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1.
Lancet Psychiatry ; 7(2): 162-172, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31948935

RESUMO

BACKGROUND: Mental health conditions are leading causes of disability worldwide. Psychosocial interventions for these conditions might have a key role in their treatment, although applicability of findings to poor-resource settings might be a challenge. We aimed to evaluate the strength and credibility of evidence generated in low-income and middle-income countries (LMICs) on the efficacy of psychosocial interventions for various mental health outcomes. METHODS: We did an umbrella review of meta-analyses of randomised studies done in LMICs. Literature searches were done in Medline, Embase, PsychINFO, CINAHL, Cochrane Library, and Epistemonikos from Jan 1, 2010, until May 31, 2019. Systematic reviews of randomised studies investigating the efficacy of psychosocial interventions for mental health conditions in LMICs were included. Systematic reviews of promotion, prevention, and protection interventions were excluded, because the focus was on treatment interventions only. Information on first author, year of publication, outcomes, number of included studies, and reported summary meta-analytic estimates was extracted from included meta-analyses. Summary effects were recalculated using a common metric and random-effects models. We assessed between-study heterogeneity, predictive intervals, publication bias, small-study effects, and whether the results of the observed positive studies were more than expected by chance. On the basis of these calculations, strength of associations was assessed using quantitative umbrella review criteria, and credibility of evidence using the GRADE approach. This study is registered with PROSPERO, number CRD42019135711. FINDINGS: 123 primary studies from ten systematic reviews were included. The evidence on the efficacy of psychosocial interventions in adults with depression in humanitarian settings (standardised mean difference 0·87, 95% CI 0·67-1·07; highly suggestive association, GRADE: moderate) and in adults with common mental disorders (0·49, 0·36-0·62; highly suggestive association, GRADE: moderate) was supported by the most robust evidence. Highly suggestive strength of association was found for psychosocial interventions in adults with schizophrenia for functional outcomes, in adults with depression, and in adults with post-traumatic stress disorder in humanitarian settings. In children in humanitarian settings, and in children with disruptive behaviour, psychosocial interventions were supported by suggestive evidence of efficacy. INTERPRETATION: A relatively large amount of evidence suggests the benefit of psychosocial interventions on various mental health outcomes in LMICs. However, strength of associations and credibility of evidence were quite variable, depending on the target mental health condition, type of population and setting, and outcome of interest. This varied evidence should be considered in the development of clinical, policy, and implementation programmes in LMICs and should prompt further studies to improve the strength and credibility of the evidence base. FUNDING: University of Verona.


Assuntos
Países em Desenvolvimento/estatística & dados numéricos , Transtornos Mentais/terapia , Metanálise como Assunto , Psicoterapia/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Humanos
2.
World Neurosurg ; 133: e135-e148, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31491576

RESUMO

BACKGROUND: Decompressive hemicraniectomy (DHC) is widely applied for patients with traumatic brain injury (TBI). Although previous studies have indicated that DHC can lead to similar or worse outcomes compared with medical treatment (MT) in patients with TBI, recent trials have suggested the benefit of DHC for neurologic function recovery. Therefore, we performed this meta-analysis to assess the efficacy and functional outcomes of DHC in patients with TBI. METHODS: In accordance with PRISMA guidelines, we searched English and Chinese databases to identify relevant randomized controlled trials (RCTs) reporting DHC for TBI. The outcomes measures included mortality, favorable outcome, unfavorable outcome, postoperative intracranial pressure (ICP), adverse events with hematoma, and hospital stay. RESULTS: Seven RCTs with a total of 779 patients with TBI were included in this meta-analysis. Compared with the MT group, the DHC group demonstrated significantly lower rates of mortality (P < 0.00001), postoperative ICP (P < 0.00001), and postoperative hematoma (P = 0.01), and significantly shorter hospital length of stay (P = 0.02). However, the rate of unfavorable outcomes was higher in the DHC group compared with the MT group (P = 0.0001). CONCLUSIONS: Our results indicate that DHC could be effective in reducing the mortality rate, incidence of ICP, and hospital length of stay in patients with TBI. However, the proportion of patients surviving with unfavorable outcomes was significantly higher in the DHC group compared with the MT group. Despite the limitations of the meta-analysis, our findings target extremely important topic and provide important evidence to facilitate clinical decision making.


Assuntos
Lesões Encefálicas Traumáticas/cirurgia , Craniectomia Descompressiva , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Adulto , Dano Encefálico Crônico/etiologia , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/mortalidade , Criança , Humanos , Hipertensão Intracraniana/etiologia , Tempo de Internação/estatística & dados numéricos , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento
3.
Br J Sports Med ; 54(1): 51-57, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31511232

