Controlled Trial Research Articles

Nutrition Therapy Promotes Overall Survival in Cachectic Cancer Patients through a New Proposed Chemical-Physical Pathway: The TiCaCONCO Trial (A Randomized Controlled Single-Blinded Trial)

Cancer threatens nutritional status, and many patients will become cachectic with a negative impact on prognosis. In the TiCaCo pilot trial, we showed a positive effect of calorie matching Nutrition Therapy on both morbidity and mortality. We attempt to validate these results in the TiCaCONCO trial. In a prospective, randomized, single-blinded, controlled trial, patients were treated with either intensive, individual biometric parameter-oriented dietary counseling (nutrition therapy or NT) for a maximum period of three months, or regular dietary counseling (control or CT), before and during conventional cancer treatment. Sixty patients were enrolled over a two-year period, with 30 receiving nutrition therapy and 30 being controls. The primary endpoint was overall survival (OS). Overall survival at 12 months in all patients was 47% (14/30 patients) in the CT group with a median OS of 45.5 weeks, and 73% (22/30 patients) in the NT group with a median OS that was undefined (i.e., cannot be calculated, as >50% of patients in the NT group were still alive at the end of the study) (p = 0.0378). The survival difference still exists when only male patients are analyzed, but is not observed in female patients. Biophysical measurements were performed at 0, 3, and 12 months in all patients. In men, the differences between CT vs NT were statistically significant for body hydration (p = 0.0400), fat mass (p = 0.0480), total energy expenditure (p = 0.0320), and median overall survival at 12 months (p = 0.0390). At 3 months (end of the intervention), the differences between CT vs NT for body hydration were 73 ± 3% vs. 75 ± 5%, for fat mass 14 ± 4% vs. 19 ± 5%, and for total energy expenditure 2231 ± 637 Kcal vs. 2408 ± 369 Kcal. In women, the differences between CT vs NT were not statistically significant for body hydration (p = 1.898), fat mass (p = 0.9495), total energy expenditure (p = 0.2875) and median overall survival at 12 months (p = 0.6486). At 3 months (end of the intervention), the differences between CT vs. NT for body hydration were 74 ± 2% vs. 78 ± 5%, for fat mass 25 ± 7% vs. 29 ± 19%, and for TEE 1657 ± 297 Kcal vs. 1917 ± 120 Kcal. Nutrition Therapy, based on patient-specific biophysical parameters, including the measurement of metabolism by indirect calorimetry and body composition measurements by BIA, improves overall survival, at least in men. The mechanism would be increasing extra energy for the body, which is necessary to fight off cancer.

Interventions to Promote the Development of Motor Performance Skills in Primary School Aged Children with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis of Controlled Trials

Background: The development of proficiency in motor performance skills (MPS) builds the foundation for the complex movement skills required to participate in a range of sports and physical activities throughout the lifespan. Objective: To assess the efficacy of different intervention approaches on developing MPS proficiency in children with autism spectrum disorder (ASD) and examine the intervention factors that influence change. Method: Searches were completed in three databases (PubMed/MEDLINE, Scopus, Web of Science) up to March 2022. Only randomised controlled trials (RCTs) or controlled trials (CTs), that evaluated the effectiveness of interventions on overall MPS proficiency or specific MPS such as balance, running speed and agility, bilateral coordination, jumping, ball skills and push-ups in children (4–13 years old) were included. The DerSimonian and Laird random-effects model was used to compute the meta-analyses. The effect sizes were reported as Hedges’ g. Using a random-effects model, potential sources of heterogeneity were identified, including subgroup analyses (type of intervention), and single training factor analysis (total number of weeks, session frequency, total intervention time, total number of training sessions). In addition, a multivariate meta-regression calculation was performed for balance. The GRADE framework was applied to assess certainty of evidence. Results: Seventeen interventions (13 RCTs and 4 CTs) revealed significant differences among groups favouring the intervention group with moderate to very large effects. Significant (p 0.05) small-to-large effects of interventions were evident on overall motor performance skills (ES = 2.43), ball skills (ES = 2.95), jumping (ES = 1.89), bilateral coordination (ES = 2.21), push-ups (ES = 1.92), balance (ES = 1.56), running speed and agility (ES = 1.31). Multivariate meta-regression for balance revealed that total sessions, total intervention time and session frequency predicted (p = 0.009, p0.001, p = 0.036, respectively) the effects of interventions on change in balance performance. Conclusion: Structured interventions that explicitly teach traditional FMS or promote the development and learning of movement skills specifically associated with a type of physical activity or sport, effectively improve MPS in children with ASD. Education settings should implement ‘planned’ movement experiences or interventions as a strategy to promote MPS proficiency in children with ASD.

