Common sugar substitute shown to impair brain cells, boost stroke risk: Study

From low-carb ice cream to keto protein bars to “sugar-free” soda, the decades-old sweetener erythritol is everywhere.

But new University of Colorado Boulder research shows the popular sugar substitute and specialty food additive comes with serious downsides, impacting brain cells in numerous ways that can boost risk of stroke.

The study was published in the Journal of Applied Physiology.

“Our study adds to the evidence suggesting that non-nutritive sweeteners that have generally been purported to be safe, may not come without negative health consequences,” said senior author Christopher DeSouza, professor of integrative physiology and director of the Integrative Vascular Biology Lab.

First approved by the Food and Drug Administration in 2001, erythritol is a sugar alcohol, often produced by fermenting corn and found in hundreds of products. It has almost no calories, is about 80% as sweet as table sugar, and has negligible impact on insulin levels, making it a favorite for people trying to lose weight, keep their blood sugar in check or avoid carbohydrates.

But recent research has begun to shed light on its risks.

One recent study involving 4,000 people in the U.S. and Europe found that men and women with higher circulating levels of erythritol were significantly more likely to have a heart attack or stroke within the next three years.

DeSouza and first author Auburn Berry, a graduate student in his lab, set out to understand what might be driving that increased risk.

Researchers in the lab treated human cells that line blood vessels in the brain for three hours with about the same amount of erythritol contained in a typical sugar-free beverage.

They observed that the treated cells were altered in numerous ways: They expressed significantly less nitric oxide, a molecule that relaxes and widens blood vessels, and more endothelin-1, a protein that constricts blood vessels. Meanwhile, when challenged with a clot-forming compound called thrombin, cellular production of the natural clot-busting compound t-PA was “markedly blunted.” The erythritol-treated cells also produced more reactive oxygen species (ROS), a.k.a. “free radicals,” metabolic byproducts which can age and damage cells and inflame tissue.

“Big picture, if your vessels are more constricted and your ability to break down blood clots is lowered, your risk of stroke goes up,” said Berry. “Our research demonstrates not only that, but how erythritol has the potential to increase stroke risk.”

DeSouza notes that their study used only a serving-size worth of the sugar substitute. For those who consume multiple servings per day, the impact, presumably, could be worse.

The authors caution that their study was a laboratory study, conducted on cells, and larger studies in people are needed.

That said, De Souza encourages consumers to read labels, looking for erythritol or “sugar alcohol” on the label.

“Given the epidemiological study that inspired our work, and now our cellular findings, we believe it would be prudent for people to monitor their consumption of non-nutrient-sweeteners such as this one,” he said.

Reference:

Auburn R. Berry,Samuel T. Ruzzene,Emily I. Ostrander,Kendra N. Wegerson, The non-nutritive sweetener erythritol adversely affects brain microvascular endothelial cell function, Journal of Applied Physiology, https://doi.org/10.1152/japplphysiol.00276.2025

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New Dawn for PONV Management: Study Validates Simplified Severity Score

Recent observational study aimed to validate the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) scale for assessing postoperative nausea and vomiting (PONV) intensity and to develop a simplified scoring system-Simplified PONV Severity Score (SPONVSS)-to evaluate its effects on sleep quality and vitality in patients undergoing surgery.

Significance of PONV

PONV is a prevalent complication affecting approximately one-third of surgical patients, significantly impacting their recovery. While existing guidelines primarily focus on PONV incidence, this study sought to address severity, recognizing that patients’ experiences of nausea and vomiting can vary widely. The complexity of the RINVR scale, however, prompted the researchers to create a more accessible metric. SPONVSS comprises three elements: vomiting times, retching times, and nausea frequency, scored on a scale from 0 to 4. The validation process involved a cohort of 967 patients, assessing the correlation between SPONVSS scores and prescribed antiemetics, as well as postoperative outcomes related to sleep and vitality.

Statistical Findings

Statistical analysis revealed strong associations between higher SPONVSS scores (≥ 3) and the need for rescue antiemetics, as well as poor sleep quality and vitality. Specifically, patients classified with severe PONV—indicated by SPONVSS ≥ 3—demonstrated significant increases in antiemetic administration (38.2%) compared to those with lower scores (1.2%). The study also found that only 8% of patients with severe PONV reported good sleep.

