TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

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

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

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

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

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

The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

• Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
• Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
• Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
• Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
• The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
• Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
• Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
• Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
• Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
• Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

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

The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

• Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
• Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
• Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
• Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
• The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
• Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
• Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
• Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
• Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
• Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

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

The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

• Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
• Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
• Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
• Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
• The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
• Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
• Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
• Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
• Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
• Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

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

TOPLINE:
 

Patients with spondyloarthritis (SpA) experience similar gut microbiota dysbiosis with related inflammatory conditions, such as acute anterior uveitis (AAU) and Crohn’s disease (CD), new data show.

METHODOLOGY:

• Researchers performed 16S rRNA sequencing on stool samples from 277 adult patients from the German Spondyloarthritis Inception Cohort (102 with SpA, 72 with CD, and 103 with AAU) and 62 control patients with chronic back pain for whom SpA had been ruled out.
• Patients were treatment naive to biologic disease-modifying antirheumatic drugs or had not received them for more than 3 months prior to study enrollment.
• The study is the first to identify the same microbiota in patients with SpA, AAU, and CD.

TAKEAWAY:

• “Our results showed a shared depletion of predominately Lachnospiraceae taxa, most notably Fusicatenibacter, which partially mediated increased CRP [C-reactive protein], and was most abundant in controls receiving NSAID monotherapy,” the researchers wrote.
• Among patients who tested positive for HLA-B27, an allele associated with SpA and other spondyloarthropathies, levels of Faecalibacterium were increased; among patients with SpA, levels of Collinsella were enriched; and among patients with CD, there was an abundance of beneficial Ruminococcus bacteria.
• The results suggest the diagnostic and therapeutic potential of the gut microbiome for mediating disease activity for patients with autoimmune diseases.
• Additional research is needed to clarify the roles of different bacteria in gut-joint inflammation and to understand the relationship between genetics and gut microbes.

IN PRACTICE:

The study is too preliminary to have applications for practice.

SOURCE:

Co–first authors Morgan Essex, MSc, and Valeria Rios Rodriguez, MD, of Charité–Universitätsmedizin Berlin and colleagues conducted the study, which was published online July 20, 2023, in Arthritis and Rheumatology.

LIMITATIONS:

• The results were limited by several factors, including the restriction to amplicon sequencing, which prevented in-depth characterization of the gut microbiome.
• More studies are needed to validate the findings, especially regarding gut bacteria as potential mediators of inflammation or disease activity. The researchers recommended studies with whole-genome sequencing and fecal metabolite quantification.

DISCLOSURES:

The study was supported in part by the Deutsche Forschungsgemeinschaft. Additional funding came from the German Federal Ministry for Health and Research and the Berlin Institute of Health. Two patient cohorts were partially and separately supported by grants from Novartis and AbbVie.

A version of this article appeared on Medscape.com.

TOPLINE:
 

Patients with spondyloarthritis (SpA) experience similar gut microbiota dysbiosis with related inflammatory conditions, such as acute anterior uveitis (AAU) and Crohn’s disease (CD), new data show.

METHODOLOGY:

• Researchers performed 16S rRNA sequencing on stool samples from 277 adult patients from the German Spondyloarthritis Inception Cohort (102 with SpA, 72 with CD, and 103 with AAU) and 62 control patients with chronic back pain for whom SpA had been ruled out.
• Patients were treatment naive to biologic disease-modifying antirheumatic drugs or had not received them for more than 3 months prior to study enrollment.
• The study is the first to identify the same microbiota in patients with SpA, AAU, and CD.

TAKEAWAY:

• “Our results showed a shared depletion of predominately Lachnospiraceae taxa, most notably Fusicatenibacter, which partially mediated increased CRP [C-reactive protein], and was most abundant in controls receiving NSAID monotherapy,” the researchers wrote.
• Among patients who tested positive for HLA-B27, an allele associated with SpA and other spondyloarthropathies, levels of Faecalibacterium were increased; among patients with SpA, levels of Collinsella were enriched; and among patients with CD, there was an abundance of beneficial Ruminococcus bacteria.
• The results suggest the diagnostic and therapeutic potential of the gut microbiome for mediating disease activity for patients with autoimmune diseases.
• Additional research is needed to clarify the roles of different bacteria in gut-joint inflammation and to understand the relationship between genetics and gut microbes.

IN PRACTICE:

The study is too preliminary to have applications for practice.

SOURCE:

Co–first authors Morgan Essex, MSc, and Valeria Rios Rodriguez, MD, of Charité–Universitätsmedizin Berlin and colleagues conducted the study, which was published online July 20, 2023, in Arthritis and Rheumatology.

LIMITATIONS:

• The results were limited by several factors, including the restriction to amplicon sequencing, which prevented in-depth characterization of the gut microbiome.
• More studies are needed to validate the findings, especially regarding gut bacteria as potential mediators of inflammation or disease activity. The researchers recommended studies with whole-genome sequencing and fecal metabolite quantification.

DISCLOSURES:

The study was supported in part by the Deutsche Forschungsgemeinschaft. Additional funding came from the German Federal Ministry for Health and Research and the Berlin Institute of Health. Two patient cohorts were partially and separately supported by grants from Novartis and AbbVie.

A version of this article appeared on Medscape.com.

TOPLINE:
 

Patients with spondyloarthritis (SpA) experience similar gut microbiota dysbiosis with related inflammatory conditions, such as acute anterior uveitis (AAU) and Crohn’s disease (CD), new data show.

METHODOLOGY:

• Researchers performed 16S rRNA sequencing on stool samples from 277 adult patients from the German Spondyloarthritis Inception Cohort (102 with SpA, 72 with CD, and 103 with AAU) and 62 control patients with chronic back pain for whom SpA had been ruled out.
• Patients were treatment naive to biologic disease-modifying antirheumatic drugs or had not received them for more than 3 months prior to study enrollment.
• The study is the first to identify the same microbiota in patients with SpA, AAU, and CD.

TAKEAWAY:

• “Our results showed a shared depletion of predominately Lachnospiraceae taxa, most notably Fusicatenibacter, which partially mediated increased CRP [C-reactive protein], and was most abundant in controls receiving NSAID monotherapy,” the researchers wrote.
• Among patients who tested positive for HLA-B27, an allele associated with SpA and other spondyloarthropathies, levels of Faecalibacterium were increased; among patients with SpA, levels of Collinsella were enriched; and among patients with CD, there was an abundance of beneficial Ruminococcus bacteria.
• The results suggest the diagnostic and therapeutic potential of the gut microbiome for mediating disease activity for patients with autoimmune diseases.
• Additional research is needed to clarify the roles of different bacteria in gut-joint inflammation and to understand the relationship between genetics and gut microbes.

IN PRACTICE:

The study is too preliminary to have applications for practice.

SOURCE:

Co–first authors Morgan Essex, MSc, and Valeria Rios Rodriguez, MD, of Charité–Universitätsmedizin Berlin and colleagues conducted the study, which was published online July 20, 2023, in Arthritis and Rheumatology.

LIMITATIONS:

• The results were limited by several factors, including the restriction to amplicon sequencing, which prevented in-depth characterization of the gut microbiome.
• More studies are needed to validate the findings, especially regarding gut bacteria as potential mediators of inflammation or disease activity. The researchers recommended studies with whole-genome sequencing and fecal metabolite quantification.

DISCLOSURES:

The study was supported in part by the Deutsche Forschungsgemeinschaft. Additional funding came from the German Federal Ministry for Health and Research and the Berlin Institute of Health. Two patient cohorts were partially and separately supported by grants from Novartis and AbbVie.

A version of this article appeared on Medscape.com.

Questions about omega-3 fatty acid supplements come up often in the atrial fibrillation (AFib) clinic.

The story begins with the simple observation that populations who eat lots of oily fish have fewer coronary events. This correlation provoked great interest in concentrating fish oils in pill form and studying their use to promote health.

A small post hoc study from a group in Norway stimulated me to review what we do and don’t know about fish pills, as I call them in clinic.
 

OMENI secondary analysis

Peder Myhre, MD, and colleagues recently published a secondary analysis of the OMENI trial looking at both the risk and possible causes of AFib in the omega-3 group.

The OMENI trial randomly assigned slightly more than 1,000 older patients (mean age, 75 years) post–myocardial infarction to either 1.8 g/d of fish oil supplements versus placebo for 2 years. The supplements comprised 930 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA). The main trial reported no difference in a composite primary endpoint of MI, revascularization, stroke, death, or hospitalization for heart failure.

The secondary analysis explored the 75% of patients in the main trial who had no history of AFib. It looked at how many in each group developed either true clinical AFib or what the authors called micro-AFib, defined as short bursts of irregular atrial activity lasting seconds.

The sub-analysis had three main findings: Patients in the supplement arm had a 90% higher rate of AFib or micro-AFib, compared with patients on placebo, EPA had the strongest effect on the association, and there was a graded risk for AFib with increasing serum EPA levels.  

