Key clinical point: Progression independent of relapse activity (PIRA) is a major contributor of confirmed disability accrual (CDA) in early relapsing-onset multiple sclerosis (MS), with age being a major determinant of the way CDA occurs.

Major finding: PIRA accounted for 27.6% of disability worsening events, whereas relapse-associated worsening (RAW) accounted for 17.8% of events, with RAW being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients.

Study details: Findings are from a retrospective cohort analysis of 5169 patients with clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥5 years.

Disclosures: No source of funding was declared. Some authors declared serving on advisory boards or receiving grants, travel compensation, speaker honoraria, or lecture and consulting fees from various sources.

Source: Portaccio E et al. Progression is independent of relapse activity in early multiple sclerosis: a real-life cohort study. Brain. 2022 (Mar 24). Doi: 10.1093/brain/awac111

Key clinical point: Progression independent of relapse activity (PIRA) is a major contributor of confirmed disability accrual (CDA) in early relapsing-onset multiple sclerosis (MS), with age being a major determinant of the way CDA occurs.

Major finding: PIRA accounted for 27.6% of disability worsening events, whereas relapse-associated worsening (RAW) accounted for 17.8% of events, with RAW being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients.

Study details: Findings are from a retrospective cohort analysis of 5169 patients with clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥5 years.

Disclosures: No source of funding was declared. Some authors declared serving on advisory boards or receiving grants, travel compensation, speaker honoraria, or lecture and consulting fees from various sources.

Source: Portaccio E et al. Progression is independent of relapse activity in early multiple sclerosis: a real-life cohort study. Brain. 2022 (Mar 24). Doi: 10.1093/brain/awac111

Key clinical point: Progression independent of relapse activity (PIRA) is a major contributor of confirmed disability accrual (CDA) in early relapsing-onset multiple sclerosis (MS), with age being a major determinant of the way CDA occurs.

Major finding: PIRA accounted for 27.6% of disability worsening events, whereas relapse-associated worsening (RAW) accounted for 17.8% of events, with RAW being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients.

Study details: Findings are from a retrospective cohort analysis of 5169 patients with clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥5 years.

Disclosures: No source of funding was declared. Some authors declared serving on advisory boards or receiving grants, travel compensation, speaker honoraria, or lecture and consulting fees from various sources.

Source: Portaccio E et al. Progression is independent of relapse activity in early multiple sclerosis: a real-life cohort study. Brain. 2022 (Mar 24). Doi: 10.1093/brain/awac111

Key clinical point: Patients with multiple sclerosis (MS) show reduced neutralizing antibody (nAb) response to SARS-CoV-2 mRNA vaccine, with B-cell depleting therapies having a significant effect on vaccine efficacy.

Major finding: Patients with MS treated with B-cell depleting therapies vs. other or no therapy showed a >9-fold decrease in the nAb response (P < .001), with 61.5% of patients showing no detectable levels of nAb. B-cell depleting therapy (P < .0001) was associated with significantly reduced neutralization titer 50% values.

Study details: This was a prospective longitudinal study including 51 patients with MS who completed the vaccination course of BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), or Ad26.COV2 (Johnson and Johnson) SARS-CoV-2 vaccine.

Disclosures: No source of funding was declared. TV Gyang reported serving as consultant and BM Segal reported serving as a consultant, moderator, and speaker and on data safety monitoring boards for various sources. The other authors declared no conflicts of interest.

Source: Gyang TV et al. Neutralizing antibody responses against SARS-CoV-2 in vaccinated people with multiple sclerosis. Mult Scler J Exp Transl Clin. 2022;8(1):1-9 (Mar 22). Doi: 10.1177/20552173221087357

Key clinical point: Patients with multiple sclerosis (MS) show reduced neutralizing antibody (nAb) response to SARS-CoV-2 mRNA vaccine, with B-cell depleting therapies having a significant effect on vaccine efficacy.

Major finding: Patients with MS treated with B-cell depleting therapies vs. other or no therapy showed a >9-fold decrease in the nAb response (P < .001), with 61.5% of patients showing no detectable levels of nAb. B-cell depleting therapy (P < .0001) was associated with significantly reduced neutralization titer 50% values.

Study details: This was a prospective longitudinal study including 51 patients with MS who completed the vaccination course of BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), or Ad26.COV2 (Johnson and Johnson) SARS-CoV-2 vaccine.

Disclosures: No source of funding was declared. TV Gyang reported serving as consultant and BM Segal reported serving as a consultant, moderator, and speaker and on data safety monitoring boards for various sources. The other authors declared no conflicts of interest.