RESUMO

BACKGROUND: In randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials-compliance with the intervention-is not always well-reported. The purpose of the present educational review was to describe the compliance during follow-up in eight large-scale sports injury trials and address compliance issues that surfaced. Then, we discuss how readers and researchers might consider interpreting results from intention-to-treat analyses depending on the observed compliance with the intervention. METHODS: Data from seven different randomised trials and one experimental study were included in the present educational review. In the trials that used training programme as an intervention, we defined full compliance as having completed the programme within ±10% of the prescribed running distance (ProjectRun21 (PR21), RUNCLEVER, Start 2 Run) or time-spent-running in minutes (Groningen Novice Running (GRONORUN)) for each planned training session. In the trials using running shoes as the intervention, full compliance was defined as wearing the prescribed running shoe in all running sessions the participants completed during follow-up. RESULTS: In the trials that used a running programme intervention, the number of participants who had been fully compliant was 0 of 839 (0%) at 24-week follow-up in RUNCLEVER, 0 of 612 (0%) at 14-week follow-up in PR21, 12 of 56 (21%) at 4-week follow-up in Start 2 Run and 8 of 532 (1%) at 8-week follow-up in GRONORUN. In the trials using a shoe-related intervention, the numbers of participants who had been fully compliant at the end of follow-up were 207 of 304 (68%) in the 21 week trial, and 322 of 423 (76%), 521 of 577 (90%), 753 of 874 (86%) after 24-week follow-up in the other three trials, respectively. CONCLUSION: The proportion of runners compliant at the end of follow-up ranged from 0% to 21% in the trials using running programme as intervention and from 68% to 90% in the trials using running shoes as intervention. We encourage sports injury researchers to carefully assess and report the compliance with intervention in their articles, use appropriate analytical approaches and take compliance into account when drawing study conclusions. In studies with low compliance, G-estimation may be a useful analytical tool provided certain assumptions are met.


Assuntos
Traumatismos em Atletas/prevenção & controle , Cooperação do Paciente , Condicionamento Físico Humano/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Interpretação Estatística de Dados , Humanos , Análise de Intenção de Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Corrida/lesões , Sapatos
4.
BMC Med ; 17(1): 190, 2019 10 23.
Artigo em Inglês | MEDLINE | ID: mdl-31640711

RESUMO

BACKGROUND: In locoregionally advanced nasopharyngeal carcinoma (LANPC) patients, variance of tumor response to induction chemotherapy (ICT) was observed. We developed and validated a novel imaging biomarker to predict which patients will benefit most from additional ICT compared with chemoradiotherapy (CCRT) alone. METHODS: All patients, including retrospective training (n = 254) and prospective randomized controlled validation cohorts (a substudy of NCT01245959, n = 248), received ICT+CCRT or CCRT alone. Primary endpoint was failure-free survival (FFS). From the multi-parameter magnetic resonance images of the primary tumor at baseline, 819 quantitative 2D imaging features were extracted. Selected key features (according to their interaction effect between the two treatments) were combined into an Induction Chemotherapy Outcome Score (ICTOS) with a multivariable Cox proportional hazards model using modified covariate method. Kaplan-Meier curves and significance test for treatment interaction were used to evaluate ICTOS, in both cohorts. RESULTS: Three imaging features were selected and combined into ICTOS to predict treatment outcome for additional ICT. In the matched training cohort, patients with a high ICTOS had higher 3-year and 5-year FFS in ICT+CCRT than CCRT subgroup (69.3% vs. 45.6% for 3-year FFS, and 64.0% vs. 36.5% for 5-year FFS; HR = 0.43, 95% CI = 0.25-0.74, p = 0.002), whereas patients with a low ICTOS had no significant difference in FFS between the subgroups (p = 0.063), with a significant treatment interaction (pinteraction <  0.001). This trend was also found in the validation cohort with high (n = 73, ICT+CCRT 89.7% and 89.7% vs. CCRT 61.8% and 52.8% at 3-year and 5-year; HR = 0.17, 95% CI = 0.06-0.51, p <  0.001) and low ICTOS (n = 175, p = 0.31), with a significant treatment interaction (pinteraction = 0.019). Compared with 12.5% and 16.6% absolute benefit in the validation cohort (3-year FFS from 69.9 to 82.4% and 5-year FFS from 63.4 to 80.0% from additional ICT), high ICTOS group in this cohort had 27.9% and 36.9% absolute benefit. Furthermore, no significant survival improvement was found from additional ICT in both groups after stratifying low ICTOS patients into low-risk and high-risks groups, by clinical risk factors. CONCLUSION: An imaging biomarker, ICTOS, as proposed, identified patients who were more likely to gain additional survival benefit from ICT+CCRT (high ICTOS), which could influence clinical decisions, such as the indication for ICT treatment. TRIAL REGISTRATION: ClinicalTrials.gov , NCT01245959 . Registered 23 November 2010.


Assuntos
Quimioterapia de Indução , Imagem por Ressonância Magnética/métodos , Carcinoma Nasofaríngeo/diagnóstico , Carcinoma Nasofaríngeo/tratamento farmacológico , Neoplasias Nasofaríngeas/diagnóstico , Neoplasias Nasofaríngeas/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimiorradioterapia , Ensaios Clínicos Fase III como Assunto/estatística & dados numéricos , Estudos de Coortes , Tomada de Decisões , Progressão da Doença , Feminino , Humanos , Quimioterapia de Indução/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Carcinoma Nasofaríngeo/epidemiologia , Carcinoma Nasofaríngeo/patologia , Neoplasias Nasofaríngeas/epidemiologia , Neoplasias Nasofaríngeas/patologia , Valor Preditivo dos Testes , Prognóstico , Planejamento da Radioterapia Assistida por Computador/métodos , Planejamento da Radioterapia Assistida por Computador/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
5.
BMC Med ; 17(1): 188, 2019 10 21.
Artigo em Inglês | MEDLINE | ID: mdl-31639007