The authors raised the possibility that more micro-AFib might be a possible mediator of AFib risk.
 

Trials of low-dose EPA and DHA

First, the low-dose trials. In the ASCEND trial from 2018, more than 15,000 patients with diabetes were randomly assigned to either 1 g of omega-3 fatty acids (460-mg EPA and 380-mg DHA) or mineral oil.

The trial was neutral. After 7.4 years, the primary endpoint of MI, stroke, transient ischemic attack, or cardiovascular death occurred in 8.9% of the supplement group versus 9.2% of the placebo arm.The incidence of AFib was higher in the omega-3 group but did not reach statistical significance (2.1% vs. 1.7% for placebo; hazard ratio, 1.23; 95% confidence interval, 0.98-1.54).

Another neutral CV trial, VITAL, specifically studied the effects of marine omega-3 pills (460-mg EPA and 380-mg DHA) in older adults without heart disease, cancer, or AFib. After slightly more than 5 years, AFib occurred at a similar rate in the active arm and placebo arms (3.7% vs. 3.4% for placebo; HR, 1.09; 95% CI, 0.96-1.24; P = .19)
 

Trials of very high-dose marine omega-3s

Next came trials of higher doses in higher-risk populations.

In 2020, JAMA published the STRENGTH trial, which compared 4 g/d of a carboxylic acid formulation of EPA and DHA with a corn oil placebo in more than 13,000 patients who either had established atherosclerotic CV disease (ASCVD) or were at high risk for ASCVD.

The trial was terminated early because of futility and a signal of increased AFib risk in the supplement arm.

Nearly the same number of patients in the supplement versus placebo arm experienced a primary composite endpoint of major adverse cardiac events: 12.0% versus 12.2%, respectively.

AFib was a tertiary endpoint in this trial. An increase in investigator-reported new-onset AFib was observed in the omega-3 group: 2.2% vs. 1.3% for corn oil (HR, 1.69; 95% CI, 1.29-2.21; nominal P < .001).

The REDUCE-IT trial randomly assigned more than 8,000 patients who had ASCVD or diabetes and high ASCVD risk and elevated triglyceride levels to either 4 g of icosapent ethyl daily, a concentrated form of EPA, or a mineral oil placebo.

After nearly 5 years, there was a 4.8% absolute risk reduction in the primary endpoint of CV death, MI, stroke, revascularization, or unstable angina with icosapent ethyl. An increase in atherogenic biomarkers in the mineral oil placebo complicated interpretation of this trial.

Hospitalization for AFib or flutter occurred in 3.1% of the active arm versus 2.1% of the mineral oil group (P = .004).
 

Meta-analysis of marine omega-3 supplement trials

In 2021, Baris Gencer and colleagues performed a meta-analysis of these five trials plus 2 more (GISSI-HF and RP) looking specifically at risk for AFib. Their final analysis included more than 81,000 patients followed for nearly 5 years.

Omega 3 fatty acid supplements associated with a 25% increase in the risk for AFib (HR, 1.25; 95% CI, 1.07-1.46P =.013). Exploring further, they noted a dose-dependent relationship. Most of the increased risk occurred in trials that tested greater than 1 g/d.
 

Summary

When faced with surprise findings, I like to think things through.

First about plausibility. Omega-3 fatty acids clearly exert electrophysiologic effects on cardiac cells, an increase in AFib risk is plausible. The exact underlying mechanism may be unknown, but exact mechanisms are less important than actual clinical effects (see sodium-glucose cotransporter 2 inhibitors).

What about causality? Factors supporting causality include plausibility, consistency of increased AFib risk in multiple studies, and a dose-response relationship.

I see multiple clinical implications of this observation.

The first is the power of the randomized trial to inform practice. If we relied only on observational evidence, we might have assumed that since high fish consumption in populations associated with lower rates of cardiac events, fish oil supplementation would also reduce cardiac events. Other than the outlier trial, REDUCE-IT, with its mineral oil placebo, the preponderance of the randomized controlled trial evidence does not support fish oils for the reduction of CV events.

Randomized controlled trials also exposed the AFib risk. This would have been difficult to sort out in nonrandom observational studies.

Another underappreciated lesson is the notion that drugs, including supplements, can have off-target effects.

Consider the case of statin drugs. It is widely assumed that statins reduce cardiac events by lowering low-density lipoprotein cholesterol (LDL-C). Yet, statins became a mainstay not because of LDL-C lowering but because multiple trials found that this class of drugs reduced cardiac events without increasing adverse effects.

Omega-3 fatty acids reduce triglyceride levels, but this is not enough to adopt the use of these pills. The lack of consistent reduction in CV events and the off-target signal of AFib risk argue against routine use of fish-oil pills.

I will close with uncertainty. Though there is plausibility and multiple reasons to infer causality of marine omega-3s in increasing AFib risk, the effect size remains unknown.

In an editorial accompanying the recent meta-analysis, epidemiologist Michelle Samuel, MPH, PhD, and electrophysiologist Stanley Nattel, MD, cautioned readers on a technical but important point. It concerns the matter of competing risks, such as death, in the analysis of AFib risk, meaning that patients who died may have developed AFib had they lived. They provide a detailed explanation in the open access article, but the take-home is that the exact effect size is difficult to quantify without patient-level original data.

No matter. I find the signal of increased AFib risk an important one to use at the bedside.

Intermittent AFib has an unpredictable natural history. It often resolves as mysteriously as it arises. When patients take fish-oil supplements, I cite these studies, note the lack of CV protection, then I recommend stopping the pills.

This allows for one of the most important interventions in AFib care: time.

Dr. Mandrola is a clinical electrophysiologist with Baptist Medical Associates, Louisville, Ky. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Questions about omega-3 fatty acid supplements come up often in the atrial fibrillation (AFib) clinic.

The story begins with the simple observation that populations who eat lots of oily fish have fewer coronary events. This correlation provoked great interest in concentrating fish oils in pill form and studying their use to promote health.

A small post hoc study from a group in Norway stimulated me to review what we do and don’t know about fish pills, as I call them in clinic.
 

OMENI secondary analysis

Peder Myhre, MD, and colleagues recently published a secondary analysis of the OMENI trial looking at both the risk and possible causes of AFib in the omega-3 group.

The OMENI trial randomly assigned slightly more than 1,000 older patients (mean age, 75 years) post–myocardial infarction to either 1.8 g/d of fish oil supplements versus placebo for 2 years. The supplements comprised 930 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA). The main trial reported no difference in a composite primary endpoint of MI, revascularization, stroke, death, or hospitalization for heart failure.

The secondary analysis explored the 75% of patients in the main trial who had no history of AFib. It looked at how many in each group developed either true clinical AFib or what the authors called micro-AFib, defined as short bursts of irregular atrial activity lasting seconds.

The sub-analysis had three main findings: Patients in the supplement arm had a 90% higher rate of AFib or micro-AFib, compared with patients on placebo, EPA had the strongest effect on the association, and there was a graded risk for AFib with increasing serum EPA levels.  

The authors raised the possibility that more micro-AFib might be a possible mediator of AFib risk.
 

Trials of low-dose EPA and DHA

First, the low-dose trials. In the ASCEND trial from 2018, more than 15,000 patients with diabetes were randomly assigned to either 1 g of omega-3 fatty acids (460-mg EPA and 380-mg DHA) or mineral oil.

The trial was neutral. After 7.4 years, the primary endpoint of MI, stroke, transient ischemic attack, or cardiovascular death occurred in 8.9% of the supplement group versus 9.2% of the placebo arm.The incidence of AFib was higher in the omega-3 group but did not reach statistical significance (2.1% vs. 1.7% for placebo; hazard ratio, 1.23; 95% confidence interval, 0.98-1.54).

Another neutral CV trial, VITAL, specifically studied the effects of marine omega-3 pills (460-mg EPA and 380-mg DHA) in older adults without heart disease, cancer, or AFib. After slightly more than 5 years, AFib occurred at a similar rate in the active arm and placebo arms (3.7% vs. 3.4% for placebo; HR, 1.09; 95% CI, 0.96-1.24; P = .19)
 

Trials of very high-dose marine omega-3s

Next came trials of higher doses in higher-risk populations.

In 2020, JAMA published the STRENGTH trial, which compared 4 g/d of a carboxylic acid formulation of EPA and DHA with a corn oil placebo in more than 13,000 patients who either had established atherosclerotic CV disease (ASCVD) or were at high risk for ASCVD.

The trial was terminated early because of futility and a signal of increased AFib risk in the supplement arm.

Nearly the same number of patients in the supplement versus placebo arm experienced a primary composite endpoint of major adverse cardiac events: 12.0% versus 12.2%, respectively.

