Abrocitinib, an investigational drug proven to be a safe and effective treatment for moderate to severe atopic dermatitis (AD) in adults 18 years and older, is also safe and effective in patients aged 12-17 years, according to a randomized trial of the oral, once-daily Janus kinase (JAK) 1 selective inhibitor, used in combination with medicated topical therapy.

The results, from the phase 3 JADE TEEN study, were presented during an oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“We’re very excited about the introduction of oral JAKs into our armamentarium for atopic dermatitis,” lead author Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and chief of pediatric and adolescent dermatology, Rady Children’s Hospital, also in San Diego, said in an interview.

AD ranges in severity, and there is a great deal of moderate to severe AD that has a tremendous negative impact on the individual, Dr. Eichenfield said. “Traditionally we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control.”

JAK inhibitors are effective mediators of the inflammation response that occurs in moderate to severe AD. They inhibit the stimulation of the JAK pathway and allow anti-inflammatory effects and therefore have potential, especially in more severe disease, Dr. Eichenfield said.

In the current study, which is a spin-off of the original study that looked at abrocitinib in adults, he and his team randomly assigned 285 teens (mean age, 14.9 years; 50.9% male; 56.1% White) with moderate to severe AD to receive one of the following treatments for 12 weeks: abrocitinib 200 mg plus topical therapy (95); abrocitinib 100 mg plus topical therapy (95); or placebo, which consisted of topical therapy alone (95).

The primary endpoints were an Investigator’s Global Assessment response of clear or almost clear (scores of 0 and 1, respectively), with an improvement of at least 2 points, and an improvement in Eczema Area and Severity Index score of at least 75% at week 12.

Secondary endpoints included an improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) response of at least 4 points at week 12.

The teens who received abrocitinib along with medicated topical therapy showed significant improvement in the severity of their AD at the end of the 12-week period, compared with those in the placebo group.

“The percentage of patients achieving essentially no itch, as captured in the fact that more than half of those on the higher dose of abrocitinib made it to no itch, is a new data point and is important to note,” Dr. Eichenfield said. “A lot of the other medicines don’t really get a significant percentage of the population to an itch score of 0 to 1. This drug brought about a rapid and profound itch relief.”

He added: “The results from JADE TEEN extend the drug’s utility in this younger population and show that abrocitinib performs the same with regard to efficacy and safety in the teenagers. Having atopic dermatitis that does not respond to treatment is especially hard for adolescents, but now we know that abrocitinib will be safe and effective and so we now have something to offer these kids.”

“Abrocitinib achieved a good response in this study that was statistically significant, compared to standard treatment,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, commented in an interview.

“JAK inhibitors are very promising, and this study adds to that promise. They play an important role in atopic dermatitis, so obviously, teenagers with AD represent an important population,” said Dr. Bernstein, who was not part of the study. “These results are very encouraging, and I think that we will probably see some of these JAK inhibitors approved by the FDA, if not this year, probably next.”

The study was sponsored by Pfizer. Dr. Eichenfield serves as an investigator, speaker, and consultant for Pfizer; and as an investigator, speaker, consultant, and/or is on a data safety monitoring board for AbbVie, Almirall, Amgen, Arcutis, Asana, Dermavant, Dermira, Forte, Galderma, Ichnos/Glenmark, Incyte, LEO, Lilly, L’Oreal, Novartis, Regeneron, Sanofi-Genzyme, and Verrica. Dr. Bernstein disclosed no relevant financial relationships.
 

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

Abrocitinib, an investigational drug proven to be a safe and effective treatment for moderate to severe atopic dermatitis (AD) in adults 18 years and older, is also safe and effective in patients aged 12-17 years, according to a randomized trial of the oral, once-daily Janus kinase (JAK) 1 selective inhibitor, used in combination with medicated topical therapy.

The results, from the phase 3 JADE TEEN study, were presented during an oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“We’re very excited about the introduction of oral JAKs into our armamentarium for atopic dermatitis,” lead author Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and chief of pediatric and adolescent dermatology, Rady Children’s Hospital, also in San Diego, said in an interview.

AD ranges in severity, and there is a great deal of moderate to severe AD that has a tremendous negative impact on the individual, Dr. Eichenfield said. “Traditionally we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control.”

JAK inhibitors are effective mediators of the inflammation response that occurs in moderate to severe AD. They inhibit the stimulation of the JAK pathway and allow anti-inflammatory effects and therefore have potential, especially in more severe disease, Dr. Eichenfield said.

In the current study, which is a spin-off of the original study that looked at abrocitinib in adults, he and his team randomly assigned 285 teens (mean age, 14.9 years; 50.9% male; 56.1% White) with moderate to severe AD to receive one of the following treatments for 12 weeks: abrocitinib 200 mg plus topical therapy (95); abrocitinib 100 mg plus topical therapy (95); or placebo, which consisted of topical therapy alone (95).

The primary endpoints were an Investigator’s Global Assessment response of clear or almost clear (scores of 0 and 1, respectively), with an improvement of at least 2 points, and an improvement in Eczema Area and Severity Index score of at least 75% at week 12.

Secondary endpoints included an improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) response of at least 4 points at week 12.

The teens who received abrocitinib along with medicated topical therapy showed significant improvement in the severity of their AD at the end of the 12-week period, compared with those in the placebo group.

“The percentage of patients achieving essentially no itch, as captured in the fact that more than half of those on the higher dose of abrocitinib made it to no itch, is a new data point and is important to note,” Dr. Eichenfield said. “A lot of the other medicines don’t really get a significant percentage of the population to an itch score of 0 to 1. This drug brought about a rapid and profound itch relief.”

He added: “The results from JADE TEEN extend the drug’s utility in this younger population and show that abrocitinib performs the same with regard to efficacy and safety in the teenagers. Having atopic dermatitis that does not respond to treatment is especially hard for adolescents, but now we know that abrocitinib will be safe and effective and so we now have something to offer these kids.”

“Abrocitinib achieved a good response in this study that was statistically significant, compared to standard treatment,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, commented in an interview.

“JAK inhibitors are very promising, and this study adds to that promise. They play an important role in atopic dermatitis, so obviously, teenagers with AD represent an important population,” said Dr. Bernstein, who was not part of the study. “These results are very encouraging, and I think that we will probably see some of these JAK inhibitors approved by the FDA, if not this year, probably next.”

The study was sponsored by Pfizer. Dr. Eichenfield serves as an investigator, speaker, and consultant for Pfizer; and as an investigator, speaker, consultant, and/or is on a data safety monitoring board for AbbVie, Almirall, Amgen, Arcutis, Asana, Dermavant, Dermira, Forte, Galderma, Ichnos/Glenmark, Incyte, LEO, Lilly, L’Oreal, Novartis, Regeneron, Sanofi-Genzyme, and Verrica. Dr. Bernstein disclosed no relevant financial relationships.
 

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

Abrocitinib, an investigational drug proven to be a safe and effective treatment for moderate to severe atopic dermatitis (AD) in adults 18 years and older, is also safe and effective in patients aged 12-17 years, according to a randomized trial of the oral, once-daily Janus kinase (JAK) 1 selective inhibitor, used in combination with medicated topical therapy.

The results, from the phase 3 JADE TEEN study, were presented during an oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“We’re very excited about the introduction of oral JAKs into our armamentarium for atopic dermatitis,” lead author Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and chief of pediatric and adolescent dermatology, Rady Children’s Hospital, also in San Diego, said in an interview.

AD ranges in severity, and there is a great deal of moderate to severe AD that has a tremendous negative impact on the individual, Dr. Eichenfield said. “Traditionally we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control.”

JAK inhibitors are effective mediators of the inflammation response that occurs in moderate to severe AD. They inhibit the stimulation of the JAK pathway and allow anti-inflammatory effects and therefore have potential, especially in more severe disease, Dr. Eichenfield said.

