Navegando por Palavras-chave "Randomized controlled trial"

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    Aripiprazole in the treatment of posttraumatic stress disorder: an open-label trial
    (Associação Brasileira de Psiquiatria - ABP, 2008-12-01) Mello, Marcelo Feijó de [UNIFESP]; Costa, Mariana Cadrobbi Pupo [UNIFESP]; Schoedl, Aline Ferri [UNIFESP]; Fiks, Jose Paulo [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    OBJECTIVE: Post traumatic stress disorder is frequent in the general population (7.8%-lifetime-USA). The selective serotonin reuptake inhibitors are the first choice of treatment but result in low remission rates. This study aims to evaluate the effect of aripiprazole monotherapy for the treatment of post traumatic stress disorder. METHOD: Thirty-two patients diagnosed with post traumatic stress disorder were included in a 16-week open label trial of aripiprazole. They were evaluated at baseline, week 8, and 16 with the Clinician-Administered PTSD Scale, Beck Depression Inventory, Beck Anxiety Inventory, Medical Outcome Study Short Form 36, and Social Adjustment Scale. Statistical analysis were performed with an intention-to-treat approach and last observation carried forward. A general linear model for repeated measures comparing the factor with 3 continuous measures from baseline, 8 and 16 weeks was used. A between-subject factor was included RESULTS: Nine patients discontinued the treatment. The mean aripiprazole dose was 9.6 (± 4.3) mg/day. The mean scores at baseline and endpoint for all measures were: Clinician-Administered PTSD Scale - 82.7 (± 23.1) and 51.4 (± 31.4) (F = 11.247, p = 0.001); Beck Anxiety Inventory - 31.7 (± 13.4) and 25.4 (± 18.2) (F = 8.931, p = 0.011); Social Adjustment Scale - 2.4 (± 0.45) and 2.27 (± 0.57) (F = 8.633, p = 0.012); Medical Outcome Study Short Form 36 - 76.6 (± 14.11) and 94.01 (± 25.06) (F = 10.127 p = 0.007); and Beck Depression Inventory - 26.06 (± 11.6) and 21.35 (± 12.6) (F = 1.580, p = 0.042). In all measurements, the differences were statistically significant. CONCLUSIONS: Patients achieved a good response to treatment with aripiprazole, but placebo-controlled studies are needed for more accurate results.
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    Avaliação dos efeitos do isostretching em pacientes com lombalgia mecânico-postural crônica
    (Universidade Federal de São Paulo (UNIFESP), 2011-02-22) Prado, Érika Rosângela Alves [UNIFESP]; Natour, Jamil [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Introduction: Physical exercise programs for treatment of patients with mechanical back pain are widely reported in the literature. However, there are no consistent results that identify whether the technique isostretching is effective for this clinical condition. Objective: Assess the effects of isostretching on patients with mechanical back pain. Patients and Methods: A randomized, controlled, clinical trial with intention-to-treat analysis was carried out following approval from the local ethics committee. Fifty-four male and female patients with mechanical back pain were submitted to evaluations at baseline (T0) and after 20 (T20) and 45 (T45) days of treatment with regard to pain (assessed using a visual analog scale), quality of life (SF-36), functional disability (Roland-Morris) and satisfaction (Likert scale). All participants were instructed to use diclofenac sodium (50 mg) as needed every eight hours for pain. The experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for. The experimental group performed 12 sessions of treatment with isostretching twice a week for 45 minutes and the control group remained on the waiting list for physical therapy. Results: The sample of 54 individuals was homogeneous made up of 19 women and eight men in the experimental group (mean age: 35.2) and 17 women and 10 men in the control group (mean age: 33.0). The experimental group exhibited statistically significant improvements in comparison to the control with regard pain (p < 0.003), functional capacity as determined by Roland-Morris score 0.001), quality of life limitation on physical aspects 0.001) and subscales SF-36 satisfaction 0.001). Conclusion: Isostretching proved effective for the treatment of patients with mechanical back pain, proving capable of reducing pain, improving both functional capacity and quality of life and diminishing the need for anti- inflammatory.
