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The Cochrane Collaboration's tool for assessing risk of bias in randomised trials
... The risk of bias was assessed using the Cochrane Risk of Bias Tool for randomized controlled trials and the ROBINS-E tool for observational studies [13]. Due to the heterogeneity of the included studies, data synthesis was narrative. ...
... [28,29].Heatmaps clearly illustrated variations in mortality rates across different regions and income levels, as well as differences in adherence rates across socioeconomic and geographical factors [35] This visual representation reinforces the importance of considering regional and economic factors in heart failure management. It underscores the importance of a nuanced, context-specific approach to heart failure management that considers different populations and regions' diverse needs and challenges [13]. Future research should aim to standardize data collection, analysis methods, and visualization practices to enhance the consistency and reliability of findings in this area. ...
... CCC and CMP evaluated the risk of bias and extracted data. The Cochrane Handbook for Systematic Reviews of Interventions tool was used to assess the risk of bias for each RCT [26]. The evaluated domains included random sequence generation, allocation concealment, the blinding of participants and personnel, the blinding of outcome assessment, incomplete outcome data, and selective reporting. ...
Background: Sodium–glucose co-transporter-2 (SGLT2) inhibitors have emerged as vital medications for the management of type 2 diabetes mellitus (T2DM). Numerous studies have highlighted the cardioprotective and renal protective benefits of SGLT2 inhibitors. Consequently, it is essential to assess their efficacy and safety in patients with chronic diseases. Method: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating the effects of SGLT2 inhibitors on major cardiovascular and safety outcomes in patients with T2DM, heart failure (HF), and chronic kidney disease (CKD). We searched the PubMed, Cochrane, and Embase databases for trials published between 30 September 2021 and 17 May 2023. The primary outcomes of interest included nonfatal myocardial infarction (MI), hospitalization for heart failure (HHF), cardiovascular death, and nonfatal stroke. The safety outcomes assessed were hypoglycemia, urinary tract infections (UTIs), and acute kidney injury (AKI). Result: We identified 13 RCTs involving 90,413 participants. In patients with T2DM, SGLT2 inhibitors significantly reduced the risk of nonfatal MI by 12% (hazard ratio [HR] = 0.88, 95% confidence interval [CI]: 0.78–0.98), HHF by 33% (HR = 0.67, 95% CI: 0.62–0.74), and cardiac death by 15% (HR = 0.95, 95% CI: 0.80–1.13). However, they did not significantly reduce the risk of nonfatal stroke (HR = 0.85, 95% CI: 0.75–0.95). In patients with HF, SGLT2 inhibitors reduced the risk of HHF by 28% (HR = 0.72, 95% CI: 0.66–0.77) and cardiac death by 12% (HR = 0.88, 95% CI: 0.80–0.96). For patients with CKD, SGLT2 inhibitors reduced the risk of HHF by 35% (HR = 0.65, 95% CI: 0.55–0.76) and cardiac death by 16% (HR = 0.84, 95% CI: 0.73–0.96). Regarding safety outcomes, SGLT2 inhibitors did not significantly increase the risk of hypoglycemia in patients with T2DM, HF, or CKD, nor did they increase the risk of urinary tract infections (UTIs) in patients with HF or CKD, or the risk of acute kidney injury (AKI) in patients with HF. However, they did increase the risk of UTIs by 8% (risk ratio [RR] = 1.08, 95% CI: 1.01–1.16) in patients with T2DM and reduced the risk of AKI by 22% (RR = 0.78, 95% CI: 0.67–0.89) and 19% (RR = 0.81, 95% CI: 0.69–0.97) in patients with T2DM and CKD, respectively. Conclusions: SGLT2 inhibitors have demonstrated a significant improvement in cardiovascular outcomes for patients with T2DM, HF, and CKD while also maintaining a favorable safety profile. These findings advocate for the broader application of SGLT2 inhibitors in the management of chronic diseases, particularly in reducing the incidence of nonfatal MI, HHF, and cardiac death. Further research is essential to optimize their use across diverse patient populations and stages of disease.
... The Cochrane risk-of-bias assessment tool 2 (ROB-2) was used to evaluate the ROB in the included RCTs [12]. The tool includes five domains: randomization, deviations, missing data, outcome measurement, and result selection. ...
... Two reviewers independently assessed the quality of included studies using the Cochrane Risk of Bias Tool for RCTs (21). It assesses bias arising from the randomization process, deviations from intended interventions, missing outcome data, outcome measurement, and selective outcome reporting. ...
OBJECTIVE
To provide an updated synthesis on effects of glucagon-like peptide 1 receptor
agonists (GLP-1 RAs) on weight, BMI, and waist circumference incorporating
newer randomized controlled trials (RCTs), particularly in individuals with over
weight or obesity.
RESEARCH DESIGN AND METHODS
We systematically searched PubMed, Embase, and Cochrane Central Register of
Controlled Trials (CENTRAL) for RCTs published from inception to 4 October 2024.
The search was limited to RCTs evaluating the use of GLP-1 RAs for mean differ
ences from baseline in weight, BMI, and waist circumference in adults with obesity
or overweight with or without diabetes. Two independent reviewers performed
the literature search and data extraction, resolving disagreements via consensus or
third-reviewer consultation.
RESULTS
Forty-seven RCTs were included, with a combined cohort of 23,244 patients.
GLP-1 RAs demonstrated a mean weight reduction of 24.57 kg (95% CI 25.35 to
23.78), mean BMI reduction of 22.07 kg/m2 (95% CI 22.53 to 21.62), and mean
waist circumference reduction of 24.55 cm (95% CI 25.72 to 23.38) compared with
placebo. This effect was consistent across diabetes status, GLP-1 RA used, and route
of administration. The greatest treatment benefit appeared to favor patients who
were younger, female, without diabetes, with higher baseline weight and BMI but
lower baseline HbA1c, and treated over a longer duration. Limitations include substan
tial statistical heterogeneity, in part due to broad inclusion criteria. However, this het
erogeneity may improve generalizability by reflecting a wide range of study designs
and patient populations.
CONCLUSIONS
GLP-1 RAs demonstrated significant weight, BMI, and waist circumference reduc
tion benefits in this meta-analysis
... Two reviewers (EJFS and BF) assessed the risk of bias in each included study using the Cochrane Collaboration's tool for RCTs. 29 Any disagreements between the reviewers were resolved through discussion or adjudication by a third reviewer (PMM). The Cochrane's risk of bias tool (RoB-1) was used since this SR is an update and because it was the previously used tool. ...
Objective
To identify the best evidence on the efficacy of treatment interventions for inclusion body myositis (IBM) and to describe their safety.
Methods
Systematic review of randomised controlled trials (RCTs) of pharmacological treatments of adults with IBM, conducted according to the Cochrane Handbook, updating a previous Cochrane review. The search strategy was run on Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL, MEDLINE and EMBASE, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. Assessment of risk of bias, data extraction and synthesis were performed independently by two reviewers. Data pooled in statistical meta-analyses, if possible.
Results
From a total of 487 records, 48 were selected for full-text review, 14 fulfilled the inclusion criteria, but only 2 RCTs were included in meta-analyses due to clinical heterogeneity (different drug interventions or dosages). Treatments included various immunosuppressive and immunomodulatory agents, alongside interventions modulating muscle growth and protein homoeostasis. Efficacy was assessed across multiple outcomes, namely muscle strength, physical function, mobility and muscle trophicity. Trials of methotrexate (MTX), intravenous immunoglobulin, interferon beta-1a and MTX, MTX and anti-T-lymphocyte immunoglobulin, oxandrolone, MTX and azathioprine, bimagrumab, arimoclomol, and sirolimus provided low-quality to high-quality evidence of having no effect on the progression of IBM.
Conclusions
Drug interventions for IBM were not effective for most of the outcomes of interest. We observed inconsistency of outcome measures across trials. More RCTs are needed, of adequate size and duration, and using a standardised set of outcome measures.
... All risk of bias assessments were duplicated, one by the study lead and a second by another reviewer, using the Cochrane risk of bias tool. 35 For each study, overall risk of bias was classified as low (no domains rated high, low risk of bias for allocation concealment, less than three domains unclear), moderate (one domain rated high, low risk of bias for allocation concealment, fewer than three domains unclear), or high (all other cases). ...
Objective
To estimate the relative efficacy of individual and combinations of prehabilitation components (exercise, nutrition, cognitive, and psychosocial) on critical outcomes of postoperative complications, length of stay, health related quality of life, and physical recovery for adults who have received surgery.