In the current study, which is a spin-off of the original study that looked at abrocitinib in adults, he and his team randomly assigned 285 teens (mean age, 14.9 years; 50.9% male; 56.1% White) with moderate to severe AD to receive one of the following treatments for 12 weeks: abrocitinib 200 mg plus topical therapy (95); abrocitinib 100 mg plus topical therapy (95); or placebo, which consisted of topical therapy alone (95).

The primary endpoints were an Investigator’s Global Assessment response of clear or almost clear (scores of 0 and 1, respectively), with an improvement of at least 2 points, and an improvement in Eczema Area and Severity Index score of at least 75% at week 12.

Secondary endpoints included an improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) response of at least 4 points at week 12.

The teens who received abrocitinib along with medicated topical therapy showed significant improvement in the severity of their AD at the end of the 12-week period, compared with those in the placebo group.

“The percentage of patients achieving essentially no itch, as captured in the fact that more than half of those on the higher dose of abrocitinib made it to no itch, is a new data point and is important to note,” Dr. Eichenfield said. “A lot of the other medicines don’t really get a significant percentage of the population to an itch score of 0 to 1. This drug brought about a rapid and profound itch relief.”

He added: “The results from JADE TEEN extend the drug’s utility in this younger population and show that abrocitinib performs the same with regard to efficacy and safety in the teenagers. Having atopic dermatitis that does not respond to treatment is especially hard for adolescents, but now we know that abrocitinib will be safe and effective and so we now have something to offer these kids.”

“Abrocitinib achieved a good response in this study that was statistically significant, compared to standard treatment,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, commented in an interview.

“JAK inhibitors are very promising, and this study adds to that promise. They play an important role in atopic dermatitis, so obviously, teenagers with AD represent an important population,” said Dr. Bernstein, who was not part of the study. “These results are very encouraging, and I think that we will probably see some of these JAK inhibitors approved by the FDA, if not this year, probably next.”

The study was sponsored by Pfizer. Dr. Eichenfield serves as an investigator, speaker, and consultant for Pfizer; and as an investigator, speaker, consultant, and/or is on a data safety monitoring board for AbbVie, Almirall, Amgen, Arcutis, Asana, Dermavant, Dermira, Forte, Galderma, Ichnos/Glenmark, Incyte, LEO, Lilly, L’Oreal, Novartis, Regeneron, Sanofi-Genzyme, and Verrica. Dr. Bernstein disclosed no relevant financial relationships.
 

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

A 51-year-old woman presented to the family medicine clinic for evaluation of a slightly tender skin lesion on her left eyebrow. The lesion had been slowly growing for a year.

The patient’s family history included multiple family members with colon or breast cancer and other relatives with pancreatic and prostate cancer. A colonoscopy performed a year earlier on the patient was negative. The patient’s past medical history included hypertension, major depressive disorder, hyperlipidemia, and venous insufficiency. She also had a colon polyp history.

Physical examination of the eyebrow showed a 3-mm papule that was firm on palpation. Dermoscopy of the lesion revealed a yellow papule with an overlying telangiectasia (FIGURE 1A and 1B). Although the lesion appeared benign, the treatment team and the patient agreed to pursue a consultation. The dermoscopy images were sent to a dermatologist to help identify the lesion.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

A rapid teledermatology consultation helped us to determine that this was a sebaceous lesion, but its location and the overlying telangiectasia raised concerns for malignancy. After shared decision-making with the patient, she agreed to proceed with a biopsy. We first made an incision into the lesion, which was hard, demonstrating that it was not cystic. A shave biopsy was then completed. The dermatopathology findings showed clear-cell change consisting of bubbly or foamy cytoplasm, with scalloping of the nuclei, which is characteristic of a sebaceous origin. There were tumor cells that were enlarged with pleomorphism, multiple nucleoli, and scattered mitotic figures. These findings pointed to a diagnosis of sebaceous carcinoma.

Sebaceous carcinomas most commonly manifest on the eyelids. They can originate from the Meibomian glands as well as from pilosebaceous glands at other sites on the body.¹ They are rare, accounting for only 1% to 5% of eyelid malignancies, and occur in approximately 2 per 1 million people.¹ Tumors can invade locally and metastasize, particularly to surrounding lymph nodes. Periocular pathology may sometimes lead to misdiagnosis, which contributes to a mortality rate that has been reported as high as 20%.¹ Suspicion for malignancy may arise due to ulceration, bleeding, pain, or rapid growth.

A lesson in considering the full differential

While sebaceous lesions on the eyelid and eyebrow are often benign, this case underscored the importance of considering the more worrisome elements in the differential. The differential diagnosis for lesions in the area of the eye include the following:

Sebaceous hyperplasia is a common condition (typically among older patients) in which sebaceous glands increase in size and number.² The classic clinical feature is yellow or skin-colored papules. The lesions typically manifest on the face—particularly on the forehead. They are benign and often have a central umbilication.²

Sebaceous adenomas are benign tumors that may manifest as tan, skin-colored, pink, or yellow papules or nodules.² The lesions are usually asymptomatic, small, and slow growing.²

Continue to: Basal and squamous cell carcinomas

Basal and squamous cell carcinomas. Basal cell carcinomas often feature translucent lesions on areas of the skin that are exposed to sunlight. These lesions often have slightly rolled border edges or overlying branching telangiectasia and may be nodular.³ Squamous cell carcinomas often feature scaled, reddened patches that may become tender and ulcerate.⁴

Hordeolums and chalazions. A hordeolum (or stye) is a painful, acute, localized swelling of the eyelid.⁵ These often develop externally at the lid margin from infection of the follicle. A chalazion is characterized by a persistent, nontender mass that results from small, noninfectious obstruction of the Meibomian glands with secondary granulomatous inflammation.⁵

Dermoscopy can (and did) help with the Dx

Dermoscopy can help confirm whether a lesion has a sebaceous origin because it would show yellow globules with “crown vessel” telangiectasias that classically do not cross midline.⁶ Unfortunately, the findings of yellow globules and dermal vessels do not adequately differentiate benign from malignant lesions.⁶ Carcinomas can manifest in an undifferentiated way early in their course.

Sebaceous carcinomas can be associated with the autosomal dominant Muir-Torre syndrome, a subset of the Lynch syndrome.^7,8 Colorectal and genitourinary carcinomas are the most common internal malignancies seen in patients with Muir-Torre syndrome.⁹

Patients benefit from Mohs surgery

Treatment outcomes for sebaceous carcinoma appear to be improved by Mohs surgery. In a recent review of 1265 patients with early-stage sebaceous carcinomas, Su et al found that 234 patients who were treated with Mohs surgery had improved overall survival, compared with 1031 who were treated with surgical excision.¹⁰

Continue to: Our patient

Our patient was referred to a Mohs surgeon who removed the lesion (FIGURES 2 and 3). Given the overall small tumor size, a sentinel lymph node biopsy was not necessary. Because of the patient’s family history, which was suggestive of a genetic predisposition to cancer, she requested a clinical genetics consultation for definitive testing. She went on to pursue genetic testing, which came back negative for Lynch syndrome genes.

The dermatologist recommended yearly skin examination for 5 years for the patient.

A 51-year-old woman presented to the family medicine clinic for evaluation of a slightly tender skin lesion on her left eyebrow. The lesion had been slowly growing for a year.

The patient’s family history included multiple family members with colon or breast cancer and other relatives with pancreatic and prostate cancer. A colonoscopy performed a year earlier on the patient was negative. The patient’s past medical history included hypertension, major depressive disorder, hyperlipidemia, and venous insufficiency. She also had a colon polyp history.