UV Irradiation of Nevi: Impact on Performance of Electrical Impedance Spectroscopy and a Convolution Neural Network.

UV irradiation of nevi induces transient melanocytic activation with dermoscopic and histological changes. We investigated whether UV irradiation of nevi may influence electrical impedance spectroscopy (EIS) or convolution neural networks (CNN). Prospective, controlled trial in 50 patients undergoing phototherapy (selective UV phototherapy (SUP), UVA1, SUP/UVA1, or PUVA). EIS (Nevisense, SciBase AB) and CNN scores (Moleanalyzer-Pro, FotoFinder Systems) of nevi were assessed before (V1) and after UV irradiation (V2). One nevus (nevusirr) was exposed to UV light, another UV-shielded (nevusnon-irr). There were no significant differences in EIS scores of nevusirr before (2.99 [2.51-3.47]) and after irradiation (3.32 [2.86-3.78]; P = 0.163), which was on average 13.28 (range 4-47) days later. Similarly, UV-shielded nevusnon-irr did not show significant changes of EIS scores (V1: 2.65 [2.19-3.11]), V2: 2.92 [2.50-3.34]; P = 0.094). Subgroup analysis by irradiation revealed a significant increase of EIS scores of nevusirr (V1: 2.69 [2.21-3.16], V2: 3.23 [2.72-3.73]; P = 0.044) and nevusnon-irr (V1: 2.57 [2.07-3.07], V2: 3.03 [2.48-3.57]; P = 0.033) for patients receiving SUP. In contrast, CNN scores of nevusirr (P = 0.995) and nevusnon-irr (P = 0.352) showed no significant differences before and after phototherapy. For the tested EIS system increased EIS scores were found in nevi exposed to SUP. In contrast, CNN results were more robust against UV exposure.

Efficacy potential of Goal Management Training to improve cognitive function in older people living with HIV

Goal Management Training® (GMT) teaches strategies to reduce cognitive load and improve focus in everyday tasks. The aim of this study was to ascertain feasibility, acceptability, and efficacy potential of GMT for people (≥50 years) with stable HIV infection scoring low on tests of cognitive ability. A two-sample, parallel, controlled trial was carried out. Feasibility was demonstrated, as 21/30 participants in the GMT group attended ≥8 of the 9 sessions and completed at least half of the homework. There was no change on the primary performance-based cognitive outcomes in the GMT group or in the control group (n = 23). There was a meaningful improvement in self-reported cognition in those adherent to the intervention. GMT is a promising intervention for people aging with HIV who are dealing with cognitive difficulties affecting their everyday life and should be further investigated.

The safety and efficacy of alfentanil combined with midazolam in fiberoptic bronchoscopy sedation: A randomized, double-blind, controlled trial.

Sedation is recommended by most guidelines to be offered to all patients undergoing diagnostic flexible bronchoscopy (DFB) without contraindications, and the most commonly reported regimen is midazolam in combination with a short-acting opioid (fentanyl or alfentanil) to provide both sedative and antitussive effects. However, the optimal dose or ideal regimen of the combination therapy with midazolam and opioids has not yet been found. So this randomized, double-blinded clinical trial was designed and registered (ChiCTR2100049052) to assess the safety and efficacy of midazolam combined with different doses of alfentanil in DFB sedation. Our study showed that relative high doses of alfentanil (10-25μg/kg) combined with a fixed low dose of midazolam can markedly reduce hemodynamic fluctuations, cough reactions, patients' discomforts, and improve their satisfaction in a dose-dependent manner during DFB, with no significant increase in the desaturation risks.

