TOPLINE:

High-frequency electric nerve block significantly reduced postamputation pain in a new study, presenting a potential new therapeutic option for amputees.

METHODOLOGY:

• The study enrolled 180 patients with unilateral lower limb amputations who were experiencing severe post-procedure pain.
• Participants were randomized 1:1 to receive 3 months of treatment with either a high-frequency nerve block (Altius; Neuros Medical) or an active sham.
• Effectiveness was measured by the percentage of participants achieving at least a 50% reduction in pain in more than half of the treatment sessions.
• The researchers attempted to control for variables including pain type and baseline pain intensity.

TAKEAWAY:

• A total of 24.7% of patients in the group that received the nerve block were responders at 30 minutes post-treatment, significantly higher than 7.1% in the control group (P = .002).
• The rate of response rose to 46.8% in the treatment group at 120 minutes, compared with 22.2% in the sham group (P = .001).
• Patients who received the nerve block reported a greater improvement in their score on the Brief Pain Inventory than those in the sham arm — 2.3 ± 0.29 vs 1.3 ± 0.26, respectively (P = .01).
• Use of opioids trended toward a greater reduction in the treatment group, although that finding was not statistically significant.

IN PRACTICE:

The results suggested “high-frequency electric nerve block could be a viable option for managing chronic post-amputation pain, potentially improving patients’ quality of life and reducing reliance on opioids,” the authors wrote. “The study addresses a critical gap in treatment options for amputees suffering from persistent pain, offering evidence for a novel therapeutic approach.”

“We have never seen a study of this magnitude and rigor in this patient population,” said lead author Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, in a press release about the data. “The data demonstrated clear and lasting benefit of treatment for pain reduction and functional outcomes at 3 months, creating great optimism for the long-term study results. These findings represent a significant advancement for an at-risk and underserved patient population in desperate need of reliable and effective treatment.”

SOURCE:

The study was led by Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, and was published online in the Journal of Pain Research.

LIMITATIONS:

The sample size of 180 participants may limit the generalizability of the findings to all amputees. A 3-month duration for assessing treatment efficacy may not capture long-term outcomes and effects. The active-sham control design, while rigorous, may not fully account for the placebo effects inherent in pain perception studies.

DISCLOSURES:

The QUEST study was funded by Neuros Medical Inc. Dr. Kapural reported personal fees from various medical companies, unrelated to this work. No other conflicts of interest were reported in this work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

High-frequency electric nerve block significantly reduced postamputation pain in a new study, presenting a potential new therapeutic option for amputees.

METHODOLOGY:

• The study enrolled 180 patients with unilateral lower limb amputations who were experiencing severe post-procedure pain.
• Participants were randomized 1:1 to receive 3 months of treatment with either a high-frequency nerve block (Altius; Neuros Medical) or an active sham.
• Effectiveness was measured by the percentage of participants achieving at least a 50% reduction in pain in more than half of the treatment sessions.
• The researchers attempted to control for variables including pain type and baseline pain intensity.

TAKEAWAY:

• A total of 24.7% of patients in the group that received the nerve block were responders at 30 minutes post-treatment, significantly higher than 7.1% in the control group (P = .002).
• The rate of response rose to 46.8% in the treatment group at 120 minutes, compared with 22.2% in the sham group (P = .001).
• Patients who received the nerve block reported a greater improvement in their score on the Brief Pain Inventory than those in the sham arm — 2.3 ± 0.29 vs 1.3 ± 0.26, respectively (P = .01).
• Use of opioids trended toward a greater reduction in the treatment group, although that finding was not statistically significant.

IN PRACTICE:

The results suggested “high-frequency electric nerve block could be a viable option for managing chronic post-amputation pain, potentially improving patients’ quality of life and reducing reliance on opioids,” the authors wrote. “The study addresses a critical gap in treatment options for amputees suffering from persistent pain, offering evidence for a novel therapeutic approach.”

“We have never seen a study of this magnitude and rigor in this patient population,” said lead author Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, in a press release about the data. “The data demonstrated clear and lasting benefit of treatment for pain reduction and functional outcomes at 3 months, creating great optimism for the long-term study results. These findings represent a significant advancement for an at-risk and underserved patient population in desperate need of reliable and effective treatment.”

SOURCE:

The study was led by Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, and was published online in the Journal of Pain Research.

LIMITATIONS:

The sample size of 180 participants may limit the generalizability of the findings to all amputees. A 3-month duration for assessing treatment efficacy may not capture long-term outcomes and effects. The active-sham control design, while rigorous, may not fully account for the placebo effects inherent in pain perception studies.

DISCLOSURES:

The QUEST study was funded by Neuros Medical Inc. Dr. Kapural reported personal fees from various medical companies, unrelated to this work. No other conflicts of interest were reported in this work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

High-frequency electric nerve block significantly reduced postamputation pain in a new study, presenting a potential new therapeutic option for amputees.

METHODOLOGY:

• The study enrolled 180 patients with unilateral lower limb amputations who were experiencing severe post-procedure pain.
• Participants were randomized 1:1 to receive 3 months of treatment with either a high-frequency nerve block (Altius; Neuros Medical) or an active sham.
• Effectiveness was measured by the percentage of participants achieving at least a 50% reduction in pain in more than half of the treatment sessions.
• The researchers attempted to control for variables including pain type and baseline pain intensity.

TAKEAWAY:

• A total of 24.7% of patients in the group that received the nerve block were responders at 30 minutes post-treatment, significantly higher than 7.1% in the control group (P = .002).
• The rate of response rose to 46.8% in the treatment group at 120 minutes, compared with 22.2% in the sham group (P = .001).
• Patients who received the nerve block reported a greater improvement in their score on the Brief Pain Inventory than those in the sham arm — 2.3 ± 0.29 vs 1.3 ± 0.26, respectively (P = .01).
• Use of opioids trended toward a greater reduction in the treatment group, although that finding was not statistically significant.

IN PRACTICE:

The results suggested “high-frequency electric nerve block could be a viable option for managing chronic post-amputation pain, potentially improving patients’ quality of life and reducing reliance on opioids,” the authors wrote. “The study addresses a critical gap in treatment options for amputees suffering from persistent pain, offering evidence for a novel therapeutic approach.”

“We have never seen a study of this magnitude and rigor in this patient population,” said lead author Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, in a press release about the data. “The data demonstrated clear and lasting benefit of treatment for pain reduction and functional outcomes at 3 months, creating great optimism for the long-term study results. These findings represent a significant advancement for an at-risk and underserved patient population in desperate need of reliable and effective treatment.”

SOURCE:

The study was led by Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, and was published online in the Journal of Pain Research.

LIMITATIONS:

The sample size of 180 participants may limit the generalizability of the findings to all amputees. A 3-month duration for assessing treatment efficacy may not capture long-term outcomes and effects. The active-sham control design, while rigorous, may not fully account for the placebo effects inherent in pain perception studies.

DISCLOSURES:

The QUEST study was funded by Neuros Medical Inc. Dr. Kapural reported personal fees from various medical companies, unrelated to this work. No other conflicts of interest were reported in this work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Pigments in permanent makeup inks include those that have been reported to cause allergic contact dermatitis (ACD), but the ability to identify these allergies in patients is limited.

METHODOLOGY:

• While the allergenic potential of pigments in traditional tattoos has been documented, there is less clarity about pigments used in inks contained in cosmetic tattoos, also known as permanent makeup, and their association with ACD.
• Researchers conducted an Internet search and identified 974 individual permanent makeup ink products sold in the United States and also identified 79 unique pigments in those products.
• They evaluated the safety data sheets of these products and performed a PubMed search to identify documented ACD cases related to these pigments.

TAKEAWAY:

• Of the 79 pigments, 20 contained inorganic metals, which included iron, aluminum, silicone, chromium, copper, titanium, molybdenum, and manganese.
• Organic pigments were more common: 59 of the remaining pigments were organic compounds, mostly azo, quinacridone, or anthraquinone dyes, including 4 black pigments made from carbon only.
• A literature search identified 29 cases where patients had developed ACD thought to be caused by at least one of the 79 pigments identified by the authors of the current study and included 10 of the 79 pigments (12%).
• In 18 of the 29 cases in the literature, patch testing to the suspected pigment had been performed; in 3 cases, ACD was suspected without confirmatory testing.

IN PRACTICE:

Permanent makeup is becoming more popular, and there have been reports of ACD related to pigments contained in the inks, the authors wrote. “Traditional patch testing methods may not be useful in confirming the presence of a pigment allergy, even if one is suspect,” they added. “Consumers and patch testing physicians would benefit from better labeling of tattoo inks and the development of protocols designed to specifically test for tattoo pigment allergies.”

SOURCE:

The study was led by Sarah Rigali, MS, of Rosalind Franklin University, Chicago Medical School, Chicago, and coauthors from the Department of Dermatology, Northwestern University, Chicago, published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The study is limited by incomplete safety data sheets. So, many brands of permanent makeup ink could not be investigated. In addition, some pigments may not be fully disclosed in ingredient lists and precise ink content measurements were not available.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Pigments in permanent makeup inks include those that have been reported to cause allergic contact dermatitis (ACD), but the ability to identify these allergies in patients is limited.

METHODOLOGY:

• While the allergenic potential of pigments in traditional tattoos has been documented, there is less clarity about pigments used in inks contained in cosmetic tattoos, also known as permanent makeup, and their association with ACD.
• Researchers conducted an Internet search and identified 974 individual permanent makeup ink products sold in the United States and also identified 79 unique pigments in those products.
• They evaluated the safety data sheets of these products and performed a PubMed search to identify documented ACD cases related to these pigments.

TAKEAWAY:

• Of the 79 pigments, 20 contained inorganic metals, which included iron, aluminum, silicone, chromium, copper, titanium, molybdenum, and manganese.
• Organic pigments were more common: 59 of the remaining pigments were organic compounds, mostly azo, quinacridone, or anthraquinone dyes, including 4 black pigments made from carbon only.
• A literature search identified 29 cases where patients had developed ACD thought to be caused by at least one of the 79 pigments identified by the authors of the current study and included 10 of the 79 pigments (12%).
• In 18 of the 29 cases in the literature, patch testing to the suspected pigment had been performed; in 3 cases, ACD was suspected without confirmatory testing.

IN PRACTICE:

Permanent makeup is becoming more popular, and there have been reports of ACD related to pigments contained in the inks, the authors wrote. “Traditional patch testing methods may not be useful in confirming the presence of a pigment allergy, even if one is suspect,” they added. “Consumers and patch testing physicians would benefit from better labeling of tattoo inks and the development of protocols designed to specifically test for tattoo pigment allergies.”

SOURCE:

The study was led by Sarah Rigali, MS, of Rosalind Franklin University, Chicago Medical School, Chicago, and coauthors from the Department of Dermatology, Northwestern University, Chicago, published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The study is limited by incomplete safety data sheets. So, many brands of permanent makeup ink could not be investigated. In addition, some pigments may not be fully disclosed in ingredient lists and precise ink content measurements were not available.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Pigments in permanent makeup inks include those that have been reported to cause allergic contact dermatitis (ACD), but the ability to identify these allergies in patients is limited.

METHODOLOGY:

• While the allergenic potential of pigments in traditional tattoos has been documented, there is less clarity about pigments used in inks contained in cosmetic tattoos, also known as permanent makeup, and their association with ACD.
• Researchers conducted an Internet search and identified 974 individual permanent makeup ink products sold in the United States and also identified 79 unique pigments in those products.
• They evaluated the safety data sheets of these products and performed a PubMed search to identify documented ACD cases related to these pigments.

TAKEAWAY:

• Of the 79 pigments, 20 contained inorganic metals, which included iron, aluminum, silicone, chromium, copper, titanium, molybdenum, and manganese.
• Organic pigments were more common: 59 of the remaining pigments were organic compounds, mostly azo, quinacridone, or anthraquinone dyes, including 4 black pigments made from carbon only.
• A literature search identified 29 cases where patients had developed ACD thought to be caused by at least one of the 79 pigments identified by the authors of the current study and included 10 of the 79 pigments (12%).
• In 18 of the 29 cases in the literature, patch testing to the suspected pigment had been performed; in 3 cases, ACD was suspected without confirmatory testing.

