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Open Heart Jun 2024Neurocardiogenic syncope is a common condition with significant associated psychological and physical morbidity. The effectiveness of therapeutic options for... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Neurocardiogenic syncope is a common condition with significant associated psychological and physical morbidity. The effectiveness of therapeutic options for neurocardiogenic syncope beyond placebo remains uncertain.
METHODS
The primary endpoint was the risk ratio (RR) of spontaneously recurring syncope following any therapeutic intervention. We also examined the effect of blinding on treatment efficacy. We identified all randomised trials which evaluated the effect of any pharmacological, device-based or supportive intervention on patients with a history of syncope. A systematic search was conducted on Medline, Embase, PubMed databases and Cochrane Central Register for Controlled Trials from 1950 to 25 April 2023. Event rates, their RRs and 95% CIs were calculated, and a random-effects meta-analysis was conducted for each intervention. Data analysis was performed in R using RStudio.
RESULTS
We identified 47 eligible trials randomising 3518 patients. Blinded trials assessing syncope recurrence were neutral for beta blockers, fludrocortisone and conventional dual-chamber pacing but were favourable for selective serotonin reuptake inhibitors (SSRIs) (RR 0.40, 95% CI 0.26 to 0.63, p<0.001), midodrine (RR 0.70, 95% CI 0.53 to 0.94, p=0.016) and closed-loop stimulation (CLS) pacing (RR 0.15, 95% CI 0.07 to 0.35, p<0.001). Unblinded trials reported significant benefits for all therapy categories other than beta blockers and consistently showed larger benefits than blinded trials.
CONCLUSIONS
Under blinded conditions, SSRIs, midodrine and CLS pacing significantly reduced syncope recurrence. Future trials for syncope should be blinded to avoid overestimating treatment effects.
PROSPERO REGISTRATION NUMBER
CRD42022330148.
Topics: Humans; Syncope, Vasovagal; Randomized Controlled Trials as Topic; Treatment Outcome; Recurrence
PubMed: 38890128
DOI: 10.1136/openhrt-2024-002669 -
Addictive Behaviors Jun 2024The extent to which heavy smoking and retirement risk are causally related remains to be determined. To overcome the endogeneity of heavy smoking behaviour, we employed...
BACKGROUND AND AIMS
The extent to which heavy smoking and retirement risk are causally related remains to be determined. To overcome the endogeneity of heavy smoking behaviour, we employed a novel approach by exploiting the genetic predisposition to heavy smoking, as measured with a polygenic risk score (PGS), in a Mendelian Randomisation approach.
METHODS
8164 participants (mean age 68.86 years) from the English Longitudinal Study of Ageing had complete data on smoking behaviour, employment and a heavy smoking PGS. Heavy smoking was indexed as smoking at least 20 cigarettes a day. A time-to-event Mendelian Randomization (MR) analysis, using a complementary log-log (cloglog) link function, was employed to model the retirement risk.
RESULTS
Our results show that being a heavy smoker significantly increases the risk of retirement (β = 1.324, standard error = 0.622, p < 0.05). Results were robust to a battery of checks and a placebo analysis considering the never-smokers.
CONCLUSIONS
Overall, our findings support a causal pathway from heavy smoking to earlier retirement.
PubMed: 38889551
DOI: 10.1016/j.addbeh.2024.108078 -
Physiological Reports Jun 2024This study investigated the effects of white meat, such as chicken, intake combined with resistance training on muscle mass and strength in the elderly women, and... (Randomized Controlled Trial)
Randomized Controlled Trial
This study investigated the effects of white meat, such as chicken, intake combined with resistance training on muscle mass and strength in the elderly women, and whether the underlying mechanism involves changes in the gut microbiota. Ninety-three volunteers (age 59-79 years) were randomly allocated to sedentary control with placebo (Sed + PL) or chicken meat (Sed + HP) and resistance training with placebo (RT + PL) or chicken meat (RT + HP). Resistance training sessions were performed 3 d/week for 12 weeks using leg extensions and curls. Boiled chicken meat (110 g, containing 22.5 g protein) was ingested 3 d/week for 12 weeks. Maximal muscle strength and whole-body lean mass increased significantly in the RT + PL group compared to the Sed + HP group, and the RT + HP group showed a significantly greater increase than the Sed + HP and RT + PL groups. Additionally, the gut microbiota composition did not change before or after the interventions in any of the four groups. Moreover, the individual comparison of gut bacteria using false discovery rate-based statistical analysis showed no alterations before or after the interventions in the four groups. Resistance training combined with chicken meat intake may effective have increased muscle mass and strength without drastically modifying the gut microbiota composition in elderly women.
