WOMENS HEALTH
Anemia may contribute to higher female mortality during heart surgery
Women are at higher risk of death when undergoing heart bypass surgery than men. Researchers at Weill Cornell Medicine have determined that this disparity is mediated, to a large extent, by intraoperative anemia—the loss of red blood cells during surgery. The study, published on March 5, in the Journal of the American College of Cardiology, suggests that strategies for minimizing anemia that occurs during this procedure could lead to better outcomes for women with cardiovascular disease.
This study set out to discover why women are less likely to survive coronary artery bypass grafting, a surgical procedure for restoring blood flow to the heart. The team, led by senior author Dr. Mario Gaudino, the Stephen and Suzanne Weiss Professor in Cardiothoracic Surgery at Weill Cornell Medicine, analyzed information obtained from the Society of Thoracic Surgeons Adult Cardiac Surgery Database on more than one million patients. Dr. Lamia Harik, fellow in Cardiothoracic Surgery Research at Weill Cornell Medicine, was first author on the paper.
They examined patient demographics (such as age and ethnicity), risk factors (including disease severity, previous heart attacks and the co-occurrence of other health conditions) and surgical data (including the time spent on the bypass machine and the volume of the components of blood, such as red blood cells).
Crunching the numbers, Dr. Gaudino and his team previously confirmed that women had a higher mortality associated with the procedure than men: 2.8 percent versus 1.7 percent, a nearly 50 percent difference. Now, using sophisticated statistical analyses to assess all the possible variables, the researchers found that a substantial portion of this enhanced risk—38 percent—could be attributed to severe intraoperative anemia. This depletion of red blood cells is an inevitable side effect of using blood-diluting fluids to prime the heart-lung bypass machine that takes over the job of pumping blood throughout the body during surgery. Women may be even more susceptible to the effects of intraoperative anemia because they tend to arrive in surgery with lower red blood cell counts and have smaller body size compared to their male counterparts.
The study does not establish that intraoperative anemia is causing greater female mortality, but the two factors are associated. It suggests that clinicians and researchers should consider interventions to prevent or minimize severe intraoperative anemia, which can lead to dangerously reduced oxygen delivery to the body’s tissues, including the heart.
Using heart-lung bypass machines with shorter circuits, for example, would limit the volume of blood-diluting solution needed to run the pump. Randomized trials to assess whether methods for curtailing anemia could improve outcomes for women undergoing heart bypass surgery are “urgently needed,” wrote Dr. Gaudino, who is also a cardiovascular surgeon at NewYork-Presbyterian/Weill Cornell Medical Center.
This research was supported in part by the National Heart, Lung, and Blood Institute grant T32 HL160520-01A1, the National Institutes of Health, the Canadian Health and Research Institutes, and the Starr Foundation.
Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosures public to ensure transparency. For this information, please see the profile for Dr. Mario Gaudino.
JOURNAL
Journal of the American College of Cardiology
Hypertensive disorders of pregnancy increase risk of cardiovascular death after giving birth
RUTGERS UNIVERSITY
Rutgers Health researchers have found that hypertensive disorders in pregnancy are strongly associated with fatal cardiovascular disease for up to a year after birth.
Among the hypertensive disorders that cause dangerously high blood pressure during pregnancy — chronic hypertension, gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia and eclampsia — all but gestational diabetes were associated with a doubling in the risk of fatal cardiovascular disease compared to women with normal blood pressure.
Eclampsia, a condition whereby hypertensive disorders cause seizures, was associated with a nearly 58-fold increase in fatal cardiovascular disease, according to a study published in Paediatric and Perinatal Epidemiology.
“Maternal and postpartum mortality rates in the U.S. are higher than in other high-income countries and rising, but more than half of cardiovascular disease-related deaths are preventable,” said lead author Rachel Lee, a data analyst at Rutgers Robert Wood Johnson Medical School. “This study provides new information about how each hypertensive disorder is related to fatal cardiovascular disease, so healthcare providers can monitor patients with such complications more closely and develop strategies for keeping them healthy postpartum.”
Hypertensive disorders of pregnancy | Adjusted risk of pregnancy-assoc mortality (2 = twice the risk of 1) | |
All-cause mortality | Cardiovascular Disease Mortality | |
Normotensive | 1.00 (Reference) | 1.00 (Reference) |
Chronic hypertension | 2.38 | 2.71 |
Gestational hypertension | 0.97 | 1.02 |
Preeclampsia without severe features | 1.98 | 1.96 |
Preeclampsia with severe features | 4.93 | 4.88 |
Superimposed preeclampsia | 4.53 | 5.26 |
Eclampsia | 45.51 | 58.55 |
The researchers used the Nationwide Readmissions Database to examine pregnancy-related mortality rates for females 15 to 54 years old from 2010 to 2018. Data from more than 33 million delivery hospitalizations identified hypertensive disorders in 11 percent of patients, but that number increased with time. In 2010, 9.4 percent of patients in the study had hypertensive disorders of pregnancy. By 2018, that figure had risen by more than half to 14.4 percent.