RESUMO

BACKGROUND: There is growing interest in evaluating differences in healthcare interventions across routinely collected demographic characteristics. However, individual subgroup analyses in randomized controlled trials are often not prespecified, adjusted for multiple testing, or conducted using the appropriate statistical test for interaction, and therefore frequently lack credibility. Meta-analyses can be used to examine the validity of potential subgroup differences by collating evidence across trials. Here, we characterize the conduct and clinical translation of age-treatment subgroup analyses in Cochrane reviews. METHODS: For a random sample of 928 Cochrane intervention reviews of randomized trials, we determined how often subgroup analyses of age are reported, how often these analyses have a P < 0.05 from formal interaction testing, how frequently subgroup differences first observed in an individual trial are later corroborated by other trials in the same meta-analysis, and how often statistically significant results are included in commonly used clinical management resources (BMJ Best Practice, UpToDate, Cochrane Clinical Answers, Google Scholar, and Google search). RESULTS: Among 928 Cochrane intervention reviews, 189 (20.4%) included plans to conduct age-treatment subgroup analyses. The vast majority (162 of 189, 85.7%) of the planned analyses were not conducted, commonly because of insufficient trial data. There were 22 reviews that conducted their planned age-treatment subgroup analyses, and another 3 reviews appeared to perform unplanned age-treatment subgroup analyses. These 25 (25 of 928, 2.7%) reviews conducted a total of 97 age-treatment subgroup analyses, of which 65 analyses (in 20 reviews) had non-overlapping subgroup levels. Among the 65 age-treatment subgroup analyses, 14 (21.5%) did not report any formal interaction testing. Seven (10.8%) reported P < 0.05 from formal age-treatment interaction testing; however, none of these seven analyses were in reviews that discussed the potential biological rationale or clinical significance of the subgroup findings or had results that were included in common clinical practice resources. CONCLUSION: Age-treatment subgroup analyses in Cochrane intervention reviews were frequently planned but rarely conducted, and implications of detected interactions were not discussed in the reviews or mentioned in common clinical resources. When subgroup analyses are performed, authors should report the findings, compare the results to previous studies, and outline any potential impact on clinical care.


Assuntos
Interpretação Estatística de Dados , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa , Literatura de Revisão como Assunto , Distribuição por Idade , Fatores Etários , Projetos de Pesquisa Epidemiológica , Estudos Epidemiológicos , Feminino , Humanos , Medicina de Precisão/métodos , Medicina de Precisão/estatística & dados numéricos , Projetos de Pesquisa/normas , Projetos de Pesquisa/estatística & dados numéricos
6.
Gynecol Oncol ; 155(2): 283-286, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31519318

RESUMO

PURPOSE: The aim of our review was to ascertain factors associated with the successful completion of a randomized controlled trial in gynecological oncology. MATERIALS AND METHODS: This retrospective cohort study utilized data collected from the National Institutes of Health's US National Library of Medicine database on ClinicalTrials.gov. Data was collected over a five year period (2009-2013). Utilizing the search terms under the National Institutes of Health recommended "Studies by Topics" gynecological oncology studies were identified. Randomized controlled trials were selected for based on intervention and randomization criteria. Elements were then compared with statistical analysis performed using SASS. RESULTS: As of September 1st 2018, 149 of the 318 identified randomized controlled trials were successfully completed over a median length of 44 months (IQR 30.0-55.0). Completed randomized controlled trials were more likely to be performed at single centers (p < 0.005). Interventional, drug and device trials were not significantly more likely to be completed. There was no difference in funding sources for completed or not completed randomized controlled trials. CONCLUSIONS: Prospective randomized trials are essential for establishing the standard of care in clinical medicine. They are, however, time and resource intensive. Herein we have attempted to identify factors associated with successful and timely completion of gynecologic oncology randomized controlled trials including site of origin, number of participating sites, funding source, intervention type, enrollment size, and study length; however, none of these factors were observed to have an association with increased rates of trial publication.


Assuntos
Neoplasias dos Genitais Femininos/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Feminino , Neoplasias dos Genitais Femininos/economia , Humanos , Estudos Multicêntricos como Assunto/economia , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Estudos Prospectivos , Editoração/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Apoio à Pesquisa como Assunto , Estudos Retrospectivos
7.
Medicine (Baltimore) ; 98(37): e17099, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31517838