IN PRACTICE:

Permanent makeup is becoming more popular, and there have been reports of ACD related to pigments contained in the inks, the authors wrote. “Traditional patch testing methods may not be useful in confirming the presence of a pigment allergy, even if one is suspect,” they added. “Consumers and patch testing physicians would benefit from better labeling of tattoo inks and the development of protocols designed to specifically test for tattoo pigment allergies.”

SOURCE:

The study was led by Sarah Rigali, MS, of Rosalind Franklin University, Chicago Medical School, Chicago, and coauthors from the Department of Dermatology, Northwestern University, Chicago, published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The study is limited by incomplete safety data sheets. So, many brands of permanent makeup ink could not be investigated. In addition, some pigments may not be fully disclosed in ingredient lists and precise ink content measurements were not available.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Among people diagnosed with cutaneous melanoma in the United States, those who live in rural areas have significantly lower rates of survival than those who live in urban areas, results from an analysis of data from the National Cancer Institute showed.

“Melanoma is currently the fifth most common malignancy in the United States, with approximately 106,000 new cases and 7180 reported deaths occurring in 2021,” the study’s first author, Mitchell Taylor, MD, a dermatology research fellow at the University of Nebraska, Omaha, and colleagues wrote in the abstract, which was presented during a poster session at the annual meeting of the Society for Investigative Dermatology. “Rural areas have been shown to bear a higher melanoma disease burden, yet there is a paucity of national-level studies examining these disparities.”

To characterize the rural population diagnosed with cutaneous melanoma and assess associated disparities in the United States, the researchers queried the NCI’s Surveillance, Epidemiology, and End Results database to identify individuals diagnosed with cutaneous melanoma from 2000 to 2020 (International Classification of Diseases, 3rd Edition, 8720/3 — 8780/3; Primary Site codes C44.0-C44.9). They drew from US Office of Management and Budget terminology to define and categorize rural and urban communities.

Among 391,047 patients included during the study period, binary logistic regression analysis revealed that patients in rural areas had a greater odds of being older, from ages 50 to 75 years (odds ratio [OR], 1.10; P < .001); had annual incomes < $70,000 (OR, 16.80; P < .001); had tumors located on the head and neck (OR, 1.24; P < .001); and presented with regional/distant disease (OR, 1.13; P < .001).

As for disease-specific survival, patients living in rural areas had significantly reduced survival compared with those living in urban areas (a mean of 207.3 vs 216.3 months, respectively; P < .001). Multivariate Cox regression revealed that living in a rural setting was significantly associated with reduced disease-specific survival (hazard ratio [HR], 1.10; P < .001), as was having head and neck tumors (HR, 1.41; P < .001).“Overall, this study underscores a significant decrease in disease-specific survival among rural patients diagnosed with cutaneous melanoma and establishes a significant association between rural living and high-risk primary tumor locations, particularly the head and neck,” the authors concluded.

Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, Colorado, who was asked to comment on the results, said the findings echo the results of a recent study which characterized melanoma rates among non-Hispanic American Indian/Alaska Native individuals from 1999 to 2019.

“I suspect this decreased disease-specific survival highlights the issues our rural-residing patients face with access to dermatology care,” Dr. Kohn told this news organization. “Dermatologists are able to detect thinner melanomas than patients [and] are preferentially concentrated in metropolitan areas. Dermatologists are also the most skilled and knowledgeable to screen, diagnose, and manage melanomas. Having fewer dermatologists in rural areas impedes melanoma care for our rural-residing patients.”

Neither the researchers nor Dr. Kohn reported any relevant disclosures.

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

Among people diagnosed with cutaneous melanoma in the United States, those who live in rural areas have significantly lower rates of survival than those who live in urban areas, results from an analysis of data from the National Cancer Institute showed.

“Melanoma is currently the fifth most common malignancy in the United States, with approximately 106,000 new cases and 7180 reported deaths occurring in 2021,” the study’s first author, Mitchell Taylor, MD, a dermatology research fellow at the University of Nebraska, Omaha, and colleagues wrote in the abstract, which was presented during a poster session at the annual meeting of the Society for Investigative Dermatology. “Rural areas have been shown to bear a higher melanoma disease burden, yet there is a paucity of national-level studies examining these disparities.”

To characterize the rural population diagnosed with cutaneous melanoma and assess associated disparities in the United States, the researchers queried the NCI’s Surveillance, Epidemiology, and End Results database to identify individuals diagnosed with cutaneous melanoma from 2000 to 2020 (International Classification of Diseases, 3rd Edition, 8720/3 — 8780/3; Primary Site codes C44.0-C44.9). They drew from US Office of Management and Budget terminology to define and categorize rural and urban communities.

Among 391,047 patients included during the study period, binary logistic regression analysis revealed that patients in rural areas had a greater odds of being older, from ages 50 to 75 years (odds ratio [OR], 1.10; P < .001); had annual incomes < $70,000 (OR, 16.80; P < .001); had tumors located on the head and neck (OR, 1.24; P < .001); and presented with regional/distant disease (OR, 1.13; P < .001).

As for disease-specific survival, patients living in rural areas had significantly reduced survival compared with those living in urban areas (a mean of 207.3 vs 216.3 months, respectively; P < .001). Multivariate Cox regression revealed that living in a rural setting was significantly associated with reduced disease-specific survival (hazard ratio [HR], 1.10; P < .001), as was having head and neck tumors (HR, 1.41; P < .001).“Overall, this study underscores a significant decrease in disease-specific survival among rural patients diagnosed with cutaneous melanoma and establishes a significant association between rural living and high-risk primary tumor locations, particularly the head and neck,” the authors concluded.

Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, Colorado, who was asked to comment on the results, said the findings echo the results of a recent study which characterized melanoma rates among non-Hispanic American Indian/Alaska Native individuals from 1999 to 2019.

“I suspect this decreased disease-specific survival highlights the issues our rural-residing patients face with access to dermatology care,” Dr. Kohn told this news organization. “Dermatologists are able to detect thinner melanomas than patients [and] are preferentially concentrated in metropolitan areas. Dermatologists are also the most skilled and knowledgeable to screen, diagnose, and manage melanomas. Having fewer dermatologists in rural areas impedes melanoma care for our rural-residing patients.”

Neither the researchers nor Dr. Kohn reported any relevant disclosures.

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

Among people diagnosed with cutaneous melanoma in the United States, those who live in rural areas have significantly lower rates of survival than those who live in urban areas, results from an analysis of data from the National Cancer Institute showed.

“Melanoma is currently the fifth most common malignancy in the United States, with approximately 106,000 new cases and 7180 reported deaths occurring in 2021,” the study’s first author, Mitchell Taylor, MD, a dermatology research fellow at the University of Nebraska, Omaha, and colleagues wrote in the abstract, which was presented during a poster session at the annual meeting of the Society for Investigative Dermatology. “Rural areas have been shown to bear a higher melanoma disease burden, yet there is a paucity of national-level studies examining these disparities.”

To characterize the rural population diagnosed with cutaneous melanoma and assess associated disparities in the United States, the researchers queried the NCI’s Surveillance, Epidemiology, and End Results database to identify individuals diagnosed with cutaneous melanoma from 2000 to 2020 (International Classification of Diseases, 3rd Edition, 8720/3 — 8780/3; Primary Site codes C44.0-C44.9). They drew from US Office of Management and Budget terminology to define and categorize rural and urban communities.

Among 391,047 patients included during the study period, binary logistic regression analysis revealed that patients in rural areas had a greater odds of being older, from ages 50 to 75 years (odds ratio [OR], 1.10; P < .001); had annual incomes < $70,000 (OR, 16.80; P < .001); had tumors located on the head and neck (OR, 1.24; P < .001); and presented with regional/distant disease (OR, 1.13; P < .001).

As for disease-specific survival, patients living in rural areas had significantly reduced survival compared with those living in urban areas (a mean of 207.3 vs 216.3 months, respectively; P < .001). Multivariate Cox regression revealed that living in a rural setting was significantly associated with reduced disease-specific survival (hazard ratio [HR], 1.10; P < .001), as was having head and neck tumors (HR, 1.41; P < .001).“Overall, this study underscores a significant decrease in disease-specific survival among rural patients diagnosed with cutaneous melanoma and establishes a significant association between rural living and high-risk primary tumor locations, particularly the head and neck,” the authors concluded.

Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, Colorado, who was asked to comment on the results, said the findings echo the results of a recent study which characterized melanoma rates among non-Hispanic American Indian/Alaska Native individuals from 1999 to 2019.

“I suspect this decreased disease-specific survival highlights the issues our rural-residing patients face with access to dermatology care,” Dr. Kohn told this news organization. “Dermatologists are able to detect thinner melanomas than patients [and] are preferentially concentrated in metropolitan areas. Dermatologists are also the most skilled and knowledgeable to screen, diagnose, and manage melanomas. Having fewer dermatologists in rural areas impedes melanoma care for our rural-residing patients.”

Neither the researchers nor Dr. Kohn reported any relevant disclosures.

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

Compared with White patients with Merkel cell carcinoma (MCC), non-White Hispanic patients more commonly presented younger than 70 years of age and were more often female. In addition, the most affected site was the upper limb/shoulder, which differs from what has been reported in previous studies.

Those are key findings from a retrospective study of national cancer data that was presented during a poster session at the annual meeting of the Society for Investigative Dermatology.

“Merkel cell carcinoma is an infrequent and aggressive form of neuroendocrine skin cancer that mainly impacts individuals of White ethnicity, with a general occurrence rate of 0.7 instances per 100,000 person-years,” one of the study authors, Luis J. Borda, MD, chief dermatology resident at Eastern Virginia Medical School, Norfolk, Virginia, told this news organization. The incidence of MCC is increasing among all racial groups, especially in the Hispanic population, he added.

To determine how age, sex, and primary site of MCC differ in White vs non-White Hispanic patients, the researchers evaluated the 22 population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program from 2000 through 2020. They reported categorical variables as counts and percentages and used chi-square test with Yates’s correction to assess the association between categorical variables.

Of the 17,920 MCCs identified by the researchers, 40 (0.22%) were in non-White Hispanic patients. Compared with the White patients with MCC, significantly fewer non-White Hispanic patients were age 70 years or older (50% vs 72.1%, respectively; P < .001), and MCC was more common in female non-White Hispanic patients (23, or 57.5%), while White patients with MCC were predominantly male (11,309, or 63.2%; P < .05). “This suggests that MCC in non-White Hispanic patients may involve different risk factors related to age beyond just cumulative UV exposure and aging-related immunosenescence, which may additionally account for the higher prevalence of females in this cohort, as historically male outdoor occupation has resulted in increased lifetime cumulative UV exposure,” Dr. Borda said.

The head and neck were the most common sites of disease involvement in White patients (41.9% vs 27.5% in non-White Hispanic patients; P = .09), while the upper limb and shoulder were the most common sites of disease involvement in non-White Hispanic patients (37.5% vs 23.8% in White patients; P = .06). This finding “differs from previous studies showing head/neck being the most common site in Hispanics,” Dr. Borda said, adding that this could be a result of White patients not being included in the Hispanic cohort in this study. “Because non-White Hispanic patients have darker skin, they may have proportionally more cases on sun-protected skin, as is described by the present data, suggesting that they are less likely to have UV-driven MCC.”

The study “highlights distinct demographic and clinical characteristics of MCC among non-White Hispanic patients compared to their White counterparts, emphasizing the importance of considering race/ethnicity in understanding the epidemiology of this rare but increasingly prevalent cancer,” Dr. Borda said. He and his co-authors are planning to do further research on the increasing incidence of MCC in non-White Hispanic patients and on staging at diagnosis compared to White patients.

Dr. Borda acknowledged certain limitations of the analysis, including the small sample size in the non-White Hispanic group, the retrospective nature of SEER data, selection bias, and the potential for underreporting. He and his co-authors reported having no financial disclosures.

