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PloS One 2017This systematic review and meta-analysis aims to assess the therapeutic and adverse effects of acupuncture for benign prostatic hyperplasia (BPH) in randomized... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
This systematic review and meta-analysis aims to assess the therapeutic and adverse effects of acupuncture for benign prostatic hyperplasia (BPH) in randomized controlled trials (RCTs).
METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, the Chinese Biomedical Database, the China National Knowledge Infrastructure, the VIP Database and the Wanfang Database. Parallel-group RCTs of acupuncture for men with symptomatic BPH were included. Data from the included trials were extracted by two independent reviewers and were analyzed with The Cochrane Collaboration Review Manager software (RevMan 5.3.5) after risk of bias judgments. The primary outcome measure of this review was a change in urological symptoms.
RESULTS
Eight RCTs, which involved 661 men with BPH, were included. Follow-up varied from 4 weeks to 18 months. Pooling of the data from three trials that compared acupuncture with sham-acupuncture revealed that in the short term (4-6 weeks), acupuncture can significantly improve IPSS (MD -1.90, 95% CI -3.58 to -0.21). A sensitivity analysis of the short-term endpoint showed the same result (MD -3.01, 95% CI -5.19 to -0.84) with a borderline minimal clinical important difference (MCID). Qmax of the short-term endpoint indicated statistically positive beneficial effects of acupuncture (MD -1.78, 95%CI -3.43, -0.14). A meta-analysis after medium-term follow-up (12-18 weeks) indicated no significant effect on IPSS when the data from two trials were combined (MD -2.04, 95% CI -4.19, 0.10).
CONCLUSION
Statistically significant changes were observed in favor of acupuncture in moderate to severe BPH with respect to short-term follow-up endpoints. The clinical significance of these changes needs to be tested by further studies with rigorous designs and longer follow-up times.
TRIAL REGISTRATION NUMBER
PROSPERO CRD42014013645.
Topics: Acupuncture Therapy; Humans; Male; Prostatic Hyperplasia; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 28376120
DOI: 10.1371/journal.pone.0174586 -
Clinical and Translational... Nov 2023Phase 2 trials are fundamental to the rational and efficient design of phase 3 trials. We aimed to determine the relationship of treatment effect size estimates from... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Phase 2 trials are fundamental to the rational and efficient design of phase 3 trials. We aimed to determine the relationship of treatment effect size estimates from phase 2 and phase 3 clinical trials on advanced therapeutics in inflammatory bowel disease.
METHODS
MEDLINE, EMBASE, CENTRAL, and the Cochrane library were searched from inception to December 19, 2022, to identify paired phase 2 and 3 placebo-controlled induction studies of advanced therapeutics for Crohn's disease (CD) and ulcerative colitis (UC). Treatment effect sizes were expressed as a risk ratio (RR) between the active arm and placebo arm. For the same therapeutics, RRs from phase 2 trials were divided by the RR from phase 3 trial to quantify the relationship of effect sizes between phases.
RESULTS
Twenty-two studies (9 phase 2 trials, 13 phase 3 trials) were included for CD and 30 studies (12 phase 2 trials, 18 phase 3 trials) for UC. In UC (pooled RR 0.72; 95% confidence interval: 0.58-0.86; RR <1 indicates smaller treatment effect sizes in phase 2 trials), but not CD (pooled RR 1.01; 95% confidence interval: 0.84-1.18), phase 2 trials systematically underestimated treatment effect sizes for the primary endpoint compared with phase 3 trials. The underestimation was observed for clinical, but not endoscopic, endpoints in UC.
DISCUSSION
Treatment effect sizes for the primary and clinical endpoints were similar across clinical trial phases in CD, but not UC, where only endoscopic endpoints were comparable. This will help inform clinical development plans and future trial design.
Topics: Humans; Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Remission Induction; Induction Chemotherapy; Clinical Trials, Phase III as Topic; Clinical Trials, Phase II as Topic
PubMed: 37578211
DOI: 10.14309/ctg.0000000000000629 -
BMC Pediatrics Feb 2018The World Health Organization (WHO) recommends rapid intravenous rehydration, using fluid volumes of 70-100mls/kg over 3-6 h, with some of the initial volume given... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The World Health Organization (WHO) recommends rapid intravenous rehydration, using fluid volumes of 70-100mls/kg over 3-6 h, with some of the initial volume given rapidly as initial fluid boluses to treat hypovolaemic shock for children with acute gastroenteritis (AGE) and severe dehydration. The evidence supporting the safety and efficacy of rapid versus slower rehydration remains uncertain.
