Renewing the dream

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Renewing the dream

The dream of family practice began more than 6 decades ago with a movement toward personal physicians who have “… the feeling of warm personal regard and concern of doctor for patient, the feeling that the doctor treats people, not illnesses ….” The personal family physician helps patients “… not because of the interesting medical problems they may present but because they are human beings in need of help.”1 One of the most influential founders of family medicine, Dr. Gayle Stephens, expounded on this idea in a series of essays that tapped into the intellectual, philosophical, historical, and moral underpinnings of our discipline.2

Following the dream and the birth of family medicine—like any organization—its lifecycle can be envisioned as proceeding through the rest of the 7 stages of organizational life (TABLE).3 Now allow me to give you some numbers. There are more than 118,000 family physicians in the United States, 784 family medicine residencies filled by 4530 medical school graduates, more than 150 departments of family medicine, multiple national family medicine organizations, and even a World Organization of Family Doctors.4,5 The American Board of Family Medicine is the second largest medical specialty board in the country. Family doctors make up nearly 40% of our total primary care workforce.6 We launched the venture, got organized, made it. We are an institution.

This final issue of The Journal of Family Practice marks the end of an era of nearly 50 years of publication.

The threat at the institution stage is that we are on the precipice of “closing in.” Many factors are driving this stage: commoditization in health care, market influences and competition for patients, alternative primary care models, erosion of the patient-physician relationship (partly driven by technology), narrowing scope of care, clinician burnout, and the challenges of implementing value-based care, to name a few. You see what comes next in the TABLE.3 The good news is that there is an alternative to the “natural” progression to the ending stage: the path of renewal.3

The 7 stages of organizational life

In the lifecycle of an organization, the path of renewal starts the cycle anew, with dreaming the dream. I recently had the opportunity to visit Singapore to learn about their health system. Singapore is one of the wealthiest countries in the world. I was impressed with their many innovations, including technological ones, as well as new models of care. However, I was most impressed that the country is betting big on family medicine. Their Ministry of Health has launched an initiative they are calling Healthier SG.7 The goal is for “all Singaporeans to have a trusted and lifelong relationship with [their] family doctor.” Their dream is to bring personal doctoring to everyone in the country to make Singapore healthier.

While their path of renewal is occurring halfway around the world, here at home, our path of renewal has been ignited over the past several years by the work of the Robert Graham Center; the Keystone Conferences; the American Board of Family Medicine; and the National Academies of Science, Engineering, and Medicine, among others.8-11 These organizations are aligning around re-centering on ­patient-clinician relationships, measuring what is important, care by interprofessional teams, payment reform, professionalism, health equity, improved information technology, and adherence to the best available evidence. We are working toward the solution shop as opposed to the production line.12 We are indeed dreaming a new dream.

While I write about this renewal, I close with an ending. This is the final issue of The Journal of Family Practice. It marks the end of an era of nearly 50 years of publication. The Journal of Family Practice has left a lasting mark, providing generations of clinicians with evidence-based, practical guidance to help care for patients as well as serving as an important venue for scholarly work by the family medicine community. Although I have had the privilege of serving the discipline as an editor-in-chief for only a brief time, I am grateful I had the opportunity. Most of all, I appreciate being on the journey of family medicine with you, renewing the dream together.

The references for this Editorial are available in the online version of the article at www.mdedge.com/familymedicine.

References

1. Fox TF. The personal doctor and his relation to the hospital. Observations and reflections on some American experiments in general practice by groups. Lancet. 1960;2:743-760.

2. Stephens, GG. The Intellectual Basis of Family Practice. Winter Publishing and Society of Teachers of Family Medicine; 1982.

3. Bridges W, Bridges S. Managing Transitions: Making the Most of Change. 4th ed. Da Capo Press; 2016.

4. Association of American Medical Colleges. Physician specialty data report. Accessed October 25, 2023. www.aamc.org/data-reports/workforce/data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2019

5. American Academy of Family Physicians. 2023 match results for family medicine. Accessed October 25, 2023. www.aafp.org/students-residents/residency-program-directors/national-resident-matching-program-results.html

6. Robert Graham Center. Primary Care in the US: A Chartbook of Facts and Statistics. Accessed October 25, 2023. www.graham-center.org/content/dam/rgc/documents/publications-reports/reports/PrimaryCareChartbook2021.pdf

7. Ministry of Health Singapore. What is Healthier SG? Accessed October 25, 2023. www.healthiersg.gov.sg/about/what-is-healthier-sg/

8. The Robert Graham Center. Accessed October 25, 2023. www.graham-center.org/home.html

9. Stange KC. Holding on and letting go: a perspective from the Keystone IV Conference. J Am Board Fam Med. 2016;29:S32-S39.

10. American Board of Family Medicine. Family medicine certification. Accessed October 25, 2023. www.theabfm.org/research-articles/family-medicine-certification?page=1

11. National Academies of Sciences, Engineering, and Medicine. Implementing high-quality primary care. Accessed October 25, 2023. www.nationalacademies.org/our-work/implementing-high-quality-primary-care

12. Sinsky CA, Panzer J. The solution shop and the production line—the case for a frameshift for physician practices. N Engl J Med. 2022;386:2452-2453.

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The dream of family practice began more than 6 decades ago with a movement toward personal physicians who have “… the feeling of warm personal regard and concern of doctor for patient, the feeling that the doctor treats people, not illnesses ….” The personal family physician helps patients “… not because of the interesting medical problems they may present but because they are human beings in need of help.”1 One of the most influential founders of family medicine, Dr. Gayle Stephens, expounded on this idea in a series of essays that tapped into the intellectual, philosophical, historical, and moral underpinnings of our discipline.2

Following the dream and the birth of family medicine—like any organization—its lifecycle can be envisioned as proceeding through the rest of the 7 stages of organizational life (TABLE).3 Now allow me to give you some numbers. There are more than 118,000 family physicians in the United States, 784 family medicine residencies filled by 4530 medical school graduates, more than 150 departments of family medicine, multiple national family medicine organizations, and even a World Organization of Family Doctors.4,5 The American Board of Family Medicine is the second largest medical specialty board in the country. Family doctors make up nearly 40% of our total primary care workforce.6 We launched the venture, got organized, made it. We are an institution.

This final issue of The Journal of Family Practice marks the end of an era of nearly 50 years of publication.

The threat at the institution stage is that we are on the precipice of “closing in.” Many factors are driving this stage: commoditization in health care, market influences and competition for patients, alternative primary care models, erosion of the patient-physician relationship (partly driven by technology), narrowing scope of care, clinician burnout, and the challenges of implementing value-based care, to name a few. You see what comes next in the TABLE.3 The good news is that there is an alternative to the “natural” progression to the ending stage: the path of renewal.3

The 7 stages of organizational life

In the lifecycle of an organization, the path of renewal starts the cycle anew, with dreaming the dream. I recently had the opportunity to visit Singapore to learn about their health system. Singapore is one of the wealthiest countries in the world. I was impressed with their many innovations, including technological ones, as well as new models of care. However, I was most impressed that the country is betting big on family medicine. Their Ministry of Health has launched an initiative they are calling Healthier SG.7 The goal is for “all Singaporeans to have a trusted and lifelong relationship with [their] family doctor.” Their dream is to bring personal doctoring to everyone in the country to make Singapore healthier.

While their path of renewal is occurring halfway around the world, here at home, our path of renewal has been ignited over the past several years by the work of the Robert Graham Center; the Keystone Conferences; the American Board of Family Medicine; and the National Academies of Science, Engineering, and Medicine, among others.8-11 These organizations are aligning around re-centering on ­patient-clinician relationships, measuring what is important, care by interprofessional teams, payment reform, professionalism, health equity, improved information technology, and adherence to the best available evidence. We are working toward the solution shop as opposed to the production line.12 We are indeed dreaming a new dream.

While I write about this renewal, I close with an ending. This is the final issue of The Journal of Family Practice. It marks the end of an era of nearly 50 years of publication. The Journal of Family Practice has left a lasting mark, providing generations of clinicians with evidence-based, practical guidance to help care for patients as well as serving as an important venue for scholarly work by the family medicine community. Although I have had the privilege of serving the discipline as an editor-in-chief for only a brief time, I am grateful I had the opportunity. Most of all, I appreciate being on the journey of family medicine with you, renewing the dream together.

The references for this Editorial are available in the online version of the article at www.mdedge.com/familymedicine.

The dream of family practice began more than 6 decades ago with a movement toward personal physicians who have “… the feeling of warm personal regard and concern of doctor for patient, the feeling that the doctor treats people, not illnesses ….” The personal family physician helps patients “… not because of the interesting medical problems they may present but because they are human beings in need of help.”1 One of the most influential founders of family medicine, Dr. Gayle Stephens, expounded on this idea in a series of essays that tapped into the intellectual, philosophical, historical, and moral underpinnings of our discipline.2

Following the dream and the birth of family medicine—like any organization—its lifecycle can be envisioned as proceeding through the rest of the 7 stages of organizational life (TABLE).3 Now allow me to give you some numbers. There are more than 118,000 family physicians in the United States, 784 family medicine residencies filled by 4530 medical school graduates, more than 150 departments of family medicine, multiple national family medicine organizations, and even a World Organization of Family Doctors.4,5 The American Board of Family Medicine is the second largest medical specialty board in the country. Family doctors make up nearly 40% of our total primary care workforce.6 We launched the venture, got organized, made it. We are an institution.

This final issue of The Journal of Family Practice marks the end of an era of nearly 50 years of publication.

The threat at the institution stage is that we are on the precipice of “closing in.” Many factors are driving this stage: commoditization in health care, market influences and competition for patients, alternative primary care models, erosion of the patient-physician relationship (partly driven by technology), narrowing scope of care, clinician burnout, and the challenges of implementing value-based care, to name a few. You see what comes next in the TABLE.3 The good news is that there is an alternative to the “natural” progression to the ending stage: the path of renewal.3

The 7 stages of organizational life

In the lifecycle of an organization, the path of renewal starts the cycle anew, with dreaming the dream. I recently had the opportunity to visit Singapore to learn about their health system. Singapore is one of the wealthiest countries in the world. I was impressed with their many innovations, including technological ones, as well as new models of care. However, I was most impressed that the country is betting big on family medicine. Their Ministry of Health has launched an initiative they are calling Healthier SG.7 The goal is for “all Singaporeans to have a trusted and lifelong relationship with [their] family doctor.” Their dream is to bring personal doctoring to everyone in the country to make Singapore healthier.

While their path of renewal is occurring halfway around the world, here at home, our path of renewal has been ignited over the past several years by the work of the Robert Graham Center; the Keystone Conferences; the American Board of Family Medicine; and the National Academies of Science, Engineering, and Medicine, among others.8-11 These organizations are aligning around re-centering on ­patient-clinician relationships, measuring what is important, care by interprofessional teams, payment reform, professionalism, health equity, improved information technology, and adherence to the best available evidence. We are working toward the solution shop as opposed to the production line.12 We are indeed dreaming a new dream.

While I write about this renewal, I close with an ending. This is the final issue of The Journal of Family Practice. It marks the end of an era of nearly 50 years of publication. The Journal of Family Practice has left a lasting mark, providing generations of clinicians with evidence-based, practical guidance to help care for patients as well as serving as an important venue for scholarly work by the family medicine community. Although I have had the privilege of serving the discipline as an editor-in-chief for only a brief time, I am grateful I had the opportunity. Most of all, I appreciate being on the journey of family medicine with you, renewing the dream together.

The references for this Editorial are available in the online version of the article at www.mdedge.com/familymedicine.

References

1. Fox TF. The personal doctor and his relation to the hospital. Observations and reflections on some American experiments in general practice by groups. Lancet. 1960;2:743-760.

2. Stephens, GG. The Intellectual Basis of Family Practice. Winter Publishing and Society of Teachers of Family Medicine; 1982.

3. Bridges W, Bridges S. Managing Transitions: Making the Most of Change. 4th ed. Da Capo Press; 2016.

4. Association of American Medical Colleges. Physician specialty data report. Accessed October 25, 2023. www.aamc.org/data-reports/workforce/data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2019

5. American Academy of Family Physicians. 2023 match results for family medicine. Accessed October 25, 2023. www.aafp.org/students-residents/residency-program-directors/national-resident-matching-program-results.html

6. Robert Graham Center. Primary Care in the US: A Chartbook of Facts and Statistics. Accessed October 25, 2023. www.graham-center.org/content/dam/rgc/documents/publications-reports/reports/PrimaryCareChartbook2021.pdf

7. Ministry of Health Singapore. What is Healthier SG? Accessed October 25, 2023. www.healthiersg.gov.sg/about/what-is-healthier-sg/

8. The Robert Graham Center. Accessed October 25, 2023. www.graham-center.org/home.html

9. Stange KC. Holding on and letting go: a perspective from the Keystone IV Conference. J Am Board Fam Med. 2016;29:S32-S39.

10. American Board of Family Medicine. Family medicine certification. Accessed October 25, 2023. www.theabfm.org/research-articles/family-medicine-certification?page=1

11. National Academies of Sciences, Engineering, and Medicine. Implementing high-quality primary care. Accessed October 25, 2023. www.nationalacademies.org/our-work/implementing-high-quality-primary-care

12. Sinsky CA, Panzer J. The solution shop and the production line—the case for a frameshift for physician practices. N Engl J Med. 2022;386:2452-2453.

References

1. Fox TF. The personal doctor and his relation to the hospital. Observations and reflections on some American experiments in general practice by groups. Lancet. 1960;2:743-760.

2. Stephens, GG. The Intellectual Basis of Family Practice. Winter Publishing and Society of Teachers of Family Medicine; 1982.

3. Bridges W, Bridges S. Managing Transitions: Making the Most of Change. 4th ed. Da Capo Press; 2016.

4. Association of American Medical Colleges. Physician specialty data report. Accessed October 25, 2023. www.aamc.org/data-reports/workforce/data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2019

5. American Academy of Family Physicians. 2023 match results for family medicine. Accessed October 25, 2023. www.aafp.org/students-residents/residency-program-directors/national-resident-matching-program-results.html

6. Robert Graham Center. Primary Care in the US: A Chartbook of Facts and Statistics. Accessed October 25, 2023. www.graham-center.org/content/dam/rgc/documents/publications-reports/reports/PrimaryCareChartbook2021.pdf

7. Ministry of Health Singapore. What is Healthier SG? Accessed October 25, 2023. www.healthiersg.gov.sg/about/what-is-healthier-sg/

8. The Robert Graham Center. Accessed October 25, 2023. www.graham-center.org/home.html

9. Stange KC. Holding on and letting go: a perspective from the Keystone IV Conference. J Am Board Fam Med. 2016;29:S32-S39.

10. American Board of Family Medicine. Family medicine certification. Accessed October 25, 2023. www.theabfm.org/research-articles/family-medicine-certification?page=1

11. National Academies of Sciences, Engineering, and Medicine. Implementing high-quality primary care. Accessed October 25, 2023. www.nationalacademies.org/our-work/implementing-high-quality-primary-care

12. Sinsky CA, Panzer J. The solution shop and the production line—the case for a frameshift for physician practices. N Engl J Med. 2022;386:2452-2453.

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Standing BP measures improve hypertension diagnosis

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TOPLINE:

Obtaining standing office blood pressure measurements improves detection of hypertension, either alone or when added to a seated BP reading, results of a new study suggest.

METHODOLOGY:

  • The study included 125 adults, mean age 49 years and 62% female, who were free of cardiovascular disease and had no previous history of hypertension.
  • Researchers collected data on 24-hour ambulatory blood pressure monitoring (ABPM), and three BP measurements in the seated position, then three in the standing position.
  • They assessed overall diagnostic accuracy of seated and standing BP using the area under the receiver operating characteristic (AUROC) curve and considered a Bayes factor (BF) of 3 or greater as significant.
  • They defined the presence of hypertension (HTN) by the 2017 American College of Cardiology/American Heart Association and 2023 European Society of Hypertension HTN guidelines based on ABPM.
  • Sensitivity and specificity of standing BP was determined using cutoffs derived from Youden index, while sensitivity and specificity of seated BP was determined using the cutoff of 130/80 mm Hg and by 140/90 mm Hg.

TAKEAWAY:

  • The AUROC for standing office systolic blood pressure (SBP; 0.81; 0.71-0.92) was significantly higher than for seated office SBP (0.70; 0.49-0.91) in diagnosing HTN when defined as an average 24-hour SBP ≥ 125 mm Hg (BF = 11.8), and significantly higher for seated versus standing office diastolic blood pressure (DBP; 0.65; 0.49-0.82) in diagnosing HTN when defined as an average 24-hour DBP ≥ 75 mm Hg (BF = 4.9).
  • The AUROCs for adding standing office BP to seated office BP improved the accuracy of detecting HTN, compared with seated office BP alone when HTN was defined as an average 24-hour SBP/DBP ≥ 125/75 mm Hg or daytime SBP/DBP ≥ 130/80 mm Hg, or when defined as an average 24-hour SBP/DBP ≥ 130/80 mm Hg or daytime SBP/DBP ≥ 135/85 mm Hg (all BFs > 3).
  • Sensitivity of standing SBP was 71%, compared with 43% for seated SBP.

IN PRACTICE:

The “excellent diagnostic performance” for standing BP measures revealed by the study “highlights that standing office BP has acceptable discriminative capabilities in identifying the presence of hypertension in adults,” the authors write.

SOURCE:

The study was conducted by John M. Giacona, Hypertension Section, department of internal medicine, University of Texas Southwestern Medical Center, Dallas, and colleagues. It was published online in Scientific Reports.

LIMITATIONS:

As the study enrolled only adults free of comorbidities who were not taking antihypertensive medications, the results may not be applicable to other patients. The study design was retrospective, and the order of BP measurements was not randomized (standing BP measurements were obtained only after seated BP).

DISCLOSURES:

The study was supported by the National Institutes of Health. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

Obtaining standing office blood pressure measurements improves detection of hypertension, either alone or when added to a seated BP reading, results of a new study suggest.

METHODOLOGY:

  • The study included 125 adults, mean age 49 years and 62% female, who were free of cardiovascular disease and had no previous history of hypertension.
  • Researchers collected data on 24-hour ambulatory blood pressure monitoring (ABPM), and three BP measurements in the seated position, then three in the standing position.
  • They assessed overall diagnostic accuracy of seated and standing BP using the area under the receiver operating characteristic (AUROC) curve and considered a Bayes factor (BF) of 3 or greater as significant.
  • They defined the presence of hypertension (HTN) by the 2017 American College of Cardiology/American Heart Association and 2023 European Society of Hypertension HTN guidelines based on ABPM.
  • Sensitivity and specificity of standing BP was determined using cutoffs derived from Youden index, while sensitivity and specificity of seated BP was determined using the cutoff of 130/80 mm Hg and by 140/90 mm Hg.

TAKEAWAY:

  • The AUROC for standing office systolic blood pressure (SBP; 0.81; 0.71-0.92) was significantly higher than for seated office SBP (0.70; 0.49-0.91) in diagnosing HTN when defined as an average 24-hour SBP ≥ 125 mm Hg (BF = 11.8), and significantly higher for seated versus standing office diastolic blood pressure (DBP; 0.65; 0.49-0.82) in diagnosing HTN when defined as an average 24-hour DBP ≥ 75 mm Hg (BF = 4.9).
  • The AUROCs for adding standing office BP to seated office BP improved the accuracy of detecting HTN, compared with seated office BP alone when HTN was defined as an average 24-hour SBP/DBP ≥ 125/75 mm Hg or daytime SBP/DBP ≥ 130/80 mm Hg, or when defined as an average 24-hour SBP/DBP ≥ 130/80 mm Hg or daytime SBP/DBP ≥ 135/85 mm Hg (all BFs > 3).
  • Sensitivity of standing SBP was 71%, compared with 43% for seated SBP.

IN PRACTICE:

The “excellent diagnostic performance” for standing BP measures revealed by the study “highlights that standing office BP has acceptable discriminative capabilities in identifying the presence of hypertension in adults,” the authors write.

SOURCE:

The study was conducted by John M. Giacona, Hypertension Section, department of internal medicine, University of Texas Southwestern Medical Center, Dallas, and colleagues. It was published online in Scientific Reports.

LIMITATIONS:

As the study enrolled only adults free of comorbidities who were not taking antihypertensive medications, the results may not be applicable to other patients. The study design was retrospective, and the order of BP measurements was not randomized (standing BP measurements were obtained only after seated BP).

DISCLOSURES:

The study was supported by the National Institutes of Health. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Obtaining standing office blood pressure measurements improves detection of hypertension, either alone or when added to a seated BP reading, results of a new study suggest.

METHODOLOGY:

  • The study included 125 adults, mean age 49 years and 62% female, who were free of cardiovascular disease and had no previous history of hypertension.
  • Researchers collected data on 24-hour ambulatory blood pressure monitoring (ABPM), and three BP measurements in the seated position, then three in the standing position.
  • They assessed overall diagnostic accuracy of seated and standing BP using the area under the receiver operating characteristic (AUROC) curve and considered a Bayes factor (BF) of 3 or greater as significant.
  • They defined the presence of hypertension (HTN) by the 2017 American College of Cardiology/American Heart Association and 2023 European Society of Hypertension HTN guidelines based on ABPM.
  • Sensitivity and specificity of standing BP was determined using cutoffs derived from Youden index, while sensitivity and specificity of seated BP was determined using the cutoff of 130/80 mm Hg and by 140/90 mm Hg.

TAKEAWAY:

  • The AUROC for standing office systolic blood pressure (SBP; 0.81; 0.71-0.92) was significantly higher than for seated office SBP (0.70; 0.49-0.91) in diagnosing HTN when defined as an average 24-hour SBP ≥ 125 mm Hg (BF = 11.8), and significantly higher for seated versus standing office diastolic blood pressure (DBP; 0.65; 0.49-0.82) in diagnosing HTN when defined as an average 24-hour DBP ≥ 75 mm Hg (BF = 4.9).
  • The AUROCs for adding standing office BP to seated office BP improved the accuracy of detecting HTN, compared with seated office BP alone when HTN was defined as an average 24-hour SBP/DBP ≥ 125/75 mm Hg or daytime SBP/DBP ≥ 130/80 mm Hg, or when defined as an average 24-hour SBP/DBP ≥ 130/80 mm Hg or daytime SBP/DBP ≥ 135/85 mm Hg (all BFs > 3).
  • Sensitivity of standing SBP was 71%, compared with 43% for seated SBP.

IN PRACTICE:

The “excellent diagnostic performance” for standing BP measures revealed by the study “highlights that standing office BP has acceptable discriminative capabilities in identifying the presence of hypertension in adults,” the authors write.

SOURCE:

The study was conducted by John M. Giacona, Hypertension Section, department of internal medicine, University of Texas Southwestern Medical Center, Dallas, and colleagues. It was published online in Scientific Reports.

LIMITATIONS:

As the study enrolled only adults free of comorbidities who were not taking antihypertensive medications, the results may not be applicable to other patients. The study design was retrospective, and the order of BP measurements was not randomized (standing BP measurements were obtained only after seated BP).

DISCLOSURES:

The study was supported by the National Institutes of Health. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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Essential oils: How safe? How effective?

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Essential oils: How safe? How effective?

Essential oils (EOs), which are concentrated plant-based oils, have become ubiquitous over the past decade. ­Given the far reach of EOs and their longtime use in traditional, complementary, alternative, and integrative medicine, it is imperative that clinicians have some knowledge of the potential benefits, risks, and overall efficacy.

