing that ECT and/or rTMS should be offered earlier in the course of therapy and believing that they should be reserved only for patients with treatment-resistant depression.

Michigan State University

Further, some psychiatrists we interviewed stated that they wanted more information about the appropriate use of these treatments. This is unsurprising, as the available guidelines for the approved electroceutical treatments are outdated. Although the American Psychiatric Association Task Force is due to publish updated guidelines for ECT, it has been more than 20 years since the current guidelines were published.³ More recent guidelines, such as those issued in 2016 by the Canadian Network for Mood and Anxiety Treatments cite studies that were even then several years old.⁴ For rTMS, newer guidelines are available, but they have not yet been revised to include recent developments such as the SAINT protocol.^5,6

While useful, clinical guidelines do not provide all of the information psychiatrists require for clinical decision-making. They are only as good as the evidence available and to the extent that they include all of the considerations important to psychiatrists and the specific patients they are treating.^7,8 We asked the psychiatrists in our interviews what practical information they would like to see included in treatment guidelines. They offered a range of suggestions: better guidance about which patients would be most likely to benefit, when to offer the treatments, and how to combine these therapies with other interventions.

Pennsylvania State University

For the experimental PEIs (DBS and ABIs), similar questions and concerns arise. In the current research context, psychiatrists may not be aware of which patients are good candidates for referral to clinical trials. If these therapies are approved, similar questions about patient selection and place in treatment (for example, first line, second line, etc.) remain.⁹

Finally, each of our participant groups believed that patients and the public lack adequate knowledge about electroceutical interventions, and they emphasized the importance of giving potential patients sufficient information to enable them to provide valid informed consent. This is important in the case of the approved electroceutical therapies (ECT and rTMS), in part because of the potential for decision-making to be influenced unduly by misinformation and controversy – especially given that the media’s depiction of these interventions might influence patients’ willingness to receive helpful therapies such as ECT.¹⁰

Our interviews were used to inform the development of a national survey of these four stakeholder groups, which will provide further information about perceived barriers to accessing PEIs.

Dr. Bluhm is associate professor of philosophy at Michigan State University, East Lansing. Dr. Achtyes is director of the division of psychiatry and behavioral medicine at Michigan State University, Grand Rapids. Dr. McCright is chair of the department of sociology at Michigan State University. Dr. Cabrera is Dorothy Foehr Huck and J. Lloyd Huck Chair in Neuroethics at the Huck Institutes of the Life Sciences, Penn State University, University Park.

References

1. Cabrera LY et al. Psychiatry Res. 2022 Jul;313:114612. doi: 10.1016/j.psychres.2022.114612.

2. Accreditation Council for Graduate Medical Education. Psychiatry – Program Requirements and FAQs. https://www.acgme.org/specialties/psychiatry/program-requirements-and-faqs-and-applications/

3. American Psychiatric Association. The Practice of Electroconvulsive Therapy, Second Edition: Recommendations for Treatment, Training, and Privileging. 2001.

4. Miley RV et al. Can J Psychiatry. 2016 Sep;61(9):561-75. doi: 10.1177/0706743716660033.

5. Perera T et al. Brain Stimul. 2016 May-Jun;9(3):336-46. doi: 10.1016/j.brs.2016.03.010.

6. Cole EJ et al. Am J Psychiatry. 2020 Aug 1;177(8):716-26. doi: 10.1176/appi.ajp.2019.19070720.

7. Gabriel FC et al. PLoS One. 2020 Apr 21;15(4):e0231700. doi: 10.1371/journal.pone.0231700.

8. Woolf SH et al. BMJ. 1999 Feb 20;318(7182):527-30. doi: 10.1136/bmj.318.7182.527.

9. Widge AS et al. Biol Psychiatry. 2016 Feb 15;79(4):e9-10. doi: 10.1016/j.biopsych.2015.06.005.

10. Sienaert P. Brain Stimul. 2016 Nov-Dec;9(6):882-91. doi: 10.1016/j.brs.2016.07.005.

The various Camellia species originated in Eastern Asia and are believed to have been introduced in northwestern Spain in the 18th century. Camellia japonica, a flowering evergreen tree with various medical and cosmetic applications, is found throughout Galicia, Spain, where it is cultivated as an ornamental plant, and is native to Japan, South Korea, and China.^1-4 The flowers and seeds of C. japonica have been used in traditional medicine and cosmetics in East Asia, with the oil of C. japonica used there to restore skin elasticity and to enhance skin health.^4-6 The identification of bioactive constituents in C. japonica is a relatively recent phenomenon and accounts for the emerging interest in its potential medical applications.^1,7

manuel m. v./flickr/Attribution CC BY 2.0

While the use of C. sinensis in traditional and modern medicine is much better researched, understood, and characterized, C. japonica is now being considered for various health benefits. This column will focus on the bioactivity and scientific support for dermatologic applications of C. japonica. It is worth noting that a dry oil known as tsubaki oil, derived from C. japonica and rich in oleic acid, polyphenols, as well as vitamins A, C, D, and E, is used for skin and hair care in moisturizers produced primarily in Japan.
 

Antioxidant activity

In 2005, Lee and colleagues determined that C. japonica leaf and flower extracts display antioxidant, antifungal, and antibacterial activities (with the latter showing greater gram-positive than gram-negative activity).⁸ Investigating the antioxidant characteristics of the ethanol extract of the C. japonica flower in 2011, Piao and colleagues reported that the botanical exerted scavenging activity against reactive oxygen species in human HaCaT keratinocytes and enhanced protein expression and function of the antioxidant enzymes superoxide dismutase, catalase, and glutathione peroxidase.⁹

Less than a decade later, Yoon and colleagues determined that C. japonica leaf extract contains high concentrations of vitamin E and rutin as well as other active constituents and that it exhibits antioxidant and antihyperuricemic activity in vitro and in vivo.⁴

Since then, Kim and colleagues have demonstrated, using cultured normal human dermal fibroblasts, that C. japonica flower extract effectively hindered urban air pollutants–induced reactive oxygen species synthesis. In ex vivo results, the investigators showed that the botanical agent suppressed matrix metalloproteinase (MMP)-1 expression, fostered collagen production, and decreased levels of pollutants-induced malondialdehyde. The authors concluded that C. japonica flower extract shows promise as a protective agent against pollutant-induced cutaneous damage.¹⁰

Anti-inflammatory and wound-healing activity

In 2012, Kim and colleagues found that C. japonica oil imparts anti-inflammatory activity via down-regulation of iNOS and COX-2 gene expression by suppressing of NF-KB and AP-1 signaling.⁶

Jeon and colleagues determined, in a 2018 investigation of 3,695 native plant extracts, that extracts from C. japonica fruit and stems improved induced pluripotent stem cell (iPSC) generation in mouse and human skin and enhanced wound healing in an in vivo mouse wound model. They suggested that their findings may point toward more effective approaches to developing clinical-grade iPSCs and wound-healing therapies.¹¹

Cosmeceutical potential

Among the important bioactive ingredients present in C. japonica are phenolic compounds, terpenoids, and fatty acids, which are thought to account for the anti-inflammatory, antioxidant, antimicrobial, and anticancer activity associated with the plant.¹ The high concentration of polyphenolic substances, in particular, is thought to at least partly account for the inclusion of C. japonica leaf extracts in antiaging cosmetics and cosmeceuticals.¹² Specifically, some of the antioxidant substances found in C. japonica extracts include quercetin, quercetin-3-O-glucoside, quercitrin, and kaempferol.⁹

Wrinkle reduction and moisturization

In 2007, Jung and colleagues found that C. japonica oil activated collagen 1A2 promotion in human dermal fibroblast cells in a concentration-dependent fashion. The oil also suppressed MMP-1 functions and spurred the production of human type I procollagen. On human skin, C. japonica oil was tested on the upper back of 30 volunteers and failed to provoke any adverse reactions. The oil also diminished transepidermal water loss on the forearm. The researchers concluded that C. japonica oil merits consideration as an antiwrinkle ingredient in topical formulations.¹³

More recently, Choi and colleagues showed that ceramide nanoparticles developed through the use of natural oils derived from Korean traditional plants (including C. japonica, along with Panax ginseng, C. sinensis, Glycine max napjakong, and Glycine max seoritae) improve skin carrier functions and promote gene expressions needed for epidermal homeostasis. The expressions of the FLG, CASP14, and INV genes were notably enhanced by the tested formulation. The researchers observed from in vivo human studies that the application of the ceramide nanoparticles yielded more rapid recovery in impaired skin barriers than the control formulation. Amelioration of stratum corneum cohesion was also noted. The investigators concluded that this and other natural oil–derived ceramide nanoparticle formulations may represent the potential for developing better moisturizers for enhancing skin barrier function.¹⁴

Hair-growth promotion and skin-whitening activity

Early in 2021, Cho and colleagues demonstrated that C. japonica phytoplacenta extract spurred the up-regulation of the expression of hair growth–marker genes in human follicle dermal papilla cells in vitro. In clinical tests with 42 adult female volunteers, a solution with 0.5% C. japonica placenta extract raised moisture content of the scalp and reduced sebum levels, dead scalp keratin, and redness. The researchers concluded that C. japonica phytoplacenta extract displays promise as a scalp treatment and hair growth–promoting agent.²

Later that year, Ha and colleagues reported on their findings regarding the tyrosinase inhibitory activity of the essential oil of C. japonica seeds. They identified hexamethylcyclotrisiloxane (42.36%) and octamethylcyclotetrasiloxane (23.28%) as the main constituents of the oil, which demonstrated comparable inhibitory activity to arbutin (positive control) against mushroom tyrosinase. Melanogenesis was also significantly suppressed by C. japonica seed essential oil in B16F10 melanoma cells. The investigators concluded that the essential oil of C. japonica seeds exhibits robust antityrosinase activity and, therefore, warrants consideration as a skin-whitening agent.¹⁵
 

Conclusion

C. japonica is not as popular or well researched as another Camellia species, C. sinensis (the primary tea plant consumed globally and highly touted and appreciated for its multitude of health benefits), but it has its own history of traditional uses for medical and cosmetic purposes and is a subject of increasing research interest along with popular applications. Its antioxidant and anti-inflammatory properties are thought to be central in conferring the ability to protect the skin from aging. Its effects on the skin barrier help skin hydration. More research is necessary to elucidate the apparently widespread potential of this botanical agent that is already found in some over-the-counter products.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as an ecommerce solution. Write to her at [email protected].

