The Diagnosis: Spiradenocylindroma

Shave biopsies of our patient’s lesions showed wellcircumscribed dermal nodules resembling a spiradenoma with 3 cell populations: those with lighter nuclei, darker nuclei, and scattered lymphocytes. However, the conspicuous globules of basement membrane material were reminiscent of a cylindroma. These overlapping features and the patient’s history of cylindroma were suggestive of a diagnosis of spiradenocylindroma.

Spiradenocylindroma is an uncommon dermal tumor with features that overlap with spiradenoma and cylindroma.¹ It may manifest as a solitary lesion or multiple lesions and can occur sporadically or in the context of a family history. Histologically, it must be distinguished from other intradermal basaloid neoplasms including conventional cylindroma and spiradenoma, dermal duct tumor, hidradenoma, and trichoblastoma.

When patients present with multiple cylindromas, spiradenomas, or spiradenocylindromas, physicians should consider genetic testing and review of the family history to assess for cylindromatosis gene mutations or Brooke-Spiegler syndrome. Biopsy and histologic examination are important because malignant tumors can evolve from pre-existing spiradenocylindromas, cylindromas, and spiradenomas,² with an increased risk in patients with Brooke-Spiegler syndrome.¹ Our patient declined further genetic workup but continues to follow up with dermatology for monitoring of lesions.

Dermal duct tumors are morphologic variants of poromas that are derived from sweat gland lineage and usually manifest as solitary dome-shaped papules, plaques, or nodules most often seen on acral surfaces as well as the head and neck.³ Clinically, they may be indistinguishable from spiradenocylindromas and require biopsy for histologic evaluation. They can be distinguished from spiradenocylindroma by the presence of small dermal nodules composed of cuboidal cells with ample pink cytoplasm and cuticle-lined ducts (Figure 1).

Trichoblastomas typically are deep-seated basaloid follicular neoplasms on the scalp with papillary mesenchyme resembling the normal fibrous sheath of the hair follicle, often replete with papillary mesenchymal bodies (Figure 2). There generally are no retraction spaces between its basaloid nests and the surrounding stroma, which is unlikely to contain mucin relative to basal cell carcinoma (BCC).^4,5

Adenoid cystic carcinoma is a rare salivary gland tumor that can metastasize to the skin and rarely arises as a primary skin adnexal tumor. It manifests as a slowgrowing mass that can be tender to palpation.⁶ Histologic examination shows dermal islands with cribriform blue and pink spaces. Compared to BCC, adenoid cystic carcinoma cells are enlarged and epithelioid with relatively scarce cytoplasm (Figure 3).^6,7 Adenoid cystic carcinoma can show variable growth patterns including infiltrative nests and trabeculae. Perineural invasion is common, and there is a high risk for local recurrence.⁷ First-line therapy usually is surgical, and postoperative radiotherapy may be required.^6,7

Nodular BCC commonly manifests as an enlarging nonhealing lesion on sun-exposed skin and has many subtypes, typically with arborizing telangiectases on dermoscopy. Histopathologic examination of nodular BCC reveals a nest of basaloid follicular germinative cells in the dermis with peripheral palisading and a fibromyxoid stroma (Figure 4).⁸ Patients with Brooke-Spiegler syndrome are at increased risk for nodular BCC, which may be clinically indistinguishable from spiradenoma, cylindroma, and spiradenocylindroma, necessitating histologic assessment.

The Diagnosis: Spiradenocylindroma

Shave biopsies of our patient’s lesions showed wellcircumscribed dermal nodules resembling a spiradenoma with 3 cell populations: those with lighter nuclei, darker nuclei, and scattered lymphocytes. However, the conspicuous globules of basement membrane material were reminiscent of a cylindroma. These overlapping features and the patient’s history of cylindroma were suggestive of a diagnosis of spiradenocylindroma.

Spiradenocylindroma is an uncommon dermal tumor with features that overlap with spiradenoma and cylindroma.¹ It may manifest as a solitary lesion or multiple lesions and can occur sporadically or in the context of a family history. Histologically, it must be distinguished from other intradermal basaloid neoplasms including conventional cylindroma and spiradenoma, dermal duct tumor, hidradenoma, and trichoblastoma.

When patients present with multiple cylindromas, spiradenomas, or spiradenocylindromas, physicians should consider genetic testing and review of the family history to assess for cylindromatosis gene mutations or Brooke-Spiegler syndrome. Biopsy and histologic examination are important because malignant tumors can evolve from pre-existing spiradenocylindromas, cylindromas, and spiradenomas,² with an increased risk in patients with Brooke-Spiegler syndrome.¹ Our patient declined further genetic workup but continues to follow up with dermatology for monitoring of lesions.

Dermal duct tumors are morphologic variants of poromas that are derived from sweat gland lineage and usually manifest as solitary dome-shaped papules, plaques, or nodules most often seen on acral surfaces as well as the head and neck.³ Clinically, they may be indistinguishable from spiradenocylindromas and require biopsy for histologic evaluation. They can be distinguished from spiradenocylindroma by the presence of small dermal nodules composed of cuboidal cells with ample pink cytoplasm and cuticle-lined ducts (Figure 1).

Trichoblastomas typically are deep-seated basaloid follicular neoplasms on the scalp with papillary mesenchyme resembling the normal fibrous sheath of the hair follicle, often replete with papillary mesenchymal bodies (Figure 2). There generally are no retraction spaces between its basaloid nests and the surrounding stroma, which is unlikely to contain mucin relative to basal cell carcinoma (BCC).^4,5

Adenoid cystic carcinoma is a rare salivary gland tumor that can metastasize to the skin and rarely arises as a primary skin adnexal tumor. It manifests as a slowgrowing mass that can be tender to palpation.⁶ Histologic examination shows dermal islands with cribriform blue and pink spaces. Compared to BCC, adenoid cystic carcinoma cells are enlarged and epithelioid with relatively scarce cytoplasm (Figure 3).^6,7 Adenoid cystic carcinoma can show variable growth patterns including infiltrative nests and trabeculae. Perineural invasion is common, and there is a high risk for local recurrence.⁷ First-line therapy usually is surgical, and postoperative radiotherapy may be required.^6,7

Nodular BCC commonly manifests as an enlarging nonhealing lesion on sun-exposed skin and has many subtypes, typically with arborizing telangiectases on dermoscopy. Histopathologic examination of nodular BCC reveals a nest of basaloid follicular germinative cells in the dermis with peripheral palisading and a fibromyxoid stroma (Figure 4).⁸ Patients with Brooke-Spiegler syndrome are at increased risk for nodular BCC, which may be clinically indistinguishable from spiradenoma, cylindroma, and spiradenocylindroma, necessitating histologic assessment.

The Diagnosis: Spiradenocylindroma

Shave biopsies of our patient’s lesions showed wellcircumscribed dermal nodules resembling a spiradenoma with 3 cell populations: those with lighter nuclei, darker nuclei, and scattered lymphocytes. However, the conspicuous globules of basement membrane material were reminiscent of a cylindroma. These overlapping features and the patient’s history of cylindroma were suggestive of a diagnosis of spiradenocylindroma.

Spiradenocylindroma is an uncommon dermal tumor with features that overlap with spiradenoma and cylindroma.¹ It may manifest as a solitary lesion or multiple lesions and can occur sporadically or in the context of a family history. Histologically, it must be distinguished from other intradermal basaloid neoplasms including conventional cylindroma and spiradenoma, dermal duct tumor, hidradenoma, and trichoblastoma.

When patients present with multiple cylindromas, spiradenomas, or spiradenocylindromas, physicians should consider genetic testing and review of the family history to assess for cylindromatosis gene mutations or Brooke-Spiegler syndrome. Biopsy and histologic examination are important because malignant tumors can evolve from pre-existing spiradenocylindromas, cylindromas, and spiradenomas,² with an increased risk in patients with Brooke-Spiegler syndrome.¹ Our patient declined further genetic workup but continues to follow up with dermatology for monitoring of lesions.

Dermal duct tumors are morphologic variants of poromas that are derived from sweat gland lineage and usually manifest as solitary dome-shaped papules, plaques, or nodules most often seen on acral surfaces as well as the head and neck.³ Clinically, they may be indistinguishable from spiradenocylindromas and require biopsy for histologic evaluation. They can be distinguished from spiradenocylindroma by the presence of small dermal nodules composed of cuboidal cells with ample pink cytoplasm and cuticle-lined ducts (Figure 1).

Trichoblastomas typically are deep-seated basaloid follicular neoplasms on the scalp with papillary mesenchyme resembling the normal fibrous sheath of the hair follicle, often replete with papillary mesenchymal bodies (Figure 2). There generally are no retraction spaces between its basaloid nests and the surrounding stroma, which is unlikely to contain mucin relative to basal cell carcinoma (BCC).^4,5

Adenoid cystic carcinoma is a rare salivary gland tumor that can metastasize to the skin and rarely arises as a primary skin adnexal tumor. It manifests as a slowgrowing mass that can be tender to palpation.⁶ Histologic examination shows dermal islands with cribriform blue and pink spaces. Compared to BCC, adenoid cystic carcinoma cells are enlarged and epithelioid with relatively scarce cytoplasm (Figure 3).^6,7 Adenoid cystic carcinoma can show variable growth patterns including infiltrative nests and trabeculae. Perineural invasion is common, and there is a high risk for local recurrence.⁷ First-line therapy usually is surgical, and postoperative radiotherapy may be required.^6,7

Nodular BCC commonly manifests as an enlarging nonhealing lesion on sun-exposed skin and has many subtypes, typically with arborizing telangiectases on dermoscopy. Histopathologic examination of nodular BCC reveals a nest of basaloid follicular germinative cells in the dermis with peripheral palisading and a fibromyxoid stroma (Figure 4).⁸ Patients with Brooke-Spiegler syndrome are at increased risk for nodular BCC, which may be clinically indistinguishable from spiradenoma, cylindroma, and spiradenocylindroma, necessitating histologic assessment.

To the Editor:

The most common malignancy in the United States is skin cancer, with melanoma accounting for the majority of skin cancer deaths.¹ Despite the lack of established guidelines for routine total-body skin examinations, many patients regularly visit their dermatologist for assessment of pigmented skin lesions.² During the COVID-19 pandemic, many patients were unable to attend in-person dermatology visits, which resulted in many high-risk individuals not receiving care or alternatively seeking virtual care for cutaneous lesions.³ There has been a lack of research in the United States exploring the utilization of teledermatology during the pandemic and its overall impact on the care of patients with a history of skin cancer. We explored the impact of the COVID-19 pandemic on care for patients with skin cancer in a large US population.

Using anonymous survey data from the 2020-2021 National Health Interview Survey,⁴ we conducted a ­population-based, cross-sectional study to evaluate access to care during the COVID-19 pandemic for patients with a self-reported history of skin cancer—melanoma, nonmelanoma skin cancer, or unknown skin cancer. The 3 outcome variables included having a virtual medical appointment in the past 12 months (yes/no), delaying medical care due to the COVID-19 pandemic (yes/no), and not receiving care due to the COVID-19 pandemic (yes/no). Multivariable logistic regression models evaluating the relationship between a history of skin cancer and access to care were constructed using Stata/MP 17.0 (StataCorp LLC). We controlled for patient age; education; race/ethnicity; received public assistance or welfare payments; sex; region; US citizenship status; health insurance status; comorbidities including history of hypertension, diabetes, and hypercholesterolemia; and birthplace in the United States in the logistic regression models.

Our analysis included 46,679 patients aged 18 years or older, of whom 3.4% (weighted)(n=2204) reported a history of skin cancer (eTable 1). The weighted percentage was calculated using National Health Interview Survey design parameters (accounting for the multistage sampling design) to represent the general US population. Compared with those with no history of skin cancer, patients with a history of skin cancer were significantly more likely to delay medical care (adjusted odds ratio [AOR], 1.37; 95% CI, 1.21-1.54; P<.001) or not receive care (AOR, 1.35; 95% CI, 1.16-1.57; P<.001) due to the pandemic and were more likely to have had a virtual medical visit in the past 12 months (AOR, 1.12; 95% CI, 1.00-1.26; P=.05). Additionally, subgroup analysis revealed that females were more likely than males to forego medical care (eTable 2). β Coefficients for independent and dependent variables were further analyzed using logistic regression (eTable 3).

After adjusting for various potential confounders including comorbidities, our results revealed that patients with a history of skin cancer reported that they were less likely to receive in-person medical care due to the COVID-19 pandemic, as high-risk individuals with a history of skin cancer may have stopped receiving total-body skin examinations and dermatology care during the pandemic. Our findings showed that patients with a history of skin cancer were more likely than those without skin cancer to delay or forego care due to the pandemic, which may contribute to a higher incidence of advanced-stage melanomas postpandemic. Trepanowski et al⁵ reported an increased incidence of patients presenting with more advanced melanomas during the pandemic. Telemedicine was more commonly utilized by patients with a history of skin cancer during the pandemic.

In the future, virtual care may help limit advanced stages of skin cancer by serving as a viable alternative to in-person care.⁶ It has been reported that telemedicine can serve as a useful triage service reducing patient wait times.⁷ Teledermatology should not replace in-person care, as there is no evidence of the diagnostic accuracy of this service and many patients still will need to be seen in-person for confirmation of their diagnosis and potential biopsy. Further studies are needed to assess for missed skin cancer diagnoses due to the utilization of telemedicine.