Commonly used for aromatic benefits (aromatherapy), EOs are now also incorporated into a multitude of products promoting health and wellness. EOs are sold as individual products and can be a component in consumer goods such as cosmetics, body care/hygiene/beauty products, laundry detergents, insect repellents, over-the-counter medications, and food.

It is important to read ingredient labels before purchasing an essential oil. Reputable companies will identify the plant ingredient, usually by the formal Latin binomial name, and explain the extraction process.

The review that follows presents the most current evidence available. With that said, it’s important to keep in mind some caveats that relate to this evidence. First, the studies cited tend to have a small sample size. Second, a majority of these studies were conducted in countries where there appears to be a significant culture of EO use, which could contribute to confirmation bias. Finally, in a number of the studies, there is concern for publication bias as well as a discrepancy between calculated statistical significance and actual clinical relevance.

Essential oils

What are essential oils?

EOs generally are made by extracting the oil from leaves, bark, flowers, seeds/fruit, rinds, and/or roots by steaming or pressing parts of a plant. It can take several pounds of plant material to produce a single bottle of EO, which usually contains ≥ 15 to 30 mL (.5 to 1 oz).1

Some commonly used EOs in the United States are lavender, peppermint, rose, clary sage, tea tree, eucalyptus, and citrus; however, there are approximately 300 EOs available.2 EOs are used most often via topical application, inhalation, or ingestion.

As with any botanical agent, EOs are complex substances often containing a multitude of chemical compounds.1 Because of the complex makeup of EOs, which often contain up to 100 volatile organic compounds, and their wide-ranging potential effects, applying the scientific method to study effectiveness poses a challenge that has limited their adoption in evidence-based practice.2

Availability and cost. EOs can be purchased at large retailers (eg, grocery stores, drug stores) and smaller health food stores, as well as on the Internet. Various EO vehicles, such as inhalers and topical creams, also can be purchased at these stores.

Continue to: The cost varies...

 

 

The cost varies enormously by manufacturer and type of plant used to make the EO. Common EOs such as peppermint and lavender oil generally cost $10 to $25, while rarer plant oils can cost $80 or more per bottle.

How safe are essential oils?

Patients may assume EOs are harmless because they are derived from natural plants and have been used medicinally for centuries. However, care must be taken with their use.

The safest way to use EOs is topically, although due to their highly concentrated nature, EOs should be diluted in an unscented neutral carrier oil such as coconut, jojoba, olive, or sweet almond.3 Ingestion of certain oils can cause hepatotoxicity, seizures, and even death.3 In fact, patients should speak with a knowledgeable physician before purchasing any oral EO capsules.

Whether used topically or ingested, all EOs carry risk for skin irritation and allergic reactions, and oral ingestion may result in some negative gastrointestinal (GI) adverse effects.4 A case report of 3 patients published in 2007 identified the potential for lavender and tea tree EOs to be endocrine disruptors.5

Inhalation of EOs may be harmful, as they emit many volatile organic compounds, some of which are considered potentially hazardous.6 At this time, there is insufficient evidence regarding inhaled EOs and their direct connection to respiratory health. It is reasonable to suggest, however, that the prolonged use of EOs and their use by patients who have lung conditions such as asthma or COPD should be avoided.7

Continue to: How are quality and purity assessed?

 

 

How are quality and purity assessed?

Like other dietary supplements, EOs are not regulated. No US regulatory agencies (eg, the US Food and Drug Administration [FDA] or Department of Agriculture [USDA]) certify or approve EOs for quality and purity. Bottles labeled with “QAI” for Quality Assurance International or “USDA Organic” will ensure the plant constituents used in the EO are from organic farming but do not attest to quality or purity.

Essential oils are one of the nonpharmacologic modalities that patients and clinicians have at their disposal for adjunctive treatment of migraine and tension-type headaches.

Manufacturers commonly use marketing terms such as “therapeutic grade” or “pure” to sell products, but again, these terms do not reflect the product’s quality or purity. A labeled single EO may contain contaminants, alcohol, or additional ingredients.7 When choosing to use EOs, identifying reputable brands is essential; one resource is the independent testing organization ConsumerLab.com.

It is important to assess the manufacturer and read ingredient labels before purchasing an EO to understand what the product contains. Reputable companies will identify the plant ingredient, usually by the formal Latin binomial name, and explain the extraction process. A more certain way to assess the quality and purity of an EO is to ask the manufacturer to provide a certificate of analysis and gas chromatography/mass spectroscopy (GC/MS) data for the specific product. Some manufacturers offer GC/MS test results on their website Quality page.8 Others have detailed information on quality and testing, and GC/MS test reports can be obtained.9 Yet another manufacturer has test results on a product page matching reports to batch codes.10

Which conditions have evidence of benefit from essential oils?

EOs currently are being studied for treatment of many conditions—including pain, GI disorders, behavioral health disorders, and women’s health issues. The TABLE summarizes the conditions treated, outcomes, and practical applications of EOs.11-44

Summary of essential oil uses, routes, and recommendations

Pain

Headache. As an adjunct to available medications and procedures for headache treatment, EOs are one of the nonpharmacologic modalities that patients and clinicians have at their disposal for both migraine and ­tension-type headaches. A systematic review of 19 randomized controlled trials (RCTs) examining the effects of herbal ingredients for the acute treatment or prophylaxis of migraines found certain topically applied or inhaled EOs, such as peppermint and chamomile, to be effective for migraine pain alleviation; however, topically applied rose oil was not effective.11-13 Note: “topical application” in these studies implies application of the EO to ≥ 1 of the following areas: temples, forehead, behind ears, or above upper lip/below the nose.

Continue to: One RCT with 120 patients...

 

 

One RCT with 120 patients evaluated diluted intranasal peppermint oil and found that it reduced migraine intensity at similar rates to intranasal lidocaine.13 In this study, patients were randomized to receive one of the following: 4% lidocaine, 1.5% peppermint EO, or placebo. Two drops of the intranasal intervention were self-administered while the patient was in a supine position with their head suspended off the edge of the surface on which they were lying. They were instructed to stay in this position for at least 30 seconds after administration.

With regard to tension headache treatment, there is limited literature on the use of EOs. One study found that a preparation of peppermint oil applied topically to the temples and forehead of study participants resulted in significant analgesic effect.14

Fibromyalgia. Usual treatments for fibromyalgia include exercise, antidepressant and anticonvulsant medications, and stress management. Evidence also supports the use of inhaled and topically applied (with and without massage) lavender oil to improve symptoms.26 Positive effects may be related to the anal­gesic, anti-­inflammatory, sleep-regulating,­ and anxiety­-reducing effects of the major volatile compounds contained in lavender oil.

In one RCT with 42 patients with fibromyalgia, the use of inhaled lavender oil was shown to increase the perception of well-­being (assessed on the validated SF-36 Health Survey Questionnaire) after 4 weeks.27 In this study, the patient applied 3 drops of an oil mixture, comprising 1 mL lavender EO and 10 mL of fixed neutral base oil, to the wrist and inhaled for 10 minutes before going to bed.

The use of a topical oil blend labeled “Oil 24” (containing camphor, rosemary, eucalyptus, peppermint, aloe vera, and lemon/orange) also has been shown to be more effective than placebo in managing fibromyalgia symptoms. A randomized controlled pilot study of 153 participants found that regular application of Oil 24 improved scores on pain scales and the Fibromyalgia Impact Questionnaire.28

Continue to: GI disorders

 

 

GI disorders

Irritable bowel syndrome. Peppermint oil relaxes GI smooth muscle, which has led to investigation of its use in irritable bowel ­syndrome (IBS) symptom amelioration.17 One meta-analysis including 12 RCTs with 835 patients with undifferentiated IBS found that orally ingested peppermint EO capsules reduced patient-reported symptoms of either abdominal pain or global symptoms.18

One study utilized the Total IBS Symptom Score to evaluate symptom reduction in patients with IBS-D (with diarrhea) and IBS-M (mixed) using 180-mg peppermint EO capsules ingested 3 times daily. There was a significant improvement in abdominal pain/discomfort, bloating/distension, pain at evacuation, and bowel urgency.19 A reduction in symptoms was observed after the first 24 hours of treatment and at the end of the 4-week treatment period.

In another study, among the 190 patients meeting Rome IV criteria for general (nonspecific) IBS who were treated with 182-mg peppermint EO capsules, no statistically significant reduction in overall symptom relief was found (based on outcome measures by the FDA and European Medicines Agency). However, in a secondary outcome analysis, peppermint oil produced greater improvements than placebo for the alleviation of abdominal pain, discomfort, and general IBS severity.20

Chemotherapy-induced nausea and vomiting. Patients with cancer undergoing chemotherapy often explore integrative medicine approaches, including aromatherapy, to ameliorate adverse effects and improve quality of life.38 A few small studies have shown potential for the use of inhaled ginger oil to reduce nausea and vomiting severity and improve health-related quality-of-life measures in these patients.

Evidence supports the use of inhaled and topically applied lavender oil to improve fibromyalgia symptoms.

For example, a study with 60 participants found that inhaling ginger EO for 10 minutes was beneficial for reducing both nausea and vomiting.39 A single-blind, controlled, ­randomized crossover study of 60 patients with breast cancer receiving chemotherapy showed that ginger EO inhaled 3 times per day for 2 minutes at a time can decrease the severity of nausea but had no effect on vomiting. The same study showed that health-­related quality of life improved with the ginger oil treatment.40

Continue to: Other EOs such as cardamom...

 

 

Other EOs such as cardamom and peppermint show promise as an adjunctive treatment for chemotherapy-induced nausea and vomiting as well.38

Postoperative nausea. A 2013 randomized trial of 303 patients examined the use of ginger EO, a blend of EOs (including ginger, spearmint, peppermint, and cardamom), and isopropyl alcohol. Both the single EO and EO blend significantly reduced the symptom of nausea. The number of antiemetic medications requested by patients receiving an EO also was significantly reduced compared to those receiving saline.15

The use of EOs to reduce nausea after cardiac operations was reviewed in an RCT of 60 surgical candidates using 10% peppermint oil via nebulization for 10 minutes.16 This technique was effective in reducing nausea during cardiac postoperative periods. Although the evidence for the use of EOs for postoperative nausea is not robust, it may be a useful and generally safe approach for this common issue.

 

Behavioral health

Insomnia. EOs have been used as a treatment for insomnia traditionally and in complementary, alternative, and integrative medicine. A 2014 systematic review of 15 quantitative studies, including 11 RCTs, evaluated the hypnotic effects of EOs through inhalation, finding the strongest evidence for lavender, jasmine, and peppermint oils.29 The majority of the studies in the systematic review used the Pittsburgh Sleep Quality Index (PSQI) to evaluate EO effectiveness. A more recent 2021 systematic review and meta-analysis that evaluated 34 RCTs found that inhalation of EOs, most notably lavender aromatherapy, is effective in improving sleep problems such as insomnia.30

Findings from multiple smaller RCTs were consistent with those of the aforementioned systematic reviews. For example, in a well-conducted parallel randomized double-blind placebo-controlled trial of 100 people using orally ingested lemon verbena, the authors concluded that this intervention can be a complementary therapy for improving sleep quality and reducing insomnia severity.31 Another RCT with 60 participants evaluated an inhaled EO blend (lemon, eucalyptus, tea tree, and peppermint) over 4 weeks and found lowered perceived stress and depression as well as better sleep quality, but no influence on objective physiologic data such as stress indices or immune states.32

Continue to: In a 2020 randomized crossover...

 

 

In a 2020 randomized crossover placebo­controlled trial of 37 participants with diabetes reporting insomnia, inhaled lavender improved sleep quality and quantity, quality of life, and mood but not physiologic or metabolic measures, such as fasting glucose.33 Findings were similar in a cohort of cardiac rehabilitation patients (n = 37) who were treated with either an inhaled combination of lavender, bergamot, and ylang ylang, or placebo; cotton balls infused with the intervention oil or placebo oil were placed at the patient’s bedside for 5 nights. Sleep quality of participants receiving intervention oil was significantly better than the sleep quality of participants receiving the placebo oil as measured by participant completion of the PSQI.34

Anxiety is a common disorder that can be managed with nonpharmacologic treatments such as yoga, deep breathing, meditation, and EO therapy.21,22 In a systematic review and meta-analysis, the inhaled and topical use (with or without massage) of lavender EO was shown to improve psychological and physical manifestations of anxiety.23 Lavender EO is purported to affect the parasympathetic nervous system via anxiolytic, sedative, analgesic, and anticonvulsant properties.24 One systematic review and meta-analysis evaluating the anxiolytic effect of both inhaled and topical lavender EO found improvement in several biomarkers and physiologic data including blood pressure, heart rate, and cortisol levels, as well as a reduction in self-reported levels of anxiety, compared with placebo.25

Anxiety related to dental procedures is another area of study for the use of EOs. Two RCTs demonstrate statistically significant improvement in anxiety-related physiologic markers such as heart rate, blood pressure, and salivary cortisol levels in children who inhaled lavender EO during dental procedures.41,42 In 1 of the RCTs, the intervention was described as 3 drops of 100% lavender EO applied to a cloth and inhaled over the course of 3 minutes.41 Additionally, 2 studies found that orange EO was beneficial for dental procedure–induced anxiety, reducing pulse rates, cortisol levels, and self-reported anxiety.43,44

Dementia-related behavioral disturbances. A small, poorly designed study examining 2 EO blends—rosemary with lemon and lavender with orange—found some potential for improving cognitive function, especially in patients with Alzheimer disease.45 A Cochrane review of 13 RCTs totaling 708 patients concluded that it is not certain from the available evidence that EO therapy benefits patients with dementia in long-term-care facilities and hospital wards.46 Given that reporting of adverse events in the trials was poor, it is not possible to make conclusions about the risk vs benefit of EO therapy in this population.

Women’s health

Dysmenorrhea. Interest has grown in the use of EOs for dysmenorrhea symptom relief, and there is a small body of evidence demonstrating that a variety of oils—most notably lavender, rose, and clary sage—may reduce symptom severity. One meta-analysis of 9 RCTs and 12 controlled clinical trials including women with moderate-to-severe dysmenorrhea found that inhaled and/or topical use of singular or mixed lavender, clary sage, rose, marjoram, and cinnamon EOs demonstrated the strongest evidence of effectiveness in reducing menstrual cramping.35

Continue to: In a randomized, double-blind clinical trial...

 

 

Use of an inhaled blend of lemon, eucalyptus, tea tree, and peppermint was associated with lower perceived stress and depression as well as better sleep quality.

In a randomized, double-blind clinical trial of 48 women, a cream-based blend of lavender, clary sage, and marjoram EO (used topically in a 2:1:1 ratio diluted in unscented cream at 3% concentration and applied daily via abdominal massage) reduced participants’ reported menstrual pain symptoms and duration of pain.36 In a meta-analysis of 6 studies, topical abdominal application of EO (mainly lavender with or without other oils) with massage showed superiority over massage with placebo oils in reducing menstrual pain.37 A reduction in pain, mood symptoms, and fatigue in women with premenstrual symptoms was seen in an RCT of 77 patients using 3 drops of inhaled lavender EO.47

Labor. There is limited evidence for the use of EOs during labor. In an RCT of 104 women, patient-selected diffused EOs, including lavender, rose geranium, citrus, or jasmine, were found to help lower pain scores during the latent and early active phase of labor. There were no differences in labor augmentation, length of labor, perinatal outcomes, or need for additional pain medication.48

 

Other uses

Antimicrobial support. Some common EOs that have demonstrated antimicrobial properties are oregano, thyme, clove, lavender, clary sage, garlic, and cinnamon.49,50 Topical lemongrass and tea tree EOs have shown some degree of efficacy as an alternative treatment for acne, decolonization of methicillin-resistant Staphylococcus aureus, and superficial fungal infections.51 Support for an oral mixture of EOs labeled Myrtol (containing eucalyptus, citrus myrtle, and lavender) for viral acute bronchitis and sinusitis was found in a review of 7 studies.52 More research needs to be done before clear recommendations can be made on the use of EOs as antimicrobials, but the current data are encouraging.

Insect repellent. Reviews of the ­insect-repellent properties of EOs have shown promise and are in the public’s interest due to increasing awareness of the potential health and environmental hazards of synthetic repellents.53 Individual compounds present in EOs such as citronella/lemongrass, basil, and eucalyptus species demonstrate high repellent activity.54 Since EOs require frequent reapplication for efficacy due to their highly volatile nature, scientists are currently developing a means to prolong their protection time through cream-based formulations.55

The bottom line

Because of the ubiquity of EOs, family physicians will undoubtedly be asked about them by patients, and it would be beneficial to feel comfortable discussing their most common uses. For most adult patients, the topical and periodic inhaled usage of EOs is generally safe.56

There is a small body of evidence demonstrating that a variety of essential oils, most notably lavender, rose, and clary sage, may reduce dysmenorrhea symptom severity.

There is existing evidence of efficacy for a number of EOs, most strongly for lavender and peppermint. Future research into EOs should include higher-powered and higher-­quality studies in order to provide more conclusive evidence regarding the continued use of EOs for many common conditions. More evidence-based information on dosing, application/use regimens, and safety in long-term use also will help providers better instruct patients on how to utilize EOs effectively and safely. 

CORRESPONDENCE
Pooja Amy Shah, MD, Columbia University College of Physicians & Surgeons, 610 West 158th Street, New York, NY 10032; pas2176@cumc.columbia.edu

References

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2. Singh B, Sellam P, Majumder, J, et al. Floral essential oils : importance and uses for mankind. HortFlora Res Spectr. 2014;3:7-13. www.academia.edu/6707801/Floral_essential_oils_Importance_and_uses_for_mankind

3. Posadzki P, Alotaibi A, Ernst E. Adverse effects of aromatherapy: a systematic review of case reports and case series. Int J Risk Saf Med. 2012;24:147-161. doi: 10.3233/JRS-2012-0568

4. Sharmeen JB, Mahomoodally FM, Zengin G, et al. Essential oils as natural sources of fragrance compounds for cosmetics and cosmeceuticals. Molecules. 2021;26:666. doi: 10.3390/molecules26030666

5. Henley DV, Lipson N, Korach KS, et al. Prepubertal gynecomastia linked to lavender and tea tree oils. N Engl J Med. 2007;356:479-485. doi: 10.1056/NEJMoa064725

6. Nematollahi N, Weinberg JL, Flattery J, et al. Volatile chemical emissions from essential oils with therapeutic claims. Air Qual Atmosphere Health. 2021;14:365-369. doi: 10.1007/s11869-020-00941-4

7. Balekian D, Long A. Essential oil diffusers and asthma. Published February 24, 2020. Accessed September 22, 2023. www.aaaai.org/Allergist-Resources/Ask-the-Expert/Answers/Old-Ask-the-Experts/oil-diffusers-asthma

8. Aura Cacia. Quality. Accessed September 22, 2023. www.auracacia.com/quality

9. Now. Essential oil identity & purity testing. Accessed September 22, 2023. www.nowfoods.com/quality-safety/essential-oil-­identity-purity-testing

10. Aura Cacia. GCMS documents. Accessed September 22, 2023. www.auracacia.com/aura-cacia-gcms-documents

11. Lopresti AL, Smith SJ, Drummond PD. Herbal treatments for migraine: a systematic review of randomised-controlled studies. Phytother Res. 2020;34:2493-2517. doi: 10.1002/ptr.6701

12. Niazi M, Hashempur MH, Taghizadeh M, et al. Efficacy of topical Rose (Rosa damascena Mill.) oil for migraine headache: A randomized double-blinded placebo-controlled cross-over trial. Complement Ther Med. 2017;34:35-41. doi: 10.1016/j.ctim. 2017.07.009

13. Rafieian-Kopaei M, Hasanpour-Dehkordi A, Lorigooini Z, et al. Comparing the effect of intranasal lidocaine 4% with peppermint essential oil drop 1.5% on migraine attacks: a double-blind clinical trial. Int J Prev Med. 2019;10:121. doi: 10.4103/ijpvm.IJPVM_530_17

14. Göbel H, Fresenius J, Heinze A, et al. [Effectiveness of Oleum menthae piperitae and paracetamol in therapy of headache of the tension type]. Nervenarzt. 1996;67:672-681. doi: 10.1007/s001150050040

15. Hunt R, Dienemann J, Norton HJ, et al. Aromatherapy as treatment for postoperative nausea: a randomized trial. Anesth Analg. 2013;117:597-604. doi: 10.1213/ANE.0b013e31824a0b1c

16. Maghami M, Afazel MR, Azizi-Fini I, et al. The effect of aromatherapy with peppermint essential oil on nausea and vomiting after cardiac surgery: a randomized clinical trial. Complement Ther Clin Pract. 2020;40:101199. doi: 10.1016/j.ctcp.2020.101199

17. Hills JM, Aaronson PI. The mechanism of action of peppermint oil on gastrointestinal smooth muscle. An analysis using patch clamp electrophysiology and isolated tissue pharmacology in rabbit and guinea pig. Gastroenterology. 1991;101:55-65. doi: 10.1016/0016-5085(91)90459-x

18. Alammar N, Wang L, Saberi B, et al. The impact of peppermint oil on the irritable bowel syndrome: a meta-analysis of the pooled clinical data. BMC Complement Altern Med. 2019;19:21. doi: 10.1186/s12906-018-2409-0

19. Cash BD, Epstein MS, Shah SM. A novel delivery system of peppermint oil is an effective therapy for irritable bowel syndrome symptoms. Dig Dis Sci. 2016;61:560-571. doi: 10.1007/s10620-015-3858-7

20. Weerts ZZRM, Masclee AAM, Witteman BJM, et al. Efficacy and safety of peppermint oil in a randomized, double-blind trial of patients with irritable bowel syndrome. Gastroenterology. 2020;158:123-136. doi: 10.1053/j.gastro.2019.08.026

21. Ma X, Yue ZQ, Gong ZQ, et al. The effect of diaphragmatic breathing on attention, negative affect and stress in healthy adults. Front Psychol. 2017;8:874. doi: 10.3389/fpsyg.2017.00874

22. Cabral P, Meyer HB, Ames D. Effectiveness of yoga therapy as a complementary treatment for major psychiatric disorders: a meta­-analysis. Prim Care Companion CNS Disord. Published July 7, 2011. doi: 10.4088/PCC.10r01068

23. Donelli D, Antonelli M, Bellinazzi C, et ala. Effects of lavender on anxiety: systematic review and meta-analysis. Phytomedicine Int J Phytother Phytopharm. 2019;65:153099. doi: 10.1016/j.phymed.2019.153099

24. Koulivand PH, Khaleghi Ghadiri M, Gorji A. Lavender and the nervous system. Evid Based Complement Alternat Med. 2013;2013:1-10. doi: 10.1155/2013/681304

25. Kang HJ, Nam ES, Lee Y, et al. How strong is the evidence for the anxiolytic efficacy of lavender? Systematic review and meta-­analysis of randomized controlled trials. Asian Nurs Res. 2019;13:295-305. doi: 10.1016/j.anr.2019.11.003

26. Barão Paixão VL, Freire de Carvalho J. Essential oil therapy in rheumatic diseases: a systematic review. Complement Ther Clin Pract. 2021;43:101391. doi: 10.1016/j.ctcp.2021.101391

27. Yasa Ozturk G, Bashan I. The effect of aromatherapy with lavender oil on the health-related quality of life in patients with fibromyalgia. J Food Qual. 2021;2021:1-5. doi: 10.1155/2021/9938630

28. Ko GD, Hum A, Traitses G, et al. Effects of topical O24 essential oils on patients with fibromyalgia syndrome: a randomized, placebo controlled pilot study. J Musculoskelet Pain. 2007;15:11-19. doi: 10.1300/J094v15n01_03

