Abiraterone or docetaxel in men with metastatic castration-sensitive prostate cancer: A pooled analysis of castration resistance-free survival and toxicity.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 354-354 ◽  
Author(s):  
Joelle Helou ◽  
Charles N Catton ◽  
Glenn Bauman ◽  
Rouhi Fazelzad ◽  
Jacques Raphael

354 Background: Recent meta-analyses suggested an improvement in overall survival (OS) with the addition of Abiraterone (A) vs Docetaxel (D) to androgen deprivation therapy (ADT) in the treatment of men with metastatic castration-sensitive prostate cancer. However, none have reported castration resistance-free survival (CFS) and toxicity data; two clinically relevant outcomes for physicians and patients. Methods: We conducted a systematic review and meta-analysis to assess CFS and toxicity of adding A or D to ADT in men with castration-sensitive prostate cancer. The electronic databases Ovid MEDLINE, Cochrane Central Register of Controlled Trials and EMBASE, were searched for randomized controlled trials. Pooled hazard ratios (HR) for CFS, and pooled risk ratios (RR) for grade 3 or higher toxicity were analyzed using the Mantel-Haenszel method and generic inverse variance. To account for between-studies heterogeneity, random-effect models were used to compute pooled estimates. Subgroup analyses compared patients on A and D in terms of CFS. Results: Five studies were included. The addition of A or D to ADT decreased the risk of development of castration-resistance by 53% (5 studies, 4,462 participants, HR = 0.47, 95% CI 0.33-0.67). In a subgroup analysis, the addition of A seemed to be better than D for the outcome CFS (5 studies, HR = 0.31, 95% CI 0.27-0.34 versus HR = 0.62, 95% CI 0.56-0.69, test for subgroup difference, p< 0.001). Different profiles of toxicity were seen with A and D. While A increased the risk of hypokalemia (3,107 participants, HR = 6.63, 95% CI 3.5-12.5) and cardiac toxicity (3,107 participants, HR = 2.4, 95% CI 1.7-3.3), D increased the risk of neutropenia (2,151 participants, HR = 13, 95% CI 8.9-18.8) and neuropathy (2,151 participants, HR = 2.25, 95% CI 1.18-4.3). Conclusions: The addition of A and D to ADT increases CFS in men with castration-sensitive prostate cancer, with a longer CFS noted for A compared to D. Considering CFS and OS, A may be preferred to D as initial therapy. Toxicity profiles differed between A and D. Quality of life and cost differences between A and D are other important factors and were not considered in this analysis.

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040931
Author(s):  
Djillali Annane ◽  
Romain Pirracchio ◽  
Laurent Billot ◽  
Andre Waschka ◽  
Sylvie Chevret ◽  
...  

IntroductionThe benefits and risks of low-dose hydrocortisone in patients with septic shock have been investigated in numerous randomised controlled trials and trial-level meta-analyses. Yet, the routine use of this treatment remains controversial. To overcome the limitations of previous meta-analyses inherent to the use of aggregate data, we will perform an individual patient data meta-analysis (IPDMA) on the effect of hydrocortisone with or without fludrocortisone compared with placebo or usual care on 90-day mortality and other outcomes in patients with septic shock.Methods and analysisTo assess the benefits and risks of hydrocortisone, with or without fludrocortisone for adults with septic shock, we will search major electronic databases from inception to September 2020 (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and Latin American Caribbean Health Sciences Literature), complimented by a search for unpublished trials. The primary analysis will compare hydrocortisone with or without fludrocortisone to placebo or no treatment in adult patients with septic shock. Secondary analyses will compare hydrocortisone to placebo (or usual care), hydrocortisone plus fludrocortisone to placebo (or usual care), and hydrocortisone versus hydrocortisone plus fludrocortisone. The primary outcome will be all cause mortality at 90 days. We will conduct both one-stage IPDMA using mixed-effect models and machine learning with targeted maximum likelihood analyses. We will assess the risk of bias related to unshared data and related to the quality of individual trial.Ethics and disseminationThis IPDMA will use existing data from completed randomised clinical trials and will comply with the ethical and regulatory requirements regarding data sharing for each of the component trials. The findings of this study will be submitted for publication in a peer-review journal with straightforward policy for open access.PROSPERO registration numberCRD42017062198.


