High-quality Randomized Clinical Trials Research Articles

Effectiveness of Alternative Nostril Breathing on Blood Pressure: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Hypertension, a significant risk factor for cardiovascular disease, has a high prevalence rate globally. While drug use is the most common approach, lifestyle improvements are crucial. Recently, there has been a notable upsurge of interest in various breathing methods, including device-induced breathing techniques like Resperate. However, the reliance on a device for these techniques has prompted the popularity of alternative breathing methods that can be performed without any external devices. One such method that has gained significant attention is alternative nostril breathing, which serves as an alternative medical treatment known for its effectiveness in reducing blood pressure. Therefore, this study aimed to systematically investigate the therapeutic effects of alternate nostril breathing. We selected 16 articles published in English, Korean, and Chinese databases, of which 14 met the eligibility criteria, and a systematic literature review was conducted. A meta-analysis was conducted on six qualified studies. Meta and sensitivity analyses were conducted using a random effects model of six randomized clinical trials (RCTs). Results of alternative nostril breathing (ANB) on 1,377 participants have been reported based on the effects of systolic and diastolic blood pressure (SBP and DBP). Both the lone ANB and combined yoga programs resulted in significant reductions in SBP and DBP. Meta-analysis of the 6 trials with 525 participants demonstrated that ANB was better in reducing SBP than that of the control group (non-intervention or placebo) (mean difference [MD]: -7.16, 95% confidence interval [CI]: -7.86 to -6.45, I2:93%). Moreover, ANB was better in reducing DBP than that of the control group (non-intervention or placebo) (MD: -5.16, 95% CI: -5.89 to -4.44, I2:87%). The results of the study are valid, however, attention is needed when interpreting the results because the heterogeneity exceeds 75%. A systematic review of 14 studies found that ANB can improve cardiovascular indicators, such as SBP and DBP, as well as non-cardiovascular factors, such as fatigue, intraocular pressure, and memory. However, the review noted that implementing double blinding in studies on yoga breathing intervention is difficult, and most studies were not double-blinded, suggesting the need for high-quality RCTs in the future. Registration: CRD42023401177.

A critical analysis of the effect of OM-85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta-analysis.

Acute respiratory tract infections (RTIs) are one of the most common causes of pediatric consultations/hospitalizations and a major trigger for asthma exacerbations. Some consensus statements have recommended the use of immunostimulants to boost natural defenses against severe or repeated infections. One of the most common immunostimulants is OM-85; while several randomized clinical trials (RCTs) have evaluated its efficacy in preventing acute RTIs and wheezing/asthma exacerbations, results have been conflicting. Similarly, various systematic reviews with meta-analyses (SRMs) on OM-85 have used different strategies, populations, and outcomes; moreover, SRM conclusions are limited when the original studies are highly heterogeneous or have a low quality, hindering the generalizability of the findings. Here we summarize the evidence on the effect of OM-85 to prevent acute RTIs, wheezing/asthma episodes, or loss of asthma control in children, by including and critically evaluating all SRMs published to date. We searched for SRMs on OM-85 in three publication databases and found nine SRMs (seven for RTI, and two for wheezing/asthma). Among those, one had a high confidence evaluation of quality (AMSTAR-2 tool) and found a reduction in the total number of acute RTIs among the OM-85 group. Overall, no strong recommendations can be derived from the existing literature, mainly due to the high heterogeneity among included RCTs and SRMs. Further, large, high-quality RCTs are needed to confirm the true efficacy of OM-85 for the prevention of acute RTIs, asthma development, and asthma exacerbations.

Anticoagulant and antiplatelet treatment effects on the incidence of major cardiovascular events in patients with coronary artery ectasia: an updated systematic review

