Deprescribing Antihypertensives May Preserve Cognitive Function in Nursing Home Residents: JAMA

USA: Deprescribing antihypertensive medications may benefit elderly individuals in long-term care facilities by reducing the risk of cognitive decline, new data from the Veterans Health Administration has shown.

The study, published in JAMA Internal Medicine, revealed that elderly patients who had their blood pressure (BP) medications reduced—either by decreasing the overall number of drugs or adjusting dosages—experienced a slower rate of cognitive decline compared to those who continued their usual medication regimen. This effect was especially notable among patients with dementia.

Deprescribing antihypertensive medications is common among nursing home residents, but the relationship between this practice and cognitive decline remains unclear. To fill this knowledge gap, Bocheng Jing, Division of Geriatrics, Department of Medicine, University of California, San Francisco, and colleagues aimed to examine the relationship between deprescribing antihypertensive medications and changes in cognitive function among nursing home residents.

For this purpose, the researchers conducted a cohort study using a target trial emulation approach, including VA long-term care residents aged 65 and older who had been in residence for at least 12 weeks between 2006 and 2019. Residents not prescribed antihypertensive medications, those with blood pressure above 160/90 mm Hg, or those with heart failure were excluded. Eligible residents with stable medication use for four weeks were divided into deprescribing or stable user groups and followed for two years or until death or discharge, for intention-to-treat (ITT) analysis. Participants who switched treatment groups were censored in the per-protocol analysis.

Deprescribing was defined as a reduction in the total number of antihypertensive medications or a dosage decrease of 30% sustained for at least two weeks. Cognitive function was evaluated using the Cognitive Function Scale (CFS), categorized as cognitively intact (CFS = 1), mildly impaired (CFS = 2), moderately impaired (CFS = 3), and severely impaired (CFS = 4).

Follow-up data were analyzed using an ordinal generalized linear mixed model, adjusting for confounders with inverse probability of treatment weighting, and per-protocol analysis included the inverse probability of censoring weighting.

The following were the key findings of the study:

  • Of 45,183 long-term care residents, 12,644 (mean age 77.7 years; 2.6% female, 97.4% male) qualified for intention-to-treat (ITT) analysis, while 12,053 (mean age 77.7 years; 2.6% female, 97.4% male) met the criteria for per-protocol analysis.
  • At the end of the follow-up, 12.0% of residents showed a worsened Cognitive Function Scale (CFS) score, while 7.7% demonstrated improvement.
  • Among the deprescribing group, 10.8% experienced a worsening CFS score compared to 12.1% in the stable user group.
  • In the per-protocol analysis, the deprescribing group had a 12% lower likelihood of progressing to a worse CFS category every 12 weeks (odds ratio, 0.88) than the stable users.
  • Among residents with dementia, deprescribing was linked to a 16% reduction in the odds of cognitive decline (odds ratio, 0.84). These trends were consistent in the ITT analysis.

This cohort study suggests that deprescribing is linked to reduced cognitive decline in nursing home residents, especially among those with dementia. The researchers suggest that additional data are necessary to fully understand the benefits and risks of antihypertensive deprescribing, which will help guide patient-centered medication management in nursing homes.

“These findings highlight the importance of patient-centered strategies for deprescribing antihypertensive medications, ensuring that treatment regimens for older adults are optimized to maintain cognitive function while minimizing potential harm,” the researchers concluded.

Reference:

Jing B, Liu X, Graham LA, et al. Deprescribing of Antihypertensive Medications and Cognitive Function in Nursing Home Residents. JAMA Intern Med. Published online September 23, 2024. doi:10.1001/jamainternmed.2024.4851

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1 in 4 Adults Suspect They Have Undiagnosed ADHD: Survey