2018 ◽  
Vol 89 (3) ◽  
pp. 495-504
Author(s):  
Ahmed Mohamed Alakttash ◽  
Mohamed Fawzi ◽  
David Bearn

ABSTRACT Objectives: To investigate whether adhesive precoated brackets (APC) are more efficient than operator-coated brackets (OPC) regarding failure rate, bonding time, patient experience, gingival health, plaque accumulation, and white spot lesion formation. Materials and Methods: Five online databases: Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, PubMed, MEDLINE, and Web of Science were searched for potential eligible randomized controlled trials (RCTs). A Google Scholar and gray literature search was undertaken. References of included studies were screened for potential eligible studies. Results were collated from each database and modified Cochrane data extraction forms were completed. Quality assessment was performed using Cochrane RoB 2.0 tool for RCTs. Results: Five studies met the inclusion criteria. All reported failure rates using metal brackets for both APC and OPC systems except one that compared clear APC to clear OPC. Three studies reported bonding time differences between the bracket systems. A quantitative synthesis of four studies reporting failure and three reporting bonding time was undertaken. Random effect meta-analysis determined there were no statistically significant differences in bond failures between bracket systems with an odds ratio of 0.890 (P = .808). Bonding time showed a statistically significant (P = .01) but not clinically significant shorter bonding time with OPC. There was insufficient evidence to assess plaque accumulation, gingival health, and either patient or operator experience. Conclusions: There is no superiority of either bracket system regarding failure rate. OPC are statistically significantly superior over APC in bonding time although this is most likely not clinically significant.


BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034846 ◽  
Author(s):  
Rutger MJ de Zoete ◽  
James H McAuley ◽  
Nigel R Armfield ◽  
Michele Sterling

IntroductionNeck pain is a global burdensome problem, with a large proportion of neck pain cases becoming chronic. Although physical exercise is a commonly prescribed treatment, the evidence on the effectiveness of isolated exercise interventions remains limited. Traditional pairwise randomised controlled trials (RCTs) and meta-analyses are limited in only comparing two interventions. This protocol describes the design of a network meta-analysis, which enables a comparative investigation of all physical exercise interventions for which RCTs are available. We aim to systematically compare the effectiveness of different types of physical exercise in people with chronic non-specific neck pain.Methods and analysisNine electronic databases (AMED, CINAHL, Cochrane Central Register of Controlled Trials, Embase, MEDLINE, Physiotherapy Evidence Database, PsycINFO, Scopus and SPORTDiscus) were searched for RCTs from inception to 12 March 2019. Titles and abstract firstly, and full-text papers secondly, will be screened by two reviewers. Data will be extracted by two reviewers. The primary outcome measure is effectiveness of the intervention. Methodological quality of included studies will be assessed by two reviewers using the PEDro scale. The overall quality of evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, which has been adapted for network meta-analyses. The available evidence will be summarised using a network diagram. A contribution matrix will be presented to allow assessment of direct and indirect evidence. Forest plots will be constructed to visualise effects of all included exercise interventions. Pairwise effect sizes will be calculated by including all evidence available in the network. Effect measures for treatments that have not been compared in a pairwise RCT can be compared indirectly by contrasting effect sizes of comparisons with a common comparator.Ethics and disseminationThis work synthesises evidence from previously published studies and does not require ethics review or approval. A manuscript describing the findings will be submitted for publication in a peer-reviewed scientific journal.PROSPERO registration numberCRD42019126523.


2020 ◽  
Vol 109 (11) ◽  
pp. 1381-1391 ◽  
Author(s):  
Hans-Josef Feistritzer ◽  
Alexander Jobs ◽  
Suzanne de Waha-Thiele ◽  
Ingo Eitel ◽  
Anne Freund ◽  
...  

