Robust Randomized Controlled Trials Research Articles

Methotrexate for osteoarthritis: a systematic review meta-analysis of randomized controlled trials.

Osteoarthritis (OA) is a common joint disorder causing pain and stiffness, with limited effective treatment options. Methotrexate, known for its anti-inflammatory properties in rheumatoid arthritis, is being explored as a treatment for OA. This study evaluates Methotrexate's efficacy compared to placebo in reducing OA symptoms, such as stiffness in the knee and hand, and its impact on pain, physical function. We systematically searched PubMed, Google Scholar, Embase, Web of Science, and Cochrane databases for randomized controlled trials (RCTs), analyzing the efficacy of Methotrexate compared to placebo in patients with OA. We pooled risk ratios (RR) for binary outcomes. For continuous outcomes, we used standard mean difference (SMD) and mean difference (MD) with 95% confidence intervals (CI). Outcomes included were related to knee and hand pain, knee stiffness, and similar outcomes. We used R version 4.4.1 for statistical analyses. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach evaluated the quality of evidence. This analysis included 5 RCTs comprising 465 patients, of whom 229 were randomized to Methotrexate. The age ranged from 52.4 to 67.5 years among studies. Compared with placebo, Methotrexate significantly reduced knee and hand stiffness at the end of follow-up (SMD -0.36; 95% CI -0.57 to -0.15; p< 0.01), knee and hand stiffness at 6months of follow-up (SMD -0.48; 95% CI -0.70 to -0.27; p< 0.01). Methotrexate significantly reduced knee stiffness in both knee and hand OA. However, current literature might be underpowered, more robust RCTs are necessary to validate these findings.

Efficacy of Antidepressants in Management of Depressive Symptoms in Dementia: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Background: Dementia is associated with a complex array of neuropsychiatric manifestations which require consideration as they worsen the course of illness, especially in neurodegenerative etiologies. Depression and subsyndromal depressive symptoms are common in dementia, usually managed with antidepressants, but evidence is weak. Objective: The objective is to study the efficacy of antidepressants compared to placebo in management of depressive symptoms in dementia. Methodology: Electronic databases such as PubMed, MEDLINE, PsychINFO, ClinicalTrials.gov, BASE, and MedNar were searched from their date of inception to March 18, 2024, with appropriate search-terms. Randomized controlled trials (RCTs) that are double-blind in nature with placebo as comparator of dementia patients (Alzheimer’s disease [AD], Frontotemporal, Lewy body, and Parkinson disease dementia) treated with antidepressants for at least ≥ 4 weeks with severity of depressive symptoms measured on standardized rating scales were included. Studies with nonrandomized/nondouble-blind design, active drug or brain stimulation methods as comparator and nonneurodegenerative etiologies of dementia were excluded. Cochrane tool for risk of bias assessment, Covidence and Microsoft Excel for data extraction and review manager version 5.4.1 for data analysis were used. Results: Our search yielded 13(N) RCTs for systematic review, majority of which reported on AD (n = 12), selective serotonin reuptake inhibitors as intervention (n = 7), and high risk of bias (n = 9). Efficacy analysis using forest-plot with seven RCTs showed no statistically significant treatment effect (standardized mean differences [SMD] = −0.04, 95%confidence interval [−0.36, 0.27], Z = 0.26, P = 0.79) between intervention and placebo group. Substantial significant heterogeneity (I 2 = 74%, P &lt; 0.001) was noted across studies. Discussion: Antidepressants administered for 6–13 weeks and different rating scales used to measure outcome in RCTs were possible reasons for heterogeneity. We conclude that antidepressants have not been found to be efficacious compared to placebo in management of depressive symptoms in dementia. Findings cannot be generalized to other etiologies as our analysis found limited data majorly on AD and RCTs with high risk or some concerns in the bias, thus throws a light on need for robust RCTs in this area.

