PHOENIX – New therapies are on the horizon for genetic neuromuscular diseases, and this will raise both hopes for patients and challenges for neurologists. Following successful genetic treatments for ALS, hereditary amyloidosis, and spinal muscular atrophy, therapies for conditions like Charcot-Marie-Tooth (CMT) neuropathy are set to change neurology practice, according to Nicolas Madigan, MBBCh, PhD, who spoke at the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM).

“I think we will very soon be in a position to tell these patients that they might actually have a better treatment outcome with a genetic treatment than if they had a sporadic or inflammatory disorder,” said Dr. Madigan, who is an assistant professor of clinical research at Mayo Clinic, Rochester, N.Y.

To illustrate how genetic therapies are changing neurology practice, Dr. Madigan focused his talk on CMT neuropathy, which is the most common hereditary neuropathy and, as a result, has become a prime focus of gene therapy development. “In a city of about a million people, there will be 100-800 patients with one of these disorders,” said Dr. Madigan.
 

Case report illustrates a change in approach

There are more than 100 known genes that can contribute to CMT, but about 90% of patients harbor alterations in one of four genes: PMP22, GJB1, MFN2, and MPZ.

The trick is determining which patients are candidates for genetic testing, according to Dr. Madigan. He presented a case report of a 39-year-old woman who had experienced sensory symptoms for years, with a sudden exacerbation along with allodynia following COVID-19 vaccination. Her cerebrospinal fluid protein was high and outside electromyography indicated mild demyelinating neuropathy, consistent with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). After her insurance denied IVIG treatment, she received solumedrol, but her symptoms worsened and she was referred to Dr. Madigan.

After 6 months of methotrexate treatment, her sensory symptoms had not improved, and she was referred for genetic testing, which revealed a truncating mutation of the MPZ gene. “What I learned from this case really was that, in a young patient with conduction slowing, you might be considering CIDP. It might actually be better to do genetic testing first as opposed to starting inflammatory neuropathy type treatments with respect to cost – the genetic tests costs $300 versus tens of thousands of dollars for IVIG – and for [patient] welfare as well,” said Dr. Madigan.

Specifically, when clinical signs point to inherited neuropathy and there is conduction slowing, “the biggest bang for your buck might to be to go straight to PMP22 deletion or duplication testing and see if you can get a diagnosis. If that is negative or the clinical features are not as you might suspect, then, if you have other supportive features such as a very young age or there’s predominance of motor or sensory symptoms, you could test more broadly with a panel. If both of these are negative, then you could consider exome sequencing if the clinical phenotype really is consistent with that,” said Dr. Madigan.
 

The treatment landscape

With a diagnosis in hand, it’s possible to turn to treatment options, and the CMT landscape is promising. Dr. Madigan’s group recently reviewed 286 CMT clinical trials published between 1999 and 2022, 86% of which were interventions. Most were procedures based on carpal or cubital tunnel release, extracorporeal shockwave therapy, or nerve hydrodissection.

The small-molecule drug combination PXT3003 (Pharnext) – comprising baclofen, naltrexone, and sorbitol – downregulated PMP22 mRNA expression and led to improved myelination in animal models. It is currently being studied in a phase 2 clinical trial. Other approaches include supplements, stem cells, anesthetics, and various devices.

Genetic therapy is in the preclinical stage, including gene replacement using adeno-associated virus (AAV) vectors, gene silencing using antisense oligonucleotides or RNA interference, and gene editing using CRISPR-Cas 9 approaches.

Gene replacement strategies include delivering a normal copy of the gene, a supportive gene, or a gene that delays or reduces axon degeneration. Gene silencing targets PMP22, while CRISPR-Cas9 gene editing aims for PMP22 or neurofilament light polypeptide (NEFL) gene knockout.

The most clinically advanced AAV program delivers neurotrophin-3 via the viral vector to the target muscle, which has been demonstrated to improve symptoms in a mouse model using a muscle-specific promoter. A phase 1/2a trial will test the approach in three patients.

In the antisense space, chemical advances have improved the profile of the RNA, including modifications that influence inflammatory properties, stability, and targeting of specific tissues through conjugation to specific lipids, proteins, or antibodies. A 2018 study sponsored by DTxPharma showed that the formulation could improve outcomes and histologic myelination in a mouse model. In the wake of Novartis’s acquisition of the technology, Dr. Madigan anticipates that clinical trials will likely begin in 2024.

Finally, CRISPR-Cas9 targeting of a promoter region that leads to PMP22 transcription improved remyelination and electrophysiological parameters after injection into the sciatic nerve of mice.
 

A need for genetic counseling

Advances in testing and therapies represent exciting developments, but they also create a need for genetic counselors, according to Dr. Madigan. His clinic has two certified genetic counselors who meet with patients and discuss testing options, including risks and benefits to family members. The counselors also provide psychological support and assist in shared decision-making. They also handle testing paperwork, which eases the burden on physicians.

If the tests are negative, the genetic counselor informs the patient and lets them know of any additional testing required. In case of a positive test, the genetic counselor informs the patient, but the physician also makes contact to discuss clinical implications of the result. “I think it’s working extremely well, and I would encourage all practices to begin to explore those options moving forward,” said Dr. Madigan.

During the Q&A session after the talk, an audience member noted that genetic counselors are not covered by insurance, which places a financial burden on providers to hire them. He noted that his facility has a large clinical genomics department that was able to fund the two counselors, though they are both part-time. “It wasn’t easy. I think there was at least a year of trying to work out how to do it in terms of finding positions and negotiating, but I think once it’s accomplished it’s incredibly cost effective in terms of getting patients what they need from that perspective, and helping with the testing,” said Dr. Madigan.

Dr. Madigan reported no relevant financial disclosures.

PHOENIX – New therapies are on the horizon for genetic neuromuscular diseases, and this will raise both hopes for patients and challenges for neurologists. Following successful genetic treatments for ALS, hereditary amyloidosis, and spinal muscular atrophy, therapies for conditions like Charcot-Marie-Tooth (CMT) neuropathy are set to change neurology practice, according to Nicolas Madigan, MBBCh, PhD, who spoke at the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM).

“I think we will very soon be in a position to tell these patients that they might actually have a better treatment outcome with a genetic treatment than if they had a sporadic or inflammatory disorder,” said Dr. Madigan, who is an assistant professor of clinical research at Mayo Clinic, Rochester, N.Y.

