Digital tool clarifies menopause symptoms

Article Type
Changed

– 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.

Publications
Topics
Sections

– 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.

– 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.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT RCGP 2023

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Popular liver supplements lack data supporting efficacy, study shows

Article Type
Changed

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.

Publications
Topics
Sections

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.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM ACG 2023

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

People with long COVID don’t show signs of brain damage

Article Type
Changed

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.

Publications
Topics
Sections

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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

AF tied to 45% increase in mild cognitive impairment

Article Type
Changed

 

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.

Publications
Topics
Sections

 

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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

ACORN: No excess AKI with pip-tazo vs. cefepime

Article Type
Changed

Two antibiotics, both alike in efficacy, are commonly prescribed for empirical treatment of infection in hospitalized adults.

Yet each drug – cefepime and piperacillin-tazobactam (Zosyn) – has its own baggage in terms of suspected associated toxicities: Cefepime has been implicated in neurologic dysfunction, and piperacillin-tazobactam has been associated with acute kidney injury (AKI).

The true nature of toxicities associated with each agent in clinical practice has been unclear, however – until now. As results of the randomized ACORN (Antibiotic Choice on Renal Outcomes) trial showed, piperacillin-tazobactam was not associated with a higher incidence of AKI, compared with cefepime, but cefepime was indeed associated with a higher incidence of neurologic dysfunction as measured by freedom from delirium and coma.

The findings, by Edward T. Qian, MD MSc and colleagues at Vanderbilt University Medical Center, Nashville, Tenn.e, were published in JAMA.
 

Questioning a common practice

In an interview, Dr. Qian said that he and his colleagues conducted the pragmatic trial to seek answers to an important issue.

“We noticed a change in practice patterns as people were afraid of using Zosyn as empiric antibody therapy because they were afraid of the risks of AKI,” he said. “And as that practice shifted with a lower quality of evidence, just from observational studies, we started using more cefepime and we started seeing more patients with this rare phenomenon called ‘cefepime neurotoxicity.’ ”

To see whether the choice of one antibiotic over the other would affect the risk for either AKI or neurologic dysfunction, the investigators enrolled adults for whom a clinician ordered antipseudomonal antibiotics with 12 hours of when they were seen in the ED or medical ICU.

The patients were randomized on a 1:1 basis to receive either cefepime or piperacillin-tazobactam.

A total of 2,511 patients treated from Nov. 10, 2021, to Oct. 7, 2022, were included in the primary analysis. A large majority of the patients (94.7%) were enrolled in the ED, and 77.2% of patients were also receiving vancomycin at the time of enrollment.
 

No added AKI risk

The investigators found that there was no significant difference between the drugs for the primary outcome of the highest stage of AKI or death within 14 days of the start of treatment.

In the cefepime arm, 85 of 1,214 patients (7.0%) had stage 3 AKI, and 92 (7.6%) died.

In the piperacillin-tazobactam arm, 97 of 1,297 patients (7.5%) had stage 3 AKI, and 78 (6%) died. As noted, the difference was not statistically significant.

In addition, there was no significant difference between the groups in the secondary endpoint of the incidence of major adverse kidney events at day 14, with 10.2% in the cefepime arm and 8.8% in the piperacillin-tazobactam arm having an event.

As noted before, however, there was a significant difference in the secondary outcome of the number of days alive and free of delirium and coma within 14 days.

Patients on cefepime had a mean 11.9 days free of delirium and coma, compared with 12.2 days for patients on piperacillin-tazobactam. This difference translated into an odds ratio of 0.79 (95% confidence interval, 0.65-0.95).

Dr. Qian said that he and his colleagues stop short of calling the neurologic dysfunction that they observed “cefepime neurotoxicity,” but added that it warrants further study.
 

 

 

Risk factors examined

The investigators plan to evaluate those patients who developed neurologic dysfunction while on the drug to see whether there were predisposing factors that might be a contraindication for cefepime in some cases.

“I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection,” Dr. Qian said.

The ACORN investigators are supported by grants from the National Heart, Lung, and Blood Institute; National Institutes of Health; National Center for Advancing Translational Science; US Defense Department; and Vanderbilt University. Dr. Qian had no conflicts of interest to disclose.

Publications
Topics
Sections

Two antibiotics, both alike in efficacy, are commonly prescribed for empirical treatment of infection in hospitalized adults.