Source: Gyang TV et al. Neutralizing antibody responses against SARS-CoV-2 in vaccinated people with multiple sclerosis. Mult Scler J Exp Transl Clin. 2022;8(1):1-9 (Mar 22). Doi: 10.1177/20552173221087357

Key clinical point: Patients with multiple sclerosis (MS) show reduced neutralizing antibody (nAb) response to SARS-CoV-2 mRNA vaccine, with B-cell depleting therapies having a significant effect on vaccine efficacy.

Major finding: Patients with MS treated with B-cell depleting therapies vs. other or no therapy showed a >9-fold decrease in the nAb response (P < .001), with 61.5% of patients showing no detectable levels of nAb. B-cell depleting therapy (P < .0001) was associated with significantly reduced neutralization titer 50% values.

Study details: This was a prospective longitudinal study including 51 patients with MS who completed the vaccination course of BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), or Ad26.COV2 (Johnson and Johnson) SARS-CoV-2 vaccine.

Disclosures: No source of funding was declared. TV Gyang reported serving as consultant and BM Segal reported serving as a consultant, moderator, and speaker and on data safety monitoring boards for various sources. The other authors declared no conflicts of interest.

Source: Gyang TV et al. Neutralizing antibody responses against SARS-CoV-2 in vaccinated people with multiple sclerosis. Mult Scler J Exp Transl Clin. 2022;8(1):1-9 (Mar 22). Doi: 10.1177/20552173221087357

Key clinical point: A favorable benefit-risk profile of ofatumumab vs. teriflunomide in recently diagnosed treatment-naive (RDTN) patients with relapsing multiple sclerosis (MS) highlights the possibility of ofatumumab being considered the first-line therapy in these patients.

Major finding: Ofatumumab vs. teriflunomide reduced the annual relapse rate (ARR), confirmed disability worsening at 6 months, and mean number of gadolinium-enhanced T1 lesions/magnetic resonance imaging scan by 50% (P < .001), 46% (P = .044), and 95% (P < .001), respectively, with a manageable and consistent safety profile.

Study details: This was a post hoc analysis of ASCLEPIOS I and II studies including 615 RDTN patients with relapsing MS who were randomly assigned to receive ofatumumab or teriflunomide for up to 30 months.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. The authors declared receiving lecture, consultancy, or speaker fees; travel grants; or personal compensation or serving as a steering committee members and on advisory boards for various sources, including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.

Citation: Gärtner J et al. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 (Mar 10). Doi: 10.1177/13524585221078825

Key clinical point: A favorable benefit-risk profile of ofatumumab vs. teriflunomide in recently diagnosed treatment-naive (RDTN) patients with relapsing multiple sclerosis (MS) highlights the possibility of ofatumumab being considered the first-line therapy in these patients.

Major finding: Ofatumumab vs. teriflunomide reduced the annual relapse rate (ARR), confirmed disability worsening at 6 months, and mean number of gadolinium-enhanced T1 lesions/magnetic resonance imaging scan by 50% (P < .001), 46% (P = .044), and 95% (P < .001), respectively, with a manageable and consistent safety profile.

Study details: This was a post hoc analysis of ASCLEPIOS I and II studies including 615 RDTN patients with relapsing MS who were randomly assigned to receive ofatumumab or teriflunomide for up to 30 months.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. The authors declared receiving lecture, consultancy, or speaker fees; travel grants; or personal compensation or serving as a steering committee members and on advisory boards for various sources, including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.

Citation: Gärtner J et al. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 (Mar 10). Doi: 10.1177/13524585221078825

Key clinical point: A favorable benefit-risk profile of ofatumumab vs. teriflunomide in recently diagnosed treatment-naive (RDTN) patients with relapsing multiple sclerosis (MS) highlights the possibility of ofatumumab being considered the first-line therapy in these patients.

Major finding: Ofatumumab vs. teriflunomide reduced the annual relapse rate (ARR), confirmed disability worsening at 6 months, and mean number of gadolinium-enhanced T1 lesions/magnetic resonance imaging scan by 50% (P < .001), 46% (P = .044), and 95% (P < .001), respectively, with a manageable and consistent safety profile.

Study details: This was a post hoc analysis of ASCLEPIOS I and II studies including 615 RDTN patients with relapsing MS who were randomly assigned to receive ofatumumab or teriflunomide for up to 30 months.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. The authors declared receiving lecture, consultancy, or speaker fees; travel grants; or personal compensation or serving as a steering committee members and on advisory boards for various sources, including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.

Citation: Gärtner J et al. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 (Mar 10). Doi: 10.1177/13524585221078825

Key clinical point: Women exposed to emotional and sexual abuse during childhood are at a significantly higher risk of developing multiple sclerosis (MS), with the risk being highest among women exposed to multiple abuse categories.

Major finding: Women exposed to sexual (adjusted hazard ratio [aHR, 1.65; 95% CI 1.13-2.39) and emotional (aHR 1.40; 95% CI 1.03-1.90) abuse in childhood were at a significantly higher risk of subsequently developing MS, with the risk being highest when exposed to 2 (aHR 1.66; 95% CI 1.04-2.67) or 3 (aHR 1.93; 95% CI 1.02-3.67) abuse categories vs. no abuse.