To illustrate how genetic therapies are changing neurology practice, Dr. Madigan focused his talk on CMT neuropathy, which is the most common hereditary neuropathy and, as a result, has become a prime focus of gene therapy development. “In a city of about a million people, there will be 100-800 patients with one of these disorders,” said Dr. Madigan.
 

Case report illustrates a change in approach

There are more than 100 known genes that can contribute to CMT, but about 90% of patients harbor alterations in one of four genes: PMP22, GJB1, MFN2, and MPZ.

The trick is determining which patients are candidates for genetic testing, according to Dr. Madigan. He presented a case report of a 39-year-old woman who had experienced sensory symptoms for years, with a sudden exacerbation along with allodynia following COVID-19 vaccination. Her cerebrospinal fluid protein was high and outside electromyography indicated mild demyelinating neuropathy, consistent with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). After her insurance denied IVIG treatment, she received solumedrol, but her symptoms worsened and she was referred to Dr. Madigan.

After 6 months of methotrexate treatment, her sensory symptoms had not improved, and she was referred for genetic testing, which revealed a truncating mutation of the MPZ gene. “What I learned from this case really was that, in a young patient with conduction slowing, you might be considering CIDP. It might actually be better to do genetic testing first as opposed to starting inflammatory neuropathy type treatments with respect to cost – the genetic tests costs $300 versus tens of thousands of dollars for IVIG – and for [patient] welfare as well,” said Dr. Madigan.

Specifically, when clinical signs point to inherited neuropathy and there is conduction slowing, “the biggest bang for your buck might to be to go straight to PMP22 deletion or duplication testing and see if you can get a diagnosis. If that is negative or the clinical features are not as you might suspect, then, if you have other supportive features such as a very young age or there’s predominance of motor or sensory symptoms, you could test more broadly with a panel. If both of these are negative, then you could consider exome sequencing if the clinical phenotype really is consistent with that,” said Dr. Madigan.
 

The treatment landscape

With a diagnosis in hand, it’s possible to turn to treatment options, and the CMT landscape is promising. Dr. Madigan’s group recently reviewed 286 CMT clinical trials published between 1999 and 2022, 86% of which were interventions. Most were procedures based on carpal or cubital tunnel release, extracorporeal shockwave therapy, or nerve hydrodissection.

The small-molecule drug combination PXT3003 (Pharnext) – comprising baclofen, naltrexone, and sorbitol – downregulated PMP22 mRNA expression and led to improved myelination in animal models. It is currently being studied in a phase 2 clinical trial. Other approaches include supplements, stem cells, anesthetics, and various devices.

Genetic therapy is in the preclinical stage, including gene replacement using adeno-associated virus (AAV) vectors, gene silencing using antisense oligonucleotides or RNA interference, and gene editing using CRISPR-Cas 9 approaches.

Gene replacement strategies include delivering a normal copy of the gene, a supportive gene, or a gene that delays or reduces axon degeneration. Gene silencing targets PMP22, while CRISPR-Cas9 gene editing aims for PMP22 or neurofilament light polypeptide (NEFL) gene knockout.

The most clinically advanced AAV program delivers neurotrophin-3 via the viral vector to the target muscle, which has been demonstrated to improve symptoms in a mouse model using a muscle-specific promoter. A phase 1/2a trial will test the approach in three patients.

In the antisense space, chemical advances have improved the profile of the RNA, including modifications that influence inflammatory properties, stability, and targeting of specific tissues through conjugation to specific lipids, proteins, or antibodies. A 2018 study sponsored by DTxPharma showed that the formulation could improve outcomes and histologic myelination in a mouse model. In the wake of Novartis’s acquisition of the technology, Dr. Madigan anticipates that clinical trials will likely begin in 2024.

Finally, CRISPR-Cas9 targeting of a promoter region that leads to PMP22 transcription improved remyelination and electrophysiological parameters after injection into the sciatic nerve of mice.
 

A need for genetic counseling

Advances in testing and therapies represent exciting developments, but they also create a need for genetic counselors, according to Dr. Madigan. His clinic has two certified genetic counselors who meet with patients and discuss testing options, including risks and benefits to family members. The counselors also provide psychological support and assist in shared decision-making. They also handle testing paperwork, which eases the burden on physicians.

If the tests are negative, the genetic counselor informs the patient and lets them know of any additional testing required. In case of a positive test, the genetic counselor informs the patient, but the physician also makes contact to discuss clinical implications of the result. “I think it’s working extremely well, and I would encourage all practices to begin to explore those options moving forward,” said Dr. Madigan.

During the Q&A session after the talk, an audience member noted that genetic counselors are not covered by insurance, which places a financial burden on providers to hire them. He noted that his facility has a large clinical genomics department that was able to fund the two counselors, though they are both part-time. “It wasn’t easy. I think there was at least a year of trying to work out how to do it in terms of finding positions and negotiating, but I think once it’s accomplished it’s incredibly cost effective in terms of getting patients what they need from that perspective, and helping with the testing,” said Dr. Madigan.

Dr. Madigan reported no relevant financial disclosures.

PHOENIX – New therapies are on the horizon for genetic neuromuscular diseases, and this will raise both hopes for patients and challenges for neurologists. Following successful genetic treatments for ALS, hereditary amyloidosis, and spinal muscular atrophy, therapies for conditions like Charcot-Marie-Tooth (CMT) neuropathy are set to change neurology practice, according to Nicolas Madigan, MBBCh, PhD, who spoke at the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM).

“I think we will very soon be in a position to tell these patients that they might actually have a better treatment outcome with a genetic treatment than if they had a sporadic or inflammatory disorder,” said Dr. Madigan, who is an assistant professor of clinical research at Mayo Clinic, Rochester, N.Y.

To illustrate how genetic therapies are changing neurology practice, Dr. Madigan focused his talk on CMT neuropathy, which is the most common hereditary neuropathy and, as a result, has become a prime focus of gene therapy development. “In a city of about a million people, there will be 100-800 patients with one of these disorders,” said Dr. Madigan.
 

Case report illustrates a change in approach

There are more than 100 known genes that can contribute to CMT, but about 90% of patients harbor alterations in one of four genes: PMP22, GJB1, MFN2, and MPZ.