Topics: Humans; Female; Gastrointestinal Microbiome; Resistance Training; Aged; Muscle Strength; Middle Aged; Chickens; Animals; Meat; Muscle, Skeletal
PubMed: 38888088
DOI: 10.14814/phy2.16100 -
Frontiers in Nutrition 2024Back pain is a common health problem that affects both workers and older people, reducing their quality of life. The primary objective was to assess the effect of...
Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study.
BACKGROUND
Back pain is a common health problem that affects both workers and older people, reducing their quality of life. The primary objective was to assess the effect of dietary supplementation with plant extracts of rosemary, ashwagandha, and sesame consumed for 12 weeks on the intensity of back pain.
METHODS
A single-center randomized double-blind study with three parallel arms depending on the product consumed. The duration of treatment was 12 weeks. The investigational product, Berelief, contained a blend of three polyphenolic standardized extracts: rosemary ( L.), ashwagandha ( L.), and sesame ( L.) seed. Two doses were tested: low dose (400 mg) and high dose (800 mg). There were 42 subjects in the placebo group, 39 in the low dose and 42 in the high dose groups. Study variables included back pain intensity [VAS score, Patient-Reported Outcomes Measurement Information System (PROMIS-29), and Cornell Musculoskeletal Discomfort Questionnaire; functionality Roland-Morris Disability (RMD) questionnaire]; quality of life (QoL) [36-item Short Form Survey (SF-36), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Perceived Stress Scale (PSS)]; sleep quality [accelerometer and Pittsburgh Sleep Quality Index (PSQI)].
RESULTS
The improvement in back pain recorded by the visual analogue scale (VAS) at the study visits after the beginning of treatment, as well as on a weekly basis recorded in the diary card was significantly higher in the intervention group than in the placebo group ( < 0.044 dose-low; < 0.005 dose-high). Significant differences in pain intensity of the PROMIS-29 ( = 0.002) and upper back pain in the Cornell questionnaire ( = 0.011) in favour of the investigational product were found. Furthermore, benefits in improving health-related quality of life, mood and sleep quality were also detected.
CONCLUSION
Dietary supplementation for 12 weeks of a blend of polyphenolic standardized extracts of rosemary, ashwagandha, and sesame was effective in reducing the intensity of pain in subjects with chronic myofascial cervical and back pain.
PubMed: 38887495
DOI: 10.3389/fnut.2024.1403108 -
PloS One 2024Most US children with acute otitis media [AOM] receive prompt antibiotic treatment, though guidelines encourage watchful waiting. Previous systematic reviews of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Most US children with acute otitis media [AOM] receive prompt antibiotic treatment, though guidelines encourage watchful waiting. Previous systematic reviews of antibiotics versus watchful waiting have focused on symptom resolution and RCTs, limiting the assessment of serious, rare complications. We sought to evaluate these complications by including observational studies.
METHODS
RCTs and observational studies that compared antibiotics to placebo or watchful waiting for pediatric clinician diagnosed AOM were identified [PubMed/MEDLINE, Embase, Cochrane Database of Systematic Reviews, Central Register of Controlled Trials, and Web of Science] and reviewed for meta-analysis. Two reviewers independently extracted study characteristics, patient characteristics, and outcomes. We assessed publication bias, study bias with ROBINS-1 and RoB-2 and used random-effects models to assess treatment effects.
RESULTS
24 studies were included. Antibiotics decreased the risk of acute mastoiditis [incidence 0.02%, RR 0.48, 95% CI 0.40-0.59; NNT 5,368]. This protective effect may be underestimated because of misclassification of non-suppurative conditions as AOM. Intracranial complications remained too rare to assess. Antibiotics markedly increased the risk of adverse effects [incidence 10.5%, RR 1.49, 1.27-1.73; NNH 23]. Studies used non-specific criteria for acute mastoiditis, potentially underestimating treatment effects.