Physical examination of the eyebrow showed a 3-mm papule that was firm on palpation. Dermoscopy of the lesion revealed a yellow papule with an overlying telangiectasia (FIGURE 1A and 1B). Although the lesion appeared benign, the treatment team and the patient agreed to pursue a consultation. The dermoscopy images were sent to a dermatologist to help identify the lesion.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

A rapid teledermatology consultation helped us to determine that this was a sebaceous lesion, but its location and the overlying telangiectasia raised concerns for malignancy. After shared decision-making with the patient, she agreed to proceed with a biopsy. We first made an incision into the lesion, which was hard, demonstrating that it was not cystic. A shave biopsy was then completed. The dermatopathology findings showed clear-cell change consisting of bubbly or foamy cytoplasm, with scalloping of the nuclei, which is characteristic of a sebaceous origin. There were tumor cells that were enlarged with pleomorphism, multiple nucleoli, and scattered mitotic figures. These findings pointed to a diagnosis of sebaceous carcinoma.

Sebaceous carcinomas most commonly manifest on the eyelids. They can originate from the Meibomian glands as well as from pilosebaceous glands at other sites on the body.¹ They are rare, accounting for only 1% to 5% of eyelid malignancies, and occur in approximately 2 per 1 million people.¹ Tumors can invade locally and metastasize, particularly to surrounding lymph nodes. Periocular pathology may sometimes lead to misdiagnosis, which contributes to a mortality rate that has been reported as high as 20%.¹ Suspicion for malignancy may arise due to ulceration, bleeding, pain, or rapid growth.

A lesson in considering the full differential

While sebaceous lesions on the eyelid and eyebrow are often benign, this case underscored the importance of considering the more worrisome elements in the differential. The differential diagnosis for lesions in the area of the eye include the following:

Sebaceous hyperplasia is a common condition (typically among older patients) in which sebaceous glands increase in size and number.² The classic clinical feature is yellow or skin-colored papules. The lesions typically manifest on the face—particularly on the forehead. They are benign and often have a central umbilication.²

Sebaceous adenomas are benign tumors that may manifest as tan, skin-colored, pink, or yellow papules or nodules.² The lesions are usually asymptomatic, small, and slow growing.²

Continue to: Basal and squamous cell carcinomas

Basal and squamous cell carcinomas. Basal cell carcinomas often feature translucent lesions on areas of the skin that are exposed to sunlight. These lesions often have slightly rolled border edges or overlying branching telangiectasia and may be nodular.³ Squamous cell carcinomas often feature scaled, reddened patches that may become tender and ulcerate.⁴

Hordeolums and chalazions. A hordeolum (or stye) is a painful, acute, localized swelling of the eyelid.⁵ These often develop externally at the lid margin from infection of the follicle. A chalazion is characterized by a persistent, nontender mass that results from small, noninfectious obstruction of the Meibomian glands with secondary granulomatous inflammation.⁵

Dermoscopy can (and did) help with the Dx

Dermoscopy can help confirm whether a lesion has a sebaceous origin because it would show yellow globules with “crown vessel” telangiectasias that classically do not cross midline.⁶ Unfortunately, the findings of yellow globules and dermal vessels do not adequately differentiate benign from malignant lesions.⁶ Carcinomas can manifest in an undifferentiated way early in their course.

Sebaceous carcinomas can be associated with the autosomal dominant Muir-Torre syndrome, a subset of the Lynch syndrome.^7,8 Colorectal and genitourinary carcinomas are the most common internal malignancies seen in patients with Muir-Torre syndrome.⁹

Patients benefit from Mohs surgery

Treatment outcomes for sebaceous carcinoma appear to be improved by Mohs surgery. In a recent review of 1265 patients with early-stage sebaceous carcinomas, Su et al found that 234 patients who were treated with Mohs surgery had improved overall survival, compared with 1031 who were treated with surgical excision.¹⁰

Continue to: Our patient

Our patient was referred to a Mohs surgeon who removed the lesion (FIGURES 2 and 3). Given the overall small tumor size, a sentinel lymph node biopsy was not necessary. Because of the patient’s family history, which was suggestive of a genetic predisposition to cancer, she requested a clinical genetics consultation for definitive testing. She went on to pursue genetic testing, which came back negative for Lynch syndrome genes.

The dermatologist recommended yearly skin examination for 5 years for the patient.

A 51-year-old woman presented to the family medicine clinic for evaluation of a slightly tender skin lesion on her left eyebrow. The lesion had been slowly growing for a year.

The patient’s family history included multiple family members with colon or breast cancer and other relatives with pancreatic and prostate cancer. A colonoscopy performed a year earlier on the patient was negative. The patient’s past medical history included hypertension, major depressive disorder, hyperlipidemia, and venous insufficiency. She also had a colon polyp history.

Physical examination of the eyebrow showed a 3-mm papule that was firm on palpation. Dermoscopy of the lesion revealed a yellow papule with an overlying telangiectasia (FIGURE 1A and 1B). Although the lesion appeared benign, the treatment team and the patient agreed to pursue a consultation. The dermoscopy images were sent to a dermatologist to help identify the lesion.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

A rapid teledermatology consultation helped us to determine that this was a sebaceous lesion, but its location and the overlying telangiectasia raised concerns for malignancy. After shared decision-making with the patient, she agreed to proceed with a biopsy. We first made an incision into the lesion, which was hard, demonstrating that it was not cystic. A shave biopsy was then completed. The dermatopathology findings showed clear-cell change consisting of bubbly or foamy cytoplasm, with scalloping of the nuclei, which is characteristic of a sebaceous origin. There were tumor cells that were enlarged with pleomorphism, multiple nucleoli, and scattered mitotic figures. These findings pointed to a diagnosis of sebaceous carcinoma.

Sebaceous carcinomas most commonly manifest on the eyelids. They can originate from the Meibomian glands as well as from pilosebaceous glands at other sites on the body.¹ They are rare, accounting for only 1% to 5% of eyelid malignancies, and occur in approximately 2 per 1 million people.¹ Tumors can invade locally and metastasize, particularly to surrounding lymph nodes. Periocular pathology may sometimes lead to misdiagnosis, which contributes to a mortality rate that has been reported as high as 20%.¹ Suspicion for malignancy may arise due to ulceration, bleeding, pain, or rapid growth.

A lesson in considering the full differential

While sebaceous lesions on the eyelid and eyebrow are often benign, this case underscored the importance of considering the more worrisome elements in the differential. The differential diagnosis for lesions in the area of the eye include the following:

Sebaceous hyperplasia is a common condition (typically among older patients) in which sebaceous glands increase in size and number.² The classic clinical feature is yellow or skin-colored papules. The lesions typically manifest on the face—particularly on the forehead. They are benign and often have a central umbilication.²

Sebaceous adenomas are benign tumors that may manifest as tan, skin-colored, pink, or yellow papules or nodules.² The lesions are usually asymptomatic, small, and slow growing.²

Continue to: Basal and squamous cell carcinomas

Basal and squamous cell carcinomas. Basal cell carcinomas often feature translucent lesions on areas of the skin that are exposed to sunlight. These lesions often have slightly rolled border edges or overlying branching telangiectasia and may be nodular.³ Squamous cell carcinomas often feature scaled, reddened patches that may become tender and ulcerate.⁴

Hordeolums and chalazions. A hordeolum (or stye) is a painful, acute, localized swelling of the eyelid.⁵ These often develop externally at the lid margin from infection of the follicle. A chalazion is characterized by a persistent, nontender mass that results from small, noninfectious obstruction of the Meibomian glands with secondary granulomatous inflammation.⁵

Dermoscopy can (and did) help with the Dx

Dermoscopy can help confirm whether a lesion has a sebaceous origin because it would show yellow globules with “crown vessel” telangiectasias that classically do not cross midline.⁶ Unfortunately, the findings of yellow globules and dermal vessels do not adequately differentiate benign from malignant lesions.⁶ Carcinomas can manifest in an undifferentiated way early in their course.

