Colloidal Nano Silver Gel effective and safe in treating bacterial vaginosis and vulvovaginal candidiasis: IJOGR

Vaginal infections, often termed “Infectious
Vaginitis,” are common concerns for women across the lifespan, with a
higher prevalence among women of reproductive age. It is the most frequent
reason for women to seek medical attention. Although these infections are not
associated with significant mortality, they are often associated with high
levels of anxiety and have a negative impact on sexual life, self-esteem, and
quality of life. The more prevalent vaginal infections are caused by
disturbances in the natural vaginal microbiome. The normal vagina flora is
characterized by the dominance of lactic acid producing bacteria, especially
Lactobacillus spp., which help to maintain an acidic pH of vaginal fluids
within the range of 3.5-4.5. Along with lactobacilli, a healthy, acidic
premenopausal vagina also contains a heterogeneous mixture of Gardnerella
vaginalis, Escherichia coli, group B streptococcus (GBS), genital Mycoplasma
species, Candida albicans, and other species.

The most commonly documented cause of vaginitis is bacterial
vaginosis (BV). BV is characterized by a dramatic switch of vaginal bacterial
flora from normal predominant Lactobacilli to a polymicrobial flora. Vulvovaginal
candidiasis (VVC) is the second most common vaginal infection, while trichomoniasis,
caused by Trichomonas vaginalis, is the most common non-viral sexually
transmitted infection. True mixed infection rarely occurs in women with
vaginitis, but coinfection occurs much more frequently. Coinfection with
Candida species is observed in about 20%-30% of women with BV. The coinfection
rates of BV pathogens and trichomoniasis are even more prevalent. Other
etiologies of vaginitis include vulvar skin diseases, desquamative inflammatory
vaginitis, and genitourinary syndrome of menopause.

Despite the availability of numerous oral, topical, and
intravaginal medications for the treatment of vaginal infections, their
management remains challenging. Associated side effects, development of
resistance, lack of prevention and destruction of biofilms, and higher
recurrences are the limitations of currently available conventional therapies.
Ineffectiveness due to poor penetration and rapid removal from the vaginal
canal are the major hurdles in achieving infection cure with local
antimicrobial therapies. There is a need to develop newer therapeutic options
for treating vaginal infections that overcomes the limitations of current
therapies.

During the last decades, nanotechnologies-based
formulations, such as nanoparticles, have been explored to overcome the
limitations of current therapies for vaginal infections. These novel
formulations can improve local drug delivery, biodistribution, retention, and
uptake in vulvovaginal tissues. Other important benefits nanotechnology-based
formulations offer are reduced toxicity, enhanced patient compliance, and
improved treatment outcomes.

The study by Dani, Godbole and Mehta evaluated the efficacy
and safety of colloidal nano silver gel (SilverSol® Vagigel) (A patented
technology from American Biotech Labs, USA) in combination with 0.2% lactic
acid in the female subjects for the treatment of vaginal infections.

This study was a multicenter, randomized, double-blind,
placebo-controlled pilot study in which post-menarchal female subjects between
18 and 65 years of age clinically diagnosed with bacterial vaginosis and
vulvovaginal candidiasis were enrolled. The participants were randomized to
receive treatment with SilverSol® Vagigel or placebo (vehicle) gel (both
treatments as one 4 gm application inserted into the vagina with an applicator
device, once daily at bedtime for internal use and 2 gm gel for local
application to the vulva and vagina for external use twice daily for a period
of 14 days). The primary endpoint evaluated was the proportion of subjects
achieving clinical cure. The secondary endpoint was the proportion of subjects
achieving microbiological cure at the end of the study visit.

A total of 57 subjects were randomized in the study out of
which 38 subjects were randomized in SilverSol® Vagigel arm and 19 subjects
were randomized in placebo arm. SilverSol® Vagigel significantly improved cure
rates of vaginal infections compared to placebo.

The proportion of subjects achieving clinical cure of
vaginal infections was higher i.e., 33 (86.84%) subjects in SilverSol® Vagigel
arm compared to 07 (41.18%) subjects in Placebo gel arm (p-value: 0.0009).