The trick is determining which patients are candidates for genetic testing, according to Dr. Madigan. He presented a case report of a 39-year-old woman who had experienced sensory symptoms for years, with a sudden exacerbation along with allodynia following COVID-19 vaccination. Her cerebrospinal fluid protein was high and outside electromyography indicated mild demyelinating neuropathy, consistent with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). After her insurance denied IVIG treatment, she received solumedrol, but her symptoms worsened and she was referred to Dr. Madigan.

After 6 months of methotrexate treatment, her sensory symptoms had not improved, and she was referred for genetic testing, which revealed a truncating mutation of the MPZ gene. “What I learned from this case really was that, in a young patient with conduction slowing, you might be considering CIDP. It might actually be better to do genetic testing first as opposed to starting inflammatory neuropathy type treatments with respect to cost – the genetic tests costs $300 versus tens of thousands of dollars for IVIG – and for [patient] welfare as well,” said Dr. Madigan.

Specifically, when clinical signs point to inherited neuropathy and there is conduction slowing, “the biggest bang for your buck might to be to go straight to PMP22 deletion or duplication testing and see if you can get a diagnosis. If that is negative or the clinical features are not as you might suspect, then, if you have other supportive features such as a very young age or there’s predominance of motor or sensory symptoms, you could test more broadly with a panel. If both of these are negative, then you could consider exome sequencing if the clinical phenotype really is consistent with that,” said Dr. Madigan.
 

The treatment landscape

With a diagnosis in hand, it’s possible to turn to treatment options, and the CMT landscape is promising. Dr. Madigan’s group recently reviewed 286 CMT clinical trials published between 1999 and 2022, 86% of which were interventions. Most were procedures based on carpal or cubital tunnel release, extracorporeal shockwave therapy, or nerve hydrodissection.

The small-molecule drug combination PXT3003 (Pharnext) – comprising baclofen, naltrexone, and sorbitol – downregulated PMP22 mRNA expression and led to improved myelination in animal models. It is currently being studied in a phase 2 clinical trial. Other approaches include supplements, stem cells, anesthetics, and various devices.

Genetic therapy is in the preclinical stage, including gene replacement using adeno-associated virus (AAV) vectors, gene silencing using antisense oligonucleotides or RNA interference, and gene editing using CRISPR-Cas 9 approaches.

Gene replacement strategies include delivering a normal copy of the gene, a supportive gene, or a gene that delays or reduces axon degeneration. Gene silencing targets PMP22, while CRISPR-Cas9 gene editing aims for PMP22 or neurofilament light polypeptide (NEFL) gene knockout.

The most clinically advanced AAV program delivers neurotrophin-3 via the viral vector to the target muscle, which has been demonstrated to improve symptoms in a mouse model using a muscle-specific promoter. A phase 1/2a trial will test the approach in three patients.

In the antisense space, chemical advances have improved the profile of the RNA, including modifications that influence inflammatory properties, stability, and targeting of specific tissues through conjugation to specific lipids, proteins, or antibodies. A 2018 study sponsored by DTxPharma showed that the formulation could improve outcomes and histologic myelination in a mouse model. In the wake of Novartis’s acquisition of the technology, Dr. Madigan anticipates that clinical trials will likely begin in 2024.

Finally, CRISPR-Cas9 targeting of a promoter region that leads to PMP22 transcription improved remyelination and electrophysiological parameters after injection into the sciatic nerve of mice.
 

A need for genetic counseling

Advances in testing and therapies represent exciting developments, but they also create a need for genetic counselors, according to Dr. Madigan. His clinic has two certified genetic counselors who meet with patients and discuss testing options, including risks and benefits to family members. The counselors also provide psychological support and assist in shared decision-making. They also handle testing paperwork, which eases the burden on physicians.

If the tests are negative, the genetic counselor informs the patient and lets them know of any additional testing required. In case of a positive test, the genetic counselor informs the patient, but the physician also makes contact to discuss clinical implications of the result. “I think it’s working extremely well, and I would encourage all practices to begin to explore those options moving forward,” said Dr. Madigan.

During the Q&A session after the talk, an audience member noted that genetic counselors are not covered by insurance, which places a financial burden on providers to hire them. He noted that his facility has a large clinical genomics department that was able to fund the two counselors, though they are both part-time. “It wasn’t easy. I think there was at least a year of trying to work out how to do it in terms of finding positions and negotiating, but I think once it’s accomplished it’s incredibly cost effective in terms of getting patients what they need from that perspective, and helping with the testing,” said Dr. Madigan.

Dr. Madigan reported no relevant financial disclosures.

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

Adverse events related to the use of embryo transfer catheters (ETCs) may be underreported to the U.S. Food and Drug Administration, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.

ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.

“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”

Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.

Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.

For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”

Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.

Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.

The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.

“That finding stood out,” Dr. Madison said.

Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.

Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.

“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”

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

Adverse events related to the use of embryo transfer catheters (ETCs) may be underreported to the U.S. Food and Drug Administration, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.

ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.

“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”

Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.

Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.

For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”

Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.

Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.

The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.

“That finding stood out,” Dr. Madison said.

Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.

Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.

“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”

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

Adverse events related to the use of embryo transfer catheters (ETCs) may be underreported to the U.S. Food and Drug Administration, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.

ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.

“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”

Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.

Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.

For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”

Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.

Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.

The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.

“That finding stood out,” Dr. Madison said.

Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.

Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.

“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”

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

GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

The 10 best-selling liver health supplements on Amazon bring in an estimated $2.5 million each month. But none of them contain ingredients recommended by major groups of doctors who treat liver issues in the United States or Europe.

Like many supplements, popular online liver products are unregulated, meaning they do not have to meet the same safety and effectiveness standards as prescription medications. 

Sales of liver supplements are growing, particularly in the last few years, said Ahmed Eltelbany, MD, MPH, a first-year gastrointestinal fellow at the University of New Mexico. One reason could be increased alcohol use during the COVID-19 pandemic.

Some manufacturers make bold claims on Amazon, said Dr. Eltelbany, author of a study that looked into the supplements. “The most recurrent claims were that their supplements maintain normal liver function, are scientifically formulated, and – my personal favorite – are a highly effective liver detox formulation developed according to the latest scientific findings.”

While these claims might sound reassuring and scientifically grounded to an average consumer, he said, most of them are not backed up by rigorous clinical research.
 

Does natural mean safe?

