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[Clinical efficacy and safety of electroacupuncture at the motor area for Parkinson's disease with musculoskeletal pain: a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy and safety of electroacupuncture (EA) at the motor area for Parkinson's disease (PD) with musculoskeletal pain. METHODS: Fifty-eight patients with PD accompanied by musculoskeletal pain were randomly assigned to an EA group (29 cases, 1 case dropped out) and a sham EA group (29 cases, 1 case dropped out). The EA group was treated with EA at the motor area contralateral to the painful side (for bilateral pain, the left motor area was selected), using disperse-dense wave (2 Hz/20 Hz), with a current intensity of 1-2 mA, and needles were retained for 30 min. The sham EA group was treated with sham EA at non-acupoint area located 5-20 mm posterior to the motor area contralateral to the painful side. The connection mode was the same as that in the EA group, but no electrical current was delivered, and the needles were retained for 30 min. Both groups were treated once daily for 5 consecutive days. Visual analogue scale (VAS) for pain, unified Parkinson's disease rating scale part &#x2162; (UPDRS-&#x2162;), 24-item Hamilton depression rating scale (HAMD-24), Hamilton anxiety rating scale (HAMA), and 39-item Parkinson's disease questionnaire (PDQ-39) scores were evaluated before treatment, immediately after treatment, and at 2 and 4 weeks after treatment completion in the two groups. Safety was also assessed in the two groups. RESULTS: In both groups, VAS scores for pain after treatment and at 2 and 4 weeks after treatment completion were lower than those before treatment (P<0.01, P<0.05). VAS scores for pain in the EA group were lower than those in the sham EA group after treatment and at 2 and 4 weeks after treatment completion (P<0.05). In the EA group, UPDRS-&#x2162;, HAMD-24, HAMA, and PDQ-39 scores after treatment and at 2 and 4 weeks after treatment completion were lower than those before treatment (P<0.05, P<0.01). In the sham EA group, there were no statistically significant differences in UPDRS-&#x2162;, HAMD-24, HAMA, and PDQ-39 scores at any post-treatment time point compared with those before treatment (P>0.05). There were no statistically significant differences in UPDRS-&#x2162;, HAMD-24, HAMA, and PDQ-39 scores between the two groups at any post-treatment time point (P>0.05). No serious adverse events occurred during the trial. CONCLUSION: EA at the motor area could reduce pain intensity in patients with PD accompanied by musculoskeletal pain, and improve pain-related motor symptoms, emotional status, and quality of life, with a favorable safety profile.

Humans

Temporal evolution of minimally invasive pediatric urolithiasis treatment over 30 years.

Urolithiasis in children has increased substantially over the past 30 years, and surgical management maintains an important role in treatment. Technological advances such as lasers and miniaturization have broadened treatment options, and researchers investigate the best indications for each procedure. The aim was to identify publication trends in the field and explore reasons why Extracorporeal Shockwave Lithotripsy is being gradually less applied in the treatment of pediatric urolithiasis. A Reverse Systematic Review of the literature was conducted regarding the surgical treatment of urolithiasis in children. Five databases were screened, gathering all articles from inception that were evaluated in systematic reviews. We examined 123 publications, 197 reports, and 15,878 procedures, consisting of the largest studied population in the field. There was an increasing number of publications, although in progressively less prestigious journals. The number of studies on miniaturized percutaneous techniques and flexible ureteroscopy has increased closely with the rise in popularity of these procedures worldwide, mainly driven by studies from Asia, Europe, and North America. A trend of self-renewed interest is fueled by technological innovation and has led to fewer publications on Extracorporeal Shockwave Lithotripsy over the years. This review highlights the fact that, despite positive results in recent studies, the low popularity of ESWL within the scientific community is driving a decline in the technique's indications. Moreover, based on the findings of this study, key research priorities include continued reporting of high-quality outcomes, and technological progress in ESWL would contribute meaningfully to the field.

Humans

Novelty seeking and rapid symptom improvement across active and sham accelerated iTBS conditions: A pooled individual-patient data analysis.