The clinical cure rate with SilverSol® Vagigel was 81.82%
(P=0.1758) for bacterial vaginosis and 92.59% (P=0.0010) for vulvovaginal
candidiasis patients at the end of the study.

Overall SilverSol® Vagigel treatment resulted in a
significantly higher microbial cure of vaginal infections (P=0.0028) compared
to placebo, with a microbial cure rate of 100% for bacterial vaginosis
(P=0.0330) and 85.19% for vulvovaginal candidiasis (P=0.0097).

No adverse events were reported in subjects treated with
SilverSol® Vagigel.

In this study, SilverSol® Vagigel was effective and safe in
treating the most common vaginal infections i.e. bacterial vaginosis and
vulvovaginal candidiasis. Overall, the findings of this study, combined with
the existing body of evidence, indicate that SilverSol® Vagigel may represent a
valuable addition to the armamentarium of available therapies for vaginal
infections, offering potential benefits for patients in terms of improved
outcomes and reduced side effects. Overall, SilverSol Vagigel represents an
excellent advancement in women’s health, offering a highly effective and safe
solution for treating vaginal infections. Leveraging the exceptional antibacterial,
antiviral, antifungal, andimmune-enhancing properties of SilverSol®, SilverSol®
Vagigel formulation can emerge as a promising therapeutic option for treating a
wide range of vaginal infections and delivering unparalleled safety and
efficacy in addressing diverse feminine health concerns.

Source: Dani, Godbole and Mehta / Indian Journal of
Obstetrics and Gynecology Research 2024;11(1):83–89;
https://doi.org/10.18231/j.ijogr.2024.015

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Hyperlipasemia immediately after pancreatic resections may predict pancreatic fistula, reveals study

Hyperlipasemia immediately after pancreatic resections may predict pancreatic fistula, reveals study published in the Surgery.

Postoperative pancreatic fistula is the most common severe complication after pancreatic surgery. It associated with increased morbidity and prolonged hospital stay. Identifying patients at low risk for postoperative pancreatic fistula is essential to enable timely removal of drains and facilitate early discharge. Although postoperative hyperamylasemia is linked to postoperative pancreatic fistula, the role of postoperative hyperlipasemia remains unclear.

This study aims to investigate the role of postoperative hyperlipasemia in predicting postoperative pancreatic fistula B/C pancreaticoduodenectomy and distal pancreatectomy. The study included 471 patients who underwent pancreaticoduodenectomy and distal pancreatectomy at our institution between January 1, 2019, and February 28, 2023. Postoperative hyperamylasemia and postoperative hyperlipasemia were defined as values above the upper limit of normal established at our institution.

Results: In univariate analysis, postoperative hyperlipasemia and postoperative hyperamylasemia on postoperative day 0 demonstrated the strongest association with postoperative pancreatic fistula B/C. Consequently, a subset of 177 patients with available serum lipase and amylase data underwent further investigation. Besides body mass index and high-risk pathology, both postoperative hyperlipasemia and postoperative hyperamylasemia on postoperative day 0 emerged as independent risk factors for postoperative pancreatic fistula B/C in univariate analysis.

In multivariate analysis, postoperative hyperlipasemia on postoperative day 0 emerged as a significant predictor of postoperative pancreatic fistula B/C, with body mass index as independent risk factor of postoperative pancreatic fistula B/C. The absence of postoperative hyperlipasemia on postoperative day 0 could potentially serve as an effective diagnostic tool for identifying patients who are at a low risk of developing postoperative pancreatic fistula B/C after pancreaticoduodenectomy and distal pancreatectomy. Consequently, not only serum amylase, but also serum lipase can be integrated into clinical practice alongside other relevant parameters

Reference:

Ughur Aghamaliyev, Ganildo Cepele, Felix O. Hofmann, Mathilda Knoblauch, Claudius Kessler, Alexander Crispin, Maximilian Weniger, Joachim Andrassy, Bernhard W. Renz, Jens Werner. Hyperlipasemia in the immediate postoperative period predicts postoperative pancreatic fistula after pancreatic resections, Surgery, 2024, ISSN 0039-6060. https://doi.org/10.1016/j.surg.2024.09.005.

