Abdominal vs. Perineal Surgery for Recurrent Rectal Prolapse: Research Highlights Higher Recurrence with Perineal Approach

Italy: A recent systematic review and meta-analysis have provided valuable insights into the effectiveness of perineal and abdominal surgical approaches for treating recurrent external rectal prolapse. The analysis revealed that the recurrence rate for the abdominal approach in treating recurrent external rectal prolapse was 15.6%, notably lower than the 27.9% observed with the perineal approach.

“Although both surgical techniques had comparable complication rates and hospital stays, the findings indicate that abdominal surgery may provide better patient outcomes,” the researchers wrote in the International Journal of Colorectal Disease.

External rectal prolapse, characterized by the protrusion of the rectum through the anal opening, often necessitates surgical intervention, especially in recurrent cases. At the same time, surgery remains the most effective treatment, recurrence rates reported in the literature range from 6% to 27%. Surgeons typically select between perineal and abdominal approaches based on patient characteristics and clinical considerations. The perineal approach, including procedures like the Altemeier and Delorme techniques, is often favored for elderly or high-risk patients due to its lower perioperative morbidity and suitability for regional anesthesia. In contrast, the abdominal approach, encompassing laparoscopic and open rectopexy techniques, offers better anatomical support and durability, potentially reducing recurrence rates.

Against the above background, Giacomo Fuschillo, Colorectal Surgery, Department of Advanced Medical and Surgical Sciences, Università Degli Studi Della Campania “Luigi Vanvitelli”, Naples, Italy, and colleagues aimed to compare the effectiveness of abdominal and perineal approaches in the surgical management of recurrent external rectal prolapse.

For this purpose, the researchers conducted a systematic search of PubMed and Embase the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. They reviewed studies published between January 2000 and May 2024 that reported surgical outcomes for recurrent external rectal prolapse.

The primary focus was on recurrence rates at the last available follow-up, while secondary outcomes included surgical complications and the length of postoperative hospitalization.

The study led to the following findings:

  • The analysis included nine studies with a total of 531 patients.
  • The recurrence rate was 26.3% at a mean follow-up of 30.5 months.
  • Recurrence after perineal surgery was 27.9%.
  • Recurrence after abdominal surgery was 15.6%.
  • The odds ratio (OR) for recurrence between the two approaches was 0.66.
  • The OR for surgical complications was 1.44.
  • The standardized mean difference (SMD) for hospital stay length was 0.49.

This meta-analysis found that the recurrence rate after the perineal approach was nearly twice that of the abdominal approach in the surgical treatment of recurrent external rectal prolapse. However, the comparison between the two techniques did not reveal a statistically significant difference.

“While the perineal approach offers the benefits of a shorter hospital stay and lower morbidity, further randomized trials are necessary to establish the most effective surgical strategy for these patients,” the researchers concluded.

Reference:

Fuschillo, G., Selvaggi, L., Cuellar-Gomez, H. et al. Comparison between perineal and abdominal approaches for the surgical treatment of recurrent external rectal prolapse: a systematic review and meta-analysis. Int J Colorectal Dis 40, 26 (2025). https://doi.org/10.1007/s00384-024-04771-z

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Study Unlocks role of long non-coding RNAs in liver disease progression

Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), is a global health challenge, affecting nearly 30% of adults worldwide. A significant subset of MASLD patients progresses to metabolic dysfunction-associated steatohepatitis (MASH), liver fibrosis, and even hepatocellular carcinoma (HCC), yet no universally approved treatment exists outside resmetirom. The increasing prevalence of MASLD, driven by obesity and diabetes, highlights an urgent need for innovative therapeutic strategies.

A new review published in eGastroenterology sheds light on the mechanistic role of long non-coding RNAs (lncRNAs) in MASLD and liver fibrosis. LncRNAs, which do not encode proteins but regulate gene expression, have emerged as critical players in metabolic and fibrotic pathways. This comprehensive review, authored by Dr. Henry Wade, Kaichao Pan, Bingrui Zhang, Dr. Wenhua Zheng, and Dr. Qiaozhu Su, provides insights into the complex interplay between lncRNAs, microRNAs, and key mediators of liver disease progression.