Sebaceous carcinomas can be associated with the autosomal dominant Muir-Torre syndrome, a subset of the Lynch syndrome.^7,8 Colorectal and genitourinary carcinomas are the most common internal malignancies seen in patients with Muir-Torre syndrome.⁹

Patients benefit from Mohs surgery

Treatment outcomes for sebaceous carcinoma appear to be improved by Mohs surgery. In a recent review of 1265 patients with early-stage sebaceous carcinomas, Su et al found that 234 patients who were treated with Mohs surgery had improved overall survival, compared with 1031 who were treated with surgical excision.¹⁰

Continue to: Our patient

Our patient was referred to a Mohs surgeon who removed the lesion (FIGURES 2 and 3). Given the overall small tumor size, a sentinel lymph node biopsy was not necessary. Because of the patient’s family history, which was suggestive of a genetic predisposition to cancer, she requested a clinical genetics consultation for definitive testing. She went on to pursue genetic testing, which came back negative for Lynch syndrome genes.

The dermatologist recommended yearly skin examination for 5 years for the patient.

EVIDENCE SUMMARY

Metformin has modest effects on body weight

A large systematic review and meta-­analysis (38 RCTs; n = 2199) published in 2020 evaluated metformin therapy in children and adolescents (including those with metabolic disease, growth problems, and psychological disorders in addition to obesity and overweight).¹ Over an average of 6 months, metformin use modestly reduced BMI (weighted mean difference [WMD] = –1.07 kg/m²; 95% CI, –1.43 to –0.72 kg/m²) and body weight (WMD = –2.51 kg; 95% CI, –3.14 to –1.89 kg) for all participants.¹

However, the authors also performed a meta-analysis of trials involving obese or overweight youth without other comorbidities. Participants in these trials ranged in age from 7 to 17 years (mean not supplied; most trials, 12-15 years), had a BMI greater than the 95th percentile for age, and took doses of metformin ranging from 1500 to 3000 mg (most trials, 1500-2000 mg/d for 24 weeks).¹ In this analysis, metformin reduced body weight (8 trials; n = 616; WMD = –2.06 kg; 95% CI, –3.47 to –0.65 kg) and body fat mass (–1.9%; 95% CI, –3.25% to –0.56%). But it did not reduce BMI (12 trials; n = 826; WMD = –0.76 kg/m²; 95 % CI, –1.61 to 0.08 kg/m²) or improve lean body mass (2 trials; N = 98; WMD = –0.74 kg; 95% CI, –2.4 to 0.91 kg).¹

The authors of this meta-analysis did not include an evaluation of the quality of the individual RCTs.

Metformin has benefits but also adverse effects

A 2016 Cochrane systematic review and ­meta-analysis assessed 8 trials (total n = 543) evaluating metformin vs placebo in adolescents prescribed exercise and lifestyle support.² This meta-analysis included 4 trials (n = 294) with obese or overweight adolescents that were also included in the newer meta-analysis,¹ as well as 4 trials involving obese adolescents with insulin resistance. The authors did not assess the effects of metformin on obese or overweight adolescents separately.

Over 6 months, metformin use reduced BMI (WMD = –1.35 kg/m²; 95% CI –2 to –0.69 kg/m²).² Metformin commonly produced gastrointestinal symptoms: diarrhea, flatulence (rates not given), and nausea in 15% to 42% compared with 3% to 21% with placebo (no comparison statistic supplied), however rarely to the point of discontinuation (< 5%).² Nine participants withdrew due to adverse effects: 5 in the metformin group and 4 in the placebo group. The authors rated the quality of the included trials as low to moderate.

An evidence report and systematic review (42 RCTs; total n = 6956) compared the efficacy of several approaches for weight loss in adolescents, including metformin (6 of the 8 RCTs included in the 2020 meta-analysis¹) and lifestyle interventions.³ Interventions comprising exercise and diet counseling for > 26 hours over 6 to 12 months produced decreases in BMI (–0.86 kg/m²; 95% CI –1.44 to –0.29 kg/m²) but not weight (–2 kg; 95% CI –3.2 to 1.2 kg).³

Recommendations from others

The US Preventive Services Task Force states that metformin treatment in adolescents who are overweight or obese produces a small reduction in BMI when compared to placebo, but the clinical significance of this reduction is unclear.³

Editor’s takeaway

The idea of using medications for weight loss remains seductive, given how hard it can be for patients to achieve significant, lasting weight loss through lifestyle modification. Evidence suggests that metformin can help in this regard but not enough to recommend it. In addition, metformin therapy is associated with gastrointestinal adverse effects.

EVIDENCE SUMMARY

Metformin has modest effects on body weight

A large systematic review and meta-­analysis (38 RCTs; n = 2199) published in 2020 evaluated metformin therapy in children and adolescents (including those with metabolic disease, growth problems, and psychological disorders in addition to obesity and overweight).¹ Over an average of 6 months, metformin use modestly reduced BMI (weighted mean difference [WMD] = –1.07 kg/m²; 95% CI, –1.43 to –0.72 kg/m²) and body weight (WMD = –2.51 kg; 95% CI, –3.14 to –1.89 kg) for all participants.¹

However, the authors also performed a meta-analysis of trials involving obese or overweight youth without other comorbidities. Participants in these trials ranged in age from 7 to 17 years (mean not supplied; most trials, 12-15 years), had a BMI greater than the 95th percentile for age, and took doses of metformin ranging from 1500 to 3000 mg (most trials, 1500-2000 mg/d for 24 weeks).¹ In this analysis, metformin reduced body weight (8 trials; n = 616; WMD = –2.06 kg; 95% CI, –3.47 to –0.65 kg) and body fat mass (–1.9%; 95% CI, –3.25% to –0.56%). But it did not reduce BMI (12 trials; n = 826; WMD = –0.76 kg/m²; 95 % CI, –1.61 to 0.08 kg/m²) or improve lean body mass (2 trials; N = 98; WMD = –0.74 kg; 95% CI, –2.4 to 0.91 kg).¹

The authors of this meta-analysis did not include an evaluation of the quality of the individual RCTs.

Metformin has benefits but also adverse effects

A 2016 Cochrane systematic review and ­meta-analysis assessed 8 trials (total n = 543) evaluating metformin vs placebo in adolescents prescribed exercise and lifestyle support.² This meta-analysis included 4 trials (n = 294) with obese or overweight adolescents that were also included in the newer meta-analysis,¹ as well as 4 trials involving obese adolescents with insulin resistance. The authors did not assess the effects of metformin on obese or overweight adolescents separately.

Over 6 months, metformin use reduced BMI (WMD = –1.35 kg/m²; 95% CI –2 to –0.69 kg/m²).² Metformin commonly produced gastrointestinal symptoms: diarrhea, flatulence (rates not given), and nausea in 15% to 42% compared with 3% to 21% with placebo (no comparison statistic supplied), however rarely to the point of discontinuation (< 5%).² Nine participants withdrew due to adverse effects: 5 in the metformin group and 4 in the placebo group. The authors rated the quality of the included trials as low to moderate.

An evidence report and systematic review (42 RCTs; total n = 6956) compared the efficacy of several approaches for weight loss in adolescents, including metformin (6 of the 8 RCTs included in the 2020 meta-analysis¹) and lifestyle interventions.³ Interventions comprising exercise and diet counseling for > 26 hours over 6 to 12 months produced decreases in BMI (–0.86 kg/m²; 95% CI –1.44 to –0.29 kg/m²) but not weight (–2 kg; 95% CI –3.2 to 1.2 kg).³

Recommendations from others

The US Preventive Services Task Force states that metformin treatment in adolescents who are overweight or obese produces a small reduction in BMI when compared to placebo, but the clinical significance of this reduction is unclear.³

Editor’s takeaway

The idea of using medications for weight loss remains seductive, given how hard it can be for patients to achieve significant, lasting weight loss through lifestyle modification. Evidence suggests that metformin can help in this regard but not enough to recommend it. In addition, metformin therapy is associated with gastrointestinal adverse effects.