IntroductionCoronary artery ectasia (CAE), widenings in sections of the arteries, is a rare condition found in up to 3-5% of angiography cases. Sometimes recurrence of major adverse cardiac events (MACE) has been reported in the CAE subjects. The present systematic review aims to collect and summarize reports on whether the use of anticoagulants in addition to single antiplatelet/dual antiplatelet therapy (SAPT/DAPT) in CAE patients with significant occlusion/ heavy thrombus is efficient and safe in decreasing the incidence/recurrence of MACE. Material and MethodsA systematically comprehensive search was performed covering PubMed, Scopus, ISI Web of Science, and Google Scholar databases. ResultsTwenty-five studies were found including 20 case reports, four case series, and one randomized clinical trial. Of 20 case reports 15 were male (75%), and five were female (25%). Of the four the case series, all showed positive outcomes after DAPT plus anticoagulant in more than 50% of patients; two took only DAPT and 13 took anticoagulant ± DAPT, and five compared both. Cases received DAPT only experienced recurrences of MACE. The other cases were uneventful with less MACE and better outcomes after the use of anticoagulant ± DAPT. Results of these case-series included 457 CAE patients showed that more than 80% of subjects were male, and in all studies tailored pharmacological interventions, including antiplatelet and anticoagulant (warfarin) therapies, resulted in less MACE and mortality. ConclusionIt can be concluded that antiplatelet (SAPT/DAPT) must be applied in combination with anticoagulants to provide more efficient protection against MACE in CAE patients. However, further high-quality randomized clinical trials are needed to confirm the results.

Palatal Graft Harvesting Site Healing and Pain Management: What Is the Best Choice? An Umbrella Review

The use of free gingival graft (FGG) and connective tissue graft (CTG) from the palate are among the most predictable periodontal and peri-implant plastic surgery procedures. However, palatal harvesting causes severe discomfort in the palatal area in patients undergoing harvesting. The aim of this umbrella review is to evaluate which products or techniques can result in fewer side effects and less morbidity in patients. Systematic reviews, with meta-analysis or not, about postoperative pain and wound healing in patients undergoing surgery to remove a free gingival graft or connective tissue graft from the palatal region, published only in the English language, were electronically searched for on BioMed Central, Scopus, MEDLINE/PubMed, the Cochrane library databases, and PROSPERO register. Of 1153 titles, only 7 articles were included in this review. The reviews included suggest that the more effective interventions for patient-reported outcomes, particularly for pain management, are cyanoacrylate adhesives, platelet-rich fibrin, hyaluronic acid, and the use of palatal stents. Low-level laser therapy also demonstrated good results in palatal wound healing speed after FGG procedures. Also, topical agents were also described. Future studies and more high-quality randomized clinical trials are needed to provide clear descriptions and standardized procedures of interventions to obtain clear results.

Safety and Efficacy of Epithelium-Off Corneal Collagen Cross-Linking for the Treatment of Corneal Ectasia: A Report by the American Academy of Ophthalmology

To review the evidence on the safety and effectiveness of epithelium-off corneal collagen cross-linking (CXL) for the treatment of progressive corneal ectasia. A literature search of the PubMed database was most recently conducted in March 2024 with no date restrictions and limited to studies published in English. The search identified 359 citations that were reviewed in abstract form, and 43 of these were reviewed in full text. High-quality randomized clinical trials comparing epithelium-off CXL with conservative treatment in patients who have keratoconus (KCN) and post-refractive surgery ectasia were included. The panel deemed 6 articles to be of sufficient relevance for inclusion, and these were assessed for quality by the panel methodologist; 5 were rated level I, and 1 was rated level II. There were no level III studies. This analysis includes 6 prospective, randomized controlled trials that evaluated the use of epithelium-off CXL to treat progressive KCN (5 studies) and post-laser refractive surgery ectasia (1 study), with a mean postoperative follow-up of 2.4 years (range, 1-5 years). All studies showed a decreased progression rate in treated patients compared with controls. Improvement in the maximum keratometry (Kmax) value, corrected distance visual acuity (CDVA), and uncorrected distance visual acuity (UDVA) was observed in the treatment groups compared with control groups. A decrease in corneal thickness was observed in both groups but was greater in the CXL group. Complications were rare. Epithelium-off CXL is effective in reducing the progression of KCN and post-laser refractive surgery ectasia in most treated patients with an acceptable safety profile. Proprietary or commercial disclosure may be found after the references.