Many supplements are marketed as “liver cleansing,” for “liver detox,” or for “liver support,” Dr. Eltelbany said as he presented the study results at the annual meeting of the American College of Gastroenterology. 

“People take these supplements because they believe they’re natural and therefore they’re safe,” said Paul Y. Kwo, MD, who moderated a session on the study at the meeting, when asked to comment. “As I tell every patient in clinic, a great white shark is natural, a scorpion is natural, and so is a hurricane. So just because they’re natural doesn’t mean they’re safe.”

At the same time, “it’s not that every supplement is bad for you. Nonetheless, there’s just a dizzying array of these out there” said Dr. Kwo, a professor of medicine at Stanford Medicine in Redwood, Calif.

“We have to be very cautious,” he said. For example, some people might believe that “if a little bit of a supplement is good, a tremendous amount must be really good.” The antioxidant turmeric, for example, has a pretty good safety record, he said. But this past year, some liver toxicity concerns arose about preparations with “very, very high concentrations” of turmeric. 
 

The top 10 sellers

Dr. Eltelbany and colleagues studied prices for 1-month supplies, monthly sales, and revenue for the top 10 liver supplements sold on Amazon on June 3, 2023:

Ranking by sales:

• 1. Liver Cleanse Detox & Repair Formula – Herbal Liver Supplement with Milk Thistle, Dandelion Root, Organic Turmeric and Artichoke Extract for Liver Health – Silymarin Milk Thistle Detox Capsules
• 2. Ancestral Supplements Grass Fed Beef Liver Capsules. Supports Energy Production, Detoxification, Digestion, Immunity and Full Body Wellness, Non-GMO, Freeze Dried Liver Health Supplement, 180 Capsules
• 3. Bronson Milk Thistle 1,000 mg Silymarin Marianum & Dandelion Root Liver Health Support, 120 Capsules
• 4. PUREHEALTH RESEARCH Liver Supplement – Herbal Liver Cleanse Detox & Repair with Milk Thistle, Artichoke Extract, Dandelion Root, Turmeric, Berberine to Healthy Liver Renew with 11 Natural Nutrients
• 5. TUDCA Bile Salts Liver Support Supplement, 500-mg Servings, Liver and Gallbladder Cleanse Supplement (60 Capsules 250 mg) Genuine Bile Acid. TUDCA Strong Bitter Taste by Double Wood
• 6. 28-in-1 Liver Cleanse Detox & Repair Fatty Liver Formula, Milk Thistle Silymarin, Artichoke Extract, Dandelion & Apple Cider Vinegar – Liver Health Supplement Support Pills – Vegan Capsules
• 7. Vita-Liver Liver Health Supplement – Support Liver Cleanse & Detox – Liquid Delivery for Absorption – Milk Thistle, Artichoke, Chanca Piedra, Dandelion & More
• 8. Liver Supplement with Milk Thistle, Liver Detox Formula, Artichoke and Turmeric. Supports Liver Health Defense & Liver Renew. Liver Cleanse Detox & Repair for Fatty Liver Support. 60 Capsules
• 9. Liver Cleanse Detox & Repair. Milk Thistle Extract with Silymarin 80%, Artichoke Extract, Dandelion Root, Chicory, 25+ Herbs – Premium Liver Health Formula, Liver Support Detox Health Formula – Liver Support Detox Cleanse Supplement
• 10. Arazo Nutrition Liver Cleanse Detox & Repair Formula – Milk Thistle Herbal Support Supplement: Silymarin, Beet, Artichoke, Dandelion, Chicory Root

The investigators found a total of 65 unique ingredients. “Most of these ingredients have historical uses linked to liver health. But our research revealed that strong scientific evidence supporting the efficacy of any of these supplements is currently lacking,” Dr. Eltelbany said. They started the study by creating a new account on Amazon to make sure the search would not be influenced by prior shopping or purchases. They next searched for supplements using the keywords “liver” and “cleanse.” To figure out sales numbers, they used the AMZScout proprietary analytics software that Amazon sellers use to track sales. 
 

Reviewing the reviews

The researchers discovered an average 11,526 reviews for each supplement product. The average rating was 4.42 stars out of 5. 

Using Fakespot.com, proprietary Amazon customer review software that analyzes the timing and language of reviews, they found that only 65% of product reviews were genuine. 

“We felt it was crucial to vet the authenticity of customer feedback,” Dr. Eltelbany said.
 

Few other options?

Liver disease remains a persistent and significant global health burden. Despite advances in many areas of gastroenterology, there remains no curative treatment for liver cirrhosis, Dr. Eltelbany said. 

The primary option for people with end-stage liver disease is a liver transplant. “However, given the scarcity of donors and the vast number of patients in need, many individuals, unfortunately, do not get a timely transplant,” he said. “This void of treatment options and the desperation to find relief often drives patients towards alternative therapies.”

Also, online shopping has made getting these supplements “as simple as a click away. But what’s more concerning is the trust placed in these products by our patients,” Dr. Eltelbany said.

“There’s a strong need for rigorous scientific investigation into the actual health benefits of any liver detox supplements,” he said. “Above all, patient education remains paramount, warning them of potential risks and unknowns of these supplements.”

A version of this article appeared on WebMD.com.

The 10 best-selling liver health supplements on Amazon bring in an estimated $2.5 million each month. But none of them contain ingredients recommended by major groups of doctors who treat liver issues in the United States or Europe.

Like many supplements, popular online liver products are unregulated, meaning they do not have to meet the same safety and effectiveness standards as prescription medications. 

Sales of liver supplements are growing, particularly in the last few years, said Ahmed Eltelbany, MD, MPH, a first-year gastrointestinal fellow at the University of New Mexico. One reason could be increased alcohol use during the COVID-19 pandemic.

Some manufacturers make bold claims on Amazon, said Dr. Eltelbany, author of a study that looked into the supplements. “The most recurrent claims were that their supplements maintain normal liver function, are scientifically formulated, and – my personal favorite – are a highly effective liver detox formulation developed according to the latest scientific findings.”

While these claims might sound reassuring and scientifically grounded to an average consumer, he said, most of them are not backed up by rigorous clinical research.
 

Does natural mean safe?

Many supplements are marketed as “liver cleansing,” for “liver detox,” or for “liver support,” Dr. Eltelbany said as he presented the study results at the annual meeting of the American College of Gastroenterology. 