EVIDENCE SUMMARY

Metformin has modest effects on body weight

A large systematic review and meta-­analysis (38 RCTs; n = 2199) published in 2020 evaluated metformin therapy in children and adolescents (including those with metabolic disease, growth problems, and psychological disorders in addition to obesity and overweight).¹ Over an average of 6 months, metformin use modestly reduced BMI (weighted mean difference [WMD] = –1.07 kg/m²; 95% CI, –1.43 to –0.72 kg/m²) and body weight (WMD = –2.51 kg; 95% CI, –3.14 to –1.89 kg) for all participants.¹

However, the authors also performed a meta-analysis of trials involving obese or overweight youth without other comorbidities. Participants in these trials ranged in age from 7 to 17 years (mean not supplied; most trials, 12-15 years), had a BMI greater than the 95th percentile for age, and took doses of metformin ranging from 1500 to 3000 mg (most trials, 1500-2000 mg/d for 24 weeks).¹ In this analysis, metformin reduced body weight (8 trials; n = 616; WMD = –2.06 kg; 95% CI, –3.47 to –0.65 kg) and body fat mass (–1.9%; 95% CI, –3.25% to –0.56%). But it did not reduce BMI (12 trials; n = 826; WMD = –0.76 kg/m²; 95 % CI, –1.61 to 0.08 kg/m²) or improve lean body mass (2 trials; N = 98; WMD = –0.74 kg; 95% CI, –2.4 to 0.91 kg).¹

The authors of this meta-analysis did not include an evaluation of the quality of the individual RCTs.

Metformin has benefits but also adverse effects

A 2016 Cochrane systematic review and ­meta-analysis assessed 8 trials (total n = 543) evaluating metformin vs placebo in adolescents prescribed exercise and lifestyle support.² This meta-analysis included 4 trials (n = 294) with obese or overweight adolescents that were also included in the newer meta-analysis,¹ as well as 4 trials involving obese adolescents with insulin resistance. The authors did not assess the effects of metformin on obese or overweight adolescents separately.

Over 6 months, metformin use reduced BMI (WMD = –1.35 kg/m²; 95% CI –2 to –0.69 kg/m²).² Metformin commonly produced gastrointestinal symptoms: diarrhea, flatulence (rates not given), and nausea in 15% to 42% compared with 3% to 21% with placebo (no comparison statistic supplied), however rarely to the point of discontinuation (< 5%).² Nine participants withdrew due to adverse effects: 5 in the metformin group and 4 in the placebo group. The authors rated the quality of the included trials as low to moderate.

An evidence report and systematic review (42 RCTs; total n = 6956) compared the efficacy of several approaches for weight loss in adolescents, including metformin (6 of the 8 RCTs included in the 2020 meta-analysis¹) and lifestyle interventions.³ Interventions comprising exercise and diet counseling for > 26 hours over 6 to 12 months produced decreases in BMI (–0.86 kg/m²; 95% CI –1.44 to –0.29 kg/m²) but not weight (–2 kg; 95% CI –3.2 to 1.2 kg).³

Recommendations from others

The US Preventive Services Task Force states that metformin treatment in adolescents who are overweight or obese produces a small reduction in BMI when compared to placebo, but the clinical significance of this reduction is unclear.³

Editor’s takeaway

The idea of using medications for weight loss remains seductive, given how hard it can be for patients to achieve significant, lasting weight loss through lifestyle modification. Evidence suggests that metformin can help in this regard but not enough to recommend it. In addition, metformin therapy is associated with gastrointestinal adverse effects.

EVIDENCE SUMMARY

Benzodiazepines work—but how do they compare?

A 2010 Cochrane meta-analysis of 64 RCTs and controlled clinical trials (CCTs; N = 4309) evaluated the use of benzodiazepines for treatment of AWS in adults.¹ This systematic review compared benzodiazepines

• vs placebo (10 studies)
• vs other drugs, including phenobarbital, carbamazepine, topiramate, lamotrigine, gabapentin, haloperidol, clonidine, hydroxyzine, propranolol, and baclofen (42 studies)
• to other benzodiazepines, including chlordiazepoxide, alprazolam, diazepam, and lorazepam (18 studies)
• in combination with other drugs vs other drugs alone (3 studies)
• administered on a fixed schedule vs symptom-triggered administration (3 studies).

Primary outcomes included efficacy (alcohol withdrawal seizures, alcohol withdrawal delirium, alcohol withdrawal symptoms, global improvement), safety (adverse events and severe, life-threatening adverse events), and acceptability (dropouts and dropouts due to adverse events).

Benzodiazepines performed better than placebo for seizures in 3 studies (N = 324), with a relative risk (RR) of 0.16 (95% confidence interval [CI], 0.04-0.69). Studies assessing the described outcomes between benzodiazepines and other drugs were often of small sample size and heterogeneous in ­interventions and outcomes, limiting the ability to draw clear conclusions regarding benzodiazepine superiority. Comparisons of different benzodiazepines with each other and comparisons of benzodiazepines combined with other drugs vs other drugs alone did not reach statistical significance. Data on harms of benzodiazepines were lacking.

Anticonvulsants are not better than placebo for AWS

Another 2010 Cochrane meta-analysis of 56 RCTs and CCTs (N = 4076) evaluated the use of anticonvulsants for AWS.² This systematic review compared anticonvulsants

• vs placebo (17 studies)
• vs other drugs, such as bromocriptine, piracetam, gamma-hydroxybutyric acid, trifluoperazine, clonidine, and various benzodiazepines (32 studies)
• to other anticonvulsants (10 studies)
• in combination with other drugs vs other drugs alone (6 studies)
• in combination with other drugs vs different anticonvulsants (1 study).

Primary outcomes included reductions in alcohol withdrawal seizures, adverse events, and acceptability of medication as indicated by participant dropouts.

Anticonvulsants were not superior to placebo for any outcome. Three studies (N = 260) favored carbamazepine over benzodiazepine (oxazepam or lorazepam) for 1 secondary outcome: a reduction of Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score (maximum score of 7; mean difference [MD] = –1 [95% CI, –1.9 to –0.2]).

Continue to: Gabapentin is effective; less sedating than chlordiazepoxide

A 2013 RCT of US veterans with AWS (N = 26; 25 men; average age, 53.5 years) compared gabapentin and chlordiazepoxide.³ Endpoints were ratings on the Epworth Sleepiness Scale (ESS; maximum score = 24), Penn Alcohol Craving Scale (PACS; maximum score, 30), and CIWA-Ar.

In the early treatment period (Days 1-4), ESS and PACS scores did not differ significantly between groups. At end of treatment (Days 5-7), ESS and PACS scores were lower in gabapentin-treated patients (ESS: MD = –3.7; 95% CI, –7.2 to –0.19; P = .04; PACS: MD = –6.05; 95% CI –12.82 to 0.72; P = .08). CIWA-Ar did not differ between treatment groups.

Recommendations from others

In January 2020, the American Society of Addiction Medicine (ASAM) published a clinical practice guideline for alcohol withdrawal management. Protocols for diagnosis, assessment, level of care determination, and management are delineated.⁴

Dozens of small trials and meta-analyses confirm the benefits (sometimes marginal) of sedation to treat alcohol withdrawal.

Benzodiazepines are the first-line treatment for moderate-to-severe AWS, or when there is risk for severe AWS. In the ambulatory setting, when AWS is mild and there is no risk for worsening, AWS can be managed with supportive care or with either benzodiazepines, gabapentin, or carbamazepine as monotherapy. ASAM recommends long-­acting benzodiazepines (eg, chlordiazepoxide or diazepam) over short-acting benzodiazepines (eg, alprazolam or lorazepam), except in the elderly and those with liver or lung disease.⁵

Editor’s takeaway

Dozens of small trials and meta-analyses confirm the benefits (sometimes marginal) of sedation to treat alcohol withdrawal. Given that the evidence fails to point to the superiority of 1 agent over another, it seems reasonable to make treatment decisions based on physician and perhaps patient preference. This review does not support a change in clinical practice.