29. Lillehei AS, Halcon LL. A systematic review of the effect of inhaled essential oils on sleep. J Altern Complement Med. 2014;20:441-451. doi: 10.1089/acm.2013.0311

30. Cheong MJ, Kim S, Kim JS, et al. A systematic literature review and meta-analysis of the clinical effects of aroma inhalation therapy on sleep problems. Medicine (Baltimore). 2021;100:e24652. doi: 10.1097/MD.0000000000024652

31. Afrasiabian F, Mirabzadeh Ardakani M, Rahmani K, et al. Aloysia citriodora Paláu (lemon verbena) for insomnia patients: a randomized, double-blind, placebo-controlled clinical trial of efficacy and safety. Phytother Res PTR. 2019;33:350-359. doi: 10.1002/ptr.6228

32. Lee M, Lim S, Song JA, et al. The effects of aromatherapy essential oil inhalation on stress, sleep quality and immunity in healthy adults: randomized controlled trial. Eur J Integr Med. 2017;12:79-86. doi: 10.1016/j.eujim.2017.04.009

33. Nasiri Lari Z, Hajimonfarednejad M, Riasatian M, et al. Efficacy of inhaled Lavandula angustifolia Mill. Essential oil on sleep quality, quality of life and metabolic control in patients with diabetes mellitus type II and insomnia. J Ethnopharmacol. 2020;251:112560. doi: 10.1016/j.jep.2020.112560

34. McDonnell B, Newcomb P. Trial of essential oils to improve sleep for patients in cardiac rehabilitation. J Altern Complement Med N Y N. 2019;25:1193-1199. doi: 10.1089/acm.2019.0222

35. Song JA, Lee MK, Min E, et al. Effects of aromatherapy on dysmenorrhea: a systematic review and meta-analysis. Int J Nurs Stud. 2018;84:1-11. doi: 10.1016/j.ijnurstu.2018.01.016

36. Ou MC, Hsu TF, Lai AC, et al. Pain relief assessment by aromatic essential oil massage on outpatients with primary dysmenorrhea: a randomized, double-blind clinical trial: PD pain relief by aromatic oil massage. J Obstet Gynaecol Res. 2012;38:817-822. doi: 10.1111/j.1447-0756.2011.01802.x

37. Sut N, Kahyaoglu-Sut H. Effect of aromatherapy massage on pain in primary dysmenorrhea: a meta-analysis. Complement Ther Clin Pract. 2017;27:5-10. doi: 10.1016/j.ctcp.2017.01.001

38. Keyhanmehr AS, Kolouri S, Heydarirad G, et al. Aromatherapy for the management of cancer complications: a narrative review. Complement Ther Clin Pract. 2018;31:175-180. doi: 10.1016/j.ctcp.2018.02.009

39. Sriningsih I, Elisa E, Lestari KP. Aromatherapy ginger use in patients with nausea & vomiting on post cervical cancer chemotherapy. KEMAS J Kesehat Masy. 2017;13:59-68. doi: 10.15294/kemas.v13i1.5367

40. Lua PL, Salihah N, Mazlan N. Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer. Complement Ther Med. 2015;23:396-404. doi: 10.1016/j.ctim.2015.03.009

41. Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020;179:985-992. doi: 10.1007/s00431-020-03595-7

42. Ghaderi F, Solhjou N. The effects of lavender aromatherapy on stress and pain perception in children during dental treatment: a randomized clinical trial. Complement Ther Clin Pract. 2020;40:101182. doi: 10.1016/j.ctcp.2020.101182

43. Jafarzadeh M, Arman S, Pour FF. Effect of aromatherapy with orange essential oil on salivary cortisol and pulse rate in children during dental treatment: a randomized controlled clinical trial. Adv Biomed Res. 2013;2:10. doi: 10.4103/2277-9175.107968

44. Lehrner J, Eckersberger C, Walla P, et al. Ambient odor of orange in a dental office reduces anxiety and improves mood in female patients. Physiol Behav. 2000;71:83-86. doi: 10.1016/S0031-9384(00)00308-5

45. Jimbo D, Kimura Y, Taniguchi M, et al. Effect of aromatherapy on patients with Alzheimer’s disease. Psychogeriatrics. 2009;9:173-179. doi: 10.1111/j.1479-8301.2009.00299.x

46. Ball EL, Owen-Booth B, Gray A, et al. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020;(8). doi: 10.1002/14651858.CD003150.pub3

47. Uzunçakmak T, Ayaz Alkaya S. Effect of aromatherapy on coping with premenstrual syndrome: a randomized controlled trial. Complement Ther Med. 2018;36:63-67. doi: 10.1016/j.ctim.2017.11.022

48. Tanvisut R, Traisrisilp K, Tongsong T. Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial. Arch Gynecol Obstet. 2018;297:1145-1150. doi: 10.1007/s00404-018-4700-1

49. Ramsey JT, Shropshire BC, Nagy TR, et al. Essential oils and health. Yale J Biol Med. 2020;93:291-305.

50. Puškárová A, Bučková M, Kraková L, et al. The antibacterial and antifungal activity of six essential oils and their cyto/genotoxicity­ to human HEL 12469 cells. Sci Rep. 2017;7:8211. doi: 10.1038/s41598-017-08673-9

51. Deyno S, Mtewa AG, Abebe A, et al. Essential oils as topical anti-infective agents: a systematic review and meta-analysis. Complement Ther Med. 2019;47:102224. doi: 10.1016/j.ctim.2019.102224

52. Prall S, Bowles EJ, Bennett K, et al. Effects of essential oils on symptoms and course (duration and severity) of viral respiratory infections in humans: a rapid review. Adv Integr Med. 2020;7:218-221. doi: 10.1016/j.aimed.2020.07.005

53. Weeks JA, Guiney PD, Nikiforov AI. Assessment of the environmental fate and ecotoxicity of N,N-diethyl-m-toluamide (DEET). Integr Environ Assess Manag. 2012;8:120-134. doi: 10.1002/ieam.1246

54. Nerio LS, Olivero-Verbel J, Stashenko E. Repellent activity of essential oils: a review. Bioresour Technol. 2010;101:372-378. doi: 10.1016/j.biortech.2009.07.048

55. Lee MY. Essential oils as repellents against arthropods. BioMed Res Int. 2018;2018:6860271. doi: 10.1155/2018/6860271

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Essential oils (EOs), which are concentrated plant-based oils, have become ubiquitous over the past decade. ­Given the far reach of EOs and their longtime use in traditional, complementary, alternative, and integrative medicine, it is imperative that clinicians have some knowledge of the potential benefits, risks, and overall efficacy.

Commonly used for aromatic benefits (aromatherapy), EOs are now also incorporated into a multitude of products promoting health and wellness. EOs are sold as individual products and can be a component in consumer goods such as cosmetics, body care/hygiene/beauty products, laundry detergents, insect repellents, over-the-counter medications, and food.

It is important to read ingredient labels before purchasing an essential oil. Reputable companies will identify the plant ingredient, usually by the formal Latin binomial name, and explain the extraction process.

The review that follows presents the most current evidence available. With that said, it’s important to keep in mind some caveats that relate to this evidence. First, the studies cited tend to have a small sample size. Second, a majority of these studies were conducted in countries where there appears to be a significant culture of EO use, which could contribute to confirmation bias. Finally, in a number of the studies, there is concern for publication bias as well as a discrepancy between calculated statistical significance and actual clinical relevance.

Essential oils

What are essential oils?

EOs generally are made by extracting the oil from leaves, bark, flowers, seeds/fruit, rinds, and/or roots by steaming or pressing parts of a plant. It can take several pounds of plant material to produce a single bottle of EO, which usually contains ≥ 15 to 30 mL (.5 to 1 oz).1

Some commonly used EOs in the United States are lavender, peppermint, rose, clary sage, tea tree, eucalyptus, and citrus; however, there are approximately 300 EOs available.2 EOs are used most often via topical application, inhalation, or ingestion.

As with any botanical agent, EOs are complex substances often containing a multitude of chemical compounds.1 Because of the complex makeup of EOs, which often contain up to 100 volatile organic compounds, and their wide-ranging potential effects, applying the scientific method to study effectiveness poses a challenge that has limited their adoption in evidence-based practice.2

Availability and cost. EOs can be purchased at large retailers (eg, grocery stores, drug stores) and smaller health food stores, as well as on the Internet. Various EO vehicles, such as inhalers and topical creams, also can be purchased at these stores.

Continue to: The cost varies...

 

 

The cost varies enormously by manufacturer and type of plant used to make the EO. Common EOs such as peppermint and lavender oil generally cost $10 to $25, while rarer plant oils can cost $80 or more per bottle.

How safe are essential oils?

Patients may assume EOs are harmless because they are derived from natural plants and have been used medicinally for centuries. However, care must be taken with their use.

The safest way to use EOs is topically, although due to their highly concentrated nature, EOs should be diluted in an unscented neutral carrier oil such as coconut, jojoba, olive, or sweet almond.3 Ingestion of certain oils can cause hepatotoxicity, seizures, and even death.3 In fact, patients should speak with a knowledgeable physician before purchasing any oral EO capsules.

Whether used topically or ingested, all EOs carry risk for skin irritation and allergic reactions, and oral ingestion may result in some negative gastrointestinal (GI) adverse effects.4 A case report of 3 patients published in 2007 identified the potential for lavender and tea tree EOs to be endocrine disruptors.5

Inhalation of EOs may be harmful, as they emit many volatile organic compounds, some of which are considered potentially hazardous.6 At this time, there is insufficient evidence regarding inhaled EOs and their direct connection to respiratory health. It is reasonable to suggest, however, that the prolonged use of EOs and their use by patients who have lung conditions such as asthma or COPD should be avoided.7

Continue to: How are quality and purity assessed?

 

 

How are quality and purity assessed?

Like other dietary supplements, EOs are not regulated. No US regulatory agencies (eg, the US Food and Drug Administration [FDA] or Department of Agriculture [USDA]) certify or approve EOs for quality and purity. Bottles labeled with “QAI” for Quality Assurance International or “USDA Organic” will ensure the plant constituents used in the EO are from organic farming but do not attest to quality or purity.

Essential oils are one of the nonpharmacologic modalities that patients and clinicians have at their disposal for adjunctive treatment of migraine and tension-type headaches.

Manufacturers commonly use marketing terms such as “therapeutic grade” or “pure” to sell products, but again, these terms do not reflect the product’s quality or purity. A labeled single EO may contain contaminants, alcohol, or additional ingredients.7 When choosing to use EOs, identifying reputable brands is essential; one resource is the independent testing organization ConsumerLab.com.

It is important to assess the manufacturer and read ingredient labels before purchasing an EO to understand what the product contains. Reputable companies will identify the plant ingredient, usually by the formal Latin binomial name, and explain the extraction process. A more certain way to assess the quality and purity of an EO is to ask the manufacturer to provide a certificate of analysis and gas chromatography/mass spectroscopy (GC/MS) data for the specific product. Some manufacturers offer GC/MS test results on their website Quality page.8 Others have detailed information on quality and testing, and GC/MS test reports can be obtained.9 Yet another manufacturer has test results on a product page matching reports to batch codes.10

Which conditions have evidence of benefit from essential oils?

EOs currently are being studied for treatment of many conditions—including pain, GI disorders, behavioral health disorders, and women’s health issues. The TABLE summarizes the conditions treated, outcomes, and practical applications of EOs.11-44

Summary of essential oil uses, routes, and recommendations

Pain

Headache. As an adjunct to available medications and procedures for headache treatment, EOs are one of the nonpharmacologic modalities that patients and clinicians have at their disposal for both migraine and ­tension-type headaches. A systematic review of 19 randomized controlled trials (RCTs) examining the effects of herbal ingredients for the acute treatment or prophylaxis of migraines found certain topically applied or inhaled EOs, such as peppermint and chamomile, to be effective for migraine pain alleviation; however, topically applied rose oil was not effective.11-13 Note: “topical application” in these studies implies application of the EO to ≥ 1 of the following areas: temples, forehead, behind ears, or above upper lip/below the nose.

Continue to: One RCT with 120 patients...

 

 

One RCT with 120 patients evaluated diluted intranasal peppermint oil and found that it reduced migraine intensity at similar rates to intranasal lidocaine.13 In this study, patients were randomized to receive one of the following: 4% lidocaine, 1.5% peppermint EO, or placebo. Two drops of the intranasal intervention were self-administered while the patient was in a supine position with their head suspended off the edge of the surface on which they were lying. They were instructed to stay in this position for at least 30 seconds after administration.

With regard to tension headache treatment, there is limited literature on the use of EOs. One study found that a preparation of peppermint oil applied topically to the temples and forehead of study participants resulted in significant analgesic effect.14

Fibromyalgia. Usual treatments for fibromyalgia include exercise, antidepressant and anticonvulsant medications, and stress management. Evidence also supports the use of inhaled and topically applied (with and without massage) lavender oil to improve symptoms.26 Positive effects may be related to the anal­gesic, anti-­inflammatory, sleep-regulating,­ and anxiety­-reducing effects of the major volatile compounds contained in lavender oil.

In one RCT with 42 patients with fibromyalgia, the use of inhaled lavender oil was shown to increase the perception of well-­being (assessed on the validated SF-36 Health Survey Questionnaire) after 4 weeks.27 In this study, the patient applied 3 drops of an oil mixture, comprising 1 mL lavender EO and 10 mL of fixed neutral base oil, to the wrist and inhaled for 10 minutes before going to bed.

The use of a topical oil blend labeled “Oil 24” (containing camphor, rosemary, eucalyptus, peppermint, aloe vera, and lemon/orange) also has been shown to be more effective than placebo in managing fibromyalgia symptoms. A randomized controlled pilot study of 153 participants found that regular application of Oil 24 improved scores on pain scales and the Fibromyalgia Impact Questionnaire.28

Continue to: GI disorders

 

 

GI disorders

Irritable bowel syndrome. Peppermint oil relaxes GI smooth muscle, which has led to investigation of its use in irritable bowel ­syndrome (IBS) symptom amelioration.17 One meta-analysis including 12 RCTs with 835 patients with undifferentiated IBS found that orally ingested peppermint EO capsules reduced patient-reported symptoms of either abdominal pain or global symptoms.18

One study utilized the Total IBS Symptom Score to evaluate symptom reduction in patients with IBS-D (with diarrhea) and IBS-M (mixed) using 180-mg peppermint EO capsules ingested 3 times daily. There was a significant improvement in abdominal pain/discomfort, bloating/distension, pain at evacuation, and bowel urgency.19 A reduction in symptoms was observed after the first 24 hours of treatment and at the end of the 4-week treatment period.

In another study, among the 190 patients meeting Rome IV criteria for general (nonspecific) IBS who were treated with 182-mg peppermint EO capsules, no statistically significant reduction in overall symptom relief was found (based on outcome measures by the FDA and European Medicines Agency). However, in a secondary outcome analysis, peppermint oil produced greater improvements than placebo for the alleviation of abdominal pain, discomfort, and general IBS severity.20

Chemotherapy-induced nausea and vomiting. Patients with cancer undergoing chemotherapy often explore integrative medicine approaches, including aromatherapy, to ameliorate adverse effects and improve quality of life.38 A few small studies have shown potential for the use of inhaled ginger oil to reduce nausea and vomiting severity and improve health-related quality-of-life measures in these patients.

Evidence supports the use of inhaled and topically applied lavender oil to improve fibromyalgia symptoms.

For example, a study with 60 participants found that inhaling ginger EO for 10 minutes was beneficial for reducing both nausea and vomiting.39 A single-blind, controlled, ­randomized crossover study of 60 patients with breast cancer receiving chemotherapy showed that ginger EO inhaled 3 times per day for 2 minutes at a time can decrease the severity of nausea but had no effect on vomiting. The same study showed that health-­related quality of life improved with the ginger oil treatment.40

Continue to: Other EOs such as cardamom...

 

 

Other EOs such as cardamom and peppermint show promise as an adjunctive treatment for chemotherapy-induced nausea and vomiting as well.38

Postoperative nausea. A 2013 randomized trial of 303 patients examined the use of ginger EO, a blend of EOs (including ginger, spearmint, peppermint, and cardamom), and isopropyl alcohol. Both the single EO and EO blend significantly reduced the symptom of nausea. The number of antiemetic medications requested by patients receiving an EO also was significantly reduced compared to those receiving saline.15

The use of EOs to reduce nausea after cardiac operations was reviewed in an RCT of 60 surgical candidates using 10% peppermint oil via nebulization for 10 minutes.16 This technique was effective in reducing nausea during cardiac postoperative periods. Although the evidence for the use of EOs for postoperative nausea is not robust, it may be a useful and generally safe approach for this common issue.

 

Behavioral health

Insomnia. EOs have been used as a treatment for insomnia traditionally and in complementary, alternative, and integrative medicine. A 2014 systematic review of 15 quantitative studies, including 11 RCTs, evaluated the hypnotic effects of EOs through inhalation, finding the strongest evidence for lavender, jasmine, and peppermint oils.29 The majority of the studies in the systematic review used the Pittsburgh Sleep Quality Index (PSQI) to evaluate EO effectiveness. A more recent 2021 systematic review and meta-analysis that evaluated 34 RCTs found that inhalation of EOs, most notably lavender aromatherapy, is effective in improving sleep problems such as insomnia.30

Findings from multiple smaller RCTs were consistent with those of the aforementioned systematic reviews. For example, in a well-conducted parallel randomized double-blind placebo-controlled trial of 100 people using orally ingested lemon verbena, the authors concluded that this intervention can be a complementary therapy for improving sleep quality and reducing insomnia severity.31 Another RCT with 60 participants evaluated an inhaled EO blend (lemon, eucalyptus, tea tree, and peppermint) over 4 weeks and found lowered perceived stress and depression as well as better sleep quality, but no influence on objective physiologic data such as stress indices or immune states.32

Continue to: In a 2020 randomized crossover...

 

 

In a 2020 randomized crossover placebo­controlled trial of 37 participants with diabetes reporting insomnia, inhaled lavender improved sleep quality and quantity, quality of life, and mood but not physiologic or metabolic measures, such as fasting glucose.33 Findings were similar in a cohort of cardiac rehabilitation patients (n = 37) who were treated with either an inhaled combination of lavender, bergamot, and ylang ylang, or placebo; cotton balls infused with the intervention oil or placebo oil were placed at the patient’s bedside for 5 nights. Sleep quality of participants receiving intervention oil was significantly better than the sleep quality of participants receiving the placebo oil as measured by participant completion of the PSQI.34

Anxiety is a common disorder that can be managed with nonpharmacologic treatments such as yoga, deep breathing, meditation, and EO therapy.21,22 In a systematic review and meta-analysis, the inhaled and topical use (with or without massage) of lavender EO was shown to improve psychological and physical manifestations of anxiety.23 Lavender EO is purported to affect the parasympathetic nervous system via anxiolytic, sedative, analgesic, and anticonvulsant properties.24 One systematic review and meta-analysis evaluating the anxiolytic effect of both inhaled and topical lavender EO found improvement in several biomarkers and physiologic data including blood pressure, heart rate, and cortisol levels, as well as a reduction in self-reported levels of anxiety, compared with placebo.25

Anxiety related to dental procedures is another area of study for the use of EOs. Two RCTs demonstrate statistically significant improvement in anxiety-related physiologic markers such as heart rate, blood pressure, and salivary cortisol levels in children who inhaled lavender EO during dental procedures.41,42 In 1 of the RCTs, the intervention was described as 3 drops of 100% lavender EO applied to a cloth and inhaled over the course of 3 minutes.41 Additionally, 2 studies found that orange EO was beneficial for dental procedure–induced anxiety, reducing pulse rates, cortisol levels, and self-reported anxiety.43,44

Dementia-related behavioral disturbances. A small, poorly designed study examining 2 EO blends—rosemary with lemon and lavender with orange—found some potential for improving cognitive function, especially in patients with Alzheimer disease.45 A Cochrane review of 13 RCTs totaling 708 patients concluded that it is not certain from the available evidence that EO therapy benefits patients with dementia in long-term-care facilities and hospital wards.46 Given that reporting of adverse events in the trials was poor, it is not possible to make conclusions about the risk vs benefit of EO therapy in this population.

Women’s health

Dysmenorrhea. Interest has grown in the use of EOs for dysmenorrhea symptom relief, and there is a small body of evidence demonstrating that a variety of oils—most notably lavender, rose, and clary sage—may reduce symptom severity. One meta-analysis of 9 RCTs and 12 controlled clinical trials including women with moderate-to-severe dysmenorrhea found that inhaled and/or topical use of singular or mixed lavender, clary sage, rose, marjoram, and cinnamon EOs demonstrated the strongest evidence of effectiveness in reducing menstrual cramping.35

Continue to: In a randomized, double-blind clinical trial...

 

 

Use of an inhaled blend of lemon, eucalyptus, tea tree, and peppermint was associated with lower perceived stress and depression as well as better sleep quality.

In a randomized, double-blind clinical trial of 48 women, a cream-based blend of lavender, clary sage, and marjoram EO (used topically in a 2:1:1 ratio diluted in unscented cream at 3% concentration and applied daily via abdominal massage) reduced participants’ reported menstrual pain symptoms and duration of pain.36 In a meta-analysis of 6 studies, topical abdominal application of EO (mainly lavender with or without other oils) with massage showed superiority over massage with placebo oils in reducing menstrual pain.37 A reduction in pain, mood symptoms, and fatigue in women with premenstrual symptoms was seen in an RCT of 77 patients using 3 drops of inhaled lavender EO.47

Labor. There is limited evidence for the use of EOs during labor. In an RCT of 104 women, patient-selected diffused EOs, including lavender, rose geranium, citrus, or jasmine, were found to help lower pain scores during the latent and early active phase of labor. There were no differences in labor augmentation, length of labor, perinatal outcomes, or need for additional pain medication.48

 

Other uses

Antimicrobial support. Some common EOs that have demonstrated antimicrobial properties are oregano, thyme, clove, lavender, clary sage, garlic, and cinnamon.49,50 Topical lemongrass and tea tree EOs have shown some degree of efficacy as an alternative treatment for acne, decolonization of methicillin-resistant Staphylococcus aureus, and superficial fungal infections.51 Support for an oral mixture of EOs labeled Myrtol (containing eucalyptus, citrus myrtle, and lavender) for viral acute bronchitis and sinusitis was found in a review of 7 studies.52 More research needs to be done before clear recommendations can be made on the use of EOs as antimicrobials, but the current data are encouraging.

Insect repellent. Reviews of the ­insect-repellent properties of EOs have shown promise and are in the public’s interest due to increasing awareness of the potential health and environmental hazards of synthetic repellents.53 Individual compounds present in EOs such as citronella/lemongrass, basil, and eucalyptus species demonstrate high repellent activity.54 Since EOs require frequent reapplication for efficacy due to their highly volatile nature, scientists are currently developing a means to prolong their protection time through cream-based formulations.55

The bottom line

Because of the ubiquity of EOs, family physicians will undoubtedly be asked about them by patients, and it would be beneficial to feel comfortable discussing their most common uses. For most adult patients, the topical and periodic inhaled usage of EOs is generally safe.56

There is a small body of evidence demonstrating that a variety of essential oils, most notably lavender, rose, and clary sage, may reduce dysmenorrhea symptom severity.

There is existing evidence of efficacy for a number of EOs, most strongly for lavender and peppermint. Future research into EOs should include higher-powered and higher-­quality studies in order to provide more conclusive evidence regarding the continued use of EOs for many common conditions. More evidence-based information on dosing, application/use regimens, and safety in long-term use also will help providers better instruct patients on how to utilize EOs effectively and safely. 