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Pressure-Mediated Biofeedback Enhances Pelvic Floor Training for Stress Urinary Incontinence, finds study

China: A new randomized clinical trial has shown that combining pressure-mediated biofeedback (BF) with pelvic floor muscle training (PFMT) is more effective in treating stress urinary incontinence (SUI) than PFMT alone.

The findings, published in JAMA Network Open, support using pressure-mediated biofeedback devices to enhance treatment outcomes for patients with stress urinary incontinence.

Stress urinary incontinence, a common condition in which patients experience involuntary leakage of urine during physical activity or stress, often results from weakened pelvic floor muscles. Pelvic floor muscle training has long been the standard conservative treatment for SUI, focusing on strengthening the muscles to improve bladder control. However, there is a need for more evidence on whether adjunctive methods would provide additional benefits.

Against the above background, Xiuqi Wang, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, China, and colleagues aimed to compare the effectiveness of PFMT with and without the use of a home-based pressure-mediated biofeedback device.

For this purpose, the researchers conducted a multicenter, assessor-blinded randomized clinical trial in five obstetric clinics in China. Eligible women with new-onset postpartum SUI were enrolled between March 28, 2022, and October 13, 2023. Participants received three months of supervised pelvic floor muscle training and were randomized to either the intervention group (PFMT with a home-based pressure-mediated biofeedback device) or the control group (home-based PFMT).

Primary outcomes included urinary incontinence severity, and secondary outcomes included cure rates, pelvic floor muscle strength, quality of life, self-efficacy, and adherence.

The study led to the following findings:

  • A total of 452 participants (median age 34 years; median body mass index 23.71; median time since delivery 50 days) were included in the analysis, with 223 in the intervention group and 229 in the control group.
  • The intervention group showed significantly greater improvements compared to the control group, including a larger reduction in incontinence severity (median, 3.00 versus 2.00 points), a higher cure rate (20.2% versus 8.7%), and a greater improvement rate (59.2% versus 44.5%).
  • Pelvic floor muscle strength was significantly higher in the intervention group (median, 26.00 versus 21.00 cm H2O), and there was a stronger correlation between subjective and objective adherence (r = 0.825 versus r = 0.627).

This randomized clinical trial found that a 3-month supervised, home-based pressure-mediated biofeedback training for postpartum stress urinary incontinence was more effective than pelvic floor muscle training alone. The intervention showed a stronger correlation between self-reported and video-recorded adherence.

“These results suggest that pressure-mediated BF devices allow clinicians to closely monitor patients, potentially easing the burden on healthcare systems. Importantly, the study provides further support for incorporating pressure-mediated BF as an adjunct to PFMT to enhance treatment outcomes for SUI patients,” the researchers concluded.

Reference:

Wang X, Qiu J, Li D, et al. Pressure-Mediated Biofeedback With Pelvic Floor Muscle Training for Urinary Incontinence: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(11):e2442925. doi:10.1001/jamanetworkopen.2024.42925

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Otolaryngology Surgical Patients: Study Reveals Low VTE Risk with Simplified Risk Assessment Models

USA: Recent research published in The Laryngoscope journal has shed light on venous thromboembolism (VTE) risk in patients undergoing otolaryngology surgeries. It reveals that this patient population generally faces a low risk of postoperative complications related to blood clots.

“Patients undergoing otolaryngology surgery have a low risk of postoperative VTE, with only two cases reported among 869 individuals studied. These findings support using shorter and simpler risk assessment models (RAMs) such as COBRA and Pannucci-NSQIP as effective alternatives to the more complex Caprini score for identifying ambulatory patients at risk,” the researchers reported. 

Venous thromboembolic events are a significant concern after surgery, contributing to complications, longer hospital stays, and higher healthcare costs. Current guidelines for prevention focus on the 2005 Caprini score, a tool designed to identify patients at risk for VTE. Although the Caprini RAM has been validated in various surgical specialties, most otolaryngology procedures are performed on an outpatient basis.

To address this, simpler RAMs like the COBRA scoring system and Pannucci-NSQIP have emerged. The study evaluates how well these three models—Caprini, COBRA, and Pannucci-NSQIP—stratify risk among patients undergoing otolaryngology surgeries. Rachel E. Weitzman, Department of Otolaryngology-Head and Neck Surgery, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, U.S.A., and colleagues aimed to determine the most effective approach to assess VTE risk in this patient population.

