2 resultados para Controlled clinical-trial

em Repositório Institucional da Universidade Federal de São Paulo - UNIFESP


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Objetivo: O objetivo deste estudo foi comparar o efeito do tratamento hormonal do hormônio Gonadotrofina Coriônica Humana (HCG), em dois esquemas posológicos diferentes, ao placebo quanto sua efetividade e segurança no tratamento da Criptorquidia. Métodos: Este estudo é um ensaio clínico randomizado, duplo-cego, placebo-controlado de 14 semanas. A amostra de 92 pacientes que foram randomizados para o grupo-HCG dias alternados, denominados de Grupo G1 (N = 29), para o grupo HCG a cada quatro dias, denominados Grupo G4 (N= 33) e o grupo-placebo, denominados como Grupo O(N = 30). 2. Os desfechos clínicos primários para este estudo foram 1) Cura, 2) Melhora, 3) Não Cura. Os desfechos complementares foram: 4) Efeitos adversos, 5) Níveis séricos hormonais. Resultados: Não existiram diferenças entre os grupos HCG dias alternados, HCG a cada quatro dias e placebo para as medidas dos desfechos primários. 1) Cura: G1: 3/29(3,3%), G4: 4/33(4,3%) e O: 3/30(3,3%) 2) Melhora: G1:3/29(3,3%), G4: 1/33(1,1%) e O: 3/30(3,3%). 3) Não Cura: G1: 23/29(25%), G4: 28/33(30,4%) e O: 24/30(26,1%) p=0,815. 4) Os efeitos adversos mais freqüentes em nossa amostra foram: Aumento do numero de ereções: não foi possível avaliar. 5) Níveis séricos hormonais: Testosterona sérica: G1: de 34,15 ± 5,8ng/ml; G4: 49,6± 5,6 ng/ml e O: 7,5± 3,5ng/ml. Hormônio Luteinizante (LH): G1: 0,22± 0,2 , G4: 0,07±0,1 e O: 0,08±0,02 Hormônio Folículo Estimulante (FSH): G1: 0,88±0,16, G4: 0,3±0,1 e O 1,15±0,6. Conclusão: Não foi encontrada nenhuma diferença estatística no tratamento com HCG, independente da posologia adotada, e placebo. Os autores concluem a hormonioterapia com HCG não demonstrou superioridade na eficácia e ou segurança no tratamento da criptorquidia ao placebo.

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BackgroundAsthma is a common condition characterised by airway inflammation and airway narrowing, which can result in intermittent symptoms of wheezing, coughing and chest tightness, possibly limiting activities of daily life. Water-based exercise is believed to offer benefits for people with asthma through pollen-free air, humidity and effects of exercise on physical function.ObjectivesTo evaluate the effectiveness and safety of water-based exercise for adults with asthma.Search methodsWe searched the Cochrane Airways Group Specialised Register of Trials (CAGR), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), PsycINFO, the Latin American and Caribbean Health Science Information Database (LILACS), the Physiotherapy Evidence Database (PEDro), the System for Information on Grey Literature in Europe (SIGLE) and Google Scholar on 13 May 2014. We handsearched ongoing clinical trial registers and meeting abstracts of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the British Thoracic Society (BTS).Selection criteriaWe included all randomised controlled trials (RCTs) of adults with asthma comparing a water-based exercise group versus one or more of the following groups: usual care, land-based exercise, non-exercise.Data collection and analysisTwo review authors (AJG, VS) independently extracted data fromthe primary studies using a standard form developed for this purpose, which includes methods, participants, interventions and outcomes. We contacted trial authors to request additional data. Data were input by one review author and were double-checked by a second review author.Main resultsIn this systematic review, we provide a narrative synthesis of available evidence from three small studies including 136 adult participants. the studies were at high risk of bias. No meta-analysis was possible because of methodological and interventional heterogeneity between included studies. the primary outcomes of quality of life and exacerbations leading to use of steroids were not reported by these studies. for exacerbations leading to health centre/hospital visits, uncertainty was wide because a very small number of events was reported (in a single study). Secondary outcomes symptoms, lung function, changes in medication and adverse effects, where available, described for each included study. the overall quality of the studies was very low, and no clear differences were noted between water-based exercise and comparator treatments. Therefore, we remain very uncertain about the effects of water-based exercise for adults with asthma.Authors' conclusionsThe small number of participants in the three included studies, the clinical and methodological heterogeneity observed and the high risk of bias assessed mean that we are unable to assess the place of water-based exercise in asthma. Randomised controlled trials are needed to assess the efficacy and safety of water-based exercise for adults with asthma. for future research, we suggest greater methodological rigour (participant selection, blinding of outcome assessors, reporting of all outcomes analysed and registering of the study protocol).