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Br J Anaesth ; 125(5): 779-801, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32798067


BACKGROUND: Despite common use, the benefit of adding steroids to local anaesthetics (SLA) for chronic non-cancer pain (CNCP) injections is uncertain. We performed a systematic review and meta-analysis of English-language RCTs to assess the benefit and safety of adding steroids to local anaesthetics (LA) for CNCP. METHODS: We searched MEDLINE, EMBASE, and CENTRAL databases from inception to May 2019. Trial selection and data extraction were performed in duplicate. Outcomes were guided by the Initiative in Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) statement with pain improvement as the primary outcome and pooled using random effects model and reported as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CIs). RESULTS: Among 5097 abstracts, 73 trials were eligible. Although SLA increased the rate of success (42 trials, 3592 patients; RR=1.14; 95% CI, 1.03-1.25; number needed to treat [NNT], 13), the effect size decreased by nearly 50% (NNT, 22) with the removal of two intrathecal injection studies. The differences in pain scores with SLA were not clinically meaningful (54 trials, 4416 patients, MD=0.44 units; 95% CI, 0.24-0.65). No differences were observed in other outcomes or adverse events. No subgroup effects were detected based on clinical categories. Meta-regression showed no significant association with steroid dose or length of follow-up and pain relief. CONCLUSIONS: Addition of cortico steroids to local anaesthetic has only small benefits and a potential for harm. Injection of local anaesthetic alone could be therapeutic, beyond being diagnostic. A shared decision based on patient preferences should be considered. If used, one must avoid high doses and series of steroid injections. CLINICAL TRIAL REGISTRATION: PROSPERO #: CRD42015020614.

Corticosteroides/uso terapêutico , Anestésicos Locais/uso terapêutico , Dor Crônica/tratamento farmacológico , Manejo da Dor/métodos , Corticosteroides/efeitos adversos , Anestésicos Locais/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
Nutr Rev ; 77(6): 430-450, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-30924853


CONTEXT: Recent evidence suggests that modulation of the gut microbiota may contribute to body weight control. OBJECTIVE: This systematic review aimed to assess the effects of oral supplementation with probiotics or synbiotics on body weight, body mass index (BMI), and waist circumference in overweight and obese adults (BMI ≥ 25 kg/m2). DATA SOURCES: Five electronic databases-PubMed, Embase, Cochrane Library/CENTRAL, LILACS, and Web of Science-were searched from inception to August 2017. No language restrictions were applied. STUDY SELECTION: Randomized and quasi-randomized parallel trials that assessed the effects of oral supplementation with probiotics or synbiotics vs any other intervention but bariatric surgery or fecal transplantation in overweight or obese adults were selected. DATA EXTRACTION: Three teams of 2 authors independently assessed risk of bias and extracted data from the included trials. Data were pooled using inverse-variance random-effects meta-analyses. The quality of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. RESULTS: Nineteen randomized trials (28 publications, 1412 participants) were included. There were no differences in mean body weight change [mean difference (MD), -0.54 kg; 95%CI, -1.09 to 0.01; I2 = 0%; moderate quality of evidence) or mean BMI change (MD, -0.19 kg/m2; 95%CI, -0.43 to 0.04; I2 = 51%; low quality of evidence) between groups who received probiotics or synbiotics and control groups. Oral supplementation with probiotics or synbiotics reduced mean waist circumference compared with control (MD, -0.82 cm; 95%CI, -1.43 to -0.21; I2 = 46%; low quality of evidence). CONCLUSIONS: The findings suggest that oral supplementation with probiotics or synbiotics has a small effect to reduce waist circumference but no effect on body weight or BMI, although the quality of evidence is low to moderate. Therefore, the current evidence is not definitive. Large-scale trials are needed and may help to better inform clinical practice. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42018075126.

Obesidade/tratamento farmacológico , Sobrepeso/tratamento farmacológico , Probióticos/administração & dosagem , Simbióticos/administração & dosagem , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Peso Corporal , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Probióticos/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Circunferência da Cintura , Adulto Jovem
BMJ Open ; 7(2): e012680, 2017 02 23.
Artigo em Inglês | MEDLINE | ID: mdl-28235965