Multimodal analgesics after adult cardiac surgery; a systematic review

Abstract Background Moderate to severe pain is frequently reported during the acute recovery phase following adult cardiac surgery. Multimodal analgesics are recommended for adult patients post cardiac surgery, but the optimal combination of multimodal analgesics is unknown. Purpose To synthesise the best available evidence about the effectiveness of multimodal analgesics on pain after adult cardiac surgery. Methods A systematic review was conducted according to the PRISMA-P statement and the published review protocol. Inclusion criteria were full-text papers or abstracts with adequate reporting, in any language, of randomised controlled trials (RCTs) in adult patients undergoing cardiac surgery that investigated the effect of multimodal postoperative analgesic regimens, compared to a control group. The highest mean level of patient self-reported pain intensity at rest, captured using a validated pain assessment tool, was the primary outcome measure. Results Of 3754 citations identified in the initial search to the 12th of December 2022, there were 1605 duplicates leaving 2149 citations for title and abstract screening, of which 2027 were irrelevant. There were 122 full-text papers assessed and 29 included in the review. Data were independently extracted by 2 reviewers in Covidence®. Participants (N = 2360), aged 59.5 + 8.2 years, were primarily male (N = 1561, 66.1%), weighing 78.1 +9.2 kilograms. Risk of bias was high and reporting quality was poor. Pain at rest reported in 18 (62%) studies was 3.5 (SD 1.2) in the control and 2.7 (SD 0.9) in the intervention groups respectively. Nurse-led versus patient-controlled analgesic administration was tested in 14 (48.3%) trials. All trials tested different analgesic combinations, none of which compared a combination of non-opioids, opioid agonist-antagonist agents, or full opioid agonists. Conclusions Poorly managed pain is associated with postoperative complications, unplanned readmissions, and the development of chronic pain. Robust RCTs are urgently needed to inform optimal combinations of multimodal analgesics to optimise patient recovery after adult cardiac surgery.Risk of Bias

Unlocking equity: assessing for gaps in cardiovascular guidelines for pregnant women

Abstract Introduction Cardiovascular disease is the primary contributor to pregnancy-related fatalities in the United States, displaying a gradual rise over the years. Pregnancy introduces unique physiological changes that can impact pre-existing cardiovascular conditions and trigger new complications. Considerable inequalities in pregnancy-related mortality built on race and ethnicity are unmistakable, with the highest rates observed in black non-Hispanic women. Purpose This study aims to evaluate current gaps in racial/ethnic minority participation in randomized control trials (RCTs) cited in major cardiology guidelines. Methods Citations in the 2018 ESC Guidelines for the Management of Cardiovascular Diseases During Pregnancy were evaluated for RCTs. The American Heart Association and American College of Cardiology guidelines were also examined. Manuscripts and supplementary data were examined for participant-level racial or ethnic data, including age, race, and ethnicity. Results Thirteen RCTs, representing 20,665 participants, spanning the period from 2002 to 2017, were reviewed. European guidelines referenced thirteen of the RCTS, while American guidelines referenced two RCTs. The average age of participants was 31 years old. Most of the trials were conducted in Europe (46%). Forty-six percent of RCTs reported race/ethnicity breakdowns, with pooled participation showing a majority of non-Hispanic white participants (76.7%), with limited representation from other racial groups (table). Eight trials focused on hypertension, two on venous thromboembolism, and one on heart failure. Conclusion Pregnant women are frequently excluded from RCTs due to concerns about potential harm to the developing fetus. Consequently, current guidelines lack robust RCTs tailored to pregnant women with various cardiovascular diseases. The underrepresentation of ethnic minorities in cardiovascular disease trials contributes to a scarcity of evidence-based recommendations for managing these conditions during pregnancy and postpartum. Future clinical practice guidelines should advocate for a more personalized and evidence-based approach to managing cardiovascular diseases in pregnancy.

A pragmatic approach to selecting a grading system for clinical practice recommendations in palliative care.