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    Efeito do tratamento da apneia obstrutiva do sono de grau leve, sobre a qualidade ee vida, humor e atenção sustentada: estudo randomizado, paralelo, simples cego e controlado
    (Universidade Federal de São Paulo (UNIFESP), 2017-05-31) Luz, Gabriela Costa Pontes [UNIFESP]; Bittencourt, Lia Rita Azeredo [UNIFESP]; Nery, Luiz Eduardo [UNIFESP]; http://lattes.cnpq.br/2605106957934146; http://lattes.cnpq.br/6882391059348792; http://lattes.cnpq.br/6552172920168051; Universidade Federal de São Paulo (UNIFESP)
    Introduction: The effect of Continuous Positive Airway Pressure (CPAP) or Oral Appliance (OA) treatment on obstructive sleep apnea (OSA) in the domains of quality of life, mood and cognition is still controversial and especially in mild OSA. Objective: To evaluate and compare the effect of treatment with CPAP and OA in patients with mild OSA in improving quality of life, mood and sustained attention. Methods: Patients of both genders were included; body mass index (BMI) ≤ 35 kg /m2; age between 18 and 65 years; diagnosis of mild OSA - apnea and hypopnea index (AHI) ≥ 5 events per hour of sleep and ≤ 15 events per hour of sleep independent of the presence of excessive daytime sleepiness (EDS), but with at least one sign and/or symptom and with a minimum mandibular protrusion of 7mm. Patients were randomly assigned to 3 groups: group 1 - CPAP, group 2 - OA and group 3 - control without treatment. The patients were submitted to two evaluations: baseline and after 6 months of treatment. The subjects performed the following procedures in these evaluations: Pittsburgh Sleep Quality Index (PSQI), physical examination, otorhinolaryngological examination, baseline polysomnography (PSG) (and using CPAP in group 1), Epworth Sleepiness Scale (ESS), Beck Anxiety and Depression Inventories (BAI and BDI), Functional Outcomes of Sleep Questionnaire (FOSQ) and 5 measures of Psychomotor Vigilance Task (PVT). For statistical analysis, we used a descriptive analysis (means ± standard deviation) and for assessment of the groups at different times we used General Linear Model (GLM). Results: 48 patients participated in the study, 15 in group 1, 15 in group 2 and 18 in group 3. Regarding the PSG, we observed better results in several variables, after six months of treatment in group 1, compared to groups 2 and 3. No differences between groups were observed in ESS, PSQI, BAI and BDI. Regarding FOSQ, we observed that group 1 presented improvement in the followings domains: general productivity; social outcomes and overall mean, when compared to the other groups. Regarding PVT, we observed no difference between the groups. Adherence to OA was higher when compared to CPAP. Conclusion: CPAP was the best intervention for normalization of polysomnographic parameters and improvement of quality of life. There was no difference in mood and sustained attention between treatments. The OA showed greater adherence than CPAP during the six months of treatment.
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    Efeitos de um treinamento de mindfulness e relaxamento para insônia (TMRI) em mulheres na pós menopausa : um ensaio clínico randomizado
    (Universidade Federal de São Paulo (UNIFESP), 2017-08-31) Garcia, Marcelo Csermak [UNIFESP]; Campos, Helena Hachul de [UNIFESP]; Kozasa, Elisa Harumi ; Mello, Luiz Eugenio Araujo de Moraes [UNIFESP]; Elisa Harumi Kozasa : http://lattes.cnpq.br/9887789366520035; Luiz Eugenio Araujo de Moraes Mello : http://lattes.cnpq.br/4462750801249231; http://lattes.cnpq.br/0292346083994904; http://lattes.cnpq.br/6012839930467648; Universidade Federal de São Paulo (UNIFESP)
    É na menopausa que há o cessamento da produção hormonal ovariana, que pode ser de forma natural ou cirúrgica, acarretando uma importante diminuição de estrogênio e progesterona no organismo. O hipoestrogenismo decorrente da pós-menopausa acarreta diversos efeitos no organismo, sendo a insônia e os sintomas vasomotores muito prevalentes nesta fase, onde há razoável prejuízo e diminuição na qualidade de vida desta mulher. A insônia é uma das queixas mais comuns e prevalentes na transição menopáusica e pós menopáusica e causa repercussões como dores de cabeça, dificuldade de atenção e memória, irritabilidade, entre outros sintomas com algum prejuízo na vida e no comportamento desde indivíduo. Assim, em razão das repercussões importantes deste distúrbio, o presente trabalho, baseado nestas premissas, avaliou o impacto de técnicas do uso de meditação denomidas de mindfulness na insônia, sintomas vasomotores, atentividade e qualidade geral de vida destas mulheres. Este estudo avaliou a intervenção desta técnica nesta população por um período de 8 semanas de treinamento seguido, com instruções presenciais semanais e a continuidade da prática em 3 x ao dia. Foram avaliadas 30 mulheres, sendo 19 que praticaram a técnica e 11 foram um grupo de espera participando de encontros informais semanais realizando palavras cruzadas nível fácil em casa, sendo que este grupo após as 8 semanas também recebeu instruções com a prática da mesma forma que o grupo intervenção. As voluntárias foram avaliadas por questionários de sono, sintomas menopausais, atenção e qualidade de vida geral na menopausa e também passaram por 2 exames de polissonografia ambulatorial antes e depois da interveção em ambos os grupos. Foram encontradas diferenças significantes para o grupo que recebeu treinamento em mindfulness em relação ao grupo controle, indicando a melhora na qualidade do sono e na severidade da insônia, na qualidade de vida, nos níveis atencionais e diminuição dos sintomas menopausais e vasomotores. Não encontramos diferenças entre os grupos e entre as noites pela avaliação da polissonografia. O treinamento de 8 semanas em meditação mindfulness melhorou a qualidade de sono, a qualidade de vida geral, o nível de atenção e diminuiu os sintomas vasomotores neste grupo. Este estudo mostra a eficácia da aplicação da técnica de meditação mindfulness para esta população insone menopsausada. Nossos achados sugerem que esta prática pode ser aplicada de forma complementar aos tratamentos já existentes para insônia e fogachos e sintomas menopausais, contribuindo para a aquisição de qualidade de vida para esta população.