“People take these supplements because they believe they’re natural and therefore they’re safe,” said Paul Y. Kwo, MD, who moderated a session on the study at the meeting, when asked to comment. “As I tell every patient in clinic, a great white shark is natural, a scorpion is natural, and so is a hurricane. So just because they’re natural doesn’t mean they’re safe.”

At the same time, “it’s not that every supplement is bad for you. Nonetheless, there’s just a dizzying array of these out there” said Dr. Kwo, a professor of medicine at Stanford Medicine in Redwood, Calif.

“We have to be very cautious,” he said. For example, some people might believe that “if a little bit of a supplement is good, a tremendous amount must be really good.” The antioxidant turmeric, for example, has a pretty good safety record, he said. But this past year, some liver toxicity concerns arose about preparations with “very, very high concentrations” of turmeric. 
 

The top 10 sellers

Dr. Eltelbany and colleagues studied prices for 1-month supplies, monthly sales, and revenue for the top 10 liver supplements sold on Amazon on June 3, 2023:

Ranking by sales:

• 1. Liver Cleanse Detox & Repair Formula – Herbal Liver Supplement with Milk Thistle, Dandelion Root, Organic Turmeric and Artichoke Extract for Liver Health – Silymarin Milk Thistle Detox Capsules
• 2. Ancestral Supplements Grass Fed Beef Liver Capsules. Supports Energy Production, Detoxification, Digestion, Immunity and Full Body Wellness, Non-GMO, Freeze Dried Liver Health Supplement, 180 Capsules
• 3. Bronson Milk Thistle 1,000 mg Silymarin Marianum & Dandelion Root Liver Health Support, 120 Capsules
• 4. PUREHEALTH RESEARCH Liver Supplement – Herbal Liver Cleanse Detox & Repair with Milk Thistle, Artichoke Extract, Dandelion Root, Turmeric, Berberine to Healthy Liver Renew with 11 Natural Nutrients
• 5. TUDCA Bile Salts Liver Support Supplement, 500-mg Servings, Liver and Gallbladder Cleanse Supplement (60 Capsules 250 mg) Genuine Bile Acid. TUDCA Strong Bitter Taste by Double Wood
• 6. 28-in-1 Liver Cleanse Detox & Repair Fatty Liver Formula, Milk Thistle Silymarin, Artichoke Extract, Dandelion & Apple Cider Vinegar – Liver Health Supplement Support Pills – Vegan Capsules
• 7. Vita-Liver Liver Health Supplement – Support Liver Cleanse & Detox – Liquid Delivery for Absorption – Milk Thistle, Artichoke, Chanca Piedra, Dandelion & More
• 8. Liver Supplement with Milk Thistle, Liver Detox Formula, Artichoke and Turmeric. Supports Liver Health Defense & Liver Renew. Liver Cleanse Detox & Repair for Fatty Liver Support. 60 Capsules
• 9. Liver Cleanse Detox & Repair. Milk Thistle Extract with Silymarin 80%, Artichoke Extract, Dandelion Root, Chicory, 25+ Herbs – Premium Liver Health Formula, Liver Support Detox Health Formula – Liver Support Detox Cleanse Supplement
• 10. Arazo Nutrition Liver Cleanse Detox & Repair Formula – Milk Thistle Herbal Support Supplement: Silymarin, Beet, Artichoke, Dandelion, Chicory Root

The investigators found a total of 65 unique ingredients. “Most of these ingredients have historical uses linked to liver health. But our research revealed that strong scientific evidence supporting the efficacy of any of these supplements is currently lacking,” Dr. Eltelbany said. They started the study by creating a new account on Amazon to make sure the search would not be influenced by prior shopping or purchases. They next searched for supplements using the keywords “liver” and “cleanse.” To figure out sales numbers, they used the AMZScout proprietary analytics software that Amazon sellers use to track sales. 
 

Reviewing the reviews

The researchers discovered an average 11,526 reviews for each supplement product. The average rating was 4.42 stars out of 5. 

Using Fakespot.com, proprietary Amazon customer review software that analyzes the timing and language of reviews, they found that only 65% of product reviews were genuine. 

“We felt it was crucial to vet the authenticity of customer feedback,” Dr. Eltelbany said.
 

Few other options?

Liver disease remains a persistent and significant global health burden. Despite advances in many areas of gastroenterology, there remains no curative treatment for liver cirrhosis, Dr. Eltelbany said. 

The primary option for people with end-stage liver disease is a liver transplant. “However, given the scarcity of donors and the vast number of patients in need, many individuals, unfortunately, do not get a timely transplant,” he said. “This void of treatment options and the desperation to find relief often drives patients towards alternative therapies.”

Also, online shopping has made getting these supplements “as simple as a click away. But what’s more concerning is the trust placed in these products by our patients,” Dr. Eltelbany said.

“There’s a strong need for rigorous scientific investigation into the actual health benefits of any liver detox supplements,” he said. “Above all, patient education remains paramount, warning them of potential risks and unknowns of these supplements.”

A version of this article appeared on WebMD.com.

The 10 best-selling liver health supplements on Amazon bring in an estimated $2.5 million each month. But none of them contain ingredients recommended by major groups of doctors who treat liver issues in the United States or Europe.

Like many supplements, popular online liver products are unregulated, meaning they do not have to meet the same safety and effectiveness standards as prescription medications. 

Sales of liver supplements are growing, particularly in the last few years, said Ahmed Eltelbany, MD, MPH, a first-year gastrointestinal fellow at the University of New Mexico. One reason could be increased alcohol use during the COVID-19 pandemic.

Some manufacturers make bold claims on Amazon, said Dr. Eltelbany, author of a study that looked into the supplements. “The most recurrent claims were that their supplements maintain normal liver function, are scientifically formulated, and – my personal favorite – are a highly effective liver detox formulation developed according to the latest scientific findings.”

While these claims might sound reassuring and scientifically grounded to an average consumer, he said, most of them are not backed up by rigorous clinical research.
 

Does natural mean safe?

Many supplements are marketed as “liver cleansing,” for “liver detox,” or for “liver support,” Dr. Eltelbany said as he presented the study results at the annual meeting of the American College of Gastroenterology. 

“People take these supplements because they believe they’re natural and therefore they’re safe,” said Paul Y. Kwo, MD, who moderated a session on the study at the meeting, when asked to comment. “As I tell every patient in clinic, a great white shark is natural, a scorpion is natural, and so is a hurricane. So just because they’re natural doesn’t mean they’re safe.”