References

1. Pereira AG et al. Food Chem X. 2022 Feb 17;13:100258.

2. Cho WK et al. FEBS Open Bio. 2021 Mar;11(3):633-51.

3. Chung MY et al. Evolution. 2003 Jan;57(1):62-73.

4. Yoon IS et al. Int J Mol Med. 2017 Jun;39(6):1613-20.

5. Lee HH et al. Evid Based Complement Alternat Med. 2016;2016:9679867.

6. Kim S et al. BMB Rep. 2012 Mar;45(3):177-82.

7. Majumder S et al. Bull Nat Res Cen. 2020 Dec;44(1):1-4.

8. Lee SY et al. Korean Journal of Medicinal Crop Science. 2005;13(3):93-100.

9. Piao MJ et al. Int J Mol Sci. 2011;12(4):2618-30.

10. Kim M et al. BMC Complement Altern Med. 2019 Jan 28;19(1):30.

11. Jeon H et al. J Clin Med. 2018 Nov 20;7(11):449.

12. Mizutani T, Masaki H. Exp Dermatol. 2014 Oct;23 Suppl 1:23-6.

13. Jung E et al. J Ethnopharmacol. 2007 May 30;112(1):127-31.

14. Choi HK et al. J Cosmet Dermatol. 2022 Oct;21(10):4931-41.

15. Ha SY et al. Evid Based Complement Alternat Med. 2021 Nov 16;2021:6328767.

The various Camellia species originated in Eastern Asia and are believed to have been introduced in northwestern Spain in the 18th century. Camellia japonica, a flowering evergreen tree with various medical and cosmetic applications, is found throughout Galicia, Spain, where it is cultivated as an ornamental plant, and is native to Japan, South Korea, and China.^1-4 The flowers and seeds of C. japonica have been used in traditional medicine and cosmetics in East Asia, with the oil of C. japonica used there to restore skin elasticity and to enhance skin health.^4-6 The identification of bioactive constituents in C. japonica is a relatively recent phenomenon and accounts for the emerging interest in its potential medical applications.^1,7

manuel m. v./flickr/Attribution CC BY 2.0

While the use of C. sinensis in traditional and modern medicine is much better researched, understood, and characterized, C. japonica is now being considered for various health benefits. This column will focus on the bioactivity and scientific support for dermatologic applications of C. japonica. It is worth noting that a dry oil known as tsubaki oil, derived from C. japonica and rich in oleic acid, polyphenols, as well as vitamins A, C, D, and E, is used for skin and hair care in moisturizers produced primarily in Japan.
 

Antioxidant activity

In 2005, Lee and colleagues determined that C. japonica leaf and flower extracts display antioxidant, antifungal, and antibacterial activities (with the latter showing greater gram-positive than gram-negative activity).⁸ Investigating the antioxidant characteristics of the ethanol extract of the C. japonica flower in 2011, Piao and colleagues reported that the botanical exerted scavenging activity against reactive oxygen species in human HaCaT keratinocytes and enhanced protein expression and function of the antioxidant enzymes superoxide dismutase, catalase, and glutathione peroxidase.⁹

Less than a decade later, Yoon and colleagues determined that C. japonica leaf extract contains high concentrations of vitamin E and rutin as well as other active constituents and that it exhibits antioxidant and antihyperuricemic activity in vitro and in vivo.⁴

Since then, Kim and colleagues have demonstrated, using cultured normal human dermal fibroblasts, that C. japonica flower extract effectively hindered urban air pollutants–induced reactive oxygen species synthesis. In ex vivo results, the investigators showed that the botanical agent suppressed matrix metalloproteinase (MMP)-1 expression, fostered collagen production, and decreased levels of pollutants-induced malondialdehyde. The authors concluded that C. japonica flower extract shows promise as a protective agent against pollutant-induced cutaneous damage.¹⁰

Anti-inflammatory and wound-healing activity

In 2012, Kim and colleagues found that C. japonica oil imparts anti-inflammatory activity via down-regulation of iNOS and COX-2 gene expression by suppressing of NF-KB and AP-1 signaling.⁶

Jeon and colleagues determined, in a 2018 investigation of 3,695 native plant extracts, that extracts from C. japonica fruit and stems improved induced pluripotent stem cell (iPSC) generation in mouse and human skin and enhanced wound healing in an in vivo mouse wound model. They suggested that their findings may point toward more effective approaches to developing clinical-grade iPSCs and wound-healing therapies.¹¹

Cosmeceutical potential

Among the important bioactive ingredients present in C. japonica are phenolic compounds, terpenoids, and fatty acids, which are thought to account for the anti-inflammatory, antioxidant, antimicrobial, and anticancer activity associated with the plant.¹ The high concentration of polyphenolic substances, in particular, is thought to at least partly account for the inclusion of C. japonica leaf extracts in antiaging cosmetics and cosmeceuticals.¹² Specifically, some of the antioxidant substances found in C. japonica extracts include quercetin, quercetin-3-O-glucoside, quercitrin, and kaempferol.⁹

Wrinkle reduction and moisturization

In 2007, Jung and colleagues found that C. japonica oil activated collagen 1A2 promotion in human dermal fibroblast cells in a concentration-dependent fashion. The oil also suppressed MMP-1 functions and spurred the production of human type I procollagen. On human skin, C. japonica oil was tested on the upper back of 30 volunteers and failed to provoke any adverse reactions. The oil also diminished transepidermal water loss on the forearm. The researchers concluded that C. japonica oil merits consideration as an antiwrinkle ingredient in topical formulations.¹³

More recently, Choi and colleagues showed that ceramide nanoparticles developed through the use of natural oils derived from Korean traditional plants (including C. japonica, along with Panax ginseng, C. sinensis, Glycine max napjakong, and Glycine max seoritae) improve skin carrier functions and promote gene expressions needed for epidermal homeostasis. The expressions of the FLG, CASP14, and INV genes were notably enhanced by the tested formulation. The researchers observed from in vivo human studies that the application of the ceramide nanoparticles yielded more rapid recovery in impaired skin barriers than the control formulation. Amelioration of stratum corneum cohesion was also noted. The investigators concluded that this and other natural oil–derived ceramide nanoparticle formulations may represent the potential for developing better moisturizers for enhancing skin barrier function.¹⁴

Hair-growth promotion and skin-whitening activity

Early in 2021, Cho and colleagues demonstrated that C. japonica phytoplacenta extract spurred the up-regulation of the expression of hair growth–marker genes in human follicle dermal papilla cells in vitro. In clinical tests with 42 adult female volunteers, a solution with 0.5% C. japonica placenta extract raised moisture content of the scalp and reduced sebum levels, dead scalp keratin, and redness. The researchers concluded that C. japonica phytoplacenta extract displays promise as a scalp treatment and hair growth–promoting agent.²

Later that year, Ha and colleagues reported on their findings regarding the tyrosinase inhibitory activity of the essential oil of C. japonica seeds. They identified hexamethylcyclotrisiloxane (42.36%) and octamethylcyclotetrasiloxane (23.28%) as the main constituents of the oil, which demonstrated comparable inhibitory activity to arbutin (positive control) against mushroom tyrosinase. Melanogenesis was also significantly suppressed by C. japonica seed essential oil in B16F10 melanoma cells. The investigators concluded that the essential oil of C. japonica seeds exhibits robust antityrosinase activity and, therefore, warrants consideration as a skin-whitening agent.¹⁵
 

Conclusion

C. japonica is not as popular or well researched as another Camellia species, C. sinensis (the primary tea plant consumed globally and highly touted and appreciated for its multitude of health benefits), but it has its own history of traditional uses for medical and cosmetic purposes and is a subject of increasing research interest along with popular applications. Its antioxidant and anti-inflammatory properties are thought to be central in conferring the ability to protect the skin from aging. Its effects on the skin barrier help skin hydration. More research is necessary to elucidate the apparently widespread potential of this botanical agent that is already found in some over-the-counter products.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as an ecommerce solution. Write to her at [email protected].

References

1. Pereira AG et al. Food Chem X. 2022 Feb 17;13:100258.

2. Cho WK et al. FEBS Open Bio. 2021 Mar;11(3):633-51.

3. Chung MY et al. Evolution. 2003 Jan;57(1):62-73.

4. Yoon IS et al. Int J Mol Med. 2017 Jun;39(6):1613-20.

5. Lee HH et al. Evid Based Complement Alternat Med. 2016;2016:9679867.

6. Kim S et al. BMB Rep. 2012 Mar;45(3):177-82.

7. Majumder S et al. Bull Nat Res Cen. 2020 Dec;44(1):1-4.

8. Lee SY et al. Korean Journal of Medicinal Crop Science. 2005;13(3):93-100.

9. Piao MJ et al. Int J Mol Sci. 2011;12(4):2618-30.

10. Kim M et al. BMC Complement Altern Med. 2019 Jan 28;19(1):30.

11. Jeon H et al. J Clin Med. 2018 Nov 20;7(11):449.

12. Mizutani T, Masaki H. Exp Dermatol. 2014 Oct;23 Suppl 1:23-6.

13. Jung E et al. J Ethnopharmacol. 2007 May 30;112(1):127-31.

14. Choi HK et al. J Cosmet Dermatol. 2022 Oct;21(10):4931-41.

15. Ha SY et al. Evid Based Complement Alternat Med. 2021 Nov 16;2021:6328767.

The various Camellia species originated in Eastern Asia and are believed to have been introduced in northwestern Spain in the 18th century. Camellia japonica, a flowering evergreen tree with various medical and cosmetic applications, is found throughout Galicia, Spain, where it is cultivated as an ornamental plant, and is native to Japan, South Korea, and China.^1-4 The flowers and seeds of C. japonica have been used in traditional medicine and cosmetics in East Asia, with the oil of C. japonica used there to restore skin elasticity and to enhance skin health.^4-6 The identification of bioactive constituents in C. japonica is a relatively recent phenomenon and accounts for the emerging interest in its potential medical applications.^1,7

manuel m. v./flickr/Attribution CC BY 2.0

While the use of C. sinensis in traditional and modern medicine is much better researched, understood, and characterized, C. japonica is now being considered for various health benefits. This column will focus on the bioactivity and scientific support for dermatologic applications of C. japonica. It is worth noting that a dry oil known as tsubaki oil, derived from C. japonica and rich in oleic acid, polyphenols, as well as vitamins A, C, D, and E, is used for skin and hair care in moisturizers produced primarily in Japan.
 