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    Effectiveness of sensorimotor training in patients with rheumatoid arthritis: a randomized controlled trial
    (Springer, 2013-09-01) Gomes da Silva, Kelson Nonato [UNIFESP]; Pedro de Paiva Teixeira, Lucas Emmanuel [UNIFESP]; Imoto, Aline Mizusaki [UNIFESP]; Atallah, Alvaro Nagib [UNIFESP]; Peccin, Maria Stella [UNIFESP]; Moca Trevisani, Virginia Fernandes [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Brazilian Cochrane Ctr; Santo Amaro Univ UNISA
    The objective of this study was to evaluate the effectiveness of a sensorimotor training in patients with rheumatoid arthritis on the improvement of functional skills and quality of life, a double-blinded, prospective, randomized controlled trial. One hundred two participants with rheumatoid arthritis were selected. After the baseline evaluation, the participants were randomized to two different groups: sensorimotor group (2 sessions per week, 30-50 min each session, besides continuing taking the same drugs as the control group) and control group (control group was only submitted to the clinical drug treatment with Methotrexate, Leflunomide and/or Prednisone (5 mg), being then evaluated 4 months later). Functional capacity [Health Assessment Questionnaire (HAQ) and Timed Up & Go Test (TU>)], Balance and Gait (Berg Balance Scale (BBS) and Tinetti Test) and Quality of Life (Short Form Health Survey-SF-36). the study had been concluded with ninety-one participants, and a statistically significant improvement was found in all variables assessed: HAQ (P < .01), TU> (P < .01), BBS (P < .01), Tinetti Test (P < .01) and improvement in the subscales of SF-36 (P < .01) in the sensorimotor group in comparison with the baseline evaluation and control group. No significant difference was found related to the pre- and post-evaluation in the control group. Therefore, the sensorimotor training is effective in the improvement of the functional capacity and quality of life of patients with rheumatoid arthritis.
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    Eficácia do topiramato no tratamento do transtorno de estresse postraumático
    (Universidade Federal de São Paulo (UNIFESP), 2010-10-27) Yeh, Mary Sau Ling [UNIFESP]; Mello, Marcelo Feijó de [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    The aim of this study was to evaluate the efficacy and tolerability of topiramate in patients with posttraumatic stress disorder (PTSD). We conducted a 12-week double-blind, randomized, placebo-controlled study comparing topiramate to placebo. Men and women aged 18 to 62 years with diagnosis of PTSD according to DSM-IV were recruited from the outpatient clinic of the violence program of Federal University of São Paulo Hospital (Prove- UNIFESP), São Paulo City, between April 2006 and December 2009. Subjects were assessed for the Clinician-Administered Posttraumatic Stress Scale (CAPS), Clinical Global Impression (CGI), and Beck Depression Inventory (BDI). After 1-week period of washout, 35 patients were randomized to either group. The primary outcome measure was the CAPS total score changes from baseline to the endpoint. In all 82.35% of patients in the topiramate group exhibited improvements in PTSD symptoms. The efficacy analysis demonstrated that patients in the topiramate group exhibited significant improvements in reexperiencing symptoms: flashbacks, intrusive memories, and nightmares of the trauma (CAPS-B; p = 0.04) and in avoidance/numbing symptoms associated with the trauma, social isolation, and emotional numbing (CAPS-C; p = 0.0001). Furthermore, the experimental group demonstrated a significant difference in decrease in CAPS total score (topiramate –57.78; placebo –32.41; p = 0.0076). Topiramate was generally well tolerated. Topiramate was effective in improving reexperiencing and avoidance/numbing symptom clusters in patients with PTSD. This study supports the use of anticonvulsants for the improvement of symptoms of PTSD.