The Effectiveness of Using DermoXen® Lenitiva for the Treatment of Women with Nonspecific Itching of the Intimate Area

Зуд определяется как неприятное кожное ощущение, связанное с немедленным желанием активизировать рефлекс чесания. В частности, зуд может возникать в области наружной генитальной зоны по нескольким причинам (бактериальная инфекция, грибковая инфекция, стресс, неадекватное интимное поведение, синтетическая одежда). Цель исследования заключалась в сравнении эффективности крема DermoXen® Lenitiva с кремом на основе метилпреднизолона ацепоната 0,1% для лечения зуда интимной зоны. Проведено независимое рандомизированное двойное слепое контролируемое исследование у 60 женщин с неспецифическим генитальным зудом и отрицательным вагинальным мазком на бактериальные и грибковые инфекции. Отмечено более выраженное снижение уровня зуда до 0,44 балла в группе использования DermoXen® Lenitiva при достижении 0,89 балла соответственно в группе использования крема метилпреднизолона ацепоната. Через 30 дней после лечения количество пациенток с легким зудом в группе кортикостероидной терапии почти в 2 раза превышало таковую в группе лечения кремом DermoXen® Lenitiva. Следует отметить статистически достоверный непрерывный рост уровня сексуального и генитального комфорта в обеих группах на протяжении всего периода лечения (p<0,05). Itching can be defined as an unpleasant skin sensation associated with an immediate urge to scratch. In particular, the external genital area may itch for several reasons (bacterial infection, fungal infection, stress, bad sexual behavior, synthetic intimate clothing). The purpose of the study was to compare the efficacy of DermoХen® Lenitiva cream versus cream-based methylprednisolone aceponate 0.1% in the treatment of vulvar pruritus. This was an independent, randomized, double-blind, controlled trial on 60 women with a specific genital pruritus with a negative vaginal smear for bacterial or fungal infection. There was a more pronounced reduction in itching to 0.44 points in the DermoXen® Lenitiva group, while reaching 0.89 points, respectively, in the methylprednisolone aceponate cream group. Four weeks after treatment, the number of patients with mild itching in the corticosteroid therapy group was almost 2 times higher than in the DermoXen® Lenitiva cream group. It should be noted a statistically significant continuous increase in the level of sexual and genital comfort in both groups throughout the entire period of treatment (p<0.05).

A systematic review and meta-analysis of prophylactic medication of vestibular migraine.

Vestibular migraine is in the process of recognition as an individual clinical entity. At present, no guidelines exist for its management. This study aimed to conduct a systematic review and meta-analysis to determine the effectiveness of available prophylactic medication. A literature search was performed using PubMed, Ovid and Embase databases. Qualitative and quantitative analysis were performed as well as risk of bias analysis. Meta-analysis for the mean differences for pre- and post-treatment impact based on Dizziness Handicap Inventory and Vertigo Symptom Scale were performed. Proportionate transformation meta-analysis for the successful event rate based on complete symptoms control was explored. Thirteen publications were identified: 3 were randomised, controlled trials and 10 were non-randomised, controlled trials. Propranolol and venlafaxine improved the Vertigo Symptom Scale score by -13.31 points and -4.16 points, respectively, and the Dizziness Handicap Inventory score by -32.24 and -21.24, respectively. Only propranolol achieved statistically significant impact with 60 per cent of patients achieving complete symptom control. Propranolol should be offered as the first-line treatment for vestibular migraine followed by venlafaxine. Amitriptyline, flunarizine and cinnarizine showed a trend for symptom improvement, but this was not statistically significant.

Effect of acupuncture for non-motor symptoms in patients with Parkinson's disease: A systematic review and meta-analysis.