Design
Systematic review with network and component network meta-analyses of randomised controlled trials.
Data sources
Medline, Embase, PsycINFO, CINAHL, Cochrane Library, and Web of Science were initially searched 1 March 2022, and updated on 25 October 2023. Certainty in findings were assessed using the Confidence in Network Meta-Analysis (CINeMA) approach.
Main outcome measures
To compare treatments and to compare individual components informed by partnership with patients, clinicians, researchers, and health system leaders using an integrated knowledge translation framework. Eligible studies were any randomised controlled trial including adults preparing for major surgery who were allocated to prehabilitation interventions or usual care, and where critical outcomes were reported.
Results
186 unique randomised controlled trials with 15 684 participants were included. When comparing treatments using random-effects network meta-analysis, isolated exercise (odds ratio 0.50 (95% confidence interval (CI) 0.39 to 0.64); very low certainty of evidence), isolated nutritional (0.62 (0.50 to 0.77); very low certainty of evidence), and combined exercise, nutrition, plus psychosocial (0.64 (0.45 to 0.92); very low certainty of evidence) prehabilitation were most likely to reduce complications compared with usual care. Combined exercise and psychosocial (−2.44 days (95% CI −3.85 to −1.04); very low certainty of evidence), combined exercise and nutrition (–1.22 days (–2.54 to 0.10); moderate certainty of evidence), isolated exercise (–0.93 days (–1.27 to –0.58); very low certainty of evidence), and isolated nutritional prehabilitation (–0.99 days (–1.49 to –0.48); very low certainty of evidence) were most likely to decrease length of stay. Combined exercise, nutrition, plus psychosocial prehabilitation was most likely to improve health related quality of life (mean difference on Short Form-36 physical component scale 3.48 (95% CI 0.82 to 6.14); very low certainty of evidence) and physical recovery (mean difference in meters on the six min walk test 43.43 (95% CI 5.96 to 80.91); very low certainty of evidence).When comparing individual components using component network meta-analysis, exercise and nutrition were the individual components most likely to improve all critical outcomes. The certainty of evidence for all comparisons across all outcomes was generally low to very low due to trial level risk of bias and imprecision; however, results for exercise and nutritional prehabilitation were robust with exclusion of high risk of bias trials.
Conclusions
Consistent and potentially meaningful effect estimates suggest that exercise prehabilitation, nutritional prehabilitation, and multicomponent interventions including exercise may benefit adults preparing for surgery and could be considered in clinical care. However, multicentre trials that are appropriately powered for high priority outcomes and that have a low risk of bias are required to have greater certainty in prehabilitation’s efficacy.
Registration
International prospective registry of systematic reviews CRD42023353710.
... Two authors (JZ and SX) independently assessed each included study's risk of bias (RoB 2) using the Cochrane Improved Risk of Bias Tool for Randomized Trials [14,15]. The RoB Excel tool was used for the RoB 2 evaluation. ...
Background
Prehabilitation is a crucial component of tumor rehabilitation that attempts to improve patients’ preoperative health, although its efficacy in treating patients with cancers of the digestive system is still up for debate.
Methods
The records from PubMed (MEDLINE), Embase, Web of Science, Cochrane Library, EBSCO, Scopus, CNKI and Wan fang database up to November 2024 were systematically searched. The Cochrane Collaboration tool was employed for evaluating the risk of bias in each study, and the PRISMA 2020 checklist provided by the EQUATOR network was utilized.
Results
Through quality analysis, 20 articles were included, involving 1719 patients. Although its effect on severe complications is still unknown, the prehabilitation significantly decreased overall postoperative complications when compared to standard care, with a risk ratio (RR) of 0.74 (95% CI: 0.65 to 0.84). Despite not shortening the postoperative hospital stay (MD: -0.13, 95% CI: -0.29 to 0.03), prehabilitation demonstrated notable improvements in the 6-minute walk distance (6MWD), with preoperative gains (MD: 25.87, 95% CI: 14.49 to 37.25) and sustained benefits at 4 weeks postoperatively (MD: 22.48, 95% CI: 7.85 to 37.12). However, no significant differences in 6MWD were observed at 6 or 8 weeks postoperatively. The average improvement in 6MWD from baseline to preoperative was 28.99 (95% CI: 10.89 to 47.08, P = 0.002), and from 4 weeks postoperative to baseline, it was 25.95 (95% CI: 6.84 to 45.07, P = 0.008), with no significant change at 8 weeks. The acceptance and completion rates of prehabilitation were commendably high at 61% (95% CI: 47–75%) and 90% (95% CI: 87–93%), respectively, alongside a relatively low dropout rate of 10% (95% CI: 7% to13%).
Conclusions
Prehabilitation reduces postoperative complications and improves short-term physical function in digestive surgery patients, with good patient acceptance; however, the long-term effects are unknown due to a lack of follow-up data.
Registration
It was registered with the International Prospective Register of Systematic Reviews (PROSPERO) with the identification code CRD42022361100.
... The assessment was conducted independently by two reviewers (RA & GE), and any discrepancies were resolved through discussion with a third reviewer (WS). Employing the Cochrane Collaboration's two-part tool for bias risk assessment [17], efforts were made to gauge bias across studies and identify papers with inherent methodological and design flaws. The factors examined for a low, high, or unclear risk of bias included: (1) random sequence generation, (2) allocation concealment, (3) blinding of participants/personnel, (4) incomplete outcome data, (5) selective reporting outcomes, and (6) other potential risks of bias. ...
Objective
This systematic review and meta-analysis aim to evaluate the therapeutic potential of boric acid as a local drug delivery agent in the treatment of periodontitis.
Methods
Following PRISMA guidelines, we registered a comprehensive protocol with PROSPERO. By employing PICOS criteria, we evaluated randomized controlled trials assessing the effects of subgingival boric acid application alongside non-surgical periodontal therapy in treatment of periodontitis. Studies were systematically searched across multiple databases, with establishment of the eligibility criteria. Data extraction and risk of bias assessment were conducted independently by reviewers.
Results
Among 1,640 records screened, 6 studies met the inclusion criteria, comprising 281 participants aged 18–65 years. At 1-month, boric acid demonstrated significant improvements in probing pocket depth (PPD), but insignificant differences were observed in clinical attachment level (CAL), and gingival index (GI). However, at 3 and 6 months, we found significant reductions in PPD while at 6 months, a significant increase in CAL gain were observed favoring boric acid. No significant changes in GI were noted at any follow-up duration.
Conclusion
Boric acid adjunctive therapy in non-surgical periodontal treatment shows promising efficacy in improving clinical parameters, particularly PPD and CAL, over time. While early outcomes may not show significance, sustained benefits are evident at longer follow-up periods. These findings underscore the potential of boric acid as a valuable addition to periodontal therapy, demanding further investigation to reveal its precise mechanisms and optimize clinical application.
... To assess the potential for bias in the included RCTs, the researchers implemented a standardized questionnaire. Using the Cochrane risk-of-bias instrument, version 2, two researchers conducted independent evaluations of the potential for bias in individual studies [32]. Five components comprised this tool: bias resulting from variations from intended interventions, bias caused by randomization, bias due to lacking outcome information, bias during outcome evaluation, and bias in selecting reported results. ...
Introduction
KOA, a chronic degenerative joint disease, is commonly treated with intra-articular HA and PRP, used alone or in combination. However, the efficacy and safety of combination therapy (PRP + HA) remain unclear.
Aim
The aim of this systematic review and meta-analysis is to assess the clinical effectiveness and safety profile of PRP + HA versus PRP monotherapy for KOA.
Material and methods
A systematic search was conducted using four electronic databases (PubMed, EMBASE, Scopus, and Cochrane Library) to select publications published in peer-reviewed journals. The mean difference (MD) and risk ratio (RR) was calculated, along with their 95% confidence intervals. We assessed heterogeneity using Cochrane Q and I²statistics and the appropriate p-value. The analysis used RevMan 5.4. GRADE system was used for evidence assessment for each outcome parameter.
Results
This meta-analysis of 11 RCTs (n = 1023 KOA patients) revealed that PRP + HA has substantial effectiveness than PRP alone in reducing OMAC total scores [MD -1.77 (95% CI -2.20 to − 1.34); I2 = 10%, and p < 0.001], VAS scores [MD -4.27 (95% CI -4.96 to − 3.58); I² = 13%, and p < 0.001], and Lequesne index score [MD -5.48 (95% CI -6.56 to − 4.40); I² = 16%, and p < 0.001], while increasing IKDC scores [MD -2.10 (95% CI -3.70 to − 0.50); I² = 9%, and p = 0.01], with low risk of adverse events [RR 0.41 (95% CI 0.35 to 0.48); I² = 12%, and p < 0.001].