Antioxidant activity

In 2005, Lee and colleagues determined that C. japonica leaf and flower extracts display antioxidant, antifungal, and antibacterial activities (with the latter showing greater gram-positive than gram-negative activity).⁸ Investigating the antioxidant characteristics of the ethanol extract of the C. japonica flower in 2011, Piao and colleagues reported that the botanical exerted scavenging activity against reactive oxygen species in human HaCaT keratinocytes and enhanced protein expression and function of the antioxidant enzymes superoxide dismutase, catalase, and glutathione peroxidase.⁹

Less than a decade later, Yoon and colleagues determined that C. japonica leaf extract contains high concentrations of vitamin E and rutin as well as other active constituents and that it exhibits antioxidant and antihyperuricemic activity in vitro and in vivo.⁴

Since then, Kim and colleagues have demonstrated, using cultured normal human dermal fibroblasts, that C. japonica flower extract effectively hindered urban air pollutants–induced reactive oxygen species synthesis. In ex vivo results, the investigators showed that the botanical agent suppressed matrix metalloproteinase (MMP)-1 expression, fostered collagen production, and decreased levels of pollutants-induced malondialdehyde. The authors concluded that C. japonica flower extract shows promise as a protective agent against pollutant-induced cutaneous damage.¹⁰

Anti-inflammatory and wound-healing activity

In 2012, Kim and colleagues found that C. japonica oil imparts anti-inflammatory activity via down-regulation of iNOS and COX-2 gene expression by suppressing of NF-KB and AP-1 signaling.⁶

Jeon and colleagues determined, in a 2018 investigation of 3,695 native plant extracts, that extracts from C. japonica fruit and stems improved induced pluripotent stem cell (iPSC) generation in mouse and human skin and enhanced wound healing in an in vivo mouse wound model. They suggested that their findings may point toward more effective approaches to developing clinical-grade iPSCs and wound-healing therapies.¹¹

Cosmeceutical potential

Among the important bioactive ingredients present in C. japonica are phenolic compounds, terpenoids, and fatty acids, which are thought to account for the anti-inflammatory, antioxidant, antimicrobial, and anticancer activity associated with the plant.¹ The high concentration of polyphenolic substances, in particular, is thought to at least partly account for the inclusion of C. japonica leaf extracts in antiaging cosmetics and cosmeceuticals.¹² Specifically, some of the antioxidant substances found in C. japonica extracts include quercetin, quercetin-3-O-glucoside, quercitrin, and kaempferol.⁹

Wrinkle reduction and moisturization

In 2007, Jung and colleagues found that C. japonica oil activated collagen 1A2 promotion in human dermal fibroblast cells in a concentration-dependent fashion. The oil also suppressed MMP-1 functions and spurred the production of human type I procollagen. On human skin, C. japonica oil was tested on the upper back of 30 volunteers and failed to provoke any adverse reactions. The oil also diminished transepidermal water loss on the forearm. The researchers concluded that C. japonica oil merits consideration as an antiwrinkle ingredient in topical formulations.¹³

More recently, Choi and colleagues showed that ceramide nanoparticles developed through the use of natural oils derived from Korean traditional plants (including C. japonica, along with Panax ginseng, C. sinensis, Glycine max napjakong, and Glycine max seoritae) improve skin carrier functions and promote gene expressions needed for epidermal homeostasis. The expressions of the FLG, CASP14, and INV genes were notably enhanced by the tested formulation. The researchers observed from in vivo human studies that the application of the ceramide nanoparticles yielded more rapid recovery in impaired skin barriers than the control formulation. Amelioration of stratum corneum cohesion was also noted. The investigators concluded that this and other natural oil–derived ceramide nanoparticle formulations may represent the potential for developing better moisturizers for enhancing skin barrier function.¹⁴

Hair-growth promotion and skin-whitening activity

Early in 2021, Cho and colleagues demonstrated that C. japonica phytoplacenta extract spurred the up-regulation of the expression of hair growth–marker genes in human follicle dermal papilla cells in vitro. In clinical tests with 42 adult female volunteers, a solution with 0.5% C. japonica placenta extract raised moisture content of the scalp and reduced sebum levels, dead scalp keratin, and redness. The researchers concluded that C. japonica phytoplacenta extract displays promise as a scalp treatment and hair growth–promoting agent.²

Later that year, Ha and colleagues reported on their findings regarding the tyrosinase inhibitory activity of the essential oil of C. japonica seeds. They identified hexamethylcyclotrisiloxane (42.36%) and octamethylcyclotetrasiloxane (23.28%) as the main constituents of the oil, which demonstrated comparable inhibitory activity to arbutin (positive control) against mushroom tyrosinase. Melanogenesis was also significantly suppressed by C. japonica seed essential oil in B16F10 melanoma cells. The investigators concluded that the essential oil of C. japonica seeds exhibits robust antityrosinase activity and, therefore, warrants consideration as a skin-whitening agent.¹⁵
 

Conclusion

C. japonica is not as popular or well researched as another Camellia species, C. sinensis (the primary tea plant consumed globally and highly touted and appreciated for its multitude of health benefits), but it has its own history of traditional uses for medical and cosmetic purposes and is a subject of increasing research interest along with popular applications. Its antioxidant and anti-inflammatory properties are thought to be central in conferring the ability to protect the skin from aging. Its effects on the skin barrier help skin hydration. More research is necessary to elucidate the apparently widespread potential of this botanical agent that is already found in some over-the-counter products.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as an ecommerce solution. Write to her at [email protected].

References

1. Pereira AG et al. Food Chem X. 2022 Feb 17;13:100258.

2. Cho WK et al. FEBS Open Bio. 2021 Mar;11(3):633-51.

3. Chung MY et al. Evolution. 2003 Jan;57(1):62-73.

4. Yoon IS et al. Int J Mol Med. 2017 Jun;39(6):1613-20.

5. Lee HH et al. Evid Based Complement Alternat Med. 2016;2016:9679867.

6. Kim S et al. BMB Rep. 2012 Mar;45(3):177-82.

7. Majumder S et al. Bull Nat Res Cen. 2020 Dec;44(1):1-4.

8. Lee SY et al. Korean Journal of Medicinal Crop Science. 2005;13(3):93-100.

9. Piao MJ et al. Int J Mol Sci. 2011;12(4):2618-30.

10. Kim M et al. BMC Complement Altern Med. 2019 Jan 28;19(1):30.

11. Jeon H et al. J Clin Med. 2018 Nov 20;7(11):449.

12. Mizutani T, Masaki H. Exp Dermatol. 2014 Oct;23 Suppl 1:23-6.

13. Jung E et al. J Ethnopharmacol. 2007 May 30;112(1):127-31.

14. Choi HK et al. J Cosmet Dermatol. 2022 Oct;21(10):4931-41.

15. Ha SY et al. Evid Based Complement Alternat Med. 2021 Nov 16;2021:6328767.

Lipoprotein(a) [Lp(a)] was first identified in 1963, just about the time that my 16-year-old arteries were probably developing fatty streaks. It soon became clear that Lp(a) was associated with atherosclerotic cardiovascular disease (ASCVD), but whether an elevated blood level was a biomarker or a causal factor proved difficult to determine. Studies of inheritance patterns confirmed that blood levels were primarily genetically determined and largely resistant to lifestyle and pharmacologic intervention. It seemed senseless to test for something that was deemed “unmodifiable,” so untreatable. That label stuck for decades.

Fortunately, a resurgent interest in molecular pathophysiology this past decade has clarified Lp(a)’s unique contribution to atherothrombotic disease and calcific aortic stenosis. While there remains much to be learned about this complex, highly atherogenic molecule and its role in cardiac disease, it seems shortsighted not to take the simple step of identifying who carries this risk. Why are we not testing everyone for an extremely common and potent risk factor for the most lethal disease on the planet?

Epidemiologic studies project a stunning number of people in the United States to be at increased risk for Lp(a)-mediated coronary and cerebrovascular events. Because the LPA gene which codes for the apo(a) component of the Lp(a) molecule is fully expressed at age 2, this is a truly lifelong risk factor for a projected 64 million individuals with blood levels (> 60 mg/dL) high enough to double their risk for ASCVD. Because risk increases linearly, this includes 16 million, like me, with levels > 116 mg/dL, who are at four times the risk for ASCVD as those with normal levels (< 30 mg/dL).

Because Lp(a) level remains relatively constant throughout life, a single blood test would help stratify the risk it confers on millions of people who, under current U.S. guidelines, would never be tested. Until Lp(a) is integrated into its algorithms, the commonly used ASCVD Risk Calculator will substantially underestimate risk in 20% of the population.

A potential barrier to universal testing is that the ideal method to measure Lp(a) has yet to be determined. Lp(a) comprises an apoB particle bonded to an apo(a) particle. Apo(a) is complex and has a number of isoforms that can result in large heterogeneity in apo(a) size between, as well as within, individuals. This contributes to controversy about the ideal assay and whether Lp(a) levels should be expressed as mass (mg/dL) or number of particles (nmols/L). This should not, however, deter universal testing.
 

One-time cost, lifetime benefit?

Absent universal testing, it’s impossible to estimate the economic toll that Lp(a) exacts, but it’s surely an extraordinary number, particularly because the highest-risk individuals are prone to recurrent, nonfatal vascular events. The substantial price tag for my personal decade of Lp(a)-induced vascular havoc included four percutaneous coronary interventions with rapid stent restenosis, an eventual bypass surgery, and an aborted left hemispheric stroke, requiring an urgent carotid endarterectomy.

As a frame of reference, U.S. expenditures related to ASCVD are estimated to be $351 billion annually. If everyone in the United States over the age of 18 were tested for Lp(a) at a cost of $100 per person, this would be a $21 billion expenditure. This nonrecurring expense would identify the 20% – or almost 42 million individuals – at high risk for ASCVD, a number of whom would have already had vascular events. This one-time cost would be a foundational step in securing year-after-year savings from enhanced ASCVD prevention and reduction in recurrent vascular events.