CORRESPONDENCE
Pooja Amy Shah, MD, Columbia University College of Physicians & Surgeons, 610 West 158th Street, New York, NY 10032; pas2176@cumc.columbia.edu

Essential oils (EOs), which are concentrated plant-based oils, have become ubiquitous over the past decade. ­Given the far reach of EOs and their longtime use in traditional, complementary, alternative, and integrative medicine, it is imperative that clinicians have some knowledge of the potential benefits, risks, and overall efficacy.

Commonly used for aromatic benefits (aromatherapy), EOs are now also incorporated into a multitude of products promoting health and wellness. EOs are sold as individual products and can be a component in consumer goods such as cosmetics, body care/hygiene/beauty products, laundry detergents, insect repellents, over-the-counter medications, and food.

It is important to read ingredient labels before purchasing an essential oil. Reputable companies will identify the plant ingredient, usually by the formal Latin binomial name, and explain the extraction process.

The review that follows presents the most current evidence available. With that said, it’s important to keep in mind some caveats that relate to this evidence. First, the studies cited tend to have a small sample size. Second, a majority of these studies were conducted in countries where there appears to be a significant culture of EO use, which could contribute to confirmation bias. Finally, in a number of the studies, there is concern for publication bias as well as a discrepancy between calculated statistical significance and actual clinical relevance.

Essential oils

What are essential oils?

EOs generally are made by extracting the oil from leaves, bark, flowers, seeds/fruit, rinds, and/or roots by steaming or pressing parts of a plant. It can take several pounds of plant material to produce a single bottle of EO, which usually contains ≥ 15 to 30 mL (.5 to 1 oz).1

Some commonly used EOs in the United States are lavender, peppermint, rose, clary sage, tea tree, eucalyptus, and citrus; however, there are approximately 300 EOs available.2 EOs are used most often via topical application, inhalation, or ingestion.

As with any botanical agent, EOs are complex substances often containing a multitude of chemical compounds.1 Because of the complex makeup of EOs, which often contain up to 100 volatile organic compounds, and their wide-ranging potential effects, applying the scientific method to study effectiveness poses a challenge that has limited their adoption in evidence-based practice.2

Availability and cost. EOs can be purchased at large retailers (eg, grocery stores, drug stores) and smaller health food stores, as well as on the Internet. Various EO vehicles, such as inhalers and topical creams, also can be purchased at these stores.

Continue to: The cost varies...

 

 

The cost varies enormously by manufacturer and type of plant used to make the EO. Common EOs such as peppermint and lavender oil generally cost $10 to $25, while rarer plant oils can cost $80 or more per bottle.

How safe are essential oils?

Patients may assume EOs are harmless because they are derived from natural plants and have been used medicinally for centuries. However, care must be taken with their use.

The safest way to use EOs is topically, although due to their highly concentrated nature, EOs should be diluted in an unscented neutral carrier oil such as coconut, jojoba, olive, or sweet almond.3 Ingestion of certain oils can cause hepatotoxicity, seizures, and even death.3 In fact, patients should speak with a knowledgeable physician before purchasing any oral EO capsules.

Whether used topically or ingested, all EOs carry risk for skin irritation and allergic reactions, and oral ingestion may result in some negative gastrointestinal (GI) adverse effects.4 A case report of 3 patients published in 2007 identified the potential for lavender and tea tree EOs to be endocrine disruptors.5

Inhalation of EOs may be harmful, as they emit many volatile organic compounds, some of which are considered potentially hazardous.6 At this time, there is insufficient evidence regarding inhaled EOs and their direct connection to respiratory health. It is reasonable to suggest, however, that the prolonged use of EOs and their use by patients who have lung conditions such as asthma or COPD should be avoided.7

Continue to: How are quality and purity assessed?

 

 

How are quality and purity assessed?

Like other dietary supplements, EOs are not regulated. No US regulatory agencies (eg, the US Food and Drug Administration [FDA] or Department of Agriculture [USDA]) certify or approve EOs for quality and purity. Bottles labeled with “QAI” for Quality Assurance International or “USDA Organic” will ensure the plant constituents used in the EO are from organic farming but do not attest to quality or purity.

Essential oils are one of the nonpharmacologic modalities that patients and clinicians have at their disposal for adjunctive treatment of migraine and tension-type headaches.

Manufacturers commonly use marketing terms such as “therapeutic grade” or “pure” to sell products, but again, these terms do not reflect the product’s quality or purity. A labeled single EO may contain contaminants, alcohol, or additional ingredients.7 When choosing to use EOs, identifying reputable brands is essential; one resource is the independent testing organization ConsumerLab.com.

It is important to assess the manufacturer and read ingredient labels before purchasing an EO to understand what the product contains. Reputable companies will identify the plant ingredient, usually by the formal Latin binomial name, and explain the extraction process. A more certain way to assess the quality and purity of an EO is to ask the manufacturer to provide a certificate of analysis and gas chromatography/mass spectroscopy (GC/MS) data for the specific product. Some manufacturers offer GC/MS test results on their website Quality page.8 Others have detailed information on quality and testing, and GC/MS test reports can be obtained.9 Yet another manufacturer has test results on a product page matching reports to batch codes.10

Which conditions have evidence of benefit from essential oils?

EOs currently are being studied for treatment of many conditions—including pain, GI disorders, behavioral health disorders, and women’s health issues. The TABLE summarizes the conditions treated, outcomes, and practical applications of EOs.11-44

Summary of essential oil uses, routes, and recommendations

Pain

Headache. As an adjunct to available medications and procedures for headache treatment, EOs are one of the nonpharmacologic modalities that patients and clinicians have at their disposal for both migraine and ­tension-type headaches. A systematic review of 19 randomized controlled trials (RCTs) examining the effects of herbal ingredients for the acute treatment or prophylaxis of migraines found certain topically applied or inhaled EOs, such as peppermint and chamomile, to be effective for migraine pain alleviation; however, topically applied rose oil was not effective.11-13 Note: “topical application” in these studies implies application of the EO to ≥ 1 of the following areas: temples, forehead, behind ears, or above upper lip/below the nose.

Continue to: One RCT with 120 patients...

 

 

One RCT with 120 patients evaluated diluted intranasal peppermint oil and found that it reduced migraine intensity at similar rates to intranasal lidocaine.13 In this study, patients were randomized to receive one of the following: 4% lidocaine, 1.5% peppermint EO, or placebo. Two drops of the intranasal intervention were self-administered while the patient was in a supine position with their head suspended off the edge of the surface on which they were lying. They were instructed to stay in this position for at least 30 seconds after administration.

With regard to tension headache treatment, there is limited literature on the use of EOs. One study found that a preparation of peppermint oil applied topically to the temples and forehead of study participants resulted in significant analgesic effect.14

Fibromyalgia. Usual treatments for fibromyalgia include exercise, antidepressant and anticonvulsant medications, and stress management. Evidence also supports the use of inhaled and topically applied (with and without massage) lavender oil to improve symptoms.26 Positive effects may be related to the anal­gesic, anti-­inflammatory, sleep-regulating,­ and anxiety­-reducing effects of the major volatile compounds contained in lavender oil.

In one RCT with 42 patients with fibromyalgia, the use of inhaled lavender oil was shown to increase the perception of well-­being (assessed on the validated SF-36 Health Survey Questionnaire) after 4 weeks.27 In this study, the patient applied 3 drops of an oil mixture, comprising 1 mL lavender EO and 10 mL of fixed neutral base oil, to the wrist and inhaled for 10 minutes before going to bed.

The use of a topical oil blend labeled “Oil 24” (containing camphor, rosemary, eucalyptus, peppermint, aloe vera, and lemon/orange) also has been shown to be more effective than placebo in managing fibromyalgia symptoms. A randomized controlled pilot study of 153 participants found that regular application of Oil 24 improved scores on pain scales and the Fibromyalgia Impact Questionnaire.28

Continue to: GI disorders

 

 

GI disorders

Irritable bowel syndrome. Peppermint oil relaxes GI smooth muscle, which has led to investigation of its use in irritable bowel ­syndrome (IBS) symptom amelioration.17 One meta-analysis including 12 RCTs with 835 patients with undifferentiated IBS found that orally ingested peppermint EO capsules reduced patient-reported symptoms of either abdominal pain or global symptoms.18

One study utilized the Total IBS Symptom Score to evaluate symptom reduction in patients with IBS-D (with diarrhea) and IBS-M (mixed) using 180-mg peppermint EO capsules ingested 3 times daily. There was a significant improvement in abdominal pain/discomfort, bloating/distension, pain at evacuation, and bowel urgency.19 A reduction in symptoms was observed after the first 24 hours of treatment and at the end of the 4-week treatment period.

In another study, among the 190 patients meeting Rome IV criteria for general (nonspecific) IBS who were treated with 182-mg peppermint EO capsules, no statistically significant reduction in overall symptom relief was found (based on outcome measures by the FDA and European Medicines Agency). However, in a secondary outcome analysis, peppermint oil produced greater improvements than placebo for the alleviation of abdominal pain, discomfort, and general IBS severity.20

Chemotherapy-induced nausea and vomiting. Patients with cancer undergoing chemotherapy often explore integrative medicine approaches, including aromatherapy, to ameliorate adverse effects and improve quality of life.38 A few small studies have shown potential for the use of inhaled ginger oil to reduce nausea and vomiting severity and improve health-related quality-of-life measures in these patients.

Evidence supports the use of inhaled and topically applied lavender oil to improve fibromyalgia symptoms.

For example, a study with 60 participants found that inhaling ginger EO for 10 minutes was beneficial for reducing both nausea and vomiting.39 A single-blind, controlled, ­randomized crossover study of 60 patients with breast cancer receiving chemotherapy showed that ginger EO inhaled 3 times per day for 2 minutes at a time can decrease the severity of nausea but had no effect on vomiting. The same study showed that health-­related quality of life improved with the ginger oil treatment.40

Continue to: Other EOs such as cardamom...

 

 

Other EOs such as cardamom and peppermint show promise as an adjunctive treatment for chemotherapy-induced nausea and vomiting as well.38

Postoperative nausea. A 2013 randomized trial of 303 patients examined the use of ginger EO, a blend of EOs (including ginger, spearmint, peppermint, and cardamom), and isopropyl alcohol. Both the single EO and EO blend significantly reduced the symptom of nausea. The number of antiemetic medications requested by patients receiving an EO also was significantly reduced compared to those receiving saline.15

The use of EOs to reduce nausea after cardiac operations was reviewed in an RCT of 60 surgical candidates using 10% peppermint oil via nebulization for 10 minutes.16 This technique was effective in reducing nausea during cardiac postoperative periods. Although the evidence for the use of EOs for postoperative nausea is not robust, it may be a useful and generally safe approach for this common issue.

 

Behavioral health

Insomnia. EOs have been used as a treatment for insomnia traditionally and in complementary, alternative, and integrative medicine. A 2014 systematic review of 15 quantitative studies, including 11 RCTs, evaluated the hypnotic effects of EOs through inhalation, finding the strongest evidence for lavender, jasmine, and peppermint oils.29 The majority of the studies in the systematic review used the Pittsburgh Sleep Quality Index (PSQI) to evaluate EO effectiveness. A more recent 2021 systematic review and meta-analysis that evaluated 34 RCTs found that inhalation of EOs, most notably lavender aromatherapy, is effective in improving sleep problems such as insomnia.30

Findings from multiple smaller RCTs were consistent with those of the aforementioned systematic reviews. For example, in a well-conducted parallel randomized double-blind placebo-controlled trial of 100 people using orally ingested lemon verbena, the authors concluded that this intervention can be a complementary therapy for improving sleep quality and reducing insomnia severity.31 Another RCT with 60 participants evaluated an inhaled EO blend (lemon, eucalyptus, tea tree, and peppermint) over 4 weeks and found lowered perceived stress and depression as well as better sleep quality, but no influence on objective physiologic data such as stress indices or immune states.32

Continue to: In a 2020 randomized crossover...

 

 

In a 2020 randomized crossover placebo­controlled trial of 37 participants with diabetes reporting insomnia, inhaled lavender improved sleep quality and quantity, quality of life, and mood but not physiologic or metabolic measures, such as fasting glucose.33 Findings were similar in a cohort of cardiac rehabilitation patients (n = 37) who were treated with either an inhaled combination of lavender, bergamot, and ylang ylang, or placebo; cotton balls infused with the intervention oil or placebo oil were placed at the patient’s bedside for 5 nights. Sleep quality of participants receiving intervention oil was significantly better than the sleep quality of participants receiving the placebo oil as measured by participant completion of the PSQI.34

Anxiety is a common disorder that can be managed with nonpharmacologic treatments such as yoga, deep breathing, meditation, and EO therapy.21,22 In a systematic review and meta-analysis, the inhaled and topical use (with or without massage) of lavender EO was shown to improve psychological and physical manifestations of anxiety.23 Lavender EO is purported to affect the parasympathetic nervous system via anxiolytic, sedative, analgesic, and anticonvulsant properties.24 One systematic review and meta-analysis evaluating the anxiolytic effect of both inhaled and topical lavender EO found improvement in several biomarkers and physiologic data including blood pressure, heart rate, and cortisol levels, as well as a reduction in self-reported levels of anxiety, compared with placebo.25

Anxiety related to dental procedures is another area of study for the use of EOs. Two RCTs demonstrate statistically significant improvement in anxiety-related physiologic markers such as heart rate, blood pressure, and salivary cortisol levels in children who inhaled lavender EO during dental procedures.41,42 In 1 of the RCTs, the intervention was described as 3 drops of 100% lavender EO applied to a cloth and inhaled over the course of 3 minutes.41 Additionally, 2 studies found that orange EO was beneficial for dental procedure–induced anxiety, reducing pulse rates, cortisol levels, and self-reported anxiety.43,44

Dementia-related behavioral disturbances. A small, poorly designed study examining 2 EO blends—rosemary with lemon and lavender with orange—found some potential for improving cognitive function, especially in patients with Alzheimer disease.45 A Cochrane review of 13 RCTs totaling 708 patients concluded that it is not certain from the available evidence that EO therapy benefits patients with dementia in long-term-care facilities and hospital wards.46 Given that reporting of adverse events in the trials was poor, it is not possible to make conclusions about the risk vs benefit of EO therapy in this population.

Women’s health

Dysmenorrhea. Interest has grown in the use of EOs for dysmenorrhea symptom relief, and there is a small body of evidence demonstrating that a variety of oils—most notably lavender, rose, and clary sage—may reduce symptom severity. One meta-analysis of 9 RCTs and 12 controlled clinical trials including women with moderate-to-severe dysmenorrhea found that inhaled and/or topical use of singular or mixed lavender, clary sage, rose, marjoram, and cinnamon EOs demonstrated the strongest evidence of effectiveness in reducing menstrual cramping.35

Continue to: In a randomized, double-blind clinical trial...

 

 

Use of an inhaled blend of lemon, eucalyptus, tea tree, and peppermint was associated with lower perceived stress and depression as well as better sleep quality.

In a randomized, double-blind clinical trial of 48 women, a cream-based blend of lavender, clary sage, and marjoram EO (used topically in a 2:1:1 ratio diluted in unscented cream at 3% concentration and applied daily via abdominal massage) reduced participants’ reported menstrual pain symptoms and duration of pain.36 In a meta-analysis of 6 studies, topical abdominal application of EO (mainly lavender with or without other oils) with massage showed superiority over massage with placebo oils in reducing menstrual pain.37 A reduction in pain, mood symptoms, and fatigue in women with premenstrual symptoms was seen in an RCT of 77 patients using 3 drops of inhaled lavender EO.47

Labor. There is limited evidence for the use of EOs during labor. In an RCT of 104 women, patient-selected diffused EOs, including lavender, rose geranium, citrus, or jasmine, were found to help lower pain scores during the latent and early active phase of labor. There were no differences in labor augmentation, length of labor, perinatal outcomes, or need for additional pain medication.48

 

Other uses

Antimicrobial support. Some common EOs that have demonstrated antimicrobial properties are oregano, thyme, clove, lavender, clary sage, garlic, and cinnamon.49,50 Topical lemongrass and tea tree EOs have shown some degree of efficacy as an alternative treatment for acne, decolonization of methicillin-resistant Staphylococcus aureus, and superficial fungal infections.51 Support for an oral mixture of EOs labeled Myrtol (containing eucalyptus, citrus myrtle, and lavender) for viral acute bronchitis and sinusitis was found in a review of 7 studies.52 More research needs to be done before clear recommendations can be made on the use of EOs as antimicrobials, but the current data are encouraging.

Insect repellent. Reviews of the ­insect-repellent properties of EOs have shown promise and are in the public’s interest due to increasing awareness of the potential health and environmental hazards of synthetic repellents.53 Individual compounds present in EOs such as citronella/lemongrass, basil, and eucalyptus species demonstrate high repellent activity.54 Since EOs require frequent reapplication for efficacy due to their highly volatile nature, scientists are currently developing a means to prolong their protection time through cream-based formulations.55

The bottom line

Because of the ubiquity of EOs, family physicians will undoubtedly be asked about them by patients, and it would be beneficial to feel comfortable discussing their most common uses. For most adult patients, the topical and periodic inhaled usage of EOs is generally safe.56

There is a small body of evidence demonstrating that a variety of essential oils, most notably lavender, rose, and clary sage, may reduce dysmenorrhea symptom severity.

There is existing evidence of efficacy for a number of EOs, most strongly for lavender and peppermint. Future research into EOs should include higher-powered and higher-­quality studies in order to provide more conclusive evidence regarding the continued use of EOs for many common conditions. More evidence-based information on dosing, application/use regimens, and safety in long-term use also will help providers better instruct patients on how to utilize EOs effectively and safely. 

CORRESPONDENCE
Pooja Amy Shah, MD, Columbia University College of Physicians & Surgeons, 610 West 158th Street, New York, NY 10032; pas2176@cumc.columbia.edu

References

1. Butnariu M, Sarac I. Essential oils from plants. J Biotechnol Biomed Sci. 2018;1:35-43. doi: 10.14302/issn.2576-6694.jbbs-18-2489

2. Singh B, Sellam P, Majumder, J, et al. Floral essential oils : importance and uses for mankind. HortFlora Res Spectr. 2014;3:7-13. www.academia.edu/6707801/Floral_essential_oils_Importance_and_uses_for_mankind

3. Posadzki P, Alotaibi A, Ernst E. Adverse effects of aromatherapy: a systematic review of case reports and case series. Int J Risk Saf Med. 2012;24:147-161. doi: 10.3233/JRS-2012-0568

4. Sharmeen JB, Mahomoodally FM, Zengin G, et al. Essential oils as natural sources of fragrance compounds for cosmetics and cosmeceuticals. Molecules. 2021;26:666. doi: 10.3390/molecules26030666

5. Henley DV, Lipson N, Korach KS, et al. Prepubertal gynecomastia linked to lavender and tea tree oils. N Engl J Med. 2007;356:479-485. doi: 10.1056/NEJMoa064725

6. Nematollahi N, Weinberg JL, Flattery J, et al. Volatile chemical emissions from essential oils with therapeutic claims. Air Qual Atmosphere Health. 2021;14:365-369. doi: 10.1007/s11869-020-00941-4

7. Balekian D, Long A. Essential oil diffusers and asthma. Published February 24, 2020. Accessed September 22, 2023. www.aaaai.org/Allergist-Resources/Ask-the-Expert/Answers/Old-Ask-the-Experts/oil-diffusers-asthma

8. Aura Cacia. Quality. Accessed September 22, 2023. www.auracacia.com/quality

9. Now. Essential oil identity & purity testing. Accessed September 22, 2023. www.nowfoods.com/quality-safety/essential-oil-­identity-purity-testing

10. Aura Cacia. GCMS documents. Accessed September 22, 2023. www.auracacia.com/aura-cacia-gcms-documents

11. Lopresti AL, Smith SJ, Drummond PD. Herbal treatments for migraine: a systematic review of randomised-controlled studies. Phytother Res. 2020;34:2493-2517. doi: 10.1002/ptr.6701

12. Niazi M, Hashempur MH, Taghizadeh M, et al. Efficacy of topical Rose (Rosa damascena Mill.) oil for migraine headache: A randomized double-blinded placebo-controlled cross-over trial. Complement Ther Med. 2017;34:35-41. doi: 10.1016/j.ctim. 2017.07.009

13. Rafieian-Kopaei M, Hasanpour-Dehkordi A, Lorigooini Z, et al. Comparing the effect of intranasal lidocaine 4% with peppermint essential oil drop 1.5% on migraine attacks: a double-blind clinical trial. Int J Prev Med. 2019;10:121. doi: 10.4103/ijpvm.IJPVM_530_17

14. Göbel H, Fresenius J, Heinze A, et al. [Effectiveness of Oleum menthae piperitae and paracetamol in therapy of headache of the tension type]. Nervenarzt. 1996;67:672-681. doi: 10.1007/s001150050040

15. Hunt R, Dienemann J, Norton HJ, et al. Aromatherapy as treatment for postoperative nausea: a randomized trial. Anesth Analg. 2013;117:597-604. doi: 10.1213/ANE.0b013e31824a0b1c

16. Maghami M, Afazel MR, Azizi-Fini I, et al. The effect of aromatherapy with peppermint essential oil on nausea and vomiting after cardiac surgery: a randomized clinical trial. Complement Ther Clin Pract. 2020;40:101199. doi: 10.1016/j.ctcp.2020.101199

17. Hills JM, Aaronson PI. The mechanism of action of peppermint oil on gastrointestinal smooth muscle. An analysis using patch clamp electrophysiology and isolated tissue pharmacology in rabbit and guinea pig. Gastroenterology. 1991;101:55-65. doi: 10.1016/0016-5085(91)90459-x

18. Alammar N, Wang L, Saberi B, et al. The impact of peppermint oil on the irritable bowel syndrome: a meta-analysis of the pooled clinical data. BMC Complement Altern Med. 2019;19:21. doi: 10.1186/s12906-018-2409-0

19. Cash BD, Epstein MS, Shah SM. A novel delivery system of peppermint oil is an effective therapy for irritable bowel syndrome symptoms. Dig Dis Sci. 2016;61:560-571. doi: 10.1007/s10620-015-3858-7

20. Weerts ZZRM, Masclee AAM, Witteman BJM, et al. Efficacy and safety of peppermint oil in a randomized, double-blind trial of patients with irritable bowel syndrome. Gastroenterology. 2020;158:123-136. doi: 10.1053/j.gastro.2019.08.026

21. Ma X, Yue ZQ, Gong ZQ, et al. The effect of diaphragmatic breathing on attention, negative affect and stress in healthy adults. Front Psychol. 2017;8:874. doi: 10.3389/fpsyg.2017.00874

22. Cabral P, Meyer HB, Ames D. Effectiveness of yoga therapy as a complementary treatment for major psychiatric disorders: a meta­-analysis. Prim Care Companion CNS Disord. Published July 7, 2011. doi: 10.4088/PCC.10r01068

23. Donelli D, Antonelli M, Bellinazzi C, et ala. Effects of lavender on anxiety: systematic review and meta-analysis. Phytomedicine Int J Phytother Phytopharm. 2019;65:153099. doi: 10.1016/j.phymed.2019.153099

24. Koulivand PH, Khaleghi Ghadiri M, Gorji A. Lavender and the nervous system. Evid Based Complement Alternat Med. 2013;2013:1-10. doi: 10.1155/2013/681304