Predictive Validity of the RINVR

The RINVR’s predictive validity was established through area under the curve (AUC) analysis, indicating strong performance in forecasting both antiemetic usage and associated quality of life outcomes. The decision to finalize SPONVSS elements was based on the combined metrics’ superior predictive power exhibited in ROC analyses.

Implications of Findings

Importantly, the findings suggest that PONV intensity independently influences sleep and vitality postoperatively, reinforcing the necessity for enhanced PONV management strategies. Additionally, demographic factors such as age, sex, and surgical type were analyzed concerning their roles in PONV severity, with variations in outcomes identified.

Conclusion and Future Research

Overall, by establishing a simplified tool for assessing PONV severity, the study aims to improve postoperative care and patient recovery through more precise management of antiemetic prescriptions, ultimately facilitating better sleep and vitality outcomes for surgical patients. Future research is encouraged to integrate objective measures of sleep quality to strengthen the findings.

Key Points

– -Validation of RINVR and Development of SPONVSS-: The study validates the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) for assessing postoperative nausea and vomiting (PONV) intensity and introduces the Simplified PONV Severity Score (SPONVSS) as a more accessible tool for evaluating PONV effects on sleep quality and vitality. SPONVSS includes three parameters: vomiting frequency, retching frequency, and nausea frequency.

– -Prevalence and Impact of PONV-: Approximately one-third of surgical patients experience PONV, significantly hindering recovery. While guideline emphasis has traditionally been on incidence, this research highlights the importance of severity in shaping patient experiences and outcomes related to nausea and vomiting.

– -Correlation with Postoperative Outcomes-: Statistical analysis demonstrated a strong correlation between SPONVSS scores (≥ 3) and increased rescue antiemetic utilization, alongside diminished sleep quality and vitality. Specifically, 38.2% of patients with severe PONV required additional antiemetics, contrasting sharply with just 1.2% in lower score groups, and only 8% of these patients reported good sleep quality.

– -Predictive Validity Assessment-: Through area under the curve (AUC) analyses, the RINVR exhibited strong predictive validity for anticipating antiemetic requirements and related quality of life outcomes, leading to the selection of SPONVSS components based on superior predictive accuracy demonstrated in ROC analyses.

– -Influence of Demographic Factors-: The study assessed the impacts of demographic variables such as age, sex, and type of surgery on PONV severity, revealing noted variability in outcomes associated with these factors, which could influence clinical PONV management strategies.

– -Implications for Management and Future Research-: Findings signal a clear link between PONV intensity and postoperative sleep and vitality, underscoring the need for improved management protocols. Future investigations are recommended to incorporate objective metrics for sleep quality to enhance and validate these findings.

Reference –

Shih-Feng Weng et al. (2025). A Prospective Cohort Observational Study To Validate A Simplified Postoperative Nausea And Vomiting Severity Scale And Its Effects On Sleep And Vitality. *BMC Anesthesiology*, 25. https://doi.org/10.1186/s12871-025-03074-2.

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PEACE Score Accurately Predicts Echo Abnormalities in Pulmonary Embolism Patients: Study Shows

Türkiye: A recent study published in BMC Emergency Medicine has validated the Pulmonary Embolism Advanced Cardiac Evaluation (PEACE) Score as a reliable tool for identifying echocardiographic abnormalities in patients diagnosed with pulmonary embolism (PE). The study, conducted by Dr. Kazım Ersin Altınsoy at Gaziantep City Hospital and Gaziantep Islam Science and Technology University, Türkiye, supports the use of the PEACE Score for early risk stratification in emergency settings.

According to the study, the PEACE Score accurately stratifies pulmonary embolism risk, with strong links to echo abnormalities (AUC 0.82) and RV dysfunction (AUC 0.85). A score >5 offers 84.6% sensitivity and 79.2% specificity, aiding swift ICU triage in high-risk cases.

Pulmonary embolism is a potentially fatal condition that demands swift clinical assessment. The PEACE Score was developed as a comprehensive risk tool that combines clinical data, lab values, and cardiac parameters to guide management decisions. This prospective study aimed to evaluate how effectively the PEACE Score correlates with echocardiographic findings, especially right ventricular dysfunction, and whether it could serve as a reliable predictor of patient outcomes.