Abstract Aims To perform a pairwise meta-analysis of randomized controlled trials (RCTs) comparing multivessel percutaneous coronary intervention (PCI) and culprit vessel-only PCI in ST-elevation myocardial infarction (STEMI) patients without cardiogenic shock. Methods We searched MEDLINE, Cochrane Central Register of Controlled Trials, and Embase for RCTs comparing multivessel PCI with culprit vessel-only PCI in STEMI patients without cardiogenic shock and multivessel coronary artery disease. Only RCTs reporting mortality or myocardial reinfarction after at least 6 months following randomization were included. Hazard ratios (HRs) were pooled using random-effect models. Results Nine RCTs were included in the final analysis. In total, 523 (8.3%) of 6314 patients suffered the combined primary endpoint of death or non-fatal reinfarction. This primary endpoint was significantly reduced with multivessel PCI compared to culprit vessel-only PCI (HR 0.63, 95% confidence interval [CI] 0.43–0.93; p = 0.03). This finding was driven by a reduction of non-fatal reinfarction (HR 0.64, 95% CI 0.52–0.79; p = 0.001), whereas no significant reduction of all-cause death (HR 0.77, 95% CI 0.44–1.35; p = 0.28) or cardiovascular death (HR 0.64, 95% CI 0.37–1.11; p = 0.09) was observed. Conclusions In STEMI patients without cardiogenic shock multivessel PCI reduced the risk of death or non-fatal reinfarction compared to culprit vessel-only PCI.


2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
Wei Jiang ◽  
Shaojun Liao ◽  
Xiankun Chen ◽  
Cecilia Stålsby Lundborg ◽  
Gaetano Marrone ◽  
...  

Background. Depression is a debilitating comorbidity of heart failure (HF) that needs assessment and management. Along with mind-body exercise to deal with HF with depression, the use of TaiChi and/or Qigong practices (TQPs) has increased. Therefore, this systematic review assesses the effects of TQPs on depression among patients with HF. Methods. Randomized controlled trials (RCTs) that examined the effect of TQPs on depression in patients with HF were searched by five databases (PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, CINAHL, and China National Knowledge Infrastructure (CNKI)). With standardized mean difference (SMD) and 95% confidence intervals (95% CI), random-effects meta-analyses of the effect of TQPs on depressive symptoms were performed. Results. Of eight included RCTs, seven (481 patients) provided data for the meta-analysis. The pooling revealed that TQPs contribute to depression remission in HF (SMD −0.66; 95% CI −0.98 to −0.33, P < 0.0001 ; I2 = 64%). Its antidepressive effect was not influenced by intervention duration or exercise setting, but rather by ejection fraction subtype, depressive severity, and depression instruments. The beneficial effects were preserved when the study with the largest effect was removed. Conclusion. This study suggests that TQPs might be a good strategy for alleviating depressive symptoms in patients with HF. And rigorous-design RCTs, which focus on the identified research gaps, are needed to further establish the therapeutic effects of TQPs for depression in HF.


Author(s):  
Karen M O'Callaghan ◽  
Mahgol Taghivand ◽  
Anna Zuchniak ◽  
Akpevwe Onoyovwi ◽  
Jill Korsiak ◽  
...  

ABSTRACT Daily oral vitamin D supplementation (400 IU) is recommended for breastfeeding infants (≤1 y). Recent studies have examined alternative approaches to preventing vitamin D deficiency in this population. This systematic review and meta-analysis aimed to estimate the effects of maternal postpartum (M-PP) or infant intermittent (I-INT) vitamin D supplementation on infant 25-hydroxyvitamin D [25(OH)D] concentrations in comparison to routine direct infant daily (I-D) oral supplementation (400 IU). MEDLINE, MEDLINE In-Process, Embase, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials were searched up to December 2018. Inclusion criteria consisted of published, peer-reviewed, vitamin D intervention trials involving lactating women and/or exclusively or partially breastfed term infants. Two reviewers independently extracted study characteristics (e.g., sample size, intervention dose, and duration and mode of administration) and related biochemical and clinical outcomes. Of 28 included trials, 5 randomized controlled trials were incorporated in meta-analyses examining infant 25(OH)D. Overall, M-PP supplementation resulted in modestly lower infant 25(OH)D compared with I-D supplementation (weighted mean difference = −8.1 nmol/L; 95% CI: −15.4, −0.9; I2 = 45%; P = 0.14; 3 trials), but the 2 most recent trials found M-PP to achieve similar infant 25(OH)D as I-D. Comparison of I-INT with I-D was confined to 2 trials with contradictory findings, and it was considered inappropriate for pooled analysis. Meta-analysis was therefore limited by a small number of eligible trials with variable quality of analytically derived 25(OH)D data and inconsistent reporting of safety outcomes, including effects on calcium homeostasis. Considering all 28 included trials, this systematic review highlights M-PP and I-INT regimens as plausible substitutes for routine daily infant vitamin D supplementation, but evidence remains too weak to support a policy update. Dose-ranging, adequately powered trials are required to establish the efficacy, safety, and feasibility of alternative strategies to prevent vitamin D deficiency in breastfeeding infants. This review was registered with PROSPERO as CRD42017069905.