25. Kang HJ, Nam ES, Lee Y, et al. How strong is the evidence for the anxiolytic efficacy of lavender? Systematic review and meta-­analysis of randomized controlled trials. Asian Nurs Res. 2019;13:295-305. doi: 10.1016/j.anr.2019.11.003

26. Barão Paixão VL, Freire de Carvalho J. Essential oil therapy in rheumatic diseases: a systematic review. Complement Ther Clin Pract. 2021;43:101391. doi: 10.1016/j.ctcp.2021.101391

27. Yasa Ozturk G, Bashan I. The effect of aromatherapy with lavender oil on the health-related quality of life in patients with fibromyalgia. J Food Qual. 2021;2021:1-5. doi: 10.1155/2021/9938630

28. Ko GD, Hum A, Traitses G, et al. Effects of topical O24 essential oils on patients with fibromyalgia syndrome: a randomized, placebo controlled pilot study. J Musculoskelet Pain. 2007;15:11-19. doi: 10.1300/J094v15n01_03

29. Lillehei AS, Halcon LL. A systematic review of the effect of inhaled essential oils on sleep. J Altern Complement Med. 2014;20:441-451. doi: 10.1089/acm.2013.0311

30. Cheong MJ, Kim S, Kim JS, et al. A systematic literature review and meta-analysis of the clinical effects of aroma inhalation therapy on sleep problems. Medicine (Baltimore). 2021;100:e24652. doi: 10.1097/MD.0000000000024652

31. Afrasiabian F, Mirabzadeh Ardakani M, Rahmani K, et al. Aloysia citriodora Paláu (lemon verbena) for insomnia patients: a randomized, double-blind, placebo-controlled clinical trial of efficacy and safety. Phytother Res PTR. 2019;33:350-359. doi: 10.1002/ptr.6228

32. Lee M, Lim S, Song JA, et al. The effects of aromatherapy essential oil inhalation on stress, sleep quality and immunity in healthy adults: randomized controlled trial. Eur J Integr Med. 2017;12:79-86. doi: 10.1016/j.eujim.2017.04.009

33. Nasiri Lari Z, Hajimonfarednejad M, Riasatian M, et al. Efficacy of inhaled Lavandula angustifolia Mill. Essential oil on sleep quality, quality of life and metabolic control in patients with diabetes mellitus type II and insomnia. J Ethnopharmacol. 2020;251:112560. doi: 10.1016/j.jep.2020.112560

34. McDonnell B, Newcomb P. Trial of essential oils to improve sleep for patients in cardiac rehabilitation. J Altern Complement Med N Y N. 2019;25:1193-1199. doi: 10.1089/acm.2019.0222

35. Song JA, Lee MK, Min E, et al. Effects of aromatherapy on dysmenorrhea: a systematic review and meta-analysis. Int J Nurs Stud. 2018;84:1-11. doi: 10.1016/j.ijnurstu.2018.01.016

36. Ou MC, Hsu TF, Lai AC, et al. Pain relief assessment by aromatic essential oil massage on outpatients with primary dysmenorrhea: a randomized, double-blind clinical trial: PD pain relief by aromatic oil massage. J Obstet Gynaecol Res. 2012;38:817-822. doi: 10.1111/j.1447-0756.2011.01802.x

37. Sut N, Kahyaoglu-Sut H. Effect of aromatherapy massage on pain in primary dysmenorrhea: a meta-analysis. Complement Ther Clin Pract. 2017;27:5-10. doi: 10.1016/j.ctcp.2017.01.001

38. Keyhanmehr AS, Kolouri S, Heydarirad G, et al. Aromatherapy for the management of cancer complications: a narrative review. Complement Ther Clin Pract. 2018;31:175-180. doi: 10.1016/j.ctcp.2018.02.009

39. Sriningsih I, Elisa E, Lestari KP. Aromatherapy ginger use in patients with nausea & vomiting on post cervical cancer chemotherapy. KEMAS J Kesehat Masy. 2017;13:59-68. doi: 10.15294/kemas.v13i1.5367

40. Lua PL, Salihah N, Mazlan N. Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer. Complement Ther Med. 2015;23:396-404. doi: 10.1016/j.ctim.2015.03.009

41. Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020;179:985-992. doi: 10.1007/s00431-020-03595-7

42. Ghaderi F, Solhjou N. The effects of lavender aromatherapy on stress and pain perception in children during dental treatment: a randomized clinical trial. Complement Ther Clin Pract. 2020;40:101182. doi: 10.1016/j.ctcp.2020.101182

43. Jafarzadeh M, Arman S, Pour FF. Effect of aromatherapy with orange essential oil on salivary cortisol and pulse rate in children during dental treatment: a randomized controlled clinical trial. Adv Biomed Res. 2013;2:10. doi: 10.4103/2277-9175.107968

44. Lehrner J, Eckersberger C, Walla P, et al. Ambient odor of orange in a dental office reduces anxiety and improves mood in female patients. Physiol Behav. 2000;71:83-86. doi: 10.1016/S0031-9384(00)00308-5

45. Jimbo D, Kimura Y, Taniguchi M, et al. Effect of aromatherapy on patients with Alzheimer’s disease. Psychogeriatrics. 2009;9:173-179. doi: 10.1111/j.1479-8301.2009.00299.x

46. Ball EL, Owen-Booth B, Gray A, et al. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020;(8). doi: 10.1002/14651858.CD003150.pub3

47. Uzunçakmak T, Ayaz Alkaya S. Effect of aromatherapy on coping with premenstrual syndrome: a randomized controlled trial. Complement Ther Med. 2018;36:63-67. doi: 10.1016/j.ctim.2017.11.022

48. Tanvisut R, Traisrisilp K, Tongsong T. Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial. Arch Gynecol Obstet. 2018;297:1145-1150. doi: 10.1007/s00404-018-4700-1

49. Ramsey JT, Shropshire BC, Nagy TR, et al. Essential oils and health. Yale J Biol Med. 2020;93:291-305.

50. Puškárová A, Bučková M, Kraková L, et al. The antibacterial and antifungal activity of six essential oils and their cyto/genotoxicity­ to human HEL 12469 cells. Sci Rep. 2017;7:8211. doi: 10.1038/s41598-017-08673-9

51. Deyno S, Mtewa AG, Abebe A, et al. Essential oils as topical anti-infective agents: a systematic review and meta-analysis. Complement Ther Med. 2019;47:102224. doi: 10.1016/j.ctim.2019.102224

52. Prall S, Bowles EJ, Bennett K, et al. Effects of essential oils on symptoms and course (duration and severity) of viral respiratory infections in humans: a rapid review. Adv Integr Med. 2020;7:218-221. doi: 10.1016/j.aimed.2020.07.005

53. Weeks JA, Guiney PD, Nikiforov AI. Assessment of the environmental fate and ecotoxicity of N,N-diethyl-m-toluamide (DEET). Integr Environ Assess Manag. 2012;8:120-134. doi: 10.1002/ieam.1246

54. Nerio LS, Olivero-Verbel J, Stashenko E. Repellent activity of essential oils: a review. Bioresour Technol. 2010;101:372-378. doi: 10.1016/j.biortech.2009.07.048

55. Lee MY. Essential oils as repellents against arthropods. BioMed Res Int. 2018;2018:6860271. doi: 10.1155/2018/6860271

56. Göbel H, Heinze A, Heinze-Kuhn K, et al. [Peppermint oil in the acute treatment of tension-type headache]. Schmerz Berl Ger. 2016;30:295-310. doi: 10.1007/s00482-016-0109-6

References

1. Butnariu M, Sarac I. Essential oils from plants. J Biotechnol Biomed Sci. 2018;1:35-43. doi: 10.14302/issn.2576-6694.jbbs-18-2489

2. Singh B, Sellam P, Majumder, J, et al. Floral essential oils : importance and uses for mankind. HortFlora Res Spectr. 2014;3:7-13. www.academia.edu/6707801/Floral_essential_oils_Importance_and_uses_for_mankind

3. Posadzki P, Alotaibi A, Ernst E. Adverse effects of aromatherapy: a systematic review of case reports and case series. Int J Risk Saf Med. 2012;24:147-161. doi: 10.3233/JRS-2012-0568

4. Sharmeen JB, Mahomoodally FM, Zengin G, et al. Essential oils as natural sources of fragrance compounds for cosmetics and cosmeceuticals. Molecules. 2021;26:666. doi: 10.3390/molecules26030666

5. Henley DV, Lipson N, Korach KS, et al. Prepubertal gynecomastia linked to lavender and tea tree oils. N Engl J Med. 2007;356:479-485. doi: 10.1056/NEJMoa064725

6. Nematollahi N, Weinberg JL, Flattery J, et al. Volatile chemical emissions from essential oils with therapeutic claims. Air Qual Atmosphere Health. 2021;14:365-369. doi: 10.1007/s11869-020-00941-4

7. Balekian D, Long A. Essential oil diffusers and asthma. Published February 24, 2020. Accessed September 22, 2023. www.aaaai.org/Allergist-Resources/Ask-the-Expert/Answers/Old-Ask-the-Experts/oil-diffusers-asthma

8. Aura Cacia. Quality. Accessed September 22, 2023. www.auracacia.com/quality

9. Now. Essential oil identity & purity testing. Accessed September 22, 2023. www.nowfoods.com/quality-safety/essential-oil-­identity-purity-testing

10. Aura Cacia. GCMS documents. Accessed September 22, 2023. www.auracacia.com/aura-cacia-gcms-documents

11. Lopresti AL, Smith SJ, Drummond PD. Herbal treatments for migraine: a systematic review of randomised-controlled studies. Phytother Res. 2020;34:2493-2517. doi: 10.1002/ptr.6701

12. Niazi M, Hashempur MH, Taghizadeh M, et al. Efficacy of topical Rose (Rosa damascena Mill.) oil for migraine headache: A randomized double-blinded placebo-controlled cross-over trial. Complement Ther Med. 2017;34:35-41. doi: 10.1016/j.ctim. 2017.07.009

13. Rafieian-Kopaei M, Hasanpour-Dehkordi A, Lorigooini Z, et al. Comparing the effect of intranasal lidocaine 4% with peppermint essential oil drop 1.5% on migraine attacks: a double-blind clinical trial. Int J Prev Med. 2019;10:121. doi: 10.4103/ijpvm.IJPVM_530_17

14. Göbel H, Fresenius J, Heinze A, et al. [Effectiveness of Oleum menthae piperitae and paracetamol in therapy of headache of the tension type]. Nervenarzt. 1996;67:672-681. doi: 10.1007/s001150050040

15. Hunt R, Dienemann J, Norton HJ, et al. Aromatherapy as treatment for postoperative nausea: a randomized trial. Anesth Analg. 2013;117:597-604. doi: 10.1213/ANE.0b013e31824a0b1c

16. Maghami M, Afazel MR, Azizi-Fini I, et al. The effect of aromatherapy with peppermint essential oil on nausea and vomiting after cardiac surgery: a randomized clinical trial. Complement Ther Clin Pract. 2020;40:101199. doi: 10.1016/j.ctcp.2020.101199

17. Hills JM, Aaronson PI. The mechanism of action of peppermint oil on gastrointestinal smooth muscle. An analysis using patch clamp electrophysiology and isolated tissue pharmacology in rabbit and guinea pig. Gastroenterology. 1991;101:55-65. doi: 10.1016/0016-5085(91)90459-x

18. Alammar N, Wang L, Saberi B, et al. The impact of peppermint oil on the irritable bowel syndrome: a meta-analysis of the pooled clinical data. BMC Complement Altern Med. 2019;19:21. doi: 10.1186/s12906-018-2409-0

19. Cash BD, Epstein MS, Shah SM. A novel delivery system of peppermint oil is an effective therapy for irritable bowel syndrome symptoms. Dig Dis Sci. 2016;61:560-571. doi: 10.1007/s10620-015-3858-7

20. Weerts ZZRM, Masclee AAM, Witteman BJM, et al. Efficacy and safety of peppermint oil in a randomized, double-blind trial of patients with irritable bowel syndrome. Gastroenterology. 2020;158:123-136. doi: 10.1053/j.gastro.2019.08.026

21. Ma X, Yue ZQ, Gong ZQ, et al. The effect of diaphragmatic breathing on attention, negative affect and stress in healthy adults. Front Psychol. 2017;8:874. doi: 10.3389/fpsyg.2017.00874

22. Cabral P, Meyer HB, Ames D. Effectiveness of yoga therapy as a complementary treatment for major psychiatric disorders: a meta­-analysis. Prim Care Companion CNS Disord. Published July 7, 2011. doi: 10.4088/PCC.10r01068

23. Donelli D, Antonelli M, Bellinazzi C, et ala. Effects of lavender on anxiety: systematic review and meta-analysis. Phytomedicine Int J Phytother Phytopharm. 2019;65:153099. doi: 10.1016/j.phymed.2019.153099

24. Koulivand PH, Khaleghi Ghadiri M, Gorji A. Lavender and the nervous system. Evid Based Complement Alternat Med. 2013;2013:1-10. doi: 10.1155/2013/681304

25. Kang HJ, Nam ES, Lee Y, et al. How strong is the evidence for the anxiolytic efficacy of lavender? Systematic review and meta-­analysis of randomized controlled trials. Asian Nurs Res. 2019;13:295-305. doi: 10.1016/j.anr.2019.11.003

26. Barão Paixão VL, Freire de Carvalho J. Essential oil therapy in rheumatic diseases: a systematic review. Complement Ther Clin Pract. 2021;43:101391. doi: 10.1016/j.ctcp.2021.101391

27. Yasa Ozturk G, Bashan I. The effect of aromatherapy with lavender oil on the health-related quality of life in patients with fibromyalgia. J Food Qual. 2021;2021:1-5. doi: 10.1155/2021/9938630

28. Ko GD, Hum A, Traitses G, et al. Effects of topical O24 essential oils on patients with fibromyalgia syndrome: a randomized, placebo controlled pilot study. J Musculoskelet Pain. 2007;15:11-19. doi: 10.1300/J094v15n01_03

29. Lillehei AS, Halcon LL. A systematic review of the effect of inhaled essential oils on sleep. J Altern Complement Med. 2014;20:441-451. doi: 10.1089/acm.2013.0311

30. Cheong MJ, Kim S, Kim JS, et al. A systematic literature review and meta-analysis of the clinical effects of aroma inhalation therapy on sleep problems. Medicine (Baltimore). 2021;100:e24652. doi: 10.1097/MD.0000000000024652

31. Afrasiabian F, Mirabzadeh Ardakani M, Rahmani K, et al. Aloysia citriodora Paláu (lemon verbena) for insomnia patients: a randomized, double-blind, placebo-controlled clinical trial of efficacy and safety. Phytother Res PTR. 2019;33:350-359. doi: 10.1002/ptr.6228

32. Lee M, Lim S, Song JA, et al. The effects of aromatherapy essential oil inhalation on stress, sleep quality and immunity in healthy adults: randomized controlled trial. Eur J Integr Med. 2017;12:79-86. doi: 10.1016/j.eujim.2017.04.009

33. Nasiri Lari Z, Hajimonfarednejad M, Riasatian M, et al. Efficacy of inhaled Lavandula angustifolia Mill. Essential oil on sleep quality, quality of life and metabolic control in patients with diabetes mellitus type II and insomnia. J Ethnopharmacol. 2020;251:112560. doi: 10.1016/j.jep.2020.112560

34. McDonnell B, Newcomb P. Trial of essential oils to improve sleep for patients in cardiac rehabilitation. J Altern Complement Med N Y N. 2019;25:1193-1199. doi: 10.1089/acm.2019.0222

35. Song JA, Lee MK, Min E, et al. Effects of aromatherapy on dysmenorrhea: a systematic review and meta-analysis. Int J Nurs Stud. 2018;84:1-11. doi: 10.1016/j.ijnurstu.2018.01.016

36. Ou MC, Hsu TF, Lai AC, et al. Pain relief assessment by aromatic essential oil massage on outpatients with primary dysmenorrhea: a randomized, double-blind clinical trial: PD pain relief by aromatic oil massage. J Obstet Gynaecol Res. 2012;38:817-822. doi: 10.1111/j.1447-0756.2011.01802.x

37. Sut N, Kahyaoglu-Sut H. Effect of aromatherapy massage on pain in primary dysmenorrhea: a meta-analysis. Complement Ther Clin Pract. 2017;27:5-10. doi: 10.1016/j.ctcp.2017.01.001

38. Keyhanmehr AS, Kolouri S, Heydarirad G, et al. Aromatherapy for the management of cancer complications: a narrative review. Complement Ther Clin Pract. 2018;31:175-180. doi: 10.1016/j.ctcp.2018.02.009

39. Sriningsih I, Elisa E, Lestari KP. Aromatherapy ginger use in patients with nausea & vomiting on post cervical cancer chemotherapy. KEMAS J Kesehat Masy. 2017;13:59-68. doi: 10.15294/kemas.v13i1.5367

40. Lua PL, Salihah N, Mazlan N. Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer. Complement Ther Med. 2015;23:396-404. doi: 10.1016/j.ctim.2015.03.009

41. Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020;179:985-992. doi: 10.1007/s00431-020-03595-7

42. Ghaderi F, Solhjou N. The effects of lavender aromatherapy on stress and pain perception in children during dental treatment: a randomized clinical trial. Complement Ther Clin Pract. 2020;40:101182. doi: 10.1016/j.ctcp.2020.101182

43. Jafarzadeh M, Arman S, Pour FF. Effect of aromatherapy with orange essential oil on salivary cortisol and pulse rate in children during dental treatment: a randomized controlled clinical trial. Adv Biomed Res. 2013;2:10. doi: 10.4103/2277-9175.107968

44. Lehrner J, Eckersberger C, Walla P, et al. Ambient odor of orange in a dental office reduces anxiety and improves mood in female patients. Physiol Behav. 2000;71:83-86. doi: 10.1016/S0031-9384(00)00308-5

45. Jimbo D, Kimura Y, Taniguchi M, et al. Effect of aromatherapy on patients with Alzheimer’s disease. Psychogeriatrics. 2009;9:173-179. doi: 10.1111/j.1479-8301.2009.00299.x

46. Ball EL, Owen-Booth B, Gray A, et al. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020;(8). doi: 10.1002/14651858.CD003150.pub3

47. Uzunçakmak T, Ayaz Alkaya S. Effect of aromatherapy on coping with premenstrual syndrome: a randomized controlled trial. Complement Ther Med. 2018;36:63-67. doi: 10.1016/j.ctim.2017.11.022

48. Tanvisut R, Traisrisilp K, Tongsong T. Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial. Arch Gynecol Obstet. 2018;297:1145-1150. doi: 10.1007/s00404-018-4700-1

49. Ramsey JT, Shropshire BC, Nagy TR, et al. Essential oils and health. Yale J Biol Med. 2020;93:291-305.

50. Puškárová A, Bučková M, Kraková L, et al. The antibacterial and antifungal activity of six essential oils and their cyto/genotoxicity­ to human HEL 12469 cells. Sci Rep. 2017;7:8211. doi: 10.1038/s41598-017-08673-9

51. Deyno S, Mtewa AG, Abebe A, et al. Essential oils as topical anti-infective agents: a systematic review and meta-analysis. Complement Ther Med. 2019;47:102224. doi: 10.1016/j.ctim.2019.102224

52. Prall S, Bowles EJ, Bennett K, et al. Effects of essential oils on symptoms and course (duration and severity) of viral respiratory infections in humans: a rapid review. Adv Integr Med. 2020;7:218-221. doi: 10.1016/j.aimed.2020.07.005

53. Weeks JA, Guiney PD, Nikiforov AI. Assessment of the environmental fate and ecotoxicity of N,N-diethyl-m-toluamide (DEET). Integr Environ Assess Manag. 2012;8:120-134. doi: 10.1002/ieam.1246

54. Nerio LS, Olivero-Verbel J, Stashenko E. Repellent activity of essential oils: a review. Bioresour Technol. 2010;101:372-378. doi: 10.1016/j.biortech.2009.07.048

55. Lee MY. Essential oils as repellents against arthropods. BioMed Res Int. 2018;2018:6860271. doi: 10.1155/2018/6860271

56. Göbel H, Heinze A, Heinze-Kuhn K, et al. [Peppermint oil in the acute treatment of tension-type headache]. Schmerz Berl Ger. 2016;30:295-310. doi: 10.1007/s00482-016-0109-6

Issue
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Essential oils: How safe? How effective?
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PRACTICE RECOMMENDATIONS

› Utilize lavender essential oil as an adjunctive treatment for fibromyalgia, dysmenorrhea, anxiety, and insomnia symptoms. B

› Recommend peppermint essential oil as an adjunctive treatment for irritable bowel syndrome, chemotherapy-induced nausea, and headache. B

Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

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Prior authorizations interfere with recommended cancer care

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Prior authorization requirements delay or preclude recommended treatment in a substantial proportion of oncology patients, findings from a survey-based cross-sectional study suggest.

Of 178 respondents with a prior authorization (PA) experience, 39 (22%) did not receive the care recommended by their treatment team because of a PA requirement, and 123 (69%) experienced a delay in receiving the recommended care, Fumiko Chino, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues reported.

Reasons for not receiving recommended care included complete denial by the insurance company (26 of 39 patients), and a change in treatment plan because of initial denial (13 of 39 patients). Delays in receiving recommended care were 2 or more weeks for 90 of 123 patients, and 1 month or more in 40 of 123 patients.

Delays in receiving recommended care were associated with increased patient anxiety, a negative perception of the PA process, and patient administrative burden, the investigators noted.

The findings, which capture patient-based perspectives in the ongoing PA debacle, were reported online in JAMA Network Open.

“Prior authorization requires clinicians and patients to navigate a complex approval pathway. Resultant delays and denial can be particularly problematic for patients with cancer, who often need urgent treatment or symptom management,” the investigators explained. “Focusing on patient experiences with PA highlights a missing perspective in policy discussions and suggests another potential factor associated with eroding trust in the health care system.”

To assess the impact of PA, they conducted an anonymous survey using a convenience sample of patients with any cancer-related PA experience from July 1 to Oct. 6, 2022. Mean self-reported PA-related anxiety scores were 74.7 on a scale of 0-100, whereas usual anxiety scores were 37.5.

PA-related anxiety scores were significantly correlated with the length of treatment delay (P = .04), time spent on PA (P < .001), and overall PA experience (P < .001).

“Dealing with PA issues adds an extra layer of stress, which is known to increase anxiety and can worsen treatment-related and disease-related symptoms and adverse effects,” the investigators noted.

PA issues also eroded trust: 89% of respondents trusted their insurance company less, and 83% trusted the health care system less after a PA experience. Patient involvement in the PA process increased the likelihood of such distrust and of having a negative experience.

Of the 178 respondents, most were women (88%), non-Hispanic White individuals (84%), college graduates (84%), and young (18-39 years, 41%; 40-54 years, 33%). Most (67%) had to personally become involved in the PA process by calling their insurance or filing an appeal.

The investigators noted that “efforts to create national health policy solutions that streamline PA and make the process more transparent have been a major lobbying effort of large oncology societies,” and that bipartisan legislation to “establish regulations on the quality and timeliness of PA in the Medicare Advantage population” has stalled.

“In the meantime, the Centers for Medicare & Medicaid Services acted directly by issuing a final rule in April 2023 aimed at improving PA processes within the Medicare Advantage population by 2024,” they wrote, adding that “streamlining the PA process is key to optimizing the quality of care delivered and improving patients’ experience with cancer care.

“Policy interventions will be necessary to reform the PA process, as will advocacy efforts at the patient, clinician, and hospital level,” they concluded.

Chino reported funding through a National Institutes of Health/National Cancer Institute Cancer Center Support Grant.