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

Compared with White patients with Merkel cell carcinoma (MCC), non-White Hispanic patients more commonly presented younger than 70 years of age and were more often female. In addition, the most affected site was the upper limb/shoulder, which differs from what has been reported in previous studies.

Those are key findings from a retrospective study of national cancer data that was presented during a poster session at the annual meeting of the Society for Investigative Dermatology.

“Merkel cell carcinoma is an infrequent and aggressive form of neuroendocrine skin cancer that mainly impacts individuals of White ethnicity, with a general occurrence rate of 0.7 instances per 100,000 person-years,” one of the study authors, Luis J. Borda, MD, chief dermatology resident at Eastern Virginia Medical School, Norfolk, Virginia, told this news organization. The incidence of MCC is increasing among all racial groups, especially in the Hispanic population, he added.

To determine how age, sex, and primary site of MCC differ in White vs non-White Hispanic patients, the researchers evaluated the 22 population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program from 2000 through 2020. They reported categorical variables as counts and percentages and used chi-square test with Yates’s correction to assess the association between categorical variables.

Of the 17,920 MCCs identified by the researchers, 40 (0.22%) were in non-White Hispanic patients. Compared with the White patients with MCC, significantly fewer non-White Hispanic patients were age 70 years or older (50% vs 72.1%, respectively; P < .001), and MCC was more common in female non-White Hispanic patients (23, or 57.5%), while White patients with MCC were predominantly male (11,309, or 63.2%; P < .05). “This suggests that MCC in non-White Hispanic patients may involve different risk factors related to age beyond just cumulative UV exposure and aging-related immunosenescence, which may additionally account for the higher prevalence of females in this cohort, as historically male outdoor occupation has resulted in increased lifetime cumulative UV exposure,” Dr. Borda said.

The head and neck were the most common sites of disease involvement in White patients (41.9% vs 27.5% in non-White Hispanic patients; P = .09), while the upper limb and shoulder were the most common sites of disease involvement in non-White Hispanic patients (37.5% vs 23.8% in White patients; P = .06). This finding “differs from previous studies showing head/neck being the most common site in Hispanics,” Dr. Borda said, adding that this could be a result of White patients not being included in the Hispanic cohort in this study. “Because non-White Hispanic patients have darker skin, they may have proportionally more cases on sun-protected skin, as is described by the present data, suggesting that they are less likely to have UV-driven MCC.”

The study “highlights distinct demographic and clinical characteristics of MCC among non-White Hispanic patients compared to their White counterparts, emphasizing the importance of considering race/ethnicity in understanding the epidemiology of this rare but increasingly prevalent cancer,” Dr. Borda said. He and his co-authors are planning to do further research on the increasing incidence of MCC in non-White Hispanic patients and on staging at diagnosis compared to White patients.

Dr. Borda acknowledged certain limitations of the analysis, including the small sample size in the non-White Hispanic group, the retrospective nature of SEER data, selection bias, and the potential for underreporting. He and his co-authors reported having no financial disclosures.

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

Compared with White patients with Merkel cell carcinoma (MCC), non-White Hispanic patients more commonly presented younger than 70 years of age and were more often female. In addition, the most affected site was the upper limb/shoulder, which differs from what has been reported in previous studies.

Those are key findings from a retrospective study of national cancer data that was presented during a poster session at the annual meeting of the Society for Investigative Dermatology.

“Merkel cell carcinoma is an infrequent and aggressive form of neuroendocrine skin cancer that mainly impacts individuals of White ethnicity, with a general occurrence rate of 0.7 instances per 100,000 person-years,” one of the study authors, Luis J. Borda, MD, chief dermatology resident at Eastern Virginia Medical School, Norfolk, Virginia, told this news organization. The incidence of MCC is increasing among all racial groups, especially in the Hispanic population, he added.

To determine how age, sex, and primary site of MCC differ in White vs non-White Hispanic patients, the researchers evaluated the 22 population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program from 2000 through 2020. They reported categorical variables as counts and percentages and used chi-square test with Yates’s correction to assess the association between categorical variables.

Of the 17,920 MCCs identified by the researchers, 40 (0.22%) were in non-White Hispanic patients. Compared with the White patients with MCC, significantly fewer non-White Hispanic patients were age 70 years or older (50% vs 72.1%, respectively; P < .001), and MCC was more common in female non-White Hispanic patients (23, or 57.5%), while White patients with MCC were predominantly male (11,309, or 63.2%; P < .05). “This suggests that MCC in non-White Hispanic patients may involve different risk factors related to age beyond just cumulative UV exposure and aging-related immunosenescence, which may additionally account for the higher prevalence of females in this cohort, as historically male outdoor occupation has resulted in increased lifetime cumulative UV exposure,” Dr. Borda said.

The head and neck were the most common sites of disease involvement in White patients (41.9% vs 27.5% in non-White Hispanic patients; P = .09), while the upper limb and shoulder were the most common sites of disease involvement in non-White Hispanic patients (37.5% vs 23.8% in White patients; P = .06). This finding “differs from previous studies showing head/neck being the most common site in Hispanics,” Dr. Borda said, adding that this could be a result of White patients not being included in the Hispanic cohort in this study. “Because non-White Hispanic patients have darker skin, they may have proportionally more cases on sun-protected skin, as is described by the present data, suggesting that they are less likely to have UV-driven MCC.”

The study “highlights distinct demographic and clinical characteristics of MCC among non-White Hispanic patients compared to their White counterparts, emphasizing the importance of considering race/ethnicity in understanding the epidemiology of this rare but increasingly prevalent cancer,” Dr. Borda said. He and his co-authors are planning to do further research on the increasing incidence of MCC in non-White Hispanic patients and on staging at diagnosis compared to White patients.

Dr. Borda acknowledged certain limitations of the analysis, including the small sample size in the non-White Hispanic group, the retrospective nature of SEER data, selection bias, and the potential for underreporting. He and his co-authors reported having no financial disclosures.

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

Stuart Malcolm, MD, a primary care physician who practices in Oregon and northern California, started seeing patients with long COVID early in the pandemic. Back then, he was frustrated by the obstacles and lack of standard diagnostic tests and treatments. Four years later, well, he still is.

“Something I learned the last few years is the logistics to get people care is really, really hard,” he said. “There’s a lot of frustration. It’s mostly frustration.”

For long COVID doctors and patients, there has been little to no progress addressing the challenges, leaving many discouraged. Researchers and clinicians now have a greater understanding of what health agencies formally call post-COVID condition, but the wide spectrum of symptoms, slow progress in launching pharmacologic clinical trials, and the research toward understanding the underlying causes mean standardized diagnostic tests and definitive treatments remain elusive.

“The frustration is that we aren’t able to help everyone with our current knowledge base. And I think the frustration lies not just with us physicians but also with patients because they’re at the point where if they tried everything, literally everything and haven’t gotten better,” said Zijian Chen, MD, director of the Mount Sinai Center for Post-COVID Care in New York City.
 

Wanted: More Funding, More Doctors, More Clinics

Between 10% and 20% of the estimated hundreds of millions of people infected worldwide with SARS-CoV-2 in the first 2 years went on to develop long-term symptoms. While many recover over time, doctors who have treated long COVID since 2020 said they see some patients still wrestling with the condition after 4 years.

The latest Centers for Disease Control and Prevention Household Pulse Survey, taken between March 5 and April 1, 2024, estimated that nearly 7% of the adult population — more than 18 million people — currently have long COVID. Data from other countries also suggest that millions have been living with long COVID for years now, and hundreds of thousands have seen their day-to-day activities significantly affected.

There is an urgent need for more funding, long COVID clinicians, multidisciplinary clinics, and education for non–long COVID physicians and specialists, doctors said. Instead, funding remains limited, clinics are closing, wait times are “horrendously long,” patients are left in limbo, and physicians are burning out.

“What’s changed in some ways is that there’s even less access to COVID rehab, which sounds crazy because there was very little to begin with,” said Alexandra Rendely, MD, a physical medicine and rehabilitation physician with the interdisciplinary Toronto Rehab, a part of the University Health Network of teaching hospitals in Toronto, Ontario, Canada.

“Patients are still being diagnosed every day, yet the resources available are becoming less and less.”

COVID-19 money earmarked during the pandemic was mostly limited to temporary emergency measures. As those funds dwindled, governments and institutions have decreased financial support. The Long COVID Moonshot campaign, organized by patients with long COVID, is pushing Congress to support $1 billion in annual research funding to close the financial chasm.
 

The Clinical Trial Conundrum

While long COVID clinics have come a long way in helping patients, gaps remain. Doctors may be unwilling to prescribe off-label treatments without proper clinical trials due to the potential risks and liabilities involved or due to the controversial or unconventional nature of the therapies, said Dr. Malcolm, who left his primary care practice more than 2 years ago to focus on long COVID.

In the absence of standard treatments, Dr. Malcolm and other doctors said they must take a trial-and-error approach in treating patients with long COVID that centers on addressing symptoms and not the underlying condition.

“There are actually a lot of treatments and a lot of them are not curative, but they can help people,” he said.

Dr. Malcolm, who is a medical director at Real Time Health Monitoring, a private clinic in the San Francisco Bay Area that specializes in long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), said it was important for him to be with a clinical team that understood and was supportive of his treatment decisions and was able to offer clinical support for those treatments if needed.

For physicians looking for clinical data before prescribing certain medications, the wait may be long. More than $1.5 billion in US federal funding has been earmarked to study long COVID, but the National Institutes of Health (NIH) has faced criticism from patients and scientists alike for its slow progress and emphasis on observational studies instead of research that could unravel the biological roots of long COVID. Among the clinical trials announced by the NIH’s RECOVER initiative, only a handful involve studying pharmaceutical treatments.

A 2023 editorial published in The Lancet called out the “dismal state of clinical research relative to the substantial burden of [long COVID]” and said, “we are clearly lacking tested pharmacological interventions that treat the underlying pathophysiology.” At the time of publication, it noted that of the 386 long COVID trials listed on ClinicalTrials.gov, only 12 were actually testing pharmacologic interventions.

There are also diagnostic and insurance barriers. The specialized tests that can detect long COVID anomalies are neither commonly known by primary care practitioners nor easily requested at the local lab, can be expensive, and are typically not covered by insurance, Dr. Malcolm explained.

Patients with long COVID also have the added barrier of being unable to advocate as easily because of their energy limitations, doctors said. Patients may appear outwardly fine, but fatigue and brain fog are among the many problems that cannot be measured in appearances. The condition has upended lives, some losing jobs, even homes, and the mental toll is why there is a “not insignificant” suicide rate.
 

One Patient’s 4-Year Journey

Charlie McCone, 34, used to be a tennis player and an active musician. But he’s spent the past 4 years mostly housebound, grappling with the aftermath of a SARS-CoV-2 infection he contracted in March 2020. He went from biking daily to work 10 miles and back to having at most 2 hours of energy per day.

In the first year alone, Mr. McCone saw more than two dozen doctors and specialists. The conditions now associated with long COVID, like ME/CFS, mast cell activation syndrome (a condition in which a patient experiences episodes of allergic symptoms such as hives, swelling, low blood pressure, and difficulty breathing), or dysautonomia (conditions that affect the autonomic nervous system, which controls automatic processes in the body) were not on physicians’ radars.

Then in 2021, he became bedbound for more than half a year after a Delta variant reinfection. He developed neurologic symptoms, including incapacitating fatigue, post-exertional malaise (where symptoms worsened after minimal physical or mental activity), left-sided weakness, and cognitive impairment. He stopped working altogether. But the worst was the shortness of breath he felt 24/7, even at rest. A battery of lab tests revealed nothing abnormal. He tried numerous drugs and the classic respiratory treatments.

Mr. McCone eventually connected with Dr. Malcolm over X and developed what he describes as an effective patient-doctor collaboration. When studies came out suggesting microclots were a common issue with patients with long COVID and positive outcomes were reported from anticoagulant therapy, they knew it could be one of the answers.