Limitations of this study included a self-reported history of skin cancer, β coefficients that may suggest a high degree of collinearity, and lack of specific survey questions regarding dermatologic care during the COVID-19 pandemic. Further long-term studies exploring the clinical applicability and diagnostic accuracy of virtual medicine visits for cutaneous malignancies are vital, as teledermatology may play an essential role in curbing rising skin cancer rates even beyond the pandemic.

To the Editor:

The most common malignancy in the United States is skin cancer, with melanoma accounting for the majority of skin cancer deaths.¹ Despite the lack of established guidelines for routine total-body skin examinations, many patients regularly visit their dermatologist for assessment of pigmented skin lesions.² During the COVID-19 pandemic, many patients were unable to attend in-person dermatology visits, which resulted in many high-risk individuals not receiving care or alternatively seeking virtual care for cutaneous lesions.³ There has been a lack of research in the United States exploring the utilization of teledermatology during the pandemic and its overall impact on the care of patients with a history of skin cancer. We explored the impact of the COVID-19 pandemic on care for patients with skin cancer in a large US population.

Using anonymous survey data from the 2020-2021 National Health Interview Survey,⁴ we conducted a ­population-based, cross-sectional study to evaluate access to care during the COVID-19 pandemic for patients with a self-reported history of skin cancer—melanoma, nonmelanoma skin cancer, or unknown skin cancer. The 3 outcome variables included having a virtual medical appointment in the past 12 months (yes/no), delaying medical care due to the COVID-19 pandemic (yes/no), and not receiving care due to the COVID-19 pandemic (yes/no). Multivariable logistic regression models evaluating the relationship between a history of skin cancer and access to care were constructed using Stata/MP 17.0 (StataCorp LLC). We controlled for patient age; education; race/ethnicity; received public assistance or welfare payments; sex; region; US citizenship status; health insurance status; comorbidities including history of hypertension, diabetes, and hypercholesterolemia; and birthplace in the United States in the logistic regression models.

Our analysis included 46,679 patients aged 18 years or older, of whom 3.4% (weighted)(n=2204) reported a history of skin cancer (eTable 1). The weighted percentage was calculated using National Health Interview Survey design parameters (accounting for the multistage sampling design) to represent the general US population. Compared with those with no history of skin cancer, patients with a history of skin cancer were significantly more likely to delay medical care (adjusted odds ratio [AOR], 1.37; 95% CI, 1.21-1.54; P<.001) or not receive care (AOR, 1.35; 95% CI, 1.16-1.57; P<.001) due to the pandemic and were more likely to have had a virtual medical visit in the past 12 months (AOR, 1.12; 95% CI, 1.00-1.26; P=.05). Additionally, subgroup analysis revealed that females were more likely than males to forego medical care (eTable 2). β Coefficients for independent and dependent variables were further analyzed using logistic regression (eTable 3).

After adjusting for various potential confounders including comorbidities, our results revealed that patients with a history of skin cancer reported that they were less likely to receive in-person medical care due to the COVID-19 pandemic, as high-risk individuals with a history of skin cancer may have stopped receiving total-body skin examinations and dermatology care during the pandemic. Our findings showed that patients with a history of skin cancer were more likely than those without skin cancer to delay or forego care due to the pandemic, which may contribute to a higher incidence of advanced-stage melanomas postpandemic. Trepanowski et al⁵ reported an increased incidence of patients presenting with more advanced melanomas during the pandemic. Telemedicine was more commonly utilized by patients with a history of skin cancer during the pandemic.

In the future, virtual care may help limit advanced stages of skin cancer by serving as a viable alternative to in-person care.⁶ It has been reported that telemedicine can serve as a useful triage service reducing patient wait times.⁷ Teledermatology should not replace in-person care, as there is no evidence of the diagnostic accuracy of this service and many patients still will need to be seen in-person for confirmation of their diagnosis and potential biopsy. Further studies are needed to assess for missed skin cancer diagnoses due to the utilization of telemedicine.

Limitations of this study included a self-reported history of skin cancer, β coefficients that may suggest a high degree of collinearity, and lack of specific survey questions regarding dermatologic care during the COVID-19 pandemic. Further long-term studies exploring the clinical applicability and diagnostic accuracy of virtual medicine visits for cutaneous malignancies are vital, as teledermatology may play an essential role in curbing rising skin cancer rates even beyond the pandemic.

To the Editor:

The most common malignancy in the United States is skin cancer, with melanoma accounting for the majority of skin cancer deaths.¹ Despite the lack of established guidelines for routine total-body skin examinations, many patients regularly visit their dermatologist for assessment of pigmented skin lesions.² During the COVID-19 pandemic, many patients were unable to attend in-person dermatology visits, which resulted in many high-risk individuals not receiving care or alternatively seeking virtual care for cutaneous lesions.³ There has been a lack of research in the United States exploring the utilization of teledermatology during the pandemic and its overall impact on the care of patients with a history of skin cancer. We explored the impact of the COVID-19 pandemic on care for patients with skin cancer in a large US population.

Using anonymous survey data from the 2020-2021 National Health Interview Survey,⁴ we conducted a ­population-based, cross-sectional study to evaluate access to care during the COVID-19 pandemic for patients with a self-reported history of skin cancer—melanoma, nonmelanoma skin cancer, or unknown skin cancer. The 3 outcome variables included having a virtual medical appointment in the past 12 months (yes/no), delaying medical care due to the COVID-19 pandemic (yes/no), and not receiving care due to the COVID-19 pandemic (yes/no). Multivariable logistic regression models evaluating the relationship between a history of skin cancer and access to care were constructed using Stata/MP 17.0 (StataCorp LLC). We controlled for patient age; education; race/ethnicity; received public assistance or welfare payments; sex; region; US citizenship status; health insurance status; comorbidities including history of hypertension, diabetes, and hypercholesterolemia; and birthplace in the United States in the logistic regression models.

Our analysis included 46,679 patients aged 18 years or older, of whom 3.4% (weighted)(n=2204) reported a history of skin cancer (eTable 1). The weighted percentage was calculated using National Health Interview Survey design parameters (accounting for the multistage sampling design) to represent the general US population. Compared with those with no history of skin cancer, patients with a history of skin cancer were significantly more likely to delay medical care (adjusted odds ratio [AOR], 1.37; 95% CI, 1.21-1.54; P<.001) or not receive care (AOR, 1.35; 95% CI, 1.16-1.57; P<.001) due to the pandemic and were more likely to have had a virtual medical visit in the past 12 months (AOR, 1.12; 95% CI, 1.00-1.26; P=.05). Additionally, subgroup analysis revealed that females were more likely than males to forego medical care (eTable 2). β Coefficients for independent and dependent variables were further analyzed using logistic regression (eTable 3).

After adjusting for various potential confounders including comorbidities, our results revealed that patients with a history of skin cancer reported that they were less likely to receive in-person medical care due to the COVID-19 pandemic, as high-risk individuals with a history of skin cancer may have stopped receiving total-body skin examinations and dermatology care during the pandemic. Our findings showed that patients with a history of skin cancer were more likely than those without skin cancer to delay or forego care due to the pandemic, which may contribute to a higher incidence of advanced-stage melanomas postpandemic. Trepanowski et al⁵ reported an increased incidence of patients presenting with more advanced melanomas during the pandemic. Telemedicine was more commonly utilized by patients with a history of skin cancer during the pandemic.

In the future, virtual care may help limit advanced stages of skin cancer by serving as a viable alternative to in-person care.⁶ It has been reported that telemedicine can serve as a useful triage service reducing patient wait times.⁷ Teledermatology should not replace in-person care, as there is no evidence of the diagnostic accuracy of this service and many patients still will need to be seen in-person for confirmation of their diagnosis and potential biopsy. Further studies are needed to assess for missed skin cancer diagnoses due to the utilization of telemedicine.

Limitations of this study included a self-reported history of skin cancer, β coefficients that may suggest a high degree of collinearity, and lack of specific survey questions regarding dermatologic care during the COVID-19 pandemic. Further long-term studies exploring the clinical applicability and diagnostic accuracy of virtual medicine visits for cutaneous malignancies are vital, as teledermatology may play an essential role in curbing rising skin cancer rates even beyond the pandemic.

To the Editor:

I was unsurprised and gratified by the information presented in the Viewpoint on skin cancer screening by Ngo¹ (Cutis. 2024;113:94-96). In my 30 years as a community dermatologist, I have observed that patients who opt to have periodic full-body skin examinations usually are more health literate, more likely to have a primary care physician (PCP) who has encouraged them to do so (ie, a conscientious practitioner directing their preventive care), more likely to have a strong will to live, and less likely to have multiple stressors that preclude self-care (eg, may be less likely to have a spouse for whom they are a caregiver) compared to those who do not get screened.

Findings on a full-body skin examination may impact patients in many ways, not only by the detection of skin cancers. I have discovered the following:

• evidence of diabetes/insulin resistance in the form of acanthosis nigricans, tinea corporis, erythrasma;
• evidence of rosacea associated with excessive alcohol intake;
• evidence of smoking-related issues such as psoriasis or hidradenitis suppurativa;
• cutaneous evidence of other systemic diseases (eg, autoimmune disease, cancer);
• elucidation of other chronic health problems (eg, psoriasis of the skin as a clue for undiagnosed psoriatic arthritis); and
• detection of parasites on the skin (eg, ticks) or signs of infection that may have notable ramifications (eg, interdigital maceration of a diabetic patient with tinea pedis).

I even saw a patient who had been sent for magnetic resonance imaging for back pain by her internist without any physical examination when she actually had an erosion over the sacrum from a rug burn!

When conducting full-body skin examinations, dermatologists should not underestimate these principles:

• The “magic” of using a relatively noninvasive and sensitive screening tool—comfort and stress reduction for the patient from a thorough visual, tactile, olfactory, and auditory examination.
• Human interaction—especially when the patient is seen annually or even more frequently over a period of years or decades, and especially when an excellent patient-physician rapport has been established.
• The impact of improving a patient’s appearance on their overall sense of well-being (eg, by ­controlling rosacea).
• The opportunity to introduce concepts (ie, educate patients) such as alcohol avoidance, smoking cessation, weight reduction, hygiene, diet, and exercise in a more tangential way than a PCP, as well as to consider with patients the idea that lifestyle modification may be an adjunct, if not a replacement, for prescription treatments.
• The stress reduction that ensues when a variety of self-identified health issues are addressed, for which the only treatment may be reassurance.

I would add to Dr. Ngo’s argument that stratifying patients into skin cancer risk categories may be a useful measure if the only goal of periodic dermatologic evaluation is skin cancer detection. One size rarely fits all when it comes to health recommendations.

In sum, I believe that periodic full-body skin examination is absolutely beneficial to patient care, and I am not at all surprised that all-cause mortality was lower in patients who have those examinations. Furthermore, when I offer my healthy, low-risk patients the option to return in 2 years rather than 1, the vast majority insist on 1 year. My mother used to say, “It’s better to be looked over than to be overlooked,” and I tell my patients that, too—but it seems they already know that instinctively.

To the Editor:

I was unsurprised and gratified by the information presented in the Viewpoint on skin cancer screening by Ngo¹ (Cutis. 2024;113:94-96). In my 30 years as a community dermatologist, I have observed that patients who opt to have periodic full-body skin examinations usually are more health literate, more likely to have a primary care physician (PCP) who has encouraged them to do so (ie, a conscientious practitioner directing their preventive care), more likely to have a strong will to live, and less likely to have multiple stressors that preclude self-care (eg, may be less likely to have a spouse for whom they are a caregiver) compared to those who do not get screened.

Findings on a full-body skin examination may impact patients in many ways, not only by the detection of skin cancers. I have discovered the following:

• evidence of diabetes/insulin resistance in the form of acanthosis nigricans, tinea corporis, erythrasma;
• evidence of rosacea associated with excessive alcohol intake;
• evidence of smoking-related issues such as psoriasis or hidradenitis suppurativa;
• cutaneous evidence of other systemic diseases (eg, autoimmune disease, cancer);
• elucidation of other chronic health problems (eg, psoriasis of the skin as a clue for undiagnosed psoriatic arthritis); and
• detection of parasites on the skin (eg, ticks) or signs of infection that may have notable ramifications (eg, interdigital maceration of a diabetic patient with tinea pedis).

I even saw a patient who had been sent for magnetic resonance imaging for back pain by her internist without any physical examination when she actually had an erosion over the sacrum from a rug burn!

When conducting full-body skin examinations, dermatologists should not underestimate these principles:

• The “magic” of using a relatively noninvasive and sensitive screening tool—comfort and stress reduction for the patient from a thorough visual, tactile, olfactory, and auditory examination.
• Human interaction—especially when the patient is seen annually or even more frequently over a period of years or decades, and especially when an excellent patient-physician rapport has been established.
• The impact of improving a patient’s appearance on their overall sense of well-being (eg, by ­controlling rosacea).
• The opportunity to introduce concepts (ie, educate patients) such as alcohol avoidance, smoking cessation, weight reduction, hygiene, diet, and exercise in a more tangential way than a PCP, as well as to consider with patients the idea that lifestyle modification may be an adjunct, if not a replacement, for prescription treatments.
• The stress reduction that ensues when a variety of self-identified health issues are addressed, for which the only treatment may be reassurance.