Study details: Findings are from a prospective analysis of 77,997 women with (n = 14,477) and without (n = 63,520) exposure to any form of childhood abuse.

Disclosures: The study did not declare any specific source of funding. Some authors declared receiving research grants, consulting or speaker fees, or serving as a steering committee member or on advisory board for various sources.

Source: Eid K et al. Association of adverse childhood experiences with the development of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 4). Doi: 10. 1136/ jnnp- 2021-328700

Key clinical point: Women exposed to emotional and sexual abuse during childhood are at a significantly higher risk of developing multiple sclerosis (MS), with the risk being highest among women exposed to multiple abuse categories.

Major finding: Women exposed to sexual (adjusted hazard ratio [aHR, 1.65; 95% CI 1.13-2.39) and emotional (aHR 1.40; 95% CI 1.03-1.90) abuse in childhood were at a significantly higher risk of subsequently developing MS, with the risk being highest when exposed to 2 (aHR 1.66; 95% CI 1.04-2.67) or 3 (aHR 1.93; 95% CI 1.02-3.67) abuse categories vs. no abuse.

Study details: Findings are from a prospective analysis of 77,997 women with (n = 14,477) and without (n = 63,520) exposure to any form of childhood abuse.

Disclosures: The study did not declare any specific source of funding. Some authors declared receiving research grants, consulting or speaker fees, or serving as a steering committee member or on advisory board for various sources.

Source: Eid K et al. Association of adverse childhood experiences with the development of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 4). Doi: 10. 1136/ jnnp- 2021-328700

Key clinical point: Women exposed to emotional and sexual abuse during childhood are at a significantly higher risk of developing multiple sclerosis (MS), with the risk being highest among women exposed to multiple abuse categories.

Major finding: Women exposed to sexual (adjusted hazard ratio [aHR, 1.65; 95% CI 1.13-2.39) and emotional (aHR 1.40; 95% CI 1.03-1.90) abuse in childhood were at a significantly higher risk of subsequently developing MS, with the risk being highest when exposed to 2 (aHR 1.66; 95% CI 1.04-2.67) or 3 (aHR 1.93; 95% CI 1.02-3.67) abuse categories vs. no abuse.

Study details: Findings are from a prospective analysis of 77,997 women with (n = 14,477) and without (n = 63,520) exposure to any form of childhood abuse.

Disclosures: The study did not declare any specific source of funding. Some authors declared receiving research grants, consulting or speaker fees, or serving as a steering committee member or on advisory board for various sources.

Source: Eid K et al. Association of adverse childhood experiences with the development of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 4). Doi: 10. 1136/ jnnp- 2021-328700

Key clinical point: Plasma neurofilament light chain (pNfL) could serve as an effective biomarker for identifying disability progression and monitoring treatment response in progressive multiple sclerosis (PMS).

Major finding: High vs. low pNfL levels increased the risk for 3-month confirmed disability progression (CDP) by 32% (P = .0055) and 49% (P = .0268) and 6-month CDP by 26% (P = .0417) and 48% (P = .0431) in patients with secondary PMS (SPMS) and primary PMS (PPMS), respectively. pNfL levels were lower in patients treated with siponimod or fingolimod vs. placebo.

Study details: This was a post hoc analysis of EXPAND and INFORMS studies including 1452 and 378 patients with SPMS and PPMS, respectively, who received siponimod, fingolimod, or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Some authors, including the lead author, reported being current or former employees of Novartis Pharma AG and some authors reported serving on advisory boards or receiving grants, speaker honoraria, lecture fees, or consulting fees from various sources, including Novartis Pharma AG.

Source: Leppert D et al. blood neurofilament light in progressive multiple sclerosis: Post hoc analysis of 2 randomized controlled trials. Neurology. 2022 (Apr 4). Doi: 10.1212/WNL.0000000000200258

Key clinical point: Plasma neurofilament light chain (pNfL) could serve as an effective biomarker for identifying disability progression and monitoring treatment response in progressive multiple sclerosis (PMS).

Major finding: High vs. low pNfL levels increased the risk for 3-month confirmed disability progression (CDP) by 32% (P = .0055) and 49% (P = .0268) and 6-month CDP by 26% (P = .0417) and 48% (P = .0431) in patients with secondary PMS (SPMS) and primary PMS (PPMS), respectively. pNfL levels were lower in patients treated with siponimod or fingolimod vs. placebo.

Study details: This was a post hoc analysis of EXPAND and INFORMS studies including 1452 and 378 patients with SPMS and PPMS, respectively, who received siponimod, fingolimod, or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Some authors, including the lead author, reported being current or former employees of Novartis Pharma AG and some authors reported serving on advisory boards or receiving grants, speaker honoraria, lecture fees, or consulting fees from various sources, including Novartis Pharma AG.