The study enrolled 120 adult patients diagnosed with PE via CT angiography in the emergency department. Based on PEACE Scores, patients were classified into three categories: low risk (<3 points), intermediate risk (3–5 points), and high risk (>5 points). Echocardiographic data were collected but not used for categorization—rather, they were evaluated separately to assess the score’s predictive validity.

The following were the key findings of the study:

  • PEACE Scores showed a strong positive correlation with abnormal echocardiographic findings (r = 0.685).
  • The score achieved an AUC of 0.82 for predicting overall echocardiographic abnormalities.
  • It recorded an AUC of 0.85 for detecting right ventricular dysfunction.
  • A PEACE Score cutoff >5 demonstrated 84.6% sensitivity and 79.2% specificity in identifying significant echocardiographic changes.
  • Higher PEACE Scores were significantly associated with elevated CRP levels (r = 0.524).
  • One-year survival rates were 85% in the low-risk group, 65% in the intermediate-risk group, and 45% in the high-risk group.
  • Kaplan-Meier analysis showed statistically significant differences in survival across the three risk categories.

Dr. Ersin Altınsoy concluded that the PEACE Score offers a rapid, accessible, and effective method for assessing PE severity and guiding early treatment decisions. Notably, patients in the high-risk category were more likely to require thrombolytic therapy and intensive care support, indicating the score’s potential role in triage and resource planning.

While promising, the author notes that the PEACE Score is not intended to predict long-term survival or evaluate comorbid conditions, and larger studies are warranted to confirm its broader applicability. Still, integrating the PEACE Score into emergency protocols could significantly enhance early diagnostic accuracy and treatment pathways for pulmonary embolism.

Reference:

Altınsoy, K.E. Validation of the PEACE score for predicting abnormal echocardiographic findings in pulmonary embolism patients. BMC Emerg Med 25, 96 (2025). https://doi.org/10.1186/s12873-025-01259-z

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Surgical ablation during CABG linked to improved survival in patients with preexisting atrial fibrillation, new study finds

A new study published in The Annals of Thoracic Surgery, a journal from The Society of Thoracic Surgeons, finds that Medicare patients with atrial fibrillation (AF) who undergo surgical ablation during isolated coronary artery bypass grafting (CABG) live longer than those who do not, offering compelling support for clinical guidelines that recommend this procedure but are too often not followed in practice.

Researchers examined Medicare claims data from more than 87,000 patients with preexisting AF who underwent CABG between 2008 and 2019. Overall, only 22% of studied patients received concomitant surgical ablation during CABG, and, although the prevalence of ablation did increase over the study period, ablation rates were only 27% in 2019 (two years after a Class I recommendation for ablation was published by the Society of Thoracic Surgeons).

The study found that surgical ablation during CABG was associated with a risk-adjusted median survival advantage of 4.4 months compared to patients who did not receive ablation (7.82 vs. 7.46 years; P<0.001). Patients treated by surgeons who frequently performed ablation had a median survival advantage of nearly five months (7.03 vs. 6.62 years; P<0.001) compared to those treated by surgeons who rarely performed the procedure.

“This study is one of several recent analyses suggesting that surgical ablation may meaningfully improve survival in patients with preexisting atrial fibrillation undergoing CABG,” said Justin Schaffer, MD, lead author of the study and medical director of surgical outcomes at Baylor Scott & White – The Heart Hospital. “Our analysis found that the treatment effect of surgical ablation for AF manifested late, over two years after CABG. We hypothesize this is because ablation leads to a decreased incidence of tachycardia-related heart failure, which translates to improved late survival.”

To reduce bias related to the fact that healthier patients are more likely to receive ablation, the researchers used two advanced statistical methods.

One method (overlap propensity score weighting) adjusted for measured differences between patients, while the other (a surgeon-preference instrumental variable analysis) compared outcomes among patients treated by surgeons who frequently ablate and those who rarely do. This method simulates the effects of randomization by leveraging variation in in clinical practice among surgeons to balance unmeasured differences between patients. Under certain assumptions, patients can be thought of as being pseudo-randomly distributed among surgeons with different approaches to ablation.