I would add to Dr. Ngo’s argument that stratifying patients into skin cancer risk categories may be a useful measure if the only goal of periodic dermatologic evaluation is skin cancer detection. One size rarely fits all when it comes to health recommendations.

In sum, I believe that periodic full-body skin examination is absolutely beneficial to patient care, and I am not at all surprised that all-cause mortality was lower in patients who have those examinations. Furthermore, when I offer my healthy, low-risk patients the option to return in 2 years rather than 1, the vast majority insist on 1 year. My mother used to say, “It’s better to be looked over than to be overlooked,” and I tell my patients that, too—but it seems they already know that instinctively.

To the Editor:

I was unsurprised and gratified by the information presented in the Viewpoint on skin cancer screening by Ngo¹ (Cutis. 2024;113:94-96). In my 30 years as a community dermatologist, I have observed that patients who opt to have periodic full-body skin examinations usually are more health literate, more likely to have a primary care physician (PCP) who has encouraged them to do so (ie, a conscientious practitioner directing their preventive care), more likely to have a strong will to live, and less likely to have multiple stressors that preclude self-care (eg, may be less likely to have a spouse for whom they are a caregiver) compared to those who do not get screened.

Findings on a full-body skin examination may impact patients in many ways, not only by the detection of skin cancers. I have discovered the following:

• evidence of diabetes/insulin resistance in the form of acanthosis nigricans, tinea corporis, erythrasma;
• evidence of rosacea associated with excessive alcohol intake;
• evidence of smoking-related issues such as psoriasis or hidradenitis suppurativa;
• cutaneous evidence of other systemic diseases (eg, autoimmune disease, cancer);
• elucidation of other chronic health problems (eg, psoriasis of the skin as a clue for undiagnosed psoriatic arthritis); and
• detection of parasites on the skin (eg, ticks) or signs of infection that may have notable ramifications (eg, interdigital maceration of a diabetic patient with tinea pedis).

I even saw a patient who had been sent for magnetic resonance imaging for back pain by her internist without any physical examination when she actually had an erosion over the sacrum from a rug burn!

When conducting full-body skin examinations, dermatologists should not underestimate these principles:

• The “magic” of using a relatively noninvasive and sensitive screening tool—comfort and stress reduction for the patient from a thorough visual, tactile, olfactory, and auditory examination.
• Human interaction—especially when the patient is seen annually or even more frequently over a period of years or decades, and especially when an excellent patient-physician rapport has been established.
• The impact of improving a patient’s appearance on their overall sense of well-being (eg, by ­controlling rosacea).
• The opportunity to introduce concepts (ie, educate patients) such as alcohol avoidance, smoking cessation, weight reduction, hygiene, diet, and exercise in a more tangential way than a PCP, as well as to consider with patients the idea that lifestyle modification may be an adjunct, if not a replacement, for prescription treatments.
• The stress reduction that ensues when a variety of self-identified health issues are addressed, for which the only treatment may be reassurance.

I would add to Dr. Ngo’s argument that stratifying patients into skin cancer risk categories may be a useful measure if the only goal of periodic dermatologic evaluation is skin cancer detection. One size rarely fits all when it comes to health recommendations.

In sum, I believe that periodic full-body skin examination is absolutely beneficial to patient care, and I am not at all surprised that all-cause mortality was lower in patients who have those examinations. Furthermore, when I offer my healthy, low-risk patients the option to return in 2 years rather than 1, the vast majority insist on 1 year. My mother used to say, “It’s better to be looked over than to be overlooked,” and I tell my patients that, too—but it seems they already know that instinctively.

On January 1, 2024, a new add-on complexity code, G2211, was implemented to the documentation of evaluation and management (E/M) visits.¹ Created by the Centers for Medicare & Medicaid Services (CMS), G2211 is defined as “visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious, or complex condition.”² It is an add-on code, meaning that it must be listed with either a new or established outpatient E/M visit.

G2211 originally was introduced in the 2021 Proposed Rule but was delayed via a congressional mandate for 3 years.¹ It originally was estimated that this code would be billed with 90% of all office visit claims, accounting for an approximately $3.3 billion increase in physician fee schedule spending; however, this estimate was revised with its reintroduction in the 2024 Final Rule, and it currently is estimated that it will be billed with 38% of all office visit claims.^3,4

This add-on code was created to capture the inherent complexity of an E/M visit that is derived from the longitudinal nature of the physician-patient relationship and to better account for the additional resources of these outpatient E/M visits.⁵ Although these criteria often are met in the setting of an E/M visit within a primary care specialty (eg, family practice, internal medicine, ­obstetrics/­gynecology, pediatrics), this code is not restricted to medical professionals based on specialties. The CMS noted that “the most important information used to determine whether the add-on code could be billed is the relationship between the practitioner and the patient,” specifically if they are fulfilling one of the following roles: “the continuing focal point for all needed health care services” or “ongoing care related to a patient's single, serious and complex condition.”⁶

Of note, further definitions regarding what constitutes a single, serious or complex condition have not yet been provided by CMS. The code should not be utilized when the relationship with the patient is of a discrete, routine, or time-limited nature. The resulting care should be personalized and should result in a comprehensive, longitudinal, and continuous relationship with the patient and should involve delivery of team-based care that is accessible, coordinated with other practitioners and providers, and integrated with the broader health care landscape.⁶

Herein, 5 examples are provided of scenarios when G2211 might be utilized as well as when it would not be appropriate to bill for this code.

Example 1

A 48-year-old man (an established patient) with a history of psoriasis and psoriatic arthritis presents to a dermatologist for follow-up. The dermatologist has been managing both conditions for 3 years with methotrexate. The patient’s disease is well controlled at the current visit, and he presents for follow-up of disease activity and laboratory monitoring every 3 months. The dermatologist continues the patient on methotrexate after reviewing the risks, benefits, and adverse effects and orders a complete blood cell count and comprehensive metabolic panel.

Would use of G2211 be appropriate for this visit?—Yes, in this case it would be appropriate to bill for G2211. In this example, the physician is providing longitudinal ongoing medical care related to a patient’s single, serious or complex condition—specifically psoriasis and psoriatic arthritis—via managing methotrexate therapy.

Let’s alter the previous example slightly: A 48-year-old man (an established patient) with a history of psoriasis and psoriatic arthritis presents to a dermatologist for follow-up. He is being followed by both a dermatologist and a rheumatologist. The patient is on methotrexate, which was prescribed by the rheumatologist, who also conducts the appropriate laboratory monitoring. The patient’s skin disease currently is well controlled, and the dermatologist discusses this with the patient and advises that he continue to follow up with rheumatology.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to utilize G2211. In this example, the dermatologist is providing longitudinal ongoing medical care; however, unlike in the first example, much of the ongoing medical care—in particular the management of the patient’s methotrexate therapy—is being performed by the rheumatologist. Therefore, although these conditions are serious or complex, the dermatologist is not the primary manager of treatment, and it would not be appropriate to bill for G2211.

Example 3

A 35-year-old woman (an established patient) presents to a dermatologist for follow-up of hidradenitis suppurativa. She currently is receiving infliximab infusions that are managed by the dermatologist. At the current presentation, physical examination reveals several persistent active lesions. After discussing possible treatment options, the dermatologist elects to continue infliximab therapy and schedule a deroofing procedure of the ­persistent areas.

Would use of G2211 be appropriate for this visit?—Yes, in this example it would be appropriate to utilize G2211. The patient has hidradenitis suppurativa, which would be considered a single, serious or complex condition. Additionally, the dermatologist is the primary manager of this condition by prescribing infliximab as well as counseling the patient on the appropriateness of procedural interventions and scheduling for these procedures; the dermatologist also is providing ongoing longitudinal care.

Example 4

Let’s alter the previous example slightly: A 35-year-old woman (an established patient) presents to a dermatologist for follow-up of hidradenitis suppurativa. She currently is receiving infliximab infusions, which are managed by the dermatologist. At the current presentation, physical examination reveals several persistent active lesions. After discussing possible treatment options, the dermatologist elects to perform intralesional triamcinolone injections to active areas during the current visit.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to bill for G2211. Similar to Example 3, the dermatologist is treating a single, serious and complex condition and is primarily managing the disease and providing longitudinal care; however, in this case the dermatologist also is performing a minor procedure during the visit: injection of intralesional triamcinolone.

Importantly, G2211 cannot be utilized when modifier -25 is being appended to an outpatient E/M visit. Modifier -25 is defined as a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of the procedure or other service.”⁷ Modifier -25 is utilized when a minor procedure is performed by a qualified health care professional on the same day (generally during the same visit) as an E/M visit. Therefore, G2211 cannot be utilized when a minor procedure (eg, a tangential biopsy, punch biopsy, destruction or intralesional injection into skin) is performed during a visit.

Example 5

A 6-year-old girl presents to a dermatologist for a new rash on the trunk that started 5 days after an upper respiratory infection. The dermatologist evaluates the patient and identifies a blanchable macular eruption on the trunk; the patient is diagnosed with a viral exanthem. Because the patient reported associated pruritus, topical triamcinolone is prescribed.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to bill for G2211. A viral exanthem would not be considered an ongoing single, serious or complex condition and would be more consistent with a discrete condition; therefore, even though the dermatologist is primarily managing the disease process, it still would not fulfill the criteria necessary to bill for G2211.

Final Thoughts

G2211 is an add-on code created by the CMS that can be utilized in conjunction with an outpatient E/M visit when certain requirements are fulfilled. Specifically, this code can be utilized when the dermatologist is the primary provider of care for a patient’s ongoing single, serious or complex condition or serves as the continuing focal point for all of the patient’s health care needs. Understanding the nuances associated with this code are critical for ­correct billing.

On January 1, 2024, a new add-on complexity code, G2211, was implemented to the documentation of evaluation and management (E/M) visits.¹ Created by the Centers for Medicare & Medicaid Services (CMS), G2211 is defined as “visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious, or complex condition.”² It is an add-on code, meaning that it must be listed with either a new or established outpatient E/M visit.

G2211 originally was introduced in the 2021 Proposed Rule but was delayed via a congressional mandate for 3 years.¹ It originally was estimated that this code would be billed with 90% of all office visit claims, accounting for an approximately $3.3 billion increase in physician fee schedule spending; however, this estimate was revised with its reintroduction in the 2024 Final Rule, and it currently is estimated that it will be billed with 38% of all office visit claims.^3,4

This add-on code was created to capture the inherent complexity of an E/M visit that is derived from the longitudinal nature of the physician-patient relationship and to better account for the additional resources of these outpatient E/M visits.⁵ Although these criteria often are met in the setting of an E/M visit within a primary care specialty (eg, family practice, internal medicine, ­obstetrics/­gynecology, pediatrics), this code is not restricted to medical professionals based on specialties. The CMS noted that “the most important information used to determine whether the add-on code could be billed is the relationship between the practitioner and the patient,” specifically if they are fulfilling one of the following roles: “the continuing focal point for all needed health care services” or “ongoing care related to a patient's single, serious and complex condition.”⁶

Of note, further definitions regarding what constitutes a single, serious or complex condition have not yet been provided by CMS. The code should not be utilized when the relationship with the patient is of a discrete, routine, or time-limited nature. The resulting care should be personalized and should result in a comprehensive, longitudinal, and continuous relationship with the patient and should involve delivery of team-based care that is accessible, coordinated with other practitioners and providers, and integrated with the broader health care landscape.⁶

Herein, 5 examples are provided of scenarios when G2211 might be utilized as well as when it would not be appropriate to bill for this code.

Example 1

A 48-year-old man (an established patient) with a history of psoriasis and psoriatic arthritis presents to a dermatologist for follow-up. The dermatologist has been managing both conditions for 3 years with methotrexate. The patient’s disease is well controlled at the current visit, and he presents for follow-up of disease activity and laboratory monitoring every 3 months. The dermatologist continues the patient on methotrexate after reviewing the risks, benefits, and adverse effects and orders a complete blood cell count and comprehensive metabolic panel.

Would use of G2211 be appropriate for this visit?—Yes, in this case it would be appropriate to bill for G2211. In this example, the physician is providing longitudinal ongoing medical care related to a patient’s single, serious or complex condition—specifically psoriasis and psoriatic arthritis—via managing methotrexate therapy.

Let’s alter the previous example slightly: A 48-year-old man (an established patient) with a history of psoriasis and psoriatic arthritis presents to a dermatologist for follow-up. He is being followed by both a dermatologist and a rheumatologist. The patient is on methotrexate, which was prescribed by the rheumatologist, who also conducts the appropriate laboratory monitoring. The patient’s skin disease currently is well controlled, and the dermatologist discusses this with the patient and advises that he continue to follow up with rheumatology.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to utilize G2211. In this example, the dermatologist is providing longitudinal ongoing medical care; however, unlike in the first example, much of the ongoing medical care—in particular the management of the patient’s methotrexate therapy—is being performed by the rheumatologist. Therefore, although these conditions are serious or complex, the dermatologist is not the primary manager of treatment, and it would not be appropriate to bill for G2211.

Example 3

A 35-year-old woman (an established patient) presents to a dermatologist for follow-up of hidradenitis suppurativa. She currently is receiving infliximab infusions that are managed by the dermatologist. At the current presentation, physical examination reveals several persistent active lesions. After discussing possible treatment options, the dermatologist elects to continue infliximab therapy and schedule a deroofing procedure of the ­persistent areas.