A new national survey of 1,000 American adults commissioned by The Ohio State University Wexner Medical Center and College of Medicine finds that 25% of adults now suspect they may have undiagnosed ADHD. But what worries mental health experts is that only 13% of survey respondents have shared their suspicions with their doctor.
That’s raising concerns about the consequences of self-diagnosis leading to incorrect treatment.
“Anxiety, depression and ADHD – all these things can look a lot alike, but the wrong treatment can make things worse instead of helping that person feel better and improving their functioning,” said psychologist Justin Barterian, PhD, clinical assistant professor in Ohio State’s Department of Psychiatry and Behavioral Health.
An estimated 4.4% of people ages 18 to 44 have ADHD, and some people aren’t diagnosed until they’re older, Barterian said.
“There’s definitely more awareness of how it can continue to affect folks into adulthood and a lot of people who are realizing, once their kids have been diagnosed, that they fit these symptoms as well, given that it’s a genetic disorder,” Barterian said.
The survey found that younger adults are more likely to believe they have undiagnosed ADHD than older generations, and they’re also more likely to do something about it.
Barterian said that should include seeing a medical professional, usually their primary care provider, to receive a referral to a mental health expert to be thoroughly evaluated, accurately diagnosed, and effectively treated.
“If you’re watching videos on social media and it makes you think that you may meet criteria for the disorder, I would encourage you to seek an evaluation from a psychologist or a psychiatrist or a physician to get it checked out,” Barterian said.
This study was conducted by SSRS on its Opinion Panel Omnibus platform. The SSRS Opinion Panel Omnibus is a national, twice-per-month, probability-based survey. Data collection was conducted from August 16 – August 18, 2024, among a sample of 1,006 respondents. The survey was conducted via web (n=975) and telephone (n=31) and administered in English. The margin of error for total respondents is +/-3.8% points at the 95% confidence level. All SSRS Opinion Panel Omnibus data are weighted to represent the target population of U.S. adults ages 18 or older.

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Bacteria involved in gum disease linked to increased risk of head and neck cancer: JAMA

More than a dozen bacterial species among the hundreds that live in people’s mouths have been linked to a collective 50% increased chance of developing head and neck squamous cell carcinoma (HNSCC), a new study shows. Some of these microbes had previously been shown to contribute to periodontal disease, serious gum infections that can eat away at the jawbone and the soft tissues that surround teeth.

Experts have long observed that those with poor oral health are statistically more vulnerable than those with healthier mouths to HNSCC, a group that includes the most common cancers of the mouth and throat. While small studies have tied some bacteria in these regions (the oral microbiome) to the cancers, the exact bacterial types most involved had until now remained unclear.

Led by researchers at NYU Langone Health and its Perlmutter Cancer Center, the new analyses looked at the genetic makeup of oral microbes collected from healthy men and women. Of the hundreds of different bacteria that are routinely found in the mouth, 13 species were shown to either raise or lower risk of HNSCC. Overall, this group was linked to a 30% greater likelihood of developing the cancers. In combination with five other species that are often seen in gum disease, the overall risk was increased by 50%.

“Our findings offer new insight into the relationship between the oral microbiome and head and neck cancers,” said study lead author Soyoung Kwak, PhD. “These bacteria may serve as biomarkers for experts to flag those at high risk,” added Kwak, a postdoctoral fellow in the Department of Population Health at NYU Grossman School of Medicine.

Previous investigations had uncovered certain bacteria in tumor samples of people already diagnosed with these cancers, says Kwak. Then, in a small 2018 assessment, the current research team explored how microbes in healthy participants may over time contribute to future risk of HNSCC.

Their latest report, publishing online Sept. 26 in the journal JAMA Oncology, is the largest and most detailed analysis of its kind to date, says Kwak. It is also among the first to examine whether common fungi, organisms like yeast and mold that, along with bacteria, make up the oral microbiome, might play a role in HNSCC. The new experiments found no such role for fungal organisms.

For the research, the team analyzed data from three ongoing investigations tracking 159,840 Americans from across the country to better understand how diet, lifestyle, medical history, and many other factors are involved in cancer. The data were gathered for the American Cancer Society Cancer Prevention Study II; the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial; and the Southern Community Cohort Study.

Shortly after enrolling, participants rinsed with mouthwash, providing saliva samples that preserved the numbers and species of microbes for testing. Researchers then followed up for roughly 10 to 15 years to record any presence of tumors.

In the current study, the investigators analyzed bacterial and fungal DNA from the spit samples. Then, they identified 236 patients who were diagnosed with HNSCC and compared the DNA of their oral microbes with that of 458 randomly selected study subjects who had remained cancer-free. In their research, the team accounted for factors known to play a role, such as age, race, and how often they smoked cigarettes or drank alcohol.

“Our results offer yet another reason to keep up good oral-hygiene habits,” said study co-senior author Richard Hayes, DDS, MPH, PhD. “Brushing your teeth and flossing may not only help prevent periodontal disease, but also may protect against head and neck cancer,” added Hayes, a professor in the Department of Population Health at NYU Grossman School of Medicine and a member of its Perlmutter Cancer Center.