The limited palliative care evidence base is poorly amenable to existing grading schemes utilized in guidelines. Many recommendations are based on expert consensus or clinical practice standards, which are often considered 'low-quality' evidence. Reinforcing provider hesitancy in translating recommendations to practice has implications for patient care. To rationalize the selection of an appropriate grading system for rating evidence to support recommendations made in palliative care clinical practice guidelines. Review of the methodology sections of international palliative care guidelines published in English identified five grading systems comparison: Grading of Recommendations, Assessment, Development and Evaluations (GRADE); the Scottish Intercollegiate Guidelines Network (SIGN); Infectious Diseases Society of America-European Society for Medical Oncology (IDSA-ESMO); Confidence in the Evidence from Reviews of Qualitative research (CERQual) and the National Service Framework for Long Term Conditions (NSF-LTC). There is heterogeneity among grading systems used in published palliative care or terminal symptom management guidelines. GRADE has been increasingly adopted for its methodological rigour and inter-guideline consistency with other medical associations. CERQual has the potential to support recommendations informed by qualitative evidence, but its role in clinical guidelines is less defined. The IDSA-ESMO system has an intuitive typology with the ability to categorize tiers of lower-quality evidence. It is challenging to apply commonly used grading systems to the palliative care evidence base, which often lacks robust randomized controlled trials (RCTs). Adoption of IDSA-ESMO offers a feasible and practical alternative for lower-resourced guideline developers and palliative clinicians without a prerequisite for methodological expertise.

The Effect of Resistance Training on Markers of Cachexia in Patients with Heart Failure: A Systematic Review and Meta‐Analysis

ABSTRACTBackgroundCachexia is a metabolic syndrome characterised by muscle wasting that is highly prevalent in subjects with heart failure (HF) and negatively affects physical function, quality of life, morbidity and mortality. Resistance training has been recently incorporated into cardiac rehabilitation exercise programmes to increase muscle strength in patients with HF. This systematic review and meta‐analysis aim to assess the effects of resistance training on markers of cachexia in patients with HF.MethodsFour electronic databases (MEDLINE, Embase, CENTRAL and CINAHL) were searched to identify randomised controlled trials (RCTs) evaluating the effects of resistance training‐only programmes on published criteria for cachexia assessment including muscle strength, body composition (e.g. lean mass/muscle mass) or biochemical markers of cachexia (e.g. inflammatory markers) in patients with HF. Studies were selected based on pre‐specified inclusion and exclusion criteria, with a risk of bias assessment carried out. Meta‐analyses of muscle strength outcomes were completed using RevMan 5.4.1.ResultsNine studies were included in this review. Pooled analysis of one repetition‐maximum strength test of the lower [SMD 0.67 (95% Cl – 0.12, 1.22) p‐value = 0.02] and upper extremities [SMD 1.20 (95% Cl – 0.62, 1.79) p‐value &lt;0.0001] showed a significant increase in muscle strength associated with resistance training, which are both important indicators of physical function. Resistance training did not increase muscle strength during rapid movements measured via peak torque at 60, 90 or 180°/s. There were no significant results recorded for changes in body composition and biochemical markers of cachexia. There were inconsistent findings for the effect of resistance training on quality of life. No studies reported findings on measures of anorexia or fatigue.ConclusionsThe findings of this review reveal the potential benefits of resistance training in preserving and enhancing muscle strength in patients with HF who are at risk of cardiac cachexia. Despite inconclusive results on body composition and quality of life, the inclusion of resistance training in cardiac rehabilitation guidelines has the potential to address issues of muscle weakness and frailty. Specific resistance training protocol recommendations to prevent or treat the development of cachexia cannot be made without the publication of more robust RCTs, specifically examining cachectic patients with heart failure with careful assessment of clinical outcomes of markers of cachexia.

Which interventions could prevent early childhood caries in pregnant women, new mothers, and other primary caregivers?