Would use of G2211 be appropriate for this visit?—Yes, in this example it would be appropriate to utilize G2211. The patient has hidradenitis suppurativa, which would be considered a single, serious or complex condition. Additionally, the dermatologist is the primary manager of this condition by prescribing infliximab as well as counseling the patient on the appropriateness of procedural interventions and scheduling for these procedures; the dermatologist also is providing ongoing longitudinal care.

Example 4

Let’s alter the previous example slightly: A 35-year-old woman (an established patient) presents to a dermatologist for follow-up of hidradenitis suppurativa. She currently is receiving infliximab infusions, which are managed by the dermatologist. At the current presentation, physical examination reveals several persistent active lesions. After discussing possible treatment options, the dermatologist elects to perform intralesional triamcinolone injections to active areas during the current visit.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to bill for G2211. Similar to Example 3, the dermatologist is treating a single, serious and complex condition and is primarily managing the disease and providing longitudinal care; however, in this case the dermatologist also is performing a minor procedure during the visit: injection of intralesional triamcinolone.

Importantly, G2211 cannot be utilized when modifier -25 is being appended to an outpatient E/M visit. Modifier -25 is defined as a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of the procedure or other service.”⁷ Modifier -25 is utilized when a minor procedure is performed by a qualified health care professional on the same day (generally during the same visit) as an E/M visit. Therefore, G2211 cannot be utilized when a minor procedure (eg, a tangential biopsy, punch biopsy, destruction or intralesional injection into skin) is performed during a visit.

Example 5

A 6-year-old girl presents to a dermatologist for a new rash on the trunk that started 5 days after an upper respiratory infection. The dermatologist evaluates the patient and identifies a blanchable macular eruption on the trunk; the patient is diagnosed with a viral exanthem. Because the patient reported associated pruritus, topical triamcinolone is prescribed.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to bill for G2211. A viral exanthem would not be considered an ongoing single, serious or complex condition and would be more consistent with a discrete condition; therefore, even though the dermatologist is primarily managing the disease process, it still would not fulfill the criteria necessary to bill for G2211.

Final Thoughts

G2211 is an add-on code created by the CMS that can be utilized in conjunction with an outpatient E/M visit when certain requirements are fulfilled. Specifically, this code can be utilized when the dermatologist is the primary provider of care for a patient’s ongoing single, serious or complex condition or serves as the continuing focal point for all of the patient’s health care needs. Understanding the nuances associated with this code are critical for ­correct billing.

On January 1, 2024, a new add-on complexity code, G2211, was implemented to the documentation of evaluation and management (E/M) visits.¹ Created by the Centers for Medicare & Medicaid Services (CMS), G2211 is defined as “visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious, or complex condition.”² It is an add-on code, meaning that it must be listed with either a new or established outpatient E/M visit.

G2211 originally was introduced in the 2021 Proposed Rule but was delayed via a congressional mandate for 3 years.¹ It originally was estimated that this code would be billed with 90% of all office visit claims, accounting for an approximately $3.3 billion increase in physician fee schedule spending; however, this estimate was revised with its reintroduction in the 2024 Final Rule, and it currently is estimated that it will be billed with 38% of all office visit claims.^3,4

This add-on code was created to capture the inherent complexity of an E/M visit that is derived from the longitudinal nature of the physician-patient relationship and to better account for the additional resources of these outpatient E/M visits.⁵ Although these criteria often are met in the setting of an E/M visit within a primary care specialty (eg, family practice, internal medicine, ­obstetrics/­gynecology, pediatrics), this code is not restricted to medical professionals based on specialties. The CMS noted that “the most important information used to determine whether the add-on code could be billed is the relationship between the practitioner and the patient,” specifically if they are fulfilling one of the following roles: “the continuing focal point for all needed health care services” or “ongoing care related to a patient's single, serious and complex condition.”⁶

Of note, further definitions regarding what constitutes a single, serious or complex condition have not yet been provided by CMS. The code should not be utilized when the relationship with the patient is of a discrete, routine, or time-limited nature. The resulting care should be personalized and should result in a comprehensive, longitudinal, and continuous relationship with the patient and should involve delivery of team-based care that is accessible, coordinated with other practitioners and providers, and integrated with the broader health care landscape.⁶

Herein, 5 examples are provided of scenarios when G2211 might be utilized as well as when it would not be appropriate to bill for this code.

Example 1

A 48-year-old man (an established patient) with a history of psoriasis and psoriatic arthritis presents to a dermatologist for follow-up. The dermatologist has been managing both conditions for 3 years with methotrexate. The patient’s disease is well controlled at the current visit, and he presents for follow-up of disease activity and laboratory monitoring every 3 months. The dermatologist continues the patient on methotrexate after reviewing the risks, benefits, and adverse effects and orders a complete blood cell count and comprehensive metabolic panel.

Would use of G2211 be appropriate for this visit?—Yes, in this case it would be appropriate to bill for G2211. In this example, the physician is providing longitudinal ongoing medical care related to a patient’s single, serious or complex condition—specifically psoriasis and psoriatic arthritis—via managing methotrexate therapy.

Let’s alter the previous example slightly: A 48-year-old man (an established patient) with a history of psoriasis and psoriatic arthritis presents to a dermatologist for follow-up. He is being followed by both a dermatologist and a rheumatologist. The patient is on methotrexate, which was prescribed by the rheumatologist, who also conducts the appropriate laboratory monitoring. The patient’s skin disease currently is well controlled, and the dermatologist discusses this with the patient and advises that he continue to follow up with rheumatology.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to utilize G2211. In this example, the dermatologist is providing longitudinal ongoing medical care; however, unlike in the first example, much of the ongoing medical care—in particular the management of the patient’s methotrexate therapy—is being performed by the rheumatologist. Therefore, although these conditions are serious or complex, the dermatologist is not the primary manager of treatment, and it would not be appropriate to bill for G2211.

Example 3

A 35-year-old woman (an established patient) presents to a dermatologist for follow-up of hidradenitis suppurativa. She currently is receiving infliximab infusions that are managed by the dermatologist. At the current presentation, physical examination reveals several persistent active lesions. After discussing possible treatment options, the dermatologist elects to continue infliximab therapy and schedule a deroofing procedure of the ­persistent areas.

Would use of G2211 be appropriate for this visit?—Yes, in this example it would be appropriate to utilize G2211. The patient has hidradenitis suppurativa, which would be considered a single, serious or complex condition. Additionally, the dermatologist is the primary manager of this condition by prescribing infliximab as well as counseling the patient on the appropriateness of procedural interventions and scheduling for these procedures; the dermatologist also is providing ongoing longitudinal care.

Example 4

Let’s alter the previous example slightly: A 35-year-old woman (an established patient) presents to a dermatologist for follow-up of hidradenitis suppurativa. She currently is receiving infliximab infusions, which are managed by the dermatologist. At the current presentation, physical examination reveals several persistent active lesions. After discussing possible treatment options, the dermatologist elects to perform intralesional triamcinolone injections to active areas during the current visit.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to bill for G2211. Similar to Example 3, the dermatologist is treating a single, serious and complex condition and is primarily managing the disease and providing longitudinal care; however, in this case the dermatologist also is performing a minor procedure during the visit: injection of intralesional triamcinolone.

Importantly, G2211 cannot be utilized when modifier -25 is being appended to an outpatient E/M visit. Modifier -25 is defined as a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of the procedure or other service.”⁷ Modifier -25 is utilized when a minor procedure is performed by a qualified health care professional on the same day (generally during the same visit) as an E/M visit. Therefore, G2211 cannot be utilized when a minor procedure (eg, a tangential biopsy, punch biopsy, destruction or intralesional injection into skin) is performed during a visit.

Example 5

A 6-year-old girl presents to a dermatologist for a new rash on the trunk that started 5 days after an upper respiratory infection. The dermatologist evaluates the patient and identifies a blanchable macular eruption on the trunk; the patient is diagnosed with a viral exanthem. Because the patient reported associated pruritus, topical triamcinolone is prescribed.

Would use of G2211 be appropriate for this visit?—No, in this case it would not be appropriate to bill for G2211. A viral exanthem would not be considered an ongoing single, serious or complex condition and would be more consistent with a discrete condition; therefore, even though the dermatologist is primarily managing the disease process, it still would not fulfill the criteria necessary to bill for G2211.

Final Thoughts

G2211 is an add-on code created by the CMS that can be utilized in conjunction with an outpatient E/M visit when certain requirements are fulfilled. Specifically, this code can be utilized when the dermatologist is the primary provider of care for a patient’s ongoing single, serious or complex condition or serves as the continuing focal point for all of the patient’s health care needs. Understanding the nuances associated with this code are critical for ­correct billing.

Practice Gap

Orodynia (OD)—together with glossodynia colloquially termed “burning mouth syndrome”—is a chronic disorder characterized by a burning sensation within the oral cavity without objective clinical signs. It is most common in perimenopausal and postmenopausal women.^1,2

Orodynia is a diagnosis of exclusion and is considered after 4 to 6 months of normal imaging and laboratory test results.^1,2 Its pathophysiology is poorly understood, as it can be intermittent or continuous, manifest with a variety of symptoms, and affect various entities of the oral cavity.^3,4 The most common structure affected is the tongue, and symptoms may include xerostomia, dysgeusia, and discomfort.^1,2 Orodynia is a frustrating condition, as many patients do not respond to treatment and experience symptoms for years.^1-4

The current approach to management of OD typically involves a combination of psychosocial strategies and pharmacologic agents. The psychosocial component consists of coping mechanisms (eg, stress management techniques and behavioral therapies) aimed at alleviating the psychological impact of the condition. Pharmacologic agents such as antidepressants, anticonvulsants, and topical medications often are prescribed to address neuropathic pain and dry mouth symptoms.^1,2 Additionally, oral rinses, saliva substitutes, and dietary supplements may be recommended to counteract the discomfort associated with xerostomia.^1,2 However, there is no stepwise protocol, leaving these treatments to be trialed in a disorganized manner.²

The Tools

In our unique approach to managing OD, physicians may employ a variety of tools, including autoantibody profiles, noninvasive salivary gland analysis, saliva analysis, patch testing for allergens, and—if deemed necessary—a minor salivary gland biopsy. The use of specific prescription medications is included in the later stages of our approach.

The Technique

First, exclude inflammatory conditions such as geographic tongue, oral lichen planus, autoimmune bullous disorders, and other treatable conditions such as dyspepsia and Sjögren syndrome using the tools described above. Noninvasive modalities should be exhausted first, and dermatologists/clinicians should exercise clinical judgement to determine whether all options should be trialed, including more invasive/costly ones.

If symptoms persist, clinicians may want to obtain a culture for oral candida. If results are positive, candida may be treated quickly with oral fluconazole. If that treatment fails and fissuring is present, advise the patient on treating the tongue; we recommend lightly brushing the tongue once daily with a hydrogen peroxide 3% solution, followed by rinsing. Next, the patient can allow an active probiotic yogurt to sit on the tongue for at least 1 minute to repopulate it with healthy oral bacteria.

If symptoms persist, prescribe gabapentin 100 to 300 mg to be taken at bedtime. Cevimeline 30 mg 3 times daily can be added to treat symptoms of xerostomia. As a last resort, a low daily dose of trifluoperazine 1 to 2 mg may alleviate the dysesthesia of OD. Because this medication is an antipsychotic, there is an increased risk for adverse effects such as tardive dyskinesia; however, given that we recommend using at most one-twentieth of the dose recommended for psychiatric illnesses such as schizophrenia, the risk appears to be minimal.⁵

We have found this protocol to be more structured, and in our practice, it has led to better outcomes than previously described therapeutic interventions.

Practice Implications

As a chronic condition, OD can be frustrating for patients, as many of them have attempted multiple treatments without success. It also may be challenging for dermatologists who are unfamiliar with its management. This approach to OD provides simple step-by-step diagnostic and therapeutic plans for a condition with an often-uncertain etiology and stubborn response to initial treatments. By following this protocol, dermatologists can be confident in their ability to help patients find relief from OD.

Practice Gap

Orodynia (OD)—together with glossodynia colloquially termed “burning mouth syndrome”—is a chronic disorder characterized by a burning sensation within the oral cavity without objective clinical signs. It is most common in perimenopausal and postmenopausal women.^1,2

Orodynia is a diagnosis of exclusion and is considered after 4 to 6 months of normal imaging and laboratory test results.^1,2 Its pathophysiology is poorly understood, as it can be intermittent or continuous, manifest with a variety of symptoms, and affect various entities of the oral cavity.^3,4 The most common structure affected is the tongue, and symptoms may include xerostomia, dysgeusia, and discomfort.^1,2 Orodynia is a frustrating condition, as many patients do not respond to treatment and experience symptoms for years.^1-4

The current approach to management of OD typically involves a combination of psychosocial strategies and pharmacologic agents. The psychosocial component consists of coping mechanisms (eg, stress management techniques and behavioral therapies) aimed at alleviating the psychological impact of the condition. Pharmacologic agents such as antidepressants, anticonvulsants, and topical medications often are prescribed to address neuropathic pain and dry mouth symptoms.^1,2 Additionally, oral rinses, saliva substitutes, and dietary supplements may be recommended to counteract the discomfort associated with xerostomia.^1,2 However, there is no stepwise protocol, leaving these treatments to be trialed in a disorganized manner.²

The Tools

In our unique approach to managing OD, physicians may employ a variety of tools, including autoantibody profiles, noninvasive salivary gland analysis, saliva analysis, patch testing for allergens, and—if deemed necessary—a minor salivary gland biopsy. The use of specific prescription medications is included in the later stages of our approach.