Yet each drug – cefepime and piperacillin-tazobactam (Zosyn) – has its own baggage in terms of suspected associated toxicities: Cefepime has been implicated in neurologic dysfunction, and piperacillin-tazobactam has been associated with acute kidney injury (AKI).

The true nature of toxicities associated with each agent in clinical practice has been unclear, however – until now. As results of the randomized ACORN (Antibiotic Choice on Renal Outcomes) trial showed, piperacillin-tazobactam was not associated with a higher incidence of AKI, compared with cefepime, but cefepime was indeed associated with a higher incidence of neurologic dysfunction as measured by freedom from delirium and coma.

The findings, by Edward T. Qian, MD MSc and colleagues at Vanderbilt University Medical Center, Nashville, Tenn.e, were published in JAMA.
 

Questioning a common practice

In an interview, Dr. Qian said that he and his colleagues conducted the pragmatic trial to seek answers to an important issue.

“We noticed a change in practice patterns as people were afraid of using Zosyn as empiric antibody therapy because they were afraid of the risks of AKI,” he said. “And as that practice shifted with a lower quality of evidence, just from observational studies, we started using more cefepime and we started seeing more patients with this rare phenomenon called ‘cefepime neurotoxicity.’ ”

To see whether the choice of one antibiotic over the other would affect the risk for either AKI or neurologic dysfunction, the investigators enrolled adults for whom a clinician ordered antipseudomonal antibiotics with 12 hours of when they were seen in the ED or medical ICU.

The patients were randomized on a 1:1 basis to receive either cefepime or piperacillin-tazobactam.

A total of 2,511 patients treated from Nov. 10, 2021, to Oct. 7, 2022, were included in the primary analysis. A large majority of the patients (94.7%) were enrolled in the ED, and 77.2% of patients were also receiving vancomycin at the time of enrollment.
 

No added AKI risk

The investigators found that there was no significant difference between the drugs for the primary outcome of the highest stage of AKI or death within 14 days of the start of treatment.

In the cefepime arm, 85 of 1,214 patients (7.0%) had stage 3 AKI, and 92 (7.6%) died.

In the piperacillin-tazobactam arm, 97 of 1,297 patients (7.5%) had stage 3 AKI, and 78 (6%) died. As noted, the difference was not statistically significant.

In addition, there was no significant difference between the groups in the secondary endpoint of the incidence of major adverse kidney events at day 14, with 10.2% in the cefepime arm and 8.8% in the piperacillin-tazobactam arm having an event.

As noted before, however, there was a significant difference in the secondary outcome of the number of days alive and free of delirium and coma within 14 days.

Patients on cefepime had a mean 11.9 days free of delirium and coma, compared with 12.2 days for patients on piperacillin-tazobactam. This difference translated into an odds ratio of 0.79 (95% confidence interval, 0.65-0.95).

Dr. Qian said that he and his colleagues stop short of calling the neurologic dysfunction that they observed “cefepime neurotoxicity,” but added that it warrants further study.
 

 

 

Risk factors examined

The investigators plan to evaluate those patients who developed neurologic dysfunction while on the drug to see whether there were predisposing factors that might be a contraindication for cefepime in some cases.

“I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection,” Dr. Qian said.

The ACORN investigators are supported by grants from the National Heart, Lung, and Blood Institute; National Institutes of Health; National Center for Advancing Translational Science; US Defense Department; and Vanderbilt University. Dr. Qian had no conflicts of interest to disclose.

Two antibiotics, both alike in efficacy, are commonly prescribed for empirical treatment of infection in hospitalized adults.

Yet each drug – cefepime and piperacillin-tazobactam (Zosyn) – has its own baggage in terms of suspected associated toxicities: Cefepime has been implicated in neurologic dysfunction, and piperacillin-tazobactam has been associated with acute kidney injury (AKI).

The true nature of toxicities associated with each agent in clinical practice has been unclear, however – until now. As results of the randomized ACORN (Antibiotic Choice on Renal Outcomes) trial showed, piperacillin-tazobactam was not associated with a higher incidence of AKI, compared with cefepime, but cefepime was indeed associated with a higher incidence of neurologic dysfunction as measured by freedom from delirium and coma.