Such savings would be significantly enhanced if and when targeted, effective Lp(a) treatments become available, but it seems shortsighted to make this the linchpin for universal testing. It’s noteworthy that Canadian and European guidelines already endorse one-time testing for all.

The confirmation of Lp(a)’s causal role in ASCVD remains underappreciated by medical providers across all specialties. Much of the elegant Lp(a)-related science of the past decade has yet to translate to the clinical world. What better way to rectify this than by identifying those with high Lp(a)? Since the advent of the statin era, “good” and “bad” cholesterol values are common conversational fare, in part because virtually every adult has had not one, but many lipid panels. Universal Lp(a) testing would spotlight this pervasive and important risk factor that was referred to as the “horrible” cholesterol in a recent review.
 

U.S. guidelines need updating

To foster this, U.S. guidelines, which influence every aspect of care, including testing, prevention, treatment, reimbursement, and medical legal issues, need to be simplified. The discussion of Lp(a) testing in the 2018 U.S. guidelines on cholesterol management is already obsolete. The contingencies on when testing is “reasonable” or “may be reasonable” are dated and cumbersome. In contrast, a recommendation to test everyone once, perhaps in adolescence, would be a useful, forward-looking strategy.

To date, trials of an antisense oligonucleotide and a small interfering RNA molecule targeting hepatic LPA messenger RNA have confirmed that plasma Lp(a) levels can be significantly and safely lowered. If the ongoing Lp(a) HORIZON and OCEAN(a) phase 3 trials have positive outcomes in patients with known ASCVD, this would spawn a host of clinical trials to explore the possibilities of these therapies in primary prevention as well. These will require tens of thousands of enrollees, and universal testing would expand the pool of potential participants.

The majority of at-risk individuals identified through universal testing would be candidates for primary prevention. This large, currently unidentified cohort should have all coexisting risk factors assessed and managed; lowering elevated LDL cholesterol early and aggressively is paramount. Recent data from the United Kingdom suggest that attainment of specific LDL cholesterol levels may offset the risk for vascular events in those with high Lp(a) levels.

Of note, this was the advice given to the small fraction of high-risk individuals like me, who had their Lp(a) level tested long before its ominous implications were understood. This recommendation was informed mostly by common sense. For any number of reasons, the same might be said for universal testing.

Dr. Leahy, a retired cardiologist in San Diego, has an abiding professional and personal interest in Lp(a), which has been responsible for a number of cardiovascular events in his own life over the past 2 decades. He was a participant in the phase 2 clinical trial of the Lp(a)-lowering antisense oligonucleotide being studied in the Lp(a) HORIZON trial, funded by Novartis, and is currently undergoing apheresis treatment. A version of this article originally appeared on Medscape.com.

Lipoprotein(a) [Lp(a)] was first identified in 1963, just about the time that my 16-year-old arteries were probably developing fatty streaks. It soon became clear that Lp(a) was associated with atherosclerotic cardiovascular disease (ASCVD), but whether an elevated blood level was a biomarker or a causal factor proved difficult to determine. Studies of inheritance patterns confirmed that blood levels were primarily genetically determined and largely resistant to lifestyle and pharmacologic intervention. It seemed senseless to test for something that was deemed “unmodifiable,” so untreatable. That label stuck for decades.

Fortunately, a resurgent interest in molecular pathophysiology this past decade has clarified Lp(a)’s unique contribution to atherothrombotic disease and calcific aortic stenosis. While there remains much to be learned about this complex, highly atherogenic molecule and its role in cardiac disease, it seems shortsighted not to take the simple step of identifying who carries this risk. Why are we not testing everyone for an extremely common and potent risk factor for the most lethal disease on the planet?

Epidemiologic studies project a stunning number of people in the United States to be at increased risk for Lp(a)-mediated coronary and cerebrovascular events. Because the LPA gene which codes for the apo(a) component of the Lp(a) molecule is fully expressed at age 2, this is a truly lifelong risk factor for a projected 64 million individuals with blood levels (> 60 mg/dL) high enough to double their risk for ASCVD. Because risk increases linearly, this includes 16 million, like me, with levels > 116 mg/dL, who are at four times the risk for ASCVD as those with normal levels (< 30 mg/dL).

Because Lp(a) level remains relatively constant throughout life, a single blood test would help stratify the risk it confers on millions of people who, under current U.S. guidelines, would never be tested. Until Lp(a) is integrated into its algorithms, the commonly used ASCVD Risk Calculator will substantially underestimate risk in 20% of the population.

A potential barrier to universal testing is that the ideal method to measure Lp(a) has yet to be determined. Lp(a) comprises an apoB particle bonded to an apo(a) particle. Apo(a) is complex and has a number of isoforms that can result in large heterogeneity in apo(a) size between, as well as within, individuals. This contributes to controversy about the ideal assay and whether Lp(a) levels should be expressed as mass (mg/dL) or number of particles (nmols/L). This should not, however, deter universal testing.
 

One-time cost, lifetime benefit?

Absent universal testing, it’s impossible to estimate the economic toll that Lp(a) exacts, but it’s surely an extraordinary number, particularly because the highest-risk individuals are prone to recurrent, nonfatal vascular events. The substantial price tag for my personal decade of Lp(a)-induced vascular havoc included four percutaneous coronary interventions with rapid stent restenosis, an eventual bypass surgery, and an aborted left hemispheric stroke, requiring an urgent carotid endarterectomy.

As a frame of reference, U.S. expenditures related to ASCVD are estimated to be $351 billion annually. If everyone in the United States over the age of 18 were tested for Lp(a) at a cost of $100 per person, this would be a $21 billion expenditure. This nonrecurring expense would identify the 20% – or almost 42 million individuals – at high risk for ASCVD, a number of whom would have already had vascular events. This one-time cost would be a foundational step in securing year-after-year savings from enhanced ASCVD prevention and reduction in recurrent vascular events.

Such savings would be significantly enhanced if and when targeted, effective Lp(a) treatments become available, but it seems shortsighted to make this the linchpin for universal testing. It’s noteworthy that Canadian and European guidelines already endorse one-time testing for all.

The confirmation of Lp(a)’s causal role in ASCVD remains underappreciated by medical providers across all specialties. Much of the elegant Lp(a)-related science of the past decade has yet to translate to the clinical world. What better way to rectify this than by identifying those with high Lp(a)? Since the advent of the statin era, “good” and “bad” cholesterol values are common conversational fare, in part because virtually every adult has had not one, but many lipid panels. Universal Lp(a) testing would spotlight this pervasive and important risk factor that was referred to as the “horrible” cholesterol in a recent review.
 

U.S. guidelines need updating

To foster this, U.S. guidelines, which influence every aspect of care, including testing, prevention, treatment, reimbursement, and medical legal issues, need to be simplified. The discussion of Lp(a) testing in the 2018 U.S. guidelines on cholesterol management is already obsolete. The contingencies on when testing is “reasonable” or “may be reasonable” are dated and cumbersome. In contrast, a recommendation to test everyone once, perhaps in adolescence, would be a useful, forward-looking strategy.

To date, trials of an antisense oligonucleotide and a small interfering RNA molecule targeting hepatic LPA messenger RNA have confirmed that plasma Lp(a) levels can be significantly and safely lowered. If the ongoing Lp(a) HORIZON and OCEAN(a) phase 3 trials have positive outcomes in patients with known ASCVD, this would spawn a host of clinical trials to explore the possibilities of these therapies in primary prevention as well. These will require tens of thousands of enrollees, and universal testing would expand the pool of potential participants.

The majority of at-risk individuals identified through universal testing would be candidates for primary prevention. This large, currently unidentified cohort should have all coexisting risk factors assessed and managed; lowering elevated LDL cholesterol early and aggressively is paramount. Recent data from the United Kingdom suggest that attainment of specific LDL cholesterol levels may offset the risk for vascular events in those with high Lp(a) levels.

Of note, this was the advice given to the small fraction of high-risk individuals like me, who had their Lp(a) level tested long before its ominous implications were understood. This recommendation was informed mostly by common sense. For any number of reasons, the same might be said for universal testing.

Dr. Leahy, a retired cardiologist in San Diego, has an abiding professional and personal interest in Lp(a), which has been responsible for a number of cardiovascular events in his own life over the past 2 decades. He was a participant in the phase 2 clinical trial of the Lp(a)-lowering antisense oligonucleotide being studied in the Lp(a) HORIZON trial, funded by Novartis, and is currently undergoing apheresis treatment. A version of this article originally appeared on Medscape.com.

Lipoprotein(a) [Lp(a)] was first identified in 1963, just about the time that my 16-year-old arteries were probably developing fatty streaks. It soon became clear that Lp(a) was associated with atherosclerotic cardiovascular disease (ASCVD), but whether an elevated blood level was a biomarker or a causal factor proved difficult to determine. Studies of inheritance patterns confirmed that blood levels were primarily genetically determined and largely resistant to lifestyle and pharmacologic intervention. It seemed senseless to test for something that was deemed “unmodifiable,” so untreatable. That label stuck for decades.

Fortunately, a resurgent interest in molecular pathophysiology this past decade has clarified Lp(a)’s unique contribution to atherothrombotic disease and calcific aortic stenosis. While there remains much to be learned about this complex, highly atherogenic molecule and its role in cardiac disease, it seems shortsighted not to take the simple step of identifying who carries this risk. Why are we not testing everyone for an extremely common and potent risk factor for the most lethal disease on the planet?

Epidemiologic studies project a stunning number of people in the United States to be at increased risk for Lp(a)-mediated coronary and cerebrovascular events. Because the LPA gene which codes for the apo(a) component of the Lp(a) molecule is fully expressed at age 2, this is a truly lifelong risk factor for a projected 64 million individuals with blood levels (> 60 mg/dL) high enough to double their risk for ASCVD. Because risk increases linearly, this includes 16 million, like me, with levels > 116 mg/dL, who are at four times the risk for ASCVD as those with normal levels (< 30 mg/dL).

Because Lp(a) level remains relatively constant throughout life, a single blood test would help stratify the risk it confers on millions of people who, under current U.S. guidelines, would never be tested. Until Lp(a) is integrated into its algorithms, the commonly used ASCVD Risk Calculator will substantially underestimate risk in 20% of the population.