“We used both as-treated and surgeon-preference analyses to provide a more complete picture of ablation’s potential benefits,” Dr. Schaffer explained. “While each method has strengths and limitations, the consistency of findings across both approaches is encouraging, especially given that a large-scale randomized trial in this area does not appear forthcoming.”

Between 10% and 20% of patients undergoing CABG have atrial fibrillation before surgery, a condition that is associated with both perioperative complications and reduced long-term survival. Prior research has shown that surgical ablation can help restore normal heart rhythm and improve long-term outcomes, but the practice remains underutilized.

“These data underscore the importance of guideline adherence and hopefully will lead to a reevaluation of surgical decision-making for patients with AF,” added study coauthor John Squiers, MD, Baylor Scott & White The Heart Hospital.

Reference:

Schaffer, Justin M. et al., Survival After Surgical Ablation of Atrial Fibrillation During Coronary Artery Bypass in Medicare Beneficiaries, The Annals of Thoracic Surgery, DOI 10.1016/j.athoracsur.2025.03.044 

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Dysregulated epigenetic memory in early embryos offers new clues to the inheritance of PCOS: Study

Novel research presented today at the 41st Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) has found that embryos from women with polycystic ovary syndrome (PCOS) carry a distinctive ‘epigenetic memory’ that could explain why the condition often runs in families.

PCOS is a common hormonal disorder affecting an estimated 1 in 10 women of reproductive age worldwide. It is characterised by irregular menstrual cycles, excess levels of androgens (male hormones) and the presence of multiple cysts on the ovaries. While it is recognised as a leading cause of infertility, the exact causes and mechanisms of inheritance remain unclear.

The study, led by Dr. Qianshu Zhu, analysed oocytes and pre-implantation embryos from 133 PCOS patients and 95 non-PCOS infertile women undergoing fertility treatment. The team used ultra-low-input sequencing to analyse both gene activity and epigenetic changes – chemical tags that regulate how genes turn on and off without altering the underlying DNA sequence.

The research revealed widespread disruptions in the activity of genes responsible for early embryonic genome activation, metabolic processes, epigenetic regulation, and chromatin structure in embryos from women with PCOS. These disruptions also affected retrotransposons – mobile DNA elements usually tightly regulated to maintain genomic stability – further highlighting how early developmental programming is affected.

These abnormalities were closely linked to irregular patterns of three histone marks that play a key role in controlling gene expression: H3K27me3, H3K4me3 and H3K9me3.

“Importantly, about half of the abnormal H3K27me3 signatures we saw in Day 3 embryos were already present in the oocyte”, said Dr. Zhu. “This tells us that an epigenetic signal is being passed from mother to embryo before implantation even begins.”

Treating affected embryos in vitro with two PRC2 inhibitors (EED226 and valemetostat) reduced abnormal H3K27me3 levels and partially restored normal gene activity, suggesting a potential therapeutic avenue for correcting epigenetic imbalances.

“We were surprised to find that H3K27me3, which is a histone mark best known in cancer biology, could also be an inherited driver of PCOS”, Dr. Zhu noted. “It opens a new window for embryo assessment and perhaps even intervention.”

Currently, PCOS diagnostics focus on hormone levels and ovarian morphology. Epigenetic profiling, particularly of H3K27me3, could eventually complement these tools, offering earlier risk assessment for offspring conceived by affected mothers. In assisted reproductive technologies (ART), H3K27me3 patterns may even serve as biomarkers for embryo selection during IVF, potentially improving the success of fertility treatments.

Dr. Zhu cautioned that the work is based on laboratory-grown embryos and does not yet prove long-term effects in children. The team’s next step is to validate the findings in mouse models by knocking down the Kdm6a and Kdm6b genes, which remove H3K27me3, to investigate whether offspring develop PCOS-like traits.

“If we confirm that altering these histone marks changes PCOS traits in the next generation, we’ll have a powerful target for prevention”, he said.

Prof. Dr. Karen Sermon, Chair of ESHRE, commented, “PCOS remains largely unsolved as to the molecular origins of the disease, and these findings on a large number of oocytes and embryos from affected women open a new avenue for its understanding and even treatment.”

Reference:

Dysregulated epigenetic memory in early embryos offers new clues to the inheritance of polycystic ovary syndrome (PCOS), European Society of Human Reproduction and Embryology, Meeting: ESHRE 41st Annual Meeting.