The researchers emphasized that their study was designed to identify correlations between risk of cancer and certain bacteria in the mouth, but not to establish a direct cause-and-effect link. That will require further research.

“Now that we have identified key bacteria that may contribute to this disease, we next plan to explore the mechanisms that allow them to do so and in what ways we can best intervene,” said study co-senior author Jiyoung Ahn, PhD. Ahn is a professor in the Departments of Population Health and Medicine at NYU Grossman School of Medicine and is the associate director for population research at its Perlmutter Cancer Center.

Ahn cautions that while the added risks from bacteria are concerning, overall cases of head and neck cancer remain fairly uncommon.

Reference:

Kwak S, Wang C, Usyk M, et al. Oral Microbiome and Subsequent Risk of Head and Neck Squamous Cell Cancer. JAMA Oncol. Published online September 26, 2024. doi:10.1001/jamaoncol.2024.4006.

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Heart failure, atrial fibrillation & coronary heart disease linked to cognitive impairment, reveals study

Three common cardiovascular diseases in adults-heart failure, atrial fibrillation and coronary heart disease-are linked to cognitive impairment and increased risk of dementia, according to “Cardiac Contributions to Brain Health,” a new scientific statement from the American Heart Association published today in the Association’s journal, Stroke.

The scientific statement reviews the latest research examining the relationship between cardiovascular health and brain health, including cognitive impairment or neuropsychological dysfunction. The statement emphasizes the interconnectivity between the brain and heart and how crucial this relationship is for overall health.

“Stroke and cognitive decline, both major determinants of brain health, are chronic and disabling conditions that have a dramatic impact at the individual and societal level,” said Chair of the statement writing group Fernando D. Testai, M.D., Ph.D., FAHA, professor of neurology and rehabilitation and vascular neurology fellowship director at the University of Illinois College of Medicine and stroke medical director at the University of Illinois Hospital in Chicago. “Managing heart health from an early age is important to prevent cardiovascular disease and cardiac events, protect brain health and reduce the risk of cognitive decline in later life.”

Testai added, “Dementia is commonly seen as an incurable and relentless disease that cannot be prevented. Evidence shows, however, that adopting a healthy lifestyle and identifying and treating vascular risk factors early may help preserve normal brain function and reduce the burden of Alzheimer’s disease and other related dementias.”

Heart Failure

Heart failure is a major public health issue with underlying causes that include high blood pressure, obesity and Type 2 diabetes. Heart failure is linked to cognitive impairment, affecting tasks like self-care and medication management, especially in older adults. A meta-analysis of previous studies found that almost 50% of people with heart failure experience some kind of cognitive impairment that may impact language, memory and/or executive function. The rate of cognitive problems tends to be higher in those with more severe types of heart failure.

Heart failure may lead to brain injury in a number of ways. Reduced blood flow can cause mini-strokes or silent brain injuries. Chronic inflammation and neurohormonal activation, which work to maintain the brain’s environment, may also contribute to brain damage. Obesity and sleep-disordered breathing are common conditions among people with heart failure and are also associated with cognitive dysfunction. Brain changes, such as gray matter volume reduction and/or white matter damage, are common in heart failure and contribute to reduced brain function. Emerging evidence also indicates that people with heart failure and people with neurodegenerative diseases such as Alzheimer’s may share genetic variations.

For patients with severe heart failure, cognitive screening is advised before surgical interventions due to the elevated risk of stroke; stroke is known to be one of the most common causes of cognitive decline.

Atrial Fibrillation

Atrial fibrillation is the most common heart rhythm disorder in adults, with the overall prevalence in the U.S. projected to increase from 2.7 million in 2020 to nearly 16 million by 2050. The link between atrial fibrillation and stroke is well-known, however, the connection between atrial fibrillation and cognitive decline requires more research. A large meta-analysis found that atrial fibrillation increases the risk of cognitive impairment by 39%.

Shared risk factors between atrial fibrillation and dementia include high blood pressure, Type 2 diabetes, heart failure, smoking, vascular disease, sleep-disordered breathing and advanced age. These factors cause structural and functional brain changes leading to cognitive decline. Stroke, a major predictor of cognitive impairment, has a direct link to atrial fibrillation. Small brain bleeds, or microhemorrhages, are also more common in people with atrial fibrillation and linked to cognitive decline.