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    Eficácia e tolerabilidade da homeopatia e da fluoxetina no tratamento da depressão
    (Universidade Federal de São Paulo (UNIFESP), 2009-07-29) Adler, Ubiratan Cardinalli [UNIFESP]; Calil, Helena Maria [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Background: Homeopathy is a Complementary and Integrative Medicine used in depression. Aims: this study investigated the non-inferiority and tolerability of individualized homeopathic medicines (Q-potencies) in acute depression, using fluoxetine as active control. Methods: Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg/day (up to 40 mg/day) in a prospective, randomized, double-blind double-dummy 8 week, single-center trial. Primary efficacy measure was the analysis of the mean change in the MADRS depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Results: Mean MADRS scores differences were not significant at the 4th (p=0.654) and 8th weeks (p=0.965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy – fluoxetine) were -3.04 (95% CI = -6.95; 0.86) and -2.4 (95% CI = -6.05; 0.77) at weeks 4th and 8th, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported adverse side effects and a there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. Conclusions: This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression.
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    Fatores preditivos de Aderência no tratamento de usuários de maconha
    (Universidade Federal de São Paulo (UNIFESP), 2011-11-24) Vilela, Fabiana Andrioni de Biaze [UNIFESP]; Laranjeira, Ronaldo [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    The present study involved secondary analysis of data from a Randomized Clinical Trial including 169 cannabis-dependents not only dependents assessed at baseline and submitted to brief treatment. Patients were first randomized into three treatment groups. OBJECTIVES: The objective was to identify characteristics which could be considered predictors of treatment dropout. RESULTS: Patients initially allocated into the control group presented a 3.47 greater chance of drop out than those of the treatment groups. Based on the socio-demographic data, it was concluded that for every year of patient age, the chances of drop out would be multiplied by 0.91, representing lower risk. For every year of cannabis use, chances of drop out would be multiplied by 0.92, again representing reduced risk. CONCLUSIONS: The importance of specific interventions for groups with a higher risk of treatment drop out was discussed, along with the relevance of other studies involving cannabis users and possible guidelines for professionals help patient to adhere.
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    Fotocoagulação de acordo com o protocolo ETDRS modificado versus laser diodo sublimiar em micropulsos para tratamento de edema macular diabético: Ensaio clínico-comparativo
    (Universidade Federal de São Paulo (UNIFESP), 2011-06-29) Lavinsky, Daniel [UNIFESP]; Belfort, Rubens Junior [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Purpose: To compare modified Early Treatment Diabetic Retinopathy Study (ETDRS) focal/grid laser photocoagulation with normal-density (ND-SDM) or high-density (HD-SDM) subthreshold diode-laser micropulse photocoagulation for the treatment diabetic macular edema (DME). Methods: We conducted a prospective, randomized, controlled, double-masked clinical trial with patients with previously untreated DME and best corrected visual acuity (BCVA) worse than 20/40 and better than 20/400. Patients were randomized to receive either modified ETDRS focal / grid photocoagulation (42 patients), ND-SDM (39 patients) or HD-SDM (42 patients). Before treatment and 3, 6 and 12 months after treatment, all patients underwent ophthalmic examinations, BCVA, color fundus photography, fluorescein angiography and optical coherence tomography (OCT). Results: At 12 months, the HD-SDM group had the best improvement in BCVA (0.25 logMAR), followed by the modified ETDRS group (0.08 logMAR), while no improvements were seen in the ND-SDM group (0.03 logMAR). All groups showed statistically significant progressive reduction of CMT throughout the study (p<0.001). The HD-SDM group exhibited the greatest CMT reduction (154 μm), which was not significantly different from that of the modified ETDRS group (126 μm; p=0.75). Conclusions: At 1 year, the clinical performance of HD-SDM was superior to that of the modified ETDRS photocoagulation technique based on the anatomic and functional measures of improvement used in this investigation. A rationale for this treatment modality as a preferable approach is suggested, and the precise role of sub-threshold micropulse laser treatment may become more defined as experience grows, guided by optimized treatment guidelines and more comprehensive trials.