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Paternal Mental Distress Linked to Poorer Child Development, Finds Meta-Analysis

Australia: A large-scale meta-analysis published in JAMA Pediatrics has highlighted a significant link between paternal mental distress during the perinatal period and adverse developmental outcomes in children from birth through adolescence. Led by Dr. Genevieve Le Bas from Deakin University’s SEED Lifespan Strategic Research Centre in Australia, the study highlights the crucial role of fathers’ mental well-being in shaping their children’s developmental trajectory.

Recent findings identify paternal mental distress as a key modifiable factor affecting child development. “Depression, anxiety, or stress in fathers was associated with poorer social-emotional (r = 0.09), cognitive (r = −0.07), language (r = −0.15), and physical (r = 0.04) outcomes in children from birth to adolescence,” the researchers noted. The associations were notably stronger for postnatal distress than prenatal symptoms.

The research team systematically reviewed and analyzed data from 48 cohort studies encompassing 674 effect sizes and spanning more than 9,500 studies identified through global databases. The comprehensive synthesis revealed that symptoms of depression, anxiety, and stress in fathers during the perinatal period — defined as both pre- and post-birth — were associated with negative effects on various dimensions of offspring development.

The study led to the following findings:

  • Paternal mental distress was significantly linked to poorer global development in children.
  • Adverse effects were observed in social-emotional development (r = 0.09).
  • Cognitive function in children showed a negative association with paternal distress (r = −0.07).
  • Language development was notably affected, with a correlation of (r = −0.15).
  • Physical development also showed a weaker but significant association (r = 0.04).
  • There were no significant associations between paternal mental distress and adaptive or motor development outcomes.
  • The impact of paternal mental distress was stronger during the postnatal period compared to the antenatal phase.
  • These findings highlight the need for ongoing mental health support for fathers beyond pregnancy and into early parenthood.

The authors emphasized the need to broaden the scope of perinatal mental health care to include fathers, who are often overlooked in routine screenings and interventions. While maternal mental health has long been a focus of research and clinical attention, this study calls for integrating paternal mental health assessments into family-centered care models.

Importantly, the study advocates for targeted preventive strategies to reduce perinatal distress among fathers, positioning it as a modifiable risk factor for poor developmental outcomes in the next generation. By identifying paternal mental distress as an actionable area, the findings open pathways for early intervention programs aimed at improving not only the psychological health of fathers but also the long-term well-being of their children.

The authors concluded, “Overall, this landmark meta-analysis contributes robust evidence to the growing body of research on the intergenerational effects of mental health, reinforcing the call for inclusive perinatal mental health policies and practices that prioritize the entire family unit.”

Reference:

Le Bas G, Aarsman SR, Rogers A, et al. Paternal Perinatal Depression, Anxiety, and Stress and Child Development: A Systematic Review and Meta-Analysis. JAMA Pediatr. Published online June 16, 2025. doi:10.1001/jamapediatrics.2025.0880

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Inflammatory Blood Markers May Signal Severity of BPH Symptoms, New Study Finds

China: A recent study conducted by researchers at Jiangnan University Medical Center, Wuxi, China, has uncovered a significant association between blood-based immune-inflammatory markers and the severity of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH).

The findings, published in the Journal of Inflammation Research, highlight the potential of simple blood indices such as the neutrophil-to-lymphocyte ratio (NLR), systemic inflammatory response index (SIRI), and systemic immune-inflammatory index (SII) as non-invasive tools for evaluating disease severity.

LUTS linked with BPH are frequently observed in aging men and, if left unchecked, can lead to serious health complications. While early detection and timely intervention are key to managing BPH effectively, there remains a lack of reliable and accessible indicators to assess symptom severity. The present study, led by Yifan Wu and colleagues from the Department of Urology, aimed to bridge this gap by investigating the predictive value of immune-inflammatory indices derived from routine blood tests.

The cross-sectional analysis included 698 male patients diagnosed with BPH/LUTS at a tertiary care hospital. Participants were categorized into two groups—mild and moderate-to-severe—based on their International Prostate Symptom Score (IPSS). Researchers then evaluated the association between symptom severity and levels of NLR, SIRI, and SII through binary logistic regression analysis.