LncRNAs influence several metabolic pathways in hepatocytes, hepatic stellate cells (HSCs), and Kupffer cells, impacting lipid metabolism, inflammation, apoptosis, and fibrogenesis. Among the most studied lncRNAs, H19 has promoted hepatic lipid accumulation and fibrosis through interactions with sterol regulatory element-binding proteins (SREBPs) and peroxisome proliferator-activated receptors (PPARs). Similarly, MALAT1 has been shown to exacerbate liver fibrosis by modulating inflammatory pathways via nuclear factor-kappa B (NF-κB) and toll-like receptors (TLRs).

One of the key findings discussed in the review is how lncRNAs regulate hepatic lipid homeostasis and fibrotic pathways. LncRNAs such as Gas5 and MEG3 appear to exert protective effects, inhibiting hepatocyte lipid accumulation and HSC activation. Conversely, lncRNAs like HOTAIR and NEAT1 drive liver disease progression by activating fibrotic and inflammatory responses. These opposing roles suggest that targeting lncRNAs could provide a dual approach—either suppressing pathogenic lncRNAs or enhancing protective ones—for MASLD treatment.

Additionally, the review explores how lncRNAs interact with microRNAs and transcription factors to regulate liver cell function. For instance, H19 interacts with miR-130a and heterogeneous nuclear ribonucleoprotein A1 (hnRNPA1) to promote steatosis, while HOTAIR regulates DNA methylation through interactions with miR-148b and DNMT1. These complex molecular networks underscore the potential of lncRNA-based interventions.

Dr. Qiaozhu Su, the corresponding author from Queen’s University Belfast, notes that lncRNAs hold promise as both diagnostic biomarkers and therapeutic targets. “Understanding how lncRNAs contribute to MASLD and fibrosis opens new avenues for therapeutic strategies. Given their regulatory roles in metabolism and inflammation, lncRNA-based therapies could be transformative,” said Dr. Su.

While the potential of lncRNA-targeted therapies is exciting, the review acknowledges significant challenges. LncRNAs exhibit species specificity, making translational research difficult. The review suggests that future studies should focus on identifying conserved lncRNAs across species to facilitate clinical applications. Developing delivery mechanisms for lncRNA-based therapeutics, such as nanoparticle-mediated RNA delivery, will be crucial for advancing this field.

This review underscores the urgent need for further investigation into lncRNAs as key regulators of liver disease. As MASLD prevalence continues to rise, unlocking the therapeutic potential of lncRNAs could mark a paradigm shift in liver disease management.

Reference:

Henry Wade, Kaichao Pan, Bingrui Zhang, Wenhua Zheng, Qiaozhu Su – Mechanistic role of long non-coding RNAs in the pathogenesis of metabolic dysfunction-associated steatotic liver disease and fibrosis: eGastroenterology 2024;2:e100115.

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FDA Approves Copper IUD for Pregnancy Prevention

The Food and Drug Administration (FDA) has approved Miudella® (copper intrauterine system [IUS]) for the prevention of pregnancy in females of reproductive potential for up to three years.

MIUDELLA is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years.

“Sebela Women’s Health is thrilled to be able to bring this hormone-free IUD option for birth control to women in the United States,” said Kelly Culwell, MD, Head of Research and Development, Sebela Women’s Health. “Our innovative copper IUD MIUDELLA® offers effective pregnancy prevention using less than half the copper of the currently available copper-based IUD in the U.S., utilizing a small, flexible nitinol frame. We believe these and other features of MIUDELLA may help address barriers to use, while also providing women with the hormone-free option some prefer.”

Guidelines from the American College of Obstetrics and Gynecology state that long-acting reversible contraceptive (LARC) methods, including intrauterine devices and contraceptive implants, are the most effective contraceptive methods, have few contraindications, and are appropriate for almost all patients. While there are a variety of contraceptive methods available to women, 41.6 percent of pregnancies in the U.S. are unintended.

MIUDELLA® is a hormone-free IUD with a flexible frame made of nitinol, a material that has super-elastic properties that enables strategic placement of the copper in a manner that allows the device to achieve similar efficacy to the currently available copper IUD with less than half the dose of copper (175mm2). MIUDELLA® uses the smallest hormone-free flexible IUD frame available in the United States, measuring 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings. Miudella does not require loading by a healthcare professional; it comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of 3.7 mm.