Differential Outcomes of Placebo Treatment Across 9 Psychiatric Disorders

Placebo is the only substance systematically evaluated across common psychiatric diagnoses, but comprehensive cross-diagnostic comparisons are lacking. To compare changes in placebo groups in recent high-quality randomized clinical trials (RCTs) across a broad spectrum of psychiatric disorders in adult patients. MEDLINE and the Cochrane Database of Systematic Reviews were systematically searched in March 2022 for the latest systematic reviews meeting predetermined high-quality criteria for 9 major psychiatric diagnoses. Using these reviews, the top 10 highest-quality (ie, lowest risk of bias, according to the Cochrane Risk of Bias tool) and most recent placebo-controlled RCTs per diagnosis (totaling 90 RCTs) were selected, adhering to predetermined inclusion and exclusion criteria. Following the Cochrane Handbook, 2 authors independently carried out the study search, selection, and data extraction. Cross-diagnosis comparisons were based on standardized pre-post effect sizes (mean change divided by its SD) for each placebo group. This study is reported following the Meta-analysis of Observational Studies in Epidemiology (MOOSE) reporting guideline. The primary outcome, pooled pre-post placebo effect sizes (dav) with 95% CIs per diagnosis, was determined using random-effects meta-analyses. A Q test assessed statistical significance of differences across diagnoses. Heterogeneity and small-study effects were evaluated as appropriate. A total of 90 RCTs with 9985 placebo-treated participants were included. Symptom severity improved with placebo in all diagnoses. Pooled pre-post placebo effect sizes differed across diagnoses (Q = 88.5; df = 8; P < .001), with major depressive disorder (dav = 1.40; 95% CI, 1.24-1.56) and generalized anxiety disorder (dav = 1.23; 95% CI, 1.06-1.41) exhibiting the largest dav. Panic disorder, attention-deficit/hyperactivity disorder, posttraumatic stress disorder, social phobia, and mania showed dav between 0.68 and 0.92, followed by OCD (dav = 0.65; 95% CI, 0.51-0.78) and schizophrenia (dav = 0.59; 95% CI, 0.41-0.76). This systematic review and meta-analysis found that symptom improvement with placebo treatment was substantial in all conditions but varied across the 9 included diagnoses. These findings may help in assessing the necessity and ethical justification of placebo controls, in evaluating treatment effects in uncontrolled studies, and in guiding patients in treatment decisions. These findings likely encompass the true placebo effect, natural disease course, and nonspecific effects.

Efficacy and safety of upstream unfractionated heparin compared with downstream administration in ST-elevation myocardial infarction patients undergoing percutaneous coronary intervention

Abstract Funding Acknowledgements None. Background Unfractionated heparin (UFH) is frequently administered before percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI)1,2. However, current guidelines do not provide clear recommendations for UFH pretreatment before arrival at the coronary catheterisation laboratory1,3. Methods Between June and July 2023, we systematically searched PubMed, Embase and Cochrane databases for studies comparing UFH pretreatments in patients with STEMI. A random-effects meta-analysis and meta-regression analyses were performed. Results Fourteen studies were included, of which four were randomised clinical trials (RCTs). A total of 76446 patients were included: 31238 in the pretreatment group and 39208 in the control group. Our meta-analysis revealed a lower all-cause mortality for the pretreatment strategy when compared with the control group, albeit with high heterogeneity (pooled odds ratio (OR) = 0.61, 95% confidence interval (CI) [0.49-0.76], P &amp;lt; 0.01; I² = 77%); lower in-hospital cardiogenic shock (pooled OR = 0.68, 95% CI [0.58-0.78], P &amp;lt; 0.21; I² = 27%) and a higher rate of spontaneous reperfusion events (pooled OR = 1.68, 95% CI [1.47-1.91], P &amp;lt; 0.01; I² = 79%). In terms of major bleeding, the UFH pretreatment strategy further revealed a decreased rate of events (pooled OR = 0.85, 95% CI [0.73-0.99], P = 0.40; I² = 4%). Conclusions From our study, UFH pretreatment in patients with STEMI undergoing primary PCI shows important benefits by reducing all-cause mortality, cardiogenic shock, enhancing reperfusion rates, whilst diminishing major bleeding events High-scale and high-quality RCTs will be required to fully address this clinical question in the future.1) Characteristics of included studies.2) Analyzed outcomes.

Clinical influencing factors of vital pulp therapy on pulpitis permanent teeth with 2 calcium silicate-based materials: A randomized clinical trial.