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    Intervenção fisioterapêutica pré-operatória para pacientes submetidos à ressecção pulmonar por câncer: revisão sistemática
    (Pontifícia Universidade Católica do Paraná, 2013-09-01) Rosa, Bruno Rodrigues [UNIFESP]; Vital, Flávia Maria Ribeiro; Silva, Brenda Nazaré Gomes da [UNIFESP]; Lisboa, Sandra; Peccin, Maria Stella [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Universidade Iguaçu; Instituto Fernandes Figueira/Fundação Oswaldo Cruz
    INTRODUCTION: The physiotherapy has been advocated as an important component in the treatment and prevention of postoperative pulmonary complications, being used in both pre and postoperative periods of lung resection surgery. The objective of this study was to assess the efficacy and safety of preoperative physiotherapy for patients who will undergo resection surgery for lung cancer. MATERIALS AND METHODS: Systematic review of randomized clinical trials carried out in accordance with the Cochrane metodology. The electronic search was performed in Cochrane Library, PEDro, MEDLINE, EMBASE, CINAHL, LILACS. We also searched for both non-published and on-going studies in the Current Controlled Trials database. In addition, a manual search in the references of all relevant studies was performed, and the authors were contacted for additional non-published data. RESULTS: Twenty-eight papers were considered potentially relevant; among them, 26 were excluded. Two randomized controlled trials met the inclusion criteria. One study compared non invasive ventilation (BILEVEL) associated to standard treatment with standard treatment alone; and other study compared inspiratory muscle training and incentive spirometry with no training. There was just one common outcome between the studies, but was not possible to perform the meta-analysis due to missing data. CONCLUSION: There is no sufficient evidence to state that the preoperative physiotherapeutic intervention has efficacy and safety for patients who will undergo resection surgery for lung cancer.
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    Laserterapia de baixa potência para xerostomia em síndrome de Sjögren primária : ensaio clínico randomizado
    (Universidade Federal de São Paulo (UNIFESP), 2017-12-20) Fidelix, Tania Sales de Alencar [UNIFESP]; Trevisani, Virginia Fernandes Moca [UNIFESP]; http://lattes.cnpq.br/9054730236021091; http://lattes.cnpq.br/3433796508300210; Universidade Federal de São Paulo (UNIFESP)
    Objetivo: Avaliar a efetividade do laser de baixa potência para o tratamento da xerostomia na síndrome de Sjögren primária (SSp). Métodos: Um ensaio clinico randomizado de pacientes com sintomas de boca seca associado a síndrome de Sjögren primária encaminhados do ambulatório de córnea do departamento de oftalmologia da Universidade Federal de São Paulo e do departamento de reumatologia da Universidade de Santo Amaro. Sessenta e seis pacientes foram randomicamente alocados em dois grupos para receber laserterapia (grupo laser=33) ou placebo (grupo placebo=33). Pacientes no grupo laser receberam 12 sessões de laserterapia duas vezes por semana por seis semanas. A irradiação por laser foi feita com laser diodo arseneto de gálio alumínio, com comprimento de onda de 808 nm, 100 mW, densidade de energia 4J por ponto e 133,33 J/cm2. O grupo placebo recebeu o mesmo protocolo usado pelos pacientes irradiados, porém com nenhuma emissão real de laser pela ponteira, coberta com papel alumínio. Os desfechos de interesse foram escores do inventário de xerostomia, fluxo salivar, beta2 microglobulina salivar, sódio e cloro salivares. Resultados: Pacientes de ambos os grupos não apresentaram melhora significativa da xerostomia. Os escores do Inventário de xerostomia não alcançaram significância (p interação=0,301), assim também como o fluxo salivar (p interação=0,643). Não houve diferenças em níveis de beta 2 microglobulina, sódio e cloro nos dois grupos antes e após a intervenção. Em análise de subgrupo, participantes brancos foram comparados a não brancos e houve um efeito positivo no fluxo salivar, favorecendo o grupo da raça branca (p=0,010). Conclusão: O protocolo de laserterapia de baixa potência utilizado neste estudo não demonstrou melhora da xerostomia ou do fluxo salivar em pacientes com síndrome de Sjögren primária.
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    Levamisol não previne lesões de estomatite aftosa recorrente: um ensaio clínico randomizado, duplo-cego e controlado por placebo
    (Associação Médica Brasileira, 2009-01-01) Weckx, Luc Louis Maurice [UNIFESP]; Hirata, Cleonice Hitomi Watashi [UNIFESP]; Abreu, Marilda Aparecida Milanez Morgado de [UNIFESP]; Fillizolla, Vilma Ciorla [UNIFESP]; Silva, Olga Maria Panhoca da; Universidade Federal de São Paulo (UNIFESP); Universidade do Oeste Paulista Serviço de Dermatologia; Universidade do Estado de Santa Catarina
    OBJECTIVE: to utilize a double-blind protocol to provide clarification about the safety and effectiveness of levamisole in the treatment of recurrent aphthous stomatitis. METHODS: Fourteen patients took a decreasing dose of oral levamisole for six months (initial dose 150mg three times a week) and ten others were placebo control patients. All were evaluated monthly. RESULTS: The number of crises had a tendency to decrease in both groups, but without a difference between groups. The number of lesions diminished significantly in the two groups, but upon comparison the difference was not significant. Duration of the lesions diminished significantly in the placebo, however when compared to the levamisole group, difference was not significant during treatment. The intensity of pain was significantly lower in the two groups, but upon comparison, pain was significantly lower in the placebo group. The final global evaluation showed improvement in 50% of patients of the levamisole group and in 70% of the placebo, without a significant difference between treatments. No difference in the frequency of collateral effects was observed between groups. CONCLUSIONS: Levamisole, as used in this protocol, is a safe drug. When compared with the placebo, levamisole is not effective in the prophylactic treatment of recurrent aphthous stomatitis. The placebo effect is important in diseases where emotional factors affect recurrence or expression of symptoms.