METHODS
We conducted a systematic review of randomised controlled trials (RCTs) on 11th of May 2017 comparing different rates of intravenous fluid therapy in children with AGE and moderate or severe dehydration, using standard search terms. Two authors independently assessed trial quality and extracted data. Non-RCTs and non-English articles were excluded. The primary endpoint was mortality and secondary endpoints included adverse events (safety) and treatment efficacy.
MAIN RESULTS
Of the 1390 studies initially identified, 18 were assessed for eligibility. Of these, 3 studies (n = 464) fulfilled a priori criteria for inclusion; most studied children with moderate dehydration and none were conducted in resource-poor settings. Volumes and rates of fluid replacement varied from 20 to 60 ml/kg given over 1-2 h (fast) versus 2-4 h (slow). There was substantial heterogeneity in methodology between the studies with only one adjudicated to be of high quality. There were no deaths in any study. Safety endpoints only identified oedema (n = 6) and dysnatraemia (n = 2). Pooled analysis showed no significant difference between the rapid and slow intravenous rehydration groups for the proportion of treatment failures (N = 468): pooled RR 1.30 (95% CI: 0.87, 1.93) and the readmission rates (N = 439): pooled RR 1.39 (95% CI: 0.68, 2.85).
CONCLUSIONS
Despite wide implementation of WHO Plan C guideline for severe AGE, we found no clinical evaluation in resource-limited settings, and only limited evaluation of the rate and volume of rehydration in other parts of the world. Recent concerns over aggressive fluid expansion warrants further research to inform guidelines on rates of intravenous rehydration therapy for severe AGE.
Topics: Acute Disease; Adolescent; Child; Child, Preschool; Dehydration; Fluid Therapy; Gastroenteritis; Humans; Infant; Infant, Newborn; Infusions, Intravenous; Randomized Controlled Trials as Topic; Risk; Time Factors; Treatment Outcome
PubMed: 29426307
DOI: 10.1186/s12887-018-1006-1 -
Critical Care (London, England) Jun 2017Hospital-acquired and ventilator-associated pneumonia (HAP/VAP) are often selected for randomized clinical trials (RCTs) aiming at new drug approval. Guidelines for the... (Review)
Review
BACKGROUND
Hospital-acquired and ventilator-associated pneumonia (HAP/VAP) are often selected for randomized clinical trials (RCTs) aiming at new drug approval. Guidelines for the design of such RCTs have been repeatedly updated by regulatory agencies. We hypothesized that large variability in the enrolled populations, the endpoints assessed and the HAP/VAP definition criteria may impact the results of these studies, and addressed this through a systematic review of HAP/VAP RCTs.
METHODS
A search (Pubmed-Embase-ICAAC-ECCMID) of all RCTs published between 1994 and 2016 comparing antimicrobial treatment for HAP/VAP in the intensive care unit was conducted. The populations enrolled, inclusion/exclusion criteria, statistical design and endpoints assessed were recorded. All unpublished RCTs recorded on the ClinicalTrials.gov registry were also screened.
RESULTS
From the 93 abstracts reviewed, 39 potentially relevant studies were inspected, leading to 27 studies being included. As expected, illness severity or the proportion with VAP (27-100%) differed greatly among the enrolled populations. The HAP/VAP definition used various clinical and biological criteria, and only 55% of studies required a microbiological sample. The mandatory duration of prior hospital stay was variable; the mechanical ventilation duration was an inclusion criterion in only 41% of VAP studies. Nine studies had non-inferiority design, but nine studies (33%) did not have a pre-specified statistical hypothesis. Clinical cure was the primary endpoint in 24 studies, but was recorded in several populations or as the co-primary endpoint in 13 studies. The definition of clinical cure and the timing of its assessment greatly differed. This variability slightly improved over time but remained significant in the 13 registered but currently unpublished RCTs that we screened.
CONCLUSION
Our study provides a description of populations and endpoints of RCTs evaluating antimicrobials for treatment of HAP/VAP in the ICU. There was significant heterogeneity in enrollment criteria, endpoints and statistical design, which may influence the ability of studies to demonstrate differences between studied drugs.