2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 366-366
Author(s):  
Tobias Engel Ayer Botrel ◽  
Otávio Clark ◽  
Francisco Flávio Horta Bretas ◽  
Marcus V. Sadi ◽  
Ubirajara Ferreira ◽  
...  

366 Background: To perform a systematic review and meta-analysis of all randomized controlled trials (RCTs) comparing efficacy of adjuvant radiotherapy (AR) versus expectant management (EM) in men who undergo radical prostatectomy for localized prostate cancer (CaP). Methods: To perform this review and meta-analysis,several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. We included all the studies that compared AR versus EM after radical surgery for CaP. The primary endpoints analyzed were biochemical progression-free survival (bPFS), metastasis-free survival (MPFS), prostate cancer-specific survival (CSS), overall survival (OS) and side effects. The data extracted from the studies were combined by using the Hazard Ratio (HR) or Risk Ratio (RR) with their corresponding Confidence Intervals of 95% (CI95%). Results: Overall, 68 studies were identified and screened. The final analysis included 7 trials (EORTC 22911, SWOG 8794, ARO 96-02/AUO AP 09/95, RAVES, FINNISH, GETUG-AFU 17 and RADICALS-RT) comprising 4,221 patients. The bPFS was higher in patients who received AR (fixed effect: HR = 0.58, CI95% = 0.52 to 0.66; p < 0.00001) but with significant heterogeneity (Chi2 = 40.34, df = 6 (P < 0.00001); I2 = 85%). We performed a random-effect model analysis to better explore this heterogeneity: in this analysis, the result remained in favor of AR (random effect: HR = 0.64, CI95% = 0.45 to 0.90; p = 0.01). The MPFS also was higher in patients who received AR (HR = 0.77, CI95% = 0.65 to 0.91; p = 0.002). The CSS and OS were not statistically different in patients with or without adjuvant radiotherapy (HR = 0.79, CI95% = 0.47 to 1.32; p = 0.36 and HR = 0.92, CI95% = 0.77 to 1.11; p = 0.38, respectively). The incidence of adverse events (gastrointestinal and genitourinary) were higher in the AR group. Conclusions: This is the first meta-analysis including the seven available RCTs in the literature (the previous meta-analysis reviewed only three), comparing adjuvant radiotherapy versus expectant management following radical prostatectomy for CaP. Adjuvant radiotherapy statistically increased the bPFS and MPFS, but did not have an impact on the OS or CSS.


2020 ◽  
Vol 48 (5) ◽  
pp. 030006052092167
Author(s):  
Bo Liu ◽  
Qiang Zhang ◽  
Chunsheng Li