Reduced cardiac output associated with atrial fibrillation (similar to heart failure) may compromise blood flow to key areas of the brain that are responsible for cognitive function. Both atrial fibrillation and Alzheimer’s disease are associated with systemic inflammation, and inflammatory biomarkers are associated with increased risk of blood clots and brain injury. While more research is needed to explore this connection, the observation illustrates the complex interaction between the nervous and cardiovascular systems.

Effective treatment of atrial fibrillation, including the use of anti-clotting medications, rhythm control or catheter ablation procedures, may reduce the risk of cognitive decline. Ongoing studies are investigating whether restoring regular heart rhythm through catheter ablation may reduce cognitive dysfunction compared to medication alone.

Coronary Heart Disease

Coronary heart disease significantly increases the risk of dementia and cognitive impairment. A large systematic review of more than 1 million adults indicates that those with heart disease have a 27% higher risk of developing dementia compared to people without heart disease. Up to 50% of people experience loss of brain function after a heart attack. Data from multiple, large-scale studies show a heart attack is linked to a steeper decline in cognitive function, including memory and executive function. Elevated levels of calcium buildup in the arteries are also linked to a greater risk of developing dementia.

Coronary heart disease can harm brain function through various mechanisms. Common risk factors like high blood pressure and Type 2 diabetes cause inflammation that affects the blood-brain barrier and reduces blood flow to the brain, leading to cognitive decline and dementia. Heart disease is also linked to small vessel disease in the brain and reduced brain blood flow, resulting in cognitive impairment. These issues are also seen in patients with Alzheimer’s, indicating a close link between blood vessel damage and brain degeneration. Additionally, genetic factors that increase heart disease risk may also contribute to brain shrinkage and cognitive decline.

Improving vascular risk factors may preserve cognitive performance, though specific effects in patients with coronary heart disease are not fully established. Intensive blood pressure treatment has shown promise in reducing mild cognitive impairment but not dementia. Other studies suggest managing cardiovascular risk factors with lifestyle interventions such as diet and exercise may help maintain cognitive health.

Testai said, “Although new medications with the potential to treat Alzheimer’s disease are being developed, the medical community is well aware that prevention is better than a cure. More research is needed to confirm and outline how cardiovascular care can improve brain health. In addition, more research is needed to understand the ways gender, race and ethnicity may influence the connection between the brain and the heart.”

“Health care professionals should approach their patients in a holistic manner with an approach to improved heart health throughout their lives. Promoting heart health earlier in life with resources that encourage healthy lifestyles is crucial, and monitoring and managing heart health through resources like the Association’s Life’s Essential 8 are important to reduce the risk of cognitive impairment.”

Reference:

Fernando D. Testai, Philip B. Gorelick, Cardiac Contributions to Brain Health: A Scientific Statement From the American Heart Association, Stroke, https://doi.org/10.1161/STR.0000000000000476.

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Autoantibodies fail to influence reproductive parameters in patients with Hashimoto thyroiditis, reports research

A new study published in the journal of Endocrine Research found that autoantibodies had no effect on reproductive characteristics, despite a mild correlation observed among thyroid volume, preterm deliveries and the quantity of antithyroid peroxidase (TPOAb).

Among autoimmune diseases, Hashimoto’s thyroiditis (HT) is the most common where the thyroid stimulating hormone (TSH) levels are up, serum free thyroxine (FT4) levels are low, anti-thyroid autoantibodies like TPOAb and anti-thyroglobulin (TGAb) are present, and there is local parenchymal lymphocytic infiltrate. According to studies, eutrophic women with thyroid autoimmunity (TAI) have a greater risk of pregnancy morbidity and loss. Also, inflammatory processes of viral/bacterial origin and autoimmune have been identified as influencing cellular structures at the maternal-fetal interface and determining various abnormalities in the product of conception. Research of the role of TAI in infertility and assisted reproduction results in women without dysfunction found that TAI had no effect on the number of oocytes retrieved, the chance of fertilization, implantation or clinical pregnancy.

In order to assess the presence as well as concentration of antithyroglobulin (TGAb) antibodies and antithyroid peroxidase at the onset of Hashimoto’s thyroiditis (HT) as well as their correlation with disease attributes and reproductive parameters both before and after diagnosis, Rafaela and colleagues conducted this study.