BackgroundAlthough non-motor symptoms of Parkinson’s disease (PD) are serious, effective treatments are still lacking. Acupuncture may have clinical benefits for non-motor symptoms of PD patients, but high-quality evidence supporting this possibility is still limited. Hence, we conducted this meta-analysis to evaluate the effect of acupuncture treatment on non-motor symptoms in patients with PD.MethodsRandomized controlled trials (RCTs) of acupuncture treatment for PD were retrieved from the following electronic databases: Medline (OVID), Embase (OVID), Cochrane Library, Web of Science, China National Knowledge Infrastructure, Chinese BioMedical Literature Database, Chonqing VIP (CQVIP), and Wangfang database. Studies evaluating non-motor symptoms of PD were retrieved. Methodological quality was assessed using the Cochrane Handbook for Systematic Reviews of Interventions.ResultsA total of 27 RCTs were included, among which 8 outcomes related to non-motor symptoms were evaluated. The results showed that acupuncture combined with medication had benefits for PD-related insomnia relative to medication alone or sham acupuncture [standardized mean difference (SMD) = 0.517; 95% confidence interval (CI) = 0.242–0.793; p = 0.000], and acupuncture treatment had benefits at 8 weeks (SMD = 0.519; 95% CI = 0.181–0.857; p = 0.003). Regarding depression, acupuncture treatment was more effective (SMD = −0.353; 95% CI = −0.669 to −0.037; p = 0.029) within 2 months (SMD = −0.671; 95% CI = −1.332 to −0.011; p = 0.046). Regarding cognition, quality of life, and Unified Parkinson’s Disease Rating Scale (UPDRS) I and II scores, acupuncture treatment was effective [SMD = 0.878, 95% CI = 0.046–1.711, p = 0.039; SMD = −0.690, 95% CI = −1.226 to −0.155, p = 0.011; weighted mean difference (WMD) = −1.536, 95% CI = −2.201 to −0.871, p = 0.000; WMD = −2.071, 95% CI = −3.792 to −0.351, p = 0.018; respectively]. A significant difference was not found in terms of PD-related constipation. Only one study evaluated PD-related fatigue.ConclusionThe results of the analysis suggested that acupuncture treatment could ameliorate the symptoms of depression, quality of life, cognition, total mentation, behavior and mood, and activities of daily living in PD patients. Nevertheless, more prospective, well-designed RCTs with larger sample sizes are required to confirm our findings.

Effects of contact with a dog on prefrontal brain activity: A controlled trial.

There is a broad range of known effects of animal contact on human mental and physical health. Neurological correlates of human interaction with animals have been sparsely investigated. We investigated changes in frontal brain activity in the presence of and during contact with a dog. Twenty-one healthy individuals each participated in six sessions. In three sessions, participants had contact with a dog, and in three control sessions they interacted with a plush animal. Each session had five two-minute phases with increasing intensity of contact to the dog or plush animal from the first to the fourth phase. We measured oxygenated, deoxygenated, and total hemoglobin and oxygen saturation of the blood in the frontal lobe/frontopolar area with functional near-infrared spectroscopy (SenSmart Model X-100) to assess brain activity. In both conditions, the concentration of oxygenated hemoglobin increased significantly from the first to the fourth phase by 2.78 μmol/l (CI = 2.03-3.53, p < .001). Oxygenated hemoglobin concentration was 0.80 μmol/l higher in the dog condition compared to in the control condition (CI = 0.27-1.33, p = .004). Deoxygenated-hemoglobin concentration, total hemoglobin concentration, and oxygen saturation showed similar patterns. Prefrontal brain activation in healthy subjects increased with the rise in interaction closeness with a dog or a plush animal. Moreover, interaction with a dog stimulated more brain activity compared to the control condition, suggesting that interactions with a dog can activate stronger attentional processes and elicit more emotional arousal than interacting with a nonliving stimulus.

Granulomatosis With Polyangiitis Presenting With Diffuse Alveolar Hemorrhage: A Systematic Review.

