New test of synovial fluid of joints of patients developed for early osteoarthritis diagnosis, reveals research

Usually osteoarthritis is diagnosed in the late stages when cartilage degradation is severe, making it difficult to distinguish it from other types of arthritis and to determine the best treatment plan. A study published in the Journal of Orthopaedic Research details the development and testing of a new diagnostic test that utilizes two specific markers found in the synovial fluid of patients’ joints.

After assessing levels of cartilage oligomeric matrix protein and interleukin‐8, the team came up with an algorithm based on the ratio of these two markers and validated its efficacy in differentiating osteoarthritis from inflammatory arthritis in 171 human knee synovial fluid specimens.

“This study addresses an unmet need for objective diagnosis of osteoarthritis to improve clinical decision-making and patient outcomes,” said corresponding author Daniel Keter, BA, of CD Diagnostics, A Division of Zimmer Biomet.

Reference:

Daniel Keter, Van Thai-Paquette, John Miamidian, Simmi Gulati, Krista Toler, Synovial fluid dual-biomarker algorithm accurately differentiates osteoarthritis from inflammatory arthritis, https://doi.org/10.1002/jor.26005

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GPT-4o found accurate for evaluating examinees’ performance on CPR skills tests, claims research

Research on large language models (LLMs) in the healthcare sector has shown their promising advantages. For instance, following the launch of ChatGPT, notable advancements have been achieved in addressing medical inquiries concerning cancer screening, pathological classification, and public health topics during medical Q&A sessions . Recent study aimed to evaluate the suitability of GPT-4o for scoring examinees’ performance on cardiopulmonary resuscitation (CPR) skills tests. Six experts reviewed CPR skills test videos of 103 examinees, which were also automatically assessed by GPT-4o across four sections: patient assessment, chest compressions, rescue breathing, and repeated operations. The experts rated GPT-4o’s reliability on a Likert scale and compared the agreement between GPT-4o’s scores and experts’ scores.

Evaluation of GPT-4o Performance

The results showed that GPT-4o achieved accuracy scores similar to senior experts in patient assessment, chest compressions, and rescue breathing, with lower accuracy in repeated operations. The reliability ratings given by experts were generally high for GPT-4o. The study highlighted the potential of using GPT-4o in medical examination settings based on its accuracy and reliability in evaluating CPR skills exam videos.

Utility of Large Language Models in Healthcare

The use of large language models (LLMs) in healthcare, such as GPT-4o, has shown progress in various medical tasks, including responding to medical queries, generating clinical records, and achieving proficiency in text-based medical scenarios. Previous studies have assessed LLMs in medical examinations, revealing mixed results in meeting passing requirements for certain exams. While opinions on LLMs in medicine vary, the study demonstrated the potential for GPT-4o in medical examination scenarios.

AI Technology in Medical Education

The study employed AI technology and LLMs to enhance medical education and examination processes. GPT-4o’s ability to assess CPR skills videos accurately and reliably suggests its potential as an examiner in clinical skill practice exams. The findings indicate that GPT-4o could improve the efficiency and accuracy of examination scoring, particularly for practical assessments like CPR skills tests. Overall, this research sheds light on the promising role of AI, specifically GPT-4o, in medical examination settings for evaluating practical skills of examinees.

Key Points

1. The study assessed the performance of GPT-4o in scoring examinees’ CPR skills test videos, using a methodology where six experts reviewed the videos and compared their ratings with those generated by GPT-4o. The evaluation covered four sections: patient assessment, chest compressions, rescue breathing, and repeated operations.

2. GPT-4o demonstrated accuracy levels similar to senior experts in patient assessment, chest compressions, and rescue breathing, albeit with lower accuracy in repeated operations. Experts generally rated the reliability of GPT-4o highly, indicating its potential for medical examination settings, specifically in evaluating CPR skills exam videos.