A total of 65 women with HT were included in this cross-sectional research, which was conducted in an outpatient clinic. Medical records were reviewed and interviews were conducted to gather data. The factors included illness features, TPOAb and TGAb levels, live births, preterm births, infertility and pregnancy losses. This research employed Spearman correlation, Mann-Whitney test, and chi-square or Fisher’s exact tests. 

The average age upon diagnosis was 38 (SD ± 11.1) years, and the disease lasted for 7.5 (SD ± 5.3) years. Of the women, 46% had spells of infertility. Also, 42 women (64.6%) had TGAb antibodies and 59/65 (90.7%) had TPOAb antibodies. Comparison between the groups with and without TPOAb or TGAb revealed no variations in any of the examined variables. TPOAb concentration was strongly connected with thyroid volume and preterm deliveries, whereas TGAb concentration was correlated with age.

Overall, the findings of this study found that among women with HT, infertility was highly prevalent. This was greater than the whole population, but there was no indication that the concentration or existence of the autoantibodies TGAb and TPOAb had any bearing on it.

Source:

de Souza, R. S. X., Quintino-Moro, A., Engelbrecht Zantut-Wittmann, D., & Fernandes, A. (2024). Antithyroid Antibodies and Reproductive Parameters of Women with Hashimoto’s Thyroiditis. In Endocrine Research (pp. 1–8). Informa UK Limited. https://doi.org/10.1080/07435800.2024.2405147

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Chronic stress accelerates colorectal cancer progression by disrupting the balance of gut microbiota, new study shows

Cutting-edge research has uncovered how chronic stress disrupts the balance of gut microbiota to speed up the progression of colorectal cancer (CRC), opening new avenues for CRC prevention and treatment.

By eliminating certain gut bacteria and inducing stress, researchers were able to conclude a relationship between stress and gut microbiota in the progression of CRC, identifying a particular bacterial species as a potential therapeutic target.

Presenting the study at UEG Week 2024, lead researcher Dr Qing Li explained, “In our study, we used an antibiotic cocktail (vancomycin, ampicillin, neomycin, and metronidazole) to eradicate gut microbiota, followed by faecal microbiota transplantation to investigate whether gut microbiota was necessary for chronic stress to accelerate CRC progression.”

The findings showed that chronic stress not only increased tumour growth but also reduced beneficial gut bacteria, particularly Lactobacillus genus, which are essential for a healthy immune response against cancer. Dr Li noted, “Stress-related CRC progression can be attributed to a reduction in beneficial gut bacteria, as this weakens the body’s immune response against cancer. Lactobacillus, being sensitive to vancomycin and ampicillin, was depleted in both the control and stress groups by the antibiotic cocktail. This depletion highlights its crucial role in maintaining gut health and its potential association with CRC progression under chronic stress.”

To further explore how Lactobacillus influences CD8+ T cell levels – which play a crucial role in the body’s anti-tumour immunity – and CRC progression, the researchers supplemented mice with Lactobacillus during chronic stress and observed reduced tumour formation. Dr Li stated, “Through faecal analysis, we found that Lactobacillus plantarum (L. plantarum) specifically regulated bile acid metabolism and enhanced the function of CD8+ T cells. This indicates how Lactobacillus may enhance anti-tumour immunity.”

Unexpected findings also emerged during the research, explained Dr Li. “Initially, we thought that L. plantarum might enhance the anti-tumour immune function of CD8+ T cells by initiating metabolite production, as previous findings suggest. However, our in vitro tests revealed that the conditioned medium from L. plantarum did not significantly stimulate CD8+ T cells to produce such key metabolites. This indicates that L. plantarum may require substances in the gut environment to enhance anti-tumour of CD8+ T cells.”

The potential for Lactobacillus-based therapies in treating patients, particularly those affected by chronic stress, is promising. “Combining traditional anti-tumour drugs with L. plantarum supplementation could be a viable therapeutic strategy for patients with stress-related CRC,” Dr Li said.

CRC is a significant health concern across Europe and is the second most prevalent cancer and second leading cause of cancer-related death.

Its incidence is predicted to rise significantly in the next decade, due to an aging population, unhealthy diets, physical inactivity and obesity.3Moving forward, the research team plans to collect faecal and tumour samples from CRC patients to analyse changes in gut microbiota among individuals with and without chronic stress. “Our aim is to verify if L. plantarum is significantly reduced in stressed CRC patients and to explore its relationship with anti-tumour immune cells,” Dr Li shared.