Conclusion
This meta-analysis reveals that, for patients with KOA, PRP + HA therapy is safe and yields better outcomes in pain relief and functional improvement compared to PRP monotherapy.
... The risk of bias assessment was conducted using Revman 5.4, in accordance with the criteria defined in the Cochrane Handbook [14]. The domains of random sequence generation, allocation concealment, blinding of participants and healthcare personnel, blinding of assessors, incomplete data, and selective reporting were classified as high risk, low risk, or uncertain risk. ...
Purpose
Uterine fibroids are the most common pelvic tumors in women, representing the primary indication of hysterectomy. Gonadotropin-releasing hormone (GnRH) antagonists represent a new therapeutic option for premenopausal women. The aim of this review is to evaluate the efficacy and safety of GnRH antagonists in the treatment of uterine fibroids (size reduction and symptom control).
Methods
A review of studies from electronic databases (PubMed and Cochrane Central) published up to December 2023 was performed. Eleven randomized clinical trials with a total of 4164 patients were included in the review, which evaluated GnRH antagonists (Relugolix, Elagolix, Linzagolix and Cetrorelix) against placebo or GnRH agonists in premenopausal women with uterine fibroids and heavy menstrual bleeding.
Results
The results of the measures evaluated to determine the efficacy and safety of GnRH antagonists versus placebo are favorable for the variables of control of uterine bleeding (Relative risk (RR) = 5.09; 95% CI 3.19 to 8.14), percentage reduction of fibroid volume (Mean difference (MD) = -27.36; 95% CI −38.89 to −15.83) and lower reduction of bone density (MD -0.35; 95% CI −0.47 to −0.24). The results do not allow us to conclude whether there are differences between the alternatives compared in the control of vasomotor symptoms.
Conclusions
GnRH antagonists represent an effective alternative for uterine fibroids treatment as they allow a superior reduction in menstrual bleeding and uterine fibroid volume compared to the placebo group.
... The Cochrane Collaboration's risk of bias (RoB) tool 35 was used to evaluate the quality of the included studies. The qualifying studies were classified into 3 categories: high, low or uncertain risk. ...
Objective
The purpose of this systematic review and meta-analysis is to examine the impact of telemedicine interventions on the quality of life (QoL) and depression in individuals with spinal cord injury (SCI).
Methods
A literature search was conducted in four electronic databases (PubMed, Web of Science, EMBASE, and the Cochrane Library) from their inception to February 1, 2024. Two authors independently screened the studies and extracted the data. Cochrane’s bias risk tool for randomized controlled trials was used to examine the methodological quality of the included studies. A meta-analysis was conducted using Review Manager (version 5.4) to synthesize the results of the included studies.
Results
A total of 10 trials with 728 participants were included in the review. The results of the meta-analysis showed that telemedicine interventions significantly improved QoL [Standardized Mean Difference (SMD)=0.72, 95% Confidence Interval (CI) (0.11, 1.32), P=0.02] and reduced depression scores [SMD=-0.18, 95% CI (-0.31, -0.05), P=0.006].
Conclusions
Telemedicine interventions are a feasible method to support people with SCI, and can mitigate depression and enhance quality of life. In the future, studies should involve larger sample sizes and extended follow-up periods to validate these findings and to identify the most effective telemedicine interventions for improving the overall health outcomes of individuals with SCI.
Systematic Review Registration
https://www.crd.york.ac.uk/prospero/ , identifier CRD42024508702.
Inguinal hernia repair (IHR) is a common surgical procedure among neonates and infants; the time of surgery is one of the major factors affecting its outcomes. Our systematic review aims to evaluate the effects of surgical timing on outcomes in inguinal hernia repairs in the newborn and infant population to establish evidence-based guidelines for optimal surgical timing. A systematic search was performed in PubMed, MEDLINE, and Web of Science databases, following PRISMA guidelines. Studies evaluating neonates and infants undergoing IHR with outcomes of recurrence, complications, and postoperative recovery were included. Data were collaboratively extracted, including patient demographics, surgical approaches, perioperative complications, and long-term outcomes. Early repair (0–28 days of life) decreased the risk of hernia incarceration but also increased the risk of preoperative complications. Delayed repair (29 days to 1 year of life) showed fewer preoperative complications but increased the risk of incarceration. The outcomes were affected by variables including patient maturity and comorbidities, along with hernia severity. Neonates with a high risk for incarceration are best treated with early repair, while stable infants can be managed safely with delayed repair. More randomized trials are needed to develop standardized guidelines that balance the associated risks of neonatal versus infant repair strategies to maximize benefits.
Background: Peripheral facial paralysis (PFP) affects the facial nerve, the seventh cranial nerve. It has an incidence rate of 20–30 cases per 100,000 habitants. The diagnosis is clinical, though imaging tests may be required in some cases. The treatment protocol includes medication, physiotherapy, and, in certain cases, surgery. Proprioceptive neuromuscular facilitation (PNF) techniques and electrical stimulation have been shown to be significant for recovery. Although PFP has a high recovery rate, up to 40% of patients may experience permanent sequelae. Objective: to assess the efficacy of treatment based on electrical stimulation and/or PNF in patients affected by PFP. Methods: A systematic search was conducted across six databases (PubMed, Medline, SportDiscus, CINAHL, Scopus, and Web of Science) in November 2024. Randomized controlled trials were included. Results: Fourteen articles were analyzed, applying PNF and/or electrical stimulation methods, pharmacological treatment, low-level laser treatment, subcutaneous collagen injections, and physiotherapy protocols involving facial expression exercises, yielding evidence for the variables assessed. Conclusions: PNF and/or electrical stimulation treatment in patients with PFP can be effective when employed early with appropriate parameters, showing promising results in improving quality of life, facial movement quality, and CMAP and reducing both the incidence and degree of synkinesis.
Background
Pediatric thrombosis is a relatively rare but severe condition in the field of pediatrics, with far-reaching consequences. Recent studies have indicated a rising incidence of this disease in children over the years. Additionally, the pharmacological treatment of thrombotic diseases in children faces numerous challenges. Due to significant physiological differences between children and adults, guidelines for the prevention and treatment of thrombotic diseases in adults cannot be directly applied to pediatric patients.
Purpose
A systematic review of the existing evidence-based medical literature should be conducted to propose pharmacological prevention and treatment recommendations for pediatric thrombotic diseases. Developing a comprehensive and practical pharmacotherapy guideline for the prevention and treatment of pediatric thrombotic diseases is essential to enhancing the rational use of medications in managing these conditions in children.
Methods
The guideline development followed the World Health Organization's (WHO) Handbook for Guideline Development. This involves systematically searching and extensively collecting data on common medication issues in the prevention and treatment of pediatric thrombosis nationwide. The Delphi method was used to survey experts and identify the clinical issues to be included. Subsequently, a systematic literature review was conducted to evaluate existing primary studies, systematic reviews, and guidelines or consensus statements from professional organizations. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. The Delphi method was employed again to reach a consensus on the recommendations and evidence levels. This process was culminated in the development of the Guideline for Pharmacological Management of Thrombotic Diseases in Children.
Results
During the guideline development process, a total of 29 clinical issues were collected and evaluated by 78 experts in clinical pharmacy and clinical medicine. Through two rounds of surveys, 13 clinical issues were selected. Under the supervision of two methodologists, 13 clinical pharmacotherapy recommendations were formulated.
Conclusion
By conducting a comprehensive assessment of the feasibility and safety of clinical practices, the guideline provides specific anticoagulant medication recommendations for pediatric healthcare professionals. This will help enhance the prevention and treatment of pediatric thrombosis, promoting more standardized and effective medical practices.
Introduction
Electro-anatomical mapping (EAM) system has been shown as an alternative procedure to fluoroscopy for conduction system pacing (CSP) in patients with severe bradyarrhythmia, however its beneficial and harmful effects has not been assessed in a systematic review (SR). We sought to assess their safety, effectiveness and cost-effectiveness.