AFib was a tertiary endpoint in this trial. An increase in investigator-reported new-onset AFib was observed in the omega-3 group: 2.2% vs. 1.3% for corn oil (HR, 1.69; 95% CI, 1.29-2.21; nominal P < .001).

The REDUCE-IT trial randomly assigned more than 8,000 patients who had ASCVD or diabetes and high ASCVD risk and elevated triglyceride levels to either 4 g of icosapent ethyl daily, a concentrated form of EPA, or a mineral oil placebo.

After nearly 5 years, there was a 4.8% absolute risk reduction in the primary endpoint of CV death, MI, stroke, revascularization, or unstable angina with icosapent ethyl. An increase in atherogenic biomarkers in the mineral oil placebo complicated interpretation of this trial.

Hospitalization for AFib or flutter occurred in 3.1% of the active arm versus 2.1% of the mineral oil group (P = .004).
 

Meta-analysis of marine omega-3 supplement trials

In 2021, Baris Gencer and colleagues performed a meta-analysis of these five trials plus 2 more (GISSI-HF and RP) looking specifically at risk for AFib. Their final analysis included more than 81,000 patients followed for nearly 5 years.

Omega 3 fatty acid supplements associated with a 25% increase in the risk for AFib (HR, 1.25; 95% CI, 1.07-1.46P =.013). Exploring further, they noted a dose-dependent relationship. Most of the increased risk occurred in trials that tested greater than 1 g/d.
 

Summary

When faced with surprise findings, I like to think things through.

First about plausibility. Omega-3 fatty acids clearly exert electrophysiologic effects on cardiac cells, an increase in AFib risk is plausible. The exact underlying mechanism may be unknown, but exact mechanisms are less important than actual clinical effects (see sodium-glucose cotransporter 2 inhibitors).

What about causality? Factors supporting causality include plausibility, consistency of increased AFib risk in multiple studies, and a dose-response relationship.

I see multiple clinical implications of this observation.

The first is the power of the randomized trial to inform practice. If we relied only on observational evidence, we might have assumed that since high fish consumption in populations associated with lower rates of cardiac events, fish oil supplementation would also reduce cardiac events. Other than the outlier trial, REDUCE-IT, with its mineral oil placebo, the preponderance of the randomized controlled trial evidence does not support fish oils for the reduction of CV events.

Randomized controlled trials also exposed the AFib risk. This would have been difficult to sort out in nonrandom observational studies.

Another underappreciated lesson is the notion that drugs, including supplements, can have off-target effects.

Consider the case of statin drugs. It is widely assumed that statins reduce cardiac events by lowering low-density lipoprotein cholesterol (LDL-C). Yet, statins became a mainstay not because of LDL-C lowering but because multiple trials found that this class of drugs reduced cardiac events without increasing adverse effects.

Omega-3 fatty acids reduce triglyceride levels, but this is not enough to adopt the use of these pills. The lack of consistent reduction in CV events and the off-target signal of AFib risk argue against routine use of fish-oil pills.

I will close with uncertainty. Though there is plausibility and multiple reasons to infer causality of marine omega-3s in increasing AFib risk, the effect size remains unknown.

In an editorial accompanying the recent meta-analysis, epidemiologist Michelle Samuel, MPH, PhD, and electrophysiologist Stanley Nattel, MD, cautioned readers on a technical but important point. It concerns the matter of competing risks, such as death, in the analysis of AFib risk, meaning that patients who died may have developed AFib had they lived. They provide a detailed explanation in the open access article, but the take-home is that the exact effect size is difficult to quantify without patient-level original data.

No matter. I find the signal of increased AFib risk an important one to use at the bedside.

Intermittent AFib has an unpredictable natural history. It often resolves as mysteriously as it arises. When patients take fish-oil supplements, I cite these studies, note the lack of CV protection, then I recommend stopping the pills.

This allows for one of the most important interventions in AFib care: time.

Dr. Mandrola is a clinical electrophysiologist with Baptist Medical Associates, Louisville, Ky. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Questions about omega-3 fatty acid supplements come up often in the atrial fibrillation (AFib) clinic.

The story begins with the simple observation that populations who eat lots of oily fish have fewer coronary events. This correlation provoked great interest in concentrating fish oils in pill form and studying their use to promote health.

A small post hoc study from a group in Norway stimulated me to review what we do and don’t know about fish pills, as I call them in clinic.
 

OMENI secondary analysis

Peder Myhre, MD, and colleagues recently published a secondary analysis of the OMENI trial looking at both the risk and possible causes of AFib in the omega-3 group.

The OMENI trial randomly assigned slightly more than 1,000 older patients (mean age, 75 years) post–myocardial infarction to either 1.8 g/d of fish oil supplements versus placebo for 2 years. The supplements comprised 930 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA). The main trial reported no difference in a composite primary endpoint of MI, revascularization, stroke, death, or hospitalization for heart failure.

The secondary analysis explored the 75% of patients in the main trial who had no history of AFib. It looked at how many in each group developed either true clinical AFib or what the authors called micro-AFib, defined as short bursts of irregular atrial activity lasting seconds.

The sub-analysis had three main findings: Patients in the supplement arm had a 90% higher rate of AFib or micro-AFib, compared with patients on placebo, EPA had the strongest effect on the association, and there was a graded risk for AFib with increasing serum EPA levels.  

The authors raised the possibility that more micro-AFib might be a possible mediator of AFib risk.
 

Trials of low-dose EPA and DHA

First, the low-dose trials. In the ASCEND trial from 2018, more than 15,000 patients with diabetes were randomly assigned to either 1 g of omega-3 fatty acids (460-mg EPA and 380-mg DHA) or mineral oil.

The trial was neutral. After 7.4 years, the primary endpoint of MI, stroke, transient ischemic attack, or cardiovascular death occurred in 8.9% of the supplement group versus 9.2% of the placebo arm.The incidence of AFib was higher in the omega-3 group but did not reach statistical significance (2.1% vs. 1.7% for placebo; hazard ratio, 1.23; 95% confidence interval, 0.98-1.54).

Another neutral CV trial, VITAL, specifically studied the effects of marine omega-3 pills (460-mg EPA and 380-mg DHA) in older adults without heart disease, cancer, or AFib. After slightly more than 5 years, AFib occurred at a similar rate in the active arm and placebo arms (3.7% vs. 3.4% for placebo; HR, 1.09; 95% CI, 0.96-1.24; P = .19)
 

Trials of very high-dose marine omega-3s

Next came trials of higher doses in higher-risk populations.

In 2020, JAMA published the STRENGTH trial, which compared 4 g/d of a carboxylic acid formulation of EPA and DHA with a corn oil placebo in more than 13,000 patients who either had established atherosclerotic CV disease (ASCVD) or were at high risk for ASCVD.

The trial was terminated early because of futility and a signal of increased AFib risk in the supplement arm.

Nearly the same number of patients in the supplement versus placebo arm experienced a primary composite endpoint of major adverse cardiac events: 12.0% versus 12.2%, respectively.

AFib was a tertiary endpoint in this trial. An increase in investigator-reported new-onset AFib was observed in the omega-3 group: 2.2% vs. 1.3% for corn oil (HR, 1.69; 95% CI, 1.29-2.21; nominal P < .001).

The REDUCE-IT trial randomly assigned more than 8,000 patients who had ASCVD or diabetes and high ASCVD risk and elevated triglyceride levels to either 4 g of icosapent ethyl daily, a concentrated form of EPA, or a mineral oil placebo.

After nearly 5 years, there was a 4.8% absolute risk reduction in the primary endpoint of CV death, MI, stroke, revascularization, or unstable angina with icosapent ethyl. An increase in atherogenic biomarkers in the mineral oil placebo complicated interpretation of this trial.

Hospitalization for AFib or flutter occurred in 3.1% of the active arm versus 2.1% of the mineral oil group (P = .004).
 

Meta-analysis of marine omega-3 supplement trials

In 2021, Baris Gencer and colleagues performed a meta-analysis of these five trials plus 2 more (GISSI-HF and RP) looking specifically at risk for AFib. Their final analysis included more than 81,000 patients followed for nearly 5 years.

Omega 3 fatty acid supplements associated with a 25% increase in the risk for AFib (HR, 1.25; 95% CI, 1.07-1.46P =.013). Exploring further, they noted a dose-dependent relationship. Most of the increased risk occurred in trials that tested greater than 1 g/d.
 

Summary

When faced with surprise findings, I like to think things through.

First about plausibility. Omega-3 fatty acids clearly exert electrophysiologic effects on cardiac cells, an increase in AFib risk is plausible. The exact underlying mechanism may be unknown, but exact mechanisms are less important than actual clinical effects (see sodium-glucose cotransporter 2 inhibitors).

What about causality? Factors supporting causality include plausibility, consistency of increased AFib risk in multiple studies, and a dose-response relationship.

I see multiple clinical implications of this observation.