“After 3 weeks on [the antiplatelet drug], I was like, oh my god, my lungs are finally opening up,” said Mr. McCone. He has taken the medication for more than a year and a half, and some days he doesn’t even think about his respiratory symptoms.

“That trial-and-error process is just really long and hard and costly,” said Dr. Malcolm.

Today, fatigue and cognitive stamina are Mr. McCone’s main challenges, and he is far from recovered.

“[I had a] very fulfilling, happy life and now, it’s hard to think about. I’ve come a long way with my mental health and all this, but I’ve lost 4 years,” Mr. McCone said. “The prospect of me being here when I’m 40 seems very real ... so it’s pretty devastating.”
 

Lessons Learned, Hope Amid Ongoing Research

Despite the daunting obstacle, doctors said the science has come a long way for a new disease. We now know long COVID is likely caused by a combination of triggers, including viral reservoir in the tissue, inflammation, autoimmunity, and microclots; severity of infection is not necessarily an accurate risk factor predictor — long COVID can strike even those who had a mild infection; upward of 200 symptoms have been identified; and we know more about potential biomarkers that could lead to better diagnostic tools.

Unlike many other diseases and conditions with standard treatment protocols, long COVID treatments are typically aimed at addressing individual symptoms.

“It is very detailed and individualized to the patient’s specific symptoms and to the patient’s specific needs,” Dr. Rendely said. Symptoms can also fluctuate, relapse, or wax and wane, for example, so what ails a patient at their first doctor’s appointment could be completely different at the next appointment 2 months later.

Doctors are still hopeful the RECOVER research, which includes trials that look at autonomic and cognitive dysfunctions, will pave the way for more effective long COVID therapies. In Canada, Dr. Rendely is also eying the RECLAIM trial that is currently testing the effectiveness of pentoxifylline, which helps blood flow, and ibudilast, an anti-inflammatory drug.

Doctors are also hopeful when they see patients who have made “tremendous gains” or even full recoveries through their clinics. “It’s a new diagnosis, so I always tell my patients to think of this as a journey because I’m learning along with you,” said Jai Marathe, MD, an infectious disease physician at Boston Medical Center and an assistant professor of infectious diseases at Boston University Chobanian & Avedisian School of Medicine.

“Now we have 4 years of experience, but at the same time, no two long COVID patients are alike.”

Long COVID has also changed the way physicians view healthcare and how they practice medicine.

“I am a completely different person than I used to be because of this illness, and I don’t even have it. That is how profoundly it has affected how I view the universe,” said Dr. Malcolm. “I’ve been doing this for 4 years, and I’m very hopeful. But I don’t think about this in terms of months anymore. I think about this in terms of years.”

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

Stuart Malcolm, MD, a primary care physician who practices in Oregon and northern California, started seeing patients with long COVID early in the pandemic. Back then, he was frustrated by the obstacles and lack of standard diagnostic tests and treatments. Four years later, well, he still is.

“Something I learned the last few years is the logistics to get people care is really, really hard,” he said. “There’s a lot of frustration. It’s mostly frustration.”

For long COVID doctors and patients, there has been little to no progress addressing the challenges, leaving many discouraged. Researchers and clinicians now have a greater understanding of what health agencies formally call post-COVID condition, but the wide spectrum of symptoms, slow progress in launching pharmacologic clinical trials, and the research toward understanding the underlying causes mean standardized diagnostic tests and definitive treatments remain elusive.

“The frustration is that we aren’t able to help everyone with our current knowledge base. And I think the frustration lies not just with us physicians but also with patients because they’re at the point where if they tried everything, literally everything and haven’t gotten better,” said Zijian Chen, MD, director of the Mount Sinai Center for Post-COVID Care in New York City.
 

Wanted: More Funding, More Doctors, More Clinics

Between 10% and 20% of the estimated hundreds of millions of people infected worldwide with SARS-CoV-2 in the first 2 years went on to develop long-term symptoms. While many recover over time, doctors who have treated long COVID since 2020 said they see some patients still wrestling with the condition after 4 years.

The latest Centers for Disease Control and Prevention Household Pulse Survey, taken between March 5 and April 1, 2024, estimated that nearly 7% of the adult population — more than 18 million people — currently have long COVID. Data from other countries also suggest that millions have been living with long COVID for years now, and hundreds of thousands have seen their day-to-day activities significantly affected.

There is an urgent need for more funding, long COVID clinicians, multidisciplinary clinics, and education for non–long COVID physicians and specialists, doctors said. Instead, funding remains limited, clinics are closing, wait times are “horrendously long,” patients are left in limbo, and physicians are burning out.

“What’s changed in some ways is that there’s even less access to COVID rehab, which sounds crazy because there was very little to begin with,” said Alexandra Rendely, MD, a physical medicine and rehabilitation physician with the interdisciplinary Toronto Rehab, a part of the University Health Network of teaching hospitals in Toronto, Ontario, Canada.

“Patients are still being diagnosed every day, yet the resources available are becoming less and less.”

COVID-19 money earmarked during the pandemic was mostly limited to temporary emergency measures. As those funds dwindled, governments and institutions have decreased financial support. The Long COVID Moonshot campaign, organized by patients with long COVID, is pushing Congress to support $1 billion in annual research funding to close the financial chasm.
 

The Clinical Trial Conundrum

While long COVID clinics have come a long way in helping patients, gaps remain. Doctors may be unwilling to prescribe off-label treatments without proper clinical trials due to the potential risks and liabilities involved or due to the controversial or unconventional nature of the therapies, said Dr. Malcolm, who left his primary care practice more than 2 years ago to focus on long COVID.

In the absence of standard treatments, Dr. Malcolm and other doctors said they must take a trial-and-error approach in treating patients with long COVID that centers on addressing symptoms and not the underlying condition.

“There are actually a lot of treatments and a lot of them are not curative, but they can help people,” he said.

Dr. Malcolm, who is a medical director at Real Time Health Monitoring, a private clinic in the San Francisco Bay Area that specializes in long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), said it was important for him to be with a clinical team that understood and was supportive of his treatment decisions and was able to offer clinical support for those treatments if needed.

For physicians looking for clinical data before prescribing certain medications, the wait may be long. More than $1.5 billion in US federal funding has been earmarked to study long COVID, but the National Institutes of Health (NIH) has faced criticism from patients and scientists alike for its slow progress and emphasis on observational studies instead of research that could unravel the biological roots of long COVID. Among the clinical trials announced by the NIH’s RECOVER initiative, only a handful involve studying pharmaceutical treatments.

A 2023 editorial published in The Lancet called out the “dismal state of clinical research relative to the substantial burden of [long COVID]” and said, “we are clearly lacking tested pharmacological interventions that treat the underlying pathophysiology.” At the time of publication, it noted that of the 386 long COVID trials listed on ClinicalTrials.gov, only 12 were actually testing pharmacologic interventions.

There are also diagnostic and insurance barriers. The specialized tests that can detect long COVID anomalies are neither commonly known by primary care practitioners nor easily requested at the local lab, can be expensive, and are typically not covered by insurance, Dr. Malcolm explained.

Patients with long COVID also have the added barrier of being unable to advocate as easily because of their energy limitations, doctors said. Patients may appear outwardly fine, but fatigue and brain fog are among the many problems that cannot be measured in appearances. The condition has upended lives, some losing jobs, even homes, and the mental toll is why there is a “not insignificant” suicide rate.
 

One Patient’s 4-Year Journey

Charlie McCone, 34, used to be a tennis player and an active musician. But he’s spent the past 4 years mostly housebound, grappling with the aftermath of a SARS-CoV-2 infection he contracted in March 2020. He went from biking daily to work 10 miles and back to having at most 2 hours of energy per day.

In the first year alone, Mr. McCone saw more than two dozen doctors and specialists. The conditions now associated with long COVID, like ME/CFS, mast cell activation syndrome (a condition in which a patient experiences episodes of allergic symptoms such as hives, swelling, low blood pressure, and difficulty breathing), or dysautonomia (conditions that affect the autonomic nervous system, which controls automatic processes in the body) were not on physicians’ radars.

Then in 2021, he became bedbound for more than half a year after a Delta variant reinfection. He developed neurologic symptoms, including incapacitating fatigue, post-exertional malaise (where symptoms worsened after minimal physical or mental activity), left-sided weakness, and cognitive impairment. He stopped working altogether. But the worst was the shortness of breath he felt 24/7, even at rest. A battery of lab tests revealed nothing abnormal. He tried numerous drugs and the classic respiratory treatments.

Mr. McCone eventually connected with Dr. Malcolm over X and developed what he describes as an effective patient-doctor collaboration. When studies came out suggesting microclots were a common issue with patients with long COVID and positive outcomes were reported from anticoagulant therapy, they knew it could be one of the answers.

“After 3 weeks on [the antiplatelet drug], I was like, oh my god, my lungs are finally opening up,” said Mr. McCone. He has taken the medication for more than a year and a half, and some days he doesn’t even think about his respiratory symptoms.

“That trial-and-error process is just really long and hard and costly,” said Dr. Malcolm.

Today, fatigue and cognitive stamina are Mr. McCone’s main challenges, and he is far from recovered.

“[I had a] very fulfilling, happy life and now, it’s hard to think about. I’ve come a long way with my mental health and all this, but I’ve lost 4 years,” Mr. McCone said. “The prospect of me being here when I’m 40 seems very real ... so it’s pretty devastating.”
 

Lessons Learned, Hope Amid Ongoing Research

Despite the daunting obstacle, doctors said the science has come a long way for a new disease. We now know long COVID is likely caused by a combination of triggers, including viral reservoir in the tissue, inflammation, autoimmunity, and microclots; severity of infection is not necessarily an accurate risk factor predictor — long COVID can strike even those who had a mild infection; upward of 200 symptoms have been identified; and we know more about potential biomarkers that could lead to better diagnostic tools.

Unlike many other diseases and conditions with standard treatment protocols, long COVID treatments are typically aimed at addressing individual symptoms.

“It is very detailed and individualized to the patient’s specific symptoms and to the patient’s specific needs,” Dr. Rendely said. Symptoms can also fluctuate, relapse, or wax and wane, for example, so what ails a patient at their first doctor’s appointment could be completely different at the next appointment 2 months later.

Doctors are still hopeful the RECOVER research, which includes trials that look at autonomic and cognitive dysfunctions, will pave the way for more effective long COVID therapies. In Canada, Dr. Rendely is also eying the RECLAIM trial that is currently testing the effectiveness of pentoxifylline, which helps blood flow, and ibudilast, an anti-inflammatory drug.

Doctors are also hopeful when they see patients who have made “tremendous gains” or even full recoveries through their clinics. “It’s a new diagnosis, so I always tell my patients to think of this as a journey because I’m learning along with you,” said Jai Marathe, MD, an infectious disease physician at Boston Medical Center and an assistant professor of infectious diseases at Boston University Chobanian & Avedisian School of Medicine.

“Now we have 4 years of experience, but at the same time, no two long COVID patients are alike.”

Long COVID has also changed the way physicians view healthcare and how they practice medicine.

“I am a completely different person than I used to be because of this illness, and I don’t even have it. That is how profoundly it has affected how I view the universe,” said Dr. Malcolm. “I’ve been doing this for 4 years, and I’m very hopeful. But I don’t think about this in terms of months anymore. I think about this in terms of years.”

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

Stuart Malcolm, MD, a primary care physician who practices in Oregon and northern California, started seeing patients with long COVID early in the pandemic. Back then, he was frustrated by the obstacles and lack of standard diagnostic tests and treatments. Four years later, well, he still is.

“Something I learned the last few years is the logistics to get people care is really, really hard,” he said. “There’s a lot of frustration. It’s mostly frustration.”

For long COVID doctors and patients, there has been little to no progress addressing the challenges, leaving many discouraged. Researchers and clinicians now have a greater understanding of what health agencies formally call post-COVID condition, but the wide spectrum of symptoms, slow progress in launching pharmacologic clinical trials, and the research toward understanding the underlying causes mean standardized diagnostic tests and definitive treatments remain elusive.