Methods
A SR of the available scientific literature was conducted on the safety, effectiveness, and cost-effectiveness of CSP using EAM system versus fluoroscopy in patients with severe bradyarrhythmia. A partial economic evaluation was carried out to compare the costs of both strategies from the perspective of the Spanish National Health System. A budget impact analysis was also conducted with a five-year horizon.
Results
Seven comparative observational studies ( N = 231), analyzing the use of EAM versus fluoroscopy were selected. Statistically significant differences were observed in total fluoroscopy time: −9.87 minutes (95%CI:−14.20, −5.53, p < 0.01; I ² = 95%; k = 7; n = 231); His-lead fluoroscopic time: −8.08 minutes (95%CI:−10.36, −5.81, p < 0.01; I ² = 0%; k = 2; n = 50); and His-lead radiation dose: −17.21 mGy (95%CI:−24.08, −10.34, p < 0.01; k = 1; n = 20). No differences in total fluoroscopy dose, successful procedure or safety were found. The use of EAM represents an increase of EUR 1397.81 per patient and a net budget impact of EUR 1.63 million.
Discussion
EAM is a valuable alternative for patients who should not be exposed to ionizing radiation with similar effectiveness and safety than fluoroscopy. However, the inclusion of EAM systems, for the indication under study, in routine clinical practice would mean an increase in costs for the Spanish National Health System.
Systematic Review Registration
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=421072 , identifier (CRD42023421072).
BACKGROUND
The application of randomized controlled trials (RCTs) outcomes of botulinum toxin type A (BoNT-A) to actual patient care faces a significant hurdle due to research waste (RW). This includes the results of RCTs that have not been published even 4 years after completion and those with insufficiently reported outcomes and design flaws. The prevalence of RW within BoNT-A-associated RCTs remains uncertain.
OBJECTIVE
To assess the extent of RW (non-publication, insufficient reporting, and design flaws) in BoNT-A RCTs.
METHODS
The authors searched the ClinicalTrials using ‘botulinum toxin type A’ as the keyword. They verified the publication status through PubMed and Scopus searches. The adequacy of reporting was assessed using the Consolidated Standards of Reporting Trials checklist, while design limitations were evaluated based on the risk of bias and systematic reviews.
RESULTS
Two hundred twenty-eight RCTs met the inclusion criteria for characteristics presentation. The RW analysis omitted 53 RCTs completed after June 2020, which remained unpublished. Of the 175 RCTs assessed, 98 were published, 71 demonstrated adequate reporting, and 25 had design limitations. Altogether, 118 RCTs (67.4%) exhibited at least 1 trait of RW. Multicenter designs and registrations post-2014 were independent protective factors against RW.
CONCLUSION
Within the 175 RCTs included in RW analysis, 67.4% of the studies presented some form of RW. The varied characteristics of the identified RW indicators offer essential insights for more rational planning of future BoNT-A RCTs.
Background
Agalsidase beta is used to treat Fabry disease (FD); however, data on cardiac and cerebrovascular outcomes with agalsidase beta treatment come from studies with limited numbers of patients.
Methods
A systematic literature review of studies reporting on the efficacy and effectiveness of agalsidase beta in FD was conducted. Studies were identified in searches of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from January 2000–June 2022. Outcomes of interest included cardiac structure and mass, cardiac events, and cerebrovascular events.
Results
Fifty-two citations (41 studies) were included. Reductions in interventricular septal thickness (IVST) and/or left ventricular posterior wall thickness (LVPWT) were demonstrated in six studies (follow-up 1–6 years, n = 4 using echocardiography, n = 2 cardiac MRI). IVST ranged from 12.1–14.9 mm at baseline and 10.8–14.1 mm at follow-up (all p < 0.05). LVPWT ranged from 11.7–16.0 mm at baseline and 10.7–13.0 mm at follow-up (all p < 0.05). Significant reductions in cardiac mass were demonstrated after 1 year of treatment in a single-arm study using cardiac MRI [left ventricular mass (LVM) 193–178 g; LVM index 102–94 g/m ² ; both p < 0.05]. Rates of composite cardiac events (3.8%–24.0%; four studies, follow-up 2–10 years) and cerebrovascular events (0.0%–18.9%; 12 studies, follow-up 1–10 years) were numerically lower than rates for placebo (follow-up 3 years).
Conclusion
Literature over the last 20 years indicates that agalsidase beta treatment may lead to stabilization or regression of cardiac structural thickness and mass, and reduction in cardiac and cerebrovascular events relative to placebo.
Dental caries is a widespread issue impacting global oral health. White spot lesions, the earliest stage of caries, compromise enamel’s esthetics and integrity. Remineralization therapies, both fluoride and non-fluoride based, aim to restore enamel, but limited comparative data exist on their effects on lesion depth and microhardness. Thus, the aim of this systematic review was to evaluate the efficacy of remineralizing agents on lesion depth and microhardness of human teeth. The literature search included the following five databases: PubMed, Web of Science, Scielo, SCOPUS, and EMBASE from the period 2012 to October 2022. Studies evaluating lesion depth and microhardness in human teeth after the application of a remineralizing agent were considered for review. The meta-analysis was performed using RevMan 5.4 (The Cochrane Collaboration, Copenhagen, Denmark). A random effect model was used to pool estimate of effect and its 95% confidence intervals (CIs) for surface microhardness and depth lesion. Subgroup analyses were performed considering the presence of fluoride or not in the remineralization agent. Thirty-three studies were included in the qualitative review. Of these, twenty-six studies were included in the meta-analysis. The main risks of bias associated with the studies included a lack of blinding of the test operator and failure to obtain sample size. To conclude, fluorinated agents are more effective in remineralizing artificially induced white spot lesion than non-fluoride remineralizing agents.
Aims
An unbiased means of documenting medication‐taking is important to ensure quality evidence about adherence research and to accurately identify individuals at risk of suboptimal adherence for the development of targeted and effective interventions. Guidance to assist researchers in the understanding of risk of bias when conducting or reviewing adherence research is currently not available. To address this gap, tools to identify and gauge the magnitude of important biases that may impact adherence research have been developed.
Methods
The Risk of Bias tool for Interventional Adherence Studies (RoBIAS) and the Risk of Bias tool for Observational Adherence Studies (RoBOAS) were constructed from a literature review of key adherence guidelines/frameworks, drafted initially through author consensus. The draft bias tools were piloted and evaluated with expert adherence researchers through an online survey platform to assess the internal consistency and agreement in responses, including gather “free text” feedback to improve the tool's utility.
Results
Of the 121 approached reviewers, only 20 out of the 30 reviewers who consented to participate completed the piloting of the tools. Both tools are structured around four domains relating to: (i) study design, (ii) randomization (RoBIAS tool) and confounding factors (RoBOAS tool), (iii) adherence outcome measurement, and (iv) data analysis. Each domain consists of items/statements, mapped to specific biases relevant to adherence research and study designs, including a domain‐based ranking scale to determine the appropriate risk of bias judgement.
Conclusions
The tools are intended to have utility when systematically reviewing adherence research and to inform the design of future adherence studies.
Background
Joint arthroplasty effectively treats osteoarthritis, providing pain relief and improving function, but postoperative venous thromboembolism (VTE) remains a common complication. This study therefore assessed the effectiveness and safety of aspirin compared with oral anticoagulants (OACs) for VTE prophylaxis after joint arthroplasty.
Methods
A systematic review and meta-analysis was performed by searching PubMed, Embase, the Web of Science, and the Cochrane Library for randomized controlled trials (RCTs) up to May 14, 2024, that compared the effect of aspirin versus OACs on VTE prophylaxis in adults undergoing joint arthroplasty. Data extraction followed the PRISMA guidelines. Two independent researchers conducted the literature searches and data extraction. A random-effects model was used to estimate effects. The primary outcome was the incidence of VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE); secondary outcomes included bleeding, wound complications, and mortality.
Results
The meta-analysis included 11 RCTs with a total of 4,717 participants (55.1% female) from several continents. The relative risk (RR) of VTE following joint arthroplasty was 1.11 (95% confidence interval [CI], 0.93 to 1.32) for aspirin compared with OACs. Similar results were observed for DVT (RR, 1.12; 95% CI, 0.90 to 1.40) and PE (RR, 1.18; 95% CI, 0.51 to 2.71). There were no significant differences in the risks of bleeding, wound complications, or mortality between patients receiving aspirin and those receiving OACs. Subgroup analyses considering factors such as study region, type of joint surgery, type of VTE detection, year of publication, use of mechanical VTE prophylaxis, aspirin dose, type of OAC comparator, study quality, and funding also found no significant differences in VTE incidence between aspirin and OACs. The overall quality of evidence for VTE and DVT outcomes was high.