The first is the power of the randomized trial to inform practice. If we relied only on observational evidence, we might have assumed that since high fish consumption in populations associated with lower rates of cardiac events, fish oil supplementation would also reduce cardiac events. Other than the outlier trial, REDUCE-IT, with its mineral oil placebo, the preponderance of the randomized controlled trial evidence does not support fish oils for the reduction of CV events.

Randomized controlled trials also exposed the AFib risk. This would have been difficult to sort out in nonrandom observational studies.

Another underappreciated lesson is the notion that drugs, including supplements, can have off-target effects.

Consider the case of statin drugs. It is widely assumed that statins reduce cardiac events by lowering low-density lipoprotein cholesterol (LDL-C). Yet, statins became a mainstay not because of LDL-C lowering but because multiple trials found that this class of drugs reduced cardiac events without increasing adverse effects.

Omega-3 fatty acids reduce triglyceride levels, but this is not enough to adopt the use of these pills. The lack of consistent reduction in CV events and the off-target signal of AFib risk argue against routine use of fish-oil pills.

I will close with uncertainty. Though there is plausibility and multiple reasons to infer causality of marine omega-3s in increasing AFib risk, the effect size remains unknown.

In an editorial accompanying the recent meta-analysis, epidemiologist Michelle Samuel, MPH, PhD, and electrophysiologist Stanley Nattel, MD, cautioned readers on a technical but important point. It concerns the matter of competing risks, such as death, in the analysis of AFib risk, meaning that patients who died may have developed AFib had they lived. They provide a detailed explanation in the open access article, but the take-home is that the exact effect size is difficult to quantify without patient-level original data.

No matter. I find the signal of increased AFib risk an important one to use at the bedside.

Intermittent AFib has an unpredictable natural history. It often resolves as mysteriously as it arises. When patients take fish-oil supplements, I cite these studies, note the lack of CV protection, then I recommend stopping the pills.

This allows for one of the most important interventions in AFib care: time.

Dr. Mandrola is a clinical electrophysiologist with Baptist Medical Associates, Louisville, Ky. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.

In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.

“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”

The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.

“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
 

Start the conversation

Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.

Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.

Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
 

Clinical considerations and contraindications

Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.

When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.

The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.

The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
 

Risks, benefits, and balance

“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.

The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.

“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.

As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
 

Contraceptive counseling is everyone’s specialty

In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.

“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.

As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.

Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.

The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.

Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.

In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.

“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”

The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.

“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
 

Start the conversation

Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.

Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.

Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
 

Clinical considerations and contraindications

Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.

When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.

The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.

The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
 

Risks, benefits, and balance

“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.

The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.

“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.

As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
 

Contraceptive counseling is everyone’s specialty

In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.

“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.

As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.

Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.

The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.

Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.

In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.

“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”

The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.

“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
 

Start the conversation

Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.

Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.

Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
 

Clinical considerations and contraindications

Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.

When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.

The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.

The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
 

Risks, benefits, and balance

“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.

The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.

“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.

As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
 

Contraceptive counseling is everyone’s specialty

In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.

“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.

As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.

Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.

The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.

This transcript has been edited for clarity.

I’d like to discuss an article that’s appeared recently in The Lancet. It looks at the impact of minimum unit pricing for alcohol on alcohol-related deaths and hospital admissions in Scotland, my home country. Why is that important to me as a cancer doctor? We know that alcohol underpins epidemiologically a whole range of different tumor types.

Anyway, it’s a really interesting experiment. It also looks at the impact of governments and health policy. In 2018, the Scottish government introduced a minimum unit pricing for alcohol of around $0.60 per unit of alcohol. The idea was that if you drive up the price of getting access to alcohol, that should reduce harm, deaths, and hospital admissions.

Wyper and colleagues did a rather nice controlled, time-interrupted series. The legislation was introduced in 2018, so they looked at our public-health databases, hospital admissions, deaths, and so on for the time span from 2012 to 2018, then for about 3 years after the introduction of legislation in 2018. They used England as a control.

They showed that there was a reduction in fully alcohol-attributed deaths by 13.4% in Scotland, and a reduction in chronic hospital admissions related to alcohol by almost 10%. It works.

What was also interesting was that the benefits were confined to the lower socioeconomic classes. One could argue, whether intended or otherwise, that this was a health-policy intervention targeted at the lower socioeconomic classes. Perhaps, one would hope as a consequence that this would reduce the health equity gap.

We know that the differences in Scotland are remarkable. When we compare the highest with the lowest socioeconomic classes, there’s a 4- to 4.5-fold difference in likelihood of death benefiting, of course, the wealthy. The health-equity gap between rich and poor is getting wider, not becoming narrower. Interventions of this sort make a difference.

Of course, there’s good evidence from other areas in which price control can make a difference. Tobacco is perhaps the best example of it. People have also talked about sugar or fat taxes to see whether their actions reduce levels of obesity, overeating, and other problems.

It’s a really nice study, with very compelling data, very well worked out in terms of the methodology and statistics. There are lives saved and lives prolonged.

What it doesn’t do is tell us about the amount of alcohol that people were taking. It shows that if you are less well off and the price of alcohol goes up, you’ve got less money to spend on alcohol. Therefore, that reduction results in the reduction in harm associated with it.

What’s really interesting is something I hadn’t realized about what’s called the alcohol-harm paradox. When you look at drinkers across the socioeconomic spectrum, including wealthy and poor drinkers, even for those who have exactly the same consumption of alcohol, there seems to be significantly more harm done to the poor than to the wealthy.

There may be some behavioral explanations for this, but they don’t explain all the difference. More work needs to be done there. It’s a really interesting story and I think a brave policy put forward by the Scottish government, which has returned rewards and is something that one would consider replicating around the world to see what other benefits might accrue from it.

I’m very interested to watch further forward over the next 2 decades to see what impact, if any, this alcohol-pricing legislation has on the incidence of cancer, looking at breast cancer, some gastrointestinal tumors, and so on, in which we know alcohol plays a part in their carcinogenesis.

Dr. Kerris a professor of cancer medicine at the University of Oxford (England). He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, Merck Serono, and Roche.

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

This transcript has been edited for clarity.

I’d like to discuss an article that’s appeared recently in The Lancet. It looks at the impact of minimum unit pricing for alcohol on alcohol-related deaths and hospital admissions in Scotland, my home country. Why is that important to me as a cancer doctor? We know that alcohol underpins epidemiologically a whole range of different tumor types.

Anyway, it’s a really interesting experiment. It also looks at the impact of governments and health policy. In 2018, the Scottish government introduced a minimum unit pricing for alcohol of around $0.60 per unit of alcohol. The idea was that if you drive up the price of getting access to alcohol, that should reduce harm, deaths, and hospital admissions.

Wyper and colleagues did a rather nice controlled, time-interrupted series. The legislation was introduced in 2018, so they looked at our public-health databases, hospital admissions, deaths, and so on for the time span from 2012 to 2018, then for about 3 years after the introduction of legislation in 2018. They used England as a control.

They showed that there was a reduction in fully alcohol-attributed deaths by 13.4% in Scotland, and a reduction in chronic hospital admissions related to alcohol by almost 10%. It works.

What was also interesting was that the benefits were confined to the lower socioeconomic classes. One could argue, whether intended or otherwise, that this was a health-policy intervention targeted at the lower socioeconomic classes. Perhaps, one would hope as a consequence that this would reduce the health equity gap.

We know that the differences in Scotland are remarkable. When we compare the highest with the lowest socioeconomic classes, there’s a 4- to 4.5-fold difference in likelihood of death benefiting, of course, the wealthy. The health-equity gap between rich and poor is getting wider, not becoming narrower. Interventions of this sort make a difference.

Of course, there’s good evidence from other areas in which price control can make a difference. Tobacco is perhaps the best example of it. People have also talked about sugar or fat taxes to see whether their actions reduce levels of obesity, overeating, and other problems.

It’s a really nice study, with very compelling data, very well worked out in terms of the methodology and statistics. There are lives saved and lives prolonged.

What it doesn’t do is tell us about the amount of alcohol that people were taking. It shows that if you are less well off and the price of alcohol goes up, you’ve got less money to spend on alcohol. Therefore, that reduction results in the reduction in harm associated with it.

What’s really interesting is something I hadn’t realized about what’s called the alcohol-harm paradox. When you look at drinkers across the socioeconomic spectrum, including wealthy and poor drinkers, even for those who have exactly the same consumption of alcohol, there seems to be significantly more harm done to the poor than to the wealthy.

There may be some behavioral explanations for this, but they don’t explain all the difference. More work needs to be done there. It’s a really interesting story and I think a brave policy put forward by the Scottish government, which has returned rewards and is something that one would consider replicating around the world to see what other benefits might accrue from it.

I’m very interested to watch further forward over the next 2 decades to see what impact, if any, this alcohol-pricing legislation has on the incidence of cancer, looking at breast cancer, some gastrointestinal tumors, and so on, in which we know alcohol plays a part in their carcinogenesis.