“The frustration is that we aren’t able to help everyone with our current knowledge base. And I think the frustration lies not just with us physicians but also with patients because they’re at the point where if they tried everything, literally everything and haven’t gotten better,” said Zijian Chen, MD, director of the Mount Sinai Center for Post-COVID Care in New York City.
 

Wanted: More Funding, More Doctors, More Clinics

Between 10% and 20% of the estimated hundreds of millions of people infected worldwide with SARS-CoV-2 in the first 2 years went on to develop long-term symptoms. While many recover over time, doctors who have treated long COVID since 2020 said they see some patients still wrestling with the condition after 4 years.

The latest Centers for Disease Control and Prevention Household Pulse Survey, taken between March 5 and April 1, 2024, estimated that nearly 7% of the adult population — more than 18 million people — currently have long COVID. Data from other countries also suggest that millions have been living with long COVID for years now, and hundreds of thousands have seen their day-to-day activities significantly affected.

There is an urgent need for more funding, long COVID clinicians, multidisciplinary clinics, and education for non–long COVID physicians and specialists, doctors said. Instead, funding remains limited, clinics are closing, wait times are “horrendously long,” patients are left in limbo, and physicians are burning out.

“What’s changed in some ways is that there’s even less access to COVID rehab, which sounds crazy because there was very little to begin with,” said Alexandra Rendely, MD, a physical medicine and rehabilitation physician with the interdisciplinary Toronto Rehab, a part of the University Health Network of teaching hospitals in Toronto, Ontario, Canada.

“Patients are still being diagnosed every day, yet the resources available are becoming less and less.”

COVID-19 money earmarked during the pandemic was mostly limited to temporary emergency measures. As those funds dwindled, governments and institutions have decreased financial support. The Long COVID Moonshot campaign, organized by patients with long COVID, is pushing Congress to support $1 billion in annual research funding to close the financial chasm.
 

The Clinical Trial Conundrum

While long COVID clinics have come a long way in helping patients, gaps remain. Doctors may be unwilling to prescribe off-label treatments without proper clinical trials due to the potential risks and liabilities involved or due to the controversial or unconventional nature of the therapies, said Dr. Malcolm, who left his primary care practice more than 2 years ago to focus on long COVID.

In the absence of standard treatments, Dr. Malcolm and other doctors said they must take a trial-and-error approach in treating patients with long COVID that centers on addressing symptoms and not the underlying condition.

“There are actually a lot of treatments and a lot of them are not curative, but they can help people,” he said.

Dr. Malcolm, who is a medical director at Real Time Health Monitoring, a private clinic in the San Francisco Bay Area that specializes in long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), said it was important for him to be with a clinical team that understood and was supportive of his treatment decisions and was able to offer clinical support for those treatments if needed.

For physicians looking for clinical data before prescribing certain medications, the wait may be long. More than $1.5 billion in US federal funding has been earmarked to study long COVID, but the National Institutes of Health (NIH) has faced criticism from patients and scientists alike for its slow progress and emphasis on observational studies instead of research that could unravel the biological roots of long COVID. Among the clinical trials announced by the NIH’s RECOVER initiative, only a handful involve studying pharmaceutical treatments.

A 2023 editorial published in The Lancet called out the “dismal state of clinical research relative to the substantial burden of [long COVID]” and said, “we are clearly lacking tested pharmacological interventions that treat the underlying pathophysiology.” At the time of publication, it noted that of the 386 long COVID trials listed on ClinicalTrials.gov, only 12 were actually testing pharmacologic interventions.

There are also diagnostic and insurance barriers. The specialized tests that can detect long COVID anomalies are neither commonly known by primary care practitioners nor easily requested at the local lab, can be expensive, and are typically not covered by insurance, Dr. Malcolm explained.

Patients with long COVID also have the added barrier of being unable to advocate as easily because of their energy limitations, doctors said. Patients may appear outwardly fine, but fatigue and brain fog are among the many problems that cannot be measured in appearances. The condition has upended lives, some losing jobs, even homes, and the mental toll is why there is a “not insignificant” suicide rate.
 

One Patient’s 4-Year Journey

Charlie McCone, 34, used to be a tennis player and an active musician. But he’s spent the past 4 years mostly housebound, grappling with the aftermath of a SARS-CoV-2 infection he contracted in March 2020. He went from biking daily to work 10 miles and back to having at most 2 hours of energy per day.

In the first year alone, Mr. McCone saw more than two dozen doctors and specialists. The conditions now associated with long COVID, like ME/CFS, mast cell activation syndrome (a condition in which a patient experiences episodes of allergic symptoms such as hives, swelling, low blood pressure, and difficulty breathing), or dysautonomia (conditions that affect the autonomic nervous system, which controls automatic processes in the body) were not on physicians’ radars.

Then in 2021, he became bedbound for more than half a year after a Delta variant reinfection. He developed neurologic symptoms, including incapacitating fatigue, post-exertional malaise (where symptoms worsened after minimal physical or mental activity), left-sided weakness, and cognitive impairment. He stopped working altogether. But the worst was the shortness of breath he felt 24/7, even at rest. A battery of lab tests revealed nothing abnormal. He tried numerous drugs and the classic respiratory treatments.

Mr. McCone eventually connected with Dr. Malcolm over X and developed what he describes as an effective patient-doctor collaboration. When studies came out suggesting microclots were a common issue with patients with long COVID and positive outcomes were reported from anticoagulant therapy, they knew it could be one of the answers.

“After 3 weeks on [the antiplatelet drug], I was like, oh my god, my lungs are finally opening up,” said Mr. McCone. He has taken the medication for more than a year and a half, and some days he doesn’t even think about his respiratory symptoms.

“That trial-and-error process is just really long and hard and costly,” said Dr. Malcolm.

Today, fatigue and cognitive stamina are Mr. McCone’s main challenges, and he is far from recovered.

“[I had a] very fulfilling, happy life and now, it’s hard to think about. I’ve come a long way with my mental health and all this, but I’ve lost 4 years,” Mr. McCone said. “The prospect of me being here when I’m 40 seems very real ... so it’s pretty devastating.”
 

Lessons Learned, Hope Amid Ongoing Research

Despite the daunting obstacle, doctors said the science has come a long way for a new disease. We now know long COVID is likely caused by a combination of triggers, including viral reservoir in the tissue, inflammation, autoimmunity, and microclots; severity of infection is not necessarily an accurate risk factor predictor — long COVID can strike even those who had a mild infection; upward of 200 symptoms have been identified; and we know more about potential biomarkers that could lead to better diagnostic tools.

Unlike many other diseases and conditions with standard treatment protocols, long COVID treatments are typically aimed at addressing individual symptoms.

“It is very detailed and individualized to the patient’s specific symptoms and to the patient’s specific needs,” Dr. Rendely said. Symptoms can also fluctuate, relapse, or wax and wane, for example, so what ails a patient at their first doctor’s appointment could be completely different at the next appointment 2 months later.

Doctors are still hopeful the RECOVER research, which includes trials that look at autonomic and cognitive dysfunctions, will pave the way for more effective long COVID therapies. In Canada, Dr. Rendely is also eying the RECLAIM trial that is currently testing the effectiveness of pentoxifylline, which helps blood flow, and ibudilast, an anti-inflammatory drug.

Doctors are also hopeful when they see patients who have made “tremendous gains” or even full recoveries through their clinics. “It’s a new diagnosis, so I always tell my patients to think of this as a journey because I’m learning along with you,” said Jai Marathe, MD, an infectious disease physician at Boston Medical Center and an assistant professor of infectious diseases at Boston University Chobanian & Avedisian School of Medicine.

“Now we have 4 years of experience, but at the same time, no two long COVID patients are alike.”

Long COVID has also changed the way physicians view healthcare and how they practice medicine.

“I am a completely different person than I used to be because of this illness, and I don’t even have it. That is how profoundly it has affected how I view the universe,” said Dr. Malcolm. “I’ve been doing this for 4 years, and I’m very hopeful. But I don’t think about this in terms of months anymore. I think about this in terms of years.”

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

TOPLINE:

Isotretinoin was effective in treating acne in individuals undergoing masculinizing gender-affirming hormone therapy in a case series, but more information is needed on dosing and barriers to treatment.

METHODOLOGY:

• Acne can be a side effect of masculinizing hormone therapy for transmasculine individuals. While isotretinoin is an effective treatment option for acne, its effectiveness and safety in transgender and gender-diverse individuals are not well understood.
• This retrospective case series included 55 patients (mean age, 25.4 years) undergoing masculinizing hormone therapy at four medical centers, who were prescribed isotretinoin for acne associated with treatment.
• Isotretinoin treatment was started a median of 22.1 months after hormone therapy was initiated and continued for a median of 6 months with a median cumulative dose of 132.7 mg/kg.
• Researchers assessed acne improvement, clearance, recurrence, adverse effects, and reasons for treatment discontinuation.

TAKEAWAY:

• Overall, 48 patients (87.3%) experienced improvement, and 26 (47.3%) achieved clearance during treatment. A higher proportion of patients experienced improvement (97% vs 72.7%) and achieved clearance (63.6% vs 22.7%) with cumulative doses of ≥ 120 mg/kg than those who received cumulative doses < 120 mg/kg.
• The risk for recurrence was 20% (in four patients) among 20 patients who achieved clearance and had any subsequent health care encounters, with a mean follow-up time of 734.3 days.
• Common adverse effects included dryness (80%), joint pain (14.5%), and headaches (10.9%). Other adverse effects included nose bleeds (9.1%) and depression (5.5%).
• Of the 22 patients with a cumulative dose < 120 mg/kg, 14 (63.6%) were lost to follow-up; among those not lost to follow-up, 2 patients discontinued treatment because of transfer of care, 1 because of adverse effects, and 1 because of gender-affirming surgery, with concerns about wound healing.

IN PRACTICE:

“Although isotretinoin appears to be an effective treatment option for acne among individuals undergoing masculinizing hormone therapy, further efforts are needed to understand optimal dosing and treatment barriers to improve outcomes in transgender and gender-diverse individuals receiving testosterone,” the authors concluded.

SOURCE:

The study, led by James Choe, BS, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, was published online in JAMA Dermatology.

LIMITATIONS:

The study population was limited to four centers, and variability in clinician- and patient-reported acne outcomes and missing information could affect the reliability of data. Because of the small sample size, the association of masculinizing hormone therapy regimens with outcomes could not be evaluated.

DISCLOSURES:

One author is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Three authors reported receiving grants or personal fees from various sources. The other authors declared no conflicts of interest.

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

TOPLINE:

Isotretinoin was effective in treating acne in individuals undergoing masculinizing gender-affirming hormone therapy in a case series, but more information is needed on dosing and barriers to treatment.

METHODOLOGY:

• Acne can be a side effect of masculinizing hormone therapy for transmasculine individuals. While isotretinoin is an effective treatment option for acne, its effectiveness and safety in transgender and gender-diverse individuals are not well understood.
• This retrospective case series included 55 patients (mean age, 25.4 years) undergoing masculinizing hormone therapy at four medical centers, who were prescribed isotretinoin for acne associated with treatment.
• Isotretinoin treatment was started a median of 22.1 months after hormone therapy was initiated and continued for a median of 6 months with a median cumulative dose of 132.7 mg/kg.
• Researchers assessed acne improvement, clearance, recurrence, adverse effects, and reasons for treatment discontinuation.

TAKEAWAY:

• Overall, 48 patients (87.3%) experienced improvement, and 26 (47.3%) achieved clearance during treatment. A higher proportion of patients experienced improvement (97% vs 72.7%) and achieved clearance (63.6% vs 22.7%) with cumulative doses of ≥ 120 mg/kg than those who received cumulative doses < 120 mg/kg.
• The risk for recurrence was 20% (in four patients) among 20 patients who achieved clearance and had any subsequent health care encounters, with a mean follow-up time of 734.3 days.
• Common adverse effects included dryness (80%), joint pain (14.5%), and headaches (10.9%). Other adverse effects included nose bleeds (9.1%) and depression (5.5%).
• Of the 22 patients with a cumulative dose < 120 mg/kg, 14 (63.6%) were lost to follow-up; among those not lost to follow-up, 2 patients discontinued treatment because of transfer of care, 1 because of adverse effects, and 1 because of gender-affirming surgery, with concerns about wound healing.