The study revealed the following findings:

  • A strong positive correlation was observed between elevated immune-inflammatory indices and increased severity of LUTS.
  • After adjusting for potential confounding factors, patients in the highest quartile of NLR had 6.20 times higher odds of experiencing moderate-to-severe symptoms compared to those in the lowest quartile.
  • For SIRI, the odds ratio for symptom severity in the highest quartile was 7.49.
  • For SII, patients in the highest quartile had an odds ratio of 7.85 for developing more severe LUTS.
  • Subgroup analyses based on age, diet, physical activity, existing health conditions, and lifestyle habits supported the consistency of these findings.
  • All three markers—NLR, SIRI, and SII—remained significantly associated with symptom severity across most subgroups.
  • Among smokers, SIRI demonstrated a particularly strong association with worsening LUTS.

The authors emphasized that the use of immune-inflammatory biomarkers is a practical and cost-effective approach for clinicians to monitor disease progression and tailor interventions in patients with BPH. They also explored potential mechanisms linking systemic inflammation to prostatic enlargement and urinary symptoms, adding a theoretical dimension to their clinical findings.

However, the study’s limitations warrant cautious interpretation. Due to its single-center and cross-sectional design, it restricts the ability to draw causal inferences. Additionally, certain variables, such as socioeconomic status and prostate volume, were not adjusted for, and multiple comparisons were not corrected, which may introduce bias or false-positive results.

Despite these limitations, the study offers valuable insights and lays the groundwork for future research. The authors advocate for large-scale, multicenter prospective studies to validate their findings and further investigate the clinical utility of these markers in diverse populations.

The authors concluded, “Elevated levels of NLR, SIRI, and SII appear to be strongly associated with the severity of LUTS in men with BPH. These readily accessible markers may serve as useful tools in identifying high-risk patients and enhancing early intervention strategies in urological practice.”

Reference:

Wu Y, Sheng J, Liu X, Huang Y, Zhang Y, Feng N. The Relationship Between Immune-Inflammatory Indexes and the Severity of Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: A Cross-Sectional Study at a Tertiary Hospital in China. J Inflamm Res. 2025;18:8509-8523https://doi.org/10.2147/JIR.S523193

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Cholesterol-lowering drugs have no antidepressive effect: Study

Lipid-lowering medicines, known as statins, are prescribed in cases of high cholesterol levels, to reduce the risk of atherosclerosis, heart attack and stroke. The results of some small studies suggest that statins could also have an antidepressive effect. Researchers from Charité – Universitätsmedizin Berlin have now conducted an extensive study to investigate this claim. However, they could not verify that statins cause any antidepressive additional effects. As a result, the researchers suggest following the general guidelines and prescribing statins to help lower cholesterol, but not to manage depression. The study has now been published in the JAMA Psychiatry journal.

Cholesterol-lowering drugs are the most commonly prescribed medicines globally. They have anti-inflammatory effects and lower the production of cholesterol in the liver, which in turn reduces the risk of developing cardiovascular diseases. In the past, numerous small studies have suggested that statins may also have antidepressive effects, alongside these more common properties. “If statins really did have this antidepressive effect, we could kill two birds with one stone,” says Prof. Christian Otte, Director of the Department of Psychiatry and Neurosciences on the Charité Campus Benjamin Franklin, and leader of the study. “Depression and adiposity, or obesity, are among the most common medical conditions globally. And they actually often appear together: Those who are obese are at a higher risk of depression. In turn, those with depression are at a higher risk of obesity.” Obese patients often have higher cholesterol levels, so statins are administered to reduce the risk of cardiovascular diseases. But could they also alleviate depression?

An extensive, controlled study

Led by Christian Otte, the research team conducted a comprehensive study to investigate the potential antidepressive effects of statins that have been suggested. A total of 161 patients took part in the study, all of whom suffered from both depression and obesity. During the 12-week study, all participants were treated with a standard antidepressant (Escitalopram). Half of the participants also received a cholesterol-lowering drug (Simvastatin), while the other half were given a placebo. It was decided at random who would receive statins and who would be given the placebo – the recipients of each were unknown to both the medical team and the participants. This ensured a randomized and double-blind study that would produce reliable results. “This method should show us whether we can observe a stronger antidepressive effect among participants treated with statins, compared to those in the placebo group,” explains co-lead author Dr. Woo Ri Chae, Charité BIH Clinician Scientist at the Department of Psychiatry and Neurosciences.