OBJECTIVE: A systematic review and meta-analysis to investigate the impact of electronic nicotine delivery systems (ENDS) and/or electronic non-nicotine delivery systems (ENNDS) versus no smoking cessation aid, or alternative smoking cessation aids, in cigarette smokers on long-term tobacco use. DATA SOURCES: Searches of MEDLINE, EMBASE, PsycInfo, CINAHL, CENTRAL and Web of Science up to December 2015. STUDY SELECTION: Randomised controlled trials (RCTs) and prospective cohort studies. DATA EXTRACTION: Three pairs of reviewers independently screened potentially eligible articles, extracted data from included studies on populations, interventions and outcomes and assessed their risk of bias. We used the Grading of Recommendations Assessment, Development and Evaluation approach to rate overall certainty of the evidence by outcome. DATA SYNTHESIS: Three randomised trials including 1007 participants and nine cohorts including 13 115 participants proved eligible. Results provided by only two RCTs suggest a possible increase in tobacco smoking cessation with ENDS in comparison with ENNDS (RR 2.03, 95% CI 0.94 to 4.38; p=0.07; I2=0%, risk difference (RD) 64/1000 over 6 to 12 months, low-certainty evidence). Results from cohort studies suggested a possible reduction in quit rates with use of ENDS compared with no use of ENDS (OR 0.74, 95% CI 0.55 to 1.00; p=0.051; I2=56%, very low certainty). CONCLUSIONS: There is very limited evidence regarding the impact of ENDS or ENNDS on tobacco smoking cessation, reduction or adverse effects: data from RCTs are of low certainty and observational studies of very low certainty. The limitations of the cohort studies led us to a rating of very low-certainty evidence from which no credible inferences can be drawn. Lack of usefulness with regard to address the question of e-cigarettes' efficacy on smoking reduction and cessation was largely due to poor reporting. This review underlines the need to conduct well-designed trials measuring biochemically validated outcomes and adverse effects.

Sistemas Eletrônicos de Liberação de Nicotina , Abandono do Hábito de Fumar/métodos , Fumar Tabaco/terapia , Terapia Comportamental , Humanos , Agonistas Nicotínicos/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Dispositivos para o Abandono do Uso de Tabaco
J Clin Epidemiol ; 84: 61-69, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28063913


OBJECTIVES: To provide a perspective on the current practice of randomized clinical trials (RCTs) of diagnostic strategies focusing on patient-important outcomes. STUDY DESIGN AND SETTING: We conducted a comprehensive search of MEDLINE and included RCTs published in full-text reports that evaluated alternative diagnostic strategies. RESULTS: Of 56,912 unique citations, we sampled 7,500 and included 103 eligible RCTs, therefore suggesting that MEDLINE includes approximately 781 diagnostic RCTs. The 103 eligible trials reported on: mortality (n = 41; 39.8%); morbidities (n = 63; 61.2%); symptoms/quality of life/functional status (n = 14; 13.6%); and on composite end points (n = 10; 9.7%). Of the studies that reported statistically significant results (n = 12; 11.6%), we judged 7 (58.3%) as at low risk of bias with respect to missing outcome data and 4 (33.3%) as at low risk of bias regarding blinding. Of the 41 RCTs that reported on mortality, only one (2.4%) reported statistically significant results. Of 63 RCTs addressing morbidity outcomes, 11 (17.5%) reported statistically significant results, all of which reported relative effects of greater than 20%. CONCLUSION: RCTs of diagnostic tests are not uncommon, and sometimes suggest benefits on patient-important outcomes but often suffer from limitations in sample size and conduct.

Testes Diagnósticos de Rotina/estatística & dados numéricos , Avaliação de Resultados da Assistência ao Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Humanos , MEDLINE
J Clin Epidemiol ; 62(4): 387-92, 2009 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-19010643


OBJECTIVE: To evaluate the quality of reporting of abstracts describing randomized controlled trials (RCTs) published in four major general medical journals. STUDY DESIGN AND SETTING: Systematic survey of published RCT abstracts, with two reviewers independently extracting data. We searched MEDLINE and identified 227 RCT abstracts published in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), British Medical Journal (BMJ), and The Lancet in the year 2006. RESULTS: Most abstracts identified the study as a randomized trial (98.7%), reported the objectives (92.5%), described the population (90.3%), detailed the intervention (81.5%), and defined the primary outcome (71.3%). Methodological quality was poorly reported: one (0.4%) described allocation concealment; 21 (9.3%) clearly specified blinding; 51 (22.5%) described intention-to-treat analysis; and 32 (14.1%) outlined losses to follow-up. Most of the abstracts reported the effect size and the confidence intervals (62.3%), but just half of them reported side effects or harms. CONCLUSION: The quality of reporting of RCT abstracts published in main general medical journals is suboptimal. Space limitations notwithstanding, with the recent recommendations from the CONSORT for Abstracts, it is expected that the transparency of abstract reporting can and should improve.

Indexação e Redação de Resumos/normas , Publicações Periódicas como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Controle de Qualidade