INTRODUCTION: Major depressive disorder (MDD) is highly prevalent and often treatment-resistant. Accelerated intermittent theta burst stimulation (aiTBS) is a promising intervention for treatment-resistant depression (TRD), though outcomes vary. Personality traits have been examined in relation to rTMS outcomes, yet their role in aiTBS remains underexplored. This pooled individual-patient-data analysis of two randomized, sham-controlled trials examined associations between baseline Temperament and Character Inventory (TCI) traits and one-week symptom change, and whether they differed by condition. METHODS: The left dorsolateral prefrontal cortex was targeted for 20 sessions over 4&#xa0;days. Personality was assessed with the TCI, depression severity with the 17-item Hamilton Depression Rating Scale (HDRS-17). TCI-symptom-change associations were examined with a robust linear mixed-effects model, adjusting for age, gender, repeated measurements, and study membership. RESULTS: 104 participants were included (M/F 45/59; mean age 40.9&#xa0;&#xb1;&#xa0;12.7; active/sham 50/54). The model yielded a Time &#xd7; Novelty Seeking interaction (&#x3b2;&#xa0;=&#xa0;-1.70, p&#xa0;=&#xa0;0.021): higher baseline Novelty Seeking was associated with faster symptom reduction, without a between-arm difference. However, the interaction did not survive Holm correction across 14 trait-interaction tests (adjusted p&#xa0;=&#xa0;0.294) and is therefore exploratory. No other interaction reached the uncorrected threshold. CONCLUSIONS: Higher baseline Novelty Seeking showed a nominal association with faster symptom reduction, without a difference between active and sham conditions. Because it did not survive multiplicity correction and was not reproduced in within-arm analyses, it is preliminary and may reflect contextual or nonspecific processes. Independent replication is required before temperament assessment can be clinically informative.

Humans

MIS-TLIF Versus Open TLIF in Combined Lumbar Stenosis and Low-Grade Spondylolisthesis : Of Discharge Timing and Treatment Pricing.

STUDY DESIGN: An open-label, randomized, noninferiority clinical trial. OBJECTIVE: To determine the effectiveness of the MIS-TLIF over the O-TLIF in patients with symptomatic lumbar stenosis combined with low-grade spondylolisthesis by comparing the clinical efficacy and safety. SUMMARY OF BACKGROUND DATA: In patients with combined lumbar spinal stenosis and spondylolisthesis, it remains uncertain whether minimally invasive fusion surgery is noninferior to the open approach. MATERIALS AND METHODS: We conducted an open-label, noninferiority trial involving patients with symptomatic lumbar stenosis combined with low-grade spondylolisthesis. Patients were randomly assigned in a 1:1 ratio to undergo either MIS-TLIF or open TLIF surgery. The primary endpoint was the reduction in the Oswestry disability index (ODI) score from baseline to three months postsurgery, with a noninferiority margin of 12 points. Secondary outcomes included three-month changes from baseline in back and leg pain, neuropathic pain, satisfaction with treatment, intraoperative data, and cost-effectiveness. RESULTS: In the modified intention-to-treat population, the mean difference was 0.4, with the corresponding 90% CI of -5.7 to 6.5, having a lower bound below the noninferiority margin of 12. Similar results were obtained by analysis of the per-protocol population. 82.8% of patients achieved the MCID for the ODI. Results for secondary outcomes (clinical scales, complications) showed no significant differences between the treatment groups (all P >0.05). Although the open TLIF group had a hospital stay that was 1.5 days longer ( P =0.005) and required additional analgesia more frequently ( P =0.026), direct costs were 10.5% higher in the MIS-TLIF group ( P <0.001). CONCLUSIONS: This is the first high-quality study comparing open TLIF and MIS-TLIF with a validated primary endpoint. Among patients with combined lumbar degenerative stenosis and degenerative spondylolisthesis, MIS-TLIF resulted in clinical outcomes at three months that were noninferior to those with open TLIF.

Humans

Artificial intelligence in treatment prediction for skeletal Class III malocclusion: A systematic review.

In skeletal Class III patients, treatment options range from orthodontics to orthognathic surgery. Choosing the optimal approach requires a comprehensive clinical evaluation, which may be supported by AI tools. The aim of this study was to assess the performance of AI models in predicting the need for orthognathic surgery and in identifying predictors influencing treatment decisions. A PRISMA-guided electronic database search (PubMed, Web of Science; 2009-2024; English/French) was performed to identify studies using machine learning (ML) or deep learning (DL) on cephalometric and clinical data. After screening and assessment for eligibility, 15 studies were critically appraised. Model performance was summarized using accuracy, sensitivity, specificity, and the area under the curve (AUC). ML algorithms (particularly Random Forest and XGBoost) and DL models (ResNet-based convolutional neural networks (CNNs)) achieved high accuracy for predicting surgical need. Frequently selected predictors included Wits appraisal, ANB angle, the maxillomandibular ratio (Mx/Md), overjet, and the divergence of the lower gonial angle. AI methods show promise for assisting treatment decisions in Class III malocclusion, with Random Forest and XGBoost performing well on tabular cephalometric data and CNNs on imaging. Larger, multicentre datasets and external validation are needed to improve reliability, address bias, and support clinical implementation.