Compared with traditional root canal therapy (RCT), vital pulp therapy (VPT) is a personalized and minimally invasive method for the treatment of pulpitis caused by dental caries. However, there are still no clear guidelines for VPT because high-quality randomized clinical trials are scarce. This prospective cohort study evaluated the clinical efficacy of VPT with the light-curable calcium silicate-based material TheraCal LC (TH) and bioceramic material iRoot BP Plus (BP) in reversible and irreversible pulpitis permanent teeth with carious exposures. 115 teeth with reversible or irreversible pulpitis caused by deep care were randomly divided into 2 groups. TheraCal LC and iRoot BP Plus were used for the pulp capping. Direct pulp capping (DPC), partial pulpotomy (PP) and full pulpotomy (FP) were performed based on observation of the exposed pulp. Postoperative discomforts were enquired and recorded via follow-up phone calls. Clinical and radiographic evaluations were performed 3, 6, and 12 months postoperatively. The overall clinical success rate in the first year was 90.4% (47/52) in both groups. The TH group required less operating time, showed lower levels of pain, and had shorter pain duration post-operative (P < .001). According to the binary logistic regression model, preoperative pain duration was significantly correlated with the prognosis of VPT (P = .011). VPT with TheraCal LC and iRoot BP Plus in pulpitis permanent carious teeth both achieved good clinical outcomes, and TheraCal LC can be easily operated for clinical use. Preoperative pain duration of the affected tooth might have a significant correlation with the prognosis of VPT.

The efficacy of immune checkpoint inhibitors on low PD-L1 cervical cancer: A meta-analysis.

The effectiveness of immune checkpoint inhibitors (ICIs) in low programmed death ligand 1 (PD-L1) expression in cervical cancer (CC) patients remains unknown. We aimed to evaluate the efficacy of ICIs in low PD-L1 expression CCpatients. The study is an individual patient data (IPD)-based meta-analysis. IPD were compiled through KMSubtraction and IPDfromKM methodologies from high-quality randomized clinical trials and single-arm studies which reported overall survival (OS) or progression-free survival (PFS) stratified by PD-L1 expression. Kaplan-Meier curves and Cox regression analysis were employed to evaluate the survival benefits of ICIs. A total of eightstudies and 1110 cases were included in the analysis. Within the low PD-L1 expression subgroup, ICI combination therapy, but not ICI monotherapy, demonstrated significant OS benefits over non-ICI treatment (hazard ratio [HR] = 0.61, 95% confidence interval [CI]:0.36-1.04, p = 0.06). Concerning PFS, ICI monotherapy was associated with a negative effect compared to non-ICI treatment (HR = 4.59, 95% CI:2.32-9.07, p < 0.001). Notably, both OS and PFS outcomes were unfavorable for ICI monotherapy compared to both non-ICI and ICI combination therapy in the combined positive score <1 subgroup (OS: HR = 2.60, 95% CI:1.31-5.16, p = 0.008; PFS: HR = 7.59, 95% CI:3.53-16.31, p < 0.001). In patients with CCand low PD-L1 expression, ICI monotherapy may not be considered as the optimal treatment strategy when compared to non-ICI treatment or ICI combination therapy. CRD42023395103.

Systematic Review: Safety and Efficacy Comparison of Laser Therapy With And Other Resurfacing Technology

There is an increasing demand of almost all young and adult population for the noninvasive cosmetic procedures specially to enhance the facial appearance and the requirement has expanded all over the world. This review was designed to identify and summarize the literature/evidence from different types of research/clinical studies conducted in facial resurfacing methodologies. A systematic review was designed and conducted in relation to facial resurfacing and rejuvenating techniques using data from PubMed, MEDLINE Cochrane database and Scopus. Systematic review protocol guidelines were used for research questions, aim of the review and PICO breakdown, eligibility criteria and used search engine and extraction of data. A minimum of 17 clinical studies and reviews were identified including randomized clinical trials. Significant results have been obtained in some clinical trials about techniques of rejuvenation and some studies have elucidated contrasting evidence. In most of the work, ablative and non-ablative laser therapy had been compared and we found that some results were compatible, and others showed contrasting evidence. In conclusion, more high-quality randomized control clinical trials are needed to decide on better safety and effectiveness of ablative or non-ablative laser therapy vs conventional treatments.

Superiority of kinematic alignment over mechanical alignment in total knee arthroplasty during medium- to long-term follow-up: Ameta-analysis and trial sequential analysis.