“Considering it has been four decades since we’ve been able to offer women a new hormone-free IUD option, I find the clinical data supporting MIUDELLA® efficacy and safety to be very exciting,” said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. “This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options.”

About MIUDELLA

MIUDELLA was investigated in three clinical trials in the U.S. in 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter single-arm open-label study was conducted in 42 centers in the U.S. with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year). In the efficacy cohort from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60) or 99% efficacy. Both clinicians and study participants also reported positive experiences with placement of Miudella, with an overall placement success rate of 98.8%. The most common adverse events across all three clinical trials were similar to those seen with use of IUDs – heavy menstrual bleeding, dysmenorrhea and intermenstrual bleeding. The incidence of these adverse events decreased over time. In the first year, 8.5% of participants across all three studies discontinued due to bleeding or pain adverse events, which decreased to 3.2% by year 3. Expulsion rates were low ranging from 1.9% in year 1 to 0.9% in year 3.

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Psoriasis in Pregnancy Elevates Risk of Maternal Preeclampsia and Cardiac Complications: Study

A recent study revealed that pregnant women with psoriasis face increased risks of adverse maternal outcomes, particularly preeclampsia and cardiac arrhythmias, during delivery. The research published in the JACC Advances journal highlighted the need for increased medical attention and monitoring for expectant mothers with this chronic skin condition.

The study utilized data from the National Inpatient Sample between 2011 and 2020 and analyzed over 37.4 million delivery-related hospitalizations in women aged 18 years and older. Out of these, 23,588 cases involved patients with psoriasis. By employing propensity score matching, this study was able to isolate the impact of psoriasis on maternal complications during delivery.

Pregnant women with psoriasis were 25% more likely to develop preeclampsia or eclampsia (Odds Ratio: 1.25; Confidence Interval: 1.08-1.43). These conditions are serious hypertensive disorders that can lead to life-threatening complications for both mother and baby. Also, psoriasis was also linked to a 44% higher likelihood of cardiac arrhythmias (Odds Ratio: 1.44; Confidence Interval: 1.08-1.93). 

Additional complications observed among psoriasis patients included acute kidney injury, pulmonary edema, and venous thromboembolism. The findings highlight the importance of specialized care for pregnant women with psoriasis. Physicians should closely monitor these patients for signs of cardiovascular issues and hypertensive disorders throughout pregnancy and delivery. Early detection and intervention can reduce the risks and ensure better maternal outcomes.

The study is among the first large-scale investigations to comprehensively assess the relationship between psoriasis and maternal cardiovascular complications during delivery. While the research sheds light on important associations, further studies are imperative to explore the underlying mechanisms driving these adverse outcomes.

Given that psoriasis is often perceived solely as a skin condition, this research serves as a reminder of its potential systemic implications, particularly in the context of pregnancy. Overall, expectant mothers with psoriasis are encouraged to discuss these findings with their physicians to ensure proactive management of their pregnancy.

Source:

Agrawal, A., Sorathia, S., Bhagat, U., Zahid, S., Arockiam, A. D., Bayat, A., Safdar, A., Rosenzveig, A., Majid, M., Chandna, S., Gupta, R., Weber, B., & Michos, E. D. (2025). Cardiovascular complications during delivery hospitalization in patients with psoriasis. JACC Advances, 4(2), 101562. https://doi.org/10.1016/j.jacadv.2024.101562

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Primary Ciliary Dyskinesia in Childhood: Study Reveals High Burden of ENT Morbidity

USA: A recent study has shed light on the progression of otologic and nasal symptoms in children with primary ciliary dyskinesia (PCD), revealing that these complications begin early in life and persist throughout childhood. The study found that children with PCD experience ongoing ear and nasal complications.

“Over a follow-up of 7.6 years, 80% required pressure equalization tubes, while hearing loss affected 68% transiently and persisted in 30% of cases. Nasal congestion was nearly universal, with 87% experiencing sinusitis and 35% undergoing multiple sinus surgeries,” the researchers reported in the journal OTO Open. These findings highlight the critical need for continuous ENT care in managing PCD-related complications.