IN PRACTICE:

“Although isotretinoin appears to be an effective treatment option for acne among individuals undergoing masculinizing hormone therapy, further efforts are needed to understand optimal dosing and treatment barriers to improve outcomes in transgender and gender-diverse individuals receiving testosterone,” the authors concluded.

SOURCE:

The study, led by James Choe, BS, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, was published online in JAMA Dermatology.

LIMITATIONS:

The study population was limited to four centers, and variability in clinician- and patient-reported acne outcomes and missing information could affect the reliability of data. Because of the small sample size, the association of masculinizing hormone therapy regimens with outcomes could not be evaluated.

DISCLOSURES:

One author is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Three authors reported receiving grants or personal fees from various sources. The other authors declared no conflicts of interest.

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

TOPLINE:

Isotretinoin was effective in treating acne in individuals undergoing masculinizing gender-affirming hormone therapy in a case series, but more information is needed on dosing and barriers to treatment.

METHODOLOGY:

• Acne can be a side effect of masculinizing hormone therapy for transmasculine individuals. While isotretinoin is an effective treatment option for acne, its effectiveness and safety in transgender and gender-diverse individuals are not well understood.
• This retrospective case series included 55 patients (mean age, 25.4 years) undergoing masculinizing hormone therapy at four medical centers, who were prescribed isotretinoin for acne associated with treatment.
• Isotretinoin treatment was started a median of 22.1 months after hormone therapy was initiated and continued for a median of 6 months with a median cumulative dose of 132.7 mg/kg.
• Researchers assessed acne improvement, clearance, recurrence, adverse effects, and reasons for treatment discontinuation.

TAKEAWAY:

• Overall, 48 patients (87.3%) experienced improvement, and 26 (47.3%) achieved clearance during treatment. A higher proportion of patients experienced improvement (97% vs 72.7%) and achieved clearance (63.6% vs 22.7%) with cumulative doses of ≥ 120 mg/kg than those who received cumulative doses < 120 mg/kg.
• The risk for recurrence was 20% (in four patients) among 20 patients who achieved clearance and had any subsequent health care encounters, with a mean follow-up time of 734.3 days.
• Common adverse effects included dryness (80%), joint pain (14.5%), and headaches (10.9%). Other adverse effects included nose bleeds (9.1%) and depression (5.5%).
• Of the 22 patients with a cumulative dose < 120 mg/kg, 14 (63.6%) were lost to follow-up; among those not lost to follow-up, 2 patients discontinued treatment because of transfer of care, 1 because of adverse effects, and 1 because of gender-affirming surgery, with concerns about wound healing.

IN PRACTICE:

“Although isotretinoin appears to be an effective treatment option for acne among individuals undergoing masculinizing hormone therapy, further efforts are needed to understand optimal dosing and treatment barriers to improve outcomes in transgender and gender-diverse individuals receiving testosterone,” the authors concluded.

SOURCE:

The study, led by James Choe, BS, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, was published online in JAMA Dermatology.

LIMITATIONS:

The study population was limited to four centers, and variability in clinician- and patient-reported acne outcomes and missing information could affect the reliability of data. Because of the small sample size, the association of masculinizing hormone therapy regimens with outcomes could not be evaluated.

DISCLOSURES:

One author is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Three authors reported receiving grants or personal fees from various sources. The other authors declared no conflicts of interest.

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

TOPLINE:

Bimekizumab, currently approved for treating psoriasis, was well tolerated and reduced abscesses and the number of inflammatory nodules in patients with moderate to severe hidradenitis suppurativa (HS), in two phase 3 studies.

METHODOLOGY:

• To assess the efficacy and safety of bimekizumab, an interleukin (IL)-17A and IL-17F antagonist, 320 mg for HS, researchers conducted two 48-week phase 3 trials BE HEARD I (n = 505) and II (n = 509), which enrolled patients with moderate to severe HS and a history of inadequate response to systemic antibiotics.
• Patients were randomly assigned to one of four groups: Bimekizumab every 2 weeks, bimekizumab every 2 weeks for 16 weeks followed by every 4 weeks of dosing, bimekizumab every 4 weeks, or placebo for 16 weeks followed by bimekizumab every 2 weeks.
• The primary outcome was an HS clinical response of at least 50% (HiSCR50) at week 16, defined as at least a 50% reduction in total abscess and inflammatory nodule count.

TAKEAWAY:

• A higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved an HiSCR50 response at week 16 in BE HEARD I (48% vs 29%; odds ratio [OR], 2.23; P = .006) and II (52% vs 32%; OR, 2.29; P = .0032) trials.
• Patients receiving bimekizumab every 4 weeks also achieved a higher HiSCR50 response at week 16 vs placebo in the BE HEARD II trial (54% vs 32%; OR, 2.42; P = .0038).
• At week 16, a higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved at least a 75% HiSCR (HiSCR75) in both trials, and a higher proportion of those receiving bimekizumab every 4 weeks achieved HiSCR75 in the BE HEARD II trial.
• At week 48, 45%-68% of patients achieved HiSCR50 in both trials.
• Patients who received bimekizumab vs placebo for the initial 16 weeks had greater improvements in patient-reported outcomes, and bimekizumab was well tolerated with a low number of serious or severe treatment-emergent adverse events.

IN PRACTICE:

“Bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses that were maintained up to 48 weeks,” the authors wrote. “These data support the use of bimekizumab as a promising new therapeutic option for patients with moderate to severe hidradenitis suppurativa.”

SOURCE:

Alexa B. Kimball, MD, MPH, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, led this study, which was published online in The Lancet.

LIMITATIONS:

The placebo-controlled part of this trial was relatively short at 16 weeks and may affect the interpretation of later efficacy data, there was a lack of an active comparator group, and the efficacy of treatment was evaluated in the presence of rescue treatment with systemic antibiotics.

DISCLOSURES:

The studies were funded by bimekizumab manufacturer UCB Pharma. Seven authors disclosed being current or former employees of UCB Pharma. Other authors reported several ties with many companies, including UCB Pharma.

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

TOPLINE:

Bimekizumab, currently approved for treating psoriasis, was well tolerated and reduced abscesses and the number of inflammatory nodules in patients with moderate to severe hidradenitis suppurativa (HS), in two phase 3 studies.

METHODOLOGY:

• To assess the efficacy and safety of bimekizumab, an interleukin (IL)-17A and IL-17F antagonist, 320 mg for HS, researchers conducted two 48-week phase 3 trials BE HEARD I (n = 505) and II (n = 509), which enrolled patients with moderate to severe HS and a history of inadequate response to systemic antibiotics.
• Patients were randomly assigned to one of four groups: Bimekizumab every 2 weeks, bimekizumab every 2 weeks for 16 weeks followed by every 4 weeks of dosing, bimekizumab every 4 weeks, or placebo for 16 weeks followed by bimekizumab every 2 weeks.
• The primary outcome was an HS clinical response of at least 50% (HiSCR50) at week 16, defined as at least a 50% reduction in total abscess and inflammatory nodule count.

TAKEAWAY:

• A higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved an HiSCR50 response at week 16 in BE HEARD I (48% vs 29%; odds ratio [OR], 2.23; P = .006) and II (52% vs 32%; OR, 2.29; P = .0032) trials.
• Patients receiving bimekizumab every 4 weeks also achieved a higher HiSCR50 response at week 16 vs placebo in the BE HEARD II trial (54% vs 32%; OR, 2.42; P = .0038).
• At week 16, a higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved at least a 75% HiSCR (HiSCR75) in both trials, and a higher proportion of those receiving bimekizumab every 4 weeks achieved HiSCR75 in the BE HEARD II trial.
• At week 48, 45%-68% of patients achieved HiSCR50 in both trials.
• Patients who received bimekizumab vs placebo for the initial 16 weeks had greater improvements in patient-reported outcomes, and bimekizumab was well tolerated with a low number of serious or severe treatment-emergent adverse events.

IN PRACTICE:

“Bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses that were maintained up to 48 weeks,” the authors wrote. “These data support the use of bimekizumab as a promising new therapeutic option for patients with moderate to severe hidradenitis suppurativa.”

SOURCE:

Alexa B. Kimball, MD, MPH, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, led this study, which was published online in The Lancet.

LIMITATIONS:

The placebo-controlled part of this trial was relatively short at 16 weeks and may affect the interpretation of later efficacy data, there was a lack of an active comparator group, and the efficacy of treatment was evaluated in the presence of rescue treatment with systemic antibiotics.

DISCLOSURES:

The studies were funded by bimekizumab manufacturer UCB Pharma. Seven authors disclosed being current or former employees of UCB Pharma. Other authors reported several ties with many companies, including UCB Pharma.

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

TOPLINE:

Bimekizumab, currently approved for treating psoriasis, was well tolerated and reduced abscesses and the number of inflammatory nodules in patients with moderate to severe hidradenitis suppurativa (HS), in two phase 3 studies.

METHODOLOGY:

• To assess the efficacy and safety of bimekizumab, an interleukin (IL)-17A and IL-17F antagonist, 320 mg for HS, researchers conducted two 48-week phase 3 trials BE HEARD I (n = 505) and II (n = 509), which enrolled patients with moderate to severe HS and a history of inadequate response to systemic antibiotics.
• Patients were randomly assigned to one of four groups: Bimekizumab every 2 weeks, bimekizumab every 2 weeks for 16 weeks followed by every 4 weeks of dosing, bimekizumab every 4 weeks, or placebo for 16 weeks followed by bimekizumab every 2 weeks.
• The primary outcome was an HS clinical response of at least 50% (HiSCR50) at week 16, defined as at least a 50% reduction in total abscess and inflammatory nodule count.

TAKEAWAY:

• A higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved an HiSCR50 response at week 16 in BE HEARD I (48% vs 29%; odds ratio [OR], 2.23; P = .006) and II (52% vs 32%; OR, 2.29; P = .0032) trials.
• Patients receiving bimekizumab every 4 weeks also achieved a higher HiSCR50 response at week 16 vs placebo in the BE HEARD II trial (54% vs 32%; OR, 2.42; P = .0038).
• At week 16, a higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved at least a 75% HiSCR (HiSCR75) in both trials, and a higher proportion of those receiving bimekizumab every 4 weeks achieved HiSCR75 in the BE HEARD II trial.
• At week 48, 45%-68% of patients achieved HiSCR50 in both trials.
• Patients who received bimekizumab vs placebo for the initial 16 weeks had greater improvements in patient-reported outcomes, and bimekizumab was well tolerated with a low number of serious or severe treatment-emergent adverse events.

IN PRACTICE:

“Bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses that were maintained up to 48 weeks,” the authors wrote. “These data support the use of bimekizumab as a promising new therapeutic option for patients with moderate to severe hidradenitis suppurativa.”

SOURCE:

Alexa B. Kimball, MD, MPH, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, led this study, which was published online in The Lancet.

LIMITATIONS:

The placebo-controlled part of this trial was relatively short at 16 weeks and may affect the interpretation of later efficacy data, there was a lack of an active comparator group, and the efficacy of treatment was evaluated in the presence of rescue treatment with systemic antibiotics.

DISCLOSURES:

The studies were funded by bimekizumab manufacturer UCB Pharma. Seven authors disclosed being current or former employees of UCB Pharma. Other authors reported several ties with many companies, including UCB Pharma.

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

MILAN — Fecal microbiota transplantation (FMT), also known as intestinal microbiota transplantation, significantly reduced recurrence of hepatic encephalopathy, compared with placebo, in patients with cirrhosis on standard-of-care treatment, results of a phase 2 randomized controlled trial show. 