Cochrane Oral Health's Trials Register, Cochrane Pregnancy and Childbirth's Trials Register, CENTRAL, MEDLINE, Embase, CINAHL EBSCO, the US National Institutes of Health Ongoing Trials Register, and WHO International Clinical Trials Registry Platform. Randomized controlled trials (RCTs) and cluster-RCTs assessing the effects of interventions targeted at pregnant women, new mothers or other primary caregivers for preventing early childhood caries (ECC) in infants during the first year of life. Selection of studies, data extraction and management, and assessment of risk of bias in the included studies were independently performed by two authors. Twenty-three trials met the inclusion criteria. Child diet and feeding practices advice could reduce the risk of developing dental caries in primary teeth by 15% with the evidence being of moderate certainty. All other measures showed little to no difference compared to standard care, with evidence of low to very low certainty. Generally, the evidence assessing the effects of interventions targeted at pregnant women and new mother for preventing early childhood caries (ECC) in infants during the first year of life is of low to very low certainty. More robust RCTs are needed to inform practice and policy making.

A Systematic Review of Laser Photobiomodulation Dosimetry and Treatment Protocols in the Management of Medications-Related Osteonecrosis of the Jaws: A Rationalised Consensus for Future Randomised Controlled Clinical Trials.

Medication-related osteonecrosis of the jaw (MRONJ) is a debilitating adverse effect of bisphosphates, antiresorptive therapy or antiangiogenic agents that can potentially increase oxidative stress, leading to progressive osteonecrosis of the jaws. Despite the large number of published systematic reviews, there is a lack of potential MRONJ treatment protocols utilising photobiomodulation (PBM) as a single or adjunct therapy for preventive or therapeutic oncology or non-oncology cohort. Hence, this systematic review aimed to evaluate PBM laser efficacy and its dosimetry as a monotherapy or combined with the standard treatments for preventive or therapeutic approach in MRONJ management. The objectives of the review were as follows: (1) to establish PBM dosimetry and treatment protocols for preventive, therapeutic or combined approaches in MRONJ management; (2) to highlight and bridge the literature gaps in MRONJ diagnostics and management; and (3) to suggest rationalised consensus recommendations for future randomised controlled trials (RCTs) through the available evidence-based literature. This review was conducted according to the PRISMA guidelines, and the protocol was registered at PROSPERO under the ID CRD42021238175. A multi-database search was performed to identify articles of clinical studies published from their earliest records until 15 December 2023. The data were extracted from the relevant papers and analysed according to the outcomes selected in this review. In total, 12 out of 126 studies met the eligibility criteria. The striking inconsistent conclusions made by the various authors of the included studies were due to the heterogeneity in the methodology, diagnostic criteria and assessment tools, as well as in the reported outcomes, made it impossible to conduct a meta-analysis. PBM as a single or adjunct treatment modality is effective for MRONJ preventive or therapeutic management, but it was inconclusive to establish a standardised and replicable protocol due to the high risk of bias in a majority of the studies, but it was possible to extrapolate the PBM dosimetry of two studies that were close to the WALT recommended parameters. In conclusion, the authors established suggested rationalised consensus recommendations for future well-designed robust RCTs, utilising PBM as a monotherapy or an adjunct in preventive or therapeutic approach of MRONJ in an oncology and non-oncology cohort. This would pave the path for standardised PBM dosimetry and treatment protocols in MRONJ management.

Comparison of low versus high (standard) intraabdominal pressure during laparoscopic colorectal surgery: systematic review and meta-analysis