Background The effect of steroid use on outcomes in patients with cardiac arrest (CA) remains controversial. We systematically reviewed the literature to investigate whether steroid use after CA increased the return of spontaneous circulation (ROSC) rate and survival to discharge in patients with CA. Methods PubMed, Embase, CNKI, and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials (RCTs) and observational studies on the effect of steroid use on outcomes in adults with CA. The outcomes were ROSC and survival to discharge. Results Seven studies (four RCTs and three observational studies) were included. Pooled analysis suggested that steroid use was associated with increased ROSC in patients with CA. Steroid use was significantly associated with survival to discharge, which was a consistent finding in RCTs and observational studies. Subgroup analysis based on the time of drug administration (during cardiopulmonary resuscitation [CPR] vs. after CA) showed that steroid use during CPR and after CA were significantly associated with an increased rate of ROSC and survival to discharge. Conclusion Current evidence indicates that steroid use after CA could increase ROSC and survival to discharge in patients with CA. However, high-quality and adequately powered RCTs are warranted.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Feistritzer ◽  
A Jobs ◽  
S De Waha-Thiele ◽  
I Eitel ◽  
A Freund ◽  
...  

Abstract Background Previous randomized controlled trials (RCTs) indicated a benefit of multivessel percutaneous coronary intervention (PCI) compared to culprit vessel-only PCI in ST-elevation myocardial infarction (STEMI) without cardiogenic shock. Purpose To perform a pairwise meta-analysis of RCTs, already including the recently published COMPLETE (The Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI) trial, comparing multivessel PCI and culprit vessel-only PCI in STEMI patients without cardiogenic shock. Methods We searched MEDLINE, Cochrane Central Register of Controlled Trials, and Embase for randomized controlled trials (RCTs) comparing multivessel PCI with culprit vessel-only PCI in STEMI patients without cardiogenic shock and multivessel coronary artery disease. Only RCTs reporting mortality or myocardial reinfarction after at least 6 months following randomization were included. Hazard ratios (HRs) were pooled using random-effect models. Results Nine RCTs were included in the final analysis. In total, 523 (8.3%) of 6,314 patients suffered the combined primary endpoint of death or non-fatal reinfarction. This primary endpoint was significantly reduced with multivessel PCI compared to culprit vessel-only PCI (HR 0.63, 95% confidence interval [CI] 0.43–0.93; p=0.03). This finding was driven by a reduction of non-fatal reinfarction (HR 0.64, 95% CI 0.52–0.79; p=0.001), whereas no significant reduction of all-cause death (HR 0.77, 95% CI 0.44–1.35; p=0.28) or cardiovascular death (HR 0.64, 95% CI 0.37–1.11; p=0.09) was observed. Conclusion In STEMI patients without cardiogenic shock multivessel PCI reduced the risk of death or non-fatal reinfarction compared to culprit vessel-only PCI. Funding Acknowledgement Type of funding source: None


BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e049213
Author(s):  
Karla Morganna Pereira Pinto de Mendonça ◽  
Sean Collins ◽  
Tácito ZM Santos ◽  
Gabriela Chaves ◽  
Sarah Leite ◽  
...  

IntroductionButeyko method is recommended as a non-pharmacological treatment for people with asthma. Although the worldwide interest in the Buteyko method, there is a paucity of studies gathering evidence to support its use. Therefore, we aim to conduct a systematic review and meta-analysis to assess the effects of the Buteyko method in children and adults with asthma.Methods and analysisWe will search on Cochrane Central Register of Controlled Trials, MEDLINE, Embase, US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov and WHO International Clinical Trials Registry Platform for studies focusing on the Buteyko method for children and adults with asthma. The searches will be carried out in September 2021 from database’s inception to the present. We will include randomised controlled trials comparing Buteyko method alone with asthma education or inactive control intervention. There will be no restriction on language. Primary outcomes include quality of life, asthma symptoms and adverse events/side effects. Two review authors will independently screen the studies for inclusion and extract data. We will assess the quality of the included studies using the ‘Risk of Bias’ tool. The certainty of the evidence will be assessed using the GRADE approach. Data synthesis will be conducted using Review Manager software. Reporting of the review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance and the Cochrane Handbook for Systematic Reviews of Interventions.Ethics and disseminationThis study will assess and provide evidence for the use of the Buteyko method in people with asthma. We will analyse secondary data and this does not require ethics approval. The findings will be published in peer-reviewed journals, at relevant conferences and will be shared in plain language in social media. Moreover, the findings of this review could guide the direction of healthcare practice and research.PROSPERO registration numberCRD42020193132.


Sign in / Sign up

Export Citation Format

Share Document