Ertugliflozin Promising in Reducing Liver Fat and Complications in NAFLD Patients with Type 2 Diabetes: Study

Pakistan: A recent randomized controlled trial has highlighted the potential of ertugliflozin in improving liver health in patients with nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus (T2DM). 

The study, published in the journal Medicine, suggests that ertugliflozin, a medication from the sodium-glucose co-transporter-2 (SGLT2) inhibitor class, may offer beneficial effects on liver enzymes, reduce liver fat accumulation, and potentially alleviate complications commonly seen in individuals with NAFLD and T2DM.

NAFLD is one of the most prevalent liver conditions globally and often coexists with type 2 diabetes, contributing to an increased risk of progression to more severe liver diseases such as nonalcoholic steatohepatitis (NASH) and cirrhosis. Managing NAFLD in the context of diabetes presents a significant challenge, as both conditions exacerbate each other, leading to a complex clinical scenario with limited treatment options.

Recent evidence suggests that ertugliflozin, an SGLT2 inhibitor, may help suppress the development of NAFLD in patients with type 2 diabetes mellitus. Building on this, Haroon Badshah, Department of Pharmacy, Abdul Wali Khan University Mardan, Mardan, Pakistan, and colleagues sought to evaluate the effect of ertugliflozin on improving NAFLD and liver enzyme function in individuals with T2DM.

For this purpose, the researchers conducted a prospective, randomized, double-blind, placebo-controlled interventional study to assess the effectiveness of 15 mg of ertugliflozin compared to 30 mg of the standard therapy pioglitazone and placebo in patients with nonalcoholic fatty liver disease and type 2 diabetes mellitus. Participants were randomly assigned to one of three groups: ertugliflozin, pioglitazone, or placebo.

The impact of therapy was assessed using liver ultrasonography and biochemical parameters. The key findings after 24 weeks of clinical study include:

• Improvement in Fatty Liver Grades:

• Significant improvement in fatty liver grades, particularly in the ertugliflozin group.

• Reduction in Hepatic Steatosis:

• A notable decrease in the number of patients with hepatic steatosis across all treatment groups categorized by fatty liver grade.

• Grade 2 Fatty Liver Reduction:

• In the ertugliflozin group, the proportion of patients in the Grade 2 fatty liver group decreased from 45% to 23.4%.

• In the pioglitazone group, the proportion decreased from 41.7% to 26.6%.

• Liver Enzyme Improvements:

• Significant reductions in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels across all groups.

• The most pronounced reduction in liver enzymes was observed in the ertugliflozin group.

“The study demonstrated that ertugliflozin, combined with other treatments, has beneficial effects on liver enzymes by reducing liver fat accumulation and mitigating complications in patients with NAFLD associated with type 2 diabetes. However, further in-depth studies are needed to fully explore all aspects of the effects of ertugliflozin,” the researchers concluded.

Reference:

Khaliq, Adil PharmD, MPhila; Badshah, Haroon PhDa,*; Shah, Yasar PhDa; Rehman, Inayat Ur PhDa,b; Khan, Kashif Ullah PhDb; Ming, Long Chiau PhDc; Cheng, Maong Hui MDc. The effect of ertugliflozin in patients with nonalcoholic fatty liver disease associated with type 2 diabetes mellitus: A randomized controlled trial. Medicine 103(45):p e40356, November 08, 2024. | DOI: 10.1097/MD.0000000000040356

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Percutaneous Mechanical Aspiration Shows Promise in Treating Right-Heart Infective Endocarditis: Study

USA: A recent study focusing on the outcomes of percutaneous mechanical aspiration (PMA) in treating right-sided infective endocarditis (RSIE) has revealed key insights into the clinical profile of these patients and their response to treatment. Right-sided infective endocarditis, though less common than its left-sided counterpart, is associated with a higher rate of pulmonary septic emboli, posing significant treatment challenges.

The multicenter, retrospective CLEAR-IE study, presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024, compared patients with RSIE undergoing surgery to those with left-sided infective endocarditis (LSIE). It found that patients undergoing surgery for right-sided infective endocarditis had a higher incidence of pulmonary septic emboli, more frequent Staphylococcus aureus infections, and larger vegetation compared to those with left-sided infective endocarditis. 

Percutaneous mechanical aspiration, a minimally invasive procedure, was utilized in treating RSIE patients to drain infected material and reduce the size of vegetations, thereby improving the patient’s prognosis. The technique has gained attention as an alternative to more invasive surgeries, offering potential benefits such as reduced recovery times and less trauma to the patient.