At the same time, “it’s not that every supplement is bad for you. Nonetheless, there’s just a dizzying array of these out there” said Dr. Kwo, a professor of medicine at Stanford Medicine in Redwood, Calif.

“We have to be very cautious,” he said. For example, some people might believe that “if a little bit of a supplement is good, a tremendous amount must be really good.” The antioxidant turmeric, for example, has a pretty good safety record, he said. But this past year, some liver toxicity concerns arose about preparations with “very, very high concentrations” of turmeric. 
 

The top 10 sellers

Dr. Eltelbany and colleagues studied prices for 1-month supplies, monthly sales, and revenue for the top 10 liver supplements sold on Amazon on June 3, 2023:

Ranking by sales:

• 1. Liver Cleanse Detox & Repair Formula – Herbal Liver Supplement with Milk Thistle, Dandelion Root, Organic Turmeric and Artichoke Extract for Liver Health – Silymarin Milk Thistle Detox Capsules
• 2. Ancestral Supplements Grass Fed Beef Liver Capsules. Supports Energy Production, Detoxification, Digestion, Immunity and Full Body Wellness, Non-GMO, Freeze Dried Liver Health Supplement, 180 Capsules
• 3. Bronson Milk Thistle 1,000 mg Silymarin Marianum & Dandelion Root Liver Health Support, 120 Capsules
• 4. PUREHEALTH RESEARCH Liver Supplement – Herbal Liver Cleanse Detox & Repair with Milk Thistle, Artichoke Extract, Dandelion Root, Turmeric, Berberine to Healthy Liver Renew with 11 Natural Nutrients
• 5. TUDCA Bile Salts Liver Support Supplement, 500-mg Servings, Liver and Gallbladder Cleanse Supplement (60 Capsules 250 mg) Genuine Bile Acid. TUDCA Strong Bitter Taste by Double Wood
• 6. 28-in-1 Liver Cleanse Detox & Repair Fatty Liver Formula, Milk Thistle Silymarin, Artichoke Extract, Dandelion & Apple Cider Vinegar – Liver Health Supplement Support Pills – Vegan Capsules
• 7. Vita-Liver Liver Health Supplement – Support Liver Cleanse & Detox – Liquid Delivery for Absorption – Milk Thistle, Artichoke, Chanca Piedra, Dandelion & More
• 8. Liver Supplement with Milk Thistle, Liver Detox Formula, Artichoke and Turmeric. Supports Liver Health Defense & Liver Renew. Liver Cleanse Detox & Repair for Fatty Liver Support. 60 Capsules
• 9. Liver Cleanse Detox & Repair. Milk Thistle Extract with Silymarin 80%, Artichoke Extract, Dandelion Root, Chicory, 25+ Herbs – Premium Liver Health Formula, Liver Support Detox Health Formula – Liver Support Detox Cleanse Supplement
• 10. Arazo Nutrition Liver Cleanse Detox & Repair Formula – Milk Thistle Herbal Support Supplement: Silymarin, Beet, Artichoke, Dandelion, Chicory Root

The investigators found a total of 65 unique ingredients. “Most of these ingredients have historical uses linked to liver health. But our research revealed that strong scientific evidence supporting the efficacy of any of these supplements is currently lacking,” Dr. Eltelbany said. They started the study by creating a new account on Amazon to make sure the search would not be influenced by prior shopping or purchases. They next searched for supplements using the keywords “liver” and “cleanse.” To figure out sales numbers, they used the AMZScout proprietary analytics software that Amazon sellers use to track sales. 
 

Reviewing the reviews

The researchers discovered an average 11,526 reviews for each supplement product. The average rating was 4.42 stars out of 5. 

Using Fakespot.com, proprietary Amazon customer review software that analyzes the timing and language of reviews, they found that only 65% of product reviews were genuine. 

“We felt it was crucial to vet the authenticity of customer feedback,” Dr. Eltelbany said.
 

Few other options?

Liver disease remains a persistent and significant global health burden. Despite advances in many areas of gastroenterology, there remains no curative treatment for liver cirrhosis, Dr. Eltelbany said. 

The primary option for people with end-stage liver disease is a liver transplant. “However, given the scarcity of donors and the vast number of patients in need, many individuals, unfortunately, do not get a timely transplant,” he said. “This void of treatment options and the desperation to find relief often drives patients towards alternative therapies.”

Also, online shopping has made getting these supplements “as simple as a click away. But what’s more concerning is the trust placed in these products by our patients,” Dr. Eltelbany said.

“There’s a strong need for rigorous scientific investigation into the actual health benefits of any liver detox supplements,” he said. “Above all, patient education remains paramount, warning them of potential risks and unknowns of these supplements.”

A version of this article appeared on WebMD.com.

A pair of new studies published about long COVID have shed more light on the sometimes-disabling condition that affects millions of people in the United States. 

Scientists worldwide have been working to understand the wide-ranging condition, from risk factors to causes to potential treatments. 

In the first study, 31 adults underwent lumbar puncture and blood draws to look for changes in their immune systems and also to look for changes in the nerve cells that could affect transmission of signals to the brain.

Among the participants, 25 people had neurocognitive symptoms of long COVID, such as memory loss or attention problems. Six participants had fully recovered from COVID, and 17 people had never had COVID. 

Those who had COVID were diagnosed between March 2020 and May 2021. Their fluid samples were drawn at least three months after their first symptoms.

The results were published in the Journal of Infectious Diseases. Study results showed that long COVID does not appear to be linked to the SARS-CoV-2 virus invading the brain or causing active brain damage.

According to a summary of the study from the University of Gothenburg (Sweden), where the researchers work, “there were no significant differences between the groups when analyzing blood and cerebrospinal fluid for immune activation or brain injury markers. The findings thus suggest that post-COVID condition is not the result of ongoing infection, immune activation, or brain damage.”

In the second study, Norwegian researchers compared the likelihood of having 17 different long COVID symptoms based on whether a person had been infected with COVID. The analysis included 53,846 people who were diagnosed with COVID between February 2020 and February 2021, as well as more than 485,000 people who were not infected. Most people had not been vaccinated against COVID-19 during the time of the study.