RESUMO

BACKGROUND: This is the first systematic review evaluating and statistically synthesis the current studies regarding the effects of Tai Chi on pain and disability in patients with low back pain (LBP). METHODS: Seven electronic databases including PubMed, EMBASE, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang and VIP information from inception to early March 2019 were searched. The Physiotherapy Evidence Database (PEDro) Scale was used to assess quality of all included randomized controlled trials (RCTs). The pooled effect size (weight mean difference, WMD) and 95% confidence interval (CI) were calculated to determine the effect of Tai Chi on pain and disability among LBP patients based on random effects model. RESULTS: The aggregated results of the meta-analysis suggested that Tai Chi significantly decreased pain (WMD = -1.27, 95%CI -1.50 to -1.04, P < .00001, I = 74%) and improve function disability, Oswestry disability index (ODI) subitems: pain intensity (WMD = -1.70, 95% CI -2.63 to -0.76, P = .0004, I = 89%); personal care (WMD = -1.93, 95% CI -2.86 to -1.00, P < .0001, I = 90%); lifting (WMD = -1.69, 95% CI -2.22 to -1.15, P < .0001, I = 66%); walking (WMD = -2.05, 95% CI -3.05 to -1.06, P < .0001, I = 88%); standing (WMD = -1.70, 95% CI -2.51 to -0.89, P < .0001, I = 84%); sleeping (WMD = -2.98, 95% CI -3.73 to -2.22, P < .00001, I = 80%); social life (WMD = -2.06, 95% CI -2.77 to -1.35, P < 0.00001, I = 80%) and traveling (WMD = -2.20, 95% CI -3.21 to -1.19, P < .0001, I = 90%), Japanese Orthopedic Association (JOA) score (WMD = 7.22, 95% CI 5.59-8.86, P < .00001, I = 0%), Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) physical functioning (WMD = 3.30, 95% CI 1.92-4.68, P < .00001), and Roland-Morris Disability Questionnaire (RMDQ) (WMD = -2.19, 95% CI -2.56 to -1.82, P < .00001). CONCLUSION: We drew a cautious conclusion that Tai Chi alone or as additional therapy with routine physical therapy may decrease pain and improve function disability for patients with LBP. Further trials are needed to be conducted with our suggestions mentioned in the systematic review.


Assuntos
Dor Lombar/terapia , Manejo da Dor/normas , Tai Ji/normas , Humanos , Manejo da Dor/métodos , Modalidades de Fisioterapia/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Tai Ji/métodos
8.
Medicine (Baltimore) ; 98(37): e17107, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31517843

RESUMO

BACKGROUND: Percutaneous mechanical circulatory support devices (pMCSDs) are increasingly used on the assumption (but without solid proof) that their use will improve prognosis. A meta-analysis was undertaken according to the PRISMA guidelines to evaluate the benefits of pMCSDs in patients undergoing high-risk percutaneous coronary intervention (hr-PCI). METHODS: We searched PubMed, EMbase, Cochrane Library, Clinical Trial.gov, and other databases to identify eligible studies. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated for 30-day and 6-month all-cause mortality rates, reinfarction, and other adverse events using a random effect model. RESULTS: Sixteen randomized controlled trials (RCTs) were included in this study. In the pooled analysis, intra-aortic balloon pump (IABP) was not associated with a decrease in 30-day and 6-month all-cause mortality (RR 1.01 95% CI 0.61-1.66; RR 0.88 95% CI 0.66-1.17), reinfarction (RR 0.89 95% CI 0.69-1.14), stroke/transient ischemic attack (TIA) (RR 1.75 95% CI 0.47-6.42), heart failure (HF) (RR 0.54 95% CI 0.11-2.66), repeat revascularization (RR 0.73 95% CI 0.25-2.10), embolization (RR 3.00 95% CI 0.13-71.61), or arrhythmia (RR 2.81 95% CI 0.30-26.11). Compared with IABP, left ventricular assist devices (LVADs) were not associated with a decrease in 30-day and 6-month all-cause mortality (RR 0.96 95% CI 0.71-1.29; RR 1.23 95% CI 0.88-1.72), reinfarction (RR 0.98 95% CI 0.68-1.42), stroke/TIA (RR 0.45 95% CI 0.1-1.95), acute kidney injury (AKI) (RR 0.83 95% CI 0.38-1.80), or arrhythmia (RR 1.52 95% CI 0.71-3.27), but LVADs were associated with a decrease in repeat revascularization (RR 0.26 95% CI 0.08-0.83). However, LVADs significantly increased the risk of bleeding compared with IABP (RR 2.85 95% CI 1.72-4.73). CONCLUSIONS: Neither LVADs nor IABP improves short or long-term survival in hr-PCI patients. LVADs are more likely to reduce repeat revascularization after PCI, but to increase the risk of bleeding events than IABP.


Assuntos
Coração Auxiliar/normas , Balão Intra-Aórtico/normas , Intervenção Coronária Percutânea/métodos , Arritmias Cardíacas/terapia , Embolização Terapêutica/métodos , Insuficiência Cardíaca/terapia , Coração Auxiliar/estatística & dados numéricos , Humanos , Balão Intra-Aórtico/métodos , Balão Intra-Aórtico/estatística & dados numéricos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Fatores de Risco , Acidente Vascular Cerebral/terapia , Resultado do Tratamento
9.
Medicine (Baltimore) ; 98(37): e17111, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31517845

RESUMO

BACKGROUND: This study aims to systematically assess the effectiveness of high frequency ultrasound (HFUS) on pressure ulcer (PU). METHODS: In this study, PubMed, EMBASE, Cochrane Library, Web of Science, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure will be searched from inception to the present without any language limitations. The primary outcomes include change in ulcer area, and time complete healing. The secondary outcomes consist of proportion of ulcers healed within trial period, quality of life, pain intensity, and adverse events. Cochrane risk of bias tool will be used to assess methodological quality. RevMan 5.3 software (London, UK) will be used to analyze the data. RESULTS: This study will analyze change in ulcer area, time complete healing, proportion of ulcers healed within study period, quality of life, pain intensity, and adverse events on HFUS in patients with PU. CONCLUSION: This study will provide most recent evidence for the effectiveness and safety of HFUS for patients with PU. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019138177.