The findings, by Edward T. Qian, MD MSc and colleagues at Vanderbilt University Medical Center, Nashville, Tenn.e, were published in JAMA.
 

Questioning a common practice

In an interview, Dr. Qian said that he and his colleagues conducted the pragmatic trial to seek answers to an important issue.

“We noticed a change in practice patterns as people were afraid of using Zosyn as empiric antibody therapy because they were afraid of the risks of AKI,” he said. “And as that practice shifted with a lower quality of evidence, just from observational studies, we started using more cefepime and we started seeing more patients with this rare phenomenon called ‘cefepime neurotoxicity.’ ”

To see whether the choice of one antibiotic over the other would affect the risk for either AKI or neurologic dysfunction, the investigators enrolled adults for whom a clinician ordered antipseudomonal antibiotics with 12 hours of when they were seen in the ED or medical ICU.

The patients were randomized on a 1:1 basis to receive either cefepime or piperacillin-tazobactam.

A total of 2,511 patients treated from Nov. 10, 2021, to Oct. 7, 2022, were included in the primary analysis. A large majority of the patients (94.7%) were enrolled in the ED, and 77.2% of patients were also receiving vancomycin at the time of enrollment.
 

No added AKI risk

The investigators found that there was no significant difference between the drugs for the primary outcome of the highest stage of AKI or death within 14 days of the start of treatment.

In the cefepime arm, 85 of 1,214 patients (7.0%) had stage 3 AKI, and 92 (7.6%) died.

In the piperacillin-tazobactam arm, 97 of 1,297 patients (7.5%) had stage 3 AKI, and 78 (6%) died. As noted, the difference was not statistically significant.

In addition, there was no significant difference between the groups in the secondary endpoint of the incidence of major adverse kidney events at day 14, with 10.2% in the cefepime arm and 8.8% in the piperacillin-tazobactam arm having an event.

As noted before, however, there was a significant difference in the secondary outcome of the number of days alive and free of delirium and coma within 14 days.

Patients on cefepime had a mean 11.9 days free of delirium and coma, compared with 12.2 days for patients on piperacillin-tazobactam. This difference translated into an odds ratio of 0.79 (95% confidence interval, 0.65-0.95).

Dr. Qian said that he and his colleagues stop short of calling the neurologic dysfunction that they observed “cefepime neurotoxicity,” but added that it warrants further study.
 

 

 

Risk factors examined

The investigators plan to evaluate those patients who developed neurologic dysfunction while on the drug to see whether there were predisposing factors that might be a contraindication for cefepime in some cases.

“I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection,” Dr. Qian said.

The ACORN investigators are supported by grants from the National Heart, Lung, and Blood Institute; National Institutes of Health; National Center for Advancing Translational Science; US Defense Department; and Vanderbilt University. Dr. Qian had no conflicts of interest to disclose.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Thoracic ultrasound advancements for the assessment and management of pleural disorders

Article Type
Changed

 

Thoracic Oncology Network

Ultrasound & Chest Imaging Section

Thoracic ultrasound (TUS) is standard of care for the detection of pleural effusion and guidance of pleural procedures. Recent advancements have further expanded the utility of TUS. TUS has better diagnostic performance than CT scan or chest radiograph for predicting complicated parapneumonic effusion (Svigals PZ, et al. Thorax. 2017;72[1]:94-5). This is likely because of better visualization of septation, but there are still limitations. In a study of 300 pleural ultrasounds, TUS was found to be inadequately reliable in the diagnosis of transudative pleural effusion as 56% of anechoic effusions were exudative, but complex appearing pleural effusion on TUS was found to have high predictive value for the diagnosis of exudative pleural effusion (Shkolnik B, et al. Chest2020;158[2]:692-7).

TUS may diagnose nonexpendable lung prior to drainage in malignant pleural effusions. Using M-mode to assess lung motion and speckled tracking for the assessment of lung stain, blunted cardio-phasic response of the lung was highly specific for the diagnosis of nonexpandable lung (Salamonsen MR, et al. Chest. 2014;146[5]:1286-93). TUS can also be used to assess the success of pleurodesis as measured by the adherence score (abolishment of pleural sliding). TUS guided pleurodesis approach was shown to decrease the hospital length of stay in patients undergoing pleurodesis for malignant pleural effusion (Psallidas I, et al. Lancet Respir Med. 2022;10[2]:139-48). Point-of-care TUS is evolving, and adapted use focusing on patient-centered outcomes will further enhance the utility of this indispensable tool.