BackgroundTo evaluate outcomes of low with high intraabdominal pressure during laparoscopic colorectal resection surgery.MethodsA systematic search of multiple electronic data sources was conducted, and all studies comparing low with high (standard) intraabdominal pressures were included. Our primary outcomes were post-operative ileus occurrence and return of bowel movement/flatus. The evaluated secondary outcomes included: total operative time, post-operative haemorrhage, anastomotic leak, pneumonia, surgical site infection, overall post-operative complications (categorised by Clavien-Dindo grading), and length of hospital stay. Revman 5.4 was used for data analysis.ResultsSix randomised controlled trials (RCTs) and one observational study with a total of 771 patients (370 surgery at low intraabdominal pressure and 401 at high pressures) were included. There was no statistically significant difference in all the measured outcomes; post-operative ileus [OR 0.80; CI (0.42, 1.52), P = 0.50], time-to-pass flatus [OR -4.31; CI (-12.12, 3.50), P = 0.28], total operative time [OR 0.40; CI (-10.19, 11.00), P = 0.94], post-operative haemorrhage [OR 1.51; CI (0.41, 5.58, P = 0.53], anastomotic leak [OR 1.14; CI (0.26, 4.91), P = 0.86], pneumonia [OR 1.15; CI (0.22, 6.09), P = 0.87], SSI [OR 0.69; CI (0.19, 2.47), P = 0.57], overall post-operative complications [OR 0.82; CI (0.52, 1.30), P = 0.40], Clavien-Dindo grade ≥ 3 [OR 1.27; CI (0.59, 2.77), P = 0.54], and length of hospital stay [OR -0.68; CI (-1.61, 0.24), P = 0.15].ConclusionLow intraabdominal pressure is safe and feasible approach to laparoscopic colorectal resection surgery with non-inferior outcomes to standard or high pressures. More robust and well-powered RCTs are needed to consolidate the potential benefits of low over high pressure intra-abdominal surgery.

Is shockwave therapy effective in the management of greater trochanteric pain syndrome? A systematic review and meta-analysis.

Evidence is lacking for the efficacy of shockwave therapy (SWT) in the treatment of greater trochanteric pain syndrome (GTPS). To investigate the efficacy of SWT on pain and function in the management of GTPS. A systematic search of electronic databases and grey literature was conducted up to May 2023. Studies utilising SWT on adults for GTPS, providing measures of pain and/or function at baseline and at follow-up were considered for inclusion. Meta-analysis was undertaken using converted pain and functional outcomes. Studies were assessed for quality and risk of bias, and assigned a level of evidence as per the Grading of Recommendations, Assessment, Development and Evaluations criteria. Twelve articles (n=1121 subjects) were included, including five randomised controlled trials (RCTs) and seven non-RCTs. No statistical differences were observed for pain over time f(1,5)=1.349 (p=0.298) or between SWT and control f(1,5)=1.782 (p=0.238). No significant differences in functional outcomes in short- (H=2.591, p=0.181) and medium-term follow-up (H=0.189, p=0.664) were identified between SWT and control. Moderate magnitude treatment effects for pain (Hedges-G [HG] 0.71) favouring SWT groups over control was identified, decreasing to low for function (HG 0.20). Further pain and functional treatment effects were identified at higher magnitudes across follow-up time-points in SWT groups compared to control. Moderate-quality evidence demonstrated no statistically significant improvements in pain and function post-SWT compared to control. Low-quality evidence established clinical improvements throughout all included studies favouring SWT over control. Consequently, owing to relatively low incidence of side effects, SWT should be considered a viable option for the management of GTPS. Issues with both clinical and statistical heterogeneity of studies and during meta-analysis require consideration, and more robust RCTs are recommended if the efficacy of SWT for the management of GTPS is to be comprehensively determined.

Drains in Breast Reduction: How Good Is the Recommendation Not to Use Them?

A clinical practice guideline (CPG) from the American Society of Plastic Surgeons recommended not to use drains in breast reduction. This CPG was based on 3 randomized controlled trials (RCTs). The objective of this review was to double-check the methodological quality of the 3 RCTs. These RCTs were critically appraised using: (1) the "User's Guide to the Surgical Literature" checklist to critically appraise the methodological quality, (2) the CONSORT guidelines for reporting quality, and (3) the Cochrane risk-of-bias tool 2 (RoB 2) for risk of bias. Weaknesses were identified in all assessments for the 3 RCTs. Items with the poorest adherence in the "User's Guide" included: "Were patients stratified?," "Was follow-up complete?," and "Were all clinically important outcomes considered?" The overall adherence to the CONSORT reporting checklist across all 3 studies was moderate with 40.0%, 62.1%, and 48.3% adherence. All 3 RCTs had a similar low to moderate risk of bias, with no areas with a high risk of bias. None of the studies took into consideration a single critical outcome (such as major hematoma) and the outcome's minimally important difference as the basis for the sample size and power calculation of the study. All 3 RCTs additionally lacked clear reporting of treatment effect sizes or precision of estimates. Our re-examination of the evidence questions the recommendation of the CPG. We believe that the recommendation should have been: "We remain uncertain whether drains in breast reduction have a salutary effect." As such, we recommend that a methodologically robust RCT be conducted to resolve the question of whether drains should be used in breast reduction.