Conclusions
Based on high-quality evidence from RCTs, aspirin is as effective and safe as OACs in preventing VTE, including DVT and PE, after joint arthroplasty, without increasing complications.
Level of Evidence
Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
Long-term data are limited comparing percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (S-DES) vs coronary artery bypass grafting (CABG) in patients with complex coronary artery disease (CAD). We aimed to conduct a systematic review and meta-analysis comparing these interventions in patients with left main or multivessel CAD. We systematically reviewed PubMed, Embase, and Cochrane for studies that compared PCI with S-DES and CABG in patients with left main or multivessel CAD with a minimum mean follow-up period of 3 years. Outcomes of interest were all-cause mortality, myocardial infarction (MI), stroke, and major adverse cardiovascular events (MACE). We extracted data from observational studies as multivariable-adjusted or propensity score-matched hazard ratio to minimize confounding and pooled hazard ratios with 95% confidence intervals (CIs) using a random effects model in Review Manager 5.4.1. We included 10 studies, 3 of which were randomized controlled trials, comprising a total of 26964 patients, of whom 14928 underwent PCI. As compared with CABG, S-DES had a significantly higher risk of all-cause mortality (hazard ratio 1.35; 95% CI 1.22–1.49; P < 0.001; I ² = 0%), MACE (hazard ratio 1.27; 95% CI 1.08–1.50; P = 0.005; I ² = 67%), and MI (hazard ratio 2.43; 95% CI 1.80–3.28; P < 0.01; I ² = 0%). There was no significant difference between groups in incidence of stroke. In this meta-analysis of patients with complex CAD, PCI with S-DES was associated with an increased risk of mortality, MI, and MACE compared with CABG.
Background
The efficacy and safety of metformin for addressing neurocognitive dysfunction in schizophrenia remain inconclusive. This systematic review evaluates the evidence from randomized controlled trials (RCTs) on the effects of metformin on neurocognitive function in patients with schizophrenia.
Methods
A comprehensive search of Chinese databases (WanFang, Chinese Journal Net) and English databases (PubMed, EMBASE, PsycINFO, and Cochrane Library) was conducted to identify RCTs assessing metformin’s impact on neurocognitive outcomes in schizophrenia.
Results
Four RCTs involving 271 patients with schizophrenia were included. Three RCTs (75%) demonstrated significant improvements in neurocognitive function with metformin compared to controls, as assessed by the MATRICS Consensus Cognitive Battery, Repeatable Battery for the Assessment of Neuropsychological Status, and Mini-Mental State Examination, but not the Brief Assessment of Cognition in Schizophrenia. Two RCTs (50%) evaluated metformin's effects on total psychopathology and found no significant differences between groups. Adverse events were reported in two RCTs, with inconsistent findings on decreased appetite and diarrhea. Other adverse events and discontinuation rates were comparable between groups.
Conclusion
Preliminary evidence suggests that metformin may improve neurocognitive function in schizophrenia. However, further large-scale, double-blind, high quality RCTs are warranted to validate these findings.
Background
Polycystic ovary syndrome (PCOS) is a complex endocrine disorder affecting ≈8% to 13% of women of reproductive age. PCOS has multifaceted effects that extend beyond reproductive health. Women with PCOS are at an elevated risk for various metabolic conditions, including obesity, type 2 diabetes, and cardiovascular disease, as well as psychological challenges, such as anxiety, depression, and reduced quality of life. This systematic review examined the effectiveness of lifestyle interventions, including dietary, exercise, and behavioral modifications, in improving reproductive outcomes, mental well-being, and quality of life in women with PCOS.
Methods
A comprehensive search was conducted using MEDLINE, EMBASE, Cochrane Library, and Web of Science databases, identifying observational and interventional studies published in English through December 2022. Studies were evaluated for methodological quality and categorized according to the type of lifestyle intervention and outcome measures.
Results
Of the 24 studies reviewed, with 16 focusing on reproductive outcomes, 4 on quality of life, and 4 on combined outcomes, encompassing 1373 participants with the mean age in the included studies ranged from 21.7 to 36.5 years. Dietary modifications, either alone or in combination with exercise, resulted in significant improvements in reproductive health, including a 5% reduction in body weight ( P < .001), increased menstrual regularity, higher pregnancy rates, and decreased testosterone levels ( P < .01). Exercise interventions further contributed to positive outcomes; a 20-week exercise program improved ovulation rates by 49.1% and significantly reduced testosterone and free androgen indices ( P < .001). In addition, structured exercise programs increased menstrual regularity by 60% and reduced body mass index and testosterone levels.
Conclusion
This review underscores the efficacy of integrated lifestyle interventions, including dietary, exercise, and behavioral approaches, in improving reproductive health, psychological well-being, and quality of life in women with PCOS. These findings highlight the potential of comprehensive nonpharmacological management strategies to address the multifaceted health challenges posed by PCOS. Future research should prioritize long-term studies to assess sustained outcomes and examine personalized intervention strategies that account for the clinical diversity and heterogeneity of PCOS presentations.
Background
The standard of care for locoregionally advanced nasopharyngeal carcinoma (LA-NPC) is induction chemotherapy (ICT) followed by concurrent chemoradiation (CCRT). However, the ideal ICT regimen for LA-NPC remains unclear. We conducted a meta-analysis to evaluate the survival outcomes, responses, and incidences of toxicities between taxane, cisplatin and fluorouracil (TPF) and cisplatin and fluorouracil (PF) ICT regimens plus CCRT in LA-NPC.
Methods
A systematic review and meta-analysis of the literature was conducted to compare the efficacy and safety of TPF versus PF followed by CCRT with cisplatin every 3 weeks or weekly cisplatin and intensity-modulated radiotherapy in LA-NPC.
Results
Three studies with 2482 patients met the inclusion criteria. ICT with the TPF regimen plus CCRT resulted in a significantly improved progression-free survival (hazard ratios [HR] 0.84 [95% CI 0.73–0.96], P = .01), overall survival (HR 0.83 [95% CI 0.71–0.97], P = .02), and 3-year locoregional recurrence-free survival (risk ratios [RR] 1.03 [95% CI 1.01–1.06], P = .009) compared with the PF regimen plus CCRT in LA-NPC. However, distant metastasis-free survival was not statistically significant ( P = .07). The incidence of grade 3 or 4 neutropenia (RR 2.08 [95% CI 1.84–2.36]) and diarrhea (RR 1.94 [95% CI 1.07–3.52]) during ICT was higher in the TPF group than in the PF group.
Conclusions
In terms of progression-free survival, overall survival, locoregional recurrence-free survival, in the era of intensity-modulated radiotherapy, the TPF plus CCRT with cisplatin is superior to PF plus CCRT with cisplatin in LA-NPC. Thus, the TPF plus CCRT regimen appears to be a reasonable treatment option, and further confirmation by prospective studies is needed.
BACKGROUND
Total intravenous anesthesia (TIVA)-based and volatile-based general anesthesia have different effects on cerebral hemodynamics. The current work compares these 2 regimens in acute ischemic stroke patients undergoing endovascular therapy.
METHODS
We conducted a systematic literature search across MEDLINE, Embase, Cochrane, CINAHL, Web of Science, and Scopus. We identified English language studies including adult acute ischemic stroke patients managed with endovascular therapy under general anesthesia delineable into TIVA only and/or volatile only, and obtained categorical data for favorable functional outcomes using the modified Rankin scale (mRS ≤2), at 90 days after endovascular therapy. Odds ratios (OR) and standardized mean differences were calculated to inform a network meta-analysis approach, which permitted the inclusion of studies comparing a form of general anesthesia (ie, TIVA only or volatile only) to conscious sedation.