Humans

Endovascular treatment after stroke beyond 24&#xa0;h vs 6-24&#xa0;h: a propensity score-matched cohort study.

BACKGROUND: Endovascular thrombectomy (EVT) is the standard treatment for acute ischemic stroke due to anterior circulation large vessel occlusion (LVO) within 6-24&#xa0;h. However, the safety and feasibility of EVT for anterior circulation strokes beyond 24&#xa0;h remain uncertain. METHODS: We conducted a retrospective cohort study of consecutive patients with anterior circulation LVO who underwent EVT at Changhai Hospital from 2018 to 2023. Patients were stratified into late (6-24&#xa0;h) and very late (>24&#xa0;h) windows. Propensity score matching (PSM) was performed to adjust for baseline imbalances, including age, sex, NIHSS, ASPECTS, occlusion location, perfusion parameters, and vascular risk factors. The primary outcome was functional independence (modified Rankin Scale [mRS]&#xa0;&#x2264;&#xa0;2) at 3&#xa0;months. Secondary outcomes included successful reperfusion (TICI 2b-3) and symptomatic intracranial hemorrhage (sICH). RESULTS: Among 1043 screened patients, 429 patients with anterior circulation LVO were included after exclusions, comprising 373 in the late window and 56 in the very late window. PSM yielded 42 matched pairs. Compared with the late window group, the very late window group showed no statistically significant differences in functional independence (54.8% vs. 57.1%; OR&#xa0;=&#xa0;0.908, 95% CI 0.382-2.153, p&#xa0;=&#xa0;0.830), successful reperfusion (88.1% vs. 92.9%; OR&#xa0;=&#xa0;1.800, 95% CI 0.481-7.096, p&#xa0;=&#xa0;0.460), sICH (2.4% vs. 9.5%; OR&#xa0;=&#xa0;0.232, 95% CI 0.012-1.652, p&#xa0;=&#xa0;0.200), intraprocedural complications (26.2% vs. 19.0%; OR&#xa0;=&#xa0;1.508, 95% CI 0.540-4.362, p&#xa0;=&#xa0;0.440), or postoperative complications (33.3% vs. 35.7%; OR&#xa0;=&#xa0;0.900, 95% CI 0.363-2.219, p&#xa0;=&#xa0;0.820). CONCLUSIONS: In this selected, single-center cohort of anterior circulation LVO patients undergoing EVT, treatment initiated beyond 24&#xa0;h appeared to have comparable effectiveness and safety to treatment initiated within 6-24&#xa0;h. Definitive evidence requires confirmation from adequately powered randomized controlled trials.

Humans

Heterogeneity in Teriflunomide Treatment Arms: A Systematic Review and Meta&#x2011;Regression of Randomised Multiple Sclerosis Trials.

BACKGROUND: Teriflunomide is widely used as an active comparator in Phase 3 randomised trials for relapsing multiple sclerosis (RMS). Temporal changes in disease activity within teriflunomide-treated cohorts have not been systematically examined. OBJECTIVES: To assess temporal trends in relapse and disability outcomes across teriflunomide arms of Phase 3 multiple sclerosis (MS) trials and identify predictors of between-trial heterogeneity. METHODS: We performed a systematic review and meta-analysis of Phase 3 randomised controlled trials including a teriflunomide arm. PubMed, Scopus, and ClinicalTrials.gov were searched up to October 2025. Annualised relapse rate (ARR) and 12- and 24-week confirmed disability worsening (CDW) were extracted together with baseline characteristics. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Random-effects meta-analyses, meta-regression, and sensitivity analyses were performed. RESULTS: Twelve teriflunomide cohorts from eight trials involving 4,900 adults with RMS were included. ARR ranged from 0.11 to 0.37 with substantial heterogeneity (I2 = 94%). Trial start year was inversely associated with ARR and explained a large proportion of between-study variability in exploratory meta-regression analyses. Confirmed disability worsening outcomes also showed substantial heterogeneity with a weaker trend toward lower event rates in more recent trials. CONCLUSION: Teriflunomide-treated trial populations have shifted toward lower relapse activity over time, and trial start year was the principal predictor of between-trial heterogeneity in ARR in exploratory analyses. These findings most plausibly reflect evolving recruitment and diagnostic practices rather than changes in drug efficacy. Accounting for these temporal dynamics is essential when interpreting outcomes from RMS trial using teriflunomide as comparator.