“We’ve gotten better at predicting, diagnosing, and treating preeclampsia in this country, so the risk of death is falling for any individual patient with that condition,” said Cande Ananth, chief of the Division of Epidemiology and Biostatistics in the Department of Obstetrics, Gynecology, and Reproductive Sciences at Rutgers Robert Wood Johnson Medical School and senior author of the study.
Unfortunately, Ananth noted, the sharp increase in the number of patients who develop chronic hypertension has more than offset the improved ability to treat it.
“Cases of chronic hypertension are rising sharply among people of childbearing age, but optimal treatment strategies remain uncertain,” he said. “While we’re treating more pregnant people with mild hypertension with antihypertensive medications, there remain many questions about the right definitions of hypertension in pregnant compared to non-pregnant individuals.”
Pregnant people with hypertensive disorders, especially those with pre-existing hypertension, need high-quality care as heart disease and related cardiac symptoms can be confused with common symptoms of normal pregnancy. Delays in diagnosis are associated with an increased incidence of preventable complications, the study authors said. Early identification and optimal treatment of hypertensive disorders, especially preeclampsia-eclampsia, are crucial for the primary prevention of maternal stroke.
Guidelines for ongoing care for up to one year after delivery are needed for each hypertensive disorder, the researchers conclude.
JOURNAL
Paediatric and Perinatal Epidemiology
METHOD OF RESEARCH
Data/statistical analysis
SUBJECT OF RESEARCH
People
ARTICLE TITLE
Pregnancy-associated mortality due to cardiovascular disease: Impact of hypertensive disorders of pregnancy
A third of women experience migraines associated with menstruation, most commonly when premenopausal
GEORGETOWN UNIVERSITY MEDICAL CENTER
WASHINGTON (April 12, 2024) – A third of the nearly 20 million women who participated in a national health survey report migraines during menstruation, and of them, 11.8 million, or 52.5%, were premenopausal. The analysis was conducted by researchers at Georgetown University Medical Center and Pfizer, Inc., which makes a migraine medication.
Because of the underuse of medications to help treat or prevent menstrual migraines, investigators wanted to understand how common menstrual migraines were and which groups of women could most benefit from potential therapies. The study will be presented April 16, at the American Academy of Neurology 2024 Annual Meeting in Denver.
“The first step in helping a woman with menstrual migraine is making a diagnosis; the second part is prescribing a treatment; and the third part is finding treatments patients are satisfied with and remain on to reduce disability and improve quality of life,” says the study author, Jessica Ailani, MD, professor of clinical neurology at Georgetown University School of Medicine and director of the MedStar Georgetown Headache Center at Medstar Georgetown University Hospital.
The researchers used the 2021 U.S. National Health and Wellness Survey, conducted by the National Center for Health Statistics, to analyze responses from women who reported their current migraine treatments, frequency and disabilities via the Migraine Disability Assessment Test (MIDAS), a five-question survey. A migraine headache can cause severe throbbing pain or a pulsing sensation, usually on one side of the head. It's often accompanied by nausea, vomiting, and extreme sensitivity to light and sound.
“Discrepancies in the incidence of who gets migraine attacks associated with menses is likely due to premenopausal women having more regular menstrual cycles and thus more menstrual-related migraines,” says Ailani. “Additionally, as women move into their 40's and become peri-menopausal, there tends to be a greater shift through the month in hormone levels also leading to frequent migraine attacks.”
The survey found that for all women during their menstrual periods, migraine attacks occurred as frequently as 4.5 times and that monthly only migraine headaches lasted 8.4 days, on average; 56.2 % of women had moderate-to-severe migraine-specific disabilities that ranked highest on the MIDAS scale.
When looking at treatments women in the survey used to help control their migraine symptoms, 42.4% used over-the-counter medications while 48.6% used prescription medications. Of the 63.9 % of women who used migraine treatments for acute symptoms, the most commonly used were triptans, a class of drugs developed in the 1990s to quiet overactive nerves associated with migraines and cluster headaches.
Sara’s story
Sara, a 38 year old mother of two, says her migraines are predictably and consistently worse during her period.