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    nsaio clínico randomizado para avaliação da eficácia do tratamento com sofosbuvir mais daclatasvir ou simeprevir no tratamento de pacientes com hepatite C crônica genótipo 1 não cirróticos
    (Universidade Federal de São Paulo (UNIFESP), 2017-12-06) Pott Junior, Henrique [UNIFESP]; Castelo Filho, Adauto [UNIFESP]; Senise, Jorge Figueiredo [UNIFESP]; http://lattes.cnpq.br/0363646811603656; http://lattes.cnpq.br/0107536337908259; http://lattes.cnpq.br/5961854320494257; Universidade Federal de São Paulo (UNIFESP)
    ABSTRACT Introduction: This study investigated the safety and efficacy of simeprevir plus sofosbuvir (SOF+SIM) or daclatasvir plus sofosbuvir (SOF+DCV) regimen in a randomized, open-label, non-inferiority trial in patients infected with HCV genotype 1 infection who had previously not responded to pegylated interferon and ribavirin or were treatment naive. Methods: Patients were assigned randomly (1:1) to receive simeprevir (150 mg, once daily) and sofosbuvir (400 mg, once daily) or daclatasvir (60 mg, once daily) and sofosbuvir (400 mg, once daily) for 12 weeks. Analysis included all participants who received at least one dose of study drugs. The primary endpoint was sustained virological response 4 weeks after ending treatment (SVR4; HCV RNA measured using COBAS TaqMan RT-PCR [lower limit of detection and quantification of 12 UI/mL]). This study is registered at the ClinicalTrials.gov, number NCT02624063. Results: 127 patients were enrolled and randomized, and 125 started treatment (n=60 in SOF+SIM and n=65 in SOF+DCV). SVR4 was achieved in 121 (96.85%) patients (n=56 [93.33%, 95% CI 83.8-98,2] in SOF+SIM and n=65 [100%, 94.5-100] in SOF+DCV; absolute difference 6.66%, 95% CI -0.159 to 0.002). The most common adverse events in the pooled groups were fatigue (n=32 [25.6%]), headache (n=27 [21.6%]), and mood swings (n=24 [19.2%]). No patients were discontinued from the study. Conclusion: Although there was no statistically significant difference in SVR4 rates between groups, non-inferiority of the SOF+SIM in relation to SOF+DCV could not be established as it violated the non-inferiority margin. Therefore, the results of SOF+SIM in relation to SOF+DCV differ enough to be clinically relevant.
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    Podcast Amantes do Corpo Humano: uma ferramenta didática complementar para estimular a aprendizagem de anatomia e fisiologia humanas.