RESULTS
The search rendered 6235 articles, of which 15 met inclusion criteria. Three studies directly investigated TIVA versus volatile, whereas 12 studies compared general anesthesia to conscious sedation. The total number of subjects was 3015 (conscious sedation: n = 1067; general anesthesia: n = 1948 [TIVA: n = 1212, volatile: n = 736]). No significant differences were identified between TIVA and volatile groups in 90-day neurological outcome (OR = 1.25, 95% confidence interval [CI], 0.81–1.91; P = .31), 90-day mortality (OR = 0.72, 95% CI, 0.42–1.24; P = .24), successful recanalization (OR = 1.33, 95% CI, 0.70–2.52; P = .39), or recanalization time (standardized mean difference = 0.03, 95% CI, –0.35 to 0.41; P = .88). Additionally, no significant differences were identified between the conscious sedation group and the TIVA group in 90-day neurological outcome (OR = 1.14, 95% CI, 0.84–1.53; P = .40), 90-day mortality (OR = 0.87, 95% CI, 0.62–1.23; P = .43), successful recanalization (OR = 0.76, 95% CI, 0.52–1.10; P = .15), or recanalization time (standardized mean difference = –0.18, 95% CI, –0.47 to 0.11; P = .23), and between the conscious sedation group and the volatile group in 90-day neurological outcome (OR = 1.42, 95% CI, 0.92–2.17; P = .11), 90-day mortality (OR = 0.63, 95% CI, 0.36–1.12; P = .11), successful recanalization (OR = 1.01, 95% CI, 0.52–1.94; P = .98), or recanalization time (standardized mean difference = –0.15, 95% CI, –0.52 to 0.23; P = .44).
CONCLUSIONS
This network meta-analysis showed that the perioperative use of either general anesthesia-based regimen, or sedation, did not significantly impact various endovascular therapy-related outcomes. However, the current work was underpowered to detect differences in anesthetic agents, clinico-demographic characteristics, or procedural factors.
Context
Prebiotics are often added to infant formulas to mimic the benefits of oligosaccharides found in human milk.
Objective
This systematic review and meta-analysis evaluated the effects of prebiotic-supplemented cow’s milk–based formula on the gut microbiota, gut environment, growth parameters, and safety and tolerance in infants ≤6 months old, compared with a standard formula or human milk comparator.
Data Sources
Searches were performed in the PubMed, Embase, Cochrane Central Register of Controlled Trials, and ProQuest Dissertations & Theses databases. Articles were included that reported on randomized controlled trials, were published from inception until April 2024, and met prespecified inclusion and exclusion criteria.
Data Extraction
Outcomes included gut microbiota (eg, diversity; taxa at phylum, family, genus and species levels), gut environment (eg, pH, secretory immunoglobulin A, fecal calprotectin, fecal metabolites), growth parameters (eg, z scores), and safety and tolerance. Fixed or random effects models were used and mean differences (MDs) with 95% CIs were calculated to assess pooled effects. Risk of bias was assessed using the Cochrane Collaboration Tool (RoB 2).
Data Analysis
A total of 30 articles met inclusion criteria, with 5290 infants included. Whereas effects on Lactobacillus were inconsistent, prebiotic formula supplementation increased Bifidobacterium counts (k = 7 [MD: 0.49; 95% CI, 0.27-0.71]; I2 = 13%; P < .00001) and decreased fecal pH (k = 7 [MD: –0.39; 95% CI, –0.57 to –0.20]; I2 = 0%; P < .0001) compared with standard formula. Prebiotic formula supplementation increased total bacteria compared with human milk (MD: 0.41 [95% CI, 0.17-0.65]; I2 = 8%; P = .0006). In terms of growth parameters, weight-for-age z scores favored the prebiotic formula group compared with the human milk group (k = 2 [MD: 0.23; 95% CI, 0.04-0.42]; I2 = 7%; P = .02).
Conclusions
Prebiotic supplementation in infant formula can positively alter the gut microbiota, particularly Bifidobacterium, without negative impacts on growth. Standardized, high-quality research is needed to confirm the study findings and inform guidelines for prebiotic use in infant nutrition.
Systematic Review Registration
PROSPERO registration no. CRD42021253589.
BACKGROUND
Some studies suggest that balanced solutions may improve outcomes in critical care patients. However, in patients with traumatic brain injury (TBI) existing data indicate that normal saline may be preferred. We hypothesized that mortality in critically ill patients with and without TBI would differ with the use of balanced salt solutions versus normal saline.
METHODS
We conducted a systematic review and meta-analysis to investigate the impact of balanced crystalloids versus normal saline on 90-day mortality in adult critical care patients with and without TBI. Secondary outcomes included length of hospital stay, renal complications, need for vasopressors or mechanical ventilation, and mortality in critically ill patients with sepsis. We followed the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analysis) statement and estimated the odds ratio (OR) and 95% confidence interval (CI) with a random-effects model.
RESULTS
We included 15 clinical trials involving 35,207 patients. The OR of mortality with balanced solutions versus saline in patients without TBI was 0.93 (95% CI, 0.87–0.98; P = .01; I ² = 0%), while the OR for mortality in patients with TBI was 1.31 (95% CI, 1.03–1.65; P = .03; I ² = 0%). We found no differences in secondary outcomes due to fluid choice although data were unavailable to calculate pooled estimates for some of the secondary outcomes for TBI patients. In patients with sepsis, the OR of mortality with balanced solutions was 0.92 (95% CI, 0.83–1.02; I ² = 0%).
CONCLUSIONS
In comparison to normal saline, balanced solutions were associated with a reduction in mortality in critical care patients without TBI. However, balanced solutions were associated with an increase in mortality in patients with TBI. These findings suggest that the effect of fluid choice on intensive care unit (ICU) outcomes may depend partially on the type of critical illness and in particular in patients with TBI.
Purpose
To do a qualitative and quantitative assessment of the existing literature on the effectiveness and safety of pilocarpine 1.25% eye drops in presbyopia management.
Methods
Relevant articles were extracted from the online database using keywords – “pilocarpine and presbyopia”, “AGN-190584 and presbyopia”, and “Vuity and presbyopia”. The primary outcome measure considered was an improvement in distance-corrected near visual acuity (DCNVA) and secondary outcome measures were improvement in distance-corrected intermediate visual acuity (DCIVA) and adverse events (AEs). Risk of bias (ROB) assessment was done using the ROB2 tool and R software was used for quantitative analysis.
Results
The 3 included randomized control trials (RCTs) had a total of 980 participants between 40–55 years of age. They were randomized into 2 groups – 489 in the pilocarpine group and 491 in the vehicle group. In the pilocarpine group, 1.25% of pilocarpine was used either once (in the Gemini 1 and 2 trials) or twice daily (Virgo trial). A significantly higher proportion of patients reported improvement of DCIVA and gain of ≥ 3 lines in binocular DCNVA in the pilocarpine group than the vehicle group ( P < 0.01). Headache was the most commonly reported AE (13.49% of participants). Three case reports published on pilocarpine use for presbyopia management have reported vitreomacular traction in 1 and retinal detachment in 5 eyes.
Conclusions
The available evidence documents significant improvement in near and intermediate vision in presbyopia participants with pilocarpine 1.25% drop. However, more RCTs, involving a wider age group, larger refractive error, longer follow-up, and clinical testing in a real-world scenario are required to conclusively prove its role in presbyopia management.
Aim
To comprehensively investigate the effects of antioxidant nutrients on muscle mass, strength and function in chronic obstructive pulmonary disease (COPD) patients.
Methods
PubMed, Embase, Cochrane Library, and Web of Science were comprehensively searched from the inception to January 3, 2024. The quality of randomized controlled trials (RCTs) was measured using the Jadad scale. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were used as the effect size for measurement data. Further, subgroup analysis was conducted based on whether patients participated in lung rehabilitation plans while receiving nutritional interventions. Sensitivity analysis was performed on all outcomes.
Results
A total of 12 studies involving 595 patients with COPD were included, with 11 studies had high quality, and one study had low quality. For muscle mass, patients receiving antioxidant nutrients had a significantly increased lean body mass index compared with those not receiving antioxidant nutrients (pooled WMD: 0.903, 95% CI: 0.264, 1.541, P = 0.006). For patients who did not participate in lung rehabilitation plan while receiving nutritional interventions, antioxidant nutrients brought about a significantly higher lean body mass index (pooled WMD: 1.360, 95% CI: 0.560, 2.160, P = 0.001). For muscle strength, patients in the antioxidant nutrient intervention group had significantly higher hand grip strength (HGS) than those in the non-antioxidant nutrient intervention group (pooled WMD: 1.976, 95% CI: 1.337, 2.615, P < 0.001). Patients receiving antioxidant nutrients had significantly greater inspiratory muscle strength (MIP) than those not receiving antioxidant nutrients (pooled WMD: 8.127, 95% CI: 2.677, 13.577, P = 0.003).
Conclusion
Antioxidant nutrient intervention significantly improved HGS, MIP and lean body mass index in COPD. Clinicians should consider increasing food intake or supplementation rich in antioxidants in the treatment plan of patients with COPD.