EVIDENCE SUMMARY

Benzodiazepines work—but how do they compare?

A 2010 Cochrane meta-analysis of 64 RCTs and controlled clinical trials (CCTs; N = 4309) evaluated the use of benzodiazepines for treatment of AWS in adults.¹ This systematic review compared benzodiazepines

• vs placebo (10 studies)
• vs other drugs, including phenobarbital, carbamazepine, topiramate, lamotrigine, gabapentin, haloperidol, clonidine, hydroxyzine, propranolol, and baclofen (42 studies)
• to other benzodiazepines, including chlordiazepoxide, alprazolam, diazepam, and lorazepam (18 studies)
• in combination with other drugs vs other drugs alone (3 studies)
• administered on a fixed schedule vs symptom-triggered administration (3 studies).

Primary outcomes included efficacy (alcohol withdrawal seizures, alcohol withdrawal delirium, alcohol withdrawal symptoms, global improvement), safety (adverse events and severe, life-threatening adverse events), and acceptability (dropouts and dropouts due to adverse events).

Benzodiazepines performed better than placebo for seizures in 3 studies (N = 324), with a relative risk (RR) of 0.16 (95% confidence interval [CI], 0.04-0.69). Studies assessing the described outcomes between benzodiazepines and other drugs were often of small sample size and heterogeneous in ­interventions and outcomes, limiting the ability to draw clear conclusions regarding benzodiazepine superiority. Comparisons of different benzodiazepines with each other and comparisons of benzodiazepines combined with other drugs vs other drugs alone did not reach statistical significance. Data on harms of benzodiazepines were lacking.

Anticonvulsants are not better than placebo for AWS

Another 2010 Cochrane meta-analysis of 56 RCTs and CCTs (N = 4076) evaluated the use of anticonvulsants for AWS.² This systematic review compared anticonvulsants

• vs placebo (17 studies)
• vs other drugs, such as bromocriptine, piracetam, gamma-hydroxybutyric acid, trifluoperazine, clonidine, and various benzodiazepines (32 studies)
• to other anticonvulsants (10 studies)
• in combination with other drugs vs other drugs alone (6 studies)
• in combination with other drugs vs different anticonvulsants (1 study).

Primary outcomes included reductions in alcohol withdrawal seizures, adverse events, and acceptability of medication as indicated by participant dropouts.

Anticonvulsants were not superior to placebo for any outcome. Three studies (N = 260) favored carbamazepine over benzodiazepine (oxazepam or lorazepam) for 1 secondary outcome: a reduction of Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score (maximum score of 7; mean difference [MD] = –1 [95% CI, –1.9 to –0.2]).

Continue to: Gabapentin is effective; less sedating than chlordiazepoxide

A 2013 RCT of US veterans with AWS (N = 26; 25 men; average age, 53.5 years) compared gabapentin and chlordiazepoxide.³ Endpoints were ratings on the Epworth Sleepiness Scale (ESS; maximum score = 24), Penn Alcohol Craving Scale (PACS; maximum score, 30), and CIWA-Ar.

In the early treatment period (Days 1-4), ESS and PACS scores did not differ significantly between groups. At end of treatment (Days 5-7), ESS and PACS scores were lower in gabapentin-treated patients (ESS: MD = –3.7; 95% CI, –7.2 to –0.19; P = .04; PACS: MD = –6.05; 95% CI –12.82 to 0.72; P = .08). CIWA-Ar did not differ between treatment groups.

Recommendations from others

In January 2020, the American Society of Addiction Medicine (ASAM) published a clinical practice guideline for alcohol withdrawal management. Protocols for diagnosis, assessment, level of care determination, and management are delineated.⁴

Dozens of small trials and meta-analyses confirm the benefits (sometimes marginal) of sedation to treat alcohol withdrawal.

Benzodiazepines are the first-line treatment for moderate-to-severe AWS, or when there is risk for severe AWS. In the ambulatory setting, when AWS is mild and there is no risk for worsening, AWS can be managed with supportive care or with either benzodiazepines, gabapentin, or carbamazepine as monotherapy. ASAM recommends long-­acting benzodiazepines (eg, chlordiazepoxide or diazepam) over short-acting benzodiazepines (eg, alprazolam or lorazepam), except in the elderly and those with liver or lung disease.⁵

Editor’s takeaway

Dozens of small trials and meta-analyses confirm the benefits (sometimes marginal) of sedation to treat alcohol withdrawal. Given that the evidence fails to point to the superiority of 1 agent over another, it seems reasonable to make treatment decisions based on physician and perhaps patient preference. This review does not support a change in clinical practice.

EVIDENCE SUMMARY

Benzodiazepines work—but how do they compare?

A 2010 Cochrane meta-analysis of 64 RCTs and controlled clinical trials (CCTs; N = 4309) evaluated the use of benzodiazepines for treatment of AWS in adults.¹ This systematic review compared benzodiazepines

• vs placebo (10 studies)
• vs other drugs, including phenobarbital, carbamazepine, topiramate, lamotrigine, gabapentin, haloperidol, clonidine, hydroxyzine, propranolol, and baclofen (42 studies)
• to other benzodiazepines, including chlordiazepoxide, alprazolam, diazepam, and lorazepam (18 studies)
• in combination with other drugs vs other drugs alone (3 studies)
• administered on a fixed schedule vs symptom-triggered administration (3 studies).

Primary outcomes included efficacy (alcohol withdrawal seizures, alcohol withdrawal delirium, alcohol withdrawal symptoms, global improvement), safety (adverse events and severe, life-threatening adverse events), and acceptability (dropouts and dropouts due to adverse events).

Benzodiazepines performed better than placebo for seizures in 3 studies (N = 324), with a relative risk (RR) of 0.16 (95% confidence interval [CI], 0.04-0.69). Studies assessing the described outcomes between benzodiazepines and other drugs were often of small sample size and heterogeneous in ­interventions and outcomes, limiting the ability to draw clear conclusions regarding benzodiazepine superiority. Comparisons of different benzodiazepines with each other and comparisons of benzodiazepines combined with other drugs vs other drugs alone did not reach statistical significance. Data on harms of benzodiazepines were lacking.

Anticonvulsants are not better than placebo for AWS

Another 2010 Cochrane meta-analysis of 56 RCTs and CCTs (N = 4076) evaluated the use of anticonvulsants for AWS.² This systematic review compared anticonvulsants

• vs placebo (17 studies)
• vs other drugs, such as bromocriptine, piracetam, gamma-hydroxybutyric acid, trifluoperazine, clonidine, and various benzodiazepines (32 studies)
• to other anticonvulsants (10 studies)
• in combination with other drugs vs other drugs alone (6 studies)
• in combination with other drugs vs different anticonvulsants (1 study).

Primary outcomes included reductions in alcohol withdrawal seizures, adverse events, and acceptability of medication as indicated by participant dropouts.

Anticonvulsants were not superior to placebo for any outcome. Three studies (N = 260) favored carbamazepine over benzodiazepine (oxazepam or lorazepam) for 1 secondary outcome: a reduction of Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score (maximum score of 7; mean difference [MD] = –1 [95% CI, –1.9 to –0.2]).

Continue to: Gabapentin is effective; less sedating than chlordiazepoxide

A 2013 RCT of US veterans with AWS (N = 26; 25 men; average age, 53.5 years) compared gabapentin and chlordiazepoxide.³ Endpoints were ratings on the Epworth Sleepiness Scale (ESS; maximum score = 24), Penn Alcohol Craving Scale (PACS; maximum score, 30), and CIWA-Ar.