Humans

Hyperbaric oxygen for the treatment of traumatic incomplete spinal cord injury: a systematic review and meta-analysis of randomized controlled trials.

The therapeutic efficacy of hyperbaric oxygen therapy for traumatic incomplete spinal cord injury remains a subject of debate. To comprehensively evaluate the impact of hyperbaric oxygen on motor function, sensory function, and activities of daily living in patients with traumatic incomplete spinal cord injury, we conducted a systematic review and meta-analysis. We performed a comprehensive search across PubMed, Embase, the Cochrane Library, Web of Science, and major Chinese databases for randomized controlled trials published through June 2025. A total of 15 randomized controlled trials were included. The pooled results indicated that hyperbaric oxygen therapy significantly improved the American Spinal Injury Association motor score (mean difference = 10.30, 95% confidence interval: 7.70-12.90), the total American Spinal Injury Association sensory score (mean difference = 29.29, 95% confidence interval: 18.82-39.75), the American Spinal Injury Association light touch score (mean difference = 9.84, 95% confidence interval: 6.15-13.53), and the American Spinal Injury Association pinprick score (mean difference = 8.75, 95% confidence interval: 4.40-13.11). Furthermore, hyperbaric oxygen therapy was associated with significant enhancements in the Barthel Index (mean difference = 16.60, 95% confidence interval: 10.51-22.68) and the Functional Independence Measure (mean difference = 17.41, 95% confidence interval: 10.83-23.98). In conclusion, adjunctive hyperbaric oxygen therapy appears to improve motor function, sensory function, and activities of daily living in patients with traumatic incomplete spinal cord injury compared to conventional treatments alone. However, due to methodological limitations and potential publication bias in the included studies, these findings should be interpreted with caution, and further high-quality, multi-center randomized controlled trials are warranted.

Humans

Meta-analysis and pharmacoeconomic study of rasagiline versus selegiline in the treatment of Parkinson's disease.

OBJECTIVE: Given the persistent absence of direct head-to-head trials, this study aimed to evaluate the comparative efficacy, safety, and cost-effectiveness of rasagiline versus selegiline as early-stage monotherapy for Parkinson's disease (PD), informing clinical selection and healthcare policies in China. METHODS: A systematic search of PubMed, Embase, and the Cochrane Library identified randomized controlled trials (RCTs) up to April 2026. Focusing on short-term outcomes (10-16&#x2009;weeks), an adjusted indirect treatment comparison (ITC) using placebo as a common anchor evaluated symptom improvement (UPDRS total scores) and adverse event (AE) incidence. For economic evaluation, a 2-year Markov model was constructed from a Chinese healthcare-system perspective. The incremental cost-effectiveness ratio (ICER) was calculated alongside robust sensitivity analyses. RESULTS: Ten RCTs (rasagiline: 6; selegiline: 4) were included. The ITC revealed no statistically significant differences between rasagiline and selegiline in short-term symptomatic relief (Mean Difference&#x2009;=&#x2009;-0.82, 95% CI [-2.08, 0.44], p&#x2009;=&#x2009;0.203) or AE risk (Odds Ratio = 0.83, 95% CI [0.50, 1.38], p&#x2009;=&#x2009;0.475). The overall evidence certainty was rated as moderate. Economically, the base-case simulation indicated rasagiline yielded a marginal benefit of 0.0088 QALYs over selegiline but incurred an additional 17,111.10 Yuan. This resulted in an ICER of 1,951,505.55 Yuan/QALY, substantially exceeding the conventional willingness-to-pay threshold. CONCLUSION: Supported by moderate-certainty evidence, rasagiline and selegiline provide comparable short-term efficacy and safety for early-stage PD monotherapy. However, at its current pricing, rasagiline is not cost-effective. Significant price reductions or definitive proof of long-term superiority are required to justify its economic value.

Humans

Cannabis and cannabinoids for the treatment of mental and substance use disorders and symptoms: A systematic review and meta-analysis of experimental and observational studies.