The results were published in the journal BMC Infectious Diseases. Study results showed that people who had COVID were more than twice as likely to experience shortness of breath or fatigue. They were also more likely to experience memory loss or headache compared to people who never had COVID. Researchers only looked at symptoms that occurred at least three months after a COVID diagnosis.

They also found that hospitalization increased the risk for experiencing long COVID symptoms of shortness of breath, fatigue, and memory loss.

The authors noted that a limitation of their study was that, often, not all symptoms reported during a visit with a general practice medical provider are recorded in Norway, which could have affected the results.

A version of this article appeared on Medscape.com.

A pair of new studies published about long COVID have shed more light on the sometimes-disabling condition that affects millions of people in the United States. 

Scientists worldwide have been working to understand the wide-ranging condition, from risk factors to causes to potential treatments. 

In the first study, 31 adults underwent lumbar puncture and blood draws to look for changes in their immune systems and also to look for changes in the nerve cells that could affect transmission of signals to the brain.

Among the participants, 25 people had neurocognitive symptoms of long COVID, such as memory loss or attention problems. Six participants had fully recovered from COVID, and 17 people had never had COVID. 

Those who had COVID were diagnosed between March 2020 and May 2021. Their fluid samples were drawn at least three months after their first symptoms.

The results were published in the Journal of Infectious Diseases. Study results showed that long COVID does not appear to be linked to the SARS-CoV-2 virus invading the brain or causing active brain damage.

According to a summary of the study from the University of Gothenburg (Sweden), where the researchers work, “there were no significant differences between the groups when analyzing blood and cerebrospinal fluid for immune activation or brain injury markers. The findings thus suggest that post-COVID condition is not the result of ongoing infection, immune activation, or brain damage.”

In the second study, Norwegian researchers compared the likelihood of having 17 different long COVID symptoms based on whether a person had been infected with COVID. The analysis included 53,846 people who were diagnosed with COVID between February 2020 and February 2021, as well as more than 485,000 people who were not infected. Most people had not been vaccinated against COVID-19 during the time of the study.

The results were published in the journal BMC Infectious Diseases. Study results showed that people who had COVID were more than twice as likely to experience shortness of breath or fatigue. They were also more likely to experience memory loss or headache compared to people who never had COVID. Researchers only looked at symptoms that occurred at least three months after a COVID diagnosis.

They also found that hospitalization increased the risk for experiencing long COVID symptoms of shortness of breath, fatigue, and memory loss.

The authors noted that a limitation of their study was that, often, not all symptoms reported during a visit with a general practice medical provider are recorded in Norway, which could have affected the results.

A version of this article appeared on Medscape.com.

A pair of new studies published about long COVID have shed more light on the sometimes-disabling condition that affects millions of people in the United States. 

Scientists worldwide have been working to understand the wide-ranging condition, from risk factors to causes to potential treatments. 

In the first study, 31 adults underwent lumbar puncture and blood draws to look for changes in their immune systems and also to look for changes in the nerve cells that could affect transmission of signals to the brain.

Among the participants, 25 people had neurocognitive symptoms of long COVID, such as memory loss or attention problems. Six participants had fully recovered from COVID, and 17 people had never had COVID. 

Those who had COVID were diagnosed between March 2020 and May 2021. Their fluid samples were drawn at least three months after their first symptoms.

The results were published in the Journal of Infectious Diseases. Study results showed that long COVID does not appear to be linked to the SARS-CoV-2 virus invading the brain or causing active brain damage.

According to a summary of the study from the University of Gothenburg (Sweden), where the researchers work, “there were no significant differences between the groups when analyzing blood and cerebrospinal fluid for immune activation or brain injury markers. The findings thus suggest that post-COVID condition is not the result of ongoing infection, immune activation, or brain damage.”

In the second study, Norwegian researchers compared the likelihood of having 17 different long COVID symptoms based on whether a person had been infected with COVID. The analysis included 53,846 people who were diagnosed with COVID between February 2020 and February 2021, as well as more than 485,000 people who were not infected. Most people had not been vaccinated against COVID-19 during the time of the study.

The results were published in the journal BMC Infectious Diseases. Study results showed that people who had COVID were more than twice as likely to experience shortness of breath or fatigue. They were also more likely to experience memory loss or headache compared to people who never had COVID. Researchers only looked at symptoms that occurred at least three months after a COVID diagnosis.

They also found that hospitalization increased the risk for experiencing long COVID symptoms of shortness of breath, fatigue, and memory loss.

The authors noted that a limitation of their study was that, often, not all symptoms reported during a visit with a general practice medical provider are recorded in Norway, which could have affected the results.

A version of this article appeared on Medscape.com.

TOPLINE:

Atrial fibrillation (AF) is associated with a 45% increased risk of mild cognitive impairment (MCI), an outcome that’s linked to cardiovascular risk factors and multi-comorbidity, results of a new study suggest.

METHODOLOGY:

• From over 4.3 million people in the UK primary electronic health record (EHR) database, researchers identified 233,833 (5.4%) with AF (mean age, 74.2 years) and randomly selected one age- and sex-matched control person without AF for each AF case patient.
• The primary outcome was incidence of mild cognitive impairment (MCI).
• The authors adjusted for age, sex, year at study entry, socioeconomic status, smoking, and a number of comorbid conditions.
• During a median of 5.3 years of follow-up, there were 4,269 incident MCI cases among both AF and non-AF patients.

TAKEAWAY:

• Individuals with AF had a higher risk of MCI than that of those without AF (adjusted hazard ratio [aHR], 1.45; 95% confidence interval [CI], 1.35-1.56).
• Besides AF, older age (risk ratio [RR], 1.08) and history of depression (RR, 1.44) were associated with greater risk of MCI, as were female sex, greater socioeconomic deprivation, stroke, and multimorbidity, including, for example, diabetes, hypercholesterolemia, and peripheral artery disease (all P < .001).
• Individuals with AF who received oral anticoagulants or amiodarone were not at increased risk of MCI, as was the case for those treated with digoxin.
• Individuals with AF and MCI were at greater risk of dementia (aHR, 1.25; 95% CI, 1.09-1.42). Sex, smoking, chronic kidney disease, and multi-comorbidity were among factors linked to elevated dementia risk.

IN PRACTICE:

The findings emphasize the association of multi-comorbidity and cardiovascular risk factors with development of MCI and progression to dementia in AF patients, the authors wrote. They noted that the data suggest combining anticoagulation and symptom and comorbidity management may prevent cognitive deterioration.