“It definitely disrupts my ability to go about my normal activities including at work,” Sara says. “I’m pretty lucky that I’m generally responsive to prescription medication, but I often still have to lie down for an hour or so while the medicine kicks in.”
Sara is being treated preventatively for migraines with Botox. She says over the past couple of months, she’s had a couple of migraines outside of when she gets her period, but that the headaches are definitely worse during menstruation.
“While I had my last period, I had a migraine every day for a week,” Sara says. “It’s starkly different [during menstruation].”
Prevention Possibilities
Non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen or ibuprofen, are sometimes used as preventive medications for women with regular menstrual periods. In this study, 21.1% of women reported use of any migraine prevention medications or therapies.
“Preventive treatments are used less frequently than acute treatment for migraine,” Alaini said.
“In my opinion, this is because preventive therapy is a long-term commitment by both a woman and her clinician to improving the disease process. Migraine is a life-long brain disease without a cure, and the goal of preventive therapy is to reduce disease burden and improve quality of life. Unfortunately, newer disease-specific treatments are costly, so generic older treatments are often used and come with greater side effects.”
Next Steps
The researcher’s next steps involve looking at larger databases to see if they can mimic findings on a global scale. They want to determine if women with menstrual-related migraine are frequently turning to non-migraine treatments as was seen in around 53% of their current study group.
“As a headache specialist in the U.S., I know I can do better for women in my clinic, but what can be done for the millions of women who don't get into a headache clinic? That is our true next step,” says Ailani. “If you have migraines related to your menstrual cycle, discuss this with your gynecologist or neurologist. There are treatments that can help and if the first treatment tried does not work, do not give up.”
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In addition to Ailani, co-authors include Joshua Brown, Motomori Lewis, Aaron Jenkins, Jessica Cirillo, Karin Hygge Blakeman, Jiyue Yang, Lucy Abraham from Pfizer, Inc, New York.
This work was supported by Pfizer.
Ailani reports receiving personal compensation for serving as a consultant for Pfizer. Additional disclosures from her and her co-authors can found be on the AAN website.
METHOD OF RESEARCH
Data/statistical analysis
SUBJECT OF RESEARCH
People
COI STATEMENT
Ailani reports receiving personal compensation for serving as a consultant for Pfizer. Additional disclosures from her and her co-authors can be on the AAN website.
Mass General study identifies an AI model that can accurately assess PTSD in postpartum women
Early intervention is critical to prevent progression of a disorder which may carry serious health consequences for as many as eight million women a year globally
MASSACHUSETTS GENERAL HOSPITAL
Key Takeaways:
- An artificial intelligence model combined with a trained machine learning algorithm was found by Mass General researchers and collaborators to accurately identify childbirth-related post-traumatic stress disorder (CB-PTSD).
- The findings could set the stage for a highly effective, low-cost, and readily accessible way to screen for the disorder, which affects up to 8M women worldwide.
- Interventions could then be offered to the mother to reduce the trauma associated with the birthing process.
BOSTON – A generative artificial intelligence (AI) model that can analyze the narrative accounts of women who have undergone recent childbirth has shown the ability to accurately screen for post-traumatic stress disorder (CB-PTSD), a study by Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham healthcare system has found.
By exploring the capabilities and shortcomings of several models from OpenAI, including ChatGPT, the researchers identified a version that offers rich insights into maternal mental health following traumatic childbirth.
The model can fit seamlessly into routine obstetric care and could potentially be harnessed to assess other mental health disorders. The results of the study were published in Scientific Reports.
“Evaluation of PTSD related to traumatic birth currently relies on extensive clinician evaluation, which fails to meet the urgent need for a rapid, low-cost assessment strategy,” says Sharon Dekel, PhD, director of MGH’s Postpartum Traumatic Stress Disorders Research Program, and senior author of the study.
“The use of brief patient narratives of childbirth analyzed by AI’s text-based computational methods could become an efficient, low-cost, and patient-friendly strategy for detecting CB-PTSD after a traumatic birth and with more research this tool may potentially aid in identifying women at risk for CB-PTSD before the condition fully develops.”
For an estimated eight million women a year globally, childbirth that is traumatic and/or medically complicated is expected to trigger post-traumatic stress disorder, a condition historically has been associated with military combat or severe sexual assault.
In recent years, childbirth has become acknowledged as a significant PTSD trigger which, if left untreated, can impair the health of both the mother and child and result in significant societal costs.
In previous studies, Dekel’s lab found evidence that brief psychological interventions delivered soon after traumatic childbirth can reduce maternal childbirth-related PTSD symptoms.