BACKGROUND: Interest in cannabinoids for mental and substance use disorders is increasing. We examined experimental and observational evidence for treating these disorders and their symptoms. METHODS: Systematic review and meta-analysis (PROSPERO CRD42023467536). We searched CENTRAL, MEDLINE, Embase and PsycINFO to May 2025 for studies of cannabinoids in adults (&#x2265;18 years) with ADHD, anxiety, depression, PTSD, psychosis or Tourette syndrome, or alcohol, cannabis, opioid or tobacco use disorders. Two reviewers screened, extracted and assessed quality using a risk-of-bias tool and GRADE. RESULTS: We included 82 experimental and 118 observational studies. In RCTs, cannabinoids reduced anxiety symptoms (SMD=-0.40; 95% CI: -0.57, -0.23; I&#xb2;=90%) and, in one small trial, PTSD symptoms (SMD=-2.60; 95% CI: -4.58, -0.62; n=20), with trivial-to-no effect on depression (SMD=-0.20; 95% CI: -0.43, 0.04; I&#xb2;=91.6%), ADHD, psychosis and Tourette syndrome. Much anxiety and depression evidence came from symptoms measured as secondary outcomes in other primary conditions. Cannabinoids worsened cannabis use disorder severity in one RCT (SMD=2.35; 95% CI: 1.49, 3.21), with no effect on craving or withdrawal; evidence for alcohol, opioid and tobacco use disorders was very limited. Observational studies suggested improvements but had high risk of bias. The only significant safety finding was increased withdrawals due to adverse events with THC (OR=2.78; 95% CI: 1.66, 4.65). Certainty was predominantly very low. DISCUSSION: The evidence base shows very low certainty, high heterogeneity and methodological limitations, and is insufficient to support cannabinoids as first-line treatment. Signals for anxiety and PTSD are limited by indirectness and low certainty; no benefit was evident for depression; THC-related safety signals warrant careful consideration.

Humans

Implementing Prolonged Exposure Therapy in a Community Substance Use Treatment Program: A Qualitative Study.

INTRODUCTION: Post-traumatic stress disorder (PTSD) commonly co-occurs with substance use disorders (SUD), yet few community-based SUD programs incorporate evidence-based trauma-focused. Prolonged exposure (PE), including its massed format (M-PE) with session frequency of 3-4 times per week, is a gold standard intervention for PTSD; however, concerns about client readiness, logistical demands and relapse risk have limited its adoption within SUD settings. This study examined staff perspectives on the feasibility and acceptability of integrating M-PE into a community-based SUD program. METHODS: Prior to launching a Hybrid Type 1 effectiveness-implementation trial (Project COMET), we conducted semi-structured virtual interviews with 15 community clinic staff: providers (n&#x2009;=&#x2009;8), administrators (n&#x2009;=&#x2009;2) and peer specialists (n&#x2009;=&#x2009;5). Interviews were recorded, transcribed and analysed using a rapid qualitative analysis framework with matrix techniques to compare themes across roles. RESULTS: Four overarching themes captured staff perspectives on integrating M-PE: (Theme 1) Prior Knowledge and Experiences: Most staff were familiar with EMDR, while direct knowledge of PE/M-PE was limited. (Theme 2) Perceptions of M-PE: M-PE was widely viewed as a promising, structured intervention that fits the pacing and duration of SUD care. (Theme 3) Symptom Reduction and Client Impact: Staff anticipated improvements in PTSD and SUD symptoms through trauma-focused treatment. (Theme 4) Barriers and Constraints: Participants identified several potential implementation challenges, including logistical barriers and client readiness. DISCUSSION AND CONCLUSIONS: Findings suggest that staff generally viewed M-PE favourably but emphasised the importance of ensuring client readiness and organisational support. Enhancing feasibility and long-term sustainability may require expanded psychoeducation, targeted provider training and flexible delivery models. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06968832.

Adult

Efficacy of afoxolaner (NexGard&#xae;) for the treatment of myiasis caused by the zoonotic tumbu fly, Cordylobia anthropophaga, in domestic dogs under field conditions.