3. The study discussed the utility of large language models (LLMs) in healthcare, exemplified by GPT-4o, which has shown promise in various medical tasks like responding to medical queries, generating clinical records, and performing well in text-based medical scenarios. Previous evaluations of LLMs in medical examinations have yielded mixed results, but the study showcased the potential of GPT-4o in such scenarios.

4. Utilizing AI technology and large language models like GPT-4o can enhance medical education and examination processes. GPT-4o’s ability to accurately and reliably assess CPR skills videos suggests its suitability as an examiner for clinical skill practice exams, potentially improving the efficiency and accuracy of examination scoring, especially for practical assessments such as CPR skills tests.

5. The research highlighted the promising role of artificial intelligence, specifically GPT-4o, in medical examination settings for evaluating the practical skills of examinees. By leveraging AI technology, institutions can potentially streamline and standardize assessment processes, providing a more objective and consistent evaluation of medical skills.8

6. Overall, the study underscored the potential benefits of incorporating AI technology, particularly large language models like GPT-4o, in medical education and examination settings. The findings suggest that AI-driven assessment tools can enhance the objectivity, accuracy, and efficiency of evaluating practical skills in medical scenarios, paving the way for advancements in medical education and assessment practices.

Reference –

Lu Wang et al. (2024). Suitability Of GPT-4o As An Evaluator Of Cardiopulmonary Resuscitation Skills Examinations.. *Resuscitation*, 110404 . https://doi.org/10.1016/j.resuscitation.2024.110404.

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Very Early endoscopy may arrest acute upper GI bleeding, cut mortality: BMC

A new study published in the journal of BMC Gastroenterology showed that the 30-day mortality rate for older individuals with acute non-variceal upper gastrointestinal hemorrhage was considerably decreased by very early endoscopy (<12 hours). There is still considerable debate over the best time to do an endoscopy for acute upper gastrointestinal bleeding (UGIB). Differences in the current guidelines for the time between presentation and endoscopy reflect this.

For the majority of UGIB patients, endoscopy within 24 hours is typically considered suitable. But organizing this is still difficult, especially in smaller centers on the weekends. Studies conducted in recent years have detailed the precise early identification of individuals with a very low chance of a bad outcome following UGIB, allowing for early outpatient endoscopic arrangements and the avoidance of inpatient. Thus, Yavuz Cagir and colleagues carried out this study to assess the ideal endoscopic duration in elderly patients with nonvariceal upper gastrointestinal bleeding (NVUGIB).

Based on endoscopic timing, the patients over 65 who present with NVUGIB fall into one of three groups as very early endoscopy (< 12 h), early endoscopy (12-24 h), or late endoscopy (> 24 h). For patients with unstable hemodynamic settings, continuous bleeding, or a low hematocrit despite transfusion, endoscopic intervention was performed during the first 12 hours. The clinical outcomes under investigation were; 30-day mortality was the primary objective, whereas duration of hospital stay, rebleeding, and the necessity for endoscopic intervention were regarded as secondary goals.

Of the 468 people in the research, 260 were over 65. 180 (69.2%) patients over 65 and 150 (72.1%) younger patients had extremely early endoscopies (within 12 hours) based on the endoscopic schedule (p > 0.05). The patients over 65 and younger patients had early endoscopies (12–24 hours) in 53 (20.4%) and 41 (19.7%) cases, respectively, whereas 27 (10.4%) and 17 (8.2%) patients had late endoscopies (24–48 hours). The clinical outcomes of comparisons between groups and subgroups depending on endoscopy time in the population aged 65 and above.

When groups were compared, it was discovered that the very early endoscopy group had a significantly lower risk of requiring surgical/radiological intervention than the late endoscopy group, and 30-day mortality rates by endoscopy timing were statistically quite distinct in the early endoscopy group (7.5%), very early group (15.6%), and late endoscopy group (29.6%).

Endoscopy within 24 to 48 hours (late) was a separate predictor of rebleeding throughout the hospital stay. Overall, early endoscopy may help control acute UGIB, particularly in the elderly with significant comorbidities and severe bleeding.