In their latest study, Dekel in collaboration with first author Alon Bartal, PhD, of Bar-Ilan University in Israel, investigated the effectiveness of artificial intelligence and related machine learning (ML) analysis strategies to detect CB-PTSD.
Specifically, they evaluated the performance of different large language models (LLMs) and variations of ChatGPT and their ability to extract novel insights from text-based data sets derived from the brief narrative descriptions by postpartum women of their childbirth experience.
As part of their work, the team collected short narrative accounts from 1,295 women who had recently given birth.
The study focused on an OpenAI model known as text-embeddings-ada-002, which converted narrative data from the personal accounts of women with and without probable CB-PTSD to a numerical format that was then analyzed by a trained machine learning algorithm developed by the team.
Researchers showed this model had superior performance in identifying postpartum traumatic stress compared to other ChatGPT and large language models, which are typically trained on huge volumes of data allowing them to understand, analyze and interpret natural language.
“The reliance of the ML model using childbirth narrative input from the Open AI model as its exclusive data source presents an efficient mechanism for data collection during the vulnerable postpartum period, demonstrating 85 percent sensitivity and 75 percent specificity in identifying CB-PTSD cases,” notes Dekel.
“Moreover, the model we developed could potentially improve accessibility to CB-PTSD screening and diagnosis by fitting seamlessly into routine obstetric care and providing a foundation for commercial product development and mainstream adoption.”
Dekel, whose research program is dedicated to exploring women’s mental health following traumatic childbirth, underscores the clinical benefits of using a pre-trained large language model to assess potential PTSD in new mothers.
“Early intervention is essential to prevent the progression of this disorder to chronic stages, which can seriously complicate treatment,” the MGH investigator points out.
“Our unique approach could introduce an innovative and cost-effective screening strategy for identifying high-risk women and facilitating timely treatment. It may also holds promise for assessing other mental health disorders, and consequently improving patient outcomes.”
The emergence of artificial intelligence tools in health has been groundbreaking and has the potential to positively reshape the continuum of care. Mass General Brigham, as one of the nation’s top integrated academic health systems and largest innovation enterprises, is leading the way in conducting rigorous research on new and emerging technologies to inform the responsible incorporation of AI into care delivery, workforce support, and administrative processes.
Dekel is a psychologist at MGH, and assistant professor of Psychology at Harvard Medical School. Bartal is an assistant professor of Information Systems at Bar-Ilan University in Israel. Co-authors in the Dekel Laboratory include Kathleen Jagodnik, PhD, a Harvard research fellow, and Sabrina Chan, a clinical research coordinator.
Dekel was supported by funds from the NIH (Eunice Kennedy Shriver National Institute of Child Health and Human Development, grants R01HD108619, R21HD109546, and R21HD100817).
About the Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. MGH is a founding member of the Mass General Brigham healthcare system.
JOURNAL
Scientific Reports
METHOD OF RESEARCH
Experimental study
SUBJECT OF RESEARCH
People
ARTICLE TITLE
AI and narrative embeddings detect PTSD following childbirth via birth stories
ARTICLE PUBLICATION DATE
11-Apr-2024
AI model has potential to detect risk of childbirth-related post-traumatic stress disorder
NIH-funded study suggests model could identify large percentage of those at risk
Media Availability
Researchers have adapted an artificial intelligence (AI) program to identify signs of childbirth-related post-traumatic stress disorder (CB-PTSD) by evaluating short narrative statements of patients who have given birth. The program successfully identified a large proportion of participants likely to have the disorder, and with further refinements—such as details from medical records and birth experience data from diverse populations—the model could potentially identify a large percentage of those at risk. The study, which was funded by the National Institutes of Health, appears in Scientific Reports.
Worldwide, CB-PTSD affects about 8 million people who give birth each year, and current practice for diagnosing CB-PTSD requires a physician evaluation, which is time-consuming and costly. An effective screening method has the potential to rapidly and inexpensively identify large numbers of postpartum patients who could benefit from diagnosis and treatment. Untreated CB-PTSD may interfere with breastfeeding, bonding with the infant and the desire for a future pregnancy. It also may worsen maternal depression, which can lead to suicidal thoughts and behaviors.
Investigators administered the CB-PTSD Checklist, which is a questionnaire designed to screen for the disorder, to 1,295 postpartum people. Participants also provided short narratives of approximately 30 words about their childbirth experience. Researchers then trained an AI model to analyze a subset of narratives from patients who also tested high for CB-PTSD symptoms on the questionnaire. Next, the model was used to analyze a different subset of narratives for evidence of CB-PTSD. Overall, the model correctly identified the narratives of participants who were likely to have CB-PTSD because they scored high on the questionnaire.