PCD is a rare genetic disorder affecting the function of motile cilia, leading to impaired mucociliary clearance. This dysfunction results in chronic respiratory issues, including persistent nasal congestion, recurrent ear infections, and progressive hearing loss. Although these symptoms are well-documented, their long-term progression and variability among patients have remained areas of active research.

While the progression of pulmonary disease has been well documented in multiple studies, longitudinal changes in otologic and nasal symptoms in patients remain poorly understood. To fill this knowledge gap, Adam J. Kimple, Marsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA, and colleagues aimed to determine the prevalence, age of onset, and age-related patterns of self-reported otologic and sinonasal comorbidities in individuals with PCD.

For this purpose, the researchers conducted a prospective, longitudinal, multicenter observational study over up to 12 years across six PCD centers in North America. The study included participants under 19 years of age with a confirmed diagnosis of PCD established through electron microscopy and/or genetic testing. During each study visit, a standardized medical history questionnaire and physical examination were performed to track the progression of symptoms. Descriptive statistical analyses were conducted for the entire cohort and subgroups classified based on ciliary ultrastructure, providing insights into the variability of otologic and sinonasal manifestations over time.

The study revealed the following findings:

  • One-hundred forty-seven participants were monitored for an average of 7.6 ± 3.2 years.
  • Pressure equalization tubes were placed in 80% of cases.
  • The transient hearing loss affected 68% of participants, while 30% experienced persistent hearing loss.
  • Hearing aids were used by 8% and 27% required speech therapy.
  • Those with inner dynein arm/microtubular disorganization defects received pressure equalization tubes earlier than those with outer dynein arm defects.
  • Chronic nasal congestion was reported in 97% of participants.
  • Sinusitis was observed in 87%, and 35% required more than one sinus surgery.

The researchers identified a high prevalence of persistent otologic and sinonasal complications in children with PCD. Nearly all experienced otitis media and nasal congestion, with early pressure equalization tube placement observed in those with specific ultrastructural defects.

“Emphasizing the need for further study, an international consortium is conducting advanced evaluations to refine diagnostic and management approaches for PCD-related upper airway morbidities,” the researchers wrote.

Reference:

Dagher I, Kimple AJ, Ferkol TW, Sagel SD, Dell SD, Milla CE, Li L, Lin FC, Sullivan KM, Zariwala MA, Knowles MR, Rosenfeld M, Leigh MW, Davis SD; Genetic Disorders of Mucociliary Clearance Consortium. Progression of Otologic and Nasal Symptoms in Primary Ciliary Dyskinesia Throughout Childhood. OTO Open. 2025 Feb 21;9(1):e70079. doi: 10.1002/oto2.70079. PMID: 39989621; PMCID: PMC11843728.

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How air pollution and wildfire smoke may contribute to memory loss in Alzheimer’s disease: Study

Air pollution contributes to nearly 7 million premature deaths each year, and its effects go far beyond the lungs. Breathing in wildfire smoke or automobile-related city smog doesn’t just increase the risk of asthma and heart disease-it may also contribute to brain diseases as diverse as Alzheimer’s and autism.

Scientists at Scripps Research have discovered how a chemical change in the brain-which can be triggered by inflammation and aging as well as toxins found in air pollution, pesticides, wildfire smoke and processed meats-disrupts normal brain cell function. Known as S-nitrosylation, this chemical change prevents brain cells from making new connections and ultimately results in cellular death, the team discovered.

The research, published in the Proceedings of the National Academy of Sciences on February 27, 2025, showed that blocking S-nitrosylation in a key brain protein partially reversed signs of memory loss in Alzheimer’s mouse models and in nerve cells produced from human stem cells.

“We’ve revealed the molecular details of how pollutants can contribute to memory loss and neurodegenerative disease,” says senior author and professor Stuart Lipton, MD, PhD, the Step Family Foundation Endowed Chair at Scripps Research and a clinical neurologist in La Jolla, California. “This could ultimately lead to new drugs that block these effects to better treat Alzheimer’s disease.”

More than two decades ago, Lipton first discovered S-nitrosylation, a chemical process whereby a molecule related to nitric oxide (NO) binds to sulfur (S) atoms within proteins (producing “SNO”), altering their function and forming what Lipton has called a “SNO-STORM” in the brain. NO is found naturally within the body and produced in response to electrical stimulation or inflammation-but it also forms in excess in response to small particulate material and nitrate-related compounds (designated PM2.5/NOx) present in or triggered by climate change and automobile-related air pollution, wildfire smoke, pesticides, and processed meats. Lipton’s research group and colleagues have previously demonstrated that aberrant S-nitrosylation reactions contribute to some forms of cancer, autism, Alzheimer’s disease, Parkinson’s disease and other conditions.