CONCLUSIONS
Prompt antibiotic therapy reduces the risk for some AOM complications. The NNT to prevent serious, rare complications is high, while the NNH is relatively low. Large-scale population-based observational studies using real-world datasets with validated measures of severe complications are needed to improve understanding of risk factors for serious AOM complications, facilitate more selective antibiotic therapy, and optimize individual outcomes and public health.
Topics: Humans; Anti-Bacterial Agents; Otitis Media; Child; Acute Disease; Child, Preschool; Mastoiditis; Randomized Controlled Trials as Topic
PubMed: 38885271
DOI: 10.1371/journal.pone.0304742 -
ARYA Atherosclerosis Jul 2023The use of allopurinol has shown promising outcomes in reducing oxidative processes responsible for atherogenic-related cardiovascular events. The current study aims to...
The Effect of High-dose Allopurinol Pretreatment on Inflammatory Biomarkers and Post-revascularization Coronary Blood Flow in Non-STEMI Patients: A Randomized Double Blind Clinical Trial.
INTRODUCTION
The use of allopurinol has shown promising outcomes in reducing oxidative processes responsible for atherogenic-related cardiovascular events. The current study aims to assess the effects of high-dose allopurinol on the post-revascularization coronary blood flow and inflammatory biomarkers in patients with non-ST segment elevated myocardial infarction (NSTEMI).
METHOD
Eighty NSTEMI patients were randomly divided into two groups: the intervention group (n=40), medicated with a high loading dose of 600 mg allopurinol before the coronary angiography, and the control group (n=40), treated with a placebo. The highly sensitive C-reactive protein (hs-CRP) was measured at baseline and within 24 hours after the cardiac interventions and compared between the case and control groups. Post percutaneous coronary intervention (PCI) Thrombolysis in Myocardial Infarction (TIMI) flow grading was also evaluated as a revascularization endpoint.
RESULTS
The two groups of the study were similar in terms of demographic, clinical, laboratory, and angiographic characteristics (P-value>0.050). The assessed TIMI flow was similar between the cases and the controls both prior to (P-value=0.141) and after (P-value=0.395) the coronary angioplasty. The hs-CRP (P-value=0.016) was significantly higher in the control group. Post-angiographic assessment of hs-CRP revealed an insignificant difference between the groups (P-value=0.104).
CONCLUSION
In conclusion, premedication with a high dose of allopurinol in NSTEMI patients did not affect the inflammatory biomarker or the revascularization endpoint.
PubMed: 38881997
DOI: 10.48305/arya.2022.11886.2722 -
Translational Cancer Research May 2024Non-small cell lung cancer (NSCLC) remains a leading cause of cancer mortality. Combined anlotinib and immune checkpoint inhibitors (ICIs) therapy may have synergistic...
Efficacy and safety of anlotinib in combination with immune checkpoint inhibitors or not as advanced non-small cell lung cancer treatment: a systematic review and network meta-analysis.
BACKGROUND
Non-small cell lung cancer (NSCLC) remains a leading cause of cancer mortality. Combined anlotinib and immune checkpoint inhibitors (ICIs) therapy may have synergistic antitumor effects in NSCLC. This study aimed to comparing the efficacy and safety of anlotinib and ICIs treatment, monotherapy and combination in NSCLC.
METHODS
We performed a systematic review and network meta-analysis of 14 studies involving 4,308 NSCLC patients across four regimens: anlotinib, ICIs, anlotinib plus ICIs, and placebo. Efficacy outcomes were progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR). Safety outcomes included treatment-related adverse events (TRAEs), TRAE grade three or higher (TRAE ≥3). Analyses were performed in RevMan 5.3 and R 3.5.1 (gemtc package). P<0.05 or effect estimate with 95% confidence interval (CI) that did not include 1 indicated statistical significance.