Topics: Anti-Bacterial Agents; Cross Infection; Humans; Intensive Care Units; Pneumonia, Ventilator-Associated; Randomized Controlled Trials as Topic; Respiration, Artificial
PubMed: 28655326
DOI: 10.1186/s13054-017-1755-5 -
BMJ Open Jun 2017To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery relative to visual assessment and pulse oximetry alone.
DESIGN AND SETTING
Systematic literature review and random effects meta-analysis of randomised controlled trials (RCTs) reporting sedation-related adverse event incidence when adding capnography to visual assessment and pulse oximetry in patients undergoing PSA during ambulatory surgery in the hospital setting. Searches for eligible studies published between 1 January 1995 and 31 December 2016 (inclusive) were conducted in PubMed, the Cochrane Library and EMBASE without any language constraints. Searches were conducted in January 2017, screening and data extraction were conducted by two independent reviewers, and study quality was assessed using a modified Jadad scale.
INTERVENTIONS
Capnography monitoring relative to visual assessment and pulse oximetry alone.
PRIMARY AND SECONDARY OUTCOME MEASURES
Predefined endpoints of interest were desaturation/hypoxaemia (the primary endpoint), apnoea, aspiration, bradycardia, hypotension, premature procedure termination, respiratory failure, use of assisted/bag-mask ventilation and death during PSA.
RESULTS
The literature search identified 1006 unique articles, of which 13 were ultimately included in the meta-analysis. Addition of capnography to visual assessment and pulse oximetry was associated with a significant reduction in mild (risk ratio (RR) 0.77, 95% CI 0.67 to 0.89) and severe (RR 0.59, 95% CI 0.43 to 0.81) desaturation, as well as in the use of assisted ventilation (OR 0.47, 95% CI 0.23 to 0.95). No significant differences in other endpoints were identified.
CONCLUSIONS
Meta-analysis of 13 RCTs published between 2006 and 2016 showed a reduction in respiratory compromise (from respiratory insufficiency to failure) during PSA with the inclusion of capnography monitoring. In particular, use of capnography was associated with less mild and severe oxygen desaturation, which may have helped to avoid the need for assisted ventilation.
Topics: Bradycardia; Capnography; Conscious Sedation; Deep Sedation; Humans; Monitoring, Physiologic; Oximetry; Patient Safety; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory Insufficiency
PubMed: 28667196
DOI: 10.1136/bmjopen-2016-013402 -
Journal of Neurosurgery. Pediatrics Sep 2019The optimal revascularization for pediatric moyamoya for reducing the incidence of future stroke events remains to be determined. (Review)
Review
OBJECTIVE
The optimal revascularization for pediatric moyamoya for reducing the incidence of future stroke events remains to be determined.
METHODS
The authors conducted a search of PubMed, MEDLINE, Embase, and Web of Science electronic databases from inception until January 2019. The primary endpoint was the presence of a future ischemic stroke event. Secondary endpoints were angiographic outcomes as measured by postoperative Matsushima grade and clinical symptom persistence. Patients who underwent either direct or combined direct/indirect revascularization were classified into the direct cohort. Data from each study on presence of postoperative stroke events were used to generate standardized mean differences and 95% confidence intervals, which were combined using inverse variance-weighted averages of standardized mean differences in a random effects model.
RESULTS
Twenty-nine studies met the inclusion criteria for analysis, comprising 2258 patients (1011 males, mean age 8.3 ± 1.8 years) who were followed up clinically for an average of 71.4 ± 51.3 months. One hundred fifty-four patients underwent direct bypass alone, 680 patients underwent either direct or combined direct/indirect revascularization procedures, while 1424 patients underwent indirect bypass alone. The frequencies of future stroke events in patients undergoing direct bypass alone, combined bypass, or indirect bypass alone were 1 per 190.3 patient-years, 1 per 108.9 patient-years, and 1 per 61.1 patient-years, respectively, in each cohort. The estimated stroke rates were 9.0% with indirect revascularization, 4.5% with direct revascularization alone, and 6.0% with combined revascularization. A forest plot did not reveal any significant differences in the incidence of future stroke events or angiographic outcomes following direct-only, combined, or indirect-only revascularization.
CONCLUSIONS
Direct, indirect, and combined indirect/direct bypass techniques are all effective revascularization options for pediatric moyamoya disease. A relative paucity of granular studies-and inherent surgical selection bias-limits direct comparison between interventions. Suitably designed prospective cohort studies may be useful in identifying patients likely to receive benefit from specific procedures.