Amit Chopra, MD, FCCP

Nicholas Villalobos, MD

Publications
Topics
Sections

 

Thoracic Oncology Network

Ultrasound & Chest Imaging Section

Thoracic ultrasound (TUS) is standard of care for the detection of pleural effusion and guidance of pleural procedures. Recent advancements have further expanded the utility of TUS. TUS has better diagnostic performance than CT scan or chest radiograph for predicting complicated parapneumonic effusion (Svigals PZ, et al. Thorax. 2017;72[1]:94-5). This is likely because of better visualization of septation, but there are still limitations. In a study of 300 pleural ultrasounds, TUS was found to be inadequately reliable in the diagnosis of transudative pleural effusion as 56% of anechoic effusions were exudative, but complex appearing pleural effusion on TUS was found to have high predictive value for the diagnosis of exudative pleural effusion (Shkolnik B, et al. Chest2020;158[2]:692-7).

TUS may diagnose nonexpendable lung prior to drainage in malignant pleural effusions. Using M-mode to assess lung motion and speckled tracking for the assessment of lung stain, blunted cardio-phasic response of the lung was highly specific for the diagnosis of nonexpandable lung (Salamonsen MR, et al. Chest. 2014;146[5]:1286-93). TUS can also be used to assess the success of pleurodesis as measured by the adherence score (abolishment of pleural sliding). TUS guided pleurodesis approach was shown to decrease the hospital length of stay in patients undergoing pleurodesis for malignant pleural effusion (Psallidas I, et al. Lancet Respir Med. 2022;10[2]:139-48). Point-of-care TUS is evolving, and adapted use focusing on patient-centered outcomes will further enhance the utility of this indispensable tool.

Amit Chopra, MD, FCCP

Nicholas Villalobos, MD

 

Thoracic Oncology Network

Ultrasound & Chest Imaging Section

Thoracic ultrasound (TUS) is standard of care for the detection of pleural effusion and guidance of pleural procedures. Recent advancements have further expanded the utility of TUS. TUS has better diagnostic performance than CT scan or chest radiograph for predicting complicated parapneumonic effusion (Svigals PZ, et al. Thorax. 2017;72[1]:94-5). This is likely because of better visualization of septation, but there are still limitations. In a study of 300 pleural ultrasounds, TUS was found to be inadequately reliable in the diagnosis of transudative pleural effusion as 56% of anechoic effusions were exudative, but complex appearing pleural effusion on TUS was found to have high predictive value for the diagnosis of exudative pleural effusion (Shkolnik B, et al. Chest2020;158[2]:692-7).

TUS may diagnose nonexpendable lung prior to drainage in malignant pleural effusions. Using M-mode to assess lung motion and speckled tracking for the assessment of lung stain, blunted cardio-phasic response of the lung was highly specific for the diagnosis of nonexpandable lung (Salamonsen MR, et al. Chest. 2014;146[5]:1286-93). TUS can also be used to assess the success of pleurodesis as measured by the adherence score (abolishment of pleural sliding). TUS guided pleurodesis approach was shown to decrease the hospital length of stay in patients undergoing pleurodesis for malignant pleural effusion (Psallidas I, et al. Lancet Respir Med. 2022;10[2]:139-48). Point-of-care TUS is evolving, and adapted use focusing on patient-centered outcomes will further enhance the utility of this indispensable tool.

Amit Chopra, MD, FCCP

Nicholas Villalobos, MD

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Seasonal variations in sleep architecture

Article Type
Changed

 

Sleep Network

Non-Respiratory Sleep Section

Do you feel like you sleep worse in the spring and have more difficulty keeping your schedule on track? There are new data to support the way you feel based on our deeper understanding of seasonal variations in sleep architecture.

Patients in a recent study had 43 minutes less total sleep time and approximately 30 less minutes of REM sleep in the late spring when compared with the winter (Seidler A, et al. Front Neurosci. 2023 Feb 17:17:1105233). Accumulation of decreased sleep time and quality can lead to the sensation of ‘running-on-empty’ by early spring.