Dr. Kerris a professor of cancer medicine at the University of Oxford (England). He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, Merck Serono, and Roche.

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

This transcript has been edited for clarity.

I’d like to discuss an article that’s appeared recently in The Lancet. It looks at the impact of minimum unit pricing for alcohol on alcohol-related deaths and hospital admissions in Scotland, my home country. Why is that important to me as a cancer doctor? We know that alcohol underpins epidemiologically a whole range of different tumor types.

Anyway, it’s a really interesting experiment. It also looks at the impact of governments and health policy. In 2018, the Scottish government introduced a minimum unit pricing for alcohol of around $0.60 per unit of alcohol. The idea was that if you drive up the price of getting access to alcohol, that should reduce harm, deaths, and hospital admissions.

Wyper and colleagues did a rather nice controlled, time-interrupted series. The legislation was introduced in 2018, so they looked at our public-health databases, hospital admissions, deaths, and so on for the time span from 2012 to 2018, then for about 3 years after the introduction of legislation in 2018. They used England as a control.

They showed that there was a reduction in fully alcohol-attributed deaths by 13.4% in Scotland, and a reduction in chronic hospital admissions related to alcohol by almost 10%. It works.

What was also interesting was that the benefits were confined to the lower socioeconomic classes. One could argue, whether intended or otherwise, that this was a health-policy intervention targeted at the lower socioeconomic classes. Perhaps, one would hope as a consequence that this would reduce the health equity gap.

We know that the differences in Scotland are remarkable. When we compare the highest with the lowest socioeconomic classes, there’s a 4- to 4.5-fold difference in likelihood of death benefiting, of course, the wealthy. The health-equity gap between rich and poor is getting wider, not becoming narrower. Interventions of this sort make a difference.

Of course, there’s good evidence from other areas in which price control can make a difference. Tobacco is perhaps the best example of it. People have also talked about sugar or fat taxes to see whether their actions reduce levels of obesity, overeating, and other problems.

It’s a really nice study, with very compelling data, very well worked out in terms of the methodology and statistics. There are lives saved and lives prolonged.

What it doesn’t do is tell us about the amount of alcohol that people were taking. It shows that if you are less well off and the price of alcohol goes up, you’ve got less money to spend on alcohol. Therefore, that reduction results in the reduction in harm associated with it.

What’s really interesting is something I hadn’t realized about what’s called the alcohol-harm paradox. When you look at drinkers across the socioeconomic spectrum, including wealthy and poor drinkers, even for those who have exactly the same consumption of alcohol, there seems to be significantly more harm done to the poor than to the wealthy.

There may be some behavioral explanations for this, but they don’t explain all the difference. More work needs to be done there. It’s a really interesting story and I think a brave policy put forward by the Scottish government, which has returned rewards and is something that one would consider replicating around the world to see what other benefits might accrue from it.

I’m very interested to watch further forward over the next 2 decades to see what impact, if any, this alcohol-pricing legislation has on the incidence of cancer, looking at breast cancer, some gastrointestinal tumors, and so on, in which we know alcohol plays a part in their carcinogenesis.

Dr. Kerris a professor of cancer medicine at the University of Oxford (England). He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, Merck Serono, and Roche.

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

FRANCE – Did you know that, long before anyone else, Leonardo da Vinci called into question Galen’s description of how the heart works?

This is just one of the many interesting tidbits featured in “Leonardo da Vinci and Anatomy, the Mechanics of Life,” an exhibition that runs until Sept. 17 at the Château du Clos Lucé – a home once owned by da Vinci – in Amboise, France.

In his book about this exhibition, Jean-Jacques Monsuez, MD, a cardiologist at Paris’ René-Muret Hospital, noted, “For a long time, very few people knew about Leonardo’s observations on the cardiovascular system’s anatomy or his rather physiological analysis of its hemodynamics. Had this not been the case, his work would, very likely, have had a significant influence on the subsequent development of knowledge about the cardiovascular system.”
 

A visionary view

In the second century AD, Galen put forth the following novel theory: The liver transforms food into blood. The blood is carried through veins to the various organs and is sent to the right ventricle through ebb and flow and to the left ventricle through intraventricular pores [which, we now know, do not exist].

In the left ventricle, the blood mixes with air – “pneuma” – from the lungs and is transformed into vital spirits. Clear blood, enriched with vital heat, is then carried by the arteries to peripheral tissues.

This erroneous explanation of how blood circulates went unchallenged for hundreds and hundreds of years.

And then along came Leonardo, anatomy pioneer and experimenter extraordinaire. Around 1513, after looking more closely at the heart chambers and the aortic valve, he arrived at the belief that, contrary to Galen’s theory, blood flow starts in the heart, not the liver.

“The heart in itself is not the origin of life, but [simply] a vessel made of dense muscle vivified and nourished by an artery and a vein, as are other muscles.”

He arrived at this insight through his in-depth dissections and studies of pig, ox, and human hearts.

A vast number of folios came about, all dedicated to the functioning of the heart. Taking his lead from Galen and Avicenna, Leonardo started off by drawing two atria and two ventricles along with Galen’s intraventricular pores.

But he quickly moved in a different direction when it came to the question of what enables the heart to produce vital spirits from blood flow.

On a double sheet showing several views of an ox heart, he drew all the components – this time with the aortic valve both open and closed.

“The accuracy of the description of the aortic valve is impressive, considering that, in a normal subject, its surface is on the order of 3 cm²,” Monsuez noted.

But Leonardo went even further, explaining the sequence of the opening and closing of the valve. To complete his demonstration, he even used a model from one of his experiments. He took some water with a suspension of grass seeds and pumped it through a glass tube that had a bulge representing the aortic sinuses. He tracked the resultant flow and eddies that mimic the hemodynamics enabling the valve to open and close.

“Recently, Professor Choudhury’s team at Oxford took Leonardo’s sketch illustrating this ingenious description and superimposed it on the 4D-MRI image of systolic flow vortices. They confirmed that Leonardo was accurate,” Monsuez reported.

But Leonardo’s ideas about the heart didn’t stop there. The polymath also provided a description of cardiac contraction. This was based on observations he had made by watching the movement of spiles that had been driven into the hearts of pigs at a slaughterhouse. He made an ancillary diagram confirming his interpretation. “N, the firm muscle is pulled back, and it’s the first cause of the heart’s movement, for, thus pulled, it lengthens, and lengthening, it shortens.”

Leonardo was the first to explain the role of the atria. “The atria are the antechambers that receive the blood from the heart when it escapes from its ventricle from the beginning until the end of the pressure.”

In addition, he showed, for the first time, the round crown-like appearance of the heart’s vasculature. “The heart has its surface divided into three parts by three veins which descend from its base, of which veins two terminate the extremities of the right ventricle and have two arteries in contact below them […] the surface space of the heart enclosed within its arteries occupies half the surface circle of the thickness of the heart […].”

Finally, Leonardo was the first to give a description and sketch of a bicuspid aortic valve, as can be seen on a 500-year-old plate in the Royal Collection Trust.
 

Wealth of knowledge

Because Leonardo’s discoveries about the cardiovascular system remained in the shadows, they did not factor into the thinking of physicians and surgeons during his lifetime or in the years that followed.

That is, until 1773, when Scottish anatomist Dr. William Hunter found out that the collection of King Charles II of England contained folios on the human body – folios that were made by Leonardo da Vinci.

The world would have to wait until the 19th century for a complete facsimile edition of the collection kept at Windsor Castle.
 

This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.

FRANCE – Did you know that, long before anyone else, Leonardo da Vinci called into question Galen’s description of how the heart works?

This is just one of the many interesting tidbits featured in “Leonardo da Vinci and Anatomy, the Mechanics of Life,” an exhibition that runs until Sept. 17 at the Château du Clos Lucé – a home once owned by da Vinci – in Amboise, France.

In his book about this exhibition, Jean-Jacques Monsuez, MD, a cardiologist at Paris’ René-Muret Hospital, noted, “For a long time, very few people knew about Leonardo’s observations on the cardiovascular system’s anatomy or his rather physiological analysis of its hemodynamics. Had this not been the case, his work would, very likely, have had a significant influence on the subsequent development of knowledge about the cardiovascular system.”
 

A visionary view

In the second century AD, Galen put forth the following novel theory: The liver transforms food into blood. The blood is carried through veins to the various organs and is sent to the right ventricle through ebb and flow and to the left ventricle through intraventricular pores [which, we now know, do not exist].

In the left ventricle, the blood mixes with air – “pneuma” – from the lungs and is transformed into vital spirits. Clear blood, enriched with vital heat, is then carried by the arteries to peripheral tissues.

This erroneous explanation of how blood circulates went unchallenged for hundreds and hundreds of years.