The Technique

First, exclude inflammatory conditions such as geographic tongue, oral lichen planus, autoimmune bullous disorders, and other treatable conditions such as dyspepsia and Sjögren syndrome using the tools described above. Noninvasive modalities should be exhausted first, and dermatologists/clinicians should exercise clinical judgement to determine whether all options should be trialed, including more invasive/costly ones.

If symptoms persist, clinicians may want to obtain a culture for oral candida. If results are positive, candida may be treated quickly with oral fluconazole. If that treatment fails and fissuring is present, advise the patient on treating the tongue; we recommend lightly brushing the tongue once daily with a hydrogen peroxide 3% solution, followed by rinsing. Next, the patient can allow an active probiotic yogurt to sit on the tongue for at least 1 minute to repopulate it with healthy oral bacteria.

If symptoms persist, prescribe gabapentin 100 to 300 mg to be taken at bedtime. Cevimeline 30 mg 3 times daily can be added to treat symptoms of xerostomia. As a last resort, a low daily dose of trifluoperazine 1 to 2 mg may alleviate the dysesthesia of OD. Because this medication is an antipsychotic, there is an increased risk for adverse effects such as tardive dyskinesia; however, given that we recommend using at most one-twentieth of the dose recommended for psychiatric illnesses such as schizophrenia, the risk appears to be minimal.⁵

We have found this protocol to be more structured, and in our practice, it has led to better outcomes than previously described therapeutic interventions.

Practice Implications

As a chronic condition, OD can be frustrating for patients, as many of them have attempted multiple treatments without success. It also may be challenging for dermatologists who are unfamiliar with its management. This approach to OD provides simple step-by-step diagnostic and therapeutic plans for a condition with an often-uncertain etiology and stubborn response to initial treatments. By following this protocol, dermatologists can be confident in their ability to help patients find relief from OD.

Practice Gap

Orodynia (OD)—together with glossodynia colloquially termed “burning mouth syndrome”—is a chronic disorder characterized by a burning sensation within the oral cavity without objective clinical signs. It is most common in perimenopausal and postmenopausal women.^1,2

Orodynia is a diagnosis of exclusion and is considered after 4 to 6 months of normal imaging and laboratory test results.^1,2 Its pathophysiology is poorly understood, as it can be intermittent or continuous, manifest with a variety of symptoms, and affect various entities of the oral cavity.^3,4 The most common structure affected is the tongue, and symptoms may include xerostomia, dysgeusia, and discomfort.^1,2 Orodynia is a frustrating condition, as many patients do not respond to treatment and experience symptoms for years.^1-4

The current approach to management of OD typically involves a combination of psychosocial strategies and pharmacologic agents. The psychosocial component consists of coping mechanisms (eg, stress management techniques and behavioral therapies) aimed at alleviating the psychological impact of the condition. Pharmacologic agents such as antidepressants, anticonvulsants, and topical medications often are prescribed to address neuropathic pain and dry mouth symptoms.^1,2 Additionally, oral rinses, saliva substitutes, and dietary supplements may be recommended to counteract the discomfort associated with xerostomia.^1,2 However, there is no stepwise protocol, leaving these treatments to be trialed in a disorganized manner.²

The Tools

In our unique approach to managing OD, physicians may employ a variety of tools, including autoantibody profiles, noninvasive salivary gland analysis, saliva analysis, patch testing for allergens, and—if deemed necessary—a minor salivary gland biopsy. The use of specific prescription medications is included in the later stages of our approach.

The Technique

First, exclude inflammatory conditions such as geographic tongue, oral lichen planus, autoimmune bullous disorders, and other treatable conditions such as dyspepsia and Sjögren syndrome using the tools described above. Noninvasive modalities should be exhausted first, and dermatologists/clinicians should exercise clinical judgement to determine whether all options should be trialed, including more invasive/costly ones.

If symptoms persist, clinicians may want to obtain a culture for oral candida. If results are positive, candida may be treated quickly with oral fluconazole. If that treatment fails and fissuring is present, advise the patient on treating the tongue; we recommend lightly brushing the tongue once daily with a hydrogen peroxide 3% solution, followed by rinsing. Next, the patient can allow an active probiotic yogurt to sit on the tongue for at least 1 minute to repopulate it with healthy oral bacteria.

If symptoms persist, prescribe gabapentin 100 to 300 mg to be taken at bedtime. Cevimeline 30 mg 3 times daily can be added to treat symptoms of xerostomia. As a last resort, a low daily dose of trifluoperazine 1 to 2 mg may alleviate the dysesthesia of OD. Because this medication is an antipsychotic, there is an increased risk for adverse effects such as tardive dyskinesia; however, given that we recommend using at most one-twentieth of the dose recommended for psychiatric illnesses such as schizophrenia, the risk appears to be minimal.⁵

We have found this protocol to be more structured, and in our practice, it has led to better outcomes than previously described therapeutic interventions.

Practice Implications

As a chronic condition, OD can be frustrating for patients, as many of them have attempted multiple treatments without success. It also may be challenging for dermatologists who are unfamiliar with its management. This approach to OD provides simple step-by-step diagnostic and therapeutic plans for a condition with an often-uncertain etiology and stubborn response to initial treatments. By following this protocol, dermatologists can be confident in their ability to help patients find relief from OD.

The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week. 

First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.

How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry? 

Why Reschedule? Why Now? 

The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III. 

DEA defines Schedule I drugs as those with no currently accepted medical use and a high potential for abuse. That class includes heroin, LSD, and ecstasy. Schedule III drugs have a moderate to low potential for physical and psychological dependence and have a currently accepted medical use. This class includes ketamine, acetaminophen with codeine, and buprenorphine. 

Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.

Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports. 

Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.

“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization. 

How Does Rescheduling Work? What’s the Timeline?

The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear. 

Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.

“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”

A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.

How Will Rescheduling Affect Medical Marijuana?

For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said. 

“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.

Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use. 

“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.

But what about patients living in states that have not legalized medical cannabis? 

“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.” 

The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.

What Does It Mean for Medical Marijuana Dispensaries?

Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.

“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said. 

“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.

However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.

“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said. 

Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said. 

“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.

Will Rescheduling Make It Easier to Conduct Cannabis-Related Research? 

Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.

“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said. 

The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition. 

In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds. 

It’s unclear whether those guidelines would be updated if the rescheduling moves forward. 

Does Rescheduling Marijuana Pose Any Risk? 

In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”

That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said. 

“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”

Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia. 

“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”

Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness. 

“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”

Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week. 

First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.

How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry? 

Why Reschedule? Why Now? 

The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III. 

DEA defines Schedule I drugs as those with no currently accepted medical use and a high potential for abuse. That class includes heroin, LSD, and ecstasy. Schedule III drugs have a moderate to low potential for physical and psychological dependence and have a currently accepted medical use. This class includes ketamine, acetaminophen with codeine, and buprenorphine. 

Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.

Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports. 

Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.

“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization. 

How Does Rescheduling Work? What’s the Timeline?

The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear. 

Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.

“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”

A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.

How Will Rescheduling Affect Medical Marijuana?

For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said. 

“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.

Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use. 

“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.

But what about patients living in states that have not legalized medical cannabis? 

“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.” 

The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.

What Does It Mean for Medical Marijuana Dispensaries?

Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.

“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said. 

“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.

However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.

“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said. 

Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said. 

“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.

Will Rescheduling Make It Easier to Conduct Cannabis-Related Research? 

Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.

“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said. 

The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition. 

In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds. 

It’s unclear whether those guidelines would be updated if the rescheduling moves forward. 

Does Rescheduling Marijuana Pose Any Risk? 

In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”

That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said. 

“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”

Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia. 

“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”

Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness. 

“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”

Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week. 

First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.

How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry? 

Why Reschedule? Why Now? 

The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III. 

DEA defines Schedule I drugs as those with no currently accepted medical use and a high potential for abuse. That class includes heroin, LSD, and ecstasy. Schedule III drugs have a moderate to low potential for physical and psychological dependence and have a currently accepted medical use. This class includes ketamine, acetaminophen with codeine, and buprenorphine. 

Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.

Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports. 

Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.

“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization. 

How Does Rescheduling Work? What’s the Timeline?

The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear. 

Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.

“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”

A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.

How Will Rescheduling Affect Medical Marijuana?

For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said. 

“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.

Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use. 

“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.

But what about patients living in states that have not legalized medical cannabis? 

“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.” 

The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.

What Does It Mean for Medical Marijuana Dispensaries?

Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.

“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said. 

“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.

However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.

“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said. 

Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said. 

“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.

Will Rescheduling Make It Easier to Conduct Cannabis-Related Research? 

Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.

“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said. 

The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition. 

In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds. 

It’s unclear whether those guidelines would be updated if the rescheduling moves forward. 

Does Rescheduling Marijuana Pose Any Risk? 

In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”

That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said. 

“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”

Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia. 

“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”

Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness. 

“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”

Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

Weight-bearing recreational activity was associated with a 22% increased odds of developing knee osteoarthritis (OA) in a large prospective cohort study in the Netherlands, but notably, the increased risk was seen only in those with low levels of lower-limb muscle mass.

The findings point toward the value of “tailored advice” for physical activity, and suggest that “caution is needed when engaging in weight-bearing activity, especially for individuals with low levels of lower-limb muscle mass,” Yahong Wu, MD, and coinvestigators, of the Erasmus Medical Center in Rotterdam, the Netherlands, wrote in JAMA Network Open.

kali9/Getty Images

Investigators used data from sequential cohorts of the longitudinal Rotterdam Study, which enrolled people aged 45 and older starting in 1990. The 5003 participants in this new analysis of physical activity and knee OA had complete records of baseline recreational physical activity, baseline knee pain, and knee radiographs from both baseline and at least one follow-up exam. Those with radiographically defined knee OA at baseline were excluded.

The incident rate of radiographically defined (x-ray) knee OA among all participants was 8.4%, with a mean follow-up time of 6.33 years. Among 3492 individuals without baseline knee pain, the researchers found no increased odds of incident radiographic OA with non–weight-bearing activity (odds ratio [OR], 1.04; 95% CI, 0.95-1.15; P = .37) but a significant association of weight-bearing activity with OA incidence (OR, 1.22; 95% CI, 1.10-1.35; P < .001).

A stratification analysis of a subset of participants whose lower-limb mass had been measured by dual-energy x-ray absorptiometry (DXA) showed, however, that the association of weight-bearing activity with incident OA was limited to patients in the lowest third of lower-limb muscle mass index (LMI), who had a 53% increased likelihood of developing knee OA (OR, 1.53; 95% CI, 1.15-2.04; P = .003).

For patients in the middle and upper tertiles, there was no significant association between weight-bearing activity and the odds of incident OA (OR, 0.93; P = .73, and OR, 1.15; P = .40, respectively).

The findings are reassuring overall, said Kelli D. Allen, PhD, research professor of medicine and exercise physiologist at the University of North Carolina at Chapel Hill, who was asked to comment on the study. “The study corroborates prior research showing that for most people, weight-bearing recreational activity does not increase the risk of knee osteoarthritis. This should be encouraging for people who want to increase their physical activity,” she said.

Physical Activity Types, Other Analyses

The researchers assessed total, weight-bearing, and non–weight-bearing physical activity using two validated questionnaires (an adapted version of the Zutphen Physical Activity Questionnaire and the Longitudinal Aging Study Amsterdam physical activity questionnaire) that asked participants about the frequency and duration of various types of physical activity. Activity was quantified as metabolic equivalent of task (MET) hours per week, and weight-bearing activities were defined as those in which the knee joint bears the body’s weight.

Walking, gardening, golf, dancing, and ball sports were among the activities qualifying as weight-bearing activities. Non–weight-bearing activities included cycling, rowing, and swimming.

Sex, body mass index, and follow-up time were among the covariates adjusted for in the primary analysis. Similar results were found when adjustments were also made for educational level, alcohol intake, lipid levels, and diabetes.

While incident radiographic knee OA (measured using the Kellgren & Lawrence grading system) was the primary outcome, the researchers also looked at symptomatic knee OA, as defined by x-ray and a knee pain questionnaire, and found no significant association of its incidence with any of the exercise categories (total, weight-bearing, or non-weight-bearing).

Coauthor Joyce B. J. van Meurs, PhD, of the departments of internal medicine and orthopedics & sports medicine at Erasmus Medical Center, told this news organization that “pain as a subjective, recurrent symptom is more difficult to study … [and] a larger sample size or more precise measurements [of pain] in future studies would help to better understand the true association” of symptomatic knee OA and physical activity.

Similarly, analyses of the 1511 patients (out of 5003) who had knee pain at baseline found no significant association of weight-bearing or non–weight-bearing physical activity with incident radiographic knee OA. The trends were similar to those found in the population without knee pain, however, which suggests the analysis was underpowered, the researchers wrote, noting too that patients with baseline pain had lower activity levels than those without pain. (Low case numbers precluded a stratification analysis on LMI for incident symptomatic OA.)
 

Thigh Circumference as an Indicator of Muscle Mass

The findings build upon an international meta-analysis published in 2021 that found no association between total physical activity and knee OA and align with other studies suggesting a link between greater mechanical stress/strain and greater OA risk, the researchers wrote. (The meta-analysis couldn’t investigate different types of activity.)