For this purpose, the researchers conducted a retrospective chart review of 869 patients who underwent surgery by Weill Cornell faculty otolaryngologists between June and December 2022. They collected data on patient demographics, VTE risk factors, admission status, types of surgeries, and postoperative events. Risk assessment model scores were calculated for each patient.

To evaluate differences in VTE risk scores, the researchers used Wilcoxon and Kruskal–Wallis rank-sum tests based on the type of procedure and admission status. They applied Spearman’s correlation to examine the agreement between the three scoring systems—Caprini, COBRA, and Pannucci-NSQIP. Additionally, multivariate linear regression analyses were conducted to identify which variables influenced the scores of the Caprini, COBRA, and NSQIP RAMs.

The following were the key findings of the study:

A total of two patients experienced postoperative venous thromboembolism.

There is a strong positive correlation between the Caprini and COBRA RAMs, even when analyzed by admission status; however, this correlation weakens in the inpatient group.

A moderate positive correlation exists between the Caprini and Pannucci-NSQIP RAMs across the entire patient cohort, but this correlation is not observed within the inpatient population.

“Patients undergoing otolaryngology surgery have a low risk of experiencing postoperative VTE. The Caprini, Pannucci-NSQIP, and COBRA risk assessment models effectively identify ambulatory patients at risk for postoperative VTE. Notably, simpler models like COBRA and Pannucci-NSQIP can serve as practical alternatives to the more complex Caprini RAM,” the researchers concluded.

Reference:

Weitzman, R. E., Zhao, K., Sclafani, M. S., Srinivasan, Y., Stein, E., Cole, A., & Sclafani, A. P. Venous Thromboembolism Risk Assessment in Inpatient and Ambulatory Otolaryngology Surgical Patients. The Laryngoscope. https://doi.org/10.1002/lary.31856

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Study Reveals Increased Risk of Myocardial Infarction in Cold Weather for MINOCA Patients

China: A recent nationwide study conducted in China has unveiled a significant link between low ambient temperatures and the incidence of myocardial infarction, particularly in patients with Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA).

The research, published in the European Heart Journal, revealed that cold weather may increase the susceptibility to myocardial infarction with non-obstructive coronary arteries compared to myocardial infarction resulting from obstructive coronary artery disease.

Myocardial infarction, commonly known as a heart attack, occurs when blood flow to the heart is severely reduced or blocked, leading to damage in the heart muscle. Traditionally, MI is associated with obstructive coronary artery disease, characterized by plaque buildup in the arteries. However, patients with MINOCA experience heart attacks despite the absence of significant blockages, suggesting that other factors contribute to their condition. One such factor is non-optimal ambient temperature, recognized as a significant non-traditional risk factor for acute MI. However, there is limited understanding of how low temperatures may differentially affect myocardial infarction with obstructive coronary artery disease (MI-CAD) and MINOCA patients.

To fill this knowledge gap, Renjie Chen, Fudan University, Shanghai, China, and colleagues conducted a nationwide, time-stratified, case-crossover investigation from 2015 to 2021 using the Chinese Cardiovascular Association database- chest Pain Center Registry. Meteorological data were sourced from a well-established satellite-based model, with daily exposure levels assigned based on each patient’s onset of myocardial infarction. A conditional logistic regression model, integrated with distributed lag non-linear models spanning 10 days, was employed to assess the exposure-response relationships.

The study led to the following findings:

  • A total of 83,784 MINOCA patients and 918,730 MI-CAD patients participated in the study.
  • The risk of both conditions related to low temperatures was evident starting at a 2-day lag and continued for up to 1 week.
  • Extremely low temperatures were linked to a notably higher odds ratio (OR) for MINOCA, with an OR of 1.58, compared to MI-CAD, which showed an unmatched OR of 1.32 and an equally matched OR of 1.25 when adjusted for age and sex, using reference temperatures of 30°C, 35°C, and 30°C.
  • Stronger associations with MINOCA were identified among patients aged ≥65, females, and those living in the southern regions.
  • There were no significant differences in the effects of high temperatures on MINOCA versus MI-CAD.