And then along came Leonardo, anatomy pioneer and experimenter extraordinaire. Around 1513, after looking more closely at the heart chambers and the aortic valve, he arrived at the belief that, contrary to Galen’s theory, blood flow starts in the heart, not the liver.

“The heart in itself is not the origin of life, but [simply] a vessel made of dense muscle vivified and nourished by an artery and a vein, as are other muscles.”

He arrived at this insight through his in-depth dissections and studies of pig, ox, and human hearts.

A vast number of folios came about, all dedicated to the functioning of the heart. Taking his lead from Galen and Avicenna, Leonardo started off by drawing two atria and two ventricles along with Galen’s intraventricular pores.

But he quickly moved in a different direction when it came to the question of what enables the heart to produce vital spirits from blood flow.

On a double sheet showing several views of an ox heart, he drew all the components – this time with the aortic valve both open and closed.

“The accuracy of the description of the aortic valve is impressive, considering that, in a normal subject, its surface is on the order of 3 cm²,” Monsuez noted.

But Leonardo went even further, explaining the sequence of the opening and closing of the valve. To complete his demonstration, he even used a model from one of his experiments. He took some water with a suspension of grass seeds and pumped it through a glass tube that had a bulge representing the aortic sinuses. He tracked the resultant flow and eddies that mimic the hemodynamics enabling the valve to open and close.

“Recently, Professor Choudhury’s team at Oxford took Leonardo’s sketch illustrating this ingenious description and superimposed it on the 4D-MRI image of systolic flow vortices. They confirmed that Leonardo was accurate,” Monsuez reported.

But Leonardo’s ideas about the heart didn’t stop there. The polymath also provided a description of cardiac contraction. This was based on observations he had made by watching the movement of spiles that had been driven into the hearts of pigs at a slaughterhouse. He made an ancillary diagram confirming his interpretation. “N, the firm muscle is pulled back, and it’s the first cause of the heart’s movement, for, thus pulled, it lengthens, and lengthening, it shortens.”

Leonardo was the first to explain the role of the atria. “The atria are the antechambers that receive the blood from the heart when it escapes from its ventricle from the beginning until the end of the pressure.”

In addition, he showed, for the first time, the round crown-like appearance of the heart’s vasculature. “The heart has its surface divided into three parts by three veins which descend from its base, of which veins two terminate the extremities of the right ventricle and have two arteries in contact below them […] the surface space of the heart enclosed within its arteries occupies half the surface circle of the thickness of the heart […].”

Finally, Leonardo was the first to give a description and sketch of a bicuspid aortic valve, as can be seen on a 500-year-old plate in the Royal Collection Trust.
 

Wealth of knowledge

Because Leonardo’s discoveries about the cardiovascular system remained in the shadows, they did not factor into the thinking of physicians and surgeons during his lifetime or in the years that followed.

That is, until 1773, when Scottish anatomist Dr. William Hunter found out that the collection of King Charles II of England contained folios on the human body – folios that were made by Leonardo da Vinci.

The world would have to wait until the 19th century for a complete facsimile edition of the collection kept at Windsor Castle.
 

This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.

FRANCE – Did you know that, long before anyone else, Leonardo da Vinci called into question Galen’s description of how the heart works?

This is just one of the many interesting tidbits featured in “Leonardo da Vinci and Anatomy, the Mechanics of Life,” an exhibition that runs until Sept. 17 at the Château du Clos Lucé – a home once owned by da Vinci – in Amboise, France.

In his book about this exhibition, Jean-Jacques Monsuez, MD, a cardiologist at Paris’ René-Muret Hospital, noted, “For a long time, very few people knew about Leonardo’s observations on the cardiovascular system’s anatomy or his rather physiological analysis of its hemodynamics. Had this not been the case, his work would, very likely, have had a significant influence on the subsequent development of knowledge about the cardiovascular system.”
 

A visionary view

In the second century AD, Galen put forth the following novel theory: The liver transforms food into blood. The blood is carried through veins to the various organs and is sent to the right ventricle through ebb and flow and to the left ventricle through intraventricular pores [which, we now know, do not exist].

In the left ventricle, the blood mixes with air – “pneuma” – from the lungs and is transformed into vital spirits. Clear blood, enriched with vital heat, is then carried by the arteries to peripheral tissues.

This erroneous explanation of how blood circulates went unchallenged for hundreds and hundreds of years.

And then along came Leonardo, anatomy pioneer and experimenter extraordinaire. Around 1513, after looking more closely at the heart chambers and the aortic valve, he arrived at the belief that, contrary to Galen’s theory, blood flow starts in the heart, not the liver.

“The heart in itself is not the origin of life, but [simply] a vessel made of dense muscle vivified and nourished by an artery and a vein, as are other muscles.”

He arrived at this insight through his in-depth dissections and studies of pig, ox, and human hearts.

A vast number of folios came about, all dedicated to the functioning of the heart. Taking his lead from Galen and Avicenna, Leonardo started off by drawing two atria and two ventricles along with Galen’s intraventricular pores.

But he quickly moved in a different direction when it came to the question of what enables the heart to produce vital spirits from blood flow.

On a double sheet showing several views of an ox heart, he drew all the components – this time with the aortic valve both open and closed.

“The accuracy of the description of the aortic valve is impressive, considering that, in a normal subject, its surface is on the order of 3 cm²,” Monsuez noted.

But Leonardo went even further, explaining the sequence of the opening and closing of the valve. To complete his demonstration, he even used a model from one of his experiments. He took some water with a suspension of grass seeds and pumped it through a glass tube that had a bulge representing the aortic sinuses. He tracked the resultant flow and eddies that mimic the hemodynamics enabling the valve to open and close.

“Recently, Professor Choudhury’s team at Oxford took Leonardo’s sketch illustrating this ingenious description and superimposed it on the 4D-MRI image of systolic flow vortices. They confirmed that Leonardo was accurate,” Monsuez reported.

But Leonardo’s ideas about the heart didn’t stop there. The polymath also provided a description of cardiac contraction. This was based on observations he had made by watching the movement of spiles that had been driven into the hearts of pigs at a slaughterhouse. He made an ancillary diagram confirming his interpretation. “N, the firm muscle is pulled back, and it’s the first cause of the heart’s movement, for, thus pulled, it lengthens, and lengthening, it shortens.”

Leonardo was the first to explain the role of the atria. “The atria are the antechambers that receive the blood from the heart when it escapes from its ventricle from the beginning until the end of the pressure.”

In addition, he showed, for the first time, the round crown-like appearance of the heart’s vasculature. “The heart has its surface divided into three parts by three veins which descend from its base, of which veins two terminate the extremities of the right ventricle and have two arteries in contact below them […] the surface space of the heart enclosed within its arteries occupies half the surface circle of the thickness of the heart […].”

Finally, Leonardo was the first to give a description and sketch of a bicuspid aortic valve, as can be seen on a 500-year-old plate in the Royal Collection Trust.
 

Wealth of knowledge

Because Leonardo’s discoveries about the cardiovascular system remained in the shadows, they did not factor into the thinking of physicians and surgeons during his lifetime or in the years that followed.

That is, until 1773, when Scottish anatomist Dr. William Hunter found out that the collection of King Charles II of England contained folios on the human body – folios that were made by Leonardo da Vinci.

The world would have to wait until the 19th century for a complete facsimile edition of the collection kept at Windsor Castle.
 

This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.

For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.

Several experts in mental health and women’s health offered their views of this new treatment option for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
 

A fast-acting option

“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.

Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).

“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.

Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.

The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.

Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.

Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.

“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).

ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.

The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
 

Beyond ‘baby blues’

The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”

No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.

Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
 

Can be a medical emergency

Severe postpartum depression requires immediate attention and treatment.

“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.

“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.

“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
 

The science that led to approval

The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”

The antidepressant effect lasted at least 4 weeks after stopping the medication.

Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
 

The start of more help for mothers?

Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.

Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”

Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
 

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

For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.

Several experts in mental health and women’s health offered their views of this new treatment option for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
 

A fast-acting option

“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.

Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).

“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.

Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.

The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.

Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.

Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.

“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).

ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.

The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
 

Beyond ‘baby blues’

The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”

No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.

Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
 

Can be a medical emergency

Severe postpartum depression requires immediate attention and treatment.

“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.

“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.

“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
 

The science that led to approval

The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”

The antidepressant effect lasted at least 4 weeks after stopping the medication.

Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
 

The start of more help for mothers?

Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.

Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”

Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
 

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

For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.

Several experts in mental health and women’s health offered their views of this new treatment option for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
 

A fast-acting option

“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.

Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).

“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.

Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.

The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.

Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.

Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.

“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).

ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.

The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
 

Beyond ‘baby blues’

The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”

No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.

Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
 

Can be a medical emergency

Severe postpartum depression requires immediate attention and treatment.

“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.

“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.

“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
 

The science that led to approval

The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”

The antidepressant effect lasted at least 4 weeks after stopping the medication.

Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
 

The start of more help for mothers?

Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.

Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”

Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
 

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

Drinking sugar-laden beverages on a regular basis may increase the risk for liver cancer and death from chronic liver disease, new research suggests.

The observational analyses revealed that postmenopausal women who consumed at least one sugar-sweetened beverage daily had an 85% higher risk of developing liver cancer and a 68% higher risk of dying from chronic liver disease, compared with those who consumed three servings or fewer per month.

Lori Martin/Fotolia.com

“If our findings are confirmed, reducing sugar-sweetened beverage consumption might serve as a public health strategy to reduce liver disease burden,” first author Longgang Zhao, PhD, with Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.

When looking at consumption of artificially sweetened drinks, however, Dr. Zhao and colleagues found no strong association between intake and risk for liver cancer or death from chronic liver disease. Because the sample size for the artificially sweetened beverage analysis was limited, Dr. Zhao said, “these results should be interpreted with caution and additional studies are needed to confirm our study findings.”

The new study was published online in JAMA.

About 40% of people with liver cancer do not have one of the well-known disease risk factors, such as chronic hepatitis B or C infection, type 2 diabetes, or obesity. In the current analysis, Dr. Zhao and colleagues wanted to determine whether sugar-sweetened or artificially sweetened beverages, consumed by a large swath of the population, could be a risk factor for liver cancer or chronic liver disease.

Two previous studies have found only a “potential association” between sugar-sweetened beverage intake and a person’s risk for liver cancer, the authors explained.

In July, the International Agency for Research on Cancer officially classified the artificial sweetener aspartame as a possible carcinogen, but cancer epidemiologist Paul Pharoah, MD, PhD, commented that “the evidence that aspartame causes primary liver cancer, or any other cancer in humans, is very weak.”

To provide greater clarity about a potential link, the study team used the Women’s Health Initiative to evaluate sugary beverage consumption among 98,786 postmenopausal women and artificially sweetened drink intake among 64,787 followed for up to a median of 20.9 years. The primary outcomes were liver cancer incidence and mortality from chronic liver disease, defined as nonalcoholic fatty liver disease, liver fibrosis, cirrhosis, alcoholic liver diseases, and chronic hepatitis.

Among these women, nearly 7% consumed at least one sugar-sweetened beverage daily and 13% consumed one or more artificially sweetened beverage servings daily.

Over the follow-up period, 207 women developed liver cancer and 148 died from chronic liver disease in the sugary beverage group while 133 women developed liver cancer and 74 died from chronic liver disease in the artificial sugar group.

Compared with women consuming three servings or fewer of sugar-sweetened beverages per month, those consuming one or more servings per day had a significantly higher risk for liver cancer (18.0 vs. 10.3 per 100,000; adjusted hazard ratio, 1.85; P = .01) and for chronic liver disease mortality (17.7 vs. 7.1 per 100,000; aHR, 1.68; P = .04).

Compared with women consuming three servings or fewer of artificially sweetened beverages per month, those drinking one or more servings per day did not have a significantly increased risk for liver cancer (11.8 vs. 10.2 per 100,000; aHR, 1.17; P = .55) or chronic liver disease mortality (7.1 vs. 5.3 per 100,000; aHR 0.95; P = .88).

The authors noted several limitations to the study, including not tracking potential changes in beverage consumption over time or details on the specific sugar content or sweetener types consumed.

Corresponding author Xuehong Zhang, ScD, also with Brigham and Women’s Hospital and Harvard Medical School, said it’s not surprising that sugar-sweetened beverages may raise the risk of adverse liver outcomes.

“Intake of sugar-sweetened beverage[s], a postulated risk factor for obesity, diabetes, and cardiovascular disease, may drive insulin resistance and inflammation, which are strongly implicated in liver carcinogenesis and liver health,” Dr. Zhang said in an interview.

The lack of an association between artificially sweetened beverages and liver outcomes is also not particularly surprising, Dr. Zhang said, “given that the consumption level of artificially sweetened beverages is low, the sample size is relatively small,” and “the dose response relationship remains unknown.”

Nancy S. Reau, MD, who was not involved in the research, said the authors should be “congratulated for trying to clarify liver-related health risk related to artificial or sugar-sweetened beverages.”

In her view, the most important finding is the association between daily consumption of sugar-sweetened beverages and liver health.

“Regardless of whether this is a surrogate marker for liver disease risk (such as fatty liver disease) or a consequence of the drink itself, it is an easy measure for clinicians to capture and an easy behavior for patients to modify,” Dr. Reau, a hepatologist at Rush Medical College, Chicago, said in an interview.

However, Dr. Reau noted, “I do not feel that this article can be used to advocate for artificially sweetened beverages as a substitute.”

It is possible, she explained, that this population was too small to see a significant signal between artificially sweetened beverages and liver health. Plus, “natural, low-caloric beverages as part of a healthy diet combined with exercise are always going to be ideal.”

Weighing in as well, Dale Shepard, MD, PhD, a medical oncologist at the Cleveland Clinic, noted that “this is another study that points to the need for moderation.”

In his view, avoiding excess consumption of sugary or artificially sweetened drinks is the best course of action, but other factors, such as smoking, excessive alcohol, sun exposure without adequate sunscreen, obesity, and inactivity “are more likely to increase one’s risk for cancer,” Dr. Shepard said.

In a statement from the U.K.-based Science Media Centre, Pauline Emmett, PhD, from the University of Bristol (England), commented that this is a “good-quality” study and “the authors have been very careful not to speculate.”

“The main limitation is that this is observational data which provides associations which suggest a relationship but cannot tell if it is causal,” Dr. Emmett said. However, “we know from a body of evidence that it is worth thinking twice before choosing to drink sugar-sweetened beverages every day.”

The study had no commercial funding. Dr. Zhao, Dr. Zhang, Dr. Reau, and Dr. Shepard reported no relevant financial relationships. Dr. Emmett is a member of the European Food Safety Authority working group on dietary sugars.

A version of this article appeared on Medscape.com.

Drinking sugar-laden beverages on a regular basis may increase the risk for liver cancer and death from chronic liver disease, new research suggests.

The observational analyses revealed that postmenopausal women who consumed at least one sugar-sweetened beverage daily had an 85% higher risk of developing liver cancer and a 68% higher risk of dying from chronic liver disease, compared with those who consumed three servings or fewer per month.

Lori Martin/Fotolia.com

“If our findings are confirmed, reducing sugar-sweetened beverage consumption might serve as a public health strategy to reduce liver disease burden,” first author Longgang Zhao, PhD, with Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.

When looking at consumption of artificially sweetened drinks, however, Dr. Zhao and colleagues found no strong association between intake and risk for liver cancer or death from chronic liver disease. Because the sample size for the artificially sweetened beverage analysis was limited, Dr. Zhao said, “these results should be interpreted with caution and additional studies are needed to confirm our study findings.”

The new study was published online in JAMA.

About 40% of people with liver cancer do not have one of the well-known disease risk factors, such as chronic hepatitis B or C infection, type 2 diabetes, or obesity. In the current analysis, Dr. Zhao and colleagues wanted to determine whether sugar-sweetened or artificially sweetened beverages, consumed by a large swath of the population, could be a risk factor for liver cancer or chronic liver disease.

Two previous studies have found only a “potential association” between sugar-sweetened beverage intake and a person’s risk for liver cancer, the authors explained.

In July, the International Agency for Research on Cancer officially classified the artificial sweetener aspartame as a possible carcinogen, but cancer epidemiologist Paul Pharoah, MD, PhD, commented that “the evidence that aspartame causes primary liver cancer, or any other cancer in humans, is very weak.”

To provide greater clarity about a potential link, the study team used the Women’s Health Initiative to evaluate sugary beverage consumption among 98,786 postmenopausal women and artificially sweetened drink intake among 64,787 followed for up to a median of 20.9 years. The primary outcomes were liver cancer incidence and mortality from chronic liver disease, defined as nonalcoholic fatty liver disease, liver fibrosis, cirrhosis, alcoholic liver diseases, and chronic hepatitis.

Among these women, nearly 7% consumed at least one sugar-sweetened beverage daily and 13% consumed one or more artificially sweetened beverage servings daily.

Over the follow-up period, 207 women developed liver cancer and 148 died from chronic liver disease in the sugary beverage group while 133 women developed liver cancer and 74 died from chronic liver disease in the artificial sugar group.

Compared with women consuming three servings or fewer of sugar-sweetened beverages per month, those consuming one or more servings per day had a significantly higher risk for liver cancer (18.0 vs. 10.3 per 100,000; adjusted hazard ratio, 1.85; P = .01) and for chronic liver disease mortality (17.7 vs. 7.1 per 100,000; aHR, 1.68; P = .04).