The authors believe their work could eventually make the diagnosis of childbirth post-traumatic stress disorder more accessible, providing a means to compensate for past socioeconomic, racial, and ethnic disparities.
The study was conducted by Alon Bartal, Ph.D., of Bar Ilan University in Israel, and led by senior author Sharon Dekel, Ph.D., of Massachusetts General Hospital and Harvard Medical School, Boston. Funding was provided by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
WHO:
Maurice Davis, D.H.A., M.P.A., M.H.S.A., of the NICHD Pregnancy and Perinatology Branch, is available for comment.
ARTICLE:
Bartal A, et al. AI and narrative embeddings detect PTSD following childbirth via birth stories. Scientific Reports (2024).
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About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit https://www.nichd.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.
JOURNAL
Scientific Reports
METHOD OF RESEARCH
Data/statistical analysis
SUBJECT OF RESEARCH
People
ARTICLE PUBLICATION DATE
11-Apr-2024
Esketamine injection just after childbirth reduces depression in new mothers
Low dose esketamine should be considered for individuals with depressive symptoms in pregnancy, say researchers
A single low dose injection of esketamine given immediately after childbirth reduces major depressive episodes in individuals with depressive symptoms during pregnancy (prenatal depression), finds a clinical trial published by The BMJ today.
The results suggest that low dose esketamine should be considered in new mothers with prenatal depressive symptoms.
Depression is common during pregnancy and shortly after giving birth and can have several adverse effects on new mothers and their infants.
Esketamine is made from a drug called ketamine. It’s used as an anaesthetic and to treat depression, yet the effect for mothers with perinatal depression is unclear.
To examine this further, researchers based in China and the USA wanted to find out if a single low dose injection of esketamine given just after childbirth might reduce subsequent depression in mothers with pre-existing prenatal depression.
Their findings are based on 361 mothers (average age 32 years) enrolled from five Chinese hospitals from June 2020 to August 2022 with no medical history of depression and no diagnosis of depression in pregnancy, but who had scores on a scale consistent with mild prenatal depression and were preparing for childbirth.
None of the participants had severe pregnancy complications, or any condition that meant they couldn’t be given esketamine.
Information on factors including age, weight (BMI), education level, family income and existing health conditions was recorded at the start of the trial and participants were randomly assigned to either esketamine or placebo intravenously infused over 40 minutes after childbirth.
Participants were interviewed 18 to 30 hours after giving birth and again at 7 and 42 days.
Major depressive episode was diagnosed with the Mini-International Neuropsychiatric Interview at 42 days. Depression was also assessed using the Edinburgh depression score at 7 and 42 days, and the Hamilton Depression Rating Scale score at 42 days. No participant took antidepressants or received psychotherapy during the follow-up period.
At 42 days after giving birth, 12 of 180 (6.7%) of mothers given esketamine experienced a major depressive episode compared with 46 of 181 (25.4%) of those given placebo (a relative risk reduction of about three-quarters).
As expected, mothers given esketamine had lower Edinburgh depression scores at 7 and 42 days, and a lower Hamilton depression score at 42 days.
Based on these figures, the researchers estimate that, for every five mothers given esketamine, one major depressive episode would be prevented.
More neuropsychiatric adverse events such as dizziness and diplopia (double vision) occurred with esketamine (45% v 22%). However, symptoms lasted less than a day and none needed drug treatment.
The researchers acknowledge that excluding mothers with pre-pregnancy mood disorders may have affected the validity of their results, and the short follow-up period may have led to under-reporting of neuropsychiatric symptoms and other adverse events.
What’s more, most participants had only mild prenatal depressive symptoms, so it’s unclear whether esketamine is equally effective in those with more severe depressive symptoms.
Nevertheless, they conclude that for mothers with prenatal depressive symptoms, a single low dose of esketamine given shortly after childbirth decreases major depressive episodes at 42 days postpartum by about three quarters.
These results are generally consistent with previous work investigating the effects of low dose ketamine or esketamine on postpartum depression, mainly in mothers after caesarean delivery, and, importantly, the researchers say their trial “extends existing understanding by targeting women with pre-existing prenatal depression, who were therefore at high risk of postnatal depression.”
As such, they conclude that low dose esketamine should be considered in mothers with symptoms of prenatal depression.