Granulomatosis with polyangiitis (GPA) is a systemic disease that has variable clinical expression. GPA is the most common antineutrophilic cytoplasmic antibody(ANCA)-associated vasculitis (AAV). Diffuse alveolar hemorrhage (DAH) is one of the least common pulmonary manifestations in patients with GPA.DAH is clinically marked by hemoptysis, anemia, and diffuse alveolar infiltrates on imagingas well as hypoxemic respiratory failure. The diagnosis and treatment are challenging. Recommendations for ANCA-associated vasculitis, in general, are already established; however, there is a knowledge gap that addresses the association of GPA and DAH. The aim of this systematic review is to focus on the main clinical aspects and treatmentof patients with GPA who presentwith DAH. Thorough research of available literature was performed, including studies published in the last 10 years, following the Preferred Items for Systematic Review and Meta-Analysis (PRISMA) 2020 recommendations. The following databases were included: PubMed, Medline, Embase, ClinicalTrials.com, Google Scholar, and Prospero. The search terms included: [granulomatosis] AND [polyangiitis] AND [diffuse alveolar hemorrhage] OR [diffuse pulmonary hemorrhage] NOT [microscopic polyangiitis] NOT [eosinophilic granulomatosis]. NOS was used to assess the internal validity of the study in four domains, including selection, ascertainment, causality, and reporting. Our initial search identified 8989 studies. After excluding duplicated data and using our predetermined inclusion and exclusion criteria, we were able to retrieve 18 studies. Twelve out of 18 (67%) studies were case reports. Five were retrospective cohorts and one controlled trial. The average age of patients with GPA with DAH was 49.55 ± 17.54 years (18 - 76). Male individuals had a slight predominance (59%) in comparison to female individuals (41%). The hemoglobin level at the time of presentation was 8.86 mg/dL ± 1.43. The majority of patients (61.5%) reported hemoptysis. Renal involvement was present in 66.7%. Patients who required mechanical ventilation represented 61.5%. Plasmapheresis was used in 71.4%. Mortality was 20%, and gender was not associated with mortality (p = 0.822). Hemoptysis was not associated with the need for mechanical ventilation (p = 0.928). Renal impairment was not a predictor of mechanical ventilation (p = 0.207). In summary, patients with GPA and DAH were severely ill, frequently had renal impairment upon admission, and frequently required mechanical ventilation. Steroids, rituximab, and cyclophosphamide are the first-line treatment, and plasmapheresis is still in use. Eventually, extracorporeal membrane oxygenation (ECMO) can be the salvage therapy.Randomized controlled clinical trials (RCTs) are needed to address the best therapeutic options for this population.

Pharmacokinetics/Pharmacodynamics and tolerability of cefiderocol in the clinical setting.

Cefiderocol is a new cephalosporin with a catechol in its chemical structure faciliting its access to the interior of bacteria through iron channels. In addition, it is broadly stable to beta-lactamases. The pharmacokinetic profile is a beta-lactam one: no oral absorption, and with a wide distribution within the vascular space and the interstitial fluid of well vascularized tissues, reaching therapeutic concentrations in the alveolar lavage fluid and within the macrophage. The binding of cefiderocol to human plasma proteins, primarily albumin, is moderate (range 40-60%). The terminal elimination half-life in healthy adult subjects was 2 to 3 hours. Cefiderocol is mainly renally eliminated, so dose adjustments are recommended in subjects with moderate / severe renal impairment, in case of dialysis, and probably in patients with external clearance. Like other beta-lactams, the PK / PD parameter that has been shown to best correlate with efficacy is the efficacy time of unbound plasma concentrations (%fT>MIC), which must be close to 100% to achieve a bactericidal effect. This is possible with 2 g in a 3-hour infusion every 8 hours. In controlled trials appears to be well tolerated, similar to comparators: meropenem or imipenem-cilastatin. Cefiderocol has no apparent clinically significant effect on ECG parameters nor on plasma iron values.

The differential effects of antihypertensive drugs on central blood pressure: nebivolol versus telmisartan (ATD-CBP)

Abstract Background Central blood pressure and central pulse pressure have a better correlation with the risk of cardiovascular disease compared to those of peripheral measurement. In a previous study, a second-generation beta-blocker showed poor CBP-lowering effects. However, the effect on CBP by third-generation beta-blockers is not fully elucidated. Thus, this randomised study investigated whether nebivolol-based hypertension treatment may confer advantages over telmisartan, an angiotensin II receptor-blocker, in reducing CBP. Methods This was a prospective, randomised, multicentre, open-label, controlled trial that evaluated 98 hypertensive patients. Patients received either nebivolol- (N=49) or telmisartan-based (N=49) treatment for hypertension for 12 weeks with a target BP of ≤140/80. The primary outcome was the difference in change from baseline central systolic BP (cSBP) after 12 weeks. Results There were no significant differences between the two groups in baseline central and peripheral SBP. The mean change in cSBP from baseline (ΔcSBP) was −17.2±3 mmHg for nebivolol group (P&amp;lt;0.001) and −29.9±3 mmHg for telmisartan group (P&amp;lt;0.001). The difference in ΔcSBP between the two groups was significant (12.7mmHg, 95% confidence interval [CI], 4.13 to 21.2; P=0.004). Peripheral SBP (pSBP) decreased less in nebivolol group compared to telmisartan group (−18.0±3 in nebivolol group vs. −26.3±3 in telmisartan group, P=0.032). After adjusting for reduction in pSBP, reduction in cSBP was higher in telmisartan group compared to nebivolol group, as shown by the ratio of changes in cSBP and pSBP (ΔcSBP/ΔpSBP; 0.67 for nebivolol group vs. 1.11 for telmisartan group, P=0.080), albeit without statistical significance. Conclusions Nebivolol-based hypertension treatment may have less potent CBP-lowering effects compared to telmisartan. However, larger-scale studies are warranted to further elaborate our findings. Funding Acknowledgement Type of funding sources: None.