Compared with women consuming three servings or fewer of artificially sweetened beverages per month, those drinking one or more servings per day did not have a significantly increased risk for liver cancer (11.8 vs. 10.2 per 100,000; aHR, 1.17; P = .55) or chronic liver disease mortality (7.1 vs. 5.3 per 100,000; aHR 0.95; P = .88).

The authors noted several limitations to the study, including not tracking potential changes in beverage consumption over time or details on the specific sugar content or sweetener types consumed.

Corresponding author Xuehong Zhang, ScD, also with Brigham and Women’s Hospital and Harvard Medical School, said it’s not surprising that sugar-sweetened beverages may raise the risk of adverse liver outcomes.

“Intake of sugar-sweetened beverage[s], a postulated risk factor for obesity, diabetes, and cardiovascular disease, may drive insulin resistance and inflammation, which are strongly implicated in liver carcinogenesis and liver health,” Dr. Zhang said in an interview.

The lack of an association between artificially sweetened beverages and liver outcomes is also not particularly surprising, Dr. Zhang said, “given that the consumption level of artificially sweetened beverages is low, the sample size is relatively small,” and “the dose response relationship remains unknown.”

Nancy S. Reau, MD, who was not involved in the research, said the authors should be “congratulated for trying to clarify liver-related health risk related to artificial or sugar-sweetened beverages.”

In her view, the most important finding is the association between daily consumption of sugar-sweetened beverages and liver health.

“Regardless of whether this is a surrogate marker for liver disease risk (such as fatty liver disease) or a consequence of the drink itself, it is an easy measure for clinicians to capture and an easy behavior for patients to modify,” Dr. Reau, a hepatologist at Rush Medical College, Chicago, said in an interview.

However, Dr. Reau noted, “I do not feel that this article can be used to advocate for artificially sweetened beverages as a substitute.”

It is possible, she explained, that this population was too small to see a significant signal between artificially sweetened beverages and liver health. Plus, “natural, low-caloric beverages as part of a healthy diet combined with exercise are always going to be ideal.”

Weighing in as well, Dale Shepard, MD, PhD, a medical oncologist at the Cleveland Clinic, noted that “this is another study that points to the need for moderation.”

In his view, avoiding excess consumption of sugary or artificially sweetened drinks is the best course of action, but other factors, such as smoking, excessive alcohol, sun exposure without adequate sunscreen, obesity, and inactivity “are more likely to increase one’s risk for cancer,” Dr. Shepard said.

In a statement from the U.K.-based Science Media Centre, Pauline Emmett, PhD, from the University of Bristol (England), commented that this is a “good-quality” study and “the authors have been very careful not to speculate.”

“The main limitation is that this is observational data which provides associations which suggest a relationship but cannot tell if it is causal,” Dr. Emmett said. However, “we know from a body of evidence that it is worth thinking twice before choosing to drink sugar-sweetened beverages every day.”

The study had no commercial funding. Dr. Zhao, Dr. Zhang, Dr. Reau, and Dr. Shepard reported no relevant financial relationships. Dr. Emmett is a member of the European Food Safety Authority working group on dietary sugars.

A version of this article appeared on Medscape.com.

Drinking sugar-laden beverages on a regular basis may increase the risk for liver cancer and death from chronic liver disease, new research suggests.

The observational analyses revealed that postmenopausal women who consumed at least one sugar-sweetened beverage daily had an 85% higher risk of developing liver cancer and a 68% higher risk of dying from chronic liver disease, compared with those who consumed three servings or fewer per month.

Lori Martin/Fotolia.com

“If our findings are confirmed, reducing sugar-sweetened beverage consumption might serve as a public health strategy to reduce liver disease burden,” first author Longgang Zhao, PhD, with Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.

When looking at consumption of artificially sweetened drinks, however, Dr. Zhao and colleagues found no strong association between intake and risk for liver cancer or death from chronic liver disease. Because the sample size for the artificially sweetened beverage analysis was limited, Dr. Zhao said, “these results should be interpreted with caution and additional studies are needed to confirm our study findings.”

The new study was published online in JAMA.

About 40% of people with liver cancer do not have one of the well-known disease risk factors, such as chronic hepatitis B or C infection, type 2 diabetes, or obesity. In the current analysis, Dr. Zhao and colleagues wanted to determine whether sugar-sweetened or artificially sweetened beverages, consumed by a large swath of the population, could be a risk factor for liver cancer or chronic liver disease.

Two previous studies have found only a “potential association” between sugar-sweetened beverage intake and a person’s risk for liver cancer, the authors explained.

In July, the International Agency for Research on Cancer officially classified the artificial sweetener aspartame as a possible carcinogen, but cancer epidemiologist Paul Pharoah, MD, PhD, commented that “the evidence that aspartame causes primary liver cancer, or any other cancer in humans, is very weak.”

To provide greater clarity about a potential link, the study team used the Women’s Health Initiative to evaluate sugary beverage consumption among 98,786 postmenopausal women and artificially sweetened drink intake among 64,787 followed for up to a median of 20.9 years. The primary outcomes were liver cancer incidence and mortality from chronic liver disease, defined as nonalcoholic fatty liver disease, liver fibrosis, cirrhosis, alcoholic liver diseases, and chronic hepatitis.

Among these women, nearly 7% consumed at least one sugar-sweetened beverage daily and 13% consumed one or more artificially sweetened beverage servings daily.

Over the follow-up period, 207 women developed liver cancer and 148 died from chronic liver disease in the sugary beverage group while 133 women developed liver cancer and 74 died from chronic liver disease in the artificial sugar group.

Compared with women consuming three servings or fewer of sugar-sweetened beverages per month, those consuming one or more servings per day had a significantly higher risk for liver cancer (18.0 vs. 10.3 per 100,000; adjusted hazard ratio, 1.85; P = .01) and for chronic liver disease mortality (17.7 vs. 7.1 per 100,000; aHR, 1.68; P = .04).

Compared with women consuming three servings or fewer of artificially sweetened beverages per month, those drinking one or more servings per day did not have a significantly increased risk for liver cancer (11.8 vs. 10.2 per 100,000; aHR, 1.17; P = .55) or chronic liver disease mortality (7.1 vs. 5.3 per 100,000; aHR 0.95; P = .88).

The authors noted several limitations to the study, including not tracking potential changes in beverage consumption over time or details on the specific sugar content or sweetener types consumed.

Corresponding author Xuehong Zhang, ScD, also with Brigham and Women’s Hospital and Harvard Medical School, said it’s not surprising that sugar-sweetened beverages may raise the risk of adverse liver outcomes.

“Intake of sugar-sweetened beverage[s], a postulated risk factor for obesity, diabetes, and cardiovascular disease, may drive insulin resistance and inflammation, which are strongly implicated in liver carcinogenesis and liver health,” Dr. Zhang said in an interview.

The lack of an association between artificially sweetened beverages and liver outcomes is also not particularly surprising, Dr. Zhang said, “given that the consumption level of artificially sweetened beverages is low, the sample size is relatively small,” and “the dose response relationship remains unknown.”

Nancy S. Reau, MD, who was not involved in the research, said the authors should be “congratulated for trying to clarify liver-related health risk related to artificial or sugar-sweetened beverages.”

In her view, the most important finding is the association between daily consumption of sugar-sweetened beverages and liver health.

“Regardless of whether this is a surrogate marker for liver disease risk (such as fatty liver disease) or a consequence of the drink itself, it is an easy measure for clinicians to capture and an easy behavior for patients to modify,” Dr. Reau, a hepatologist at Rush Medical College, Chicago, said in an interview.

However, Dr. Reau noted, “I do not feel that this article can be used to advocate for artificially sweetened beverages as a substitute.”

It is possible, she explained, that this population was too small to see a significant signal between artificially sweetened beverages and liver health. Plus, “natural, low-caloric beverages as part of a healthy diet combined with exercise are always going to be ideal.”

Weighing in as well, Dale Shepard, MD, PhD, a medical oncologist at the Cleveland Clinic, noted that “this is another study that points to the need for moderation.”

In his view, avoiding excess consumption of sugary or artificially sweetened drinks is the best course of action, but other factors, such as smoking, excessive alcohol, sun exposure without adequate sunscreen, obesity, and inactivity “are more likely to increase one’s risk for cancer,” Dr. Shepard said.

In a statement from the U.K.-based Science Media Centre, Pauline Emmett, PhD, from the University of Bristol (England), commented that this is a “good-quality” study and “the authors have been very careful not to speculate.”

“The main limitation is that this is observational data which provides associations which suggest a relationship but cannot tell if it is causal,” Dr. Emmett said. However, “we know from a body of evidence that it is worth thinking twice before choosing to drink sugar-sweetened beverages every day.”

The study had no commercial funding. Dr. Zhao, Dr. Zhang, Dr. Reau, and Dr. Shepard reported no relevant financial relationships. Dr. Emmett is a member of the European Food Safety Authority working group on dietary sugars.

A version of this article appeared on Medscape.com.

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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