Assuntos
Lesão por Pressão/terapia , Ultrassonografia/normas , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Ultrassonografia/métodos , Cicatrização
11.
Phytother Res ; 33(11): 2918-2926, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31429515

RESUMO

Given the proliferation in studies investigating green coffee bean extract (GCBE) supplementation, the purpose of this study was to determine the efficacy and effectiveness of GCBE supplementation on indices of blood pressure. The literature search was performed in four databases, namely, PubMed/Medline, Scopus, the Cochrane Library, and Google Scholar, to identify clinical trials that examined the effects of green coffee supplements on systolic blood pressure (SBP) and diastolic blood pressure (DBP) up to February 2019. Mean change and standard deviation (SD) of the outcome measures were used to estimate the mean difference between the intervention group and the control group at follow-up. Nine studies reported SBP and DBP as an outcome measure. Results revealed significant reduction in SBP (weighted mean difference: -3.093 mmHg, 95% confidence interval [CI]: -3.914, -2.273; I2 = 0.0%) and DBP (-2.170 mmHg, 95% CI: -2.749, -1.590; I2 = 46.5%) after green coffee supplementation with low heterogeneity among the studies. In addition, in subgroup analysis, a significant reduction in SBP and DBP in studies with hypertensive patients, green coffee dosage <400 mg, and administered for 4 weeks was identified. The results of the current meta-analysis study support the use of GCBE supplementation for the improvement of blood pressure indices, with subgroup analysis highlighting improvements in hypertensive patients.


Assuntos
Pressão Sanguínea/efeitos dos fármacos , Café/química , Extratos Vegetais/farmacologia , Suplementos Nutricionais , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/fisiopatologia , Extratos Vegetais/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos
12.
Phytother Res ; 33(11): 2989-2995, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31423626

RESUMO

Impaired endothelial function is an important risk factor for cardiovascular disease (CVD). Curcumin supplementation might be an appropriate approach to decrease the complications of CVD. Randomized controlled trials assessing the effects of curcumin supplementation on endothelial function were included. Two independent authors systematically searched online database including EMBASE, Scopus, PubMed, Cochrane Library, and Web of Science with no time restriction. Cochrane Collaboration risk of bias tool was applied to assess the methodological quality of included trials. Between-study heterogeneities were estimated using the Cochran's Q test and I-square (I2 ) statistic. Data were pooled using a random-effects model, and weighted mean differences (WMDs) were considered as the overall effect sizes. Ten studies with 11 effect sizes were included. We found a significant increase in flow-mediated dilation (FMD) following curcumin supplementation (WMD: 1.49; 95% CI [0.16, 2.82]). There was no effect of curcumin supplement on pulse wave velocity (PWV; WMD: -41.59; 95% CI [-86.59, 3.42]), augmentation index (Aix; WMD: 0.71; 95% CI [-1.37, 2.79]), endothelin-1 (ET-1; WMD: -0.30; 95% CI [-0.96, 0.37]), and soluble intercellular adhesion molecule-1 (sICAM-1; WMD: -10.11; 95% CI [-33.67, 13.46]). This meta-analysis demonstrated the beneficial effects of curcumin supplementation on improving FMD, though it did not influence PWV, Aix, Et-1, and sICAM-1.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Curcumina/farmacologia , Endotélio Vascular/efeitos dos fármacos , Idoso , Doenças Cardiovasculares/fisiopatologia , Suplementos Nutricionais , Endotélio Vascular/fisiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise de Onda de Pulso , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Fluxo Sanguíneo Regional/efeitos dos fármacos , Vasodilatação/efeitos dos fármacos
13.
Phytother Res ; 33(11): 2862-2869, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31423665

RESUMO

The aims of this study were to evaluate the efficacy of corn silk decoction on lipid profile in patients with angina pectoris. PubMed, Cochrane, Embase, Google Scholar, Chongqing VIP Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure, and Wanfang database were searched up to January 2019 for randomized controlled trials that assessed the impact of corn silk decoction on total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol in patients with angina pectoris. Study evaluation and synthesis methods were in accordance with the Cochrane Handbook, and data were analyzed using Review Manager (version 5.3) software. Random effects model was applied in this systematic review and meta-analysis to compensate for potential heterogeneity among the included studies. A total of four randomized controlled trials were eligible for meta-analysis. Pooled results of these studies indicated that corn silk decoction might improve high-density lipoprotein cholesterol and reduce total cholesterol, triglycerides, and low-density lipoprotein cholesterol in patients with angina pectoris. Subgroup analyses showed that corn silk decoction or modified corn silk decoction plus conventional pharmaceutical treatment could have favorable effects on blood lipids. However, the lack of blinding in most studies may have led to overestimation of these effects. Further studies with better design are needed to confirm these findings.