    (Universidade Federal de São Paulo, 2023-01-10) Oliveira, Leticia Reis [UNIFESP]; Santos, Camilo Lellis [UNIFESP]; http://lattes.cnpq.br/6884091896706349
    O crescente desenvolvimento da tecnologia de telefonia móvel está abrindo uma condição fortuita para a aquisição de qualquer conhecimento ou habilidade por meio do uso da tecnologia móvel, em qualquer lugar e a qualquer hora. Esse tipo de aprendizagem, a aprendizagem móvel (do inglês m-learning), é apreciada por estudantes das gerações de nativos digitais e aprendizes do mundo contemporâneo. Um exemplo de ferramenta m-learning é o podcast, onde um dispositivo é usado para escutar uma mídia de áudio ou vídeo, esses áudios são publicados na internet e baixados automaticamente no dispositivo móvel ou em um computador. Neste estudo, apresentamos o projeto de um podcast desenvolvido para servir de ferramenta didática complementar aos estudantes matriculados na unidade curricular Corpo Humano: Estrutura e Função (CHEF) na UNIFESP. O podcast, chamado “Amantes do Corpo Humano”, foi disponibilizado no Spotify e no Spreaker, e os episódios abordam conteúdos da área de anatomia e fisiologia humanas (A&F). A fim de identificar o potencial didático do podcast como um recurso complementar, os episódios de conteúdo autoral foram disponibilizados na semana em que o assunto de A&F foi abordado de acordo com o conteúdo programático de CHEF. Foram utilizadas as próprias bases de dados dos agregadores para identificar os padrões de usabilidade da ferramenta, por meio de uma análise quantitativa e qualitativa. O estudo randomizado controlado envolveu um grupo de estudantes (n=18), onde o grupo ouvinte (n=10) foi semanalmente convidado a ouvir os episódios. Houve uma diferença significativa (P<0,05) no nível de segurança e na pontuação calibrada em todos os conteúdos de A&F abordados no podcast, logo, pode-se inferir que os estudantes ouvintes se tornaram mais confiantes nas respostas que eles deram após utilizarem o podcast. Não houve diferença significativa na aprendizagem de conceitos mais complexos de A&F, assim entende-se que ouvir o podcast auxilia na assimilação de reforçar conhecimentos prévios mas não é autossuficiente para promover aprendizagem de conceitos no Ensino Superior. Em 2019 (n=18), 2020 (n=16) e 2021 (n=18), os estudantes ouvintes avaliaram o podcast como um potente recurso educacional, onde os estudantes de 2019 (61,5%), 2020 (63,6%) e 2021 (40,0%) consideraram que o uso do podcast contribuiu muito para o aprendizado. Estudantes que escolheram utilizar a ferramenta o fizeram pela facilidade de acesso e por terem uma motivação pessoal para tal. Houve acessos aos episódios do podcast em outros países além do Brasil e mesmo após o término da UC CHEF. Portanto, o trabalho comprova que re-expor o aluno ao conteúdo diminui a chance dele esquecer e o torna mais seguro nas respostas de testes conceituais. O uso de podcast se demonstrou ser um recurso educacional potente para abordagens didáticas de aprendizagem móvel e complementar aos recursos utilizados pelos professores durante as aulas.
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    Randomized clinical study on the analgesic effect of local infiltration versus spinal block for hemorrhoidectomy
    (Associacao Paulista Medicina, 2017) Borges, Luis Antonio [UNIFESP]; Leal, Plinio da Cunha [UNIFESP]; Rey Moura, Ed Carlos [UNIFESP]; Sakata, Rioko Kimiko [UNIFESP]
    BACKGROUND AND OBJECTIVES: Postoperative analgesia and early recovery are important for hospital discharge. The primary objective of this study was to compare the analgesic effectiveness of perianal infiltration and subarachnoid anesthesia for hemorrhoidectomy. The secondary objective was to compare time to discharge, adverse effects and complications. DESIGN AND SETTING: Randomized, prospective and comparative study at Dr. Mario Gatti Hospital. METHODS: Forty patients aged 18-60, in American Society of Anesthesiologists physical status category 1 or 2, were included. The local group (LG) received local infiltration (0.75% ropivacaine) under general anesthesia
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    Sensory-motor training versus resistance training among patients with knee osteoarthritis: randomized single-blind controlled trial
    (Associacao Paulista Medicina, 2018) Gomiero, Aline Bassoli [UNIFESP]; Kayo, Andrea [UNIFESP]; Abraao, Marcelo [UNIFESP]; Peccin, Maria Stella [UNIFESP]; Grande, Antonio Jose; Trevisani, Virginia Fernandes [UNIFESP]
    BACKGROUND: Osteoarthritis of the knee is defined as a progressive disease of the synovial joints and is characterized by failure of joint damage repair. The objective here was to compare the effectiveness of sensory-motor training versus resistance training among patients with knee osteoarthritis. DESIGN AND SETTING: Randomized, single-blinded controlled trial conducted at the outpatient service of the University of Santo Amaro. METHODS: A total of 64 patients were randomly assigned to sensory-motor training or resistance training. The evaluations were performed at baseline and 16 weeks after the intervention and included pain evaluation on a visual analogue scale, isometric quadriceps femoris force measurement using a dynamometer, Timed Up and Go test, Tinetti balance scale, Western Ontario and McMaster Universities osteoarthritis index, and the SF-36 quality-of-life questionnaire. Data analysis was performed using analysis of variance with repeated measurements and Cohen's effect size. RESULTS: Sensory-motor training may be a plausible alternative and showed a small effect on pain and a medium effect on maximal voluntary isometric contraction. Resistance training showed a small effect on balance and a medium effect on mobility. CONCLUSION: Resistance training and sensory motor training for the lower limbs among patients with knee osteoarthritis seemed to present similar effects on pain and function. However, because there was a considerable risk of type 2 error, further randomized clinical trials are still needed to provide a sound conclusion.