“The nationwide study emphasizes the heightened vulnerability of MINOCA patients to low ambient temperatures in contrast to MI-CAD patients,” the researchers concluded.

Reference:

Huang, J., He, Q., Jiang, Y., Wong, J. M., Li, J., Liu, J., Wang, R., Chen, R., Dai, Y., & Ge, J. Low ambient temperature and incident myocardial infarction with or without obstructive coronary arteries: A Chinese nationwide study. European Heart Journal. https://doi.org/10.1093/eurheartj/ehae711

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Study Evaluates Propofol Wastage Reduction Strategies in Total Intravenous Anesthesia

A recent study found that syringe pump induction of propofol
significantly reduced the wastage compared to manual induction across patient
groups. The study results were published in the British Journal of Anesthesia.

Climate change is a serious public health issue and hence new
strategies have to be developed for sustainable healthcare practices. Among the
hospitals, Anesthesia and intensive care are noted for high resource and energy
consumption contributing heavily to hospital waste. Hence, Associations like
the Association of Anaesthetists of Great Britain and Ireland and the German
Society for Anaesthesiology have recommended reducing carbon dioxide emissions from
hospitals. Medications like propofol which are commonly used anesthetic agents significantly
contribute to medication waste from the hospitals. Total intravenous anesthesia
(TIVA) uses both induction and maintenance of anesthesia by using propofol.
Maintenance of TIVA is commonly achieved using an automated syringe pump,
whereas induction is achieved either manually using a separate syringe or by
programming a bolus through the syringe pump. Hence, current protocols suggest
using smaller vials and prediction tools to reduce the wastage of propofol in
hospital settings. As there is limited data on effective methods of using these,
researchers conducted a retrospective study to investigate the amount of
propofol wastage using either of the induction methods.

A retrospective analysis was carried out by including adult
patients (≥18 years) undergoing TIVA at the University Hospital Bonn. Data was
collected on the complete anesthetic and waste documentation from both paper
and electronic anesthesia records by recording anesthetic duration, patient
characteristics, substance use, and propofol administered. Induction was done with
a separate syringe for manual induction or by a bolus programmed on an
automated syringe pump for induction and maintenance. The primary endpoint was
total propofol waste during surgery including the unused amounts in the syringe
and pump.

Results:

  • Syringe
    pump induction was associated with 32.8% less waste of propofol (P<0.001)
    than manual method.
  • This
    reduction was most pronounced in procedures lasting 20–60 min (up to 46.9% less
    in procedures lasting 20–40 min, P<0.001) and 80–120 min (up to
    48.8% less in procedures lasting 100–120 min, P=0.003).
  • Variables
    like biological sex, age, weight, BMI, or ASA physical status did not affect
    the amount of wastage.
  • Syringe
    pump induction was consistently associated with less waste, except in patients
    with obesity.
  • Patients
    with active substance use had 27.6% more waste with manual induction (P=0.031)
    but not with syringe pump induction.
  • In
    patients with and without active substance use, syringe pump induction resulted
    in less waste (substance use: 48.7% less, P=0.0015; without
    substance use: 22.7% less, P=0.0045).

Thus, the study concluded that Syringe pump induction reduced
propofol waste during TIVA, regardless of patient characteristics. This
method could be a more sustainable, cost-effective method considering the
impact of manual induction on the environment.

Further reading: Windler F, Coburn M, Bette B, Fingerhut D,
Jacobi A, Kruse P. Effects of manual and syringe pump induction of total
intravenous anaesthesia on propofol waste: a single-centre retrospective
analysis. Br J Anaesth. Published online October 28, 2024.
doi:10.1016/j.bja.2024.10.002

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Low dose clozapine effective in Indians with drug induced tardive dyskinesia and dystonia, finds study

A new study published in the Asian Journal of Psychiatry showed that people of Indian heritage require lower effective dosages of clozapine for drug induced tardive dyskinesia and tardive dystonia when compared to Western populations. Long-term usage of dopamine antagonists can cause delayed-onset movement problems known as tardive syndromes (TS). Clozapine has been recommended for the treatment of TS in earlier research, showing symptom relief in as little as 1 to 3 months. Thus, by examining the clinical records of patients at a tertiary care hospital who first reported with tardive dyskinesia, tardive dystonia, or both, this retrospective study by Sandeep Grover and his team assessed the long-term efficacy of clozapine in treating TS. 