A potential barrier to universal testing is that the ideal method to measure Lp(a) has yet to be determined. Lp(a) comprises an apoB particle bonded to an apo(a) particle. Apo(a) is complex and has a number of isoforms that can result in large heterogeneity in apo(a) size between, as well as within, individuals. This contributes to controversy about the ideal assay and whether Lp(a) levels should be expressed as mass (mg/dL) or number of particles (nmols/L). This should not, however, deter universal testing.
 

One-time cost, lifetime benefit?

Absent universal testing, it’s impossible to estimate the economic toll that Lp(a) exacts, but it’s surely an extraordinary number, particularly because the highest-risk individuals are prone to recurrent, nonfatal vascular events. The substantial price tag for my personal decade of Lp(a)-induced vascular havoc included four percutaneous coronary interventions with rapid stent restenosis, an eventual bypass surgery, and an aborted left hemispheric stroke, requiring an urgent carotid endarterectomy.

As a frame of reference, U.S. expenditures related to ASCVD are estimated to be $351 billion annually. If everyone in the United States over the age of 18 were tested for Lp(a) at a cost of $100 per person, this would be a $21 billion expenditure. This nonrecurring expense would identify the 20% – or almost 42 million individuals – at high risk for ASCVD, a number of whom would have already had vascular events. This one-time cost would be a foundational step in securing year-after-year savings from enhanced ASCVD prevention and reduction in recurrent vascular events.

Such savings would be significantly enhanced if and when targeted, effective Lp(a) treatments become available, but it seems shortsighted to make this the linchpin for universal testing. It’s noteworthy that Canadian and European guidelines already endorse one-time testing for all.

The confirmation of Lp(a)’s causal role in ASCVD remains underappreciated by medical providers across all specialties. Much of the elegant Lp(a)-related science of the past decade has yet to translate to the clinical world. What better way to rectify this than by identifying those with high Lp(a)? Since the advent of the statin era, “good” and “bad” cholesterol values are common conversational fare, in part because virtually every adult has had not one, but many lipid panels. Universal Lp(a) testing would spotlight this pervasive and important risk factor that was referred to as the “horrible” cholesterol in a recent review.
 

U.S. guidelines need updating

To foster this, U.S. guidelines, which influence every aspect of care, including testing, prevention, treatment, reimbursement, and medical legal issues, need to be simplified. The discussion of Lp(a) testing in the 2018 U.S. guidelines on cholesterol management is already obsolete. The contingencies on when testing is “reasonable” or “may be reasonable” are dated and cumbersome. In contrast, a recommendation to test everyone once, perhaps in adolescence, would be a useful, forward-looking strategy.

To date, trials of an antisense oligonucleotide and a small interfering RNA molecule targeting hepatic LPA messenger RNA have confirmed that plasma Lp(a) levels can be significantly and safely lowered. If the ongoing Lp(a) HORIZON and OCEAN(a) phase 3 trials have positive outcomes in patients with known ASCVD, this would spawn a host of clinical trials to explore the possibilities of these therapies in primary prevention as well. These will require tens of thousands of enrollees, and universal testing would expand the pool of potential participants.

The majority of at-risk individuals identified through universal testing would be candidates for primary prevention. This large, currently unidentified cohort should have all coexisting risk factors assessed and managed; lowering elevated LDL cholesterol early and aggressively is paramount. Recent data from the United Kingdom suggest that attainment of specific LDL cholesterol levels may offset the risk for vascular events in those with high Lp(a) levels.

Of note, this was the advice given to the small fraction of high-risk individuals like me, who had their Lp(a) level tested long before its ominous implications were understood. This recommendation was informed mostly by common sense. For any number of reasons, the same might be said for universal testing.

Dr. Leahy, a retired cardiologist in San Diego, has an abiding professional and personal interest in Lp(a), which has been responsible for a number of cardiovascular events in his own life over the past 2 decades. He was a participant in the phase 2 clinical trial of the Lp(a)-lowering antisense oligonucleotide being studied in the Lp(a) HORIZON trial, funded by Novartis, and is currently undergoing apheresis treatment. A version of this article originally appeared on Medscape.com.

Most doctors in primary care would agree that lymphedema is a difficult and frustrating disorder to treat. Despite treatments, patients still continue to suffer with symptoms such as pain and leg heaviness, and get only mild improvement. Patients receiving treatments rarely become symptom free.

According to the National Institutes of Health (NIH), primary or congenital lymphedema is a rare disorder occurring in 1 out of 100,00 Americans. On the other hand, secondary or acquired lymphedema is seen in 1 out of every 1,000 and is a complication of many cancers. For example, 1 out of every 5 women who survive breast cancer will develop lymphedema.

Given the statistics, primary care doctors will likely be responsible for treating patients with this disorder. It is important to note that the American Venous Forum consensus statement concluded that the diagnosis can be made based on clinical exam alone.

Given this fact, practitioners should be able to distinguish lymphedema from other similar diseases. As primary care doctors, we are likely to be the first ones to evaluate and diagnose this disease and need to be proficient on physical findings. We should also know the risk factors. No tests need to be performed, and this is a positive in this time of rising health care costs.

Another important conclusion of the consensus statement is that patients with chronic venous insufficiency should be treated the same as patients with lymphedema, especially given the fact that it can be a secondary cause of lymphedema. However, those disagreeing with this in the panel that developed the consensus statement endorsed doing a venous ultrasound to establish the cause.

Chronic venous insufficiency and lymphedema are often confused for each other, and the fact that they should be treated the same further establishes the fact that no further testing is needed. It can be argued that if we order a test when we suspect lymphedema, it serves only to drive up the cost and delays the initiation of treatment.

One area in which the panel of experts who developed the consensus statement showed some variability was in their recommendations for the treatment of lymphedema. Regular use of compression stockings to reduce lymphedema progression and manual lymphatic drainage were favored by most of the panel members, while Velcro devices and surgery were not.

While it is worthwhile to note this conclusion, determining how to treat a patient in clinical practice is often much more difficult. For one thing, some of these treatments are hard to get covered by insurance companies. Also, there is no objective data, unlike blood pressure or diabetic readings, to show the efficacy of a therapy for lymphedema. Instead, a diagnosis of lymphedema is based on a patient’s subjective symptoms. Many patients experience no substantial improvement from treatment, and even modest improvements can be considered a failure to them.

Another obstacle to treatment is that many patients find the treatment modalities uncomfortable or unsustainable. Some find the compression devices painful, for example. But often, they are given ones that have not been custom fitted to them, especially in the days of COVID when these are most often shipped to the patients’ homes. Also, manual drainage can be very time-consuming. To be effective, some patients need to do it more than once a day and it can take 30-60 minutes. Patients have jobs to go to and just don’t have the downtime to be able to do it effectively.

While this consensus statement does a good job analyzing current diagnosis and treatment of lymphedema, further research is needed to find new treatments and better education of clinicians needs to be done.

Lymphedema is an often-overlooked diagnosis despite having obvious clinical findings. There is currently no cure for lymphedema and the treatments that we do have available are not going to eliminate symptoms.

Patients are often frustrated by the lack of clinical improvement and there is little left to offer them. If we truly want to make an impact in our lymphedema patients, we need a better treatment. For now, we can offer them what is proven by the best evidence to reduce symptoms and support them in their suffering. Sometimes a listening ear and kind heart can make an even larger impact than just offering a treatment that doesn’t cure their disease.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Most doctors in primary care would agree that lymphedema is a difficult and frustrating disorder to treat. Despite treatments, patients still continue to suffer with symptoms such as pain and leg heaviness, and get only mild improvement. Patients receiving treatments rarely become symptom free.

According to the National Institutes of Health (NIH), primary or congenital lymphedema is a rare disorder occurring in 1 out of 100,00 Americans. On the other hand, secondary or acquired lymphedema is seen in 1 out of every 1,000 and is a complication of many cancers. For example, 1 out of every 5 women who survive breast cancer will develop lymphedema.

Given the statistics, primary care doctors will likely be responsible for treating patients with this disorder. It is important to note that the American Venous Forum consensus statement concluded that the diagnosis can be made based on clinical exam alone.

Given this fact, practitioners should be able to distinguish lymphedema from other similar diseases. As primary care doctors, we are likely to be the first ones to evaluate and diagnose this disease and need to be proficient on physical findings. We should also know the risk factors. No tests need to be performed, and this is a positive in this time of rising health care costs.

Another important conclusion of the consensus statement is that patients with chronic venous insufficiency should be treated the same as patients with lymphedema, especially given the fact that it can be a secondary cause of lymphedema. However, those disagreeing with this in the panel that developed the consensus statement endorsed doing a venous ultrasound to establish the cause.

Chronic venous insufficiency and lymphedema are often confused for each other, and the fact that they should be treated the same further establishes the fact that no further testing is needed. It can be argued that if we order a test when we suspect lymphedema, it serves only to drive up the cost and delays the initiation of treatment.

One area in which the panel of experts who developed the consensus statement showed some variability was in their recommendations for the treatment of lymphedema. Regular use of compression stockings to reduce lymphedema progression and manual lymphatic drainage were favored by most of the panel members, while Velcro devices and surgery were not.

While it is worthwhile to note this conclusion, determining how to treat a patient in clinical practice is often much more difficult. For one thing, some of these treatments are hard to get covered by insurance companies. Also, there is no objective data, unlike blood pressure or diabetic readings, to show the efficacy of a therapy for lymphedema. Instead, a diagnosis of lymphedema is based on a patient’s subjective symptoms. Many patients experience no substantial improvement from treatment, and even modest improvements can be considered a failure to them.

Another obstacle to treatment is that many patients find the treatment modalities uncomfortable or unsustainable. Some find the compression devices painful, for example. But often, they are given ones that have not been custom fitted to them, especially in the days of COVID when these are most often shipped to the patients’ homes. Also, manual drainage can be very time-consuming. To be effective, some patients need to do it more than once a day and it can take 30-60 minutes. Patients have jobs to go to and just don’t have the downtime to be able to do it effectively.

While this consensus statement does a good job analyzing current diagnosis and treatment of lymphedema, further research is needed to find new treatments and better education of clinicians needs to be done.

Lymphedema is an often-overlooked diagnosis despite having obvious clinical findings. There is currently no cure for lymphedema and the treatments that we do have available are not going to eliminate symptoms.