To compare and determine the reliability and conclusiveness of the medium- and long-term efficacy in terms of patient-reported outcome measures and the risk of revisions or reoperations (RRRs) of kinematic alignment (KA) and mechanical alignment (MA) in total knee arthroplasty. A comprehensive search was conducted in Medline, EMBASE, Web of Scienceand Cochrane Database Library to identify relevant literature. Only randomised clinical trials (RCTs) published before July 2023 were included. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Knee Score(OKS), Forgotten Joint Score (FJS)and RRR were compared. Additionally, OKS and RRR were subjected to a trial sequential analysis. Seven RCTs involving 572 knees were identified. The pooled analysis of the included studies demonstrated that KA showed better medium-term WOMAC and OKS (mean difference [MD] = -6.3, 95% confidence interval [CI]:-9.52 to -2.99, p < 0.05and MD = 1.1, 95% CI: 0.05-2.15, p < 0.05), respectively), but no significant differences were observed in the long-term follow-up (MD = 2.1, 95% CI: -3.21 to 7.31, not significant [n.s.] and MD = 0.01, 95% CI: -2.43 to 2.46, n.s., respectively). FJS (standardised MD = -0.03, 95% CI: -0.25 to 0.19, n.s.) and RRR (risk ratio = 1.0, 95% CI: 0.57 to 1.74, n.s.) showed no significant intergroup differences (n.s.). The evidence quality ranged from moderate to high, and the trial sequential analysis indicated the need for additional high-quality RCTs to draw more conclusive results. KA showed better medium-term WOMAC and OKS, while KA and MA had similar FJS without increasing the RRR in medium- and long-term follow-up. Further research is needed for more conclusive results. LevelII (meta-analyses).

Comparing robotic and open surgical techniques in gallbladder cancer management: a detailed systematic review and meta-analysis.

This meta-analysis aims to evaluate the safety and oncological outcomes of robotic surgery compared to open surgery in treating gallbladder cancer (GBC). In October 2023, we performed a literature search across major global databases such as PubMed, Embase, and the Cochrane Library. We employed a Review Manager for parameter comparisons. This study has been registered with PROSPERO under the identifier CRD42023476686. Our final meta-analysis incorporated 5 cohort studies, encompassing a total of 353 patients. Compared to the Open Group (OG), the Robotic Group (RG) had reduced intraoperative blood loss (WMD - 217.72ml, 95% CI - 371.08 to - 64.35; p = 0.005), shorter hospital stay (WMD - 1.80days, 95% CI - 2.66 to - 0.95; p < 0.0001), and fewer overall complications (OR 0.31, 95% CI 0.10-0.97; p = 0.04). However, there was no significant difference between the two groups in terms of operation duration, postoperative inpatient days, readmission rate, major complications, 1-year postoperative survival, 2-year postoperative survival, and mortality rates. In our study, we found that for patients with gallbladder cancer, robotic radical cholecystectomy offers certain potential advantages over open radical cholecystectomy. This suggests that robotic radical cholecystectomy might be the optimal choice for treating gallbladder cancer. However, further validation from high-quality randomized clinical trials is required.

Pharmacological Considerations during Percutaneous Treatment of Heart Failure.

Heart Failure (HF) remains a global health challenge, marked by its widespread prevalence and substantial resource utilization. Although the prognosis has improved in recent decades due to the treatments implemented, it continues to generate high morbidity and mortality in the medium to long term. Interventional cardiology has emerged as a crucial player in HF management, offering a diverse array of percutaneous treatments for both acute and chronic HF. This article aimed to provide a comprehensive review of the role of percutaneous interventions in HF patients, with a primary focus on key features, clinical effectiveness, and safety outcomes. Despite the growing utilization of these interventions, there remain critical gaps in the existing body of evidence. Consequently, the need for high-quality randomized clinical trials and extensive international registries is emphasized to shed light on the specific patient populations and clinical scenarios that stand to benefit most from these innovative devices.

Ablation for malignant liver tumor using high-intensity focused ultrasound and radio-frequency: A meta-analysis.