The researchers used established clinical interviews and self-completed questionnaires to record the severity of depression in the patients at the beginning and end of the study. Blood samples were taken from the participants to determine their blood lipid levels and level of the C-reactive protein (CRP), which are known indicators of inflammatory processes in the body. “People with obesity and/or depression commonly exhibit slightly raised inflammatory markers in the blood. For some of those affected, this can actually be the cause of depression,” explains Christian Otte. “And this is precisely where we began with our hypothesis on the potential antidepressive effect of statins: If administering statins leads to an improvement in inflammatory markers, could this also possibly be accompanied by an antidepressive effect for some of the study participants?”

Traditional antidepressants remain the gold standard

At the beginning of the study, the participants ranged from moderately to severely depressed. Over the course of the 12-week study, the depression symptoms in all patients showed clear improvement – there was, however, no difference between those who received statins and those in the placebo group. “Administering the cholesterol-lowering drug improved blood lipid levels, as expected, and the inflammatory marker CRP also displayed a marked reduction,” says Woo Ri Chae. “So, unfortunately, this does not point to an additional antidepressive effect.” Christian Otte adds: “When it comes to treating depression, statins therefore have no additional benefit. To our present knowledge, traditional antidepressants remain the gold standard.” According to current guidelines, statins should be prescribed to reduce the risk of atherosclerosis and cardiovascular diseases. The researchers recommend that the same should naturally also apply for patients suffering from depression.

In further studies, Christian Otte’s team will conduct a more thorough analysis of the blood samples taken as part of this research on a cellular and molecular level, to reveal potential differences and correlations. The researchers are also continuing to work at full speed on improved strategies for treating patients with depression who also suffer from other conditions.

Reference:

Otte C, Chae WR, Dogan DY, et al. Simvastatin as Add-On Treatment to Escitalopram in Patients With Major Depression and Obesity: A Randomized Clinical Trial. JAMA Psychiatry. Published online June 04, 2025. doi:10.1001/jamapsychiatry.2025.0801

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Hearing Devices Significantly Improve Social Lives of Those with Hearing Loss: Study

 Hearing loss doesn’t just affect how people hear the world-it can also change how they connect with it.

A new study from the USC Caruso Department of Otolaryngology – Head and Neck Surgery, part of Keck Medicine of USC, published today in JAMA Otolaryngology – Head & Neck Surgery, is the first to link hearing aids and cochlear implants, surgically implanted devices that help those with profound hearing loss perceive sound, to improved social lives among adults with hearing loss.

“We found that adults with hearing loss who used hearing aids or cochlear implants were more socially engaged and felt less isolated compared to those who didn’t use them,” said Janet Choi, MD, MPH, an otolaryngologist with Keck Medicine and lead researcher of the study. “This suggests that hearing devices may help prevent the social disconnection and broader health consequences that can follow untreated hearing loss.”

Hearing loss affects an estimated 40 million American adults, yet many go untreated. When left unaddressed, hearing loss can make communication difficult, leading people to withdraw from conversations and social activities, according to Choi.

Previous research has shown that over time, social withdrawal can reduce mental stimulation and increase the risk of loneliness, anxiety, depression, cognitive decline and dementia. It has also linked chronic social isolation to biological and neurological changes, including increased brain inflammation and alterations in brain structure.

“Understanding the link between hearing loss, hearing device use and social isolation is crucial,” said Choi. “Until this study, it has been unclear whether hearing devices could help reverse the isolation.”

Choi and her fellow researchers conducted a comprehensive, systematic review and meta-analysis of 65 previously published studies, encompassing over five thousand participants, on how hearing aids and cochlear implants affect three key measures: social quality of life, perceived social handicap, which refers to the limitations and frustrations hearing loss can create in social situations, and loneliness.