“Although we cannot establish a causal relationship … we hypothesize that the mechanical loading on joints and cartilage could explain the association of weight-bearing activity with osteoarthritis in the low LMI tertile group,” they said.

It is possible that thigh muscle-specific strength or mass may temper the risk of knee OA, they wrote, but the lack of thigh strength data in the Rotterdam Study precluded such evaluation. Still, in everyday practice, the researchers noted, lower limb muscle function could be assessed using thigh circumference.

Dr. Allen agreed. “ ‘Gold standard’ assessment of muscle mass is not common in routine practice, but clinicians can evaluate muscle mass in other ways, such as thigh circumference,” she told this news organization, noting that measurement should align with procedures described by the National Health and Nutrition Examination Survey in its anthropometry procedures manual.

“If low lower-limb muscle mass is suspected, a referral to a physical therapist can be helpful for more formally assessing muscle mass and muscle strength,” she added, “and for instructions for a safe and appropriate exercise program for building muscle and protecting joints.”

Among other limitations of the study, according to the researchers, are an ethnically nondiverse population, the unavailability of knee injury data, and the assessment of physical activity only at baseline.

Moving forward, Dr. van Meurs told this news organization, “the main question regarding physical activity and OA is still, if people already have pain or early OA complaints, what kinds of sports they can do without hurting their joints?” This “should be tested,” she said, “in a real-life, ideally trial-like intervention study.”

The study was funded by the Erasmus Medical Center and Erasmus University as well as through various government grants. Dr. Wu also had study support from the China Scholarship Council. Two of the authors reported relationships with arthritis-related organizations. Dr. Allen reported having no disclosures relevant to her comments.

Weight-bearing recreational activity was associated with a 22% increased odds of developing knee osteoarthritis (OA) in a large prospective cohort study in the Netherlands, but notably, the increased risk was seen only in those with low levels of lower-limb muscle mass.

The findings point toward the value of “tailored advice” for physical activity, and suggest that “caution is needed when engaging in weight-bearing activity, especially for individuals with low levels of lower-limb muscle mass,” Yahong Wu, MD, and coinvestigators, of the Erasmus Medical Center in Rotterdam, the Netherlands, wrote in JAMA Network Open.

kali9/Getty Images

Investigators used data from sequential cohorts of the longitudinal Rotterdam Study, which enrolled people aged 45 and older starting in 1990. The 5003 participants in this new analysis of physical activity and knee OA had complete records of baseline recreational physical activity, baseline knee pain, and knee radiographs from both baseline and at least one follow-up exam. Those with radiographically defined knee OA at baseline were excluded.

The incident rate of radiographically defined (x-ray) knee OA among all participants was 8.4%, with a mean follow-up time of 6.33 years. Among 3492 individuals without baseline knee pain, the researchers found no increased odds of incident radiographic OA with non–weight-bearing activity (odds ratio [OR], 1.04; 95% CI, 0.95-1.15; P = .37) but a significant association of weight-bearing activity with OA incidence (OR, 1.22; 95% CI, 1.10-1.35; P < .001).

A stratification analysis of a subset of participants whose lower-limb mass had been measured by dual-energy x-ray absorptiometry (DXA) showed, however, that the association of weight-bearing activity with incident OA was limited to patients in the lowest third of lower-limb muscle mass index (LMI), who had a 53% increased likelihood of developing knee OA (OR, 1.53; 95% CI, 1.15-2.04; P = .003).

For patients in the middle and upper tertiles, there was no significant association between weight-bearing activity and the odds of incident OA (OR, 0.93; P = .73, and OR, 1.15; P = .40, respectively).

The findings are reassuring overall, said Kelli D. Allen, PhD, research professor of medicine and exercise physiologist at the University of North Carolina at Chapel Hill, who was asked to comment on the study. “The study corroborates prior research showing that for most people, weight-bearing recreational activity does not increase the risk of knee osteoarthritis. This should be encouraging for people who want to increase their physical activity,” she said.

Physical Activity Types, Other Analyses

The researchers assessed total, weight-bearing, and non–weight-bearing physical activity using two validated questionnaires (an adapted version of the Zutphen Physical Activity Questionnaire and the Longitudinal Aging Study Amsterdam physical activity questionnaire) that asked participants about the frequency and duration of various types of physical activity. Activity was quantified as metabolic equivalent of task (MET) hours per week, and weight-bearing activities were defined as those in which the knee joint bears the body’s weight.

Walking, gardening, golf, dancing, and ball sports were among the activities qualifying as weight-bearing activities. Non–weight-bearing activities included cycling, rowing, and swimming.

Sex, body mass index, and follow-up time were among the covariates adjusted for in the primary analysis. Similar results were found when adjustments were also made for educational level, alcohol intake, lipid levels, and diabetes.

While incident radiographic knee OA (measured using the Kellgren & Lawrence grading system) was the primary outcome, the researchers also looked at symptomatic knee OA, as defined by x-ray and a knee pain questionnaire, and found no significant association of its incidence with any of the exercise categories (total, weight-bearing, or non-weight-bearing).

Coauthor Joyce B. J. van Meurs, PhD, of the departments of internal medicine and orthopedics & sports medicine at Erasmus Medical Center, told this news organization that “pain as a subjective, recurrent symptom is more difficult to study … [and] a larger sample size or more precise measurements [of pain] in future studies would help to better understand the true association” of symptomatic knee OA and physical activity.

Similarly, analyses of the 1511 patients (out of 5003) who had knee pain at baseline found no significant association of weight-bearing or non–weight-bearing physical activity with incident radiographic knee OA. The trends were similar to those found in the population without knee pain, however, which suggests the analysis was underpowered, the researchers wrote, noting too that patients with baseline pain had lower activity levels than those without pain. (Low case numbers precluded a stratification analysis on LMI for incident symptomatic OA.)
 

Thigh Circumference as an Indicator of Muscle Mass

The findings build upon an international meta-analysis published in 2021 that found no association between total physical activity and knee OA and align with other studies suggesting a link between greater mechanical stress/strain and greater OA risk, the researchers wrote. (The meta-analysis couldn’t investigate different types of activity.)

“Although we cannot establish a causal relationship … we hypothesize that the mechanical loading on joints and cartilage could explain the association of weight-bearing activity with osteoarthritis in the low LMI tertile group,” they said.

It is possible that thigh muscle-specific strength or mass may temper the risk of knee OA, they wrote, but the lack of thigh strength data in the Rotterdam Study precluded such evaluation. Still, in everyday practice, the researchers noted, lower limb muscle function could be assessed using thigh circumference.

Dr. Allen agreed. “ ‘Gold standard’ assessment of muscle mass is not common in routine practice, but clinicians can evaluate muscle mass in other ways, such as thigh circumference,” she told this news organization, noting that measurement should align with procedures described by the National Health and Nutrition Examination Survey in its anthropometry procedures manual.

“If low lower-limb muscle mass is suspected, a referral to a physical therapist can be helpful for more formally assessing muscle mass and muscle strength,” she added, “and for instructions for a safe and appropriate exercise program for building muscle and protecting joints.”

Among other limitations of the study, according to the researchers, are an ethnically nondiverse population, the unavailability of knee injury data, and the assessment of physical activity only at baseline.

Moving forward, Dr. van Meurs told this news organization, “the main question regarding physical activity and OA is still, if people already have pain or early OA complaints, what kinds of sports they can do without hurting their joints?” This “should be tested,” she said, “in a real-life, ideally trial-like intervention study.”

The study was funded by the Erasmus Medical Center and Erasmus University as well as through various government grants. Dr. Wu also had study support from the China Scholarship Council. Two of the authors reported relationships with arthritis-related organizations. Dr. Allen reported having no disclosures relevant to her comments.

Weight-bearing recreational activity was associated with a 22% increased odds of developing knee osteoarthritis (OA) in a large prospective cohort study in the Netherlands, but notably, the increased risk was seen only in those with low levels of lower-limb muscle mass.

The findings point toward the value of “tailored advice” for physical activity, and suggest that “caution is needed when engaging in weight-bearing activity, especially for individuals with low levels of lower-limb muscle mass,” Yahong Wu, MD, and coinvestigators, of the Erasmus Medical Center in Rotterdam, the Netherlands, wrote in JAMA Network Open.

kali9/Getty Images

Investigators used data from sequential cohorts of the longitudinal Rotterdam Study, which enrolled people aged 45 and older starting in 1990. The 5003 participants in this new analysis of physical activity and knee OA had complete records of baseline recreational physical activity, baseline knee pain, and knee radiographs from both baseline and at least one follow-up exam. Those with radiographically defined knee OA at baseline were excluded.

The incident rate of radiographically defined (x-ray) knee OA among all participants was 8.4%, with a mean follow-up time of 6.33 years. Among 3492 individuals without baseline knee pain, the researchers found no increased odds of incident radiographic OA with non–weight-bearing activity (odds ratio [OR], 1.04; 95% CI, 0.95-1.15; P = .37) but a significant association of weight-bearing activity with OA incidence (OR, 1.22; 95% CI, 1.10-1.35; P < .001).

A stratification analysis of a subset of participants whose lower-limb mass had been measured by dual-energy x-ray absorptiometry (DXA) showed, however, that the association of weight-bearing activity with incident OA was limited to patients in the lowest third of lower-limb muscle mass index (LMI), who had a 53% increased likelihood of developing knee OA (OR, 1.53; 95% CI, 1.15-2.04; P = .003).

For patients in the middle and upper tertiles, there was no significant association between weight-bearing activity and the odds of incident OA (OR, 0.93; P = .73, and OR, 1.15; P = .40, respectively).

The findings are reassuring overall, said Kelli D. Allen, PhD, research professor of medicine and exercise physiologist at the University of North Carolina at Chapel Hill, who was asked to comment on the study. “The study corroborates prior research showing that for most people, weight-bearing recreational activity does not increase the risk of knee osteoarthritis. This should be encouraging for people who want to increase their physical activity,” she said.

Physical Activity Types, Other Analyses

The researchers assessed total, weight-bearing, and non–weight-bearing physical activity using two validated questionnaires (an adapted version of the Zutphen Physical Activity Questionnaire and the Longitudinal Aging Study Amsterdam physical activity questionnaire) that asked participants about the frequency and duration of various types of physical activity. Activity was quantified as metabolic equivalent of task (MET) hours per week, and weight-bearing activities were defined as those in which the knee joint bears the body’s weight.

Walking, gardening, golf, dancing, and ball sports were among the activities qualifying as weight-bearing activities. Non–weight-bearing activities included cycling, rowing, and swimming.

Sex, body mass index, and follow-up time were among the covariates adjusted for in the primary analysis. Similar results were found when adjustments were also made for educational level, alcohol intake, lipid levels, and diabetes.

While incident radiographic knee OA (measured using the Kellgren & Lawrence grading system) was the primary outcome, the researchers also looked at symptomatic knee OA, as defined by x-ray and a knee pain questionnaire, and found no significant association of its incidence with any of the exercise categories (total, weight-bearing, or non-weight-bearing).

Coauthor Joyce B. J. van Meurs, PhD, of the departments of internal medicine and orthopedics & sports medicine at Erasmus Medical Center, told this news organization that “pain as a subjective, recurrent symptom is more difficult to study … [and] a larger sample size or more precise measurements [of pain] in future studies would help to better understand the true association” of symptomatic knee OA and physical activity.

Similarly, analyses of the 1511 patients (out of 5003) who had knee pain at baseline found no significant association of weight-bearing or non–weight-bearing physical activity with incident radiographic knee OA. The trends were similar to those found in the population without knee pain, however, which suggests the analysis was underpowered, the researchers wrote, noting too that patients with baseline pain had lower activity levels than those without pain. (Low case numbers precluded a stratification analysis on LMI for incident symptomatic OA.)
 

Thigh Circumference as an Indicator of Muscle Mass

The findings build upon an international meta-analysis published in 2021 that found no association between total physical activity and knee OA and align with other studies suggesting a link between greater mechanical stress/strain and greater OA risk, the researchers wrote. (The meta-analysis couldn’t investigate different types of activity.)

“Although we cannot establish a causal relationship … we hypothesize that the mechanical loading on joints and cartilage could explain the association of weight-bearing activity with osteoarthritis in the low LMI tertile group,” they said.

It is possible that thigh muscle-specific strength or mass may temper the risk of knee OA, they wrote, but the lack of thigh strength data in the Rotterdam Study precluded such evaluation. Still, in everyday practice, the researchers noted, lower limb muscle function could be assessed using thigh circumference.

Dr. Allen agreed. “ ‘Gold standard’ assessment of muscle mass is not common in routine practice, but clinicians can evaluate muscle mass in other ways, such as thigh circumference,” she told this news organization, noting that measurement should align with procedures described by the National Health and Nutrition Examination Survey in its anthropometry procedures manual.

“If low lower-limb muscle mass is suspected, a referral to a physical therapist can be helpful for more formally assessing muscle mass and muscle strength,” she added, “and for instructions for a safe and appropriate exercise program for building muscle and protecting joints.”

Among other limitations of the study, according to the researchers, are an ethnically nondiverse population, the unavailability of knee injury data, and the assessment of physical activity only at baseline.

Moving forward, Dr. van Meurs told this news organization, “the main question regarding physical activity and OA is still, if people already have pain or early OA complaints, what kinds of sports they can do without hurting their joints?” This “should be tested,” she said, “in a real-life, ideally trial-like intervention study.”