Reduction of symptoms on the Unified Dystonia Rating Scale (UDRS) and Abnormal Involuntary Movement Scale (AIMS) was the main end measure. A total of 66 participants from a larger cohort of 1050 patients who mostly suffered from schizophrenia and a lesser percentage with affective disorders were included in the current study. All of the patients were followed for TS after using antipsychotics for an extended period of time.

  • When commencing clozapine, 69.7% of the subjects had dyskinesia and 74.2% had dystonia, whereas 48.5% of the patients had both tardive dyskinesia and tardive dystonia symptoms. The mean age of this group was 41.83 years, and most of the people were men.
  • The patients had previously been exposed to a variety of antipsychotics, and the majority had received treatment with second-generation antipsychotics such as olanzapine and risperidone. In more than 74% of instances, these interventions were linked to the development of TS.
  • Nearly 72.2% of patients saw a reduction in AIMS scores of at least 50% throughout the roughly 33-month follow-up period, with 66.6% achieving a reduction of at least 75%. Of the patients, 54.5% had complete remission of tardive dyskinesia, while 56.1% had remission of tardive dystonia.

Moreover, the greatest gains were seen in individuals with higher baseline AIMS and UDRS scores. Overall, although the results of this study indicate that the distinction between psychotic disorders and other mental illnesses is not as great as documented in studies from other regions of the world, they do support the use of greater dosages in individuals with psychotic disorders.

Reference:

Grover, S., Chaurasia, N., & Chakrabarti, S. (2024). Management of tardive dyskinesia and tardive dystonia with clozapine: A retrospective study. In Asian Journal of Psychiatry (Vol. 102, p. 104245). Elsevier BV. https://doi.org/10.1016/j.ajp.2024.104245

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Injectable semaglutide may reduce body weight and knee osteoarthritis-associated pain: NEJM

A new study published in the New England Journal of Medicine showed that once-weekly injectable semaglutide led to considerably higher reductions in body weight and knee osteoarthritis pain among patients with obesity and moderate-to-severe pain. It has been shown that losing weight can reduce the discomfort associated with osteoarthritis of the knee. Not much research has been done on how glucagon-like peptide-1 receptor agonists affect the course of osteoarthritis in the knees of obese individuals. Thereby, Henning Bliddal and associates conducted this research to rule out the efficacy of semaglutide in individuals with osteoarthritis and obesity.

A 68-week, double-blind, randomized, placebo-controlled study was carried out at 61 locations throughout 11 nations. In addition to counseling on physical activity and a lower-calorie diet, participants with obesity (defined as a body-mass index [BMI] of ≥30] and a clinical and radiologic diagnosis of moderate knee osteoarthritis with at least moderate pain were randomized, in a 2:1 ratio, to receive once-weekly subcutaneous semaglutide (2.4 mg) or a placebo. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score (which ranges from 0 to 100, with higher scores indicating worse results) and the percentage change in body weight were the main endpoints. The 36-item Short Form Health Survey (SF-36), version 2’s physical-function was a crucial confirmatory secondary end objective, where higher scores denoted more well-being.

There were a total of 407 competitors in all, where the average WOMAC pain score was 70.9, the average age was 56, and the average BMI was 40.3. Women made up 81.6% of the participants overall. Semaglutide caused a mean decrease in body weight of 13.7% from baseline to week 68, while a placebo caused a decrease of 3.2% (P<0.001). At week 68, the average change in the WOMAC pain score was -27.5 points with a placebo and -41.7 points with semaglutide (P<0.001).

The SF-36 physical-function score improved more in the semaglutide group than in the placebo group (mean change, 12.0 points vs. 6.5 points; P<0.001). In both groups, the frequency of severe adverse events was comparable. 3.0% of participants in the placebo group and 6.7% of those in the semaglutide group experienced adverse events that resulted in the permanent cessation of the trial regimen. Whereas, the most frequent cause of termination was gastrointestinal issues. Overall, the findings of this study clearly indicates the positive effects of once-weekly dose of semaglutide in obesity and osteoarthritis based knee pain.