This study highlights the intricate relationship between stress, gut microbiota, and CRC, suggesting that strategies to restore gut health may play a critical role in cancer care, particularly for patients facing chronic stress. “Restoring beneficial bacteria in the gut, such as Lactobacillus, could strengthen the body’s natural defences against colorectal cancer,” concluded Dr Li.

Reference:

Chronic stress accelerates colorectal cancer progression by disrupting the balance of gut microbiota, new study shows, Beyond, Meeting: UEG Week 2024.

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Dupilumab therapy reduced atopic dermatitis symptoms in pediatric population, finds study

A new study published in the Journal of American Academy of Dermatology found that Dupilumab improved atopic dermatitis (AD) symptoms as well as quality of life (QoL) in pediatric patients and caregivers/families.

The effects of moderate-to-severe atopic dermatitis on kids and caregivers are significant. Assessing several symptoms (such as pruritus and sleep disruption) is challenging for professionals. In addition to clinician-reported outcomes, patient-reported outcomes (PROs) offer valuable support. When young patients cannot offer meaningful, trustworthy self-reports on their experiences, the US Food and Drug Administration and the International Society for Pharmacoeconomics and Outcomes Research Task Force recommend the use of observer-reported outcomes. Thus, this study by Amy Paller and colleagues was to assess how dupilumab medication affected young children’s quality of life and symptoms of AD as reported by patients and caregivers.

Children with moderate-to-severe AD who were 6 months to 5 years old were enrolled in the randomized, placebo-controlled LIBERTY AD PRESCHOOL trial. They were given low-potency topical corticosteroids along with either dupilumab or a placebo for 16 weeks. The change in caregiver-reported outcomes of AD symptoms (such as itching and sleep) and QoL of patients as well as their caregivers/families was evaluated in this post-hoc study between baseline and week 16.

The participants who received dupilumab showed substantial improvements in caregiver-reported AD symptoms and quality of life when compared to the ones who received a placebo. When compared to the placebo group, the dupilumab group showed a least square mean (LSM) drop of -3.6 from baseline on the Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) in week 1 and maintained it through week 16.

Also, 48% of the dupilumab group satisfied the criterion for a clinically relevant change in WSI-MRS, against 9% in the placebo group. The dupilumab group improved their sleep quality numerical rating scale (NRS) by 2.0 points from baseline to week 16 when compared to a 0.3 point change in the placebo group for both individuals and caregivers. The number of patients declaring no days or 1-2 days of itching in the previous 7 days differed more in the dupilumab group from baseline than in the placebo group.

Similarly, the proportion of patients stating no days and 1-2 days of sleep disturbances in the previous 7 days differed more between week 16 and baseline. Overall, Dupilumab helped individuals with AD symptoms and their families/caregivers’ quality of life.

Source:

Paller, A. S., Silverberg, J. I., Simpson, E. L., Cork, M. J., Arkwright, P. D., Chen, Z., Bansal, A., Prescilla, R., Wang, Z., & Marco, A. R. (2024). The effect of dupilumab on caregiver- and patient-reported outcomes in young children with moderate-to-severe atopic dermatitis: results from a placebo-controlled, phase 3 study. In Journal of the American Academy of Dermatology. Elsevier BV. https://doi.org/10.1016/j.jaad.2024.09.039

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Use of OdonAssist device tied to higher rate of successful assisted vaginal deliveries, finds study

Recent research paper “Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study” aimed to investigate the safety and efficacy of the OdonAssist inflatable device before conducting a randomized controlled trial. The study was an open-label, nonrandomized investigation of 104 women with clinically indicated assisted vaginal delivery using the OdonAssist at the Besancon University Hospital, France. The primary outcome measure was the proportion of successful assisted vaginal births using the OdonAssist, and the secondary outcomes included neonatal and maternal data, ease of use of the device, and maternal perception ratings of the birth experience.

Safety and Efficacy Results

The study reported a success rate of 88.5% for assisted vaginal births using the OdonAssist, with no emergency cesarean deliveries performed in the OdonAssist group, and no serious adverse maternal or neonatal reactions related to the use of the device. The rate of third- and fourth-degree perineal tears with the OdonAssist was 3.8%, and maternal perception ratings of the birth experience with the OdonAssist were high. The paper also highlighted the safety and efficacy of the OdonAssist as an alternative to other current devices for assisted vaginal births, with high acceptance rates among pregnant women and the high rate of successful assisted vaginal births using the OdonAssist confirming the feasibility of a future randomized controlled trial.