The incidence of RSIE has been rising, largely due to the global increase in intravenous drug use (IVDU) and the growing use of implantable cardiac devices and central venous catheters. Considering this, Sabbagh, Mayo Clinic, Jacksonville, FL, and colleagues aimed to examine the differences in clinical presentation, microbiological findings, and prognosis between patients undergoing surgery for right-sided infective endocarditis and those with left-sided infective endocarditis.

For this purpose, the researchers retrospectively analyzed relevant clinical data from 432 consecutive patients who underwent valve surgery for infective endocarditis (IE) at their institution between January 2009 and December 2018. The data collected included patients’ demographics, preoperative comorbidities, IE manifestations based on the recently modified Duke Criteria, perioperative information, and key clinical outcomes.

The following were the key findings of the study:

• Surgery for Infective Endocarditis:

• 93.3% of patients underwent surgery for left-sided infective endocarditis (LSIE).

• 6.7% of patients underwent surgery for right-sided infective endocarditis (RSIE).

• 11 RSIE patients (37.9%) had a concomitant left-sided infection.

• Demographic and Comorbidity Differences:

• RSIE patients were significantly younger (47.5 years versus 65.1 years for LSIE).

• RSIE patients had fewer comorbidities:

• Hypertension: 41.4% in RSIE vs. 65.3% in LSIE.

• Coronary artery disease: 6.9% in RSIE versus 29.0% in LSIE.

• Risk Factors and Infections:

• RSIE patients had higher rates of:

• Intravenous drug use (IVDU): 34.5% versus 4.5% in LSIE.

• Human immunodeficiency virus (HIV): 10.3% versus 1.7% in LSIE.

• Hepatitis C virus (HCV) infection: 24.1% vs. 5.2% in LSIE.

• Microbiological Findings:

 • The proportion of Staphylococcus aureus infections was higher in RSIE (37.9%) compared to LSIE (21.1%).

• 30-Day Mortality:

• 30-day mortality after surgery:

• RSIE: 6.9%.

• LSIE: 14.6%.

“Larger, multicenter prospective studies are required to gather more reliable data on the clinical profiles of these patients, helping to establish the most effective surgical management strategies,” the researchers concluded.

Reference:

El Sabbagh A. Outcomes of percutaneous mechanical aspiration of right-sided infective endocarditis. Presented at: TCT 2024. October 30, 2024. Washington, DC.

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Component separation in ventral hernia repair shows long-term protective impact on recurrence: JAMA

A new study published in the Journal of American Medical Association found that component separation appears to have a protective effect on long-term operative recurrence following ventral hernia repair among Medicare seniors. Component separation is a reconstructive procedure used to allow midline closure of big or complicated ventral hernias. The prevalence and long-term effects following component separation are unclear, despite a recent spike in popularity. To assess the frequency and long-term results of component separation for abdominal wall hernia repair, Brian Fry and his team carried out this investigation.

From January 1, 2007, to December 31, 2021, 100% of Medicare administrative claims data were analyzed in this cohort research. Adults (≥18 years old) who had elective inpatient ventral hernia repair were the participants. The primary exposure occurred during the closure of a ventral hernia when the component separation approach was used. The main results were the rates of operational recurrence up to 10 years following surgery for hernia repairs with and without component separation, as well as the incidence of component separation with time. The rate of surgical recurrence following component separation, stratified by surgeon volume, was the secondary outcome.

The average age of the 2,18,518 patients who had their ventral hernia repaired was 69.1 years and 90,661 (41.5%) of the patients were men and 127 857 (58.5%) were women. Component separation was performed on 23,768 patients in order to correct abdominal wall hernias. Following index hernia surgery, the median (IQR) follow-up period was 7.2 (2.7 to 10) years. The patients having repair with component separation were somewhat younger, more likely to be male, more likely to have comorbidities, such as obesity, and had operations that were more likely to be open and employ mesh than those without component separation.

From 1.6% of all inpatient hernia procedures in 2007 (279 patients) to 21.4% in 2021, proportional utilization of component separation grew. When compared to hernia surgeries done without component separation, the 10-year adjusted surgical recurrence rate following component separation was reduced. The top 5% of surgeons by component separation volume had a decreased rate of operational recurrence when compared to the lowest 95% of surgeons by volume. Overall, although surgeon volume was linked to just a little decrease in recurrence rates, component separation seems to have a protective impact on long-term surgical recurrence.