Source:

Cagir, Y., Durak, M. B., & Yuksel, I. (2024). Optimal endoscopy timing in elderly patients presenting with acute non-variceal upper gastrointestinal bleeding. In BMC Gastroenterology (Vol. 24, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s12876-024-03541-z

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COPD patients have a higher risk of developing cognitive impairment: BMJ

A new study published in the BMJ Open Respiratory Research journal showed that patients with chronic obstructive pulmonary disease (COPD) are more likely to experience cognitive impairment and amnestic mild cognitive impairment (na-MCI) when compared to people without.

Many patients with COPD suffer from cognitive impairment, which is the primary cause of quality of life to varied degrees. However, due to variations in study designs, participant age ranges, inclusion criteria, and evaluation procedures, there were still significant differences in these prevalence percentages. Although earlier research showed a link between COPD and cognitive decline, the findings were still debatable. Thereby, Xia Chen and team present this systematic study to determine if COPD is an indicator for cognitive impairment in and of itself.

This research was a meta-analysis and systematic review. From the beginning until December 1, 2022, the Cochrane Library, PubMed, MEDLINE, Web of Science, Embase, China Knowledge Resource Integrated Database, Chinese Biomedical Database, Wanfang Database, and Weipu Database were searched for data. Studies that documented cognitive impairment in COPD were required to meet the inclusion criteria. Cohort designs that have been published in either Chinese or English were merely included by the researchers. 

A total of 12 studies from 10 papers that included 625,644 individuals were finalized. The results showed that individuals with COPD had a higher probability of cognitive impairment than the ones without the disease at baseline. Age and sex did not substantially alter the connection, according to subgroup analysis, which further supported the idea that COPD is more likely than amnestic MCI to cause non-amnestic mild cognitive impairment (na-MCI).

Overall, this study shows that individuals with COPD have a higher risk of dementia or cognitive impairment, and that this risk seemed to be constant across age and gender groups. The subgroup analysis results showed that among patients with COPD, na-MCI was more common than a-MCI. The need for focused cognitive assessments is further highlighted by this difference, which highlights the varying effects of COPD on different cognitive domains.

Reference:

Chen, X., Yu, Z., Liu, Y., Zhao, Y., Li, S., & Wang, L. (2024). Chronic obstructive pulmonary disease as a risk factor for cognitive impairment: a systematic review and meta-analysis. In BMJ Open Respiratory Research (Vol. 11, Issue 1, p. e001709). BMJ. https://doi.org/10.1136/bmjresp-2023-001709

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Sleep apnea linked to changes in brain including enlarged hippocampus, finds research

According to a study published in December 18, 2024, online issue of Neurology®, Individuals with sleep-related breathing problems may have an enlarged hippocampus, the brain region responsible for memory and cognition.

The study, which included mostly Latino people, also found that those with lower oxygen levels during sleep had changes in the deep parts of the brain, the white matter, a common finding of decreased brain health that develops with age.

Sleep disordered breathing is a range of conditions that cause abnormal breathing during sleep including snoring and obstructive sleep apnea. Obstructive sleep apnea is when a person stops breathing five or more times per hour. When breathing stops, it can lower oxygen levels, affecting the brain.

“Some studies have found sleep problems and lower oxygen levels during sleep have been linked to brain shrinkage while others have found a link to brain growth,” said study author Alberto R. Ramos, MD, of the University of Miami and Fellow of the American Academy of Neurology. “Both brain shrinkage and brain growth can harm memory and thinking by disrupting normal brain functions, increasing the risk of cognitive decline and dementia. Our study looked at Latino people, who have a higher risk of dementia when compared to non-Latino white people.”

The study involved 2,667 Latino people with an average age of 68.

At the start of the study, each participant was given a take-home sleep test that measured how often they stopped breathing, called apneas, and how often they had slow or shallow breathing, called hypopneas.