Design and Innovation

The study used an innovative design combining mechanical principles that favor the progression of the fetal head, including propulsion, flexion, and traction. The device was reported to be safer, easier to use, and more acceptable to women and obstetricians than currently available instruments. The success rate was higher than previously reported in a feasibility study, and the results confirmed the feasibility of conducting randomized controlled trials to evaluate the efficacy of OdonAssist in comparison with other assisted vaginal delivery devices.

Conclusion

Overall, the study concluded that the OdonAssist is a safe and effective alternative to other current devices for assisted vaginal births, with the high acceptance rate among pregnant women and the high rate of successful assisted vaginal births using the OdonAssist confirming the feasibility of a future randomized controlled trial. The detailed findings and safety and efficacy data from this study contribute to the existing knowledge on the OdonAssist device and support the feasibility of future randomized controlled trials to further evaluate its performance and safety in comparison with other assisted vaginal delivery devices.

Key Points

1. The study aimed to investigate the safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth before conducting a randomized controlled trial.

2. Safety and efficacy results revealed a success rate of 88.5% for assisted vaginal births using the OdonAssist, with no emergency cesarean deliveries performed in the OdonAssist group and no serious adverse maternal or neonatal reactions related to the use of the device. The rate of third- and fourth-degree perineal tears with the OdonAssist was 3.8%, and maternal perception ratings of the birth experience with the OdonAssist were high.

3. The study used an innovative design combining mechanical principles favoring fetal head progression, including propulsion, flexion, and traction. The OdonAssist was reported to be safer, easier to use, and more acceptable to women and obstetricians than currently available instruments. The high success rate confirmed the feasibility of conducting randomized controlled trials to evaluate the efficacy of OdonAssist in comparison with other assisted vaginal delivery devices.

4. The OdonAssist was highlighted as a safe and effective alternative to other current devices for assisted vaginal births, with high acceptance rates among pregnant women. The detailed findings and safety and efficacy data from this study contribute to the existing knowledge on the OdonAssist device, supporting the feasibility of future randomized controlled trials to further evaluate its performance and safety in comparison with other assisted vaginal delivery devices.

5. The primary outcome measure was the proportion of successful assisted vaginal births using the OdonAssist, and the secondary outcomes included neonatal and maternal data, ease of use of the device, and maternal perception ratings of the birth experience.

6. Overall, the study concluded that the OdonAssist is a safe and effective alternative to other current devices for assisted vaginal births, with the high acceptance rate among pregnant women and the high rate of successful assisted vaginal births using the OdonAssist confirming the feasibility of a future randomized controlled trial.

Reference 

Mottet N, Hotton E, Eckman-Lacroix A, Bourtembourg A, Metz JP, Cot S, Poitrey E, Delhomme L, Languerrand E, Nallet C, Lallemant M, Draycott T, Riethmuller D. Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study. Am J Obstet Gynecol. 2024 Mar;230(3S):S947-S958. doi: 10.1016/j.ajog.2023.05.016. Epub 2023 Aug 1. PMID: 38462265.

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Coffee during pregnancy safe for baby’s brain development, reveals research

A University of Queensland-led study has failed to find any strong links between drinking coffee during pregnancy and neurodevelopmental difficulties in children, but researchers are advising expectant mothers to continue following medical guidelines on caffeine consumption.

Dr Gunn-Helen Moen and PhD student Shannon D’Urso from UQ’s Institute for Molecular Bioscience (IMB) led an in-depth genetic analysis of data from tens of thousands of families in Norway.

“Scandinavians are some of the biggest coffee consumers in the world, drinking at least 4 cups a day, with little stigma about drinking coffee during pregnancy,” Dr Moen said.

“Our study used genetic data from mothers, fathers and babies as well as questionnaires about the parents’ coffee consumption before and during pregnancy.

“The participants also answered questions about their child’s development until the age of 8, including their social, motor, and language skills.”

“Our analysis found no link between coffee consumption during pregnancy and children’s neurodevelopmental difficulties.”

The researchers said physiological changes during pregnancy prevent caffeine breaking down easily and it can cross the placenta and reach the foetus, where there are no enzymes to metabolise it.