Cordylobia anthropophaga is a major cause of furuncular myiasis in dogs and humans in sub-Saharan Africa, yet evidence for pharmacological control remains limited. Current management relies mainly on mechanical larval removal, and no controlled studies have assessed the efficacy of modern antiparasitic agents. This study evaluated the curative and preventive efficacy of a single dose of afoxolaner (NexGard&#xae;) in dogs with naturally acquired C. anthropophaga infestation under field conditions and explored a possible indirect protective effect in puppies after maternal treatment. A randomized, blinded, negative-controlled field study was conducted in Samburu County, Kenya, and included 104 naturally infested dogs allocated to a treated group (n&#x202f;=&#x202f;53) or an untreated control group (n&#x202f;=&#x202f;51). Clinical evaluations were performed on Days 0, 15 (&#xb1;2), 30 (&#xb1;2), and 45 (&#xb1;2). Efficacy was assessed based on the presence of active nodules and clinical scores. Additional observational data were collected from puppies born to or nursing from treated bitches. Compared to the control group, parasiticide efficacy was 94% on Day 15 and 100% on Day 30. The number of parasite-free dogs reached 86.3% on Day 15, 100% on Day 30, and 95.3% on Day 45. Treated dogs showed a significant clinical improvement from the first post-treatment assessment, whereas infestation persisted in controls (nodules: OR = 0.003, 95% CI 0.001-0.017; skin lesions: OR = 0.010, 95% CI 0.002-0.051; lymph node: OR = 0.013, 95% CI 0.002-0.074; body condition: OR = 0.073, 95% CI 0.027-0.195; all p&#x202f;<&#x202f;.001), with large effect sizes at the final visit for all outcomes (r&#x202f;=&#x202f;0.521-0.793). No C. anthropophaga infestations were detected in examined puppies from treated dams, including puppies exposed during pregnancy or lactation, up to 4 weeks after birth and up to 11 weeks of age, respectively. Afoxolaner appears effective to control canine cordylobiosis and may offer indirect protection to puppies, warranting further investigation.

Animals

Treatment of Established Groin Lymphatic Complications After Arterial Surgery: A Systematic Review.

BACKGROUND: To systematically review the effectiveness and safety of interventions for established groin lymphatic complications after arterial vascular surgery. METHODS: PubMed, Embase, and Cochrane CENTRAL were searched from inception to May 28, 2025. This review was registered in PROSPERO (CRD420251061708) and conducted according to PRISMA, PRISMA-S, and Synthesis Without Meta-analysis (SWiM) guidance. Eligible studies included adults with established groin lymphorrhea/lymphocutaneous fistula or seroma/lymphocele after arterial exposure in the common femoral or iliofemoral region. Prophylactic studies were excluded. Two reviewers independently screened studies and assessed full texts. Prespecified outcomes were resolution, time to resolution, length of stay, surgical site infection, wound complications, reintervention, and recurrence. Owing to substantial heterogeneity, meta-analysis was not performed. RESULTS: Eighteen retrospective single-center studies were included; no randomized trials were identified. Reported strategy-family totals were operative control (n = 240, including 55 dye-assisted cases), intranodal lymphangiography with glue embolization (n = 39), intracavitary or chemical instillation (n = 52), negative-pressure wound therapy (n = 20), radiotherapy (n = 206), and drainage or aspiration alone (n = 7). One additional cohort compared nonsurgical with surgical management. Definitions, follow-up windows, and statistical reporting were inconsistent, and arm-level denominators were frequently incomplete. Risk of bias was serious to critical across the evidence base, mainly because of retrospective design, confounding by indication, treatment-selection bias, inconsistent outcome definitions, and incomplete reporting. Using GRADE principles, certainty of evidence was very low across strategies and phenotypes. Across study arms, conduit-directed approaches for external leak and cavity-directed approaches for encapsulated collections often achieved control, but valid comparative inference was not possible. CONCLUSION: Evidence is limited to small retrospective series with heterogeneous definitions, serious to critical risk of bias, and very low certainty. Reliable comparisons between interventions cannot currently be made. Standardized phenotype-specific definitions and outcome reporting are needed to support prospective studies and future trials.

Humans

Craniotomy versus Endoscopic Membranectomy in the Treatment of Non-Homogeneous Chronic Subdural Hematoma: A Pilot Randomized Parallel-Group Active-Controlled Trial (EMiT CSDH 2).