Patients are often frustrated by the lack of clinical improvement and there is little left to offer them. If we truly want to make an impact in our lymphedema patients, we need a better treatment. For now, we can offer them what is proven by the best evidence to reduce symptoms and support them in their suffering. Sometimes a listening ear and kind heart can make an even larger impact than just offering a treatment that doesn’t cure their disease.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Most doctors in primary care would agree that lymphedema is a difficult and frustrating disorder to treat. Despite treatments, patients still continue to suffer with symptoms such as pain and leg heaviness, and get only mild improvement. Patients receiving treatments rarely become symptom free.

According to the National Institutes of Health (NIH), primary or congenital lymphedema is a rare disorder occurring in 1 out of 100,00 Americans. On the other hand, secondary or acquired lymphedema is seen in 1 out of every 1,000 and is a complication of many cancers. For example, 1 out of every 5 women who survive breast cancer will develop lymphedema.

Given the statistics, primary care doctors will likely be responsible for treating patients with this disorder. It is important to note that the American Venous Forum consensus statement concluded that the diagnosis can be made based on clinical exam alone.

Given this fact, practitioners should be able to distinguish lymphedema from other similar diseases. As primary care doctors, we are likely to be the first ones to evaluate and diagnose this disease and need to be proficient on physical findings. We should also know the risk factors. No tests need to be performed, and this is a positive in this time of rising health care costs.

Another important conclusion of the consensus statement is that patients with chronic venous insufficiency should be treated the same as patients with lymphedema, especially given the fact that it can be a secondary cause of lymphedema. However, those disagreeing with this in the panel that developed the consensus statement endorsed doing a venous ultrasound to establish the cause.

Chronic venous insufficiency and lymphedema are often confused for each other, and the fact that they should be treated the same further establishes the fact that no further testing is needed. It can be argued that if we order a test when we suspect lymphedema, it serves only to drive up the cost and delays the initiation of treatment.

One area in which the panel of experts who developed the consensus statement showed some variability was in their recommendations for the treatment of lymphedema. Regular use of compression stockings to reduce lymphedema progression and manual lymphatic drainage were favored by most of the panel members, while Velcro devices and surgery were not.

While it is worthwhile to note this conclusion, determining how to treat a patient in clinical practice is often much more difficult. For one thing, some of these treatments are hard to get covered by insurance companies. Also, there is no objective data, unlike blood pressure or diabetic readings, to show the efficacy of a therapy for lymphedema. Instead, a diagnosis of lymphedema is based on a patient’s subjective symptoms. Many patients experience no substantial improvement from treatment, and even modest improvements can be considered a failure to them.

Another obstacle to treatment is that many patients find the treatment modalities uncomfortable or unsustainable. Some find the compression devices painful, for example. But often, they are given ones that have not been custom fitted to them, especially in the days of COVID when these are most often shipped to the patients’ homes. Also, manual drainage can be very time-consuming. To be effective, some patients need to do it more than once a day and it can take 30-60 minutes. Patients have jobs to go to and just don’t have the downtime to be able to do it effectively.

While this consensus statement does a good job analyzing current diagnosis and treatment of lymphedema, further research is needed to find new treatments and better education of clinicians needs to be done.

Lymphedema is an often-overlooked diagnosis despite having obvious clinical findings. There is currently no cure for lymphedema and the treatments that we do have available are not going to eliminate symptoms.

Patients are often frustrated by the lack of clinical improvement and there is little left to offer them. If we truly want to make an impact in our lymphedema patients, we need a better treatment. For now, we can offer them what is proven by the best evidence to reduce symptoms and support them in their suffering. Sometimes a listening ear and kind heart can make an even larger impact than just offering a treatment that doesn’t cure their disease.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Innovations in biomedical technology – from modern endoscopic devices and techniques to harnessing the microbiome to prevent and treat disease – have fundamentally changed the way in which we practice medicine and significantly improved the lives of our patients. In our February issue, we are pleased to highlight the launch of AGA’s GI Opportunity Fund, a new investment vehicle that provides AGA members and others a direct pathway to support development of promising, early-stage innovations by funding carefully vetted, cutting-edge start-up companies. We hope you will enjoy learning more about this exciting new initiative, which recently made its first major investment.

In our February Member Spotlight column, we feature Dr. Simon Mathews and his work to bring greater visibility to digital health technologies and their use in gastroenterology and beyond. I want to thank GIHN Associate Editor Dr. Janice Jou for agreeing to spearhead this new column as its section editor – again, we invite you to nominate your colleagues, mentees, and others to be featured in future Member Spotlight columns.

We also highlight several recent papers published in AGA’s flagship journals, including a study assessing clinical outcomes and adverse events in patients receiving oral vs. colonic fecal microbiota transplant (FMT) for recurrent C. difficile infection, and another evaluating the cost-effectiveness of earlier colorectal cancer screening in patients with obesity. On the policy front, we summarize GI-relevant portions of the $1.7 trillion FY 2023 Omnibus Appropriations bill, signed into law on Dec. 30, 2022, by President Biden, and assess its impact on Medicare payments, continuation of support for telehealth/virtual care, and NIH-funding. We hope you enjoy reading these and other articles presented in our February issue.
 

Don’t forget to register for DDW 2023, May 6-9, 2023, in Chicago – general registration is now open!

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

Innovations in biomedical technology – from modern endoscopic devices and techniques to harnessing the microbiome to prevent and treat disease – have fundamentally changed the way in which we practice medicine and significantly improved the lives of our patients. In our February issue, we are pleased to highlight the launch of AGA’s GI Opportunity Fund, a new investment vehicle that provides AGA members and others a direct pathway to support development of promising, early-stage innovations by funding carefully vetted, cutting-edge start-up companies. We hope you will enjoy learning more about this exciting new initiative, which recently made its first major investment.

In our February Member Spotlight column, we feature Dr. Simon Mathews and his work to bring greater visibility to digital health technologies and their use in gastroenterology and beyond. I want to thank GIHN Associate Editor Dr. Janice Jou for agreeing to spearhead this new column as its section editor – again, we invite you to nominate your colleagues, mentees, and others to be featured in future Member Spotlight columns.

We also highlight several recent papers published in AGA’s flagship journals, including a study assessing clinical outcomes and adverse events in patients receiving oral vs. colonic fecal microbiota transplant (FMT) for recurrent C. difficile infection, and another evaluating the cost-effectiveness of earlier colorectal cancer screening in patients with obesity. On the policy front, we summarize GI-relevant portions of the $1.7 trillion FY 2023 Omnibus Appropriations bill, signed into law on Dec. 30, 2022, by President Biden, and assess its impact on Medicare payments, continuation of support for telehealth/virtual care, and NIH-funding. We hope you enjoy reading these and other articles presented in our February issue.
 

Don’t forget to register for DDW 2023, May 6-9, 2023, in Chicago – general registration is now open!

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

Innovations in biomedical technology – from modern endoscopic devices and techniques to harnessing the microbiome to prevent and treat disease – have fundamentally changed the way in which we practice medicine and significantly improved the lives of our patients. In our February issue, we are pleased to highlight the launch of AGA’s GI Opportunity Fund, a new investment vehicle that provides AGA members and others a direct pathway to support development of promising, early-stage innovations by funding carefully vetted, cutting-edge start-up companies. We hope you will enjoy learning more about this exciting new initiative, which recently made its first major investment.

In our February Member Spotlight column, we feature Dr. Simon Mathews and his work to bring greater visibility to digital health technologies and their use in gastroenterology and beyond. I want to thank GIHN Associate Editor Dr. Janice Jou for agreeing to spearhead this new column as its section editor – again, we invite you to nominate your colleagues, mentees, and others to be featured in future Member Spotlight columns.

We also highlight several recent papers published in AGA’s flagship journals, including a study assessing clinical outcomes and adverse events in patients receiving oral vs. colonic fecal microbiota transplant (FMT) for recurrent C. difficile infection, and another evaluating the cost-effectiveness of earlier colorectal cancer screening in patients with obesity. On the policy front, we summarize GI-relevant portions of the $1.7 trillion FY 2023 Omnibus Appropriations bill, signed into law on Dec. 30, 2022, by President Biden, and assess its impact on Medicare payments, continuation of support for telehealth/virtual care, and NIH-funding. We hope you enjoy reading these and other articles presented in our February issue.
 

Don’t forget to register for DDW 2023, May 6-9, 2023, in Chicago – general registration is now open!

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

It’s a common scenario. A patient, Agnes, with symptoms of an upper respiratory infection (URI), but what’s the cause? Is it COVID-19, flu, or even RSV? I recently described just such a patient, an obese woman with type 2 diabetes, presenting with fever, cough, myalgia, and fatigue. I asked readers whether they agreed with my management of this patient.

Thank you for your comments as we continue to react to high rates of URIs. Your comments highlight the importance of local resources and practice habits when managing patients with URI.

It was clear that readers value testing to distinguish between infections. However, access to testing is highly variable around the world and is likely to be routinely used only in high-income countries. The Kaiser Family Foundation performed a cost analysis of testing for SARS-CoV-2 in 2020 and found, not surprisingly, wide variability in the cost of testing. Medicare covers tests at rates of $36-$143 per test; a study of list prices for SARS-CoV-2 tests at 93 hospitals found a median cost of $148 per test. And this does not include collection or facility fees. About 20% of tests cost more than $300.

These costs are prohibitive for many health systems. However, more devices have been introduced since that analysis, and competition and evolving technology should drive down prices. Generally, multiplex polymerase chain reaction (PCR) testing for multiple pathogens is less expensive than ordering two or three separate molecular tests and is more convenient for patients and practices alike.

Other reader comments focused on the challenges of getting accurate data on viral epidemiology, and there is certainly a time lag between infection trends and public health reports. This is exacerbated by underreporting of symptoms and more testing at home using antigen tests.

But please do not give up on epidemiology! If a test such as PCR is 90% sensitive for identifying infection, the yield in terms of the number of individuals infected with a particular virus should be high, and that is true when infection is in broad circulation. If 20% of a population of 1,000 has an infection and the test sensitivity is 90%, the yield of testing is 180 true cases versus 20 false positives.

However, if just 2% of the population of 1,000 has the infection in this same scenario, then only 18 true cases are identified. The effect on public health is certainly less, and a lower prevalence rate means that confounding variables, such as how long an individual might shed viral particles and the method of sample collection, have an outsized effect on results. This reduces the validity of diagnostic tests.