Assuntos
Angina Pectoris/tratamento farmacológico , Flores/química , Metabolismo dos Lipídeos/efeitos dos fármacos , Lipídeos/sangue , Extratos Vegetais/uso terapêutico , Zea mays/química , Angina Pectoris/sangue , China/epidemiologia , HDL-Colesterol/sangue , HDL-Colesterol/efeitos dos fármacos , LDL-Colesterol/sangue , LDL-Colesterol/efeitos dos fármacos , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Hipolipemiantes/química , Hipolipemiantes/farmacologia , Hipolipemiantes/uso terapêutico , Fitoterapia , Extratos Vegetais/química , Extratos Vegetais/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Triglicerídeos/sangue
14.
Urology ; 133: 204-210, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31374290

RESUMO

OBJECTIVE: To review the robustness of hydronephrosis literature with the application of fragility index (FI) and fragility quotient (FQ) calculations. METHODS: A literature review was conducted using Pubmed, Medline, and Ovid for "hydronephrosis" and associated terms and we included all studies with at least 2 groups being compared. FI was calculated by populating study results into a 2-by-2 contingency table and generating a P value using Fisher's exact test. Next, events were manually added to the group with the fewest events, while removing a nonevent from the same group and Fisher's exact test repeated until the P value was >.05. FQ was calculated by dividing FI by the total sample size. RESULTS: The 130 included articles were published between 1986 and 2018 in 32 journals. Median citation count was 14 (0-252), 30% were RCTs and most papers originated in the United States (28%), Turkey(10%), and Canada(9%). Median FI was 2 (1-112), FQ was 0.023 (0.0010-0.55), and 60 papers (46%) had a FI of 1, indicating extremely fragile results. There was a significant difference in the FI between observational studies and RCTs (10 ± 17 vs 4 ± 5; P = .02); however, there was no difference in FQ (0.032 ± 0.030 vs 0.053 ± 0.080; P = .09) between them. CONCLUSION: Nearly half of studies in hydronephrosis literature reporting significant results are extremely fragile, requiring addition of only a couple of events in 1 treatment arm to significantly modify the results. As such, objective reporting of robustness of results should include FI and FQ which may help diminish over-reliance on P values as the main indicator of clinical significance in comparative studies.


Assuntos
Coleta de Dados/estatística & dados numéricos , Hidronefrose , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Urologia/estatística & dados numéricos , Humanos , Reprodutibilidade dos Testes
15.
J Abnorm Psychol ; 128(6): 563-573, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31368735

RESUMO

Considerable effort and funding have been spent on developing Attention Bias Modification (ABM) as a treatment for anxiety disorders, theorized to exert therapeutic effects through reduction of a tendency to orient attention toward threat. However, meta-analytical evidence that clinical anxiety is characterized by threat-related attention bias is thin. The largest meta-analysis to date included dot-probe data for n = 337 clinically anxious individuals. Baseline measures of biased attention obtained in ABM RCTs form an additional body of data that has not previously been meta-analyzed. This article presents a meta-analysis of threat-related dot-probe bias measured at baseline for 1,005 clinically anxious individuals enrolled in 13 ABM RCTs. Random-effects meta-analysis indicated no evidence that the mean bias index (BI) differed from zero (k = 13, n = 1005, mean BI = 1.8 ms, SE = 1.26 ms, p = .144, 95% confidence interval [-0.6, 4.3]. Additional Bayes factor analyses also supported the point-zero hypothesis (BF10 = .23), whereas interval-based analysis indicated that mean bias in clinical anxiety is unlikely to extend beyond the 0 to 5 ms interval. Findings are discussed with respect to strengths (relatively large samples, possible bypassing of publication bias), limitations (lack of control comparison, repurposing data, specificity to dot-probe data), and theoretical and practical context. We suggest that it should no longer be assumed that clinically anxious individuals are characterized by selective attention toward threat. Clinically anxious individuals enrolled in RCTs for Attention Bias Modification are not characterized by threat-related attention bias at baseline. (PsycINFO Database Record (c) 2019 APA, all rights reserved).


Assuntos
Transtornos de Ansiedade/fisiopatologia , Transtornos de Ansiedade/terapia , Viés de Atenção/fisiologia , Terapia Cognitivo-Comportamental , Ensaios Clínicos Controlados Aleatórios como Assunto , Transtornos de Estresse Pós-Traumáticos/fisiopatologia , Transtornos de Estresse Pós-Traumáticos/terapia , Terapia Cognitivo-Comportamental/estatística & dados numéricos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos
16.
Br J Anaesth ; 123(2): e434-e441, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31331592

RESUMO

BACKGROUND: Several randomised controlled trials show that maintenance of labour epidural analgesia with programmed intermittent epidural bolus reduces the maternal motor block compared with maintenance with a continuous infusion. However, these trials were usually restricted to healthy nulliparous parturients. To assess the generalisability of these randomised controlled trials to 'real-world' conditions, we compared maternal motor function (modified Bromage score) over time between healthy nulliparous and parous women using routinely collected quality-control data. METHODS: After ethical approval, all parturients receiving programmed intermittent epidural bolus labour analgesia between June 2013 and October 2014 were included in this prospective cohort study. Bupivacaine 0.1% with fentanyl 2 µg ml-1 was used allowing for patient-controlled bolus every 20 min. The maternal motor function (primary outcome) was regularly assessed from insertion of the epidural catheter until delivery. RESULTS: Of the 839 parturients included, 553 (66%) were nulliparous and 286 (34%) were parous. The parous women had a shorter median duration of epidural analgesia (3 h 59 min vs 5 h 45 min) and a higher incidence of spontaneous delivery (66% vs 37%). The probability of being in a certain Bromage category at birth was similar in nulliparous and parous women in a general additive model adjusting for duration of epidural analgesia, number of rescue top-ups, and number of catheter manipulations (cumulative odds ratio: 1.18; 95% confidence interval: 0.98-1.41). Parous women required a higher time-weighted number and volume of rescue top-ups. CONCLUSIONS: The results of the randomised controlled trials on a reduced motor block with programmed intermittent epidural bolus seem generalisable to parturients typically not included in these trials.