Source:

Fry, B. T., Schoel, L. J., Howard, R. A., Thumma, J. R., Kappelman, A. L., Hallway, A. K., Ehlers, A. P., O’Neill, S. M., Rubyan, M. A., Shao, J. M., & Telem, D. A. (2024). Long-Term Outcomes of Component Separation for Abdominal Wall Hernia Repair. In JAMA Surgery. American Medical Association (AMA). https://doi.org/10.1001/jamasurg.2024.5091

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Second-Hand Smoke Linked to 20 Percent Increased Lung Cancer Risk in Never-Smokers: Meta-Analysis Confirms

Italy: A recent review, published in European Respiratory Review found that second-hand smoke (SHS) exposure increased the risk of lung cancer by 24% in non-smokers. The risk was higher with greater intensity, longer duration, and more pack-years of exposure.

The researchers note that the highest risk was observed in workplace environments (1.38), followed by a slightly lower risk at home (1.20). They emphasized that prolonged and intense exposure further heightened the likelihood of developing lung cancer.

Lung cancer is the leading cause of cancer-related deaths globally, and research indicates that second-hand smoke exposure is a significant risk factor for lung cancer in individuals who have never smoked. With this in mind, Irene Possenti, Department of Medical Epidemiology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy, and colleagues aimed to provide the most precise assessment of the link between SHS exposure and the increased risk of lung cancer in never-smokers.

For this purpose, the researchers conducted a systematic review and meta-analysis of epidemiological studies examining the link between second-hand smoke (SHS) exposure and lung cancer risk in never-smokers. By employing an innovative method to identify original publications, they included all relevant studies published up to May 2023. Pooled relative risks were calculated using random-effects models, and dose-response relationships were analyzed through log-linear functions or cubic splines to better understand the intensity and duration of exposure’s impact on lung cancer risk.

The study revealed the following findings:

· 126 eligible studies were identified, with 97 original articles included in the meta-analysis.

· The pooled relative risk for lung cancer due to overall SHS exposure was 1.24 (based on 82 studies).

· Setting-specific relative risks for lung cancer were:

  • 1.20 (n=67) for SHS exposure at home.
  • 1.38 (n=30) for SHS exposure in the workplace.
  • 1.37 (n=28) for SHS exposure in both home and workplace settings.
  • 1.27 (n=24) for SHS exposure in nonspecified settings.

· The risk of lung cancer significantly increased with longer duration, higher intensity, and more pack-years of SHS exposure.

“Our meta-analysis offers robust and current evidence highlighting second-hand smoke exposure as a significant risk factor for lung cancer in never-smokers. These findings have crucial public health implications, stressing the importance of raising awareness about the dangers of SHS exposure. It encourages individuals to adopt smoke-free environments, such as smoke-free homes,” the researchers wrote.

“Additionally, policymakers are urged to incorporate these findings into the creation, implementation, and enforcement of comprehensive smoke-free policies, particularly in workplaces, to reduce SHS exposure and mitigate the associated health risks,” they concluded.

Reference:

Possenti I, Romelli M, Carreras G, et al. Association between second-hand smoke exposure and lung cancer risk in never-smokers: a systematic review and meta-analysis. Eur Respir Rev 2024; 33: 240077 [DOI: 10.1183/16000617.0077-2024].

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Women with PCOS have Lower Parity and deliver children later finds study

Researchers have found that women with polycystic ovary syndrome (PCOS) attain lower parity and have a higher odds of having the baby after advanced maternal age than women without PCOS. The relationship is also linked to greater risks of complications in pregnancy, including gestational diabetes. A recent study was conducted by Dr. Maria and colleagues and was published in the American Journal of Obstetrics and Gynecology.

PCOS is one of the most common endocrine disorders affecting women of reproductive age. Many implications of the disorder are already well-documented regarding fertility and early reproductive years, but little is known about reproductive outcomes at the end of the reproductive lifespan in women with PCOS. Thus, the purpose of the study was to fill this gap by comparing maternal age, parity, and pregnancy-related complications between women with and without PCOS.

This analysis utilized the Australian Longitudinal Study on Women’s Health, a prospective population-based cohort followed up every three years from 1996 to 2021. The women were aged 18 to 23 years at the commencement of the study and followed up until they turned 43 to 48 years of age. PCOS diagnoses were assessed based on self-report.