The study was funded by the Erasmus Medical Center and Erasmus University as well as through various government grants. Dr. Wu also had study support from the China Scholarship Council. Two of the authors reported relationships with arthritis-related organizations. Dr. Allen reported having no disclosures relevant to her comments.

TOPLINE:

Differences in prodromal or early symptoms of mpox between White non-Hispanic patients and patients of color suggest healthcare disparities in vulnerable populations.

METHODOLOGY:

• There is limited information on the populations disproportionately affected by the recent global mpox outbreak, particularly in individuals with HIV and racial and ethnic minorities.
• To investigate morphologic and clinical presentations of mpox in diverse populations, researchers conducted a review of the records of 54 individuals (mean age, 42.4 years) diagnosed with mpox at a San Francisco clinic for patients with HIV or at high risk for HIV, between June and October 2022.
• All patients were assigned male at birth, and three identified themselves as transgender women.
• Morphologic descriptions were documented through either photographic evidence or physical examination notes.

TAKEAWAY:

• Pustules or pseudopustules were the most common morphologic finding in 57.1% of the White non-Hispanic patients and 62.5% of the patients of color (P = .72).
• White non-Hispanic patients were more likely to have no prodromal symptoms (50.0% vs 17.5%; P = .02) and were more likely to have genital lesions (78.6% vs 40.0%; P = .01) than patients of color. These differences were significant or nearly significant when White non-Hispanic patients were compared with Hispanic patients but not in other ethnic or racial groups.
• There were no differences in HIV viral loads or CD4 counts between racial and ethnic groups, and no variations in clinical presentations were observed based on CD4 counts.
• Patients with higher HIV viral loads were more likely to have concurrent sexually transmitted infections (57.1% vs 25%; P = .03).
• Symptoms resolved in all patients, regardless of medical intervention, within weeks of initial presentation, and there were no hospitalizations or deaths.

IN PRACTICE:

Considering that HIV viral burden was not significantly different between White non-Hispanic patients and patients of color, the difference in presentation of the prodrome “may indicate disparities in vulnerable populations,” the authors wrote, noting that more research in large groups is needed to confirm their results.

SOURCE:

The study, led by Richard W. Kim, BS, from the University of California San Francisco, was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Inclusion of “other” racial category in the records highlighted potential inaccuracies in data representation.

DISCLOSURES:

The study received no external funding. The authors did not declare any competing interests.

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

TOPLINE:

Differences in prodromal or early symptoms of mpox between White non-Hispanic patients and patients of color suggest healthcare disparities in vulnerable populations.

METHODOLOGY:

• There is limited information on the populations disproportionately affected by the recent global mpox outbreak, particularly in individuals with HIV and racial and ethnic minorities.
• To investigate morphologic and clinical presentations of mpox in diverse populations, researchers conducted a review of the records of 54 individuals (mean age, 42.4 years) diagnosed with mpox at a San Francisco clinic for patients with HIV or at high risk for HIV, between June and October 2022.
• All patients were assigned male at birth, and three identified themselves as transgender women.
• Morphologic descriptions were documented through either photographic evidence or physical examination notes.

TAKEAWAY:

• Pustules or pseudopustules were the most common morphologic finding in 57.1% of the White non-Hispanic patients and 62.5% of the patients of color (P = .72).
• White non-Hispanic patients were more likely to have no prodromal symptoms (50.0% vs 17.5%; P = .02) and were more likely to have genital lesions (78.6% vs 40.0%; P = .01) than patients of color. These differences were significant or nearly significant when White non-Hispanic patients were compared with Hispanic patients but not in other ethnic or racial groups.
• There were no differences in HIV viral loads or CD4 counts between racial and ethnic groups, and no variations in clinical presentations were observed based on CD4 counts.
• Patients with higher HIV viral loads were more likely to have concurrent sexually transmitted infections (57.1% vs 25%; P = .03).
• Symptoms resolved in all patients, regardless of medical intervention, within weeks of initial presentation, and there were no hospitalizations or deaths.

IN PRACTICE:

Considering that HIV viral burden was not significantly different between White non-Hispanic patients and patients of color, the difference in presentation of the prodrome “may indicate disparities in vulnerable populations,” the authors wrote, noting that more research in large groups is needed to confirm their results.

SOURCE:

The study, led by Richard W. Kim, BS, from the University of California San Francisco, was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Inclusion of “other” racial category in the records highlighted potential inaccuracies in data representation.

DISCLOSURES:

The study received no external funding. The authors did not declare any competing interests.

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

TOPLINE:

Differences in prodromal or early symptoms of mpox between White non-Hispanic patients and patients of color suggest healthcare disparities in vulnerable populations.

METHODOLOGY:

• There is limited information on the populations disproportionately affected by the recent global mpox outbreak, particularly in individuals with HIV and racial and ethnic minorities.
• To investigate morphologic and clinical presentations of mpox in diverse populations, researchers conducted a review of the records of 54 individuals (mean age, 42.4 years) diagnosed with mpox at a San Francisco clinic for patients with HIV or at high risk for HIV, between June and October 2022.
• All patients were assigned male at birth, and three identified themselves as transgender women.
• Morphologic descriptions were documented through either photographic evidence or physical examination notes.

TAKEAWAY:

• Pustules or pseudopustules were the most common morphologic finding in 57.1% of the White non-Hispanic patients and 62.5% of the patients of color (P = .72).
• White non-Hispanic patients were more likely to have no prodromal symptoms (50.0% vs 17.5%; P = .02) and were more likely to have genital lesions (78.6% vs 40.0%; P = .01) than patients of color. These differences were significant or nearly significant when White non-Hispanic patients were compared with Hispanic patients but not in other ethnic or racial groups.
• There were no differences in HIV viral loads or CD4 counts between racial and ethnic groups, and no variations in clinical presentations were observed based on CD4 counts.
• Patients with higher HIV viral loads were more likely to have concurrent sexually transmitted infections (57.1% vs 25%; P = .03).
• Symptoms resolved in all patients, regardless of medical intervention, within weeks of initial presentation, and there were no hospitalizations or deaths.

IN PRACTICE:

Considering that HIV viral burden was not significantly different between White non-Hispanic patients and patients of color, the difference in presentation of the prodrome “may indicate disparities in vulnerable populations,” the authors wrote, noting that more research in large groups is needed to confirm their results.

SOURCE:

The study, led by Richard W. Kim, BS, from the University of California San Francisco, was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Inclusion of “other” racial category in the records highlighted potential inaccuracies in data representation.

DISCLOSURES:

The study received no external funding. The authors did not declare any competing interests.

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

In the US Department of Veterans Affairs (VA) health care system, head and neck cancer is one of the most complex oncologic conditions to treat because so many medical professionals are involved in its care. Specialists in speech therapy, nutrition, lymphedema, and dentistry are all part of the picture.

“It takes a complete team to treat cancer in a comprehensive manner, and specialists work hand-in-hand,” said Cindy Bowman, MSN, RN, OCN, president of the Association of VA Hematology/Oncology (AVAHO).

AVAHO held a regional meeting in Seattle on May 4, 2024, that was entirely devoted to head and neck cancer. “The goal was to help the VA oncology professionals gain a global view of how various team members can seamlessly work together,” said Bowman, an oncology nurse navigator and coordinator of the Cancer Care Navigation Program at Bay Pines VA Healthcare System in the Tampa-St. Petersburg, FL area.

According to a 2017 report, 2031 cases of head and neck cancer were diagnosed in 2010 among VA patients, accounting for 4.4% of all cancers. “Veterans are especially vulnerable to this type of cancer for several reasons, such as high rates of smoking and alcohol use,” Bowman said. In addition, she said veterans who served in parts of Southeast Asia, North Africa, and the Middle East are at higher risk of nasopharyngeal carcinoma, which has been linked to Epstein-Barr virus infections in those regions.

Radiation treatment were a significant topic at the regional meeting, and 1 session was focused on the importance of prompt care. “Head and neck cancers are very aggressive,” Bowman said. “The sooner we identify them, the sooner we get treatment started.”

Attendees also heard from a speech therapist and a dietician, who discussed a collaborative approach to improving treatment outcomes. “These are two very important pieces of the puzzle.” Bowman said.

On the nutrition front, a lot of newly diagnosed patients already have malnutrition because they have been having difficulty swallowing. So right up front, a registered dietician works with them and individualizes their nutrition treatment plans all the way into recovery. Some of these folks will end up with their relationship with their dietitian for many years.

“Speech therapists work with patients to design swallowing and tongue exercises that target their individual cancer.” Bowman said. The goal is to prevent the need for a feeding tube.

Another session at the regional conference focused on lymphedema—swelling that can develop due to radiation treatment. “All patients with head and neck cancer should be sent to a lymphedema specialist prior to starting treatment since the specialists can prevent this from happening by giving the patients tools, such as compression garments,” Bowman said. “This way, we don’t end up with somebody 15 or 20 years from now coming back and saying they’re not able to move their neck or unable to swallow the right way.”

Another session highlighted the important role of dental care for patients with head and neck cancer. “We send patients to the dentist prior to ever starting anything. We know that radiation therapy can cause osteoradionecrosis, in which people’s teeth begin to crumble. Fortunately, the VA is now covering dentures for these patients, and they automatically get dental care coverage.” Bowman said.

“In the big picture,” she said, “Attendees should come out of the regional meeting with new insight into the importance of teamwork in head and neck cancer care. We need to make sure that all the pieces to the puzzle are there, and everybody is working together to expedite care for the veterans so that they have the best outcomes possible.”

In the US Department of Veterans Affairs (VA) health care system, head and neck cancer is one of the most complex oncologic conditions to treat because so many medical professionals are involved in its care. Specialists in speech therapy, nutrition, lymphedema, and dentistry are all part of the picture.

“It takes a complete team to treat cancer in a comprehensive manner, and specialists work hand-in-hand,” said Cindy Bowman, MSN, RN, OCN, president of the Association of VA Hematology/Oncology (AVAHO).

AVAHO held a regional meeting in Seattle on May 4, 2024, that was entirely devoted to head and neck cancer. “The goal was to help the VA oncology professionals gain a global view of how various team members can seamlessly work together,” said Bowman, an oncology nurse navigator and coordinator of the Cancer Care Navigation Program at Bay Pines VA Healthcare System in the Tampa-St. Petersburg, FL area.

According to a 2017 report, 2031 cases of head and neck cancer were diagnosed in 2010 among VA patients, accounting for 4.4% of all cancers. “Veterans are especially vulnerable to this type of cancer for several reasons, such as high rates of smoking and alcohol use,” Bowman said. In addition, she said veterans who served in parts of Southeast Asia, North Africa, and the Middle East are at higher risk of nasopharyngeal carcinoma, which has been linked to Epstein-Barr virus infections in those regions.

Radiation treatment were a significant topic at the regional meeting, and 1 session was focused on the importance of prompt care. “Head and neck cancers are very aggressive,” Bowman said. “The sooner we identify them, the sooner we get treatment started.”

Attendees also heard from a speech therapist and a dietician, who discussed a collaborative approach to improving treatment outcomes. “These are two very important pieces of the puzzle.” Bowman said.

On the nutrition front, a lot of newly diagnosed patients already have malnutrition because they have been having difficulty swallowing. So right up front, a registered dietician works with them and individualizes their nutrition treatment plans all the way into recovery. Some of these folks will end up with their relationship with their dietitian for many years.

“Speech therapists work with patients to design swallowing and tongue exercises that target their individual cancer.” Bowman said. The goal is to prevent the need for a feeding tube.

Another session at the regional conference focused on lymphedema—swelling that can develop due to radiation treatment. “All patients with head and neck cancer should be sent to a lymphedema specialist prior to starting treatment since the specialists can prevent this from happening by giving the patients tools, such as compression garments,” Bowman said. “This way, we don’t end up with somebody 15 or 20 years from now coming back and saying they’re not able to move their neck or unable to swallow the right way.”

Another session highlighted the important role of dental care for patients with head and neck cancer. “We send patients to the dentist prior to ever starting anything. We know that radiation therapy can cause osteoradionecrosis, in which people’s teeth begin to crumble. Fortunately, the VA is now covering dentures for these patients, and they automatically get dental care coverage.” Bowman said.

“In the big picture,” she said, “Attendees should come out of the regional meeting with new insight into the importance of teamwork in head and neck cancer care. We need to make sure that all the pieces to the puzzle are there, and everybody is working together to expedite care for the veterans so that they have the best outcomes possible.”

In the US Department of Veterans Affairs (VA) health care system, head and neck cancer is one of the most complex oncologic conditions to treat because so many medical professionals are involved in its care. Specialists in speech therapy, nutrition, lymphedema, and dentistry are all part of the picture.

“It takes a complete team to treat cancer in a comprehensive manner, and specialists work hand-in-hand,” said Cindy Bowman, MSN, RN, OCN, president of the Association of VA Hematology/Oncology (AVAHO).

AVAHO held a regional meeting in Seattle on May 4, 2024, that was entirely devoted to head and neck cancer. “The goal was to help the VA oncology professionals gain a global view of how various team members can seamlessly work together,” said Bowman, an oncology nurse navigator and coordinator of the Cancer Care Navigation Program at Bay Pines VA Healthcare System in the Tampa-St. Petersburg, FL area.