Even trends on a national level can provide some insight regarding whom to test. Traditionally, our practice has been to not routinely test patients for influenza or RSV from late spring to early fall unless there was a compelling reason, such as recent travel to an area where these infections were more prevalent. The loss of temporality for these infections since 2020 has altered this approach and made us pay more attention to reports from public health organizations.

I also appreciate the discussion of how to treat Agnes’s symptoms as she waits to improve, and anyone who suffers with or treats a viral URI knows that there are few interventions effective for such symptoms as cough and congestion. A systematic review of 29 randomized controlled trials of over-the-counter medications for cough yielded mixed and largely negative results.

Antihistamines alone do not seem to work, and guaifenesin was successful in only one of three trials. Combinations of different drug classes appeared to be slightly more effective.

My personal favorite for the management of acute cough is something that kids generally love: honey. In a review of 14 studies, 9 of which were limited to pediatric patients, honey was associated with significant reductions in cough frequency, cough severity, and total symptom score. However, there was a moderate risk of bias in the included research, and evidence of honey’s benefit in placebo-controlled trials was limited. Honey used in this research came in a variety of forms, so the best dosage is uncertain.

Clearly, advancements are needed. Better symptom management in viral URI will almost certainly improve productivity across the population and will probably reduce the inappropriate use of antibiotics as well. I have said for years that the scientists who can solve the Gordian knot of pediatric mucus deserve three Nobel prizes. I look forward to that golden day.

Dr. Vega is a clinical professor of family medicine at the University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

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

It’s a common scenario. A patient, Agnes, with symptoms of an upper respiratory infection (URI), but what’s the cause? Is it COVID-19, flu, or even RSV? I recently described just such a patient, an obese woman with type 2 diabetes, presenting with fever, cough, myalgia, and fatigue. I asked readers whether they agreed with my management of this patient.

Thank you for your comments as we continue to react to high rates of URIs. Your comments highlight the importance of local resources and practice habits when managing patients with URI.

It was clear that readers value testing to distinguish between infections. However, access to testing is highly variable around the world and is likely to be routinely used only in high-income countries. The Kaiser Family Foundation performed a cost analysis of testing for SARS-CoV-2 in 2020 and found, not surprisingly, wide variability in the cost of testing. Medicare covers tests at rates of $36-$143 per test; a study of list prices for SARS-CoV-2 tests at 93 hospitals found a median cost of $148 per test. And this does not include collection or facility fees. About 20% of tests cost more than $300.

These costs are prohibitive for many health systems. However, more devices have been introduced since that analysis, and competition and evolving technology should drive down prices. Generally, multiplex polymerase chain reaction (PCR) testing for multiple pathogens is less expensive than ordering two or three separate molecular tests and is more convenient for patients and practices alike.

Other reader comments focused on the challenges of getting accurate data on viral epidemiology, and there is certainly a time lag between infection trends and public health reports. This is exacerbated by underreporting of symptoms and more testing at home using antigen tests.

But please do not give up on epidemiology! If a test such as PCR is 90% sensitive for identifying infection, the yield in terms of the number of individuals infected with a particular virus should be high, and that is true when infection is in broad circulation. If 20% of a population of 1,000 has an infection and the test sensitivity is 90%, the yield of testing is 180 true cases versus 20 false positives.

However, if just 2% of the population of 1,000 has the infection in this same scenario, then only 18 true cases are identified. The effect on public health is certainly less, and a lower prevalence rate means that confounding variables, such as how long an individual might shed viral particles and the method of sample collection, have an outsized effect on results. This reduces the validity of diagnostic tests.

Even trends on a national level can provide some insight regarding whom to test. Traditionally, our practice has been to not routinely test patients for influenza or RSV from late spring to early fall unless there was a compelling reason, such as recent travel to an area where these infections were more prevalent. The loss of temporality for these infections since 2020 has altered this approach and made us pay more attention to reports from public health organizations.

I also appreciate the discussion of how to treat Agnes’s symptoms as she waits to improve, and anyone who suffers with or treats a viral URI knows that there are few interventions effective for such symptoms as cough and congestion. A systematic review of 29 randomized controlled trials of over-the-counter medications for cough yielded mixed and largely negative results.

Antihistamines alone do not seem to work, and guaifenesin was successful in only one of three trials. Combinations of different drug classes appeared to be slightly more effective.

My personal favorite for the management of acute cough is something that kids generally love: honey. In a review of 14 studies, 9 of which were limited to pediatric patients, honey was associated with significant reductions in cough frequency, cough severity, and total symptom score. However, there was a moderate risk of bias in the included research, and evidence of honey’s benefit in placebo-controlled trials was limited. Honey used in this research came in a variety of forms, so the best dosage is uncertain.

Clearly, advancements are needed. Better symptom management in viral URI will almost certainly improve productivity across the population and will probably reduce the inappropriate use of antibiotics as well. I have said for years that the scientists who can solve the Gordian knot of pediatric mucus deserve three Nobel prizes. I look forward to that golden day.

Dr. Vega is a clinical professor of family medicine at the University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

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

It’s a common scenario. A patient, Agnes, with symptoms of an upper respiratory infection (URI), but what’s the cause? Is it COVID-19, flu, or even RSV? I recently described just such a patient, an obese woman with type 2 diabetes, presenting with fever, cough, myalgia, and fatigue. I asked readers whether they agreed with my management of this patient.

Thank you for your comments as we continue to react to high rates of URIs. Your comments highlight the importance of local resources and practice habits when managing patients with URI.

It was clear that readers value testing to distinguish between infections. However, access to testing is highly variable around the world and is likely to be routinely used only in high-income countries. The Kaiser Family Foundation performed a cost analysis of testing for SARS-CoV-2 in 2020 and found, not surprisingly, wide variability in the cost of testing. Medicare covers tests at rates of $36-$143 per test; a study of list prices for SARS-CoV-2 tests at 93 hospitals found a median cost of $148 per test. And this does not include collection or facility fees. About 20% of tests cost more than $300.

These costs are prohibitive for many health systems. However, more devices have been introduced since that analysis, and competition and evolving technology should drive down prices. Generally, multiplex polymerase chain reaction (PCR) testing for multiple pathogens is less expensive than ordering two or three separate molecular tests and is more convenient for patients and practices alike.

Other reader comments focused on the challenges of getting accurate data on viral epidemiology, and there is certainly a time lag between infection trends and public health reports. This is exacerbated by underreporting of symptoms and more testing at home using antigen tests.

But please do not give up on epidemiology! If a test such as PCR is 90% sensitive for identifying infection, the yield in terms of the number of individuals infected with a particular virus should be high, and that is true when infection is in broad circulation. If 20% of a population of 1,000 has an infection and the test sensitivity is 90%, the yield of testing is 180 true cases versus 20 false positives.

However, if just 2% of the population of 1,000 has the infection in this same scenario, then only 18 true cases are identified. The effect on public health is certainly less, and a lower prevalence rate means that confounding variables, such as how long an individual might shed viral particles and the method of sample collection, have an outsized effect on results. This reduces the validity of diagnostic tests.

Even trends on a national level can provide some insight regarding whom to test. Traditionally, our practice has been to not routinely test patients for influenza or RSV from late spring to early fall unless there was a compelling reason, such as recent travel to an area where these infections were more prevalent. The loss of temporality for these infections since 2020 has altered this approach and made us pay more attention to reports from public health organizations.

I also appreciate the discussion of how to treat Agnes’s symptoms as she waits to improve, and anyone who suffers with or treats a viral URI knows that there are few interventions effective for such symptoms as cough and congestion. A systematic review of 29 randomized controlled trials of over-the-counter medications for cough yielded mixed and largely negative results.

Antihistamines alone do not seem to work, and guaifenesin was successful in only one of three trials. Combinations of different drug classes appeared to be slightly more effective.

My personal favorite for the management of acute cough is something that kids generally love: honey. In a review of 14 studies, 9 of which were limited to pediatric patients, honey was associated with significant reductions in cough frequency, cough severity, and total symptom score. However, there was a moderate risk of bias in the included research, and evidence of honey’s benefit in placebo-controlled trials was limited. Honey used in this research came in a variety of forms, so the best dosage is uncertain.

Clearly, advancements are needed. Better symptom management in viral URI will almost certainly improve productivity across the population and will probably reduce the inappropriate use of antibiotics as well. I have said for years that the scientists who can solve the Gordian knot of pediatric mucus deserve three Nobel prizes. I look forward to that golden day.

Dr. Vega is a clinical professor of family medicine at the University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

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

New treatments for psoriasis constitute an embarrassment of riches compared to any other area of dermatology. Despite the many advances over the last 25 years, additional topical and systemic treatments have recently become available. Gosh, it’s great!

In May 2022, once-daily tapinarof cream 1% was approved for the topical treatment of plaque psoriasis in adults.¹ Tapinarof was identified as a metabolite made by bacteria symbiotic to a nematode, allowing the nematode to infect insects.² Tapinarof’s anti-inflammatory effect extends to mammals. The drug works by activating the aryl hydrocarbon receptor, downregulating proinflammatory cytokines such as IL-17, and normalizing the expression of skin barrier proteins such as filaggrin.² In two 12-week, phase 3, randomized trials with 510 and 515 patients, respectively, 35% to 40% of tapinarof-treated psoriasis patients were clear or almost clear compared with only 6% of patients in the placebo group. The drug appears safe; common adverse events (AEs) included folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus.³

A second new topical treatment for plaque psoriasis was approved in July 2022—once-daily roflumilast 0.3% cream—for patients 12 years and older.⁴ Similar to apremilast, roflumilast is a phosphodiesterase 4 inhibitor that blocks the degradation of cAMP and reduces the downstream production of inflammatory molecules implicated in psoriasis.⁵ In two 8-week, phase 3 clinical trials (ClinicalTrials.gov Identifiers NCT04211363 and NCT04211389)(N=881), approximately 40% of roflumilast-treated patients were clear or almost clear vs approximately 6% in the placebo group. Topical roflumilast was well-tolerated; the most common AEs included diarrhea, headache, insomnia, nausea, application-site pain, upper respiratory tract infection, and urinary tract infection.⁶

We have so many patients—and many more people with psoriasis who are not yet patients—with limited psoriasis who would be amenable to topical treatment but who are not responding to current treatments. There is considerable enthusiasm for the new topicals, but it is still questionable how much they will help our patients. The main reason the current topicals fail is poor adherence to the treatment. If we give these new treatments to patients who used existing topicals and failed, thereby inadvertently selecting patients with poor adherence to topicals, it will be surprising if the new treatments live up to expectations. Perhaps tapinarof and roflumilast will revolutionize the management of localized psoriasis; perhaps their impact will be similar to topical crisaborole— exciting in trials and less practical in real life. It may be that apremilast, which is now approved for psoriasis of any severity, will make a bigger difference for patients who can access it for limited psoriasis.