Women with PCOS: n=981 (9.9%)

Women without PCOS: n=13,266

The researchers analyzed reproductive outcomes, such as parity, maternal age at childbirth, and pregnancy complications.

Key Findings

Parity and Nulliparity:

  • Women with PCOS had fewer births than women without PCOS (1.7 ± 1.3 vs. 1.9 ± 1.2; p<0.001).

  • The nulliparity rate was higher for women in the PCOS group (23% vs. 18%; p=0.003).

Maternal Age:

  • The first birth occurred among women with PCOS at a higher maternal age compared to women without PCOS (29.5 ± 5.5 vs. 28.8 ± 5.5 years; p<0.001).

  • Age at second birth was also higher (32.1 ± 5.2 vs. 31.1 ± 5.0 years; p<0.001).

Odds of Advanced Maternal Age:

  • PCOS increased the odds of advanced maternal age at first birth by 40% (aOR: 1.40; 95% CI: 1.10–1.80).

  • Late PCOS diagnosis nearly doubled the odds of advanced maternal age (aOR: 1.98; 95% CI: 1.22–3.22).

Pregnancy Complications:

  • The results revealed that PCOS is associated with a higher risk of gestational diabetes (aOR: 3.90; 95% CI: 2.99–5.10).

  • For type 2 diabetes, no association was found (aOR: 0.81; 95% CI: 0.43–1.50) nor for hypertension (aOR: 0.78; 95% CI: 0.59–1.03).

In comparison to the average population of women, those affected with PCOS encounter lower parity, delayed childbearing, and greater complications associated with bearing. Early diagnosis and targeted interventions are considered as crucial in managing such difficulties, particularly those concerning the risks associated with advanced maternal age. Those presenting with PCOS require ongoing monitoring and tailored reproductive care.

Reference:

Forslund, M., Teede, H., Melin, J., Tay, C. T., Loxton, D., & Joham, A. E. (2024). Fertility and age at childbirth in Polycystic Ovary Syndrome: Results from a longitudinal population-based cohort study. American Journal of Obstetrics and Gynecology. https://doi.org/10.1016/j.ajog.2024.11.010

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Switching to E-Cigarettes or Quitting Reduces Cardiac Risks After PCI

Researchers have found that patients with coronary artery disease (CAD) who had transitioned entirely to e-cigarettes or quit smoking altogether after percutaneous coronary intervention (PCI) had fewer major adverse cardiac events (MACE) compared to those who continued smoking combustible cigarettes. A recent study was conducted by Danbee Kang and colleagues which was published in the European Heart Journal.

Smoking is a major modifiable risk factor for cardiovascular disease, including coronary artery disease. Quitting smoking has been shown to improve the outcome, but how E-cigarettes serve as an alternative remains unclear. In this study, researchers examined whether switching to E-cigarettes has an impact on post-PCI outcomes, specifically on the risk of MACE.

Grouping from the Korean National Health Insurance database, 17,973 adult smokers (≥20 years) who underwent PCI and had completed health screens within 3 years before and after PCI. Participants were categorized into three groups:

  • Continued combustible cigarette users (49.8%, n=8,951).

  • Switchers to E-cigarettes (9.4%, n=1,694).

  • Subdivided into dual users and exclusive E-cigarette users.

  • Successful quitters (40.7%, n=7,328).

MACE incidence:

  • Continued combustible cigarette smokers: 17%.

  • E-cigarette switchers: 10%.

  • Successful quitters: 13.4%.

Adjusted hazard ratios for MACE:

  • E-cigarette switchers: 0.82 (95% CI: 0.69–0.98).

  • Successful quitters: 0.87 (95% CI: 0.79–0.96).

Dual users compared with exclusive E-cigarette users:

  • Exclusive e-cigarette use was strongly associated with reduced risk of MACE compared with dual use (HR: 0.71; 95% CI: 0.51-0.99).

Among smokers with PCI for CAD, smoking cessation and switching to e-cigarettes were both associated with less risk for MACE. These results show that smoking treatments which may improve the outcome in patients after PCI are necessary.