In the new study, Lipton’s group investigated the effect of S-nitrosylation on the protein CRTC1, which helps regulate genes that are critical for forming and maintaining connections between brain cells, an essential process for learning and long-term memory.

Using cultured brain cells from mice and humans, the researchers first confirmed that excess NO leads to S-nitrosylation of CRTC1. They then discovered that this chemical modification prevented CRTC1 from binding to another critical brain regulatory protein, CREB. As a result, other genes necessary for forming connections between neurons failed to be stimulated.

“This is a pathway that affects your memory and is directly implicated in human Alzheimer’s disease,” says Lipton.

Indeed, the team observed high levels of S-nitrosylated CRTC1 at an early stage of disease in Alzheimer’s mouse models and in human neurons derived from stem cells of Alzheimer’s patients, further supporting the idea that the chemical change plays a key role in the development of disease symptoms.

Next, the research team genetically engineered a version of CRTC1 that could no longer undergo S-nitrosylation, as the protein now lacked the sulfur-containing amino acid (called cysteine) required for the chemical reaction. In a petri dish, introducing this modified version of CRTC1 into human nerve cells derived from Alzheimer’s patient stem cells prevented signs of disease, including withering of nerve cell connections and decreased nerve cell survival. In Alzheimer’s mouse models, the re-engineered CRTC1 restored the activation of genes required for memory formation and synaptic plasticity-the brain’s ability to strengthen connections between neurons.

“We could nearly completely rescue molecular pathways involved in making new memories,” says Lipton. “It suggests that this is a druggable target that could make a real difference in treating Alzheimer’s and potentially other neurological diseases.”

Given that environmental toxins, including automobile pollution and wildfire smoke, can result in elevated NO levels in the brain, the new study strengthens the hypothesis that these toxins can accelerate brain aging and Alzheimer’s through S-nitrosylation. Preventing S-nitrosylation of CRTC1 could be a viable pathway toward slowing or preventing this type of Alzheimer’s-related brain damage, says Lipton.

The findings may also help explain why Alzheimer’s risk increases with age, he adds. Even without exposure to environmental toxins, aging leads to increased inflammation and higher NO levels, while the body’s antioxidant defenses weaken-making proteins more susceptible to harmful S-nitrosylation reactions.

“We’re learning that S-nitrosylation affects numerous proteins throughout the body, but reversing just some of these changes-like those on CRTC1-could have a significant impact on memory function,” explains Lipton.

His research group is now working to develop drugs that can selectively block certain S-nitrosylation reactions, including those affecting CRTC1.

Reference:

Zhang X, Vlkolinsky R, Wu C, Dolatabadi N, Scott H, Prikhodko O, Zhang A, Blanco M, Lang N, Piña-Crespo J, Nakamura T, Roberto M, Lipton SA. S-Nitrosylation of CRTC1 in Alzheimer’s disease impairs CREB-dependent gene expression induced by neuronal activity. Proc Natl Acad Sci U S A. 2025 Mar 4;122(9):e2418179122. doi: 10.1073/pnas.2418179122.

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Proton Pump Inhibitors May Speed Up Kidney Disease Progression in Pre-ESRD Patients: Study

Taiwan: A new nationwide population-based study has raised concerns about the potential impact of proton pump inhibitors (PPIs) on renal disease progression in patients with pre-end-stage renal disease (pre-ESRD). The study revealed that PPI use may accelerate the progression of chronic kidney disease (CKD) to kidney failure.

“Our study highlights the heightened renal risk, particularly for patients with moderate to advanced CKD, when prescribing PPIs, emphasizing the need for careful consideration by clinicians managing pre-ESRD patients with PPIs and H2 blockers (H2Bs),” the researchers wrote in BMC Nephrology.