Source: Leppert D et al. blood neurofilament light in progressive multiple sclerosis: Post hoc analysis of 2 randomized controlled trials. Neurology. 2022 (Apr 4). Doi: 10.1212/WNL.0000000000200258

Key clinical point: Plasma neurofilament light chain (pNfL) could serve as an effective biomarker for identifying disability progression and monitoring treatment response in progressive multiple sclerosis (PMS).

Major finding: High vs. low pNfL levels increased the risk for 3-month confirmed disability progression (CDP) by 32% (P = .0055) and 49% (P = .0268) and 6-month CDP by 26% (P = .0417) and 48% (P = .0431) in patients with secondary PMS (SPMS) and primary PMS (PPMS), respectively. pNfL levels were lower in patients treated with siponimod or fingolimod vs. placebo.

Study details: This was a post hoc analysis of EXPAND and INFORMS studies including 1452 and 378 patients with SPMS and PPMS, respectively, who received siponimod, fingolimod, or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Some authors, including the lead author, reported being current or former employees of Novartis Pharma AG and some authors reported serving on advisory boards or receiving grants, speaker honoraria, lecture fees, or consulting fees from various sources, including Novartis Pharma AG.

Source: Leppert D et al. blood neurofilament light in progressive multiple sclerosis: Post hoc analysis of 2 randomized controlled trials. Neurology. 2022 (Apr 4). Doi: 10.1212/WNL.0000000000200258

Key clinical point: The average relapse rates and the rate of severe relapses did not increase significantly after fingolimod discontinuation in patients with relapsing multiple sclerosis (MS); however, delaying the commencement of immunotherapy increased the risk for relapse.

Major finding: The annualized relapse rate (ARR) was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior and after fingolimod cessation. However, delaying the recommencement of therapy from 2 to 4 months vs. beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse.

Study details: Findings are from an analysis of 685 patients with relapsing MS who received fingolimod therapy for at least 12 months and were followed-up for at least 12 months after fingolimod cessation.

Disclosures: Open access funding was enabled by CAUL and its member institutions. Some authors declared receiving research support, personal compensation, speaker or consulting fees, or nonfinancial support from various sources.

Source: Malpas CB et al. Multiple sclerosis relapses following cessation of fingolimod. Clin Drug Investig. 2022;42:355-364 (Mar 18). Doi: 10.1007/s40261-022-01129-7

Key clinical point: The average relapse rates and the rate of severe relapses did not increase significantly after fingolimod discontinuation in patients with relapsing multiple sclerosis (MS); however, delaying the commencement of immunotherapy increased the risk for relapse.

Major finding: The annualized relapse rate (ARR) was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior and after fingolimod cessation. However, delaying the recommencement of therapy from 2 to 4 months vs. beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse.

Study details: Findings are from an analysis of 685 patients with relapsing MS who received fingolimod therapy for at least 12 months and were followed-up for at least 12 months after fingolimod cessation.

Disclosures: Open access funding was enabled by CAUL and its member institutions. Some authors declared receiving research support, personal compensation, speaker or consulting fees, or nonfinancial support from various sources.

Source: Malpas CB et al. Multiple sclerosis relapses following cessation of fingolimod. Clin Drug Investig. 2022;42:355-364 (Mar 18). Doi: 10.1007/s40261-022-01129-7

Key clinical point: The average relapse rates and the rate of severe relapses did not increase significantly after fingolimod discontinuation in patients with relapsing multiple sclerosis (MS); however, delaying the commencement of immunotherapy increased the risk for relapse.

Major finding: The annualized relapse rate (ARR) was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior and after fingolimod cessation. However, delaying the recommencement of therapy from 2 to 4 months vs. beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse.

Study details: Findings are from an analysis of 685 patients with relapsing MS who received fingolimod therapy for at least 12 months and were followed-up for at least 12 months after fingolimod cessation.

Disclosures: Open access funding was enabled by CAUL and its member institutions. Some authors declared receiving research support, personal compensation, speaker or consulting fees, or nonfinancial support from various sources.

Source: Malpas CB et al. Multiple sclerosis relapses following cessation of fingolimod. Clin Drug Investig. 2022;42:355-364 (Mar 18). Doi: 10.1007/s40261-022-01129-7

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.

Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.

“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”

The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.

States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.

“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”

The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”

They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.

The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.

Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.

Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.

Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.

Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.

The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.

Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.

Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.

“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”

The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.

States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.

“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”

The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”

They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.

The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.

Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.

Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.

Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.

Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.

The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.

Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.

Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.

“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”

The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.

States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.

“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”

The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”

They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.

The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.

Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.

Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.

Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.

Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.

The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.