The researchers found that adults using hearing devices feel more socially connected and less limited in social situations. They are better able to engage in group conversations and feel more at ease in noisy or challenging listening environments. Participants also reported feeling less socially handicapped by their hearing loss, with fewer barriers and frustrations during interactions and an improved ability to stay engaged without feeling excluded. This increased confidence can help users connect more easily with family, friends and colleagues, leading to stronger feelings of belonging and reduced social anxiety. The study also suggested hearing devices may reduce loneliness, although further research is needed in this area, according to Choi.

Those with cochlear implants reported the most improvement in their social quality of life. This is likely because cochlear implants offer greater hearing restoration than hearing aids, especially for individuals with more severe hearing loss. As a result, they may experience more noticeable improvements in social engagement once their hearing is restored.

While it was outside the scope of the study to measure how better social lives relate to improved cognitive outcomes, Choi believes there may be a connection, as previous research has found managing hearing loss may be key to reducing the risk of cognitive decline and dementia. “While our study didn’t directly measure cognitive outcomes, the improvements we saw in communication and social engagement suggest that by restoring clearer communication, hearing devices may help preserve cognitive health by keeping the brain more actively involved and people more connected,” Choi said.

This research follows a January 2024 study by Choi showing that adults with hearing loss who use hearing aids have an almost 25% lower risk of mortality, suggesting that treating hearing loss can improve lifespan as well as social quality of life.

“These new findings add to a growing body of research showing that hearing health is deeply connected to overall well-being,” said Choi. “We hope this encourages more people to seek treatment and helps clinicians start conversations with patients about how hearing devices can improve their quality of life.” 

Reference:

Hori K, Shah R, Paladugu A, et al. Social Outcomes Among Adults With Hearing Aids and Cochlear Implants: A Systematic Review and Meta-Analysis. JAMA Otolaryngol Head Neck Surg. Published online July 03, 2025. doi:10.1001/jamaoto.2025.1777

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Danegaptide Advances to Phase 2 for Diabetic Retinopathy Treatment

Breye Therapeutics has announced that danegaptide, a potential oral treatment for nonproliferative diabetic retinopathy, has progressed to a phase 2 trial. This advancement follows a phase 1b trial in which the drug demonstrated a favorable safety profile.

Diabetic retinopathy (DR) is a leading cause of vision loss globally, affecting millions of people with diabetes. While there has been successful development of intravitreally administered products, injected directly into the eye, for patients with late-stage disease, treatment options are currently limited for patients in the earlier or moderate stages. The intravitreal treatments are burdensome, often poorly tolerated and associated with low compliance, highlighting the critical need for effective and non-invasive alternatives.

Danegaptide is a first-in-class oral small molecule with a novel mode of action, that stabilizes the vasculature and protects from cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia.

The orally administered treatment was well tolerated across all dose levels in the 24 patients enrolled, with no dose-limiting toxicities reported. Pharmacokinetic (PK) data confirmed that targeted exposures of danegaptide were reached as guided by preclinical data. Early signs of clinical activity were observed, as measured by retinal imaging outcomes, representing reductions in retinal vascular leakage and improvements in anatomical parameters.

Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: “These results continue to support danegaptide’s potential as an oral, non-invasive therapeutic solution for patients in the earlier stages of diabetic retinopathy. As we now prepare to advance into Phase 2 clinical evaluation, our focus is on validating these findings using regulatory-accepted clinical outcomes to progress our mission of developing safe and effective treatment options for these patients to preserve their vision before the onset of irreversible damage. Additionally, we believe this treatment solution may also support the maintenance of treatment response after induction therapy with intravitreally administered products.”

Prof. Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, Member of the Breye Therapeutics Scientific Advisory Board, commented: “An oral approach like danegaptide has the potential to fundamentally shift how we treat moderate to severe-stages of diabetic eye disease, offering patients a much-needed and non-invasive treatment solution for the large group of patients with NPDR.”

The Phase 1b trial was a multicenter, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics (PK) and early signs of biological activity of danegaptide in patients with NPDR and associated diabetic macular edema (DME), a complication of NPDR. Conducted across 11 clinical sites in the UK, Germany and the US, the study confirmed a favourable safety profile, plasma levels within the targeted therapeutic range and early signs of clinical activity.

A subsequent Phase 2 trial is planned to evaluate danegaptide in a targeted NPDR patient population using the regulatory endpoint of ≥2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Breye is actively fundraising to support this next phase of development.

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