RESULTS
Fourteen publications involving 4,308 patients across four treatment regimens (anlotinib, ICIs, anlotinib plus ICIs, placebo) were included. For PFS, network meta-analysis showed all three interventions significantly improved PFS versus placebo. Anlotinib plus ICIs demonstrated the greatest PFS improvement [hazard ratio (HR) =0.24; 95% CI: 0.14, 0.36], followed by anlotinib (HR =0.37; 95% CI: 0.23, 0.58), and ICIs (HR =0.43; 95% CI: 0.27, 0.67). For OS, compared to placebo, anlotinib plus ICIs showed the greatest OS improvement (HR =0.52; 95% CI: 0.33, 0.74), followed by anlotinib (HR =0.66; 95% CI: 0.47, 0.95), and ICIs (HR =0.72; 95% CI: 0.54, 0.97). For ORR, anlotinib plus ICIs demonstrated the greatest improvement versus placebo [odds ratio (OR) =5.29; 95% CI: 3.32, 8.58], followed by anlotinib (OR =4.38; 95% CI: 2.42, 8.19), and ICIs (OR =2.17; 95% CI: 1.65, 2.89). For DCR, anlotinib plus ICIs showed the greatest improvement versus placebo (OR =13.32; 95% CI: 4.99, 45.09), followed by anlotinib (OR =5.56; 95% CI: 2.17, 14.38), and ICIs (OR =3.46; 95% CI: 1.29, 10.85). Compared to placebo, anlotinib was associated with the highest risk of TRAEs (OR =3.67, 95% CI: 1.12, 15.77), followed by ICIs (OR =1.83; 95% CI: 1.26, 2.69). Due to lack of data on anlotinib plus ICIs, no comparison was conducted. For grade ≥3 TRAEs, compared to placebo, anlotinib increased the risk (OR =3.67; 95% CI: 1.12, 15.77), while anlotinib plus ICIs (OR =2.45; 95% CI: 0.51, 11.6) and ICIs (OR =1.29; 95% CI: 0.33, 4.38) did not increase the risk.
CONCLUSIONS
Anlotinib combined with ICIs demonstrates improved efficacy over monotherapy for NSCLC treatment, without increased adverse events.
PubMed: 38881944
DOI: 10.21037/tcr-23-1483 -
Endocrinology, Diabetes & Metabolism Jul 2024Diabetes mellitus (DM) is a chronic metabolic disorder characterised by high blood sugar (BS) levels due to impaired insulin production or insulin resistance. It is a... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Diabetes mellitus (DM) is a chronic metabolic disorder characterised by high blood sugar (BS) levels due to impaired insulin production or insulin resistance. It is a global health concern with significant implications for morbidity and mortality. Persian medicine has long utilised natural remedies, such as Pistacia atlantica Desf., for various diseases. In this randomised clinical trial, the effects of P. atlantica oleoresin in the improvement of lipid profiles, glucose indices and blood pressure (BP) were assessed in patients with Type 2 DM.
MATERIALS AND METHODS
In this randomised, single-blind, placebo-controlled study, 42 patients with Type 2 DM were randomly allocated to receive either P. atlantica oleoresin or placebo capsule for 3 months. Patients were evaluated prior to and 12 weeks after the beginning of the intervention, in terms of changes in lipid profiles, glucose indices and BP.
RESULTS
After 3 months, the mean BP in patients with DM receiving P. atlantica oleoresin was significantly reduced compared with the baseline (p = 0.001). Also, these changes were significantly higher than those of the control group. The mean of total cholesterol (p = 0.89), low-density lipoprotein (LDL) (p = 0.43) and triglyceride (TG) (p = 0.98) in the intervention group after 3 months was lower than that in the control group, but this difference was not statistically significant.
CONCLUSION
After 3 months, there was no significant difference between the P. atlantica and control groups in terms of blood sugar and lipid profiles. The mean BP in patients with DM receiving P. atlantica oleoresin was significantly reduced compared with that in the beginning of the study. Also, these changes were significant compared with the control group.
Topics: Humans; Diabetes Mellitus, Type 2; Male; Single-Blind Method; Middle Aged; Female; Plant Extracts; Blood Glucose; Pistacia; Blood Pressure; Adult; Lipids; Phytotherapy; Aged
PubMed: 38881209
DOI: 10.1002/edm2.504 -
American Journal of Ophthalmology Jun 2024To study the long-term effects of perinatal high-dose recombinant human erythropoietin (rhEPO) on macular structural and vascular development in preterm children.
PURPOSE
To study the long-term effects of perinatal high-dose recombinant human erythropoietin (rhEPO) on macular structural and vascular development in preterm children.