Background
Non-pharmacological interventions are increasingly explored as alternatives to pharmacological treatments for managing migraine, with the aim of reducing attack frequency and migraine days per month. This meta-analysis evaluates the efficacy of non-pharmacological interventions versus pharmacological treatments in addressing these parameters.
Methods
The present study conforms to the PRISMA guidelines for conducting systematic review and meta-analysis. An electronic search was conducted with PubMed, Scopus, Web of Science, and Cochrane Library databases for articles published between 2000 and 2024. RCTs that compare non-pharmacological and pharmacological treatments of migraine patients were included. Details of data extraction and analysis were done by two researchers, while statistical analysis was done using R 4.2.2. For continuous data, the mean differences with the corresponding 95% CIs and the I² statistic for heterogeneity were used.
Results
A significant reduction in attack frequency per month was observed with non-pharmacological interventions compared to pharmacological treatments, as indicated by a negative mean difference (−0.2896) in the common effect model. However, the random effects model suggested greater variability in results, highlighting the need for nuanced interpretation. No statistically significant difference was found in migraine days per month between the two interventions, although observed heterogeneity underscores the importance of individualized approaches in migraine management.
Discussion
Publication bias was detected in the analysis of attack frequency, emphasizing the need for cautious interpretation. The assessment of study quality revealed limitations, indicating the necessity for improved reporting standards and methodological rigor in migraine research.
Conclusion
Non-pharmacological interventions show effectiveness in decreasing migraine attack frequency compared to pharmacological treatments, highlighting their potential in symptom management. Nevertheless, the variability in outcomes and the presence of publication bias advise against making conclusive judgments. The intricate management of migraines necessitates personalized strategies that align with the unique needs of each patient.
Background
This study aimed to evaluate and compare the efficacy of ibuprofen and acetaminophen in managing post-operative pain in paediatric patients. The review seeks to determine which analgesic is more effective in reducing pain intensity, minimizing post-operative agitation, and reducing the need for additional analgesics.
Materials and Methods
We conducted a comprehensive search across electronic databases, including PubMed, Scopus, Web of Science, and Cochrane Library. Statistical analyses were performed using R software 4.2.2. Effect sizes (Cohen’s d) and variances were calculated by first converting P values into Z -scores using Z = qnorm (1 − P /2) for two-tailed tests. Cohen’s d was then approximated as d = Z/ √(n1 + n2)/2, where n1 and n2 are the sample sizes. Variance was calculated as 1/(n1 + n2). Heterogeneity was assessed with the Cochrane Q P value and I ² statistic, using both random-effects and common effect models. Publication bias was evaluated with funnel plots and Egger’s regression test. The meta-analysis followed Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines.
Results
The meta-analysis of five studies comparing ibuprofen and acetaminophen shows mixed results. The common effect model suggests that ibuprofen may be more effective, with a significant pooled effect size of 0.2642 (95% confidence interval [CI]: 0.1128–0.4156, P = 0.0006). However, the random effects model shows a slightly higher effect size of 0.3494 but is not statistically significant ( P = 0.1668) with a 95% CI crossing zero. There is significant heterogeneity amongst the studies ( I ² = 78.1%, P = 0.0011). After excluding one study, heterogeneity decreased ( I ² = 30.5%), and the common effect model still showed a small, significant advantage for ibuprofen (effect size = 0.1761, 95% CI: 0.0178–0.3344, P = 0.0292). However, the random effects model did not show statistical significance ( P = 0.1597).
Conclusion
The meta-analysis suggests that ibuprofen may have a modest edge over acetaminophen for pain management, but the findings are inconsistent and vary depending on the analytical model used. The common effect model shows a statistically significant benefit for ibuprofen, but this is not supported when the variability between studies is considered in the random effects model. The significant heterogeneity amongst the studies makes the results more complex to interpret, although this variability is reduced when one outlier study is excluded from the study. Overall, while ibuprofen appears potentially more effective, additional research is necessary to validate these results.
Background
To evaluate and compare the efficacy of ibuprofen and acetaminophen with codeine in managing post-operative pain in paediatric patients. The review seeks to determine which analgesic is more effective in reducing pain intensity, minimising post-operative agitation and reducing the need for additional analgesics.
Material and Methods
We conducted a comprehensive search across electronic databases, including PubMed, Scopus, Web of Science and Cochrane Library. Statistical analyses were performed using R software 4.2.2. Effect sizes (Cohen’s d ) and variances were calculated by first converting P values into Z-scores using Z = qnorm (1 − P /2) for two-tailed tests. Cohen’s d was then approximated as d = Z/√(n1 + n2)/2, where n1 and n2 are the sample sizes. Variance was calculated as 1/(n1 + n2). Heterogeneity was assessed with the Cochrane Q P value and I ² statistic, using both random effects and common effect models. Publication bias was evaluated with funnel plots and Egger’s regression test. The meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Results
The meta-analysis comparing ibuprofen to acetaminophen with codeine across five studies demonstrates a very small overall effect size favouring ibuprofen, with a standardised mean difference of 0.0701 (95% confidence interval: −0.0143–0.1545) in the random effects model. This effect is not statistically significant ( P = 0.1034), and the confidence interval includes zero, suggesting that the observed difference may be attributable to chance. The heterogeneity assessment indicates no significant variation among studies ( I ² =0.0%, P = 0.4834), reflecting consistency in the results. Therefore, the analysis does not provide strong evidence for the superiority of ibuprofen over acetaminophen with codeine, as both treatments appear to offer similar efficacy.
Conclusion
The meta-analysis indicates a minimal, statistically non-significant advantage for ibuprofen compared to acetaminophen with codeine. The results show no substantial difference between the two treatments, suggesting that both are similarly effective for pain management.
Background
Rho-Kinase Inhibitor (RKIs) showed competitive efficacy in reducing intraocular pressure (IOP) in recently published large randomised controlled trials compared to first-line treatment of glaucoma, prostaglandin analogues and beta blockers. Yet there is no published meta-analysis which summarises and gives a conclusion about its efficacy and adverse events, except for one with reported statistical heterogeneity. We conducted this systematic review and meta-analysis to evaluate the efficacy of RKI compared to timolol in reducing IOP.
Methods
We conducted an extensive search within four electronic databases, namely, Cochrane Central Register of Controlled Trials, PubMed, Scopus and Web of Science, up until April 2024. Our aim was to identify pertinent studies that evaluated the efficacy and safety of netarsudil in contrast to timolol for the treatment of open-angle glaucoma and ocular hypertension. The quality of evidence from these trials was assessed using the risk of bias 2 tool. Subsequently, data from the selected studies were systematically extracted into a uniform online sheet and analysed using RevMan 5.4 software.
Results
Our search led to the identification of 4 clinical trials involving a total of 2305 patients. The meta-analysis results demonstrated that netarsudil showed better IOP reduction at 4:0 am after 2 weeks (mean difference [MD] = −0.56, 95% confidence interval [CI] [ − 0.88, −0.25], P = 0.0005), however, results of pooled effect at 8:00 am after 6 weeks and 3 months showed statistically significant difference favouring timolol over netarsudil (MD = 0.58, 95% CI [0.23, 0.92], P = 0.0010) and (MD = 0.69, 95% CI [0.34, 1.04], P = 0.0001), respectively. In addition, at 10:00 am, results of pooled effect after 3 months showed a statistically significant difference favouring timolol over netarsudil (MD = 0.34, 95% CI [0.03, 0.65], P = 0.03).
Conclusion
In conclusion, the study highlights the importance of time-specific and safe glaucoma treatment strategies, with timolol’s long-term effectiveness at 8:00 am and 10:00 am and netarsudil’s short-term effectiveness at 4:00 pm, while prioritising timolol’s better safety profile.
Background
Sleeplessness or insomnia is another type of sleep disorder and is prevalent in a large part of the global population which interferes with normal daily activities and overall quality of life. Some of the treatments are directed to neurotransmitter systems such as GABA and melatonin receptor sites. Suvorexant, a recently developed orexin receptor antagonist, is a promising pharmacotherapeutic target; however the superiority over placebo of suvorexant deserves further investigation.
Methods
An extensive search of the bibliographic databases was done using the web sources such as PubMed, Scopus, Web of science, Cochrane and Google Scholar. Informed by the PICOT question, only RCTs based on peer-reviewed journal articles were collected, and only those that focused on suvorexant for insomnia patients specifically. Data analysis was carried out in R software version 4.2.2. Categorical data were presented using odds ratios (ORs) with 95% CIs for binary variables, while MDs with 95% CIs were used to compare the means of the four continuous variables at follow-up. Inter-study variability was determined using the Chi-square Cochrane test and the I-squared test. Publication bias was checked by Funnel plot and Egger’s regression test.