Debridement for surgical wounds.

Debridement for surgical wounds.

Postoperative Gastrointestinal Dysfunction After Neuromuscular Blockade Reversal With Sugammadex Versus Cholinesterase Inhibitors in Patients Undergoing Gastrointestinal Surgery: A Systematic Review and Meta-Analysis.

Postoperative gastrointestinal dysfunction (POGD) commonly occurs following gastrointestinal (GI) surgery and is associated with specific anesthetic agents. Cholinesterase inhibitors employed for reversing neuromuscular blockade have been implicated in development of POGD. Sugammadex, a novel reversal agent, is linked with reduced POGD. However, there is a lack of comprehensive comparative review between these agents regarding their impact on POGD following GI surgery. This study aims to systematically review the effects of sugammadex on POGD compared to cholinesterase inhibitors following GI surgery. MEDLINE, EMBASE, and CENTRAL were searched as of July 2022 to identify articles comparing sugammadex with cholinesterase inhibitors in patients undergoing gastrointestinal surgery, specifically in relation to POGD. Secondary endpoints included length of hospital stay, readmission rates, pulmonary complications, and postoperative morbidity. From 198 citations, 2 randomized controlled trials (RCTs) and 3 retrospective cohorts with 717 patients receiving sugammadex and 812 patients receiving cholinesterase inhibitors were included. Significantly lower rates of prolonged postoperative ileus (OR .44, 95% CI .25-.77, P < .05, I2 = 56%, low certainty evidence) was observed with sugammadex. No significant difference in any other outcome was observed. Narrative review of readmission data demonstrated no significant difference. The use of sugammadex following gastrointestinal surgery is associated with significantly lower rates of prolonged postoperative ileus compared to cholinesterase inhibitors. However, these do not translate into a significant reduction in length of stay, morbidity, or postoperative nausea and vomiting. Results are limited by the numer of studies included and missing data, more robust RCTs are needed before recommendations can be made.

Population-based interventions for preventing falls and fall-related injuries in older people.

Population-based interventions for preventing falls and fall-related injuries in older people.

Effectiveness of computer-based telerehabilitation software (RehaCom) compared to other treatments for patients with cognitive impairments: A systematic review.

The rehabilitation process for cognitive disorders is long and complex, which can lead to reduced rehabilitation outcomes and reduced quality improvement. Thus, there is a need to use new methods to boost conventional rehabilitation (e.g., drug therapy, herbal therapy, paper, and pencil tasks). Innovations such as RehaCom can be helpful to remove the obstacles to treatment, but evidence for their effectiveness is limited. To compare the effectiveness of RehaCom with other cognitive therapies (computer-based, non- computer) in patients with cognitive impairment (CI). Eight bibliographic databases (PubMed, Cochran Library, Scopus, Science Direct, Web of Science, Embase, ProQuest, and google scholar) were used in this research. The initial search resulted in the extraction of 2466 articles; after the review of the title, abstract, and full text, 19 articles were selected. Quality assessment was performed using the CONSORT checklist. Then, data extraction was done using the form set by the researcher in Word 2016 software. Overall, RehaCom achieved more positive clinical effects compared to other cognitive therapies (e.g., improvement in memory, attention, and motor function) on multiple sclerosis (n = 7), schizophrenia (n = 6), stroke (n = 3), Parkinson (n = 1), mild CI (n = 1), and acquired brain damage (n = 1). In six studies, a follow-up period of some weeks to 6 months has been used. Additionally, six studies used conventional therapy plus RehaCom for intervention. Except one study, all studies used RehaCom individual training. This review provides evidence for the potential effectiveness of RehaCom for the improvement of clinical outcomes in patients with CI. However, more robust Randomised Controlled Trials (RCTs) are needed to confirm the observed positive effects.