DESIGN
Randomized, double-blind clinical trial follow-up plus cohort study.
METHODS
Setting: Department of Ophthalmology, University Hospital Zurich, Zurich, Switzerland.
STUDY POPULATION
extremely or very preterm born children aged 7-15 years from an ongoing neuropediatric study (EpoKids). These had been previously randomized to receive either high-dose rhEPO or placebo perinatally.
INCLUSION CRITERIA
participation in the EpoKids Study, written informed consent (IC).
EXCLUSION CRITERIA
previous ocular trauma or surgery; retinal or developmental disease unrelated to prematurity. Term-born children of comparable age were enrolled as a healthy control (HC) group.
INCLUSION CRITERIA
term birth, IC.
EXCLUSION CRITERIA
any ocular or visual abnormality, high refractive error. Examiners were blinded regarding intervention status until completion of all analyses. (Participants/guardians remain blinded).
OBSERVATION PROCEDURES
Spectral-domain OCT scans (Heidelberg Spectralis system) and OCTA imaging (Zeiss PlexElite 9000) were obtained. Ophthalmological and orthoptic examinations excluded ocular comorbidities.
MAIN OUTCOME MEASURES
OCT (central retinal thickness, CRT; total macular volume, TMV), superficial plexus OCTA (foveal avascular zone, FAZ; vessel density, VD; vessel length density, VLD) parameters and foveal hypoplasia grade according to published criteria.
RESULTS
Macular vessel density parameters (VD and VLD) were significantly lower (p =0.015, CI-95: 0.01 to 0.06 and p=0.015, CI-95: 0.74 to 3.64) in the EPO group (n= 52) when compared to placebo (n=35). No other significant differences were observed between the EPO and placebo group. When comparing the intervention subgroups to HC we found six significant differences in OCT and OCTA parameters (FAZ, VD, VLD and CRT comparing HC and EPO group; FAZ and CRT when comparing HC and placebo group).
CONCLUSIONS
Early high-dose rhEPO in infants born extremely or very preterm affects macular vessel density parameters compared to placebo. Premature birth (regardless of intervention status) affects retinal structure and vascular development. Our findings on macular vascular development do not contraindicate the administration of early high-dose EPO in preterm infants. For further understanding of the role of EPO on macular development and its clinical significance, future studies are needed.
PubMed: 38880371
DOI: 10.1016/j.ajo.2024.06.005 -
Scientific Reports Jun 2024Neurological and cardiac injuries are significant contributors to morbidity and mortality following pediatric in-hospital cardiac arrest (IHCA). Preservation of...
Neurological and cardiac injuries are significant contributors to morbidity and mortality following pediatric in-hospital cardiac arrest (IHCA). Preservation of mitochondrial function may be critical for reducing these injuries. Dimethyl fumarate (DMF) has shown potential to enhance mitochondrial content and reduce oxidative damage. To investigate the efficacy of DMF in mitigating mitochondrial injury in a pediatric porcine model of IHCA, toddler-aged piglets were subjected to asphyxia-induced CA, followed by ventricular fibrillation, high-quality cardiopulmonary resuscitation, and random assignment to receive either DMF (30 mg/kg) or placebo for four days. Sham animals underwent similar anesthesia protocols without CA. After four days, tissues were analyzed for mitochondrial markers. In the brain, untreated CA animals exhibited a reduced expression of proteins of the oxidative phosphorylation system (CI, CIV, CV) and decreased mitochondrial respiration (p < 0.001). Despite alterations in mitochondrial content and morphology in the myocardium, as assessed per transmission electron microscopy, mitochondrial function was unchanged. DMF treatment counteracted 25% of the proteomic changes induced by CA in the brain, and preserved mitochondrial structure in the myocardium. DMF demonstrates a potential therapeutic benefit in preserving mitochondrial integrity following asphyxia-induced IHCA. Further investigation is warranted to fully elucidate DMF's protective mechanisms and optimize its therapeutic application in post-arrest care.
Topics: Animals; Heart Arrest; Asphyxia; Swine; Disease Models, Animal; Dimethyl Fumarate; Mitochondria; Brain; Humans; Myocardium; Oxidative Phosphorylation
PubMed: 38879681
DOI: 10.1038/s41598-024-64317-9