Effects of Pre-Exercise Voluntary Hyperventilation on Metabolic and Cardiovascular Responses During and After Intense Exercise

ABSTRACTPurpose: We investigated the effects of pre-exercise voluntary hyperventilation and the resultant hypocapnia on metabolic and cardiovascular responses during and after high-intensity exercise. Methods: Ten healthy participants performed a 60-s cycling exercise at a workload of 120% peak oxygen uptake in control (spontaneous breathing), hypocapnia and normocapnia trials. Hypocapnia was induced through 20-min pre-exercise voluntary hyperventilation. In the normocapnia trial, voluntary hyperpnea was performed with CO2 inhalation to prevent hypocapnia. Results: Pre-exercise end-tidal CO2 partial pressure was lower in the hypocapnia trial than the control or normocapnia trial, with similar levels in the control and normocapnia trials. Average V˙O2 during the entire exercise was lower in both the hypocapnia and normocapnia trials than in the control trial (1491 ± 252vs.1662 ± 169vs.1806 ± 149 mL min−1), with the hypocapnia trial exhibiting a greater reduction than the normocapnia trial. Minute ventilation during exercise was lower in the hypocapnia trial than the normocapnia trial. In addition, minute ventilation during the first 10s of the exercise was lower in the normocapnia than the control trial. Pre-exercise hypocapnia also reduced heart rates and arterial blood pressures during the exercise relative to the normocapnia trial, a response that lasted through the subsequent early recovery periods, though end-tidal CO2 partial pressure was similar in the two trials. Conclusions: Our results suggest that pre-exercise hyperpnea and the resultant hypocapnia reduce V˙O2 during high-intensity exercise. Moreover, hypocapnia may contribute to voluntary hyperventilation-mediated cardiovascular responses during the exercise, and this response can persist into the subsequent recovery period, despite the return of arterial CO2 pressure to the normocapnic level.

Impact of Phenol-Enriched Olive Oils on Serum Metabonome and Its Relationship with Cardiometabolic Parameters: A Randomized, Double-Blind, Cross-Over, Controlled Trial.

Phenol-rich foods consumption such as virgin olive oil (VOO) has been shown to have beneficial effects on cardiovascular diseases. The broader biochemical impact of VOO and phenol-enriched OOs remains, however, unclear. A randomized, double-blind, cross-over, controlled trial was performed with thirty-three hypercholesterolemic individuals who ingested for 3-weeks (25 mL/day): (1) an OO enriched with its own olive oil phenolic compounds (PCs) (500 ppm; FOO); (2) an OO enriched with its own olive oil PCs (250 ppm) plus thyme PCs (250 ppm; FOOT); and (3) a VOO with low phenolic content (80 ppm). Serum lipid and glycemic profiles, serum 1H-NMR spectroscopy-based metabolomics, endothelial function, blood pressure, and cardiovascular risk were measured. We combined OPLS-DA with machine learning modelling to identify metabolites discrimination of the treatment groups. Both phenol-enriched OO interventions decreased the levels of glutamine, creatinine, creatine, dimethylamine, and histidine in comparison to VOO one. In addition, FOOT decreased the plasma levels of glycine and DMSO2 compared to VOO, while FOO decreased the circulating alanine concentrations but increased the plasma levels of acetone and 3-HB compared to VOO. Based on these findings, phenol-enriched OOs were shown to result in a favorable shift in the circulating metabolic phenotype, inducing a reduction in metabolites associated with cardiometabolic diseases.