BACKGROUND: Chronic subdural hematoma (CSDH) is a prevalent neurosurgical condition with persistent challenges related to recurrence. Endoscopic membranectomy (EM) has shown promising results in managing symptomatic non-homogenous (SNH)-CSDH, but comparative evidence against craniotomy with membranectomy (CM) is lacking. OBJECTIVES: To compare the safety and efficacy of EM versus CM in managing SNH-CSDH. MATERIALS AND METHODS: A pilot randomized parallel-group active-controlled open- labeled superiority trial from September 2023 to November 2024 at Government Kilpauk Medical College, Chennai, India. Sixty patients with SNH-CSDH were randomized into EM and CM groups. Recurrence was the primary outcome. Secondary outcomes included operative time, complications, radiological indices, pain, hospital stay, and functional recovery. All patients were followed for six months. RESULTS: No recurrence was observed in either group at six months. Two CM patients required reoperation on postoperative day one ( P = 0.15). EM was associated with shorter operative time ( P = 0.02), lower incidence of post-operative subdural residual fluid ( P = 0.015), better early hematoma reduction/subdural space reduction index ( P = 0.008), midline shift/symmetry improvement index ( P = 0.001), and lesser surgical site swelling ( P < 0.001). All patients were ambulant and had a Glasgow coma scale (GCS) 15 at discharge and at six months (including reoperated patients). Pain scores and functional recovery were comparable. EM patients had shorter hospital stays ( P = 0.004) and no significant complications. CONCLUSION: EM demonstrated favorable early radiological outcomes, fewer complications, and comparable functional recovery and recurrence versus CM in SNH-CSDH. Independent reproduction and larger multicentric trials are needed for validity and generalizability.

Humans

[Comparative analysis of comprehensive treatment outcomes in patients with chronic bacterial prostatitis with the addition of the multicomponent complex AndrOPREN].

INTRODUCTION: Type II chronic bacterial prostatitis is characterized by persistent infection, insufficient efficacy of standard therapy, and a high recurrence rate, which necessitates the search for additional treatment options. AIM: To evaluate the efficacy and safety of adding the multicomponent complex AndrOPREN to comprehensive therapy for type II chronic bacterial prostatitis. MATERIALS AND METHODS: This prospective, comparative, randomized study included 233 patients allocated to the main group (n=126) and the control group (n=107). In both groups, patients received standard therapy; men in the main group additionally received the multi-ingredient complex AndrOPREN at a dose of two capsules of No. 1 and two capsules of No. 2 daily for 1-2 months. The follow-up period was 60 days. Changes in symptoms according to the IPSS and QoL scores, urinalysis parameters, microscopy findings of expressed prostatic secretions, pathogen eradication, and biochemical safety parameters were assessed. RESULTS: Improvement was observed in both groups and was more pronounced in the main group. By day 14, the median IPSS score was 14.0 [12.0; 16.0] vs. 18.0 [15.0; 20.0] in the control group (p<0.001); by day 60, the corresponding values were 7.0 [5.0; 9.0] and 11.0 [9.0; 13.0] (p<0.001). At the end of follow-up, the QoL score was 2.0 [1.0; 2.0] and 3.0 [2.0; 3.0], respectively. No microbial growth was detected in 91.2% and 80.4% of patients, respectively (p=0.026); Escherichia coli eradication was achieved in 91.7% and 76.9%, respectively. No biochemical changes indicative of nephrotoxicity or hepatotoxicity were detected. DISCUSSION: The addition of the multicomponent complex AndrOPREN was associated with more rapid symptom resolution, a reduction in inflammatory changes, restoration of the secretory function of the prostate, and greater microbiological efficacy. CONCLUSION: The addition of the multicomponent complex AndrOPREN to comprehensive therapy for type II chronic bacterial prostatitis improves treatment efficacy while maintaining a favorable safety profile.

Humans

Comparative efficacy of percutaneous vertebroplasty combined with minimally invasive pedicle screw fixation versus percutaneous vertebroplasty alone in the treatment of elderly osteoporotic vertebral compression fractures.

The study aimed to assess the comparative efficacy of percutaneous vertebroplasty (PVP) combined with minimally invasive pedicle screw fixation versus PVP alone in elderly patients with osteoporotic vertebral compression fractures (OVCF). Ninety-four elderly patients with OVCF were randomly classified into the control (47 patients) and combined (47 patients) groups. The control group received PVP, while the combined group received PVP combined with minimally invasive pedicle screw fixation. Perioperative indicators such as intraoperative blood lose, operative time, and hospitalization time were recorded. Pain was assessed using the VAS before and at baseline and 1, 3, and 7 days postoperatively. At 1 and 3 days postoperatively, Serum CRP levels, WBC, and neutrophil counts were measured postoperatively. Radiographic outcomes (vertebral height ratio and Cobb angle), ADL scores, JOA scores, and ODI were evaluated preoperatively and at 3 months post-operation. Postoperative complications were documented. Baseline characteristics were comparable. The combined group showed superior pain relief, vertebral height restoration, Cobb angle correction, functional recovery, and reduced inflammatory markers (CRP, WBC, neutrophils) postoperatively (all P&#x2009;<&#x2009;0.05). Blood loss and hospital stay were shorter in the combined group, though operative time was longer (P&#x2009;<&#x2009;0.05). Complication rates did not differ significantly (P&#x2009;>&#x2009;0.05). PVP combined with minimally invasive pedicle screw fixation yields better outcomes in elderly OVCF patients by enhancing pain control, vertebral height, and functional recovery without increasing perioperative risk.