“Not only was FMT more beneficial, but also it didn’t matter which route of administration was used — oral or enema — which is good because people don’t really like enemas,” said Jasmohan S. Bajaj, MD, AGAF, professor, School of Medicine, Virginia Commonwealth University, Richmond, and hepatologist at Richmond VA Medical Center.

Resetting the Gut

The double-blind, randomized, placebo-controlled trial enrolled a total of 60 patients with cirrhosis who had experienced hepatic encephalopathy. Aged 61-65 years, participants had Model for End-Stage Liver Disease (MELD) scores of 12-13, all were taking lactulose and rifaximin, and all had experienced their last hepatic encephalopathy episode 8-13 months prior. 

Participants had similar baseline cognition, Sickness Impact Profile (SIP), and cirrhosis severity. Those with recent infections, taking other antibiotics, with a MELD score > 22, had received a transplant, or were immunosuppressed were excluded. 

Study participants were divided into four dose administration groups (n = 15 each): oral and enema active FMT therapy (group 1), oral active FMT and enema placebo (group 2), oral placebo and enema active FMT (group 3), and oral and enema placebo (group 4). 

The range of FMT dose frequency was zero (all placebo), or one, two, or three FMT administrations, each given 1 month apart. 

Two thirds of those receiving active FMT were given omnivore-donor FMT, and one third were given vegan-donor FMT, in addition to receiving standard of care. 

“Colony-forming units were standard and the same whether given via oral capsule or enema,” Dr. Bajaj said. This is “similar to what we used in our phase 1 study.”

Intent-to-treat (ITT) analysis was performed with 6-month data. The primary outcomes were safety and hepatic encephalopathy recurrence defined as ≥ grade 2 on West-Haven criteria. Secondary outcomes included other adverse events, changes in infections, severity of cirrhosis and cognition, and patient-reported outcomes. A statistical regression for hepatic encephalopathy recurrence was also performed. Patients were followed for 6 months or until death.
 

One Dose of FMT Better Than None

Hepatic encephalopathy recurrence was highest (40%) in group 4 patients, compared with those in group 1 (13%), group 2 (13%), and group 3 (0%), as were liver-related hospitalizations (47% vs 7%-20%). 

SIP total/physical and psych scores improved with FMT (P = .003).

When all patients were included in the analysis, the hepatic encephalopathy recurrence was related to dose number (odds radio [OR], 0.27; 95% CI, 0.10-0.79; P = .02), male sex (OR, 0.16; 95% CI, 0.03-0.89; P = .04), and physical SIP (OR, 1.05; 95% CI, 1.01-1.10, P = .05). However, when analyzing results from FMT recipients only, FMT dose, route of administration, and donor source were not found to affect recurrence. 

Of those on placebo alone, six patients (40%) had a recurrence, compared with four on FMT (8.8%) in the combined FMT groups. 

“As long as a patient received at least one FMT dose, they had a better response than a patient who had none,” Dr. Bajaj said.

Six patients dropped out; two in group 1 died after hepatic encephalopathy and falls, and one in group 2 died after a seizure. Three others did not return for follow-up visits. Four patients developed infections, including spontaneous bacterial peritonitis, cholecystitis, and cellulitis, all unrelated to FMT. 

“I think many patients in Western countries are underserved because apart from lactulose and rifaximin, there is little else to give them,” Dr. Bajaj said. “The assumption is because rifaximin kills everything, we shouldn’t give FMT. But here, we administered it to a harsh and hostile wasteland of microbiota, and it still got a toehold and generated a reduction in hepatic encephalopathy.”

He pointed out that in smaller prior studies, the effects lasted up to 1 year. 
 

Setting the Stage for Phase 3 Trials

Dr. Bajaj noted that this phase 2 study sets the stage for larger phase 3 trials in patients not responding to first-line therapy. 

“Given how well-tolerated and effective FMT appears to be in these patients, if the larger phase 3 trial shows similar results, I can imagine FMT becoming a standard therapy,” said Colleen R. Kelly, MD, AGAF, gastroenterologist at Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not involved in the study.

A version of this article appeared on Medscape.com.

MILAN — Fecal microbiota transplantation (FMT), also known as intestinal microbiota transplantation, significantly reduced recurrence of hepatic encephalopathy, compared with placebo, in patients with cirrhosis on standard-of-care treatment, results of a phase 2 randomized controlled trial show. 

“Not only was FMT more beneficial, but also it didn’t matter which route of administration was used — oral or enema — which is good because people don’t really like enemas,” said Jasmohan S. Bajaj, MD, AGAF, professor, School of Medicine, Virginia Commonwealth University, Richmond, and hepatologist at Richmond VA Medical Center.

Resetting the Gut

The double-blind, randomized, placebo-controlled trial enrolled a total of 60 patients with cirrhosis who had experienced hepatic encephalopathy. Aged 61-65 years, participants had Model for End-Stage Liver Disease (MELD) scores of 12-13, all were taking lactulose and rifaximin, and all had experienced their last hepatic encephalopathy episode 8-13 months prior. 

Participants had similar baseline cognition, Sickness Impact Profile (SIP), and cirrhosis severity. Those with recent infections, taking other antibiotics, with a MELD score > 22, had received a transplant, or were immunosuppressed were excluded. 

Study participants were divided into four dose administration groups (n = 15 each): oral and enema active FMT therapy (group 1), oral active FMT and enema placebo (group 2), oral placebo and enema active FMT (group 3), and oral and enema placebo (group 4). 

The range of FMT dose frequency was zero (all placebo), or one, two, or three FMT administrations, each given 1 month apart. 

Two thirds of those receiving active FMT were given omnivore-donor FMT, and one third were given vegan-donor FMT, in addition to receiving standard of care. 

“Colony-forming units were standard and the same whether given via oral capsule or enema,” Dr. Bajaj said. This is “similar to what we used in our phase 1 study.”

Intent-to-treat (ITT) analysis was performed with 6-month data. The primary outcomes were safety and hepatic encephalopathy recurrence defined as ≥ grade 2 on West-Haven criteria. Secondary outcomes included other adverse events, changes in infections, severity of cirrhosis and cognition, and patient-reported outcomes. A statistical regression for hepatic encephalopathy recurrence was also performed. Patients were followed for 6 months or until death.
 

One Dose of FMT Better Than None

Hepatic encephalopathy recurrence was highest (40%) in group 4 patients, compared with those in group 1 (13%), group 2 (13%), and group 3 (0%), as were liver-related hospitalizations (47% vs 7%-20%). 

SIP total/physical and psych scores improved with FMT (P = .003).

When all patients were included in the analysis, the hepatic encephalopathy recurrence was related to dose number (odds radio [OR], 0.27; 95% CI, 0.10-0.79; P = .02), male sex (OR, 0.16; 95% CI, 0.03-0.89; P = .04), and physical SIP (OR, 1.05; 95% CI, 1.01-1.10, P = .05). However, when analyzing results from FMT recipients only, FMT dose, route of administration, and donor source were not found to affect recurrence. 

Of those on placebo alone, six patients (40%) had a recurrence, compared with four on FMT (8.8%) in the combined FMT groups. 

“As long as a patient received at least one FMT dose, they had a better response than a patient who had none,” Dr. Bajaj said.

Six patients dropped out; two in group 1 died after hepatic encephalopathy and falls, and one in group 2 died after a seizure. Three others did not return for follow-up visits. Four patients developed infections, including spontaneous bacterial peritonitis, cholecystitis, and cellulitis, all unrelated to FMT. 

“I think many patients in Western countries are underserved because apart from lactulose and rifaximin, there is little else to give them,” Dr. Bajaj said. “The assumption is because rifaximin kills everything, we shouldn’t give FMT. But here, we administered it to a harsh and hostile wasteland of microbiota, and it still got a toehold and generated a reduction in hepatic encephalopathy.”

He pointed out that in smaller prior studies, the effects lasted up to 1 year. 
 

Setting the Stage for Phase 3 Trials

Dr. Bajaj noted that this phase 2 study sets the stage for larger phase 3 trials in patients not responding to first-line therapy. 

“Given how well-tolerated and effective FMT appears to be in these patients, if the larger phase 3 trial shows similar results, I can imagine FMT becoming a standard therapy,” said Colleen R. Kelly, MD, AGAF, gastroenterologist at Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not involved in the study.

A version of this article appeared on Medscape.com.

MILAN — Fecal microbiota transplantation (FMT), also known as intestinal microbiota transplantation, significantly reduced recurrence of hepatic encephalopathy, compared with placebo, in patients with cirrhosis on standard-of-care treatment, results of a phase 2 randomized controlled trial show. 

“Not only was FMT more beneficial, but also it didn’t matter which route of administration was used — oral or enema — which is good because people don’t really like enemas,” said Jasmohan S. Bajaj, MD, AGAF, professor, School of Medicine, Virginia Commonwealth University, Richmond, and hepatologist at Richmond VA Medical Center.

Resetting the Gut

The double-blind, randomized, placebo-controlled trial enrolled a total of 60 patients with cirrhosis who had experienced hepatic encephalopathy. Aged 61-65 years, participants had Model for End-Stage Liver Disease (MELD) scores of 12-13, all were taking lactulose and rifaximin, and all had experienced their last hepatic encephalopathy episode 8-13 months prior. 

Participants had similar baseline cognition, Sickness Impact Profile (SIP), and cirrhosis severity. Those with recent infections, taking other antibiotics, with a MELD score > 22, had received a transplant, or were immunosuppressed were excluded. 

Study participants were divided into four dose administration groups (n = 15 each): oral and enema active FMT therapy (group 1), oral active FMT and enema placebo (group 2), oral placebo and enema active FMT (group 3), and oral and enema placebo (group 4). 

The range of FMT dose frequency was zero (all placebo), or one, two, or three FMT administrations, each given 1 month apart. 

Two thirds of those receiving active FMT were given omnivore-donor FMT, and one third were given vegan-donor FMT, in addition to receiving standard of care. 

“Colony-forming units were standard and the same whether given via oral capsule or enema,” Dr. Bajaj said. This is “similar to what we used in our phase 1 study.”

Intent-to-treat (ITT) analysis was performed with 6-month data. The primary outcomes were safety and hepatic encephalopathy recurrence defined as ≥ grade 2 on West-Haven criteria. Secondary outcomes included other adverse events, changes in infections, severity of cirrhosis and cognition, and patient-reported outcomes. A statistical regression for hepatic encephalopathy recurrence was also performed. Patients were followed for 6 months or until death.
 

One Dose of FMT Better Than None

Hepatic encephalopathy recurrence was highest (40%) in group 4 patients, compared with those in group 1 (13%), group 2 (13%), and group 3 (0%), as were liver-related hospitalizations (47% vs 7%-20%). 

SIP total/physical and psych scores improved with FMT (P = .003).

When all patients were included in the analysis, the hepatic encephalopathy recurrence was related to dose number (odds radio [OR], 0.27; 95% CI, 0.10-0.79; P = .02), male sex (OR, 0.16; 95% CI, 0.03-0.89; P = .04), and physical SIP (OR, 1.05; 95% CI, 1.01-1.10, P = .05). However, when analyzing results from FMT recipients only, FMT dose, route of administration, and donor source were not found to affect recurrence. 

Of those on placebo alone, six patients (40%) had a recurrence, compared with four on FMT (8.8%) in the combined FMT groups. 

“As long as a patient received at least one FMT dose, they had a better response than a patient who had none,” Dr. Bajaj said.

Six patients dropped out; two in group 1 died after hepatic encephalopathy and falls, and one in group 2 died after a seizure. Three others did not return for follow-up visits. Four patients developed infections, including spontaneous bacterial peritonitis, cholecystitis, and cellulitis, all unrelated to FMT. 

“I think many patients in Western countries are underserved because apart from lactulose and rifaximin, there is little else to give them,” Dr. Bajaj said. “The assumption is because rifaximin kills everything, we shouldn’t give FMT. But here, we administered it to a harsh and hostile wasteland of microbiota, and it still got a toehold and generated a reduction in hepatic encephalopathy.”