Source:

Bliddal, H., Bays, H., Czernichow, S., Uddén Hemmingsson, J., Hjelmesæth, J., Hoffmann Morville, T., Koroleva, A., Skov Neergaard, J., Vélez Sánchez, P., Wharton, S., Wizert, A., & Kristensen, L. E. (2024). Once-Weekly Semaglutide in Persons with Obesity and Knee Osteoarthritis. In New England Journal of Medicine (Vol. 391, Issue 17, pp. 1573–1583). Massachusetts Medical Society. https://doi.org/10.1056/nejmoa2403664

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Depression, its severity and insufficient sleep quality associated with with asthma: Study

Depression, its severity, poor and insufficient sleep quality associated with with asthma suggests a new study published in the Frontiers in Psychiatry.

Asthma, depression, and sleep problems are three significant public health issues that are closely interrelated. This study aims to explore the relationship between depression, sleep status and asthma, as well as the potential interaction among these conditions and their effects on asthma. This cross-sectional study utilized data from the 2005-2008 National Health and Nutritional Examination Survey, including information on asthma, depression, sleep status and confounding factors. Multivariate logistic regression analyses were conducted to investigate the relationship between depression, sleep status, and asthma. Subgroup analyses were conducted to test the p-interaction between depression and each stratified variable. Additionally, both multiplicative and additive approaches were employed to assess the interaction between depression and sleep status on asthma, as well as to quantify their combined effects. Results: A total of 8,327 participants (mean age 46.53 years) were included in this study. Compared to the individuals without depression, those with depression have an increased risk of asthma [Odds ratio (OR) = 1.57, 95% Confidence interval (CI) = 1.22-2.03], and an increase in the severity of depressive symptoms is associated with a higher risk of developing asthma. Additionally, poor sleep quality, sleep disorders, and insufficient sleep was associated with an increased risk of asthma. Effect modification was observed between depression and PIR status, smoking status, and sleep disorders in relation to asthma (p-interaction <0.05). Moreover, we found a positive interaction between severe depression and excessive sleep (OR = 29.07, 95% CI = 3.24-260.38). Furthermore, we observed the quantitative additive interaction indicators between moderately severe depression and insufficient sleep [Relative excess risk due to interaction (RERI) = 1.63, 95%CI = 0.18-3.83; Attributable proportion (AP) = 0.51, 95%CI = 0.15-0.87; Synergy index (SI) = 3.92, 95%CI = 1.65-23.50] influencing asthma risk. The study revealed distinct associations between depression, the severity of depressive symptoms, poor sleep quality, sleep disorders, and insufficient sleep with asthma. Additionally, there was an interaction between moderately severe depression and insufficient sleep on asthma. Psychological and sleep assessment are essential in asthma management. Clinicians should consider the potential risk of depression and sleep problems in asthma patients and intervene. Further longitudinal research is needed to better understand the pathophysiological mechanisms behind the interactions between asthma, depression, and sleep problems.

Reference:

Lai, Yuxin, et al. “The Interaction Effects Between Depression and Sleep Status On Asthma: a National Cross-sectional Study.” Frontiers in Psychiatry, vol. 15, 2024, p. 1487550.

Keywords:

Depression, severity, poor, insufficient sleep, quality associated, asthma, Lai, Yuxin

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Preventing obesity in very young children could be in palm of parents’ hands, suggests study

A study co-led by a Johns Hopkins Children’s Center clinician-researcher shows that adding text messaging and other electronic feedback to traditional in-clinic health counseling for parents about feeding habits, playtime and exercise prevents very young children from developing obesity and potentially lifelong obesity-related problems.

Findings from the study, which was co-led by Eliana Perrin, M.D., M.P.H., Bloomberg Distinguished Professor of Primary Care at the Johns Hopkins University Schools of Medicine, Nursing and Public Health, will be published in JAMA and presented at the Obesity Society’s “Obesity Week” in San Antonio, both on Nov. 3. The work stems from decades of research showing that having obesity in early childhood significantly increases the risk of lifetime obesity, cardiovascular disease, diabetes and other serious diseases, particularly in low-income and minority populations.