Humans

Electro-clinical efficacy and safety of midazolam in neonatal seizures: a systematic review with individual level exploratory analysis of gestational age-related treatment response.

UNLABELLED: Neonatal seizures are the most common neurological emergency during the neonatal period and are associated with increased mortality and adverse neurodevelopmental outcomes. Despite current recommendations supporting phenobarbital as first-line therapy, seizure control remains suboptimal in a large proportion of neonates, prompting the use of second-line antiseizure medications. Midazolam is increasingly administered in refractory neonatal seizures but evidence regarding its electro-clinical efficacy and safety remains limited and heterogeneous. To systematically review the available evidence on the electro-clinical efficacy and safety of midazolam in neonatal seizures and to perform an exploratory individual-level analysis investigating the association between gestational age and treatment response. A systematic review was conducted according to PRISMA 2020 guidelines. Studies including neonates with EEG- or aEEG-confirmed seizures treated with midazolam were included. Binary logistic regression was performed to assess the individual-level association between gestational age and treatment response. Eleven studies involving 146 neonates treated with midazolam were included. Electro-clinical response was observed in 101/146 neonates (69.2%), while seizure cessation was achieved in 61/146 neonates (41.8%). In an exploratory complete-case logistic regression analysis, higher gestational age appeared to be associated with a greater probability of electro-clinical response. The predicted probability curve crossed the 50% response probability at approximately 36.5&#xa0;weeks of gestation. Hypotension was the most frequently reported adverse event, while respiratory depression, sedation-related effects, and transient EEG/aEEG suppression were reported less frequently. CONCLUSIONS: Midazolam may have a role as an add-on antiseizure medication in neonatal seizures, particularly in refractory cases. However, the evidence remains limited by heterogeneity in study design, EEG monitoring strategies, outcome definitions, and incomplete individual-level data. The observed association between gestational age and response is hypothesis-generating and requires prospective validation. WHAT IS KNOWN: &#x2022; Phenobarbital often provides incomplete seizure control in neonates, making second-line antiseizure therapies necessary in refractory cases. &#x2022; Evidence supporting midazolam for neonatal seizures remains limited and heterogeneous. WHAT IS NEW: &#x2022; This systematic review summarizes the electro-clinical efficacy and safety of midazolam and includes an exploratory patient-level analysis suggesting that higher gestational age may be associated with improved treatment response. &#x2022; These findings support further prospective studies on developmental determinants of response to GABAergic therapy.

Humans

A randomized trial of omega-3 fatty acids plus inositol versus N-acetylcysteine for the treatment of depression and mania in emotionally dysregulated youth age 5-17 with and without autism traits.

The aim of this study was to assess the effectiveness of the nutraceutical treatments combined omega-3 fatty acid plus inositol (O3I) versus N-acetylcysteine (NAC) in children and adolescents with emotional dysregulation and the impact of the co-occurrence of autism traits (AT). Participants were male and female children (5-17) with emotional dysregulation and the presence/absence of AT, as defined by Child Behavior Checklist score, randomized to receive open-label O3I (1020&#xa0;mg EPA and 1000-2000&#xa0;mg Inositol) or NAC (1800-2700&#xa0;mg) daily for 6&#xa0;weeks. Clinicians measured severity and improvement of depression and mania with the NIMH Clinical Global Improvement Scale (CGI). Parents completed Parent-Youth Mania Rating Scale (P-YMRS) and Children's Depression Inventory (CDI). Both O3I and NAC resulted in modest improvements in mania and depression and did not differ significantly in between group comparison in their effectiveness. Participants taking O3I, but not NAC, demonstrated statistically significant within group improvement in depression per CDI. Participants taking NAC had a greater decrease in P-YMRS scores versus O3I, but the difference did not reach statistical significance. In the presence of AT, NAC was more effective than O3I for mania but not for depression. Further, participants taking NAC, but not O3I, demonstrated significant within group improvement in SRS and BRIEF scores. These results suggest that O3I and NAC may be beneficial for mania and depression in youth, with trends towards O3I more effective for depression and NAC more effective for mania. The presence of AT in youth with emotional dysregulation may moderate the impact of NAC.

Humans