Primary liver cancer is a major health issue, so finding the most effective treatment is vital. The present meta-analysis compares high-intensity focused ultrasound (HIFU) to radiofrequency (RF) ablation for primary liver cancer treatment. PubMed, MEDLINE, CNKI, VIP, and Wanfang were used to search for English and Chinese papers. After carefully confirming data completeness and applying inclusion and exclusion criteria, RevMan 5.3 was used to evaluate the included literature. Data analysis utilized a fixed-effects model for heterogeneity between 0.1 and 0.5. The meta-analysis included 304 patients: 119 had HIFU and 185 RF ablation. For primary liver cancer, HIFU and RF ablation were equally efficacious (odds ratio 1.02, 95% confidence interval [0.54, 1.92]). Overall survival, disease-free survival, and complications at 1, 2, and 3 years were not significantly different (odds ratio 0.72, 95% confidence range [0.04, 12.79], P= 0.82). The meta-analysis shows no significant difference in efficacy, long-term survival rates, or complication rates between HIFU and RF ablation for primary liver cancer, but more large-scale, high-quality randomized clinical trials are needed to prove their equivalence. Both therapy strategies seem promising, but additional information is needed to determine their respective merits.

Modified dietary fat intake for treatment of gallstone disease in people of any age.

The prevalence of gallstones varies between less than 1% and 64% in different populations and is thought to be increasing in response to changes in nutritional intake and increasing obesity. Some people with gallstones have no symptoms but approximately 2% to 4% develop them each year, predominantly including severe abdominal pain. People who experience symptoms have a greater risk of developing complications. The main treatment for symptomatic gallstones is cholecystectomy. Traditionally, a low-fat diet has also been advised to manage gallstone symptoms, but there is uncertainty over the evidence to support this. To evaluate the benefits and harms of modified dietary fat intake in the treatment of gallstone disease in people of any age. We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials in the Cochrane Library, MEDLINE ALL Ovid, Embase Ovid, and three other databases to 17 February 2023 to identify randomised clinical trials in people with gallstones. We also searched online trial registries and pharmaceutical company sources, for ongoing or unpublished trials to March 2023. We included randomised clinical trials (irrespective of language, blinding, or status) in people with gallstones diagnosed using ultrasonography or conclusive imaging methods. We excluded participants diagnosed with another condition that may compromise dietary fat tolerance. We excluded trials where data from participants with gallstones were not reported separately from data from participants who did not have gallstones. We included trials that investigated other interventions (e.g. trials of drugs or other dietary (non-fat) components) providing that the trial groups had received the same proportion of drug or other dietary (non-fat) components in the intervention. We intended to undertake meta-analysis and present the findings according to Cochrane recommendations. However, as we identified only five trials, with data unsuitable and insufficient for analyses, we described the data narratively. We included five trials but only one randomised clinical trial (69 adults), published in 1986, reported outcomes of interest to the review. The trial had four dietary intervention groups, three of which were relevant to this review. We assessed the trial at high risk of bias. The dietary fat modifications included a modified cholesterol intake and medium-chain triglyceride supplementation. The control treatment was a standard diet. The trial did not report on any of the primary outcomes in this review (i.e. all-cause mortality, serious adverse events, and health-related quality of life). The trial reported on gallstone dissolution, one of our secondary outcomes. We were unable to apply the GRADE approach to determine certainty of evidence because the included trial did not provide data that could be used to generate an estimate of the effect on this or any other outcome. The trial expressed its finding as "no significant effect of a low-cholesterol diet in the presence of ursodeoxycholic acid on gallstone dissolution." There were no serious adverse events reported. The included trial reported that they received no funding that could bias the trial results through conflicts of interest. We found no ongoing trials. The evidence about the effects of modifying dietary fat on gallstone disease versus standard diet is scant. We lack results from high-quality randomised clinical trials which investigate the effects of modification of dietary fat and other nutrient intakes with adequate follow-up. There is a need for well-designed trials that should include important clinical outcomes such as mortality, quality of life, impact on dissolution of gallstones, hospital admissions, surgical intervention, and adverse events.