Experts believe these seasonal variations in sleep architecture are mainly secondary to circadian shifts. Our social synchronization overrides our natural alignment with daylight patterns and can lead to known consequences of circadian misalignment. Common consequences of poor circadian alignment include worsening sleep disturbances, cognitive impairments, occupational mistakes, and metabolic and mental health disturbances (Schmal C, et al. Front Physiol. 2020 Apr 28:11:334; Boivin D, et al. J Biol Rhythms. 2022 Feb;37[1]:3-28).

The effects of circadian misalignment can be particularly dramatic in children receiving less than their age-appropriate hours of sleep. Children with sleep deprivation are at increased risk of attention, behavior, and learning problems (Paruthi S, et al. J Clinl Sleep Med. 2016;12[6]:785-6).

To improve circadian alignment in spring, it is recommended to achieve morning bright light exposure and perform regular exercise. The elimination of daylight savings time to a consensus of permanent standard time will optimize circadian alignment.

Christopher Izzo, DO – Section Fellow-in-Training

William Healy, MD – Section Member-at-Large

Mariam Louis, MD – Section Chair

Publications
Topics
Sections

 

Sleep Network

Non-Respiratory Sleep Section

Do you feel like you sleep worse in the spring and have more difficulty keeping your schedule on track? There are new data to support the way you feel based on our deeper understanding of seasonal variations in sleep architecture.

Patients in a recent study had 43 minutes less total sleep time and approximately 30 less minutes of REM sleep in the late spring when compared with the winter (Seidler A, et al. Front Neurosci. 2023 Feb 17:17:1105233). Accumulation of decreased sleep time and quality can lead to the sensation of ‘running-on-empty’ by early spring.

Experts believe these seasonal variations in sleep architecture are mainly secondary to circadian shifts. Our social synchronization overrides our natural alignment with daylight patterns and can lead to known consequences of circadian misalignment. Common consequences of poor circadian alignment include worsening sleep disturbances, cognitive impairments, occupational mistakes, and metabolic and mental health disturbances (Schmal C, et al. Front Physiol. 2020 Apr 28:11:334; Boivin D, et al. J Biol Rhythms. 2022 Feb;37[1]:3-28).

The effects of circadian misalignment can be particularly dramatic in children receiving less than their age-appropriate hours of sleep. Children with sleep deprivation are at increased risk of attention, behavior, and learning problems (Paruthi S, et al. J Clinl Sleep Med. 2016;12[6]:785-6).

To improve circadian alignment in spring, it is recommended to achieve morning bright light exposure and perform regular exercise. The elimination of daylight savings time to a consensus of permanent standard time will optimize circadian alignment.

Christopher Izzo, DO – Section Fellow-in-Training

William Healy, MD – Section Member-at-Large

Mariam Louis, MD – Section Chair

 

Sleep Network

Non-Respiratory Sleep Section

Do you feel like you sleep worse in the spring and have more difficulty keeping your schedule on track? There are new data to support the way you feel based on our deeper understanding of seasonal variations in sleep architecture.

Patients in a recent study had 43 minutes less total sleep time and approximately 30 less minutes of REM sleep in the late spring when compared with the winter (Seidler A, et al. Front Neurosci. 2023 Feb 17:17:1105233). Accumulation of decreased sleep time and quality can lead to the sensation of ‘running-on-empty’ by early spring.

Experts believe these seasonal variations in sleep architecture are mainly secondary to circadian shifts. Our social synchronization overrides our natural alignment with daylight patterns and can lead to known consequences of circadian misalignment. Common consequences of poor circadian alignment include worsening sleep disturbances, cognitive impairments, occupational mistakes, and metabolic and mental health disturbances (Schmal C, et al. Front Physiol. 2020 Apr 28:11:334; Boivin D, et al. J Biol Rhythms. 2022 Feb;37[1]:3-28).

The effects of circadian misalignment can be particularly dramatic in children receiving less than their age-appropriate hours of sleep. Children with sleep deprivation are at increased risk of attention, behavior, and learning problems (Paruthi S, et al. J Clinl Sleep Med. 2016;12[6]:785-6).

To improve circadian alignment in spring, it is recommended to achieve morning bright light exposure and perform regular exercise. The elimination of daylight savings time to a consensus of permanent standard time will optimize circadian alignment.

Christopher Izzo, DO – Section Fellow-in-Training

William Healy, MD – Section Member-at-Large

Mariam Louis, MD – Section Chair

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article