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Prior authorization requirements delay or preclude recommended treatment in a substantial proportion of oncology patients, findings from a survey-based cross-sectional study suggest.

Of 178 respondents with a prior authorization (PA) experience, 39 (22%) did not receive the care recommended by their treatment team because of a PA requirement, and 123 (69%) experienced a delay in receiving the recommended care, Fumiko Chino, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues reported.

Reasons for not receiving recommended care included complete denial by the insurance company (26 of 39 patients), and a change in treatment plan because of initial denial (13 of 39 patients). Delays in receiving recommended care were 2 or more weeks for 90 of 123 patients, and 1 month or more in 40 of 123 patients.

Delays in receiving recommended care were associated with increased patient anxiety, a negative perception of the PA process, and patient administrative burden, the investigators noted.

The findings, which capture patient-based perspectives in the ongoing PA debacle, were reported online in JAMA Network Open.

“Prior authorization requires clinicians and patients to navigate a complex approval pathway. Resultant delays and denial can be particularly problematic for patients with cancer, who often need urgent treatment or symptom management,” the investigators explained. “Focusing on patient experiences with PA highlights a missing perspective in policy discussions and suggests another potential factor associated with eroding trust in the health care system.”

To assess the impact of PA, they conducted an anonymous survey using a convenience sample of patients with any cancer-related PA experience from July 1 to Oct. 6, 2022. Mean self-reported PA-related anxiety scores were 74.7 on a scale of 0-100, whereas usual anxiety scores were 37.5.

PA-related anxiety scores were significantly correlated with the length of treatment delay (P = .04), time spent on PA (P < .001), and overall PA experience (P < .001).

“Dealing with PA issues adds an extra layer of stress, which is known to increase anxiety and can worsen treatment-related and disease-related symptoms and adverse effects,” the investigators noted.

PA issues also eroded trust: 89% of respondents trusted their insurance company less, and 83% trusted the health care system less after a PA experience. Patient involvement in the PA process increased the likelihood of such distrust and of having a negative experience.

Of the 178 respondents, most were women (88%), non-Hispanic White individuals (84%), college graduates (84%), and young (18-39 years, 41%; 40-54 years, 33%). Most (67%) had to personally become involved in the PA process by calling their insurance or filing an appeal.

The investigators noted that “efforts to create national health policy solutions that streamline PA and make the process more transparent have been a major lobbying effort of large oncology societies,” and that bipartisan legislation to “establish regulations on the quality and timeliness of PA in the Medicare Advantage population” has stalled.

“In the meantime, the Centers for Medicare & Medicaid Services acted directly by issuing a final rule in April 2023 aimed at improving PA processes within the Medicare Advantage population by 2024,” they wrote, adding that “streamlining the PA process is key to optimizing the quality of care delivered and improving patients’ experience with cancer care.

“Policy interventions will be necessary to reform the PA process, as will advocacy efforts at the patient, clinician, and hospital level,” they concluded.

Chino reported funding through a National Institutes of Health/National Cancer Institute Cancer Center Support Grant.

Prior authorization requirements delay or preclude recommended treatment in a substantial proportion of oncology patients, findings from a survey-based cross-sectional study suggest.

Of 178 respondents with a prior authorization (PA) experience, 39 (22%) did not receive the care recommended by their treatment team because of a PA requirement, and 123 (69%) experienced a delay in receiving the recommended care, Fumiko Chino, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues reported.

Reasons for not receiving recommended care included complete denial by the insurance company (26 of 39 patients), and a change in treatment plan because of initial denial (13 of 39 patients). Delays in receiving recommended care were 2 or more weeks for 90 of 123 patients, and 1 month or more in 40 of 123 patients.

Delays in receiving recommended care were associated with increased patient anxiety, a negative perception of the PA process, and patient administrative burden, the investigators noted.

The findings, which capture patient-based perspectives in the ongoing PA debacle, were reported online in JAMA Network Open.

“Prior authorization requires clinicians and patients to navigate a complex approval pathway. Resultant delays and denial can be particularly problematic for patients with cancer, who often need urgent treatment or symptom management,” the investigators explained. “Focusing on patient experiences with PA highlights a missing perspective in policy discussions and suggests another potential factor associated with eroding trust in the health care system.”

To assess the impact of PA, they conducted an anonymous survey using a convenience sample of patients with any cancer-related PA experience from July 1 to Oct. 6, 2022. Mean self-reported PA-related anxiety scores were 74.7 on a scale of 0-100, whereas usual anxiety scores were 37.5.

PA-related anxiety scores were significantly correlated with the length of treatment delay (P = .04), time spent on PA (P < .001), and overall PA experience (P < .001).

“Dealing with PA issues adds an extra layer of stress, which is known to increase anxiety and can worsen treatment-related and disease-related symptoms and adverse effects,” the investigators noted.

PA issues also eroded trust: 89% of respondents trusted their insurance company less, and 83% trusted the health care system less after a PA experience. Patient involvement in the PA process increased the likelihood of such distrust and of having a negative experience.

Of the 178 respondents, most were women (88%), non-Hispanic White individuals (84%), college graduates (84%), and young (18-39 years, 41%; 40-54 years, 33%). Most (67%) had to personally become involved in the PA process by calling their insurance or filing an appeal.

The investigators noted that “efforts to create national health policy solutions that streamline PA and make the process more transparent have been a major lobbying effort of large oncology societies,” and that bipartisan legislation to “establish regulations on the quality and timeliness of PA in the Medicare Advantage population” has stalled.

“In the meantime, the Centers for Medicare & Medicaid Services acted directly by issuing a final rule in April 2023 aimed at improving PA processes within the Medicare Advantage population by 2024,” they wrote, adding that “streamlining the PA process is key to optimizing the quality of care delivered and improving patients’ experience with cancer care.

“Policy interventions will be necessary to reform the PA process, as will advocacy efforts at the patient, clinician, and hospital level,” they concluded.

Chino reported funding through a National Institutes of Health/National Cancer Institute Cancer Center Support Grant.

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Studies address primary care oral health screening and prevention for children

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Two sets of evidence reports address the primary care physicians’ role in children and adolescents’ oral health and the effectiveness of the fluoride gels and sealants offered at dental offices and schools.

Both were published online in JAMA.

In one report, the United States Preventive Services Task Force (USPSTF) concludes that there is not enough evidence to assess harms versus benefits of routine screening or interventions for oral health conditions, including dental caries, in primary care for asymptomatic children and adolescents aged 5-17 years.

The evidence report on administering fluoride supplements, fluoride gels, sealants and varnish finds evidence that they improve outcomes. The report was done to inform the USPSTF for a new recommendation on primary care screening, dental referral, behavioral counseling, and preventive interventions for oral health in children and adolescents aged 5-17.
 

Primary care physicians’ role

One problem the USPSTF identified in its report was limited evidence on available clinical screening tools or assessments to identify which children have oral health conditions in the primary care setting.

The USPSTF’s team, led by Michael J. Barry, MD, of Harvard Medical School in Boston, calls for more research to fill in the gaps before it can reassess.

Michael S. Reddy, DMD, DMSc, with University of California San Francisco School of Dentistry, Oral Health Affairs, said in an accompanying editorial that the current lack of data should not keep primary care physicians from considering oral health during routine medical exams or keep dentists from finding ways to collaborate with primary care physicians. “Medical primary care must partner with dentistry,” they wrote.

Until there is enough evidence for a USPSTF reevaluation on the topic, primary care clinicians should ask patients about their oral hygiene routines, whether they have any dental symptoms, and when they last saw a dentist, as well as referring to a dentist as necessary, the editorialists wrote.

That works both ways, the editorialists added. “Equally important, oral health professionals are encouraged to collaborate and be a resource for their primary care colleagues. Prevention is one of the best tools clinicians have, and it is promoted by integrated, whole-person health effort, “ wrote Dr. Reddy and colleagues.

When oral health stays separate from medical care, patients are left vulnerable, and referrals between medical and dental offices should be a stronger two-way system, the editorialists said.

“[N]ot every primary care patient has access to a dentist,” they wrote. “Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health. Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Evidence that gels, varnish, sealants are effective

In a companion paper, done to inform the USPSTF, Roger Chou, MD, with Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology at Oregon Health & Science University in Portland, and colleagues found that when administered by a dental professional or in school settings, fluoride supplements, gels and varnish, and resin-based sealants improved health outcomes.

The findings were based on three systematic reviews (20,684 participants) and 19 randomized clinical trials; three nonrandomized trials; and one observational study (total 15,026 participants.)

With fluoride versus placebo or no intervention, researchers found a decrease from baseline in the number of decayed, missing, or filled permanent teeth (DMFT index) or decayed or filled permanent teeth (DFT index). The average difference was −0.73 [95% confidence interval [CI], −1.30 to −0.19]) at 1.5 to 3 years (six trials; n = 1,395).

Fluoride gels were associated with a DMFT- or DFT-prevented fraction of 0.18 (95% CI, 0.09-0.27) at outcomes closest to 3 years (four trials; n = 1,525).

Researchers found an association between fluoride varnish and a DMFT- or DFT-prevented fraction of 0.44 (95% CI, 0.11-0.76) at 1 to 4.5 years (five trials; n = 3,902). The sealants tested were associated with decreased risk of caries in first molars (odds ratio, 0.21 [95% CI, 0.16-0.28]) at 48-54 months (four trials; n = 440).

They noted that the feasibility of administering preventive measures in primary care is unknown; the effectiveness shown here was based on administration in dental and supervised school settings.

Barriers in primary care settings may include lack of training and equipment (particularly for sealants), uncertain reimbursement and lack of acceptance and uptake.
 

USPSTF working to close evidence gaps

Wanda Nicholson, MD, MPH, Prevention and Community Health, George Washington Milken Institute of Public Health in Washington, wrote in an accompanying editorial that to speed necessary research to facilitate recommendations, “the USPSTF and its stakeholders need a transparent, easily implementable communication tool that will systematically describe the research necessary to be directly responsive to the evidence gaps.”

The editorialists noted that the USPSTF in trying to update recommendations often has few, if any, high-quality additional studies to consider since its previous recommendation.

To address that, meetings were conducted in November of 2022 involving USPSTF members, Agency for Healthcare Research and Quality (AHRQ) staff, and leadership from the Office of Disease Prevention and the National Institutes of Health. Members formed a working group “to develop a standardized template for communicating research gaps” according to a framework developed by the National Academies of Sciences, Engineering, and Medicine.

Dr. Nicholson and colleagues wrote, “classifying evidence gaps and calling for specific research needs is a prudent, collaborative step in addressing missing evidence,” particularly for underserved populations.

The authors and editorialists declared no relevant conflicts of interest.

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Two sets of evidence reports address the primary care physicians’ role in children and adolescents’ oral health and the effectiveness of the fluoride gels and sealants offered at dental offices and schools.

Both were published online in JAMA.

In one report, the United States Preventive Services Task Force (USPSTF) concludes that there is not enough evidence to assess harms versus benefits of routine screening or interventions for oral health conditions, including dental caries, in primary care for asymptomatic children and adolescents aged 5-17 years.

The evidence report on administering fluoride supplements, fluoride gels, sealants and varnish finds evidence that they improve outcomes. The report was done to inform the USPSTF for a new recommendation on primary care screening, dental referral, behavioral counseling, and preventive interventions for oral health in children and adolescents aged 5-17.
 

Primary care physicians’ role

One problem the USPSTF identified in its report was limited evidence on available clinical screening tools or assessments to identify which children have oral health conditions in the primary care setting.

The USPSTF’s team, led by Michael J. Barry, MD, of Harvard Medical School in Boston, calls for more research to fill in the gaps before it can reassess.

Michael S. Reddy, DMD, DMSc, with University of California San Francisco School of Dentistry, Oral Health Affairs, said in an accompanying editorial that the current lack of data should not keep primary care physicians from considering oral health during routine medical exams or keep dentists from finding ways to collaborate with primary care physicians. “Medical primary care must partner with dentistry,” they wrote.

Until there is enough evidence for a USPSTF reevaluation on the topic, primary care clinicians should ask patients about their oral hygiene routines, whether they have any dental symptoms, and when they last saw a dentist, as well as referring to a dentist as necessary, the editorialists wrote.

That works both ways, the editorialists added. “Equally important, oral health professionals are encouraged to collaborate and be a resource for their primary care colleagues. Prevention is one of the best tools clinicians have, and it is promoted by integrated, whole-person health effort, “ wrote Dr. Reddy and colleagues.

When oral health stays separate from medical care, patients are left vulnerable, and referrals between medical and dental offices should be a stronger two-way system, the editorialists said.

“[N]ot every primary care patient has access to a dentist,” they wrote. “Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health. Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Evidence that gels, varnish, sealants are effective

In a companion paper, done to inform the USPSTF, Roger Chou, MD, with Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology at Oregon Health & Science University in Portland, and colleagues found that when administered by a dental professional or in school settings, fluoride supplements, gels and varnish, and resin-based sealants improved health outcomes.

The findings were based on three systematic reviews (20,684 participants) and 19 randomized clinical trials; three nonrandomized trials; and one observational study (total 15,026 participants.)

With fluoride versus placebo or no intervention, researchers found a decrease from baseline in the number of decayed, missing, or filled permanent teeth (DMFT index) or decayed or filled permanent teeth (DFT index). The average difference was −0.73 [95% confidence interval [CI], −1.30 to −0.19]) at 1.5 to 3 years (six trials; n = 1,395).

Fluoride gels were associated with a DMFT- or DFT-prevented fraction of 0.18 (95% CI, 0.09-0.27) at outcomes closest to 3 years (four trials; n = 1,525).

Researchers found an association between fluoride varnish and a DMFT- or DFT-prevented fraction of 0.44 (95% CI, 0.11-0.76) at 1 to 4.5 years (five trials; n = 3,902). The sealants tested were associated with decreased risk of caries in first molars (odds ratio, 0.21 [95% CI, 0.16-0.28]) at 48-54 months (four trials; n = 440).

They noted that the feasibility of administering preventive measures in primary care is unknown; the effectiveness shown here was based on administration in dental and supervised school settings.

Barriers in primary care settings may include lack of training and equipment (particularly for sealants), uncertain reimbursement and lack of acceptance and uptake.
 

USPSTF working to close evidence gaps

Wanda Nicholson, MD, MPH, Prevention and Community Health, George Washington Milken Institute of Public Health in Washington, wrote in an accompanying editorial that to speed necessary research to facilitate recommendations, “the USPSTF and its stakeholders need a transparent, easily implementable communication tool that will systematically describe the research necessary to be directly responsive to the evidence gaps.”

The editorialists noted that the USPSTF in trying to update recommendations often has few, if any, high-quality additional studies to consider since its previous recommendation.

To address that, meetings were conducted in November of 2022 involving USPSTF members, Agency for Healthcare Research and Quality (AHRQ) staff, and leadership from the Office of Disease Prevention and the National Institutes of Health. Members formed a working group “to develop a standardized template for communicating research gaps” according to a framework developed by the National Academies of Sciences, Engineering, and Medicine.

Dr. Nicholson and colleagues wrote, “classifying evidence gaps and calling for specific research needs is a prudent, collaborative step in addressing missing evidence,” particularly for underserved populations.

The authors and editorialists declared no relevant conflicts of interest.

Two sets of evidence reports address the primary care physicians’ role in children and adolescents’ oral health and the effectiveness of the fluoride gels and sealants offered at dental offices and schools.

Both were published online in JAMA.

In one report, the United States Preventive Services Task Force (USPSTF) concludes that there is not enough evidence to assess harms versus benefits of routine screening or interventions for oral health conditions, including dental caries, in primary care for asymptomatic children and adolescents aged 5-17 years.

The evidence report on administering fluoride supplements, fluoride gels, sealants and varnish finds evidence that they improve outcomes. The report was done to inform the USPSTF for a new recommendation on primary care screening, dental referral, behavioral counseling, and preventive interventions for oral health in children and adolescents aged 5-17.
 

Primary care physicians’ role

One problem the USPSTF identified in its report was limited evidence on available clinical screening tools or assessments to identify which children have oral health conditions in the primary care setting.

The USPSTF’s team, led by Michael J. Barry, MD, of Harvard Medical School in Boston, calls for more research to fill in the gaps before it can reassess.

Michael S. Reddy, DMD, DMSc, with University of California San Francisco School of Dentistry, Oral Health Affairs, said in an accompanying editorial that the current lack of data should not keep primary care physicians from considering oral health during routine medical exams or keep dentists from finding ways to collaborate with primary care physicians. “Medical primary care must partner with dentistry,” they wrote.

Until there is enough evidence for a USPSTF reevaluation on the topic, primary care clinicians should ask patients about their oral hygiene routines, whether they have any dental symptoms, and when they last saw a dentist, as well as referring to a dentist as necessary, the editorialists wrote.

That works both ways, the editorialists added. “Equally important, oral health professionals are encouraged to collaborate and be a resource for their primary care colleagues. Prevention is one of the best tools clinicians have, and it is promoted by integrated, whole-person health effort, “ wrote Dr. Reddy and colleagues.

When oral health stays separate from medical care, patients are left vulnerable, and referrals between medical and dental offices should be a stronger two-way system, the editorialists said.

“[N]ot every primary care patient has access to a dentist,” they wrote. “Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health. Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Evidence that gels, varnish, sealants are effective

In a companion paper, done to inform the USPSTF, Roger Chou, MD, with Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology at Oregon Health & Science University in Portland, and colleagues found that when administered by a dental professional or in school settings, fluoride supplements, gels and varnish, and resin-based sealants improved health outcomes.

The findings were based on three systematic reviews (20,684 participants) and 19 randomized clinical trials; three nonrandomized trials; and one observational study (total 15,026 participants.)

With fluoride versus placebo or no intervention, researchers found a decrease from baseline in the number of decayed, missing, or filled permanent teeth (DMFT index) or decayed or filled permanent teeth (DFT index). The average difference was −0.73 [95% confidence interval [CI], −1.30 to −0.19]) at 1.5 to 3 years (six trials; n = 1,395).

Fluoride gels were associated with a DMFT- or DFT-prevented fraction of 0.18 (95% CI, 0.09-0.27) at outcomes closest to 3 years (four trials; n = 1,525).

Researchers found an association between fluoride varnish and a DMFT- or DFT-prevented fraction of 0.44 (95% CI, 0.11-0.76) at 1 to 4.5 years (five trials; n = 3,902). The sealants tested were associated with decreased risk of caries in first molars (odds ratio, 0.21 [95% CI, 0.16-0.28]) at 48-54 months (four trials; n = 440).

They noted that the feasibility of administering preventive measures in primary care is unknown; the effectiveness shown here was based on administration in dental and supervised school settings.

Barriers in primary care settings may include lack of training and equipment (particularly for sealants), uncertain reimbursement and lack of acceptance and uptake.
 

USPSTF working to close evidence gaps

Wanda Nicholson, MD, MPH, Prevention and Community Health, George Washington Milken Institute of Public Health in Washington, wrote in an accompanying editorial that to speed necessary research to facilitate recommendations, “the USPSTF and its stakeholders need a transparent, easily implementable communication tool that will systematically describe the research necessary to be directly responsive to the evidence gaps.”

The editorialists noted that the USPSTF in trying to update recommendations often has few, if any, high-quality additional studies to consider since its previous recommendation.

To address that, meetings were conducted in November of 2022 involving USPSTF members, Agency for Healthcare Research and Quality (AHRQ) staff, and leadership from the Office of Disease Prevention and the National Institutes of Health. Members formed a working group “to develop a standardized template for communicating research gaps” according to a framework developed by the National Academies of Sciences, Engineering, and Medicine.

Dr. Nicholson and colleagues wrote, “classifying evidence gaps and calling for specific research needs is a prudent, collaborative step in addressing missing evidence,” particularly for underserved populations.

The authors and editorialists declared no relevant conflicts of interest.

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Veterans Get $6 billion in Hearing Loss Settlement

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Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

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Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

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Body dysmorphic disorder diagnosis guidelines completed in Europe

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European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Dr. Maria-Angeliki Gkini


“BDD is a relatively common disorder in which the patients are preoccupied with a perceived defect or defects,” Dr. Gkini explained. “This affects them so intensely that it affects their mental health and their quality of life.”

In the DSM-5, published by the American Psychiatric Association, BDD is specifically defined as a preoccupation with “one or more perceived defects or flaws in physical appearance that are not observable or appear slight to others.” But Dr. Gkini said that BDD can also develop as a comorbidity of dermatological disorders that are visible.

These patients are challenging because they are difficult to please, added Dr. Gkini, who said they commonly become involved in doctor shopping, leaving negative reviews on social media for the clinicians they have cycled through. The problem is that the defects they seek to resolve typically stem from distorted perceptions.

BDD is related to obsessive-compulsive disorder by the frequency with which patients pursue repetitive behaviors related to their preoccupation, such as intensive grooming, frequent trips to the mirror, or difficulty in focusing on topics other than their own appearance.

The process to develop the soon-to-be-published guidelines began with a literature search. Of the approximately 3,200 articles identified on BDD, only 10 involved randomized controlled trials. Moreover, even the quality of these trials was considered “low to very low” by the experts who reviewed them, Dr. Gkini said.

One explanation is that psychodermatology has only recently started to attract more research interest, and better studies are now underway, she noted.

However, because of the dearth of high quality evidence now available, the guideline development relied on a Delphi method to reach consensus based on expert opinion in discussion of the available data.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

 

 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”



She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

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European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Dr. Maria-Angeliki Gkini


“BDD is a relatively common disorder in which the patients are preoccupied with a perceived defect or defects,” Dr. Gkini explained. “This affects them so intensely that it affects their mental health and their quality of life.”

In the DSM-5, published by the American Psychiatric Association, BDD is specifically defined as a preoccupation with “one or more perceived defects or flaws in physical appearance that are not observable or appear slight to others.” But Dr. Gkini said that BDD can also develop as a comorbidity of dermatological disorders that are visible.

These patients are challenging because they are difficult to please, added Dr. Gkini, who said they commonly become involved in doctor shopping, leaving negative reviews on social media for the clinicians they have cycled through. The problem is that the defects they seek to resolve typically stem from distorted perceptions.

BDD is related to obsessive-compulsive disorder by the frequency with which patients pursue repetitive behaviors related to their preoccupation, such as intensive grooming, frequent trips to the mirror, or difficulty in focusing on topics other than their own appearance.

The process to develop the soon-to-be-published guidelines began with a literature search. Of the approximately 3,200 articles identified on BDD, only 10 involved randomized controlled trials. Moreover, even the quality of these trials was considered “low to very low” by the experts who reviewed them, Dr. Gkini said.

One explanation is that psychodermatology has only recently started to attract more research interest, and better studies are now underway, she noted.

However, because of the dearth of high quality evidence now available, the guideline development relied on a Delphi method to reach consensus based on expert opinion in discussion of the available data.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

 

 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”



She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Dr. Maria-Angeliki Gkini


“BDD is a relatively common disorder in which the patients are preoccupied with a perceived defect or defects,” Dr. Gkini explained. “This affects them so intensely that it affects their mental health and their quality of life.”

In the DSM-5, published by the American Psychiatric Association, BDD is specifically defined as a preoccupation with “one or more perceived defects or flaws in physical appearance that are not observable or appear slight to others.” But Dr. Gkini said that BDD can also develop as a comorbidity of dermatological disorders that are visible.

These patients are challenging because they are difficult to please, added Dr. Gkini, who said they commonly become involved in doctor shopping, leaving negative reviews on social media for the clinicians they have cycled through. The problem is that the defects they seek to resolve typically stem from distorted perceptions.