[Ends]
JOURNAL
The BMJ
METHOD OF RESEARCH
Randomized controlled/clinical trial
SUBJECT OF RESEARCH
People
ARTICLE TITLE
Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial
ARTICLE PUBLICATION DATE
10-Apr-2024
COI STATEMENT
All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-ofinterest/ and declare: support from the National Natural Science Foundation of China, National High Level Hospital Clinical Research Funding, Peking University First Hospital, and Zhejiang University; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
CAMH develops first ever clinically validated natural supplement to prevent postpartum blues
Product now available in the U.S. with global distribution planned
CENTRE FOR ADDICTION AND MENTAL HEALTH
IMAGE:
CENTRE FOR ADDICTION AND MENTAL HEALTH (CAMH) RESERACHER DR. JEFFREY MEYER STANDS WITH HIS INVENTION, THE FIRST EVER CLINICALLY VALIDATED NATURAL SUPPLEMENT TO PREVENT POSTPARTUM BLUES.
view moreCREDIT: IMAGE COURTESY OF CAMH. ALL RIGHTS RESERVED.
A new study published in the Lancet discovery science journal eClinicalMedicine has confirmed that a novel natural supplement—invented, researched, developed and commercialized at the Centre for Addiction and Mental Health (CAMH)—prevents postpartum blues, and reduces symptoms of postpartum depression over the following six months after giving birth.
Up to 8 out of ten new mothers experience postpartum, or ‘baby,’ blues, characterized by mood swings, crying spells, anxiety and difficulty sleeping. The condition usually begins within the first few days after delivery and may last for up to two weeks. Postpartum blues strongly raises the risk of postpartum depression, a serious mental illness affecting 13 per cent of mothers. Postpartum depression has important health care consequences: impairing quality of life, increasing risk for future depressive episodes and suicide, and is associated with cognitive and emotional effects in children. Until now, options for widespread prevention have been lacking for either condition.
The study, entitled Dietary Supplement for Mood Symptoms in Early Postpartum: A Double-Blind Randomized Placebo Controlled Trial, involved more than 100 postpartum participants between January 2019 and December 2022 who either took four doses of the natural supplement several days after giving birth, or a matching placebo. Within the supplement group, two-thirds (66 per cent) experienced either no symptoms or only negligible symptoms of postpartum blues. Furthermore, in the following six months, participants who received the supplement experienced less symptoms of depression with none reaching the clinical threshold of postpartum depression six months after giving birth.
“Globally 140 million births take place every year. Most women then experience postpartum blues, which, when severe, increases the likelihood of getting full-blown postpartum depression at least fourfold. Our study showed that both postpartum blues and later symptoms of depression were lower in women who received the dietary supplement,” said Dr. Jeffrey Meyer, inventor of the nutraceutical and study senior author. “Providing this specialized dietary support in the first few days after giving birth is a crucial window to avoid depressive symptoms which is tremendously important given there is considerable risk that they may recur and have lifelong impact.”
Dr. Meyer has been investigating postpartum blues for more than 15 years. His previous imaging research found that a protein called MAO-A rises dramatically in the brains of postpartum women and this protein removes important brain chemicals—like serotonin and dopamine—that support normal mood. It also acts as an oxidant and is linked to the development and progression of certain mental illnesses. To combat this effect, the nutraceutical is made up of a patented unique combination of natural ingredients, including blueberry extract, which contain antioxidants, and amino acids that replenish essential neurochemicals in the brain to support healthy mood and the ability to concentrate under stress. The supplement was well tolerated and women who took it tended to report less symptoms, in part due to less drowsiness, headache and restlessness. The researchers previously showed that the amino acids in the supplement do not affect their total concentrations in breast milk, which was expected since these amino acids are already found in proteins in breast milk.
CAMH has partnered with international women’s health supplement and pharmaceutical company Exeltis via a licensing agreement to bring the product to market under the name Blues Away®. Exeltis has maintained the natural health product approach in their preparations and manufacture for widespread distribution of the supplement. It is expected that the product will be available for sale in the U.S. beginning April 11, 2024. It is also in the process of being brought to other global markets—including Canada—with the pace of approvals being dependent on each country’s regulatory requirements and reviews.
“We are thrilled to unveil the culmination of years of dedication and collaboration in the form of our groundbreaking nutraceutical for postpartum blues prevention. It is great that we are able to simultaneously share our clinical research around this product while also partnering with a global women’s health industry leader to make it available to the new mothers who need it,” said Klara Vichnevetski, Director of Industry Partnerships and Technology Transfer. CAMH has nurtured this innovation from its inception, guiding it from bench to bedside where it can make an immediate and profound difference in the lives of millions of women and their families.”
A limitation of the study was that, of the several measures of depression in the study, the supplement did not demonstrate the expected protective effect in an experimental test that involves inducing low mood with sad stimuli, although it is possible that the stress of the COVID-19 pandemic and moving the setting of the study to participant’s homes during the pandemic may have influenced the results of this particular test.