PubMed: 31518973
DOI: 10.3171/2019.6.PEDS19241 -
HPB : the Official Journal of the... Jun 2023Spleen preserving distal pancreatectomy (SPDP) represents a widely adopted procedure in the presence of benign or low-grade malignant tumors. Splenic vessels... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Spleen preserving distal pancreatectomy (SPDP) represents a widely adopted procedure in the presence of benign or low-grade malignant tumors. Splenic vessels preservation and resection (Kimura and Warshaw techniques respectively) represent the two main surgical modalities to avoid splenic resection. Each one is characterized by strengths and drawbacks. The aim of the present study is to systematically review the current high-quality evidence regarding these two techniques and analyze their short-term outcomes.
METHODS
A systematic review was conducted according to PRISMA, AMSTAR II and MOOSE guidelines. The primary endpoint was to assess the incidence of splenic infarction and splenic infarction leading to splenectomy. As secondary endpoints, specific intraoperative variables and postoperative complications were explored. Metaregression analysis was conducted to evaluate the effect of general variables on specific outcomes.
RESULTS
Seventeen high-quality studies were included in quantitative analysis. A significantly lower risk of splenic infarction for patients undergoing Kimura SPDP (OR = 0.14; p < 0.0001). Similarly, splenic vessel preservation was associated with a reduced risk of gastric varices (OR = 0.1; 95% p < 0.0001). Regarding all secondary outcome variables, no differences between the two techniques were noticed. Metaregression analysis failed to identify independent predictors of splenic infarction, blood loss, and operative time among general variables.
CONCLUSIONS
Although Kimura and Warshaw SPDP have been demonstrated comparable for most of postoperative outcomes, the former resulted superior compared to the latter in reducing the risk of splenic infarction and gastric varices. For benign pancreatic tumors and low-grade malignancies Kimura SPDP may be preferred.
Topics: Humans; Esophageal and Gastric Varices; Pancreatectomy; Pancreatic Neoplasms; Postoperative Complications; Retrospective Studies; Splenic Artery; Splenic Infarction; Treatment Outcome
PubMed: 36941150
DOI: 10.1016/j.hpb.2023.02.009 -
Clinical Cardiology Oct 2022In the past decade, direct oral anticoagulants (DOACs) have proven to be the best option for patients with nonvalvular atrial fibrillation. Nevertheless, evidence for... (Comparative Study)
Comparative Study Meta-Analysis Review
Comparison of efficacy and safety between VKAs and DOACs in patients with atrial fibrillation after transcatheter aortic valve replacement: A systematic review and meta-analysis.
In the past decade, direct oral anticoagulants (DOACs) have proven to be the best option for patients with nonvalvular atrial fibrillation. Nevertheless, evidence for the use of DOACs for anticoagulation in valvular atrial fibrillation, particularly after aortic valve replacement, remains inadequate. Thus, we conducted a meta-analysis to compare the efficacy and safety of vitamin K antagonists (VKAs) and DOACs in patients with atrial fibrillation after transcatheter aortic valve replacement (TAVR). We conducted a comprehensive search of online databases, and 11 studies were included in the final analysis. The primary endpoint was all-cause mortality. Secondary endpoints included stroke and cardiovascular death. The safe endpoint is major and/or life-threatening bleeding. Subgroup analysis was conducted according to the different follow-up time of each study. Random-effects models were used for all outcomes. Statistical heterogeneity was assessed using χ tests and quantified using I statistics. Patients in the DOACs group had a significantly lower risk of all-cause mortality compared with patients in the VKAs group (relative risk [RR]: 1.20, 95% confidence interval [CI]: 1.01-1.43, p = .04). This benefit may be greater with longer follow-up. In a subgroup analysis based on the length of follow-up, a significantly lower risk of all-cause mortality was found in the DOACs group in the subgroup with a follow-up time of >12 months (RR: 1.50, 95% CI: 1.07-2.09, p = .001). There were no significant differences between the two groups in cardiovascular death, stroke, and major and/or life-threatening bleeding. For patients with atrial fibrillation after TAVR, the use of DOACs may be superior to VKAs, and the benefit may be greater with longer follow-up. The anticoagulant strategy for atrial fibrillation after TAVR is a valuable direction for future research.