The impact of the COVID-19 pandemic on alcohol-related emergency department visits in a large European city

Introduction: The COVID-19 (Coronavirus infectious disease 2019) pandemic has caused global behavioural changes due to the need to remain in quarantine by large groups of the population. Earlier work on the effects of other epidemics on the human psyche has revealed a possible increase in the number of people who abuse alcohol as a method of coping with mental stress. Despite this, the studies on the COVID-19 pandemic have not shown a clear correlation between lockdowns and quarantines and an increase in alcohol consumption. This study focused on examining the impact of the pandemic on the number of alcohol-related attendances in the Emergency Department in Poznan (Poland). Material and methods: The periods of one year before the pandemic (control trial) and the first year of the COVID-19 pandemic (study group) were analysed retrospectively using the data of ED patients who were under the documented influence of alcohol. Total number, alcohol concentration, waiting time for a medical examination, the patient’s aggressive behaviour, length of stay in the ED, the need for additional examinations, suturing wounds or endotracheal intubation were analysed. Results: 954 patients were identified, which constituted 2.9% of all patients admitted to the ED during this period (the total number of patients admitted was 33510). During the control period, the total number of ED admissions was 30388 and 794 (2.6%) of them were in the control group. The median body alcohol concentration was 2.6%%. It has been shown that during the pandemic more women and fewer men under the influence of alcohol were admitted to the ED (212 (22.2%) females and 742 (77.8%) males) than in the pre-pandemic period [135 (17.0%) females and 659 (83.0%) males]. Additional examinations were performed less frequently (84.1% vs. 73.9%; p = 0.00000) and patients were admitted to other departments more often (25.7% vs. 40.9%; p = 0.00000). Other examined parameters did not change significantly. Conclusions: The study shows an increase in the number of patients under the influence of alcohol during the pandemic presenting to the ED and a noticeable change in management patterns’ variables such as shorter LOW, fewer performed laboratory tests and more admissions to wards. However, this data requires further analysis and comparison with studies from other centres to draw more general conclusions.

A Randomized Controlled Double Blind clinical trial to evaluate the efficacy of Vedanasthapana Mahakashaya as an anxiolytic and analgesic polyherbal drug in perioperative anorectal cases

Introduction: In surgery, pre-operatively anxiolytic drugs and analgesics are very essential for major or minor surgical procedures to better operative and post-operative outcomes. The Vedanasthapana mahakashaya, described by the Acharya Charaka, is a group of 10 herbs and those herbs are advocated as analgesic, and anxiolytic polyherbal composition by various text books of ayurveda. So, the aim of this study was to evaluate and compare the efficacy of the Vedanasthapana mahakashaya as an analgesic drug during post operative period and as an anxiolytic drug for pre operative anxiety. Metarials &amp; Methods: The study was a prospective, randomized, double blind, controlled trial. 80 patients of anorectal diseases who undergone for surgical intervention were randomly allocated in one of two groups. Group-1 received Vedanasthapana mahakashaya kwath (Decoction), 30ml orally in preoperative and postoperative period while group-2 was treated with Tab. Alprazolam 0.25mg pre-operatively and Tab. Paracetamol 500 mg postoperatively. Anxiety was assessed on the basis of Anxiety score of Hospital Anxiety and Depression Scale (HADS) preoperatively and analgesia was assessed postoperatively by internationally validated Visual Analogue Scale. Inj. Diclofenac sodium 75mg IM was administered as a rescue analgesic. Results: Pain-baseline pain scores were not statistically differed in both groups. Both the groups showed statistically significant reduction in pain at the end of trial period. Both were found to be significantly similar (P 0.4856) but group-1 showed more reduction in pain 84.72% (P&lt;0.0001) than the group-2 which have 80.08% reduction in VAS score (P&lt;0.0001) Anxiety- The values of both the groups were showing statistically significant difference at different observational intervals but the reduction was significantly higher in group-2 (P&lt;0.0158). Conclusion: Administration of the Vedanasthapana mahakashaya decoction is effective for post operative pain relief but less effective for preoperative anxiety.

Acute effects of one-leg standing on arterial stiffness in older women: Role of the vision condition and standing dose.