He pointed out that in smaller prior studies, the effects lasted up to 1 year. 
 

Setting the Stage for Phase 3 Trials

Dr. Bajaj noted that this phase 2 study sets the stage for larger phase 3 trials in patients not responding to first-line therapy. 

“Given how well-tolerated and effective FMT appears to be in these patients, if the larger phase 3 trial shows similar results, I can imagine FMT becoming a standard therapy,” said Colleen R. Kelly, MD, AGAF, gastroenterologist at Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not involved in the study.

A version of this article appeared on Medscape.com.

I am going to guess that if we asked 500,000 adults in this country if they felt that children and adolescents were spending too much time on their smartphones, we would elicit almost uniform agreement that, yes indeed, smartphone use is gobbling up too much time from our young people. And, the adults would volunteer a long laundry list of all the bad consequences this overuse was generating. If you ask this same sample of adults if they too were spending too much time on their smartphones they would answer yes and, again, give you a list of the problems they feel are the result of this overuse.

We might begin to find a scattering of responses if we ask the adults when a child is too young to have his/her own cell phone. But, they would all agree that “young children” weren’t ready to be trusted with a cell phone. The “when” they were ready would be up for discussion. However, I suspect we might see a clustering around age 10 years. The reality is that despite what the majority may believe, a 2022 survey found that 42% of children have a cell phone by age 10, 71% by age 12, and 91% by age 14.

So, it would appear that, while we believe there can be significant downsides to having a cell phone, we are having great difficulty in policing ourselves and creating limits for our children. Does cell phone use qualify as an addiction, or is it just another example of how adults have lost the ability to say “no” to themselves and to their children?

When it comes to cell phones in school, the situation gets increasingly murky. The teachers I speak with are very clear that cell phones are creating problems for both the academic and the social experiences of their students. One teacher referred me to an article from the Norwegian Institute of Public Health, which found that banning cell phones in school decreased the incidence of psychological symptoms and diseases in girls. Bullying decreased in both genders and the girls’ GPA scores improved. In schools with cell phone bans, girls were more likely to choose and attend academic track programs, an effect which was more pronounced in young women with lower socioeconomic backgrounds. But, the if, when, and how to institute smartphone bans in school is complicated.

On one front, the movement toward cell phone bans in school has been given a major boost with the publication and publicity of a new book titled The Anxious Generation by social psychologist Jonathan Haidt, PhD. The New York University professor sees the GenZ’ers as experiencing a tsunami of mental health challenges including anxiety, self-harm, and suicide. And, he lays much of the blame for this situation on cell phone use.

He is optimistic about turning the tide because he claims that everywhere he speaks about the problem he says “I feel that I’m pushing on open doors.” Comparing the phenomenon to the collapse of the Berlin Wall, Dr. Haidt says “When you have a system that everyone hates, and then you have a way to escape it, it can change in a year.”

I wish I could share in his optimism, although I did just encounter a news story in the Portland paper describing a national program called “Wait Until 8th,” which is being considered by a parents’ group here in Maine.

The usual suspects have their own predictable take on the issue. The House and Senate have proposed a study on the use of cell phones in elementary and secondary schools and a pilot program awarding grants to some schools to create mobile device–free environments. Sounds like a momentum killer to me.

Not surprisingly, the issue of cell phone bans in school has taken on a bit of a political odor. The National Parents Union reports in a very small and inadequately described sample that 56% of parents are against total school bans. In the accompanying press release, the organizations offers an extensive list of concerns parents have reported — many cite the need to remain in contact with their children throughout the day. One has to wonder how often these concerns are a reflection of unresolved separation anxiety.

The American Academy of Pediatrics has rolled out a “5 Cs” framework that pediatricians can use to discuss media use with families. As usual, the thought is that talking about a problem is going to somehow convince parents to do what they already know is the correct action. And, of course, pediatricians have plenty of time to initiate this discussion of the obvious.

A recent study from the Department of Pediatrics at University of California, San Francisco, has found that parental monitoring, limit setting, and modeling good screen use behavior (my bolding) are the most effective strategies for reducing adolescent screen time. Using screen time allowances as a reward or punishment does not seem to be effective.

So there you have it. It looks like cell phone overuse, particularly in school, is something most of us see as a problem deserving an immediate solution. However, despite Dr. Haidt’s optimism about a seismic turnaround, I suspect it will more likely be guerrilla warfare — one family, one school, or one school district at a time.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I am going to guess that if we asked 500,000 adults in this country if they felt that children and adolescents were spending too much time on their smartphones, we would elicit almost uniform agreement that, yes indeed, smartphone use is gobbling up too much time from our young people. And, the adults would volunteer a long laundry list of all the bad consequences this overuse was generating. If you ask this same sample of adults if they too were spending too much time on their smartphones they would answer yes and, again, give you a list of the problems they feel are the result of this overuse.

We might begin to find a scattering of responses if we ask the adults when a child is too young to have his/her own cell phone. But, they would all agree that “young children” weren’t ready to be trusted with a cell phone. The “when” they were ready would be up for discussion. However, I suspect we might see a clustering around age 10 years. The reality is that despite what the majority may believe, a 2022 survey found that 42% of children have a cell phone by age 10, 71% by age 12, and 91% by age 14.

So, it would appear that, while we believe there can be significant downsides to having a cell phone, we are having great difficulty in policing ourselves and creating limits for our children. Does cell phone use qualify as an addiction, or is it just another example of how adults have lost the ability to say “no” to themselves and to their children?

When it comes to cell phones in school, the situation gets increasingly murky. The teachers I speak with are very clear that cell phones are creating problems for both the academic and the social experiences of their students. One teacher referred me to an article from the Norwegian Institute of Public Health, which found that banning cell phones in school decreased the incidence of psychological symptoms and diseases in girls. Bullying decreased in both genders and the girls’ GPA scores improved. In schools with cell phone bans, girls were more likely to choose and attend academic track programs, an effect which was more pronounced in young women with lower socioeconomic backgrounds. But, the if, when, and how to institute smartphone bans in school is complicated.

On one front, the movement toward cell phone bans in school has been given a major boost with the publication and publicity of a new book titled The Anxious Generation by social psychologist Jonathan Haidt, PhD. The New York University professor sees the GenZ’ers as experiencing a tsunami of mental health challenges including anxiety, self-harm, and suicide. And, he lays much of the blame for this situation on cell phone use.

He is optimistic about turning the tide because he claims that everywhere he speaks about the problem he says “I feel that I’m pushing on open doors.” Comparing the phenomenon to the collapse of the Berlin Wall, Dr. Haidt says “When you have a system that everyone hates, and then you have a way to escape it, it can change in a year.”

I wish I could share in his optimism, although I did just encounter a news story in the Portland paper describing a national program called “Wait Until 8th,” which is being considered by a parents’ group here in Maine.

The usual suspects have their own predictable take on the issue. The House and Senate have proposed a study on the use of cell phones in elementary and secondary schools and a pilot program awarding grants to some schools to create mobile device–free environments. Sounds like a momentum killer to me.

Not surprisingly, the issue of cell phone bans in school has taken on a bit of a political odor. The National Parents Union reports in a very small and inadequately described sample that 56% of parents are against total school bans. In the accompanying press release, the organizations offers an extensive list of concerns parents have reported — many cite the need to remain in contact with their children throughout the day. One has to wonder how often these concerns are a reflection of unresolved separation anxiety.

The American Academy of Pediatrics has rolled out a “5 Cs” framework that pediatricians can use to discuss media use with families. As usual, the thought is that talking about a problem is going to somehow convince parents to do what they already know is the correct action. And, of course, pediatricians have plenty of time to initiate this discussion of the obvious.

A recent study from the Department of Pediatrics at University of California, San Francisco, has found that parental monitoring, limit setting, and modeling good screen use behavior (my bolding) are the most effective strategies for reducing adolescent screen time. Using screen time allowances as a reward or punishment does not seem to be effective.

So there you have it. It looks like cell phone overuse, particularly in school, is something most of us see as a problem deserving an immediate solution. However, despite Dr. Haidt’s optimism about a seismic turnaround, I suspect it will more likely be guerrilla warfare — one family, one school, or one school district at a time.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I am going to guess that if we asked 500,000 adults in this country if they felt that children and adolescents were spending too much time on their smartphones, we would elicit almost uniform agreement that, yes indeed, smartphone use is gobbling up too much time from our young people. And, the adults would volunteer a long laundry list of all the bad consequences this overuse was generating. If you ask this same sample of adults if they too were spending too much time on their smartphones they would answer yes and, again, give you a list of the problems they feel are the result of this overuse.

We might begin to find a scattering of responses if we ask the adults when a child is too young to have his/her own cell phone. But, they would all agree that “young children” weren’t ready to be trusted with a cell phone. The “when” they were ready would be up for discussion. However, I suspect we might see a clustering around age 10 years. The reality is that despite what the majority may believe, a 2022 survey found that 42% of children have a cell phone by age 10, 71% by age 12, and 91% by age 14.

So, it would appear that, while we believe there can be significant downsides to having a cell phone, we are having great difficulty in policing ourselves and creating limits for our children. Does cell phone use qualify as an addiction, or is it just another example of how adults have lost the ability to say “no” to themselves and to their children?

When it comes to cell phones in school, the situation gets increasingly murky. The teachers I speak with are very clear that cell phones are creating problems for both the academic and the social experiences of their students. One teacher referred me to an article from the Norwegian Institute of Public Health, which found that banning cell phones in school decreased the incidence of psychological symptoms and diseases in girls. Bullying decreased in both genders and the girls’ GPA scores improved. In schools with cell phone bans, girls were more likely to choose and attend academic track programs, an effect which was more pronounced in young women with lower socioeconomic backgrounds. But, the if, when, and how to institute smartphone bans in school is complicated.

On one front, the movement toward cell phone bans in school has been given a major boost with the publication and publicity of a new book titled The Anxious Generation by social psychologist Jonathan Haidt, PhD. The New York University professor sees the GenZ’ers as experiencing a tsunami of mental health challenges including anxiety, self-harm, and suicide. And, he lays much of the blame for this situation on cell phone use.

He is optimistic about turning the tide because he claims that everywhere he speaks about the problem he says “I feel that I’m pushing on open doors.” Comparing the phenomenon to the collapse of the Berlin Wall, Dr. Haidt says “When you have a system that everyone hates, and then you have a way to escape it, it can change in a year.”

I wish I could share in his optimism, although I did just encounter a news story in the Portland paper describing a national program called “Wait Until 8th,” which is being considered by a parents’ group here in Maine.

The usual suspects have their own predictable take on the issue. The House and Senate have proposed a study on the use of cell phones in elementary and secondary schools and a pilot program awarding grants to some schools to create mobile device–free environments. Sounds like a momentum killer to me.

Not surprisingly, the issue of cell phone bans in school has taken on a bit of a political odor. The National Parents Union reports in a very small and inadequately described sample that 56% of parents are against total school bans. In the accompanying press release, the organizations offers an extensive list of concerns parents have reported — many cite the need to remain in contact with their children throughout the day. One has to wonder how often these concerns are a reflection of unresolved separation anxiety.

The American Academy of Pediatrics has rolled out a “5 Cs” framework that pediatricians can use to discuss media use with families. As usual, the thought is that talking about a problem is going to somehow convince parents to do what they already know is the correct action. And, of course, pediatricians have plenty of time to initiate this discussion of the obvious.

A recent study from the Department of Pediatrics at University of California, San Francisco, has found that parental monitoring, limit setting, and modeling good screen use behavior (my bolding) are the most effective strategies for reducing adolescent screen time. Using screen time allowances as a reward or punishment does not seem to be effective.

So there you have it. It looks like cell phone overuse, particularly in school, is something most of us see as a problem deserving an immediate solution. However, despite Dr. Haidt’s optimism about a seismic turnaround, I suspect it will more likely be guerrilla warfare — one family, one school, or one school district at a time.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].