Although proton pump inhibitors are widely prescribed for gastrointestinal (GI) diseases, numerous studies have raised concerns about their potential adverse effects on kidney health. Most existing evidence has focused on evaluating the risks associated with PPI use in individuals with normal renal function, with limited data on their impact in patients with moderate to advanced chronic kidney disease. Ching-Lan Cheng, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan, and colleagues address this gap by examining the accelerated decline in renal function associated with PPI use and the heightened risk of acute kidney injury (AKI) in pre-end-stage renal disease patients.

For this purpose, the researchers conducted a retrospective cohort study, including adult patients with CKD stages 3b to 5 who initiated PPI or H2 blocker (H2B) therapy between 2011 and 2018. To evaluate the risk of renal events, they utilized the Cox proportional hazard model to estimate the adjusted hazard ratio (HR) and 95% confidence interval (CI). Additionally, sensitivity analyses were performed, incorporating propensity score matching, as-treated analysis, and subgroup analysis to ensure the robustness of the findings.

The following were the key findings of the study:

  • The study analyzed a cohort of 83,432 pre-ESRD patients, including 5,138 treated with H2 blockers (H2B) and 1,051 with proton pump inhibitors (PPIs).
  • Patients using PPIs had a significantly higher likelihood of progressing to ESRD compared to those on H2B (adjusted HR: 1.495).
  • Omeprazole use was associated with an increased risk of ESRD and AKI (adjusted HR: 1.784).
  • Esomeprazole use also showed a significantly higher risk of ESRD and AKI (adjusted HR: 1.847).

The study conducted in Taiwan highlights a significant association between PPI use and an increased risk of accelerated progression to ESRD and AKI in pre-ESRD patients compared to H2 blockers.

“These findings demonstrate a more pronounced renal risk than previous cohort studies, particularly in this vulnerable population. Subgroup analyses further revealed that PPIs like omeprazole and esomeprazole, which have auto-inhibition effects on CYP2C19, were linked to higher hazard ratios for ESRD development than other PPIs,” the researchers wrote.

“Given Taiwan’s distinction as having the highest global incidence of ESRD, we emphasize the need for a more personalized approach to PPI use in pre-ESRD patients. This includes reconsidering prescription practices, especially for those in the late stages of CKD, and promoting de-prescription strategies to enhance renal safety,” they concluded.

Reference:

Huang, CH., Tsai, CJ., Su, CC. et al. Accelerated risk of renal disease progression in pre-ESRD patients with proton pump inhibitors use: a nationwide population-based study. BMC Nephrol 25, 469 (2024). https://doi.org/10.1186/s12882-024-03867-6

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Omitting race from lung function equations increases detection of asthma in Black children: JAMA

Despite ongoing progress, structural racism and health disparities continue to shape healthcare practices in ways healthcare providers may not even realize. A recent study in JAMA Network Open, published Feb. 28, 2025, shows that continued use of race-specific equations in the diagnostic process of children with asthma symptoms limits the identification of reduced lung function in Black children.

“This finding is important because when these children are not identified as having reduced lung function, they may not receive further testing. This can lead to under-diagnosis, delayed treatment, and long-term lung health issues,” says Gurjit Khurana Hershey, MD, PhD, senior author of the study.

Addressing an outdated equation

Diagnosing children with asthma is a multi-step process.

Reports of asthma symptoms from a physician or parental guardian start the diagnosis. Children then participate in pulmonary function testing to assess their lung function, including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) tests. Children found to have abnormal lung function go on to further diagnostic testing.

Importantly, the FEV1 and FVC testing results in a percentage value compared to expected lung function. This expected lung function calculation is built into US spirometers–devices that measure lung function–and follows a standard equation using age, sex, body size and race.

Outdated and flawed studies led to the belief that white people have “naturally higher” lung function than other races. Thus, the calculation with race as a variable adjusts lung function by 10-15% for Black individuals and 4-6% for Asian individuals. However, this assumption and the resulting adjustments overlooks socioeconomic differences between racial groups. As a result, they unintentionally contribute to health disparities.

Updated equation still underused

In 2022, the Global Lung Initiative (GLI) Network updated lung function reference equations. To lower the negative impact of using race-specific equations, the new equations exclude race. However, healthcare providers have not universally adopted this new race-neutral equation.

The study led by first author Wan Chi Chang, MS, showed that the new race-neutral equation led to 2.5-4-fold more Black children with asthma symptoms as having reduced lung function compared to the race-specific equation.