Aristotle Voineskos, Vice President of Research, added: “Two major pillars of our CAMH approach to research are the importance of integrating scientific findings into advancing mental health care and the value of early intervention. Through the perseverance and dedication of our researchers and technology transfer team, this novel preventative therapy may contribute to best practice when it comes to postpartum care and help women around the world avoid more serious and chronic mental illness.”
This research was funded by CAMH, with some additional funding from Exeltis.
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About the Centre for Addiction and Mental Health (CAMH)
CAMH is Canada's largest mental health and addiction teaching hospital and a world leading research centre in this field. CAMH combines clinical care, research, education, policy development and health promotion to help transform the lives of people affected by mental illness and addiction. CAMH is fully affiliated with the University of Toronto, and is a Pan American Health Organization/World Health Organization Collaborating Centre. For more information, please visit camh.ca or follow @CAMHnews on Twitter.
Media Contact:
CAMH Media Relations
media@camh.ca
JOURNAL
EClinicalMedicine
METHOD OF RESEARCH
Randomized controlled/clinical trial
SUBJECT OF RESEARCH
People
ARTICLE TITLE
Dietary supplement for mood symptoms in early postpartum: a double-blind randomized placebo controlled trial
ARTICLE PUBLICATION DATE
10-Apr-2024
COI STATEMENT
JHM is the inventor on patents for the dietary supplement and there is an agreement between CAMH and Exeltis for the latter to manufacture, and distribute the dietary supplement. JHM also has patents for blood biomarkers in mood disorders to predict neuroinflammation, elevated MAO-B level and elevated MAO-A level in the brain. JHM has received operating grant funding from Exeltis and Sanofi in the past 2 years. MIH receives research grants from the Canadian Institutes of Health Research, CAMH Foundation, University of Toronto, COMPASS Pathfinder; stipend from Society of Biological Psychiatry; payment or honoraria from the American Society of Clinical Psychopharmacology and American College Health Association; consulting fees from Wake Network Inc. and stock options in Mindset Pharma Inc.
Acetaminophen use during pregnancy and children’s risk of autism, ADHD, and intellectual disability
JAMA
About The Study: Acetaminophen use during pregnancy was not associated with children’s risk of autism, attention-deficit/hyperactivity disorder (ADHD), or intellectual disability in sibling control analysis. This suggests that associations observed in other models may have been attributable to familial confounding.
Authors: Brian K. Lee, Ph.D., of Drexel University in Philadelphia, is the corresponding author.
To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/
(doi:10.1001/jama.2024.3172)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.
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Embed this link to provide your readers free access to the full-text article This link will be live at the embargo time https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2024.3172?guestAccessKey=32d8014d-f026-4985-9e72-d514cb2f81dc&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=040924
JAMA
About The Study: Acetaminophen use during pregnancy was not associated with children’s risk of autism, attention-deficit/hyperactivity disorder (ADHD), or intellectual disability in sibling control analysis. This suggests that associations observed in other models may have been attributable to familial confounding.
Authors: Brian K. Lee, Ph.D., of Drexel University in Philadelphia, is the corresponding author.
To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/
(doi:10.1001/jama.2024.3172)
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JOURNAL
JAMA
JAMA
No link between acetaminophen use during pregnancy and children’s risk of autism, ADHD, and intellectual disability says large sibling study from Drexel University and Sweden’s Karolinska Institutet
April 9, 2024
No Link Between Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability Says Large Sibling Study from Drexel University and Sweden’s Karolinska Institutet
PHILADELPHIA -- In the largest study to date on the subject, researchers found no evidence to support a causal link between acetaminophen use during pregnancy and increased risk of autism, ADHD and intellectual disability in children. The findings, using data from a nationwide cohort of over 2.4 million children born in Sweden, including siblings not exposed to the drug before birth, were published today in the Journal of the American Medical Association (JAMA) from researchers at Drexel’s Dornsife School of Public Health and Karolinska Institutet of Sweden.
Advertised as a pain reliever and fever reducer, the generic drug acetaminophen is the active ingredient in Tylenol and is an ingredient in versions of other drugs, such as Theraflu, Excedrin, and Mucinex, among others.
Following each child up to 26 years after birth, the team found a small increased risk of autism, ADHD and intellectual disability in the overall population – as seen in similar previous studies that reported such a link. However, the authors found no increased risk of any of the conditions when comparing full siblings when one sibling was exposed to acetaminophen while in the uterus before birth and the other sibling was not. Because siblings share a substantial portion of their genetic background, as well as similar exposure to many of the same environmental factors during development, comparing siblings helps to control for these shared factors that are otherwise hard to measure in epidemiological studies, the authors noted.