Efficacy and Complications Associated with Acellular Dermal Substitute Use in the Treatment of Acute Burns: A Systematic Review and Meta-Analysis.

Over several decades, skin substitutes have become an essential tool in acute burn surgery, particularly in major burns, where scarce donor tissues can limit the availability of autografts. This systematic review aimed to assess the efficacy, complication rates, and long-term outcomes of acellular dermal substitutes in acute burns and compare these to conventional skin grafting methods of coverage. A search of PubMed, Web of Science, and CENTRAL for appropriate randomized controlled trials (RCTs), non-randomized trials, and observational studies was conducted. Following screening, nine RCTs and seven observational studies fulfilled our inclusion and exclusion criteria. Our primary outcomes, which were graft take and incidence of infection, found no significant difference between the substitute and control procedures in a meta-analysis (p = 0.37 and p = 0.87, respectively). For our secondary outcomes, the studies were analyzed via narrative synthesis, which reported variable rates of graft loss and duration of acute hospital stay, from which definitive conclusions could not be drawn due to the heterogeneity in reporting. Despite a high risk of bias in the included studies, the evidence reviewed suggests that the treatment of an acute burn with a substitute may improve scar quality when compared to conventional grafting. This review therefore suggests that acellular dermal substitutes offer a viable method for staging the closure of deep partial- and full-thickness acute burns, although more robust RCTs with less heterogeneity are needed to support these conclusions.

Yoga as a complementary therapy in neuropathic pain: A systematic review and meta-analysis of randomized controlled trials

ABSTRACT Yoga is an ancient wisdom comprising a multitude of physical and mental practices that are aimed toward a state of optimum physical, mental, social, and spiritual health. Neuropathic pain (NP) is caused by a lesion or disease of the somatosensory nervous system that is often unresponsive to currently available modes of treatment, portending an inferior quality of life for patients. This systematic review and meta-analysis aim to investigate the effect and the potential role of yoga in NP syndromes. PubMed, Scopus, Elton Bryson Stephens Company (EBSCO), and Cochrane Library were screened for randomized controlled trials (RCTs) assessing the effects of yoga in patients on NP. Usual care, no treatment, or any active treatments were acceptable as control interventions. Primary outcome measures were objective or subjective assessment measures of pain intensity. For each outcome, standardized mean differences and 95% confidence intervals (CIs) were calculated. A total of four studies were included for qualitative synthesis. Meta-analysis of three studies revealed an overall effect (Z) in the favor of yoga as an intervention for NP, when compared to controls, although the effect was not statistically significant (three RCTs; Z = 1.10 [P = 0.27]; Heterogeneity: τ2 = 0.37; χ2 = 27.78, df = 2 [P &lt; 0.00001]; I 2 = 93%). This review divulged the overall favorable effect of yoga in NP, although it was not statistically significant. It highlights the promising role of yoga on pain intensity and quality of life in NP syndromes while showing that yoga has the advantage of being an inexpensive and easily accessible mode of therapy. Extensive research on the efficiency and safety of yoga must be conducted using robust RCTs with rigorous methodologies.

Oxytocin treatment for core symptoms in children with autism spectrum disorder: a systematic review and meta-analysis.

The purpose of this article is to examine the efficacy of oxytocin in treating core symptoms of autism spectrum disorder (ASD) with children. A systematic literature search was conducted to identify randomized controlled trials (RCTs) of oxytocin for the treatment of core symptoms in children with ASD. The search included studies published between January 1, 1999 and March 15, 2023, that were randomized, single or double-blinded, and included a placebo control group. Standard screening rules were applied to select relevant studies, resulting in the inclusion of five RCTs involving 486 children with ASD. Ultimately, a total of five RCTs, involving 486 children with ASD, were included in the review using standard screening rules.One of the included studies demonstrated a statistically significant improvement in Social Responsiveness Scale (SRS) and Repetitive Behavior Scale-Revised (RBS) scores when children with ASD were treated with oxytocin (24 IU/2 days for 6 weeks). The improvement in core symptoms persisted at the 6-month follow-up. The meta-analysis findings suggested that oxytocin might have a moderate effect in improving the core symptom of narrow interests and repetitive stereotyped behaviors in children with ASD. While the therapeutic value of oxytocin in treating core symptoms of ASD in children is not fully established, the results of this meta-analysis indicate a potential moderate effect. However, further studies with larger sample sizes and more robust RCTs are needed to directly demonstrate the efficacy of oxytocin. Future research should also focus on effect size and outcome evaluation accuracy while minimizing bias in RCT experiments.