Abstract WMP73: Minimally Invasive Surgery for Intracerebral Hemorrhage: Meta-Analysis of High Quality RCTs

Background: Intracerebral hemorrhage (ICH) represents a devastating clinical entity with disproportionately higher rates of mortality and functional disability compared to ischemic stroke. As large trials of craniotomy in ICH failed to prove functional benefits, minimally invasive surgery (MIS) represents a potential frontier of ICH management with evidence of functional and mortality improvements. We aimed to provide level A evidence of MIS role in ICH management. Methods: Independent authors searched four electronic databases (Medline, Embase, Web of Science, and CENTRAL) and assessed the methodological quality of included studies using the Cochrane risk of bias tool (RoB2). Only high-quality (low risk of bias in all RoB2 domains) randomized clinical trial (RCTs) were included. We pooled odd ratios (ORs) with corresponding 95% confidence intervals (CIs) using random-effects model. Results: Six high-quality RCTs met our inclusion criteria. Among 1551 ICH patients, 810 were allocated to the MIS group and 741 to non-MIS. MIS was associated with significantly lower odds of mortality or disability at 90-days (OR, 0.71 [95% CI, 0.52-0.97]; p = 0.03) and lower odds of 90-days mortality (OR, 0.71 [95% CI, 0.49-1.03]; p = 0.07). Rates of functional independence and favorable functional outcomes was higher in MIS treated individuals (OR, 1.81 [95% CI, 0.78-1.79]; p = 0.43) and (OR, 1.31 [95% CI, 0.96-1.78]; p = 0.09), respectfully. Conclusions: This meta-analysis provides level A evidence that supports the current notion of mortality and functional improvement in ICH individuals treated with MIS. Further RCTs are warranted to validate the generalizability of these results.

Efficacy of Acupuncture in the Treatment of Obstructive Sleep Apnea: A Review

Context: Obstructive sleep apnea is one of the most common sleep disorders, and it is associated with several conditions, including cardiovascular diseases and neuropsychiatric events. Due to its significant burden and increasing prevalence, the treatment of obstructive sleep apnea is of great importance. Evidence Acquisition: Continuous airway pressure (CPAP) has been the standard treatment for managing clinically significant obstructive sleep apnea in recent decades. However, compliance with CPAP treatment is as low as 60% in patients with obstructive sleep apnea. Additionally, CPAP only suppresses respiratory disturbances during sleep while using the devices and does not provide a permanent resolution. Given the limitations of prevalent treatments for obstructive sleep apnea, various alternative therapies have been explored. Among these, acupuncture is a traditional yet novel treatment for obstructive sleep apnea. Acupuncture is widely accepted by many people and specialists in different fields and is commonly used to treat various conditions. Several studies have shown that acupuncture effectively improves the apnea-hypopnea index (AHI). In this review article, we conducted a comprehensive literature search to assess the impact of acupuncture on obstructive sleep apnea. Our findings suggest that acupuncture may represent an effective and safe therapy option for individuals dealing with obstructive sleep apnea. Results: Acupuncture may also assist patients with obstructive sleep apnea in enhancing their oxygen saturation and improving their sleep quality. This discovery holds particular significance for individuals with moderate to severe obstructive sleep apnea. However, it is worth noting that methodological weaknesses in most of the trials in this field may overstate the clinical efficacy of acupuncture therapy. Conclusions: Further high-quality randomized clinical trials are warranted to establish the effectiveness and safety of acupuncture for obstructive sleep apnea patients.

Problem-Solving Skills Training for Parents of Children With Chronic Health Conditions

Problem-solving skills training (PSST) has a demonstrated potential to improve psychosocial well-being for parents of children with chronic health conditions (CHCs), but such evidence has not been fully systematically synthesized. To evaluate the associations of PSST with parental, pediatric, and family psychosocial outcomes. Six English-language databases (PubMed, Embase, CINAHL, PsycINFO, Web of Science, and Cochrane Library), 3 Chinese-language databases (China National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang), gray literature, and references were searched from inception to April 30, 2023. Randomized clinical trials (RCTs) that performed PSST for parents of children with CHCs and reported at least 1 parental, pediatric, or family psychosocial outcome were included. Study selection, data extraction, and quality assessment were conducted independently by 2 reviewers. Data were pooled for meta-analysis using the standardized mean difference (SMD) by the inverse variance method or a random-effects model. Subgroup analyses of children- and intervention-level characteristics were conducted. The psychosocial outcomes of the parents, their children, and their families, such as problem-solving skills, negative affectivity, quality of life (QOL), and family adaptation. The systematic review included 23 RCTs involving 3141 parents, and 21 of these trials were eligible for meta-analysis. There was a significant association between PSST and improvements in parental outcomes, including problem-solving skills (SMD, 0.43; 95% CI, 0.27-0.58), depression (SMD, -0.45; 95% CI, -0.66 to -0.23), distress (SMD, -0.61; 95% CI, -0.81 to -0.40), posttraumatic stress (SMD -0.39; 95% CI, -0.48 to -0.31), parenting stress (SMD, -0.62; 95% CI, -1.05 to -0.19), and QOL (SMD, 0.45; 95% CI, 0.15-0.74). For children, PSST was associated with better QOL (SMD, 0.76; 95% CI, 0.04-1.47) and fewer mental problems (SMD, -0.51; 95% CI, -0.68 to -0.34), as well as with less parent-child conflict (SMD, -0.38; 95% CI, -0.60 to -0.16). Subgroup analysis showed that PSST was more efficient for parents of children aged 10 years or younger or who were newly diagnosed with a CHC. Significant improvements in most outcomes were associated with PSST delivered online. These findings suggest that PSST for parents of children with CHCs may improve the psychosocial well-being of the parents, their children, and their families. Further high-quality RCTs with longer follow-up times and that explore physical and clinical outcomes are encouraged to generate adequate evidence.