Assuntos
Analgesia Epidural/métodos , Analgesia Obstétrica/métodos , Analgesia Controlada pelo Paciente/métodos , Trabalho de Parto , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Adolescente , Adulto , Anestésicos Locais/administração & dosagem , Bupivacaína/administração & dosagem , Estudos de Coortes , Feminino , Fentanila/administração & dosagem , Humanos , Pessoa de Meia-Idade , Gravidez , Estudos Prospectivos , Adulto Jovem
17.
Crit Rev Oncol Hematol ; 141: 163-173, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31306986

RESUMO

INTRODUCTION: PARP inhibitors are a new class of drugs that are currently being studied in several malignancies. Olaparib is FDA-approved for advanced breast cancer and advanced ovarian cancer patients. Fatigue and anemia are among the most common cancer and treatment-related symptoms. Therefore, we conducted a meta-analysis of randomized controlled trials (RCT) to characterize the incidence and relative risks (RRs) of fatigue and anemia associated with olaparib. METHODS: PubMed, Cohrane, Embase and abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO) were searched for articles published from 2000 to June 2018. The eligible studies were phase II and III RCT of olaparib. Safety profile from each selected study was evaluated for all-grade and high-grade fatigue and anemia adverse events. Summary incidences and the RR, with 95% confidence intervals, of all-grade and high-grade events were calculated using random-effects or fixed-effects model based on the heterogeneity of selected studies. RESULTS: A total of 9 trials were selected, and included 2074 patients with advanced ovarian, gastric, prostate, lung or breast cancer. 908 patients received placebo/control treatments and 1166 received olaparib alone or combination with other active cancer treatments. The RR of all-grade and high fatigue was 1.24 (95% CI, 1.10-1.39) and 1.71 (95% CI, 1.06-2.77), respectively. The RR of all-grade and high-grade anemia was 2.10 (95% CI, 1.48-2.98) and 3.15 (95% CI, 1.73-5.71), respectively. CONCLUSION: Our findings suggest that the olaparib treatment is associated with an increased risk of fatigue and anemia. Since fatigue and anemia are very common treatment related adverse events, and both can impair the quality of life of patients, it is important to identify them early and manage it accordingly in order to optimize the overall treatment.


Assuntos
Anemia/etiologia , Fadiga/etiologia , Neoplasias/tratamento farmacológico , Ftalazinas/uso terapêutico , Piperazinas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia/induzido quimicamente , Anemia/epidemiologia , Progressão da Doença , Fadiga/induzido quimicamente , Fadiga/epidemiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Neoplasias/patologia , Qualidade de Vida , Risco , Fatores de Risco , Adulto Jovem
18.
Medicina (Kaunas) ; 55(7)2019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-31311075

RESUMO

Background and objectives: Informed decision-making requires the ability to identify and integrate high-quality scientific evidence in daily practice. We aimed to assess whether randomized controlled trials (RCTs) on endometriosis therapy follow methodological criteria corresponding to the RCTs' specific level in the hierarchy of evidence in such details to allow the reproduction and replication of the study. Materials and Methods: Using the keywords "therapy" and "endometriosis" and "efficacy" three bibliographic databases were searched for English written scientific articles published from 1 January 2008 to 3 March 2018. Only the randomized clinical trials (RCTs) were evaluated in terms of whether they provided the appropriate level of scientific evidence, equivalent to level 1, degree 1b in the hierarchy of evidence. A list of criteria to ensure study replication and reproduction, considering CONSORT guideline and MECIR standards, was developed and used to evaluate RCTs' methodological soundness, and scores were granted. Three types of bias, namely selection bias (random sequence generation and allocation concealment), detection bias (blinding of outcome assessment), and attrition bias (incomplete outcome data) were also evaluated. Results: We found 387 articles on endometriosis therapy, of which 38 were RCTs: 30 double-blinded RCTs and 8 open-label RCTs. No article achieved the maximum score according to the evaluated methodological criteria. Even though 73.3% of the double-blinded RCTs had clear title, abstract, introduction, and objectives, only 13.3% provided precise information regarding experimental design and randomization, and also showed a low risk of bias. The blinding method was poorly reported in 43.3% of the double-blinded RCTs, while allocation concealment and random sequence generation were inadequate in 33.3% of them. Conclusions: None of the evaluated RCTs met all the methodological criteria, none had only a low risk of bias and provided sufficient details on methods and randomization to allow for the reproduction and replication of the study. Consequently, the appropriate level of scientific evidence (level 1, degree 1b) could not be granted. On endometriosis therapy, this study evaluated the quality of reporting in RCTs and not the quality of how the studies were performed.