Reference:

Kang, D., Choi, K. H., Kim, H., Park, H., Heo, J., Park, T. K., Lee, J. M., Cho, J., Yang, J. H., Hahn, J.-Y., Choi, S.-H., Gwon, H.-C., & Song, Y. B. (2024). Prognosis after switching to electronic cigarettes following percutaneous coronary intervention: a Korean nationwide study. European Heart Journal. https://doi.org/10.1093/eurheartj/ehae705

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Replacing animal products with plant-based foods tied to 92% reduction in hot flashes in postmenopausal women, finds new study

Replacing meat and dairy products with plant-based foods, both “healthy” and “unhealthy” as defined by the plant-based index, leads to weight loss and a reduction of hot flashes in postmenopausal women, according to new research by the Physicians Committee for Responsible Medicine published in BMC Women’s Health.

“Simply replacing meat and dairy products with plant-based foods can lead to weight loss and a reduction in hot flashes in postmenopausal women,” says Hana Kahleova, MD, PhD, a co-author of the paper and director of clinical research at the Physicians Committee for Responsible Medicine.

The new research is a secondary analysis of data from a Physicians Committee study published in the journal Menopause. In the study, 84 postmenopausal women reporting two or more moderate-to-severe hot flashes daily were randomly assigned to either the intervention group that was asked to follow a low-fat vegan diet, including a half cup cooked soybeans a day, or to the control group that continued their usual diets for 12 weeks.

The new analysis assessed the association of a plant-based index (PDI), healthful plant-based index (hPDI), and unhealthful plant-based index (uPDI), with changes in hot flashes. The PDI measures adherence to a plant-based diet in general, the hPDI includes more fruits, vegetables, grains, and beans, and the uPDI includes more foods such as refined grains and fruit juices. The scores of all three indexes are higher with increased consumption of plant-based foods and reduced consumption of animal products.

In the new analysis, all three scores increased in the vegan group, compared with no change in the control group. Both the “healthy” and “unhealthy” plant-based indices-hPDI and uPDI-were associated with weight loss and a reduction in hot flashes. Severe hot flashes were reduced by 92% in the vegan group and did not change significantly in the control group. Participants in the vegan group also lost an average of 3.6 kilograms (about 8 pounds), while the control group lost an average of 0.2 kilograms (about half a pound).

The authors say that the results of the analysis suggest that consuming even the so-called “unhealthy” plant-based foods, as defined by the plant-based index, may lead to weight loss when they replace animal products. For example, fruit juices, refined grains, and potatoes, which are all included on the uPDI, are higher in carbohydrates and lower in fat than meat, dairy products, and eggs; carbohydrates have only 4 calories per gram, while fat has 9 calories per gram.

“The good news is that our new analysis helps clarify that even plant-based foods that are defined as “unhealthy” by the plant-based index are better than animal products in terms of weight loss and reduction in hot flashes,” says Dr. Kahleova. “If you want to lose weight, fight hot flashes, or improve other diet-related conditions like type 2 diabetes and heart disease, it’s always best to choose the plant-based option over animal products.”

Reference:

Brennan, H., Znayenko-Miller, T., Sutton, M. et al. Diet quality, body weight, and postmenopausal hot flashes: a secondary analysis of a randomized clinical trial. BMC Women’s Health 24, 620 (2024). https://doi.org/10.1186/s12905-024-03467-4

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Frailty Assessment Helps Predict Dementia Risk Long Before Symptoms Emerge, claims research

Researchers found nearly 30,000 older adults from the United States and the United Kingdom in a new study found frailty as a precursor to future risk of dementia. Tracking frailty trajectories from 1997 to 2024 the researchers came to learn that participants who were more frail had a higher likelihood of getting dementia years before cognitive symptoms appeared. This study was published in JAMA Neurology.

Frailty is an age-related condition characterized by the decline in the resilience of multiple body systems and therefore contributes to increased vulnerability to adverse health events. This paper, by David Ward, PhD, of the University of Queensland, addressed how frailty levels may be related to dementia risk independently of age. Assessments of frailty, which measure health deficits such as joint pain, vision loss and cardiovascular problems, might help clinicians more clearly identify dementia risk based on their diagnosis of the acceleration of physical health decline occurring before cognitive decline.

This study was done using data obtained from four of the most important longitudinal studies: the English Longitudinal Study of Aging, the Health and Retirement Study, the Rush Memory and Aging Project, and the NIH’s National Alzheimer’s Coordinating Center. The participants consisted of 29,849 individuals aged 60 and older who were cognitively unimpaired at baseline. Examination of the follow-up periods, with a median range of 5 to 10 years, thereby showing how frailty progresses over time and how it relates to the onset of dementia later on.