About 1 in 5 school-aged children were affected by obesity in 2017–18, according to the U.S. Centers for Disease Control and Prevention-rates that have only increased during and since the COVID-19 pandemic. Efforts to reduce the rate have relied heavily on in-person interventions by pediatric providers, with limited success.

In an earlier study, also co-led by Perrin, investigators demonstrated that a “health literacy-informed” primary care-based intervention called the Greenlight Program, which Perrin and colleagues at other medical centers developed for parents, improved healthy growth in newborns until 18 months of age, but found that improvements were not sustained at age 2 years.

In an effort to extend the improvements through 2 years of age, when pediatrics office visits become less frequent, the new study focused on using digital technology to reinforce elements of the Greenlight Program, which previously only consisted of written materials and health counseling during primary care visits.

“We found that parents are eager for more information to help their children grow up healthy, and the vast majority of parents own smartphones,” says Perrin, who is also a general pediatrician at the Harriet Lane Clinic at the Children’s Center.

Building on that knowledge, to conduct the new study, which was co-led by Vanderbilt University and five other academic medical institutions, the researchers recruited nearly 900 parent-infant pairs between October 2019 and January 2022 from newborn nurseries or pediatric primary care clinics at Duke University, University of Miami, New York University/Bellevue Hospital Center, University of North Carolina, Stanford University and Vanderbilt University Medical Center.

At the start of the trial, all babies were 21 days old or younger, born after 34 weeks gestation, at a healthy weight, and with no chronic medical conditions that might affect weight gain.

The participants were about 45% Hispanic, 20% white and nearly 16% Black. More than 55% were considered to have limited health literacy based on the Newest Vital Sign, a widely used health literacy screening tool developed by researchers at the University of Arizona, and nearly 16% reported household food insecurity, meaning limited access to healthy food choices.

The infant-parent pairs were randomly sorted into two groups. Both groups received Greenlight Program education, with counseling on healthy nutrition and behaviors from their primary care providers, along with eight educational booklets matching the child’s age at regular well visits, with guidance and goal-setting tips in English or Spanish on feeding, physical activity, sleep and screen time.

Next, half (449) of the infant-parent pairs received personalized, interactive text messages from a fully automated system to support health behavior goals and also access to a web-based “dashboard” designed to help parents keep track of healthy goals.

Goals (such as fewer sugar-sweetened beverages or less screen time) were texted in English or Spanish every two weeks until 2 years of age. Those texts were followed by five automated check-in messages throughout the two weeks. Parents were asked to self-rate their goal progress.

Based on parents’ responses, the automated digital intervention system then provided immediate feedback, tips for addressing challenges and encouragement based on progress.

The researchers found that children of parents who received the digital intervention as well as personal counseling had healthier weight-for-length growth curves over the first two years of life than children of parents who had counseling only, which resulted in an estimated reduction of 0.33 kg/m at the 24-month time point. Researchers say while this doesn’t sound like a lot, it’s consistent with the U.S. Preventive Services Task Force target for effective obesity trials. Also, obesity prevention for the digital group was significant. Some 7% of the digital intervention group had obesity, compared with nearly 13% of the clinic-only group, which is a nearly 45% adjusted relative reduction.

The researchers conclude that their digital intervention led to healthier weight-for-length paths and reduced the incidence of obesity at 2 years of age when added to in-person health counseling.

The investigators say the digital services were effective in populations that traditionally experience the highest risk of obesity, and “could have significant impact” if implemented on a broader scale.

Moreover, they concluded “the intervention effect” occurred as early as 4 months and sustained throughout the two years. The researchers say this study may be one of the first ever to prevent early childhood obesity, particularly in a large group of diverse participants.

Perrin indicated that research shows most young children with obesity do not outgrow it. “What is kind of exciting from our study is we prevented those children who would have had an unhealthy weight in the first place and helped them have a healthier weight, which sets them up better for health throughout their lives,” she says.

Finally, the researchers say the digital intervention had a greater effect on children from households with food insecurity, on Hispanic and non-Hispanic Black children, and those with lower health literacy. “If we can prevent obesity in these children at greatest risk, we can also create better health equity in the future,” Perrin says.

Reference:

Heerman WJ, Rothman RL, Sanders LM, et al. A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial. JAMA. Published online November 03, 2024. doi:10.1001/jama.2024.22362

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