In the early treatment period (Days 1-4), ESS and PACS scores did not differ significantly between groups. At end of treatment (Days 5-7), ESS and PACS scores were lower in gabapentin-treated patients (ESS: MD = –3.7; 95% CI, –7.2 to –0.19; P = .04; PACS: MD = –6.05; 95% CI –12.82 to 0.72; P = .08). CIWA-Ar did not differ between treatment groups.

Recommendations from others

In January 2020, the American Society of Addiction Medicine (ASAM) published a clinical practice guideline for alcohol withdrawal management. Protocols for diagnosis, assessment, level of care determination, and management are delineated.⁴

Dozens of small trials and meta-analyses confirm the benefits (sometimes marginal) of sedation to treat alcohol withdrawal.

Benzodiazepines are the first-line treatment for moderate-to-severe AWS, or when there is risk for severe AWS. In the ambulatory setting, when AWS is mild and there is no risk for worsening, AWS can be managed with supportive care or with either benzodiazepines, gabapentin, or carbamazepine as monotherapy. ASAM recommends long-­acting benzodiazepines (eg, chlordiazepoxide or diazepam) over short-acting benzodiazepines (eg, alprazolam or lorazepam), except in the elderly and those with liver or lung disease.⁵

Editor’s takeaway

Dozens of small trials and meta-analyses confirm the benefits (sometimes marginal) of sedation to treat alcohol withdrawal. Given that the evidence fails to point to the superiority of 1 agent over another, it seems reasonable to make treatment decisions based on physician and perhaps patient preference. This review does not support a change in clinical practice.

Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?

Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.

“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”

She could pinpoint the day – March 22, 2020 – when she came up with the idea to start a peer-to-peer physician support hotline: psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.

She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.

Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”

Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.

Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.

The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”

The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.

The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?

Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.

“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”

She could pinpoint the day – March 22, 2020 – when she came up with the idea to start a peer-to-peer physician support hotline: psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.

She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.

Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”

Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.

Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.

The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”

The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.

The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?

Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.

“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”

She could pinpoint the day – March 22, 2020 – when she came up with the idea to start a peer-to-peer physician support hotline: psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.

She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.

Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”

Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.

Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.

The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”

The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.

The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

A 49-year-old woman with a history of end-stage renal disease, uncontrolled type 2 diabetes, and congestive heart failure visited the hospital for an acute heart failure exacerbation secondary to missed dialysis appointments. On admission, her provider noted that she had tender, pruritic lesions on the extensor surface of her arms. She said they had appeared 2 to 3 months after she started dialysis. She had attempted to control the pain and pruritus with over-the-counter topical hydrocortisone and oral diphenhydramine but nothing provided relief. She was recommended for follow-up at the hospital for further examination and biopsy of one of her lesions.

At this follow-up visit, the patient noted that the lesions had spread to her left knee. Multiple firm discrete papules and nodules, with central hyperkeratotic plugs, were noted along the extensor surfaces of her forearms, left extensor knee, and around her ankles (FIGURES 1A and 1B). Some of the lesions were tender. Examination of the rest of her skin was normal. A punch biopsy was obtained.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Kyrle disease

The patient’s end-stage renal disease and type 2 diabetes—along with findings from the physical examination—led us to suspect Kyrle disease. The punch biopsy, as well as the characteristic keratotic plugs (FIGURE 2) within epidermal invagination that was bordered by hyperkeratotic epidermis, confirmed the diagnosis.

The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.

Kyrle disease (also known as hyperkeratosis follicularis et follicularis in cutem penetrans) is a rare skin condition. It is 1 of 4 skin conditions that are classified as perforating skin disorders; the other 3 are elastosis perforans serpiginosa, reactive perforating collagenosis, and perforating folliculitis (TABLE^1,2).³ Perforating skin disorders share the common characteristic of transepidermal elimination of material from the upper dermis.⁴ These disorders are typically classified based on the nature of the eliminated material and the type of epidermal disruption.⁵

There are 2 forms of Kyrle disease: an inherited form often seen in childhood that is not associated with systemic disease and an acquired form that occurs in adulthood, most commonly among women ages 35 to 70 years who have systemic disease.^3,4,6 The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.^7,8

Characteristic findings include discrete pruritic, dry papules and nodules with central keratotic plugs that are occasionally tender. These can manifest over the extensor surface of the extremities, trunk, face, and scalp.^4,7,9 Lesions most commonly manifest on the extensor surfaces of the lower extremities.

Other conditions that feature pruritic lesions

In addition to the other perforating skin disorders described in the TABLE,^1,2 the differential for Kyrle disease includes the following:

Prurigo nodularis (PN) is a skin disorder in which the manifestation of extremely pruritic nodules leads to vigorous scratching and secondary infections. These lesions typically have a grouped and symmetrically distributed appearance. They often appear on extensor surfaces of upper and lower extremities.¹⁰ PN has no known etiology, but like Kyrle disease, is associated with renal failure. Biopsy can help to distinguish PN from Kyrle disease.

Continue to: Hypertrophic lichen planus

Hypertrophic lichen planus is a pruritic skin disorder characterized by the “6 Ps”: planar, purple, polygonal, pruritic, papules, and plaques. These lesions can mimic the early stages of Kyrle disease.¹¹ However, in the later stages of Kyrle disease, discrete papules with hyperkeratotic plugs develop, whereas large plaques will be seen with lichen planus.

Keratosis pilaris (KP) is an extremely common, yet benign, disorder in which hair follicles become keratinized.¹² KP can feature rough papules that are often described as “goosebumps” or having a sandpaper–like appearance. These papules often affect the upper arms. KP usually manifests in adolescents or young adults and tends to improve with age.¹² The lesions are typically smaller than those seen in Kyrle disease and are asymptomatic. In addition, KP is not associated with systemic disease.

Target symptoms and any underlying conditions

In patients who have an acquired form of the disease, symptoms may improve by treating the underlying condition. For instance, better control of type 2 diabetes may improve symptoms. In patients with end-stage renal disease, a renal transplant can bring complete resolution.¹³

For patients whose Kyrle disease is inherited or whose underlying condition is not easily treated, there are a number of treatment options to consider. First-line treatment includes topical keratolytics (salicylic acid and urea), topical retinoids, and ultraviolet light therapy.^5,7 Systemic retinoids, topical steroids, cryotherapy, electrosurgery, CO₂ laser surgery, and surgical excision have also been used with some success.^7,14 Oral histamines and emollients also may help to relieve the pruritus. Lesions often recur upon discontinuation of therapy.

Our patient was referred to Dermatology for ultraviolet light therapy. She was also treated with topical 12% ammonium lactate twice daily. Within a few months, she reported improvement of her symptoms.

A 49-year-old woman with a history of end-stage renal disease, uncontrolled type 2 diabetes, and congestive heart failure visited the hospital for an acute heart failure exacerbation secondary to missed dialysis appointments. On admission, her provider noted that she had tender, pruritic lesions on the extensor surface of her arms. She said they had appeared 2 to 3 months after she started dialysis. She had attempted to control the pain and pruritus with over-the-counter topical hydrocortisone and oral diphenhydramine but nothing provided relief. She was recommended for follow-up at the hospital for further examination and biopsy of one of her lesions.

At this follow-up visit, the patient noted that the lesions had spread to her left knee. Multiple firm discrete papules and nodules, with central hyperkeratotic plugs, were noted along the extensor surfaces of her forearms, left extensor knee, and around her ankles (FIGURES 1A and 1B). Some of the lesions were tender. Examination of the rest of her skin was normal. A punch biopsy was obtained.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Kyrle disease

The patient’s end-stage renal disease and type 2 diabetes—along with findings from the physical examination—led us to suspect Kyrle disease. The punch biopsy, as well as the characteristic keratotic plugs (FIGURE 2) within epidermal invagination that was bordered by hyperkeratotic epidermis, confirmed the diagnosis.

The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.