They were divided into three groups: those who had fewer than five sleep disruptions per hour, or no sleep problems; those with five to 15 disruptions, mild sleep problems; and those with more than 15, moderate to severe sleep problems. Of the total participants, 56% had no sleep problems, 28% had mild sleep problems and 16% had moderate to severe sleep problems.

Researchers also measured oxygen levels in the bloodstream during sleep.

Ten years later, participants had brain scans to measure brain volume and white matter hyperintensities, areas in the white matter where the brain tissue has been damaged.

After adjusting for factors such as age, sex, high blood pressure and whether a participant had insurance, they found that people in the group with the most sleep problems had 0.24 cubic centimeters (cm3) greater brain volume in the hippocampus than those with no sleep problems.

They also found that for each additional sleep disruption, there was a 0.006 cm3 increase of brain volume in the hippocampus. Researchers found lower oxygen during sleep was also associated with increased hippocampal volume as well as increased white matter hyperintensities.

“Our findings highlight the complex relationships between sleep health and brain aging and show there is a need for longer studies that follow people beginning in middle age or earlier,” Ramos said. “A clear understanding of how brain volume is affected by sleep apnea and other sleep disorders is essential so people can receive early and effective treatment, especially in people who may be at higher risk for dementia.”

A limitation of the study was that it only included Latino adults, so results may not be the same for other populations.

Reference:

Alberto R. Ramos, Christian Agudelo Sleep Disordered Breathing and Subsequent Neuroimaging Markers of Brain Health in Hispanic/Latino Adults, Neurology, https://doi.org/10.1212/WNL.0000000000210183

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Transcendental Meditation most effective at treating PTSD in largest review to date

Researchers from Maharishi International University (MIU) and Augusta University have conducted the largest review and meta-analysis to date on meditation for PTSD treatment. Analyzing 61 studies with over 3,400 participants, the study compared four categories of meditation: Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Other techniques (MBO), Other Meditations (OM), and Transcendental Meditation (TM). Effect sizes for the first three categories of meditation ranged from -.52 to -.66, a moderate effect, compared to -1.13 for TM, a large effect. Results indicate that TM is significantly more effective compared to each of the other modalities. The study is published in Medicina 2024, 60(12), 2050.

Lead author MIU Professor Emeritus Dr. David Orme-Johnson explained, “Our findings show that all meditation techniques studied can help alleviate PTSD symptoms, but TM stands out as producing the largest and most consistent reductions across diverse trauma populations. Studies show that TM works in men and women, in youth and the elderly, in war veterans and war refugees, in women survivors of interpersonal violence, in prison inmates, in tsunami and earthquake survivors, and in nurses who became traumatized during the 2019 pandemic.”

Robust Selection Criteria and Advanced Statistical Methods

This meta-analysis sets a new standard in rigor and comprehensiveness, adhering to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The study included longitudinal research designs such as randomized controlled trials, controlled trials, and single-group case series, ensuring a comprehensive dataset. The researchers analyzed within-group effects, which show how much PTSD changes over time due to treatment, and then directly compared different meditation techniques on this measure.

Dr. Orme-Johnson noted, “We employed meta-regression to identify predictors of effectiveness, such as type of trauma, age, and research design. These methods allowed us to control for all variables that influence the size of the effect, making our conclusions about differences in meditation techniques highly reliable.”

A Supplementary Solution

Meditation, especially TM, offers a complementary approach that can enhance standard medical care, providing a natural and effective way to promote full recovery.

Second author Dr. Vernon Barnes, Emeritus Assistant Professor, Georgia Prevention Institute, Augusta University, shared his perspective: “I’ve been teaching TM in a hospital clinic for 12 years, working with soldiers experiencing PTSD and traumatic brain injuries. The clinic is regarded as cutting edge for the treatment of complex concussion, which includes combat-related PTSD. TM is one of the few interventions with benefits that can be immediately translated into improved care in military medicine.”

Co-author Brian Rees, Colonel (Ret.), Medical Corps, U.S. Army Reserve added: “TM offers a non-trauma focused modality that produces clinically significant mitigation of the symptoms of traumatic stress without the discomfort associated with psychologically demanding standard therapies.”