EFEITOS DO PILATES VS TREINAMENTO AERÓBIO EM HIPERTENSOS: ENSAIO RANDOMIZADO

ABSTRACT Introduction: The Pilates method (PM) combines slow-deep breathing with strengthening and stretching exercises. However, it has been proposed as a method of physical conditioning for several decades and only recently aroused academic/scientific interest, with few reports of the effects of this intervention in hypertensive patients. Objective: to compare PM to aerobic training (AT) effects on hypertensive subjects’ blood pressure (BP), functional capacity and autonomic balance. Methods: Twenty-four hypertensive subjects were randomly allocated into two groups: ATG performed three 40 min sessions/week, moderate intensity (40-70% of reserve HR), and PMG performed two 60 min sessions/week; both during the same eight weeks period. Blood pressure (casual and for 24 hours), 6-minute walking test (6-MWT) and autonomic balance were evaluated before and after intervention. Results: There was a reduction on systolic BP (SBP, p=0.007), diastolic (p=0.032) and mean blood pressure (MBP, p=0.016), measured on 24h, on PMG. There was also a 24h SBP reduction on ATG (p=0.021). The PMG had a greater reduction on 24h SBP (-3.4 mmHg, 95% CI -6.6 to -0.2) and MBP (-3.3 mmHg, 95% CI -6.3 to -0.3) than the ATG. ATG held a longer distance in 6-MWT. Casual BP and autonomic balance had no difference. Conclusion: This PM protocol was superior to AT on BP monitored for 24 hours in hypertensive subjects, but AT was better for functional capacity. The eight weeks of training were not enough to change the autonomic balance. Level of Evidence: I; High-quality randomized clinical trial with or without statistically significant difference, but with narrow confidence intervals.

The Effect of Cognitive Functional Therapy on Psychological Variables in Women With Non-specific Chronic Back Pain: A Randomized Control Trial

Purpose: Chronic non-specific low back pain (CNSLBP) is a common health issue caused by a mix of biological, psychological, and social factors. Cognitive functional therapy (CFT) is a comprehensive way to treat CNSLBP that focuses on changing negative thoughts and unhelpful habits through relaxation techniques. Since the evidence on the efficacy of CFT is still limited, it is essential to conduct clinical trials aimed at the effectiveness of CFT in the treatment of CNSLBP. This study aims to examine the effect of cognitive functional therapy on psychological variables in women with CNSLBP. Methods: Thirty women with CNSLBP were recruited for the clinical trial. They were randomly divided into two experimental and control groups (15 patients in each group). Our experimental group will have 18 individualized CFT sessions, each lasting an hour, over two months. The control group received no intervention. Pain intensity, disability, and kinesiophobia were assessed via the visual analog scale, Oswestry, and Tampa scale, respectively. Two-way repeated measures analysis of variance (ANOVA) was used to compare results between groups. Results: Two-way repeated measures ANOVA results showed that the experimental group compared to the control group in reducing pain (P=0.000, ηp2=0.787), disability (P=0.005, ηp2=0.457) and Kinesiophobia (P=0.000, ηp2=0.561) had a significant difference. Conclusion: CFT reduced pain, disability, and kinesiophobia in patients with CNSLBP. Further evaluation of the efficacy of CFT in high-quality randomized clinical trials among patients with CNSLBP is recommended.