Cannabinoids for Substance Use Disorder Treatment: What Does the Current Evidence Say?

Background: The prevalence of Substance Use Disorder (SUD) is increasing along with the need to develop approaches to reduce the harm associated with substance use, including investigating alternatives such as cannabinoids, which show promising results, although the current evidence is limited. This scoping review focuses on the limitations and potentials of cannabinoid-based treatments for SUDs. Methods: We examined between-subject randomized controlled trials (RCTs) investigating the use of CBD and THC as pharmacological treatment for SUDs in adults, with the procedures attending the expectations of the Preferred Reporting Items for Scoping reviews and Meta-Analyses (PRISMA) for Scoping Reviews guidelines and assessed risk of bias using the Cochrane Risk of Bias Assessment Tool 2. Results: Ten RCTs were included, with six demonstrating low risk of bias, and positive results were found for treating Cannabis Use Disorder, while contradictory results were found for Opioid Use Disorder, and inconclusive results for treating Cocaine Use Disorder. Conclusions: CBD and THC demonstrate potential for treating some SUDs, but evidence is limited. Robust RCTs with larger samples and longer follow-up periods are necessary to assess carefully developed outcomes for different SUD patients. New cannabinoid-based medications and scientific-based policies may advance SUD treatment. A comprehensive approach to treatment and careful methodological choices may benefit patients with SUD.

Network Meta-Analysis Comparing Transcatheter, Minimally Invasive, and Conventional Surgical Aortic Valve Replacement

The landscape of aortic valve replacement (AVR) has evolved dramatically over the years, but time-varying outcomes have yet to be comprehensively explored. This study aimed to compare the all-cause mortality among 3 AVR techniques: transcatheter (TAVI), minimally invasive (MIAVR), and conventional AVR (CAVR). An electronic literature search was performed for randomized controlled trials (RCTs) comparing TAVI with CAVR and RCTs or propensity score-matched (PSM) studies comparing MIAVR with CAVR or MIAVR to TAVI. Individual patient data for all-cause mortality were derived from graphical reconstruction of Kaplan-Meier curves. Pairwise comparisons and network meta-analysis were conducted. Sensitivity analyses were performed in the TAVI arm for high risk and low/intermediate risk, as well as patients who underwent transfemoral (TF) TAVI. A total of 27 studies with 16,554 patients were included. In the pairwise comparisons, TAVI showed superior mortality to CAVR until 37.5months, beyond which there was no significant difference. When restricted to TF TAVI versus CAVR, a consistent mortality benefit favoring TF TAVI was seen (shared frailty hazard ratio [HR] = 0.86, 95% confidence interval [CI] = 0.76 to 0.98, p = 0.024). In the network meta-analysis involving majority PSM data, MIAVR demonstrated significantly lower mortality than TAVI (HR = 0.70, 95% CI = 0.59 to 0.82) and CAVR (HR = 0.69, 95% CI = 0.59 to 0.80); this association remained compared with TF TAVI but with a lower extent of benefit (HR = 0.80, 95% CI = 0.65 to 0.99). In conclusion, the initial short- to medium-term mortality benefit for TAVI over CAVR was attenuated over the longer term. In the subset of patients who underwent TF TAVI, a consistent benefit was found. Among majority PSM data, MIAVR showed improved mortality compared with TAVI and CAVR but less than the TF TAVI subset, which requires validation by robust RCTs.