Implications for Active-Duty Military Members, Veterans and Beyond

The review covered a wide range of trauma populations and was well accepted. Of the individuals offered TM, 86% were willing to try it, and 92% completed the instruction and continued the twice-daily practice-a testament to its accessibility and acceptability. Dr. Barnes emphasized, “This meta-analysis surpasses previous reviews in scope and depth, making it an important resource for policymakers and healthcare providers looking to implement evidence-based PTSD interventions.”

The authors recommend large-scale clinical trials to further validate TM’s efficacy and to explore its integration into diverse healthcare settings. With the growing recognition of meditation as a valuable tool for mental health, this study positions TM as a vital component in the future of PTSD treatment.

One Reviewer’s Comment

One of the reviewers commented that this was an excellent review to contribute to the research community as it explains how meditation modalities compare with one another and highlights key directions for further research. “The results on the transformative power of TM are especially potent and have come in line with increasing focus on non-pharmacological treatment for PTSD.”

Building on Previous Research in the Field of Meditation and Health

This study builds upon prior research from MIU and elsewhere indicating potential health benefits of Transcendental Meditation that include lowering high blood pressure, reducing cardiovascular risk, and improvements in mental health. The present study offers a comprehensive look at how this meditation technique compares with other meditation types for treatment of PTSD and is an important addition to the Medicina Special Issue “Transcendental Meditation and Treatment for Stress” whose articles relate to effects of stress on both individuals and society as a whole.

Reference:

Orme-Johnson DW, Barnes VA, Rees B, Tobin J, Walton KG. Effectiveness of Meditation Techniques in Treating Post-Traumatic Stress Disorder: A Systematic Review and Meta-Analysis. Medicina. 2024; 60(12):2050. https://doi.org/10.3390/medicina60122050

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Case Study Highlights Risk of Pancytopenia in Methotrexate Treatment for Cesarean Scar Pregnancy

Greece: A recent case report published in Medicina Journal has brought attention to a severe instance of methotrexate-induced toxicity following its use to treat a cesarean scar pregnancy (CSP).

Cesarean scar pregnancy is a rare and potentially dangerous type of ectopic pregnancy where implantation occurs at the site of a previous cesarean section scar. While methotrexate (MTX) is commonly used to manage CSP due to its efficacy in stopping abnormal pregnancies, its administration is linked to a range of side effects, including hematological toxicities.

Sofoklis Stavros, National, and Kapodistrian University of Athens, Athens, Greece, and colleagues presented a case report highlighting a cesarean scar pregnancy treated with an intragestational injection of methotrexate. The patient subsequently developed pancytopenia, a rare but serious complication of MTX therapy, emphasizing the need for caution even with localized, low-dose administration.

The case concerns a 23-year-old woman at six weeks and six days of pregnancy who was referred with a suspected cesarean scar pregnancy. Following confirmation of the diagnosis, she underwent treatment involving a transvaginal ultrasound-guided intragestational injection of 80 mg methotrexate, adjusted to 50 mg/m² of body surface area, administered under sedation.

Four days after the procedure, the patient developed oral ulcers, fever, and a pruritic phlyctenular maculopapular rash. Her condition progressed to febrile neutropenia, necessitating admission to the Intensive Care Unit (ICU). By day six, her symptoms worsened, with an exacerbation of the rash characterized by blisters and purplish spots, accompanied by odynophagia (painful swallowing) and sialorrhea (excessive salivation). The patient ultimately developed pancytopenia due to bone marrow suppression.

Despite the severe complications, the patient gradually improved with appropriate medical management. By the 15th day post-MTX administration, she had recovered fully and was discharged in stable condition. Her β-hCG levels had significantly decreased, indicating resolution of the CSP, and she was afebrile and hemodynamically stable upon discharge.