BDD is related to obsessive-compulsive disorder by the frequency with which patients pursue repetitive behaviors related to their preoccupation, such as intensive grooming, frequent trips to the mirror, or difficulty in focusing on topics other than their own appearance.

The process to develop the soon-to-be-published guidelines began with a literature search. Of the approximately 3,200 articles identified on BDD, only 10 involved randomized controlled trials. Moreover, even the quality of these trials was considered “low to very low” by the experts who reviewed them, Dr. Gkini said.

One explanation is that psychodermatology has only recently started to attract more research interest, and better studies are now underway, she noted.

However, because of the dearth of high quality evidence now available, the guideline development relied on a Delphi method to reach consensus based on expert opinion in discussion of the available data.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

 

 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”



She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

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Monitoring Thyrotropin in Veterans With Thyroid Nodules

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When thyroid nodules are found clinically or incidentally on imaging, the patient’s thyrotropin level should be measured.1 Ultrasound is the first-line imaging recommended to assess thyroid nodules.1,2 Nodules can then be evaluated by a fine-needle aspiration (FNA) biopsy, which provides cytological information to determine whether the nodule is benign or malignant.1,3,4 Most thyroid nodules pose a low risk of malignancy.1

The American Thyroid Association guidelines on thyroid nodule management do not specify any recommendations for follow-up thyrotropin testing in patients who do not have any history that is known to affect thyroid function.1 Therefore, clinicians have to make decisions regarding follow-up testing in these patients without any evidence-based guidelines. There is a lack of data in the literature on whether thyrotropin levels change over time in this patient population. If thyrotropin levels do not become abnormal over time, then patients would not need thyrotropin monitoring or treatment for hypo- or hyperthyroidism.

The aim of this study was to determine whether thyrotropin levels change over time in patients with thyroid nodules and determine whether repeat thyrotropin testing was required after initial testing. The authors hypothesized that thyrotropin values do not change substantially over time in patients with thyroid nodules, except in patients with a history of hot nodules, autoimmune thyroid disease, thyroid or pituitary surgery, radioactive iodine ablation, neck radiation, or use of medications affecting thyroid function. This study may be able to contribute to the clinical guidelines for thyrotropin testing in patients with thyroid nodules so that clinicians can make evidence-based decisions.

METHODS

This retrospective chart review was conducted using the Computerized Patient Record System at the Veterans Affairs Dayton Healthcare System (VADHS) in Ohio. Patients aged ≥ 18 years who were diagnosed with ≥ 1 thyroid nodule from January 2010 to December 2016 and had a normal thyrotropin level at the time of diagnosis were included in the study. Patients who were found to have thyroid nodules multiple times were included only once from the time of the initial diagnosis. Patients were excluded if they had a medical history known to affect thyroid function. Exclusion criteria included a history of hot thyroid nodules; autoimmune thyroid disease on imaging or blood work; history of thyroid surgery, including pituitary surgery; history of radioactive iodine treatment; history of neck radiation; use of thyroxine before nodule diagnosis; use of amiodarone, programmed cell death-1 inhibitors, programmed cell death ligand-1 inhibitors, or cytotoxic T-lymphocyte-associated protein-4 inhibitors; or 3 consecutive months of steroid use.

Age at nodule diagnosis, sex, race, thyrotropin values at and after the time of nodule diagnosis, and duration from nodule diagnosis to most recent thyrotropin value were retrospectively collected until 100 patients met inclusion criteria for the study. Of note, from 2010 to 2016, the assays used at the VADHS to measure thyrotropin values changed over time, as did the normal reference ranges and the type of sample used for the assays. Normal thyrotropin range at time of diagnosis based on serum or plasma samples and for repeat thyrotropin levels are provided in Table 1, also based on serum or plasma samples. All collected data in the study was de-identified for analysis.

Statistical Analysis

Patients were divided into 2 groups: those who had an abnormal most recent thyrotropin value and those who did not. Mean (SD) of both groups was calculated for continuous variables of age at diagnosis, initial thyrotropin value and most recent thyrotropin value, and time from diagnosis to most recent thyrotropin value. Percentages for both groups were calculated for categorical variables of sex, race, and whether initial and most recent thyrotropin values were based on serum or plasma samples and old or new reference ranges. A 95% CI was determined for the true population rate of patients with an abnormal thyrotropin value at most recent testing. Independent sample t tests were used to compare the continuous variables between the abnormal and normal most recent thyrotropin groups. Categorical variables between the 2 groups were compared using χ2 tests. P < .05 was considered statistically significant. Statistical analyses were completed using IBM SPSS Statistics 27. This study was approved by the Wright State University Institutional Review Board and the VADHS Research and Development Committee.

 

 

RESULTS

Of 557 patient charts studied, 100 patients were included; the mean (SD) age at nodule diagnosis was 62.4 (11.1) years, and the mean (SD) initial thyrotropin level at nodule diagnosis was 1.51 (0.87) μIU/mL. The mean (SD) most recent thyrotropin level was 1.60 (1.03) μIU/mL after a mean duration of 5.7 (2.5) years postnodule diagnosis (Table 2).

Six patients (6%; 95% CI, 2.5%-12.7%) who had a normal thyrotropin level at nodule diagnosis developed an abnormal thyrotropin level in a mean (SD) of 6.9 (3.1) years. These 6 patients had a mean age at nodule diagnosis of 69.2 (11.4) years. Five of the 6 were male, and all were White patients. One patient’s thyrotropin level rose from an initial thyrotropin of 3.38 μIU/mL at nodule diagnosis to a high of 7.76 μIU/mL after 8.5 years. This patient was diagnosed with subclinical hypothyroidism and did not require treatment.

Five patients’ thyrotropin levels dropped below normal in a mean 7 years, with levels ranging from 0.25 to 0.52 μIU/mL. Of these patients, 2 became symptomatic from the nodules, experiencing dysphagia or hoarseness, with 1 diagnosed with hyperthyroidism. This patient was treated with methimazole and radioactive iodine ablation 9 years after diagnosis. The other 3 patients who developed low thyrotropin had no nodule symptoms or treatment. Ninety-four patients maintained thyrotropin values in the normal range for a mean (SD) of 5.7 (2.5) years and had a mean (SD) age at nodule diagnosis of 61.9 (11.0) years.

Both thyrotropin groups were compared. For categorical variables, there were no significant differences for sex (P = .99) or race (P = .55). For continuous variables, there were no significant differences in age at diagnosis (P = .12), initial thyrotropin (P = .24), most recent thyrotropin (P = .98), or time from diagnosis to most recent thyrotropin level (P = .23) (Table 3).

Of note, the VADHS changed the type of blood sample used to generate thyrotropin values from serum to plasma and had 3 different normal reference ranges during the 2010 to 2016 period studied. The thyrotropin values fell into 4 categories: serum sample with normal range 0.4 to 5.5 μIU/mL, serum sample with normal range 0.4 to 4.0 μIU/mL, plasma sample with normal range 0.4 to 4.0 μIU/mL, and plasma sample with normal range 0.6 to 4.8 μIU/mL. There were no significant differences between the abnormal and normal most recent thyrotropin groups in sample type for initial or most recent thyrotropin (P = .44 and P = .99, respectively) or in normal range for initial or most recent thyrotropin level (P = .99 and P = .09, respectively).

DISCUSSION

We found no statistically significant change in blood thyrotropin levels over time among patients with thyroid nodules with no history of medical conditions or medications known to affect thyroid hormone levels. Six of 100 patients developed abnormal thyrotropin, but only 2 eventually were treated for thyroid dysfunction: 1 for hypothyroidism and 1 for hyperthyroidism. The other 4 patients who did not receive treatment developed low thyrotropin but had no official diagnosis of hyperthyroidism in their health records, seemingly due to lack of multiple, consistently low thyrotropin values or due to lack of follow-up. Based on these data, monitoring thyrotropin over time may not be necessary in patients without any medical history known to affect thyroid function. The results provide support for the original hypothesis.

 

 

Although only thyrotropin values at the time of nodule diagnosis and most recent thyrotropin values were analyzed, thyrotropin trends over time were considered. Some patients did have transient abnormal thyrotropin values; however, a search of the patients’ records showed that these transient abnormalities did not lead to any initiation of hypothyroidism or hyperthyroidism treatment.

Another consideration is that changes in the sample type processed and in the normal thyrotropin ranges over time could have been confounding variables. However, statistical analyses showed that the abnormal and normal most recent thyrotropin groups did not show any significant differences in sample type or reference range for either the initial or most recent thyrotropin values. Hospitals change the laboratory assays they use for clinical tests over time, but these changes likely did not affect the results of this study.

The data from this study showed similar results to previously reported research. This study found that 6% of patients developed abnormal thyrotropin levels over time. A study of 157 patients with nonfunctioning benign thyroid nodules found that 8.3% of patients developed thyroid dysfunction.5 In another follow-up study on patients with thyroid nodules who were otherwise euthyroid, 2 of 118 patients eventually received treatment for hyperthyroidism.6 In the current study, we report that just 1 of 100 included patients had to begin treatment for hyperthyroidism.

The literature also includes research on using thyrotropin and age to predict malignancy in patients with thyroid nodules. One study suggested that a thyrotropin cutoff point of ≥ 2.1 mU/I and an age cutoff point of ≥ 47 years were significantly associated with a diagnosis of malignancy.7 Although the current study did not study malignancy, the results showed that the mean age at nodule diagnosis was higher in patients who had abnormal vs normal most recent thyrotropin levels: 69 vs 62 years, respectively. Future studies could determine whether a certain initial thyrotropin value or age could be used as a cutoff for requiring further thyrotropin monitoring to check for development of hyperthyroidism or hypothyroidism.

Limitations

This study was limited by its small size of 100 subjects. Most patients had to be excluded to focus on the aim of determining whether thyrotropin monitoring is needed in the specific group of patients without medical history that would be expected to affect thyroid function. Another limitation was that 83% of the patients included in the study were male, which does not reflect the general population. Future studies should include a greater number of patients and aim for a balance of 50% male and 50% female patients.

Additionally, it is important to note that the changing definition of the normal thyrotropin range was a limitation. It is possible that some patients who were considered normal at the time of a particular thyrotropin measurement may have had an abnormal reading if measured at a different time. Another consideration is that the VADHS changed the type of blood sample used to generate thyrotropin values from serum to plasma during the time that analyzed thyrotropin values were measured. This could have led to different thyrotropin values and, therefore, different results of this study compared with if the sample type had stayed the same. However, a previous study showed very similar thyrotropin values generated from serum and plasma samples in 17 patients.8 Therefore, possibly the change in sample type in the current study only minimally affected the results.

CONCLUSIONS

Current American Thyroid Association guidelines do not specify recommendations for follow-up thyrotropin testing in patients with thyroid nodules who do not have a history of conditions or medications known to affect thyroid hormone levels.1 This study suggests that repeat thyrotropin monitoring may not be necessary for this group of patients. Individuals who had an abnormal most recent thyrotropin had an older age at thyroid nodule diagnosis compared with patients who had a normal most recent thyrotropin, so it is possible that thyrotropin monitoring may be recommended for people with nodules who are above a certain age. The results of this study as well as future studies could help create new clinical recommendations for thyrotropin monitoring in patients with thyroid nodules that clinicians can use to make evidence-based clinical decisions. There would also be a decreased financial, physical, and time burden on the patients if guidelines specify that they are not required to get continued blood thyrotropin testing.

Acknowledgments

The authors acknowledge Ronald J. Markert, PhD, formerly of Wright State University Boonshoft School of Medicine, for his contributions to the statistical analysis of this research.

References

1. Haugen BR, Alexander EK, Bible KC, et al. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020

2. Chambara N, Liu SYW, Lo X, Ying M. Diagnostic performance evaluation of different TI-RADS using ultrasound computer-aided diagnosis of thyroid nodules: an experience with adjusted settings. PLoS One. 2021;16(1):e0245617. doi:10.1371/journal.pone.0245617

3. Livhits MJ, Zhu CY, Kuo EJ, et al. Effectiveness of molecular testing techniques for diagnosis of indeterminate thyroid nodules: a randomized clinical trial. JAMA Oncol. 2021;7(1):70-77. doi:10.1001/jamaoncol.2020.5935

4. Grani G, Lamartina L, Ascoli V, et al. Reducing the number of unnecessary thyroid biopsies while improving diagnostic accuracy: toward the “right” TIRADS. J Clin Endocrinol Metab. 2019;104(1):95-102. doi:10.1210/jc.2018-01674

5. Memon R, Salgado Nunez Del Prado SR, Lamos EM, et al. Biochemical follow-up of nonfunctioning benign thyroid nodules. Clin Endocrinol (Oxf). 2021;94(2):322-329. doi:10.1111/cen.14303

6. Bajuk Studen K, Gaberscek S, Pirnat E, Zaletel K. Five-year follow-up and clinical outcome in euthyroid patients with thyroid nodules. Radiol Oncol. 2021;55(3):317-322. Published 2021 May 31. doi:10.2478/raon-2021-0025

7. Fernández-Trujillo C, Pérez-Zaballos J, Rodríguez-Pérez CA, et al. TSH level and risk of malignancy in patients with Bethesda category IV thyroid nodules. Horm Cancer. 2020;11(3-4):200-204. doi:10.1007/s12672-020-00384-4

8. Villanger GD, Learner E, Longnecker MP, et al. Effects of sample handling and analytical procedures on thyroid hormone concentrations in pregnant women’s plasma. Epidemiology. 2017;28(3):365-369. doi:10.1097/EDE.0000000000000606

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Sabrina Kaula,b; Ankur Gupta, MDa,b

Correspondence: Ankur Gupta (ankur.gupta@va.gov)

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aVeterans Affairs Dayton Healthcare System, Ohio

bWright State University Boonshoft School of Medicine, Dayton, Ohio

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

This retrospective study was approved by the Wright State University Institutional Review Board as well as the Dayton Veterans Affairs Medical Center Research & Development Committee (No. 06478).

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Correspondence: Ankur Gupta (ankur.gupta@va.gov)

Author affiliations

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bWright State University Boonshoft School of Medicine, Dayton, Ohio

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

This retrospective study was approved by the Wright State University Institutional Review Board as well as the Dayton Veterans Affairs Medical Center Research & Development Committee (No. 06478).

Author and Disclosure Information

Sabrina Kaula,b; Ankur Gupta, MDa,b

Correspondence: Ankur Gupta (ankur.gupta@va.gov)

Author affiliations

aVeterans Affairs Dayton Healthcare System, Ohio

bWright State University Boonshoft School of Medicine, Dayton, Ohio

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

This retrospective study was approved by the Wright State University Institutional Review Board as well as the Dayton Veterans Affairs Medical Center Research & Development Committee (No. 06478).

Article PDF
Article PDF

When thyroid nodules are found clinically or incidentally on imaging, the patient’s thyrotropin level should be measured.1 Ultrasound is the first-line imaging recommended to assess thyroid nodules.1,2 Nodules can then be evaluated by a fine-needle aspiration (FNA) biopsy, which provides cytological information to determine whether the nodule is benign or malignant.1,3,4 Most thyroid nodules pose a low risk of malignancy.1

The American Thyroid Association guidelines on thyroid nodule management do not specify any recommendations for follow-up thyrotropin testing in patients who do not have any history that is known to affect thyroid function.1 Therefore, clinicians have to make decisions regarding follow-up testing in these patients without any evidence-based guidelines. There is a lack of data in the literature on whether thyrotropin levels change over time in this patient population. If thyrotropin levels do not become abnormal over time, then patients would not need thyrotropin monitoring or treatment for hypo- or hyperthyroidism.

The aim of this study was to determine whether thyrotropin levels change over time in patients with thyroid nodules and determine whether repeat thyrotropin testing was required after initial testing. The authors hypothesized that thyrotropin values do not change substantially over time in patients with thyroid nodules, except in patients with a history of hot nodules, autoimmune thyroid disease, thyroid or pituitary surgery, radioactive iodine ablation, neck radiation, or use of medications affecting thyroid function. This study may be able to contribute to the clinical guidelines for thyrotropin testing in patients with thyroid nodules so that clinicians can make evidence-based decisions.

METHODS

This retrospective chart review was conducted using the Computerized Patient Record System at the Veterans Affairs Dayton Healthcare System (VADHS) in Ohio. Patients aged ≥ 18 years who were diagnosed with ≥ 1 thyroid nodule from January 2010 to December 2016 and had a normal thyrotropin level at the time of diagnosis were included in the study. Patients who were found to have thyroid nodules multiple times were included only once from the time of the initial diagnosis. Patients were excluded if they had a medical history known to affect thyroid function. Exclusion criteria included a history of hot thyroid nodules; autoimmune thyroid disease on imaging or blood work; history of thyroid surgery, including pituitary surgery; history of radioactive iodine treatment; history of neck radiation; use of thyroxine before nodule diagnosis; use of amiodarone, programmed cell death-1 inhibitors, programmed cell death ligand-1 inhibitors, or cytotoxic T-lymphocyte-associated protein-4 inhibitors; or 3 consecutive months of steroid use.

Age at nodule diagnosis, sex, race, thyrotropin values at and after the time of nodule diagnosis, and duration from nodule diagnosis to most recent thyrotropin value were retrospectively collected until 100 patients met inclusion criteria for the study. Of note, from 2010 to 2016, the assays used at the VADHS to measure thyrotropin values changed over time, as did the normal reference ranges and the type of sample used for the assays. Normal thyrotropin range at time of diagnosis based on serum or plasma samples and for repeat thyrotropin levels are provided in Table 1, also based on serum or plasma samples. All collected data in the study was de-identified for analysis.

Statistical Analysis

Patients were divided into 2 groups: those who had an abnormal most recent thyrotropin value and those who did not. Mean (SD) of both groups was calculated for continuous variables of age at diagnosis, initial thyrotropin value and most recent thyrotropin value, and time from diagnosis to most recent thyrotropin value. Percentages for both groups were calculated for categorical variables of sex, race, and whether initial and most recent thyrotropin values were based on serum or plasma samples and old or new reference ranges. A 95% CI was determined for the true population rate of patients with an abnormal thyrotropin value at most recent testing. Independent sample t tests were used to compare the continuous variables between the abnormal and normal most recent thyrotropin groups. Categorical variables between the 2 groups were compared using χ2 tests. P < .05 was considered statistically significant. Statistical analyses were completed using IBM SPSS Statistics 27. This study was approved by the Wright State University Institutional Review Board and the VADHS Research and Development Committee.

 

 

RESULTS

Of 557 patient charts studied, 100 patients were included; the mean (SD) age at nodule diagnosis was 62.4 (11.1) years, and the mean (SD) initial thyrotropin level at nodule diagnosis was 1.51 (0.87) μIU/mL. The mean (SD) most recent thyrotropin level was 1.60 (1.03) μIU/mL after a mean duration of 5.7 (2.5) years postnodule diagnosis (Table 2).

Six patients (6%; 95% CI, 2.5%-12.7%) who had a normal thyrotropin level at nodule diagnosis developed an abnormal thyrotropin level in a mean (SD) of 6.9 (3.1) years. These 6 patients had a mean age at nodule diagnosis of 69.2 (11.4) years. Five of the 6 were male, and all were White patients. One patient’s thyrotropin level rose from an initial thyrotropin of 3.38 μIU/mL at nodule diagnosis to a high of 7.76 μIU/mL after 8.5 years. This patient was diagnosed with subclinical hypothyroidism and did not require treatment.

Five patients’ thyrotropin levels dropped below normal in a mean 7 years, with levels ranging from 0.25 to 0.52 μIU/mL. Of these patients, 2 became symptomatic from the nodules, experiencing dysphagia or hoarseness, with 1 diagnosed with hyperthyroidism. This patient was treated with methimazole and radioactive iodine ablation 9 years after diagnosis. The other 3 patients who developed low thyrotropin had no nodule symptoms or treatment. Ninety-four patients maintained thyrotropin values in the normal range for a mean (SD) of 5.7 (2.5) years and had a mean (SD) age at nodule diagnosis of 61.9 (11.0) years.

Both thyrotropin groups were compared. For categorical variables, there were no significant differences for sex (P = .99) or race (P = .55). For continuous variables, there were no significant differences in age at diagnosis (P = .12), initial thyrotropin (P = .24), most recent thyrotropin (P = .98), or time from diagnosis to most recent thyrotropin level (P = .23) (Table 3).

Of note, the VADHS changed the type of blood sample used to generate thyrotropin values from serum to plasma and had 3 different normal reference ranges during the 2010 to 2016 period studied. The thyrotropin values fell into 4 categories: serum sample with normal range 0.4 to 5.5 μIU/mL, serum sample with normal range 0.4 to 4.0 μIU/mL, plasma sample with normal range 0.4 to 4.0 μIU/mL, and plasma sample with normal range 0.6 to 4.8 μIU/mL. There were no significant differences between the abnormal and normal most recent thyrotropin groups in sample type for initial or most recent thyrotropin (P = .44 and P = .99, respectively) or in normal range for initial or most recent thyrotropin level (P = .99 and P = .09, respectively).

DISCUSSION

We found no statistically significant change in blood thyrotropin levels over time among patients with thyroid nodules with no history of medical conditions or medications known to affect thyroid hormone levels. Six of 100 patients developed abnormal thyrotropin, but only 2 eventually were treated for thyroid dysfunction: 1 for hypothyroidism and 1 for hyperthyroidism. The other 4 patients who did not receive treatment developed low thyrotropin but had no official diagnosis of hyperthyroidism in their health records, seemingly due to lack of multiple, consistently low thyrotropin values or due to lack of follow-up. Based on these data, monitoring thyrotropin over time may not be necessary in patients without any medical history known to affect thyroid function. The results provide support for the original hypothesis.

 

 

Although only thyrotropin values at the time of nodule diagnosis and most recent thyrotropin values were analyzed, thyrotropin trends over time were considered. Some patients did have transient abnormal thyrotropin values; however, a search of the patients’ records showed that these transient abnormalities did not lead to any initiation of hypothyroidism or hyperthyroidism treatment.

Another consideration is that changes in the sample type processed and in the normal thyrotropin ranges over time could have been confounding variables. However, statistical analyses showed that the abnormal and normal most recent thyrotropin groups did not show any significant differences in sample type or reference range for either the initial or most recent thyrotropin values. Hospitals change the laboratory assays they use for clinical tests over time, but these changes likely did not affect the results of this study.

The data from this study showed similar results to previously reported research. This study found that 6% of patients developed abnormal thyrotropin levels over time. A study of 157 patients with nonfunctioning benign thyroid nodules found that 8.3% of patients developed thyroid dysfunction.5 In another follow-up study on patients with thyroid nodules who were otherwise euthyroid, 2 of 118 patients eventually received treatment for hyperthyroidism.6 In the current study, we report that just 1 of 100 included patients had to begin treatment for hyperthyroidism.

The literature also includes research on using thyrotropin and age to predict malignancy in patients with thyroid nodules. One study suggested that a thyrotropin cutoff point of ≥ 2.1 mU/I and an age cutoff point of ≥ 47 years were significantly associated with a diagnosis of malignancy.7 Although the current study did not study malignancy, the results showed that the mean age at nodule diagnosis was higher in patients who had abnormal vs normal most recent thyrotropin levels: 69 vs 62 years, respectively. Future studies could determine whether a certain initial thyrotropin value or age could be used as a cutoff for requiring further thyrotropin monitoring to check for development of hyperthyroidism or hypothyroidism.

Limitations

This study was limited by its small size of 100 subjects. Most patients had to be excluded to focus on the aim of determining whether thyrotropin monitoring is needed in the specific group of patients without medical history that would be expected to affect thyroid function. Another limitation was that 83% of the patients included in the study were male, which does not reflect the general population. Future studies should include a greater number of patients and aim for a balance of 50% male and 50% female patients.