Kyrle disease (also known as hyperkeratosis follicularis et follicularis in cutem penetrans) is a rare skin condition. It is 1 of 4 skin conditions that are classified as perforating skin disorders; the other 3 are elastosis perforans serpiginosa, reactive perforating collagenosis, and perforating folliculitis (TABLE^1,2).³ Perforating skin disorders share the common characteristic of transepidermal elimination of material from the upper dermis.⁴ These disorders are typically classified based on the nature of the eliminated material and the type of epidermal disruption.⁵

There are 2 forms of Kyrle disease: an inherited form often seen in childhood that is not associated with systemic disease and an acquired form that occurs in adulthood, most commonly among women ages 35 to 70 years who have systemic disease.^3,4,6 The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.^7,8

Characteristic findings include discrete pruritic, dry papules and nodules with central keratotic plugs that are occasionally tender. These can manifest over the extensor surface of the extremities, trunk, face, and scalp.^4,7,9 Lesions most commonly manifest on the extensor surfaces of the lower extremities.

Other conditions that feature pruritic lesions

In addition to the other perforating skin disorders described in the TABLE,^1,2 the differential for Kyrle disease includes the following:

Prurigo nodularis (PN) is a skin disorder in which the manifestation of extremely pruritic nodules leads to vigorous scratching and secondary infections. These lesions typically have a grouped and symmetrically distributed appearance. They often appear on extensor surfaces of upper and lower extremities.¹⁰ PN has no known etiology, but like Kyrle disease, is associated with renal failure. Biopsy can help to distinguish PN from Kyrle disease.

Continue to: Hypertrophic lichen planus

Hypertrophic lichen planus is a pruritic skin disorder characterized by the “6 Ps”: planar, purple, polygonal, pruritic, papules, and plaques. These lesions can mimic the early stages of Kyrle disease.¹¹ However, in the later stages of Kyrle disease, discrete papules with hyperkeratotic plugs develop, whereas large plaques will be seen with lichen planus.

Keratosis pilaris (KP) is an extremely common, yet benign, disorder in which hair follicles become keratinized.¹² KP can feature rough papules that are often described as “goosebumps” or having a sandpaper–like appearance. These papules often affect the upper arms. KP usually manifests in adolescents or young adults and tends to improve with age.¹² The lesions are typically smaller than those seen in Kyrle disease and are asymptomatic. In addition, KP is not associated with systemic disease.

Target symptoms and any underlying conditions

In patients who have an acquired form of the disease, symptoms may improve by treating the underlying condition. For instance, better control of type 2 diabetes may improve symptoms. In patients with end-stage renal disease, a renal transplant can bring complete resolution.¹³

For patients whose Kyrle disease is inherited or whose underlying condition is not easily treated, there are a number of treatment options to consider. First-line treatment includes topical keratolytics (salicylic acid and urea), topical retinoids, and ultraviolet light therapy.^5,7 Systemic retinoids, topical steroids, cryotherapy, electrosurgery, CO₂ laser surgery, and surgical excision have also been used with some success.^7,14 Oral histamines and emollients also may help to relieve the pruritus. Lesions often recur upon discontinuation of therapy.

Our patient was referred to Dermatology for ultraviolet light therapy. She was also treated with topical 12% ammonium lactate twice daily. Within a few months, she reported improvement of her symptoms.

A 49-year-old woman with a history of end-stage renal disease, uncontrolled type 2 diabetes, and congestive heart failure visited the hospital for an acute heart failure exacerbation secondary to missed dialysis appointments. On admission, her provider noted that she had tender, pruritic lesions on the extensor surface of her arms. She said they had appeared 2 to 3 months after she started dialysis. She had attempted to control the pain and pruritus with over-the-counter topical hydrocortisone and oral diphenhydramine but nothing provided relief. She was recommended for follow-up at the hospital for further examination and biopsy of one of her lesions.

At this follow-up visit, the patient noted that the lesions had spread to her left knee. Multiple firm discrete papules and nodules, with central hyperkeratotic plugs, were noted along the extensor surfaces of her forearms, left extensor knee, and around her ankles (FIGURES 1A and 1B). Some of the lesions were tender. Examination of the rest of her skin was normal. A punch biopsy was obtained.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Kyrle disease

The patient’s end-stage renal disease and type 2 diabetes—along with findings from the physical examination—led us to suspect Kyrle disease. The punch biopsy, as well as the characteristic keratotic plugs (FIGURE 2) within epidermal invagination that was bordered by hyperkeratotic epidermis, confirmed the diagnosis.

The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.

Kyrle disease (also known as hyperkeratosis follicularis et follicularis in cutem penetrans) is a rare skin condition. It is 1 of 4 skin conditions that are classified as perforating skin disorders; the other 3 are elastosis perforans serpiginosa, reactive perforating collagenosis, and perforating folliculitis (TABLE^1,2).³ Perforating skin disorders share the common characteristic of transepidermal elimination of material from the upper dermis.⁴ These disorders are typically classified based on the nature of the eliminated material and the type of epidermal disruption.⁵

There are 2 forms of Kyrle disease: an inherited form often seen in childhood that is not associated with systemic disease and an acquired form that occurs in adulthood, most commonly among women ages 35 to 70 years who have systemic disease.^3,4,6 The acquired form of Kyrle disease is associated with diabetes and renal failure, but there is a lack of data on its pathogenesis.^7,8

Characteristic findings include discrete pruritic, dry papules and nodules with central keratotic plugs that are occasionally tender. These can manifest over the extensor surface of the extremities, trunk, face, and scalp.^4,7,9 Lesions most commonly manifest on the extensor surfaces of the lower extremities.

Other conditions that feature pruritic lesions

In addition to the other perforating skin disorders described in the TABLE,^1,2 the differential for Kyrle disease includes the following:

Prurigo nodularis (PN) is a skin disorder in which the manifestation of extremely pruritic nodules leads to vigorous scratching and secondary infections. These lesions typically have a grouped and symmetrically distributed appearance. They often appear on extensor surfaces of upper and lower extremities.¹⁰ PN has no known etiology, but like Kyrle disease, is associated with renal failure. Biopsy can help to distinguish PN from Kyrle disease.

Continue to: Hypertrophic lichen planus

Hypertrophic lichen planus is a pruritic skin disorder characterized by the “6 Ps”: planar, purple, polygonal, pruritic, papules, and plaques. These lesions can mimic the early stages of Kyrle disease.¹¹ However, in the later stages of Kyrle disease, discrete papules with hyperkeratotic plugs develop, whereas large plaques will be seen with lichen planus.

Keratosis pilaris (KP) is an extremely common, yet benign, disorder in which hair follicles become keratinized.¹² KP can feature rough papules that are often described as “goosebumps” or having a sandpaper–like appearance. These papules often affect the upper arms. KP usually manifests in adolescents or young adults and tends to improve with age.¹² The lesions are typically smaller than those seen in Kyrle disease and are asymptomatic. In addition, KP is not associated with systemic disease.

Target symptoms and any underlying conditions

In patients who have an acquired form of the disease, symptoms may improve by treating the underlying condition. For instance, better control of type 2 diabetes may improve symptoms. In patients with end-stage renal disease, a renal transplant can bring complete resolution.¹³

For patients whose Kyrle disease is inherited or whose underlying condition is not easily treated, there are a number of treatment options to consider. First-line treatment includes topical keratolytics (salicylic acid and urea), topical retinoids, and ultraviolet light therapy.^5,7 Systemic retinoids, topical steroids, cryotherapy, electrosurgery, CO₂ laser surgery, and surgical excision have also been used with some success.^7,14 Oral histamines and emollients also may help to relieve the pruritus. Lesions often recur upon discontinuation of therapy.

Our patient was referred to Dermatology for ultraviolet light therapy. She was also treated with topical 12% ammonium lactate twice daily. Within a few months, she reported improvement of her symptoms.