The frailty index scores were developed and validated for each cohort, retrospectively calculated to assess frailty, including over 50 health deficits, from vision loss to hearing loss, from osteoarthritis to atrial fibrillation. Every 0.1 increase in frailty index score added 4-5 health deficits. Importantly, cognition-related deficits were excluded from these indices to avoid confounding dementia risk with the presence of existing cognitive impairment.

  • This study took place over 257,963 person-years of follow-up, where 3,154 patients developed dementia.

  • Adjusted hazard ratios (HRs) for dementia were between 1.18 (95% CI 1.13-1.24) and 1.73 (95% CI 1.57-1.92), with frailty stages drastically increasing from 4 to 9 years before the onset of dementia.

  • Women had a higher level of frailty compared to men who eventually developed dementia.

  • For each 0.1-point increase in the frailty index, the risk of dementia was increased (HRs between 1.18 and 1.43). Accumulation of health deficits was an independent risk factor underlying many other covariates.

Frailty is a significant risk factor for a quicker onset of dementia risk, and thus its implications hint toward proactive prevention in health management. Routine assessment in health care would also identify more at-risk people and reduce chances of dementia, thus opening earlier opportunities for interventions and targeted preventive dementia strategies.

Reference:

Ward, D. D., Flint, J. P., Littlejohns, T. J., Foote, I. F., Canevelli, M., Wallace, L. M. K., Gordon, E. H., Llewellyn, D. J., Ranson, J. M., Hubbard, R. E., Rockwood, K., & Stolz, E. (2024). Frailty trajectories preceding dementia in the US and UK. JAMA Neurology. https://doi.org/10.1001/jamaneurol.2024.3774

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Study Reveals Increased Stiffness in Deep Lumbar Multifidus Muscle in Athletes with Chronic Low Back Pain

Hong Kong: Research published in the Archives of Physical Medicine and Rehabilitation highlights using shear-wave elastography to measure tissue stiffness in athletes with low-back pain (LBP). The study, led by Siu Ngor Fu, PhD, from the Hong Kong Polytechnic University, found that athletes with low-back pain exhibited increased stiffness in the deep lumbar multifidus (DLM) muscle. At the same time, those involved in sports requiring significant back extension had higher stiffness in the superficial lumbar multifidus (SLM) muscle.

The researchers suggest that rehabilitation for chronic low-back pain should focus on reducing stiffness in the DLM through targeted interventions. Additionally, they recommend sport-specific conditioning programs to address SLM stiffness, which can help prevent injuries and improve athletic performance. The findings underscore the importance of tailoring rehabilitation and conditioning strategies to the specific muscle layer affected by low-back pain and the demands of the sport.

Elevated stiffness in the lumbar multifidus has been noted in individuals with chronic low back pain. However, the differential modulation of stiffness in the deep (DLM) and superficial (SLM) layers of the lumbar multifidus, given their distinct structural roles and functions, has not been fully explored, particularly in athletes. To address this gap, the researchers aimed to compare the stiffness of the DLM and SLM in professional athletes from various sports, both with and without chronic LBP.

For this purpose, the researchers conducted a cross-sectional study at a provincial sports training centre. Ninety-nine professional athletes (aged 18-27 years) from weightlifting, badminton, and track and field teams were recruited, with 38 experiencing chronic bilateral low back pain. Ultrasound shear wave elastography (SWE) was used to measure the Young’s modulus (a stiffness indicator) of the deep lumbar multifidus (DLM) and superficial lumbar multifidus (SLM) at the L4/5 facet joint level. A two-way analysis of variance was performed to examine the effects of chronic LBP and sport type on DLM and SLM stiffness while accounting for relevant confounders.

The key findings of the study were as follows:

  • Athletes with chronic low back pain exhibited significantly higher deep lumbar multifidus (DLM) stiffness compared to pain-free athletes.
  • DLM stiffness was increased by 17.73% on the dominant side (mean difference [MD] = 2.52kPa) and by 13.54% on the non-dominant side (MD = 1.83kPa).
  • Superficial lumbar multifidus (SLM) stiffness showed significant variation among the three athlete groups.
  • Post-hoc analyses revealed that weightlifters had significantly higher SLM stiffness on the non-dominant side than badminton players (by 51.76%, MD = 8.97kPa) and track and field athletes (by 72.01%, MD = 11.01kPa).