Objective: One-leg standing has been used exclusively for static balance testing and training purposes. We investigated the acute effects of one-leg standing with open or closed eyes on arterial stiffness in older women and explored the role of standing dose in arterial stiffness regulation. Methods: Eighteen older women (60 ± 2 years) underwent non-intervention control (CON), one-leg standing with open eyes for 2 × 3 min (SO2), and one-leg standing with closed eyes for 1 × 3 min (SC1), 2 × 3 min (SC2), and 3 × 3 min trials (SC3) in a randomized self-controlled crossover fashion. Arterial stiffness in the cardio-ankle vascular index (CAVI) was measured at baseline (BL), immediately (0 min), and 10 and 20 min after standing. CAVI changes from BL in the same trial (⊿CAVI) were used for analysis. Results: ⊿CAVI of the non-standing and standing side did not change with time in CON and SO2 trials. In SC1, SC2, and SC3 trials, ⊿CAVI of the standing side decreased significantly at 0 min compared to their corresponding BL (p < 0.01) and reverted gradually to the BL level afterward, with ⊿CAVI of the non-standing side undergoing no changes. At the time point of 0 min, only in the SC2 trial, ⊿CAVI of the standing side was significantly lower than that of CON (p < 0.01). Conclusion: One-leg standing with closed eyes, but not with open eyes, resulted in transient arterial stiffness improvement in older women. The improvement was restricted to standing leg, and the moderate standing dose had maximal benefit on arterial stiffness.

Effect of compassion-focused therapy on self-criticism and self-soothing: A meta-analysis.

Compassion is oriented towards perceiving and relieving suffering. Hence, its development is beneficial for mental health. Many interventions aimed at cultivating compassion in patients have been empirically supported. This meta-analysis analyses the effectiveness of compassion-focused therapy (CFT) in decreasing self-criticism, a vulnerability factor that has been related to several mental health problems, and in increasing self-soothing. A literature search was conducted in the PsycInfo, Web of Science, Medline and Scopus databases, through which 7 controlled trials (N= 640) and 7 observational studies (N= 207) were retrieved. The results of the meta-analysis determine that CFT decreases the level of self-criticism and increases the ability to experience soothing. The size of the effect varies depending on the design of the study and the subscale of the test used to measure self-criticism (Forms of Self-Criticizing/Attacking and Self-Reassuring Scale). CFT has proven to be an effective intervention for reducing self-criticism. However, given that the number of studies is small and that only half of them are controlled trials, the results must be interpreted cautiously. More randomized controlled trials comparing CFT with other therapies are needed to determine the effect of this intervention on self-criticism with more scientific evidence.

Polyphenol-Rich Ginger (Zingiber officinale) for Iron Deficiency Anaemia and Other Clinical Entities Associated with Altered Iron Metabolism.

Ginger (Zingiber officinale) is rich in natural polyphenols and may potentially complement oral iron therapy in treating and preventing iron deficiency anaemia (IDA). This narrative review explores the benefits of ginger for IDA and other clinical entities associated with altered iron metabolism. Through in vivo, in vitro, and limited human studies, ginger supplementation was shown to enhance iron absorption and thus increase oral iron therapy’s efficacy. It also reduces oxidative stress and inflammation and thus protects against excess free iron. Ginger’s bioactive polyphenols are prebiotics to the gut microbiota, promoting gut health and reducing the unwanted side effects of iron tablets. Moreover, ginger polyphenols can enhance the effectiveness of erythropoiesis. In the case of iron overload due to comorbidities from chronic inflammatory disorders, ginger can potentially reverse the adverse impacts and restore iron balance. Ginger can also be used to synthesise nanoparticles sustainably to develop newer and more effective oral iron products and functional ingredients for IDA treatment and prevention. Further research is still needed to explore the applications of ginger polyphenols in iron balance and anaemic conditions. Specifically, long-term, well-designed, controlled trials are required to validate the effectiveness of ginger as an adjuvant treatment for IDA.

Anterior quadratus lumborum block does not reduce postoperative opioid consumption following laparoscopic hemicolectomy: a randomized, double-blind, controlled trial in an ERAS setting

Background and aimsAn opioid-sparing postoperative analgesic regimen following laparoscopic hemicolectomy is optimal to promote minimal postoperative pain, early mobilization, and improved quality of recovery. Various regional anesthesia techniques have been...