“While methotrexate is a highly effective treatment for cesarean scar pregnancies, clinicians must remain vigilant about the potential risks associated with its use, even when administered locally. This case represents, to our knowledge, the first reported instance of pancytopenia resulting from bone marrow suppression following a single intragestational methotrexate injection for cesarean scar pregnancy,” the researchers wrote.

“Further research is crucial to optimize the management of such complex cases, ensuring the best outcomes through minimally invasive and fertility-sparing approaches.”

“The report highlights the importance of close monitoring and early intervention when using MTX for CSP and other similar conditions. As this case marks the first documented instance of pancytopenia following a single low-dose intragestational MTX injection, it serves as a critical reminder of the balance required between therapeutic efficacy and patient safety,” they concluded.

Reference:

Stavros, S., Potiris, A., Gerede, A., Zikopoulos, A., Giourga, M., Karasmani, C., Karpouzos, A., Karampitsakos, T., Topis, S., Anagnostaki, I., Louis, K., Tsakiridis, I., Dagklis, T., Drakakis, P., & Domali, E. (2024). Methotrexate-Induced Toxicity After Ultrasound-Guided Intragestational Injection in a Patient with Caesarean Scar Pregnancy—A Case Report. Medicina, 60(11), 1900. https://doi.org/10.3390/medicina60111900

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Diets higher in inflammatory foods associated with increased dementia risk among elderly: Study

Diets higher in inflammatory foods associated with increased dementia risk among elderly suggests a study published in the Alzheimer’s & Dementia

They evaluated whether higher Dietary Inflammatory Index (DII) scores were associated with increased incidence of all-cause dementia and Alzheimer’s disease (AD) dementia over 22.3 years of follow-up in the community-based Framingham Heart Study Offspring cohort. One thousand four hundred eighty-seven participants (mean ± standard deviation, age in years 69 ± 6) completed food frequency questionnaires (FFQs) and had incident all-cause dementia and AD surveillance data available. RESULTS: Two hundred forty-six participants developed all-cause dementia (including AD, n = 187) over a median follow-up time of 13.1 years. Higher DII scores, averaged across a maximum of three timepoints, were associated with an increased incidence of all-cause dementia and AD after adjustment for demographic, lifestyle, and clinical covariates (hazard ratio [HR] 1.21, 95% confidence interval [CI] 1.10–1.33, P < 0.001; HR 1.20, 95% CI: 1.07–1.34d, P = 0.001, respectively). Higher DII scores were associated with a higher risk of incident all-cause dementia and AD. Although these promising findings need to be replicated and further validated, the results suggest that diets that correlate with low DII scores may prevent late-life dementia.

Highlights:

Higher Dietary Inflammatory Index (DII) scores were associated with an increased incidence of all-cause dementia.

Higher DII scores were associated with an increased incidence of Alzheimer’s disease dementia.

Diets that correlate with low DII scores may prevent late-life dementia.

Reference:

van Lent DM, Mesa HG, Short MI, et al. Association between dietary inflammatory index score and incident dementia. Alzheimer’s Dement. 2024; 1-11. https://doi.org/10.1002/alz.14390

Keywords:

Diets, higher, inflammatory, foods, associated, increased, dementia risk, among, elderly, Study , van Lent DM, Mesa HG, Short MI, Alzheimer’s & Dementia

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WHO Releases Updates Guidelines on Oxytocin Use for Postpartum Hemorrhage Prevention

USA: The World Health Organization (WHO) has issued updated guidelines on the administration of oxytocin for the prevention of postpartum hemorrhage (PPH) following vaginal birth. PPH, defined as a blood loss of 500 mL or more within 24 hours after delivery, remains a leading cause of maternal mortality, particularly in low-income countries. These recommendations aim to enhance care during childbirth and support global health goals, including reducing maternal mortality to fewer than 70 per 100,000 live births by 2030.