This study included three cohorts of children from the Childhood Asthma Management Project (CAMP), the Cincinnati Childhood Allergy and Air Pollution Study (CCAAPS) and the Mechanisms of Progression of Atopic Dermatitis to Asthma (MPAACH) cohort. These cohorts include children with asthma or a high risk of asthma; 21% of these 1,533 children were Black. The use of the race-neutral equation changed 39% of all Black children from normal to reduced lung function when compared to the race-specific equation.

Additionally, when the race-neutral equation was used, 38-44% of Black children in the CCAAPS and MPAACH cohorts who were not initially eligible for further diagnostic testing became eligible. Importantly, using the race-neutral equation on White children had no meaningful impact on the lung function tests. These findings demonstrate that the race-specific equation overestimates lung function in Black children. This leads to under-diagnosis of asthma in this group.

Co-authors of this study recommend the universal use of the race-neutral equation. This will increase the diagnosis and treatment of asthma and alleviate asthma-related health disparities. Moving forward, they propose further evaluations of the race-neutral equation in measuring lung function in other ethnic groups.

Reference:

Chang WC, Burkle JW, Williams LR, et al. Race-Specific and Race-Neutral Equations for Lung Function and Asthma Diagnosis in Black Children. JAMA Netw Open. 2025;8(2):e2462176. doi:10.1001/jamanetworkopen.2024.62176

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Delgocitinib Cream found Effective for Chronic Hand Eczema in Phase 3 trial

Researchers have found in DELTA China trial that delgocitinib cream (Anzupgo) 20 mg/g significantly reduces severity of chronic hand eczema (CHE), meeting its primary endpoint. These phase 3 results highlight its potential for adolescents aged 12 and older.

The phase 3 trial consists of a 16-week randomized, double-blind, vehicle-controlled, treatment period, followed by an open-label treatment period of 36 weeks. A total of 362 subjects were recruited and randomized in a 2:1 ratio to receive either Anzupgo or cream vehicle.

The results announced today cover the double-blind treatment period of the DELTA China trial from Week 0 to Week 16 of Anzupgo treatment and are an important milestone in the Chinese market as there are currently no approved treatment options specifically indicated for moderate to severe CHE in China. The primary endpoint for DELTA China was the Investigator’s Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16, which was met with a statistically significant improvement in CHE severity after 16 weeks of treatment with Anzupgo compared to cream vehicle.

Furthermore, the 16-week safety profile of Anzupgo was consistent with previous pivotal trials, and the pharmacokinetics (PK) data supported low systemic exposure.

The open-label treatment period of the DELTA China trial runs from Week 16 to Week 52 and is still ongoing. The results from this stage of the trial will be released at a later date.

The primary objective of the study was to evaluate the efficacy of twice-daily applications of Anzupgo compared with cream vehicle in the treatment of Chinese subjects with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.

“Following the results from DELTA China, including the consistent safety profile and pharmacokinetics data, we will continue our work to investigate delgocitinib cream as a potential treatment option for patients living with moderate to severe CHE, as there are currently no approved treatments specifically for CHE available here in China,” said Byron Yin, General Manager for LEO Pharma in China. “LEO Pharma has a unique heritage for innovative topicals, and I look forward to seeing the full data set, which I hope will set us up for further advances and ultimately help us to introduce this new treatment option in China.”

The DELTA China trial was structured in line with the DELTA 1 and 2 phase 3 trials investigating CHE in Europe and Canada, which both met all primary and secondary endpoints.

“DELTA China demonstrates LEO Pharma’s truly global approach when it comes to addressing the unmet needs of patients living with moderate to severe CHE worldwide,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “Skin conditions are not specific to borders and nor is our commitment to research. The results from this phase 3 trial in the Chinese population builds upon our expanding collection of scientific data for treating moderate to severe CHE globally. Our work will continue to advance the standard of care for this debilitating condition.”

Currently, Anzupgo is approved for adults in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under investigation in other markets, including the United States.

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Hallucinogen use linked to 2.6-fold increase in risk of death for people needing emergency care

People seeking emergency care for hallucinogen use were at a 2.6-fold higher risk of death within five years than the general population, according to a study published in the Canadian Medical Association Journal.

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