Assuntos
Endometriose/terapia , Prática Clínica Baseada em Evidências/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Adolescente , Adulto , Análise de Variância , Endometriose/complicações , Prática Clínica Baseada em Evidências/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Resultado do Tratamento
19.
Crit Care ; 23(1): 241, 2019 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-31269976

RESUMO

BACKGROUND: Epidemiologic data have shown an increasing incidence and declining mortality rate in sepsis. However, confounding effects due to differences in disease classification might have contributed to these trends. To assess if a declining mortality over time could be supported by data derived from high-quality prospective studies, we performed a meta-analysis using data from randomised controlled trials (RCTs) on sepsis. The primary aim was to assess whether the mortality in sepsis trials has changed over time. The secondary aim was to investigate how many of the included trials could show efficacy of the studied intervention regarding 28-day mortality. METHODS: We searched PubMed for RCTs enrolling patients with severe sepsis and septic shock, published between 2002 and 2016. The included trials were assessed for quality and sorted by date of first inclusion. A meta-analysis was performed to synthesise data from the individual sepsis trials. RESULTS: Of 418 eligible articles, 44 RCTs on sepsis were included in the analysis, enrolling 13,315 patients in the usual care arm between 1991 and 2013. In this time period, mortality decreased by 0.42% annually (p = 0.04) to give a total decline of 9.24%. In subgroup analyses with adjustments for APACHE II, SAPS II and SOFA scores, the observed time trend was not significant (p = 0.45, 0.23 and 0.98 respectively). Only four of the included trials showed any efficacy with regard to mortality. CONCLUSIONS: Data from RCTs show a declining trend in 28-day mortality in severe sepsis and septic shock patients during the years from 1991 to 2013. However, when controlling for severity at study inclusion, there was no significant change in mortality over time. The number of trials presenting new treatment options was low. TRIAL REGISTRATION: PROSPERO CRD42018091100 . Registered 27 August 2018.


Assuntos
Mortalidade/tendências , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Sepse/mortalidade , Fatores de Tempo , Saúde Global/tendências , Humanos , Sepse/epidemiologia
20.
BMC Infect Dis ; 19(1): 484, 2019 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-31146698

RESUMO

BACKGROUND: Network meta-analyses (NMAs) provide comparative treatment effects estimates in the absence of head-to-head randomized controlled trials (RCTs). This NMA compared the efficacy and safety of dolutegravir (DTG) with other recommended or commonly used core antiretroviral agents. METHODS: A systematic review identified phase 3/4 RCTs in treatment-naïve patients with HIV-1 receiving core agents: ritonavir-boosted protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), or integrase strand inhibitors (INSTIs). Efficacy (virologic suppression [VS], CD4+ cell count change from baseline) and safety (adverse events [AEs], discontinuations, discontinuation due to AEs, lipid changes) were analyzed at Week 48 using Bayesian NMA methodology, which allowed calculation of probabilistic results. Subgroup analyses were conducted for VS (baseline viral load [VL] ≤/> 100,000copies/mL, ≤/> 500,000copies/mL; baseline CD4+ ≤/>200cells/µL). Results were adjusted for the nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) combined with the core agent (except subgroup analyses). RESULTS: The NMA included 36 studies; 2 additional studies were included in subgroup analyses only. Odds of achieving VS with DTG were statistically superior to PIs (odds ratios [ORs] 1.78-2.59) and NNRTIs (ORs 1.51-1.86), and similar but numerically higher than other INSTIs. CD4+ count increase was significantly greater with DTG than PIs (difference: 23.63-31.47 cells/µL) and efavirenz (difference: 34.54 cells/µL), and similar to other core agents. INSTIs were more likely to result in patients achieving VS versus PIs (probability: 76-100%) and NNRTIs (probability: 50-100%), and a greater CD4+ count increase versus PIs (probability: 72-100%) and NNRTIs (probability: 60-100%). DTG was more likely to result in patients achieving VS (probability: 94-100%), and a greater CD4+ count increase (probability: 53-100%) versus other core agents, including INSTIs (probability: 94-97% and 53-93%, respectively). Safety outcomes with DTG were generally similar to other core agents. In patients with baseline VL > 100,000copies/mL or ≤ 200 CD4+cells/µL (18 studies), odds of achieving VS with DTG were superior or similar to other core agents. CONCLUSION: INSTI core agents had superior efficacy and similar safety to PIs and NNRTIs at Week 48 in treatment-naïve patients with HIV-1, with DTG being among the most efficacious, including in patients with baseline VL > 100,000copies/mL or ≤ 200 CD4+cells/µL, who can be difficult to treat.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , HIV-1/efeitos dos fármacos , Compostos Heterocíclicos com 3 Anéis/uso terapêutico , Adolescente , Adulto , Fármacos Anti-HIV/efeitos adversos , Fármacos Anti-HIV/classificação , Teorema de Bayes , Benzoxazinas/uso terapêutico , Contagem de Linfócito CD4 , Ensaios Clínicos Fase III como Assunto/estatística & dados numéricos , Ensaios Clínicos Fase IV como Assunto/estatística & dados numéricos , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/virologia , Compostos Heterocíclicos com 3 Anéis/efeitos adversos , Humanos , Masculino , Meta-Análise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Inibidores da Transcriptase Reversa/uso terapêutico , Ritonavir/uso terapêutico , Resultado do Tratamento , Carga Viral/efeitos dos fármacos , Adulto Jovem
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