Results
The meta-analysis analyzed five, RCTs all together enrolling 1, 540 participants. Suvorexant showed a statistically significant improvement in TST, with a mean difference of 32.07 units (95% CI: 27.Seventy to 36.26 P < 0.0001, and WASO compared with placebo was also significantly shorter by a mean of − 27.92 (95% CI: − 30.33 to − 25.52) P < 0.0001. There was low level of heterogeneity (I² = 3.6 %) suggesting that all the studies pointed to similar conclusions. They found out that they did not observe publication bias.
Conclusion
Given the foregoing, let it be noted that suvorexant alleviates sleep debit and produces robust improvements in total sleep time and worst awake sleep time as compared to placebo. Overall, the results show that suvorexant is an effective treatment for insomnia although it appears that the degree of effectiveness varies somewhat. More studies are required to establish its continued efficiency and safety of, in addition to, evaluating its effectiveness in contrast to other kinds of insomnia therapies.
Background
Infertility treatments such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) often involve preparatory interventions to enhance success rates. One such intervention, oral contraceptive pill (OCP) pre-treatment, has gained attention for its potential impact on treatment outcomes. Despite its widespread use, evidence regarding its efficacy remains inconclusive.This systematic review and meta-analysis aim to assess the impact of OCP pre-treatment on pregnancy rates in IVF/ICSI procedures. By synthesizing available evidence, this study provides insights into the implications of OCP usage within fertility treatment protocols.
Methods
A comprehensive literature search was conducted to identify studies evaluating the effects of OCP pre-treatment in IVF/ICSI cycles. Two independent investigators extracted data on study characteristics, participant details, interventions, outcomes, and funding sources. Pregnancy rates were compared using odds ratios (ORs) and 95% confidence intervals (CI). Study quality was assessed using the Cochrane Risk of Bias Tool for Randomised Controlled Trials, ensuring transparency and reproducibility. Meta-analyses were performed using both common-effect and random-effects models to account for variability between studies.
Results
The meta-analysis included studies reporting pregnancy rates in IVF/ICSI patients with and without OCP pre-treatment. Results showed a consistent trend across models, with a lower odds of pregnancy observed in the OCP pre-treatment group (pooled OR < 1, 95% CI). Minimal heterogeneity was noted between studies, indicating consistency in effect estimates. While publication bias was not statistically significant, potential biases in individual study designs were identified.
Conclusion
This systematic review and meta-analysis suggest that OCP pre-treatment is associated with reduced pregnancy rates in IVF/ICSI procedures. Although findings are consistent, the clinical significance warrants cautious interpretation due to potential biases in the included studies. Further research is required to confirm these results and explore the underlying mechanisms affecting treatment outcomes.
Background
This study undertakes a systematic review of randomised controlled trials (RCTs) to evaluate and compare the effectiveness of risperidone versus placebo in managing autism spectrum disorder (ASD). The goal is to gather and analyse strong evidence on how risperidone affects symptoms and overall outcomes in individuals with ASD, as compared to those receiving a placebo. The meta-analysis aims to provide a thorough assessment of risperidone’s potential benefits and limitations, thereby guiding evidence-based practices and therapeutic decisions in clinical settings.
Materials and Methods
This review examined peer-reviewed RCTs in English that evaluated the efficacy of risperidone versus placebo for treating ASD in children aged 2–18 years. It included studies from the introduction of risperidone for ASD treatment to the present while excluding non-English publications, animal studies and non-RCT designs. Data extraction and quality assessment were rigorously performed using the Cochrane risk of bias tool. Statistical analyses were conducted using R software, including mean differences with 95% confidence intervals and assessments of heterogeneity and publication bias. This systematic approach aimed to deliver reliable insights into the effectiveness and safety of risperidone for ASD treatment.
Results
The meta-analysis of risperidone versus placebo for both Aberrant Behaviour Checklist-irritability (ABC-I) and ABC-withdrawal scores shows significant results. For ABC-I, the P = 0.0103, indicating a substantial reduction in irritability with risperidone. For ABC-withdrawal scores, the P = 0.0017, demonstrating a significant improvement in withdrawal symptoms with risperidone compared to placebo. These results underline the effectiveness of risperidone in managing these symptoms in ASD.
Conclusion
The meta-analyses strongly support the effectiveness of risperidone in alleviating symptoms of ASD, especially irritability and withdrawal behaviours. The notable decreases in both ABC-I and ABC-withdrawal scores underscore risperidone’s advantages over placebo. Nevertheless, the studies also show variations in bias risk and moderate heterogeneity in the results.
Objective
The objective of this research is twofold: first, to ascertain whether insufficient sleep correlates with the occurrence of obesity and second, to explore whether interventions aimed at improving sleep patterns can mitigate weight gain in preschoolers.
Methods
A thorough search of PubMed, Embase, Web of Science and Cochrane databases was conducted up to 9 th December 2019. For the first objective, prospective studies with a follow-up period of at least 1 year were included, assessing sleep duration at baseline alongside relevant outcome measures. For the second objective, intervention trials implementing sleep-focused interventions and measuring indicators of overweight or obesity were considered. Data extraction followed Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines.
Results
Children with shorter sleep durations were found to be at a higher risk of developing overweight or obesity, as indicated by a pooled analysis of 13 studies involving 42,878 participants (relative risk: 1.54; 95% confidence interval [CI]: 1.33–1.77; P < 0.001). In addition, there was a significant association between sleep duration and changes in body mass index (BMI) Z-score, based on the data from 10 studies across 11 cohorts with a total of 29,553 participants, showing a mean difference of − 0.02 units per hour of sleep (95% CI: −0.03 to − 0.01; P < 0.001). Moreover, four out of five intervention studies reported positive outcomes, demonstrating improvements in BMI (−0.27 kg/m ² ; 95% CI: −0.50 to − 0.03; P = 0.03) and BMI Z-score (−0.07 units; 95% CI: −0.12 to − 0.02; P = 0.006), suggesting that enhancing sleep quality may help reduce weight gain in pre-school children.
Conclusion
These results suggest that insufficient sleep duration is a significant risk factor for the development of obesity in pre-school children. In addition, intervention studies imply that enhancing sleep quality may be linked to a reduction in weight gain amongst these young children.
Background
Bronchiolitis, predominantly associated with respiratory syncytial virus (RSV), is a major cause of acute lower respiratory tract infections. Recent studies underscore RSV’s significant impact, challenging previous assumptions and revealing associations with other respiratory viruses. Despite its prevalence, current treatments for bronchiolitis are primarily supportive, with no routine use of specific antiviral drugs. Similarly, acute bronchitis, affecting 5% of adults annually, is primarily caused by viruses, with Mycoplasma pneumoniae and potential contributions from Chlamydia pneumoniae as non-viral agents. The distinct aetiologies of bronchiolitis and acute bronchitis emphasise the need for a nuanced approach to their management and further research to enhance understanding and treatment strategies.
Objective
The objective of this meta-analysis is to systematically assess the antiviral capabilities of different drugs, aiming to offer evidence-based insights into their effectiveness for treating patients with acute bronchiolitis and bronchitis.
Materials and Methods
Statistical analyses were conducted using R software 4.2.2, including mean differences (standard deviation) with a 95% confidence interval (CI) for continuous outcomes. Heterogeneity was assessed using Cochrane Q P value and I ² statistic with both random-effects and common effect models. Publication bias was evaluated through funnel plots and Egger’s regression test.
Results
The meta-analysis demonstrates a significant positive impact of antiviral medication on acute bronchitis, with a mean difference of 5.4027 (95% CI: 4.5771–6.2283, P < 0.0001). However, substantial heterogeneity amongst studies ( P < 0.001) emphasises the need for further exploration into sources of variation. A cautious interpretation, considering study characteristics, is crucial for a comprehensive understanding.
Conclusion
The meta-analysis indicates a significant positive effect of antiviral medication on acute bronchitis. However, the presence of notable heterogeneity amongst the studies emphasises the need for careful interpretation and further exploration into potential sources of variation. Despite these challenges, the findings suggest the potential efficacy of antiviral medication in treating acute bronchitis, providing valuable insights for clinical practice.
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