“Chronic low back pain and the type of sport significantly influence multifidus muscle stiffness, highlighting the importance of targeted clinical assessments and reconditioning strategies. These should focus on the deep lumbar multifidus for those with chronic LBP and the superficial lumbar multifidus for athletes engaged in trunk extension-intensive sports,” the researchers concluded.

Reference: https://www.archives-pmr.org/article/S0003-9993(24)01353-4/abstract

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Sediflù Syrup Effective and Safe for Managing Pediatric Cough, Study Finds

Spain: A recent clinical trial, SEPEDIA, has highlighted the efficacy and safety of SEDIFLÙ syrup in managing cough symptoms among children. The study, published in Clinical Pediatrics, indicated that Sediflù syrup is a viable option for managing cough in younger children with upper respiratory tract infections, effectively reducing the duration of symptoms.

Coughing, a common symptom of upper respiratory tract infections (URTIs), significantly impacts children’s quality of life, often disrupting sleep and causing distress. URTIs, highly recurrent in children, can lead to persistent coughs lasting beyond three days, requiring effective management to relieve symptoms without hindering natural recovery.

SEDIFLÙ syrup, a medical device combining natural ingredients like eucalyptus honey and herbal extracts, offers a dual action: mucolytic effects for productive coughs and a demulcent effect for dry coughs. By forming a protective barrier, increasing saliva production, and reducing inflammation, it soothes mucosa and alleviates the cough reflex, promoting faster symptom relief.

Against the above background, Ester Risco, Unitat de Farmacologia, Farmacognòsia i Terapèutica, Facultat de Farmàcia, Universitat de Barcelona, Barcelona, Spain, and colleagues aimed to evaluate the efficacy of Sediflù, a medical device formulated with active herbal ingredients, in managing nocturnal and diurnal persistent coughs in children lasting 3 to 7 days.

For this purpose, the researchers conducted a prospective, interventional, multicenter, placebo-controlled, double-blind, randomized clinical study involving children with dry and/or productive coughs. The study assessed the clinical efficacy of Sediflù by evaluating its soothing effects on coughing during both day and night. Additionally, the researchers examined the impact of coughing on sleep-related outcomes, including cough frequency, the child’s sleep quality, parental sleep quality, and overall symptom severity.

Study Results on Sediflù Efficacy and Safety

Baseline Characteristics

  • 60 children with dry/productive cough were recruited; 56 completed the study (Sediflù: 27, Placebo: 29).
  • Mean age: 8.65 years.
  • Gender distribution: 53% boys, 47% girls.

Efficacy of Sediflù

  1. Cough Scores
    • Significant reduction in night-time and day-time cough scores in the Sediflù group from Day 2 (D2) to Day 7 (D7) than baseline.
    • Sediflù group had a 28%-71% lower night-time scores and 22%-71% lower day-time scores than the placebo group across D3-D7.
  2. Sleep-Related Variables
    • Nocturnal variables (frequency, severity, bothersomeness, child and parental sleep quality) were significantly improved from D2 to D7.
    • By D7, Sediflù reduced frequency by 89%, severity by 87%, and bothersomeness by 87% compared to baseline.
    • Child’s sleep quality improved by 89%, and parental sleep quality by 92%.
  3. Severe Cough Subgroup
    • There were significant reductions in frequency and severity scores from D1 in children with severe cough.
    • At D7, Sediflù showed 51%-70% improvement across all variables compared to placebo.

Safety

  • No adverse effects were observed in either group.

The study showed that Sediflù syrup effectively alleviates disturbances associated with day-time and night-time cough, significantly reducing cough severity and frequency from the first day of treatment. It also shortens the duration of coughs in children while demonstrating an excellent safety profile.

“These results support Sediflù as a reliable treatment option for managing cough, particularly in younger children with upper respiratory tract infections. Its efficacy is attributed to the formation of a protective mechanical barrier on the oropharyngeal mucosa, combined with complementary physicochemical effects,” the researchers concluded.

Reference:

Núñez C, Chiatti MC, Tansella F, Coronel-Rodríguez C, Risco E. Efficacy and tolerability of SEDIFLÙ in treating dry or productive cough in the pediatric population (SEPEDIA): A pilot, randomized, double-blind, placebo-controlled, multicenter clinical trial. Clin Pediatr (Phila). 2024 Nov;63(11):1510-1519. doi: 10.1177/00099228241228074. Epub 2024 Feb 7. PMID: 38323572; PMCID: PMC11468240.

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