SOURCE:

The study was conducted by Sheng-Chia Chung, PhD, Institute of Health informatics Research, University College London, and colleagues. It was published online Oct. 25, 2023, as a research letter in the Journal of the American College of Cardiology (JACC): Advances. 

LIMITATIONS:

The EHR dataset may have lacked granularity and detail, and some risk factors or comorbidities may not have been measured. While those with AF receiving digoxin or amiodarone treatment had no higher risk of MCI than their non-AF peers, the study’s observational design and very wide confidence intervals for these subgroups prevent making solid inferences about causality or a potential protective role of these drugs.

DISCLOSURES:

Dr. Chung is supported by the National Institute of Health and Care Research (NIHR) Author Rui Providencia, MD, PhD, of the Institute of Health informatics Research, University College London, is supported by the University College London British Heart Foundation and NIHR. All other authors report no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Atrial fibrillation (AF) is associated with a 45% increased risk of mild cognitive impairment (MCI), an outcome that’s linked to cardiovascular risk factors and multi-comorbidity, results of a new study suggest.

METHODOLOGY:

• From over 4.3 million people in the UK primary electronic health record (EHR) database, researchers identified 233,833 (5.4%) with AF (mean age, 74.2 years) and randomly selected one age- and sex-matched control person without AF for each AF case patient.
• The primary outcome was incidence of mild cognitive impairment (MCI).
• The authors adjusted for age, sex, year at study entry, socioeconomic status, smoking, and a number of comorbid conditions.
• During a median of 5.3 years of follow-up, there were 4,269 incident MCI cases among both AF and non-AF patients.

TAKEAWAY:

• Individuals with AF had a higher risk of MCI than that of those without AF (adjusted hazard ratio [aHR], 1.45; 95% confidence interval [CI], 1.35-1.56).
• Besides AF, older age (risk ratio [RR], 1.08) and history of depression (RR, 1.44) were associated with greater risk of MCI, as were female sex, greater socioeconomic deprivation, stroke, and multimorbidity, including, for example, diabetes, hypercholesterolemia, and peripheral artery disease (all P < .001).
• Individuals with AF who received oral anticoagulants or amiodarone were not at increased risk of MCI, as was the case for those treated with digoxin.
• Individuals with AF and MCI were at greater risk of dementia (aHR, 1.25; 95% CI, 1.09-1.42). Sex, smoking, chronic kidney disease, and multi-comorbidity were among factors linked to elevated dementia risk.

IN PRACTICE:

The findings emphasize the association of multi-comorbidity and cardiovascular risk factors with development of MCI and progression to dementia in AF patients, the authors wrote. They noted that the data suggest combining anticoagulation and symptom and comorbidity management may prevent cognitive deterioration.

SOURCE:

The study was conducted by Sheng-Chia Chung, PhD, Institute of Health informatics Research, University College London, and colleagues. It was published online Oct. 25, 2023, as a research letter in the Journal of the American College of Cardiology (JACC): Advances. 

LIMITATIONS:

The EHR dataset may have lacked granularity and detail, and some risk factors or comorbidities may not have been measured. While those with AF receiving digoxin or amiodarone treatment had no higher risk of MCI than their non-AF peers, the study’s observational design and very wide confidence intervals for these subgroups prevent making solid inferences about causality or a potential protective role of these drugs.

DISCLOSURES:

Dr. Chung is supported by the National Institute of Health and Care Research (NIHR) Author Rui Providencia, MD, PhD, of the Institute of Health informatics Research, University College London, is supported by the University College London British Heart Foundation and NIHR. All other authors report no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Atrial fibrillation (AF) is associated with a 45% increased risk of mild cognitive impairment (MCI), an outcome that’s linked to cardiovascular risk factors and multi-comorbidity, results of a new study suggest.

METHODOLOGY:

• From over 4.3 million people in the UK primary electronic health record (EHR) database, researchers identified 233,833 (5.4%) with AF (mean age, 74.2 years) and randomly selected one age- and sex-matched control person without AF for each AF case patient.
• The primary outcome was incidence of mild cognitive impairment (MCI).
• The authors adjusted for age, sex, year at study entry, socioeconomic status, smoking, and a number of comorbid conditions.
• During a median of 5.3 years of follow-up, there were 4,269 incident MCI cases among both AF and non-AF patients.

TAKEAWAY:

• Individuals with AF had a higher risk of MCI than that of those without AF (adjusted hazard ratio [aHR], 1.45; 95% confidence interval [CI], 1.35-1.56).
• Besides AF, older age (risk ratio [RR], 1.08) and history of depression (RR, 1.44) were associated with greater risk of MCI, as were female sex, greater socioeconomic deprivation, stroke, and multimorbidity, including, for example, diabetes, hypercholesterolemia, and peripheral artery disease (all P < .001).
• Individuals with AF who received oral anticoagulants or amiodarone were not at increased risk of MCI, as was the case for those treated with digoxin.
• Individuals with AF and MCI were at greater risk of dementia (aHR, 1.25; 95% CI, 1.09-1.42). Sex, smoking, chronic kidney disease, and multi-comorbidity were among factors linked to elevated dementia risk.

IN PRACTICE:

The findings emphasize the association of multi-comorbidity and cardiovascular risk factors with development of MCI and progression to dementia in AF patients, the authors wrote. They noted that the data suggest combining anticoagulation and symptom and comorbidity management may prevent cognitive deterioration.

SOURCE:

The study was conducted by Sheng-Chia Chung, PhD, Institute of Health informatics Research, University College London, and colleagues. It was published online Oct. 25, 2023, as a research letter in the Journal of the American College of Cardiology (JACC): Advances. 

LIMITATIONS:

The EHR dataset may have lacked granularity and detail, and some risk factors or comorbidities may not have been measured. While those with AF receiving digoxin or amiodarone treatment had no higher risk of MCI than their non-AF peers, the study’s observational design and very wide confidence intervals for these subgroups prevent making solid inferences about causality or a potential protective role of these drugs.

DISCLOSURES:

Dr. Chung is supported by the National Institute of Health and Care Research (NIHR) Author Rui Providencia, MD, PhD, of the Institute of Health informatics Research, University College London, is supported by the University College London British Heart Foundation and NIHR. All other authors report no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.