According to a 2017 report, 2031 cases of head and neck cancer were diagnosed in 2010 among VA patients, accounting for 4.4% of all cancers. “Veterans are especially vulnerable to this type of cancer for several reasons, such as high rates of smoking and alcohol use,” Bowman said. In addition, she said veterans who served in parts of Southeast Asia, North Africa, and the Middle East are at higher risk of nasopharyngeal carcinoma, which has been linked to Epstein-Barr virus infections in those regions.

Radiation treatment were a significant topic at the regional meeting, and 1 session was focused on the importance of prompt care. “Head and neck cancers are very aggressive,” Bowman said. “The sooner we identify them, the sooner we get treatment started.”

Attendees also heard from a speech therapist and a dietician, who discussed a collaborative approach to improving treatment outcomes. “These are two very important pieces of the puzzle.” Bowman said.

On the nutrition front, a lot of newly diagnosed patients already have malnutrition because they have been having difficulty swallowing. So right up front, a registered dietician works with them and individualizes their nutrition treatment plans all the way into recovery. Some of these folks will end up with their relationship with their dietitian for many years.

“Speech therapists work with patients to design swallowing and tongue exercises that target their individual cancer.” Bowman said. The goal is to prevent the need for a feeding tube.

Another session at the regional conference focused on lymphedema—swelling that can develop due to radiation treatment. “All patients with head and neck cancer should be sent to a lymphedema specialist prior to starting treatment since the specialists can prevent this from happening by giving the patients tools, such as compression garments,” Bowman said. “This way, we don’t end up with somebody 15 or 20 years from now coming back and saying they’re not able to move their neck or unable to swallow the right way.”

Another session highlighted the important role of dental care for patients with head and neck cancer. “We send patients to the dentist prior to ever starting anything. We know that radiation therapy can cause osteoradionecrosis, in which people’s teeth begin to crumble. Fortunately, the VA is now covering dentures for these patients, and they automatically get dental care coverage.” Bowman said.

“In the big picture,” she said, “Attendees should come out of the regional meeting with new insight into the importance of teamwork in head and neck cancer care. We need to make sure that all the pieces to the puzzle are there, and everybody is working together to expedite care for the veterans so that they have the best outcomes possible.”

DENVER — Among patients with major depressive disorder, transcranial magnetic stimulation (TMS) had similar efficacy to electroconvulsive therapy (ECT), according to results from a retrospective study of patients treated in the past 20 years.

“We always learn in our textbooks that after about two or three medication trials is when you can start exploring more serious treatment protocols, such as ECT or TMS, but a lot of these patients weren’t going forward with it, and I was curious about it. I figured that TMS, which is a less expensive, less scary procedure that patients would more likely be open to, that is also approved for treatment resistant depression, would be a good alternative to ECT,” said Anuttham Kandhadai, a third-year medical student at University of Texas Medical Branch at Galveston, who presented the study at the 2024 annual meeting of the American Academy of Neurology.
 

Study Findings Lead to More Questions

The researchers found lower rates of depressive episodes, suicidal attempts, and suicidal ideation among patients treated with TMS, but an important limitation was that the researchers did not know the severity of the depression in the two patient groups, according to Branch Coslett, MD, who attended the session and has performed research with TMS to treat aphasia in stroke patients. “I think it’s a very interesting study, and certainly something worth pursuing, but given that ECT is only used as a last resort, whereas TMS is often used as a second-line therapy, I think you’re really talking about very different populations that have had these treatments,” said Dr. Coslett.

Mr. Kandhadai recognized the limitations of the study and looks forward to expanding the research. “I’d love to explore cost effectiveness of the treatments. I’d love to explore patient familiarity and patient comfort with different treatments. And I’d also love to explore a more controlled study that can determine how severe someone’s depression is, and then be able to control for that and explore the outcomes based on the treatment protocol,” he said.

The ideal comparative study would be prospective, “but that will never be done. One Flew Over the Cuckoo’s Nest and similar sources of information have really poisoned the well,” said Dr. Coslett. However, he noted that advances have been made in ECT, and that targeting the right hemisphere produces fewer side effects: “The outcomes from unilateral right hemisphere stimulation are said to be every bit as good or maybe better, and you don’t get the confusion, you don’t get the memory loss, you don’t get all that sort of stuff that you’d expect when somebody has a prolonged, generalized tonic-clonic seizure.”

Still, people are naturally reluctant to undergo ECT. “I’ve seen it. It’s pretty barbaric. It’s better now and at my institution, people do get it, but they really, really have to be intractable,” he said.
 

Comparing Treatment Options

Mr. Kandhadai and his co-authors used the TriNetX database to identify patients with treatment-resistant major depressive disorder who received TMS or ECT in the past 20 years. There were 2,916 patients in both cohorts, who were matched by age, sex, ethnicity, mood and behavioral disorders, endocrine disorders, intellectual disabilities, cerebrovascular disease, and other nervous system disorders. The mean age at treatment was 48.2 years, 38.5% were male, and 3.1% were Black or African American.

Short-term outcomes favored TMS, including the frequency of disorientation (0.41% vs 2.81%), retrograde amnesia (0.34% vs 0.65%), and headache (4.36% vs 7.20%). Long-term outcomes from 1 month to 5 years post treatment were also better in the TMS group, including depressive episodes (44.99% vs 53.77%), suicide attempts (3.98% vs 6.86%), and suicidal ideation (12.38% vs 23.49%). Kaplan-Meier curve analysis between 1 month and 5 years showed a benefit to TMS in probability of not experiencing a depressive episode, and not experiencing suicidal ideation.

“ECT has been the gold standard of treatment resistant depression for a long time, and it deserves to be. I think it’s something you should offer your patients. Not everyone might be comfortable with it, and if they’re not, I think it’s important to not stop the conversation there, but to offer something like TMS because TMS is something that might be more accessible to patients. It might be more affordable, and it might be less scary,” said Mr. Kandhadai

Mr. Kandhadai and Dr. Coslett have no relevant financial disclosures.

DENVER — Among patients with major depressive disorder, transcranial magnetic stimulation (TMS) had similar efficacy to electroconvulsive therapy (ECT), according to results from a retrospective study of patients treated in the past 20 years.

“We always learn in our textbooks that after about two or three medication trials is when you can start exploring more serious treatment protocols, such as ECT or TMS, but a lot of these patients weren’t going forward with it, and I was curious about it. I figured that TMS, which is a less expensive, less scary procedure that patients would more likely be open to, that is also approved for treatment resistant depression, would be a good alternative to ECT,” said Anuttham Kandhadai, a third-year medical student at University of Texas Medical Branch at Galveston, who presented the study at the 2024 annual meeting of the American Academy of Neurology.
 

Study Findings Lead to More Questions

The researchers found lower rates of depressive episodes, suicidal attempts, and suicidal ideation among patients treated with TMS, but an important limitation was that the researchers did not know the severity of the depression in the two patient groups, according to Branch Coslett, MD, who attended the session and has performed research with TMS to treat aphasia in stroke patients. “I think it’s a very interesting study, and certainly something worth pursuing, but given that ECT is only used as a last resort, whereas TMS is often used as a second-line therapy, I think you’re really talking about very different populations that have had these treatments,” said Dr. Coslett.

Mr. Kandhadai recognized the limitations of the study and looks forward to expanding the research. “I’d love to explore cost effectiveness of the treatments. I’d love to explore patient familiarity and patient comfort with different treatments. And I’d also love to explore a more controlled study that can determine how severe someone’s depression is, and then be able to control for that and explore the outcomes based on the treatment protocol,” he said.

The ideal comparative study would be prospective, “but that will never be done. One Flew Over the Cuckoo’s Nest and similar sources of information have really poisoned the well,” said Dr. Coslett. However, he noted that advances have been made in ECT, and that targeting the right hemisphere produces fewer side effects: “The outcomes from unilateral right hemisphere stimulation are said to be every bit as good or maybe better, and you don’t get the confusion, you don’t get the memory loss, you don’t get all that sort of stuff that you’d expect when somebody has a prolonged, generalized tonic-clonic seizure.”

Still, people are naturally reluctant to undergo ECT. “I’ve seen it. It’s pretty barbaric. It’s better now and at my institution, people do get it, but they really, really have to be intractable,” he said.
 

Comparing Treatment Options

Mr. Kandhadai and his co-authors used the TriNetX database to identify patients with treatment-resistant major depressive disorder who received TMS or ECT in the past 20 years. There were 2,916 patients in both cohorts, who were matched by age, sex, ethnicity, mood and behavioral disorders, endocrine disorders, intellectual disabilities, cerebrovascular disease, and other nervous system disorders. The mean age at treatment was 48.2 years, 38.5% were male, and 3.1% were Black or African American.

Short-term outcomes favored TMS, including the frequency of disorientation (0.41% vs 2.81%), retrograde amnesia (0.34% vs 0.65%), and headache (4.36% vs 7.20%). Long-term outcomes from 1 month to 5 years post treatment were also better in the TMS group, including depressive episodes (44.99% vs 53.77%), suicide attempts (3.98% vs 6.86%), and suicidal ideation (12.38% vs 23.49%). Kaplan-Meier curve analysis between 1 month and 5 years showed a benefit to TMS in probability of not experiencing a depressive episode, and not experiencing suicidal ideation.

“ECT has been the gold standard of treatment resistant depression for a long time, and it deserves to be. I think it’s something you should offer your patients. Not everyone might be comfortable with it, and if they’re not, I think it’s important to not stop the conversation there, but to offer something like TMS because TMS is something that might be more accessible to patients. It might be more affordable, and it might be less scary,” said Mr. Kandhadai

Mr. Kandhadai and Dr. Coslett have no relevant financial disclosures.

DENVER — Among patients with major depressive disorder, transcranial magnetic stimulation (TMS) had similar efficacy to electroconvulsive therapy (ECT), according to results from a retrospective study of patients treated in the past 20 years.

“We always learn in our textbooks that after about two or three medication trials is when you can start exploring more serious treatment protocols, such as ECT or TMS, but a lot of these patients weren’t going forward with it, and I was curious about it. I figured that TMS, which is a less expensive, less scary procedure that patients would more likely be open to, that is also approved for treatment resistant depression, would be a good alternative to ECT,” said Anuttham Kandhadai, a third-year medical student at University of Texas Medical Branch at Galveston, who presented the study at the 2024 annual meeting of the American Academy of Neurology.
 

Study Findings Lead to More Questions

The researchers found lower rates of depressive episodes, suicidal attempts, and suicidal ideation among patients treated with TMS, but an important limitation was that the researchers did not know the severity of the depression in the two patient groups, according to Branch Coslett, MD, who attended the session and has performed research with TMS to treat aphasia in stroke patients. “I think it’s a very interesting study, and certainly something worth pursuing, but given that ECT is only used as a last resort, whereas TMS is often used as a second-line therapy, I think you’re really talking about very different populations that have had these treatments,” said Dr. Coslett.

Mr. Kandhadai recognized the limitations of the study and looks forward to expanding the research. “I’d love to explore cost effectiveness of the treatments. I’d love to explore patient familiarity and patient comfort with different treatments. And I’d also love to explore a more controlled study that can determine how severe someone’s depression is, and then be able to control for that and explore the outcomes based on the treatment protocol,” he said.

The ideal comparative study would be prospective, “but that will never be done. One Flew Over the Cuckoo’s Nest and similar sources of information have really poisoned the well,” said Dr. Coslett. However, he noted that advances have been made in ECT, and that targeting the right hemisphere produces fewer side effects: “The outcomes from unilateral right hemisphere stimulation are said to be every bit as good or maybe better, and you don’t get the confusion, you don’t get the memory loss, you don’t get all that sort of stuff that you’d expect when somebody has a prolonged, generalized tonic-clonic seizure.”

Still, people are naturally reluctant to undergo ECT. “I’ve seen it. It’s pretty barbaric. It’s better now and at my institution, people do get it, but they really, really have to be intractable,” he said.
 

Comparing Treatment Options

Mr. Kandhadai and his co-authors used the TriNetX database to identify patients with treatment-resistant major depressive disorder who received TMS or ECT in the past 20 years. There were 2,916 patients in both cohorts, who were matched by age, sex, ethnicity, mood and behavioral disorders, endocrine disorders, intellectual disabilities, cerebrovascular disease, and other nervous system disorders. The mean age at treatment was 48.2 years, 38.5% were male, and 3.1% were Black or African American.

Short-term outcomes favored TMS, including the frequency of disorientation (0.41% vs 2.81%), retrograde amnesia (0.34% vs 0.65%), and headache (4.36% vs 7.20%). Long-term outcomes from 1 month to 5 years post treatment were also better in the TMS group, including depressive episodes (44.99% vs 53.77%), suicide attempts (3.98% vs 6.86%), and suicidal ideation (12.38% vs 23.49%). Kaplan-Meier curve analysis between 1 month and 5 years showed a benefit to TMS in probability of not experiencing a depressive episode, and not experiencing suicidal ideation.

“ECT has been the gold standard of treatment resistant depression for a long time, and it deserves to be. I think it’s something you should offer your patients. Not everyone might be comfortable with it, and if they’re not, I think it’s important to not stop the conversation there, but to offer something like TMS because TMS is something that might be more accessible to patients. It might be more affordable, and it might be less scary,” said Mr. Kandhadai

Mr. Kandhadai and Dr. Coslett have no relevant financial disclosures.