Topics: Humans; Administration, Oral; Anticoagulants; Atrial Fibrillation; Fibrinolytic Agents; Hemorrhage; Stroke; Transcatheter Aortic Valve Replacement; Vitamin K
PubMed: 36030549
DOI: 10.1002/clc.23909 -
Frontiers in Cardiovascular Medicine 2023This study aimed to systematically evaluate the effects of different types and doses of pretreatment with P2Y inhibitors in patients with non-ST-elevation acute coronary... (Review)
Review
BACKGROUND
This study aimed to systematically evaluate the effects of different types and doses of pretreatment with P2Y inhibitors in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).
METHODS
Electronic databases were searched for studies comparing pretreatment with different types and doses of P2Y inhibitors or comparison between P2Y inhibitor pretreatment and nonpretreatment. Electronic databases included the Cochrane Library, PubMed, EMBASE, and Web of Science. Literature was obtained from the establishment of each database until June 2022. The patients included in the study had pretreatment with P2Y inhibitors with long-term oral or loading doses, or conventional aspirin treatment (non-pretreatment). The primary endpoint was major adverse cardiac and cerebrovascular events (MACCEs) during follow-up within 30 days after PCI, which included determining the composite endpoints of cardiac death, myocardial infarction, ischemia-driven revascularization, and stroke. The safety endpoint was a major bleeding event.
RESULTS
A total of 119,014 patients from 21 studies were enrolled, including 13 RCTs and eight observational studies. A total of six types of interventions were included-nonpretreatment (placebo), clopidogrel pretreatment, ticagrelor pretreatment, prasugrel pretreatment, double loading pretreatment (double loading dose of clopidogrel, ticagrelor, prasugrel) and P2Y inhibitors pretreatment (the included studies did not distinguish the types of P2Y inhibitors, including clopidogrel, ticagrelor, and prasugrel). The network meta-analysis results showed that compared to patients without pretreatment, patients receiving clopidogrel pretreatment (= 0.78, :0.66, 0.91, < 0.05) and double-loading pretreatment (= 0.62, :0.41, 0.95, < 0.05) had a lower incidence of MACCEs. There was no statistically significant difference in the incidence of major bleeding events among the six pretreatments ( > 0.05).
CONCLUSIONS
In patients with NSTE-ACS, pretreatment with P2Y inhibitors before percutaneous intervention reduced the incidence of recurrent ischemic events without increasing the risk of major bleeding after PCI compared with nonpretreatment. Clopidogrel or double loading dose P2Y inhibitors can be considered for the selection of pretreatment drugs.
PubMed: 37539086
DOI: 10.3389/fcvm.2023.1191777 -
Clinical Lymphoma, Myeloma & Leukemia Jul 2022We performed a systematic literature review to identify the most recently published randomized controlled trials (RCTs) in multiple myeloma (MM) with a patient-reported... (Review)
Review
BACKGROUND
We performed a systematic literature review to identify the most recently published randomized controlled trials (RCTs) in multiple myeloma (MM) with a patient-reported outcome (PRO) endpoint, and to summarize both clinical and PRO results, as well as to examine the quality of reporting by phase of disease. We also aimed to describe main type of PRO analysis used and interpretation of clinical significance of PRO findings.
MATERIALS AND METHODS
We searched PubMed and the Cochrane Central Register of Controlled Trials to identify RCTs of cancer-directed therapy in patients with MM published between January 2014 and April 2021.
RESULTS
Thirty-two RCTs with a total of 19,798 patients enrolled were identified in our review. In all studies, PROs were secondary or exploratory endpoints. Half of the studies (n = 16) included newly diagnosed patients, 15 RCTs included patients with relapsed/refractory MM, and one study included patients with smoldering MM. Progression-free survival was the most frequently used primary endpoint. All studies provided unique PRO information that could be used to more comprehensively assess the risk/benefit of the newly tested drugs. However, the identified RCTs were heterogeneous regarding the presentation, and interpretation of PRO results.
CONCLUSION
The number of RCTs including PROs in MM research has notably increased in recent years. However, more consistency in the methodological approach to PRO assessment, and interpretation of outcomes is needed to ensure that PRO findings will be more impactful on patient care.
Topics: Humans; Multiple Myeloma; Patient Outcome Assessment; Patient Reported Outcome Measures; Randomized Controlled Trials as Topic
PubMed: 35183476
DOI: 10.1016/j.clml.2022.01.009