Deucravacitinib is a once-daily oral selective tyrosine kinase 2 inhibitor that blocks IL-23 and type I interferon signaling. It was approved for adults with moderate to severe plaque psoriasis in September 2021.⁷ We know patients want oral treatment; they ask for apremilast even though injections may be much more potent. In a 16-week, phase 3 clinical trial comparing daily deucravacitinib (n=332), apremilast (n=168), and placebo (n=166), rates of clear or almost clear were approximately 55% in the deucravacitinib group, 32% in the apremilast group, and 7% with placebo. The most common AEs included nasopharyngitis, upper respiratory tract infection, headache, diarrhea, and nausea.⁸ Although deucravacitinib is much more effective than apremilast, deucravacitinib will require monitoring and may have some risk for viral reactivation of herpes simplex and zoster (and hopefully not much else). Whether physicians view it as a replacement for apremilast, which requires no laboratory monitoring, remains to be seen.

Bimekizumab, a humanized monoclonal IgG1 antibody expected to receive US Food and Drug Administration approval in the coming months, inhibits both IL-17A and IL-17F and may become our most effective treatment of psoriasis. Although we are probably not hungering for a more effective psoriasis treatment (given our current embarrassment of riches), bimekizumab’s remarkably high efficacy for psoriatic arthritis may be a quantum leap forward, especially if no new safety signals are identified; bimekizumab treatment is associated with a higher risk of oral candidiasis than other currently available IL-17 antagonists.⁹ Biosimilars may reduce the cost of psoriasis management to the health system, but it seems unlikely that biosimilars will allow us to help patients who we cannot already help with the existing extensive psoriasis treatment armamentarium.

New treatments for psoriasis constitute an embarrassment of riches compared to any other area of dermatology. Despite the many advances over the last 25 years, additional topical and systemic treatments have recently become available. Gosh, it’s great!

In May 2022, once-daily tapinarof cream 1% was approved for the topical treatment of plaque psoriasis in adults.¹ Tapinarof was identified as a metabolite made by bacteria symbiotic to a nematode, allowing the nematode to infect insects.² Tapinarof’s anti-inflammatory effect extends to mammals. The drug works by activating the aryl hydrocarbon receptor, downregulating proinflammatory cytokines such as IL-17, and normalizing the expression of skin barrier proteins such as filaggrin.² In two 12-week, phase 3, randomized trials with 510 and 515 patients, respectively, 35% to 40% of tapinarof-treated psoriasis patients were clear or almost clear compared with only 6% of patients in the placebo group. The drug appears safe; common adverse events (AEs) included folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus.³

A second new topical treatment for plaque psoriasis was approved in July 2022—once-daily roflumilast 0.3% cream—for patients 12 years and older.⁴ Similar to apremilast, roflumilast is a phosphodiesterase 4 inhibitor that blocks the degradation of cAMP and reduces the downstream production of inflammatory molecules implicated in psoriasis.⁵ In two 8-week, phase 3 clinical trials (ClinicalTrials.gov Identifiers NCT04211363 and NCT04211389)(N=881), approximately 40% of roflumilast-treated patients were clear or almost clear vs approximately 6% in the placebo group. Topical roflumilast was well-tolerated; the most common AEs included diarrhea, headache, insomnia, nausea, application-site pain, upper respiratory tract infection, and urinary tract infection.⁶

We have so many patients—and many more people with psoriasis who are not yet patients—with limited psoriasis who would be amenable to topical treatment but who are not responding to current treatments. There is considerable enthusiasm for the new topicals, but it is still questionable how much they will help our patients. The main reason the current topicals fail is poor adherence to the treatment. If we give these new treatments to patients who used existing topicals and failed, thereby inadvertently selecting patients with poor adherence to topicals, it will be surprising if the new treatments live up to expectations. Perhaps tapinarof and roflumilast will revolutionize the management of localized psoriasis; perhaps their impact will be similar to topical crisaborole— exciting in trials and less practical in real life. It may be that apremilast, which is now approved for psoriasis of any severity, will make a bigger difference for patients who can access it for limited psoriasis.

Deucravacitinib is a once-daily oral selective tyrosine kinase 2 inhibitor that blocks IL-23 and type I interferon signaling. It was approved for adults with moderate to severe plaque psoriasis in September 2021.⁷ We know patients want oral treatment; they ask for apremilast even though injections may be much more potent. In a 16-week, phase 3 clinical trial comparing daily deucravacitinib (n=332), apremilast (n=168), and placebo (n=166), rates of clear or almost clear were approximately 55% in the deucravacitinib group, 32% in the apremilast group, and 7% with placebo. The most common AEs included nasopharyngitis, upper respiratory tract infection, headache, diarrhea, and nausea.⁸ Although deucravacitinib is much more effective than apremilast, deucravacitinib will require monitoring and may have some risk for viral reactivation of herpes simplex and zoster (and hopefully not much else). Whether physicians view it as a replacement for apremilast, which requires no laboratory monitoring, remains to be seen.

Bimekizumab, a humanized monoclonal IgG1 antibody expected to receive US Food and Drug Administration approval in the coming months, inhibits both IL-17A and IL-17F and may become our most effective treatment of psoriasis. Although we are probably not hungering for a more effective psoriasis treatment (given our current embarrassment of riches), bimekizumab’s remarkably high efficacy for psoriatic arthritis may be a quantum leap forward, especially if no new safety signals are identified; bimekizumab treatment is associated with a higher risk of oral candidiasis than other currently available IL-17 antagonists.⁹ Biosimilars may reduce the cost of psoriasis management to the health system, but it seems unlikely that biosimilars will allow us to help patients who we cannot already help with the existing extensive psoriasis treatment armamentarium.

New treatments for psoriasis constitute an embarrassment of riches compared to any other area of dermatology. Despite the many advances over the last 25 years, additional topical and systemic treatments have recently become available. Gosh, it’s great!

In May 2022, once-daily tapinarof cream 1% was approved for the topical treatment of plaque psoriasis in adults.¹ Tapinarof was identified as a metabolite made by bacteria symbiotic to a nematode, allowing the nematode to infect insects.² Tapinarof’s anti-inflammatory effect extends to mammals. The drug works by activating the aryl hydrocarbon receptor, downregulating proinflammatory cytokines such as IL-17, and normalizing the expression of skin barrier proteins such as filaggrin.² In two 12-week, phase 3, randomized trials with 510 and 515 patients, respectively, 35% to 40% of tapinarof-treated psoriasis patients were clear or almost clear compared with only 6% of patients in the placebo group. The drug appears safe; common adverse events (AEs) included folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus.³

A second new topical treatment for plaque psoriasis was approved in July 2022—once-daily roflumilast 0.3% cream—for patients 12 years and older.⁴ Similar to apremilast, roflumilast is a phosphodiesterase 4 inhibitor that blocks the degradation of cAMP and reduces the downstream production of inflammatory molecules implicated in psoriasis.⁵ In two 8-week, phase 3 clinical trials (ClinicalTrials.gov Identifiers NCT04211363 and NCT04211389)(N=881), approximately 40% of roflumilast-treated patients were clear or almost clear vs approximately 6% in the placebo group. Topical roflumilast was well-tolerated; the most common AEs included diarrhea, headache, insomnia, nausea, application-site pain, upper respiratory tract infection, and urinary tract infection.⁶

We have so many patients—and many more people with psoriasis who are not yet patients—with limited psoriasis who would be amenable to topical treatment but who are not responding to current treatments. There is considerable enthusiasm for the new topicals, but it is still questionable how much they will help our patients. The main reason the current topicals fail is poor adherence to the treatment. If we give these new treatments to patients who used existing topicals and failed, thereby inadvertently selecting patients with poor adherence to topicals, it will be surprising if the new treatments live up to expectations. Perhaps tapinarof and roflumilast will revolutionize the management of localized psoriasis; perhaps their impact will be similar to topical crisaborole— exciting in trials and less practical in real life. It may be that apremilast, which is now approved for psoriasis of any severity, will make a bigger difference for patients who can access it for limited psoriasis.

Deucravacitinib is a once-daily oral selective tyrosine kinase 2 inhibitor that blocks IL-23 and type I interferon signaling. It was approved for adults with moderate to severe plaque psoriasis in September 2021.⁷ We know patients want oral treatment; they ask for apremilast even though injections may be much more potent. In a 16-week, phase 3 clinical trial comparing daily deucravacitinib (n=332), apremilast (n=168), and placebo (n=166), rates of clear or almost clear were approximately 55% in the deucravacitinib group, 32% in the apremilast group, and 7% with placebo. The most common AEs included nasopharyngitis, upper respiratory tract infection, headache, diarrhea, and nausea.⁸ Although deucravacitinib is much more effective than apremilast, deucravacitinib will require monitoring and may have some risk for viral reactivation of herpes simplex and zoster (and hopefully not much else). Whether physicians view it as a replacement for apremilast, which requires no laboratory monitoring, remains to be seen.

Bimekizumab, a humanized monoclonal IgG1 antibody expected to receive US Food and Drug Administration approval in the coming months, inhibits both IL-17A and IL-17F and may become our most effective treatment of psoriasis. Although we are probably not hungering for a more effective psoriasis treatment (given our current embarrassment of riches), bimekizumab’s remarkably high efficacy for psoriatic arthritis may be a quantum leap forward, especially if no new safety signals are identified; bimekizumab treatment is associated with a higher risk of oral candidiasis than other currently available IL-17 antagonists.⁹ Biosimilars may reduce the cost of psoriasis management to the health system, but it seems unlikely that biosimilars will allow us to help patients who we cannot already help with the existing extensive psoriasis treatment armamentarium.