Additionally, it is important to note that the changing definition of the normal thyrotropin range was a limitation. It is possible that some patients who were considered normal at the time of a particular thyrotropin measurement may have had an abnormal reading if measured at a different time. Another consideration is that the VADHS changed the type of blood sample used to generate thyrotropin values from serum to plasma during the time that analyzed thyrotropin values were measured. This could have led to different thyrotropin values and, therefore, different results of this study compared with if the sample type had stayed the same. However, a previous study showed very similar thyrotropin values generated from serum and plasma samples in 17 patients.8 Therefore, possibly the change in sample type in the current study only minimally affected the results.

CONCLUSIONS

Current American Thyroid Association guidelines do not specify recommendations for follow-up thyrotropin testing in patients with thyroid nodules who do not have a history of conditions or medications known to affect thyroid hormone levels.1 This study suggests that repeat thyrotropin monitoring may not be necessary for this group of patients. Individuals who had an abnormal most recent thyrotropin had an older age at thyroid nodule diagnosis compared with patients who had a normal most recent thyrotropin, so it is possible that thyrotropin monitoring may be recommended for people with nodules who are above a certain age. The results of this study as well as future studies could help create new clinical recommendations for thyrotropin monitoring in patients with thyroid nodules that clinicians can use to make evidence-based clinical decisions. There would also be a decreased financial, physical, and time burden on the patients if guidelines specify that they are not required to get continued blood thyrotropin testing.

Acknowledgments

The authors acknowledge Ronald J. Markert, PhD, formerly of Wright State University Boonshoft School of Medicine, for his contributions to the statistical analysis of this research.

When thyroid nodules are found clinically or incidentally on imaging, the patient’s thyrotropin level should be measured.1 Ultrasound is the first-line imaging recommended to assess thyroid nodules.1,2 Nodules can then be evaluated by a fine-needle aspiration (FNA) biopsy, which provides cytological information to determine whether the nodule is benign or malignant.1,3,4 Most thyroid nodules pose a low risk of malignancy.1

The American Thyroid Association guidelines on thyroid nodule management do not specify any recommendations for follow-up thyrotropin testing in patients who do not have any history that is known to affect thyroid function.1 Therefore, clinicians have to make decisions regarding follow-up testing in these patients without any evidence-based guidelines. There is a lack of data in the literature on whether thyrotropin levels change over time in this patient population. If thyrotropin levels do not become abnormal over time, then patients would not need thyrotropin monitoring or treatment for hypo- or hyperthyroidism.

The aim of this study was to determine whether thyrotropin levels change over time in patients with thyroid nodules and determine whether repeat thyrotropin testing was required after initial testing. The authors hypothesized that thyrotropin values do not change substantially over time in patients with thyroid nodules, except in patients with a history of hot nodules, autoimmune thyroid disease, thyroid or pituitary surgery, radioactive iodine ablation, neck radiation, or use of medications affecting thyroid function. This study may be able to contribute to the clinical guidelines for thyrotropin testing in patients with thyroid nodules so that clinicians can make evidence-based decisions.

METHODS

This retrospective chart review was conducted using the Computerized Patient Record System at the Veterans Affairs Dayton Healthcare System (VADHS) in Ohio. Patients aged ≥ 18 years who were diagnosed with ≥ 1 thyroid nodule from January 2010 to December 2016 and had a normal thyrotropin level at the time of diagnosis were included in the study. Patients who were found to have thyroid nodules multiple times were included only once from the time of the initial diagnosis. Patients were excluded if they had a medical history known to affect thyroid function. Exclusion criteria included a history of hot thyroid nodules; autoimmune thyroid disease on imaging or blood work; history of thyroid surgery, including pituitary surgery; history of radioactive iodine treatment; history of neck radiation; use of thyroxine before nodule diagnosis; use of amiodarone, programmed cell death-1 inhibitors, programmed cell death ligand-1 inhibitors, or cytotoxic T-lymphocyte-associated protein-4 inhibitors; or 3 consecutive months of steroid use.

Age at nodule diagnosis, sex, race, thyrotropin values at and after the time of nodule diagnosis, and duration from nodule diagnosis to most recent thyrotropin value were retrospectively collected until 100 patients met inclusion criteria for the study. Of note, from 2010 to 2016, the assays used at the VADHS to measure thyrotropin values changed over time, as did the normal reference ranges and the type of sample used for the assays. Normal thyrotropin range at time of diagnosis based on serum or plasma samples and for repeat thyrotropin levels are provided in Table 1, also based on serum or plasma samples. All collected data in the study was de-identified for analysis.

Statistical Analysis

Patients were divided into 2 groups: those who had an abnormal most recent thyrotropin value and those who did not. Mean (SD) of both groups was calculated for continuous variables of age at diagnosis, initial thyrotropin value and most recent thyrotropin value, and time from diagnosis to most recent thyrotropin value. Percentages for both groups were calculated for categorical variables of sex, race, and whether initial and most recent thyrotropin values were based on serum or plasma samples and old or new reference ranges. A 95% CI was determined for the true population rate of patients with an abnormal thyrotropin value at most recent testing. Independent sample t tests were used to compare the continuous variables between the abnormal and normal most recent thyrotropin groups. Categorical variables between the 2 groups were compared using χ2 tests. P < .05 was considered statistically significant. Statistical analyses were completed using IBM SPSS Statistics 27. This study was approved by the Wright State University Institutional Review Board and the VADHS Research and Development Committee.

 

 

RESULTS

Of 557 patient charts studied, 100 patients were included; the mean (SD) age at nodule diagnosis was 62.4 (11.1) years, and the mean (SD) initial thyrotropin level at nodule diagnosis was 1.51 (0.87) μIU/mL. The mean (SD) most recent thyrotropin level was 1.60 (1.03) μIU/mL after a mean duration of 5.7 (2.5) years postnodule diagnosis (Table 2).

Six patients (6%; 95% CI, 2.5%-12.7%) who had a normal thyrotropin level at nodule diagnosis developed an abnormal thyrotropin level in a mean (SD) of 6.9 (3.1) years. These 6 patients had a mean age at nodule diagnosis of 69.2 (11.4) years. Five of the 6 were male, and all were White patients. One patient’s thyrotropin level rose from an initial thyrotropin of 3.38 μIU/mL at nodule diagnosis to a high of 7.76 μIU/mL after 8.5 years. This patient was diagnosed with subclinical hypothyroidism and did not require treatment.

Five patients’ thyrotropin levels dropped below normal in a mean 7 years, with levels ranging from 0.25 to 0.52 μIU/mL. Of these patients, 2 became symptomatic from the nodules, experiencing dysphagia or hoarseness, with 1 diagnosed with hyperthyroidism. This patient was treated with methimazole and radioactive iodine ablation 9 years after diagnosis. The other 3 patients who developed low thyrotropin had no nodule symptoms or treatment. Ninety-four patients maintained thyrotropin values in the normal range for a mean (SD) of 5.7 (2.5) years and had a mean (SD) age at nodule diagnosis of 61.9 (11.0) years.

Both thyrotropin groups were compared. For categorical variables, there were no significant differences for sex (P = .99) or race (P = .55). For continuous variables, there were no significant differences in age at diagnosis (P = .12), initial thyrotropin (P = .24), most recent thyrotropin (P = .98), or time from diagnosis to most recent thyrotropin level (P = .23) (Table 3).

Of note, the VADHS changed the type of blood sample used to generate thyrotropin values from serum to plasma and had 3 different normal reference ranges during the 2010 to 2016 period studied. The thyrotropin values fell into 4 categories: serum sample with normal range 0.4 to 5.5 μIU/mL, serum sample with normal range 0.4 to 4.0 μIU/mL, plasma sample with normal range 0.4 to 4.0 μIU/mL, and plasma sample with normal range 0.6 to 4.8 μIU/mL. There were no significant differences between the abnormal and normal most recent thyrotropin groups in sample type for initial or most recent thyrotropin (P = .44 and P = .99, respectively) or in normal range for initial or most recent thyrotropin level (P = .99 and P = .09, respectively).

DISCUSSION

We found no statistically significant change in blood thyrotropin levels over time among patients with thyroid nodules with no history of medical conditions or medications known to affect thyroid hormone levels. Six of 100 patients developed abnormal thyrotropin, but only 2 eventually were treated for thyroid dysfunction: 1 for hypothyroidism and 1 for hyperthyroidism. The other 4 patients who did not receive treatment developed low thyrotropin but had no official diagnosis of hyperthyroidism in their health records, seemingly due to lack of multiple, consistently low thyrotropin values or due to lack of follow-up. Based on these data, monitoring thyrotropin over time may not be necessary in patients without any medical history known to affect thyroid function. The results provide support for the original hypothesis.

 

 

Although only thyrotropin values at the time of nodule diagnosis and most recent thyrotropin values were analyzed, thyrotropin trends over time were considered. Some patients did have transient abnormal thyrotropin values; however, a search of the patients’ records showed that these transient abnormalities did not lead to any initiation of hypothyroidism or hyperthyroidism treatment.

Another consideration is that changes in the sample type processed and in the normal thyrotropin ranges over time could have been confounding variables. However, statistical analyses showed that the abnormal and normal most recent thyrotropin groups did not show any significant differences in sample type or reference range for either the initial or most recent thyrotropin values. Hospitals change the laboratory assays they use for clinical tests over time, but these changes likely did not affect the results of this study.

The data from this study showed similar results to previously reported research. This study found that 6% of patients developed abnormal thyrotropin levels over time. A study of 157 patients with nonfunctioning benign thyroid nodules found that 8.3% of patients developed thyroid dysfunction.5 In another follow-up study on patients with thyroid nodules who were otherwise euthyroid, 2 of 118 patients eventually received treatment for hyperthyroidism.6 In the current study, we report that just 1 of 100 included patients had to begin treatment for hyperthyroidism.

The literature also includes research on using thyrotropin and age to predict malignancy in patients with thyroid nodules. One study suggested that a thyrotropin cutoff point of ≥ 2.1 mU/I and an age cutoff point of ≥ 47 years were significantly associated with a diagnosis of malignancy.7 Although the current study did not study malignancy, the results showed that the mean age at nodule diagnosis was higher in patients who had abnormal vs normal most recent thyrotropin levels: 69 vs 62 years, respectively. Future studies could determine whether a certain initial thyrotropin value or age could be used as a cutoff for requiring further thyrotropin monitoring to check for development of hyperthyroidism or hypothyroidism.

Limitations

This study was limited by its small size of 100 subjects. Most patients had to be excluded to focus on the aim of determining whether thyrotropin monitoring is needed in the specific group of patients without medical history that would be expected to affect thyroid function. Another limitation was that 83% of the patients included in the study were male, which does not reflect the general population. Future studies should include a greater number of patients and aim for a balance of 50% male and 50% female patients.

Additionally, it is important to note that the changing definition of the normal thyrotropin range was a limitation. It is possible that some patients who were considered normal at the time of a particular thyrotropin measurement may have had an abnormal reading if measured at a different time. Another consideration is that the VADHS changed the type of blood sample used to generate thyrotropin values from serum to plasma during the time that analyzed thyrotropin values were measured. This could have led to different thyrotropin values and, therefore, different results of this study compared with if the sample type had stayed the same. However, a previous study showed very similar thyrotropin values generated from serum and plasma samples in 17 patients.8 Therefore, possibly the change in sample type in the current study only minimally affected the results.

CONCLUSIONS

Current American Thyroid Association guidelines do not specify recommendations for follow-up thyrotropin testing in patients with thyroid nodules who do not have a history of conditions or medications known to affect thyroid hormone levels.1 This study suggests that repeat thyrotropin monitoring may not be necessary for this group of patients. Individuals who had an abnormal most recent thyrotropin had an older age at thyroid nodule diagnosis compared with patients who had a normal most recent thyrotropin, so it is possible that thyrotropin monitoring may be recommended for people with nodules who are above a certain age. The results of this study as well as future studies could help create new clinical recommendations for thyrotropin monitoring in patients with thyroid nodules that clinicians can use to make evidence-based clinical decisions. There would also be a decreased financial, physical, and time burden on the patients if guidelines specify that they are not required to get continued blood thyrotropin testing.

Acknowledgments

The authors acknowledge Ronald J. Markert, PhD, formerly of Wright State University Boonshoft School of Medicine, for his contributions to the statistical analysis of this research.

References

1. Haugen BR, Alexander EK, Bible KC, et al. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020

2. Chambara N, Liu SYW, Lo X, Ying M. Diagnostic performance evaluation of different TI-RADS using ultrasound computer-aided diagnosis of thyroid nodules: an experience with adjusted settings. PLoS One. 2021;16(1):e0245617. doi:10.1371/journal.pone.0245617

3. Livhits MJ, Zhu CY, Kuo EJ, et al. Effectiveness of molecular testing techniques for diagnosis of indeterminate thyroid nodules: a randomized clinical trial. JAMA Oncol. 2021;7(1):70-77. doi:10.1001/jamaoncol.2020.5935

4. Grani G, Lamartina L, Ascoli V, et al. Reducing the number of unnecessary thyroid biopsies while improving diagnostic accuracy: toward the “right” TIRADS. J Clin Endocrinol Metab. 2019;104(1):95-102. doi:10.1210/jc.2018-01674

5. Memon R, Salgado Nunez Del Prado SR, Lamos EM, et al. Biochemical follow-up of nonfunctioning benign thyroid nodules. Clin Endocrinol (Oxf). 2021;94(2):322-329. doi:10.1111/cen.14303

6. Bajuk Studen K, Gaberscek S, Pirnat E, Zaletel K. Five-year follow-up and clinical outcome in euthyroid patients with thyroid nodules. Radiol Oncol. 2021;55(3):317-322. Published 2021 May 31. doi:10.2478/raon-2021-0025

7. Fernández-Trujillo C, Pérez-Zaballos J, Rodríguez-Pérez CA, et al. TSH level and risk of malignancy in patients with Bethesda category IV thyroid nodules. Horm Cancer. 2020;11(3-4):200-204. doi:10.1007/s12672-020-00384-4

8. Villanger GD, Learner E, Longnecker MP, et al. Effects of sample handling and analytical procedures on thyroid hormone concentrations in pregnant women’s plasma. Epidemiology. 2017;28(3):365-369. doi:10.1097/EDE.0000000000000606

References

1. Haugen BR, Alexander EK, Bible KC, et al. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020

2. Chambara N, Liu SYW, Lo X, Ying M. Diagnostic performance evaluation of different TI-RADS using ultrasound computer-aided diagnosis of thyroid nodules: an experience with adjusted settings. PLoS One. 2021;16(1):e0245617. doi:10.1371/journal.pone.0245617

3. Livhits MJ, Zhu CY, Kuo EJ, et al. Effectiveness of molecular testing techniques for diagnosis of indeterminate thyroid nodules: a randomized clinical trial. JAMA Oncol. 2021;7(1):70-77. doi:10.1001/jamaoncol.2020.5935

4. Grani G, Lamartina L, Ascoli V, et al. Reducing the number of unnecessary thyroid biopsies while improving diagnostic accuracy: toward the “right” TIRADS. J Clin Endocrinol Metab. 2019;104(1):95-102. doi:10.1210/jc.2018-01674

5. Memon R, Salgado Nunez Del Prado SR, Lamos EM, et al. Biochemical follow-up of nonfunctioning benign thyroid nodules. Clin Endocrinol (Oxf). 2021;94(2):322-329. doi:10.1111/cen.14303

6. Bajuk Studen K, Gaberscek S, Pirnat E, Zaletel K. Five-year follow-up and clinical outcome in euthyroid patients with thyroid nodules. Radiol Oncol. 2021;55(3):317-322. Published 2021 May 31. doi:10.2478/raon-2021-0025

7. Fernández-Trujillo C, Pérez-Zaballos J, Rodríguez-Pérez CA, et al. TSH level and risk of malignancy in patients with Bethesda category IV thyroid nodules. Horm Cancer. 2020;11(3-4):200-204. doi:10.1007/s12672-020-00384-4

8. Villanger GD, Learner E, Longnecker MP, et al. Effects of sample handling and analytical procedures on thyroid hormone concentrations in pregnant women’s plasma. Epidemiology. 2017;28(3):365-369. doi:10.1097/EDE.0000000000000606

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Piperacillin-tazobactam poses no renal risk in adults with sepsis

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TOPLINE: 

A new study shows that piperacillin-tazobactam and cefepime are equally safe for acute kidney injury (AKI) in acute infection, with cefepime linked to more neurological issues.

METHODOLOGY:

The coadministration of piperacillin-tazobactam and vancomycin may raise the risk for AKI, according to a warning from the Food and Drug Administration.

The ACORN trial included 2,511 adults presenting to emergency department or intensive care unit with suspected infection.

Within 12 hours of presentation, these individuals were prescribed either cefepime (n = 1,214) or piperacillin-tazobactam (n = 1,297).

The primary outcome was the risk for the highest stage of AKI or death within 14 days of randomization.
 

TAKEAWAY:

The highest stage of AKI or death within 14 days did not differ significantly between the cefepime and piperacillin-tazobactam groups (odds ratio, 0.95; P = .56).

The incidence of major adverse kidney events by day 14 was not significantly different between the two groups (absolute risk difference, 1.4%; 95% confidence interval, −1.0% to 3.8%).

Patients in the cefepime versus piperacillin-tazobactam group had fewer days alive and free of delirium and coma within 14 days (OR, 0.79; 95% CI, 0.65-0.95).
 

IN PRACTICE:

In an accompanying editorial, Steven Y. C. Tong, department of infectious diseases, University of Melbourne, and colleagues wrote: “Because institutions must make decisions about which antibiotics to position on medical wards for rapid administration in patients meeting sepsis criteria, these data should offer solace that if the choice is made to use piperacillin-tazobactam, there is not an increased risk of AKI.”

SOURCE:

The study was led by Edward T. Qian, MD, of Vanderbilt University Medical Center, Nashville, Tenn. It was published online in JAMA with an accompanying editorial.

LIMITATIONS:

The study was conducted at a single academic center, which may limit the generalizability of findings.

Both patients and clinicians were not blinded to group assignment, which may have influenced clinical assessments like Richmond Agitation-Sedation Scale and CAM-ICU or the frequency of laboratory measurements like creatinine.
 

DISCLOSURES:

The project was supported by the Vanderbilt Institute for Clinical and Translational Research and several other sources, including grants from the National Center for Advancing Translational Sciences. Some authors declared receiving travel grant, personal fees, honoraria, and unrelated research support from various sources.

A version of this article appeared on Medscape.com.

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TOPLINE: 

A new study shows that piperacillin-tazobactam and cefepime are equally safe for acute kidney injury (AKI) in acute infection, with cefepime linked to more neurological issues.

METHODOLOGY:

The coadministration of piperacillin-tazobactam and vancomycin may raise the risk for AKI, according to a warning from the Food and Drug Administration.

The ACORN trial included 2,511 adults presenting to emergency department or intensive care unit with suspected infection.

Within 12 hours of presentation, these individuals were prescribed either cefepime (n = 1,214) or piperacillin-tazobactam (n = 1,297).

The primary outcome was the risk for the highest stage of AKI or death within 14 days of randomization.
 

TAKEAWAY:

The highest stage of AKI or death within 14 days did not differ significantly between the cefepime and piperacillin-tazobactam groups (odds ratio, 0.95; P = .56).

The incidence of major adverse kidney events by day 14 was not significantly different between the two groups (absolute risk difference, 1.4%; 95% confidence interval, −1.0% to 3.8%).

Patients in the cefepime versus piperacillin-tazobactam group had fewer days alive and free of delirium and coma within 14 days (OR, 0.79; 95% CI, 0.65-0.95).
 

IN PRACTICE:

In an accompanying editorial, Steven Y. C. Tong, department of infectious diseases, University of Melbourne, and colleagues wrote: “Because institutions must make decisions about which antibiotics to position on medical wards for rapid administration in patients meeting sepsis criteria, these data should offer solace that if the choice is made to use piperacillin-tazobactam, there is not an increased risk of AKI.”

SOURCE:

The study was led by Edward T. Qian, MD, of Vanderbilt University Medical Center, Nashville, Tenn. It was published online in JAMA with an accompanying editorial.

LIMITATIONS:

The study was conducted at a single academic center, which may limit the generalizability of findings.

Both patients and clinicians were not blinded to group assignment, which may have influenced clinical assessments like Richmond Agitation-Sedation Scale and CAM-ICU or the frequency of laboratory measurements like creatinine.
 

DISCLOSURES:

The project was supported by the Vanderbilt Institute for Clinical and Translational Research and several other sources, including grants from the National Center for Advancing Translational Sciences. Some authors declared receiving travel grant, personal fees, honoraria, and unrelated research support from various sources.

A version of this article appeared on Medscape.com.

 

TOPLINE: 

A new study shows that piperacillin-tazobactam and cefepime are equally safe for acute kidney injury (AKI) in acute infection, with cefepime linked to more neurological issues.

METHODOLOGY:

The coadministration of piperacillin-tazobactam and vancomycin may raise the risk for AKI, according to a warning from the Food and Drug Administration.

The ACORN trial included 2,511 adults presenting to emergency department or intensive care unit with suspected infection.

Within 12 hours of presentation, these individuals were prescribed either cefepime (n = 1,214) or piperacillin-tazobactam (n = 1,297).

The primary outcome was the risk for the highest stage of AKI or death within 14 days of randomization.
 

TAKEAWAY:

The highest stage of AKI or death within 14 days did not differ significantly between the cefepime and piperacillin-tazobactam groups (odds ratio, 0.95; P = .56).

The incidence of major adverse kidney events by day 14 was not significantly different between the two groups (absolute risk difference, 1.4%; 95% confidence interval, −1.0% to 3.8%).

Patients in the cefepime versus piperacillin-tazobactam group had fewer days alive and free of delirium and coma within 14 days (OR, 0.79; 95% CI, 0.65-0.95).
 

IN PRACTICE:

In an accompanying editorial, Steven Y. C. Tong, department of infectious diseases, University of Melbourne, and colleagues wrote: “Because institutions must make decisions about which antibiotics to position on medical wards for rapid administration in patients meeting sepsis criteria, these data should offer solace that if the choice is made to use piperacillin-tazobactam, there is not an increased risk of AKI.”

SOURCE:

The study was led by Edward T. Qian, MD, of Vanderbilt University Medical Center, Nashville, Tenn. It was published online in JAMA with an accompanying editorial.

LIMITATIONS:

The study was conducted at a single academic center, which may limit the generalizability of findings.

Both patients and clinicians were not blinded to group assignment, which may have influenced clinical assessments like Richmond Agitation-Sedation Scale and CAM-ICU or the frequency of laboratory measurements like creatinine.
 

DISCLOSURES:

The project was supported by the Vanderbilt Institute for Clinical and Translational Research and several other sources, including grants from the National Center for Advancing Translational Sciences. Some authors declared receiving travel grant, personal fees, honoraria, and unrelated research support from various sources.

A version of this article appeared on Medscape.com.

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One-year anniversary

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Dear Friends,

It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. This issue highlights topics that may be overwhelming for trainees and early faculty, including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.

In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.

Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.

Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.

In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.


Yours truly,

Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis

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Dear Friends,

It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. This issue highlights topics that may be overwhelming for trainees and early faculty, including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.

In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.

Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.

Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.

In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.


Yours truly,

Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis

Dear Friends,

It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. This issue highlights topics that may be overwhelming for trainees and early faculty, including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.

In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.

Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.

Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.

In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.


Yours truly,

Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis

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