Caffeine accumulation was thought to impact the developing foetal brain, but Dr Moen said previous observational studies couldn’t account for other environmental factors such as alcohol, cigarette smoke or poor diet.

“We used a method called Mendelian randomisation which uses genetic variants that predict coffee drinking behaviour and can separate out the effect of different factors during pregnancy,” she said.

“It mimics a randomised controlled trial without subjecting pregnant mothers and their babies to any ill effects.

“The benefit of this method is the effects of caffeine, alcohol, cigarettes and diet can be separated in the data, so we can look solely at the impact of caffeine on the pregnancy.”

The researchers use genetic analysis to understand complex traits and diseases especially in early life, with a previous study by Dr Moen showing that drinking coffee in pregnancy did not affect birth weight, risk of miscarriage or stillbirth.

They emphasise the importance of following advice from healthcare providers to limit caffeine consumption during pregnancy, as caffeine may influence other pregnancy outcomes.

The researchers are now looking to apply similar analyses to understand more about genetic and environmental causes of neurodiversity, and the effect of it from other factors on brain development during pregnancy.

Reference:

D’Urso S, Wootton RE, Ask H, et al. Mendelian randomization analysis of maternal coffee consumption during pregnancy on offspring neurodevelopmental difficulties in the Norwegian Mother, Father and Child Cohort Study (MoBa). Psychological Medicine. Published online 2024:1-14. doi:10.1017/S0033291724002216.

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Innovative nanoparticle therapy targets fat absorption to combat obesity: Study

Researchers have unveiled a novel approach to tackle obesity by targeting fat absorption in the small intestine. The cutting-edge nanoparticle system, engineered to deliver therapeutic molecules directly to the digestive tract, has shown significant potential to prevent diet-induced obesity.

Presented today at UEG Week 2024, the study focuses on an enzyme called Sterol O-acyltransferase 2 (SOAT2), which plays a critical role in fat absorpsion in the small intestine. By inhibiting this enzyme in the small intestine, the study offers a promising therapeutic approach to reduce fat absorption and potentially prevent obesity.

Despite extensive research into fat metabolism, effective inhibitors of intestinal fatty acid uptake have until now remained elusive. “For years, researchers have studied fat metabolism, but finding an effective way to block fat absorption has been difficult,” explained lead researcher Dr Wentao Shao. “While most strategies focus on reducing dietary fat intake, our approach targets the body’s fat absorption process directly.”

The research team developed an innovative delivery system using nanoparticles – a tiny capsule made from a polymer core, coated in a protective shell. The system was designed to efficiently carry small interfering RNAs (siRNAs) to the small intestine, where they can reduce SOAT2 expression, inhibiting fat absorption. In mouse models, the animals treated with the nanoparticle therapy absorbed less fat and avoided obesity, even on a high-fat diet.

“This oral treatment offers several advantages”, said Dr Shao. “It’s non-invasive, has low toxicity, and it has high potential for better patient compliance compared to current obesity treatments, which are often invasive or difficult to maintain. This makes it a promising alternative.”

The study also uncovered the underlying mechanism by which SOAT2 regulates fat absorption. Inhibition of SOAT2 in the small intestine triggers degradation of CD36, a protein reponsible for transporting fat. This process involves both cellular stress and the recruitment of E3 ligase RNF5, an enzyme that enhances CD36 degradation.

Previous studies have shown that blocking hepatic SOAT2 leads to fat accumulation in the liver, whereas this intestine-specific approach circumvents that risk, offering a safer and more focused treatment for obesity.

Professor Zhaoyan Jiang, study supervisor, explained, “One of the most exciting aspects of this therapy is its ability to target fat absorption in the intestines without affecting the liver. This is important because previous studies showed that blocking SOAT2 in the liver can lead to fat buildup there – a risk our treatment avoids by focusing only on intestinal SOAT2.”

Looking ahead, the research team plans to test the nanoparticle system in larger animal models to confirm its effectiveness and safety for potential use in humans.

“We believe that this nanoparticle system represents a breakthrough in obesity management, offering a new solution that tackles both fat metabolism and diet-related weight gain, potentially ushering in a new era of more effective treatments”, Professor Jiang concluded.

Reference:

Innovative nanoparticle therapy targets fat absorption to combat obesity, Beyond, Meeting: UEG Week 2024.

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