“Users of acetaminophen differ from non-users in a number of ways and standard statistical analyses without a sibling control can’t control for all of the differences,” said co-senior author Brian Lee, PhD, an associate professor in Drexel’s Dornsife School of Public Health, fellow at the A.J. Drexel Autism Institute, and research affiliate at the Karolinska Institutet. “Sibling comparisons allow us to control for familial characteristics that might explain an apparent relationship between acetaminophen use during pregnancy and risk of neurodevelopmental conditions.”
Using data from Sweden’s national health and prescription drug registers, the researchers gathered data on medication use throughout pregnancy for births from 1995 to 2019. Only about 7.5% of the study sample – 185,909 children – were exposed to acetaminophen during pregnancy. In previous studies, acetaminophen use during pregnancy varied greatly depending on the study setting; a study in Denmark reported 6.2% use while one study in the U.S. reported 10-fold higher use. Previous studies suggested that many pregnant people, who may benefit from acetaminophen, do not take it for fear of side effects, such as a 2019 study that surveyed 850 pregnant Swedish persons, in which more than 60% considered medication use during early pregnancy to be “probably harmful” or “harmful.”
“This study’s findings may be welcome news for birthing people who use acetaminophen as a pain or fever management option, since there are few safe alternatives for relief available,” said co-senior author Renee M. Gardner, PhD, of Sweden’s Karolinska Institutet. “We hope that our results provide reassurance to expectant parents when faced with the sometimes fraught decision of whether to take these medications during pregnancy when suffering from pain or fever.”
The authors say all patients should follow the guidance from their physician on whether acetaminophen is safe for them and their future children.
The study authors said that the statistically increased risk of neurodevelopmental disorders in children exposed to acetaminophen in the womb is likely due to other factors.
“Our study and others suggest there are many different health and familial factors that are associated with both acetaminophen use and neurodevelopmental disorders,” said Lee. “Genetics likely play a role, but future work to elucidate this mechanism is crucial.”
In 2015, the U.S. Food and Drug Administration said that studies on over-the-counter pain medicines “are too limited to make any recommendations,” but noted that “severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother.” A 2021 consensus statement in Nature Reviews Endocrinology by an international group of scientists and clinicians recommended that pregnant individuals “minimize exposure (to acetaminophen) by using the lowest effective dose for the shortest possible time” due to research suggesting that prenatal exposure to the drug could increase the risk of neurodevelopmental and other disorders.
Although the Drexel and Karolinska study used data on prescribed acetaminophen and reports from pregnant people to their midwives during prenatal care and may not capture all over-the-counter use in all patients, the findings represent data from a large representative sample and controls for many other factors that may be linked to neurodevelopmental disorders.
The study was supported by National Institutes of Health’s National Institute of Neurological Disorders and Stroke 1R01NS107607. Beyond funding, NIH had no role in carrying out the study or interpretation of its findings. Lee has received consulting fees for literature reviews for law firms, but has provided no expert litigation, and no external parties had any role in the study.
Other than Gardner and Lee, other authors on the paper include shared lead authors Viktor H. Ahlqvist, PhD, and Hugo Sjöqvist, Christina Dalman, MD, PhD, Håkan Karlsson, PhD, Olof Stephansson, MD, PhD, Stefan Johansson, MD, PhD, and Cecilia Magnusson, MD, PhD, all who hold academic appointments at the Karolinska Institutet.
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JOURNAL
JAMA
METHOD OF RESEARCH
Observational study
SUBJECT OF RESEARCH
People
ARTICLE TITLE
Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability
ARTICLE PUBLICATION DATE
9-Apr-2024
COI STATEMENT
Dr Johansson reported being a founder of Neobiomics AB, a startup company located at the Karolinska Campus that works with niche food supplement solutions for infants. Dr Gardner reported receiving grants Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability Original Investigation Research from Swedish Research Council during the conduct of the study. Dr Lee reported receiving personal fees from Beasley Allen Law Firm, Patterson BelknapWebb & Tyler LLP, and AlphaSights and grants from NIH (1R01NS107607) during the conduct of the study and grants from NIH (1P50HD11142-01, 3 P50HD111142-02S1, 1 R01 NS131433-01), Pennsylvania Department of Human Services, US Department of Defense, and Pennsylvania Department of Health CURE SAP (# 410008574)7 outside the submitted work. No other disclosures were reported.
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