The WHO recommends administering 10 international units (IU) of oxytocin intramuscularly or intravenously to prevent PPH in all vaginal births. In cases where women already have intravenous (IV) access, slow IV administration is preferred due to its superior health outcomes. Evidence indicates that IV oxytocin reduces the risk of PPH, severe PPH, the need for blood transfusions, and severe maternal complications compared to intramuscular (IM) administration.
“Oxytocin (10 international units [IU]) is recommended for preventing postpartum hemorrhage in all births, administered either intramuscularly or intravenously. For women undergoing vaginal delivery who already have intravenous access, the slow intravenous administration of 10 IU oxytocin is preferred over intramuscular administration,” the WHO stated.
However, the WHO cautions against routine IV access solely for oxytocin administration, emphasizing its feasibility and the potential impact on resources, health equity, and maternal comfort. The guideline advises that IV oxytocin be administered slowly to mitigate potential safety risks, such as hemodynamic changes, associated with rapid IV bolus injections.
While both IV and IM routes effectively prevent PPH, the updated recommendation underscores the importance of tailoring practices to specific clinical contexts. For example, in settings where IV access is not routinely available, IM oxytocin remains a reliable option.
The updated guidance reflects the WHO’s rigorous review process, which includes systematic evidence assessments and consultations with global experts. These recommendations supersede those issued in the 2012 guideline on PPH prevention and address the latest evidence to guide healthcare providers, policy-makers, and program managers worldwide.
The WHO emphasizes that the effective prevention of PPH requires more than just clinical interventions; it involves addressing inequities in maternal health and ensuring the availability of skilled healthcare personnel, adequate resources, and evidence-based practices. By implementing these guidelines, the global community takes a crucial step toward improving maternal health outcomes and reducing disparities in care.
This latest update aligns with WHO’s broader mission to enhance maternal and perinatal health, ensuring that childbirth is safer for all women, regardless of their geographic or socioeconomic circumstances.
Reference:
WHO recommendation on routes of oxytocin administration for the prevention of postpartum haemorrhage after vaginal birth. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.

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FDA approves tapinarof cream for topical treatment of atopic dermatitis

The US Food and Drug Administration (FDA) has approved Vtama® (tapinarof) cream 1%, an aryl hydrocarbon receptor agonist, for the topical treatment of atopic dermatitis in adults and children aged 2 years and older.

Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.

With the FDA’s approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected,” said Kevin Ali, Organon’s Chief Executive Officer. “Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.”

In the ADORING pivotal studies, VTAMA cream, 1% demonstrated, in moderate to severe patients as young as 2 years old with AD, a statistically significant difference versus vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at Week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) 45.4% versus 13.9% of patients in ADORING 1 and 46.4% versus 18.0% in ADORING 2 (both P<0.0001). The difference between patients who received VTAMA cream and those that received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of at least 75% (EASI75) from baseline at Week 8 and achievement of a ≥4-point improvement in the patients reported Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 8 in patients ≥12 years of age. The most common adverse reactions (incidence ≥1%) were upper respiratory tract infection (12%), red raised bumps around the hair pores (folliculitis) (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area (abdominal) pain (1%).

ADORING 3, a 48-week open-label, LTE study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics trial, and direct enrollees who were VTAMA cream-naive patients 2-17 years of age with mild, moderate or severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did not meet pivotal studies inclusion criteria.

In ADORING 3, patients (N=728) were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD≥1) were treated with VTAMA cream, 1% until complete disease clearance was achieved (vIGA-AD=0) or study completion. For the 378 patients who entered with or achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment with VTAMA cream, the mean duration of the first treatment-free (remittive) interval was approximately 80 consecutive days. Patients whose AD returned to mild or above (vIGA-AD≥2) were re-treated with VTAMA cream until complete disease clearance was achieved again or study completion. The safety profile with long term use was generally consistent with the safety profile observed at Week 8.

“VTAMA cream approval in AD is important because it can be prescribed for children as young as 2 years old. VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease,” said Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program. “Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream.”

In May 2022, the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults, making it the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis with no label warnings or precautions, contraindications, restrictions on duration of use, or percentage of body surface area affected.

About Atopic Dermatitis

Atopic dermatitis (AD), commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom for those with AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.

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