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    Shrinkage evaluation of heavyweight and lightweight polypropylene meshes in inguinal hernia repair: a randomized controlled trial
    (Springer, 2011-12-01) Silvestre, A. C.; Mathia, G. B. de; Fagundes, D. J. [UNIFESP]; Medeiros, L. R.; Rosa, M. I.; Univ Extremo Sul Catarinense; Universidade Federal de São Paulo (UNIFESP); Univ Fed Rio Grande do Sul
    One of the current complications in inguinal repair is shrinkage following the use of mesh. the selected mesh material, heavyweight (HWM) mesh or lightweight (LWM) mesh, is associated with the frequency of shrinkage. the aim of this study was to investigate shrinkage of these two types of mesh in a controlled trial of male inguinal hernia repair.Thirty-two healthy men with primary unilateral inguinal hernias (Nyhus classification), who presented at So Jos, Hospital of CriciA(0)ma, Brazil, underwent the Lichtenstein procedure. in total, 16 polypropylene HWM (105 g/m(2)) and 16 partially absorbable LWM (28 g/m(2)) were implanted into randomly selected patients. On post-operative days 1, 30, 60 and 90, the area of the mesh was evaluated by digital radiography.The study randomized 32 patients and analyzed 30 patients-15 for each type of mesh. At baseline, there were no differences between groups. There were significant differences between the two meshes when comparing the total area initially and on postoperative day 90 (P = 0.001). the HWM had significantly less area initial area, as compared with 90 days postoperatively (P = 0.04).Shrinkage was significantly higher for HWM, although the difference was not large.
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    Task shifting interpersonal counseling for depression: a pragmatic randomized controlled trial in primary care
    (Biomed Central Ltd, 2017) Matsuzaka, Camila T. [UNIFESP]; Wainberg, Milton; Pala, Andrea Norcini; Hoffmann, Elis V. [UNIFESP]; Coimbra, Bruno M. [UNIFESP]; Braga, Rosaly F. [UNIFESP]; Sweetland, Annika C.; Mello, Marcelo F. [UNIFESP]
    Background: Task shifting approaches (rational redistribution of tasks among health workforce teams) to train lay professionals to assist with integrating mental health treatment in primary care has been recommended to close the mental health treatment gap for depression in low-and middle-income countries. This study aims to examine the a new model for depression care in a low-resource environment compared to enhanced treatment at usual (E-TAU). Methods: We trained non-specialist community health workers (local lay employees of the public health system) to provide Interpersonal Counseling (IPC) to treat depressive symptoms in the Brazilian, Sao Paulo city, family health strategy (FHS). We conducted a randomized controlled trial involving 86 patients with a current major depressive disorder or dysthymia (based on DSM-IV) recruited from an FHS clinic. Participants were randomized to IPC intervention (n = 43) or E-TAU (n = 43). Participants allocated to IPC received 3-4 sessions provided by community health workers
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    Uso de ganciclovir 0,15% gel para tratamento de ceratoconjuntivite adenoviral
    (Conselho Brasileiro de Oftalmologia, 2011-12-01) Yabiku, Simone Tiemi [UNIFESP]; Yabiku, Mariann Midori [UNIFESP]; Bottós, Kátia Mantovani [UNIFESP]; Araújo, Aline Lutz [UNIFESP]; Freitas, Denise de [UNIFESP]; Belfort, Rubens Junior [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    PURPOSE: To evaluate the efficacy and the toxicity of 0.15% ganciclovir gel in the treatment of adenoviral conjunctivitis and in preventing ocular complications after adenoviral conjunctivitis, such as corneal infiltrates and pseudomembranes. METHODS: Double blind, interventional and randomized clinical trial. Thirty-three patients with clinical diagnosis of adenoviral conjunctivitis with onset of symptoms for five or less days were randomized in two groups: Group 1 (treatment) with 19 patients used ganciclovir gel and Group 2 (control) with 14 patients used artificial tears without preservative. Patients answered a questionnaire of signs and symptoms and were submitted to an ophthalmologic exam. On the 6th and 10th days of treatment they answered the same questions and were re-examined by the same ophthalmologist. Signs and symptoms were compared. T Student, Mann-Whitney e Wilcoxon tests were used to statistical analysis. RESULTS: Trend of better response in the treatment group in relation of patients' perception, besides faster improvement of this group compared to the control group (p=0.26). There were lower transmission to the fellow eye (p=0.86) and to people living together (p=0.16) in the treatment group. No statistical difference related to signs and symptoms of conjunctivitis were found comparing both groups. We observed statistical difference in pain, itch and photophobia only in the treatment group, comparing each group alone. No toxicity and more tolerance of the ganciclovir were observed. There was no statistical difference in the ocular complications after conjunctivitis between both groups. CONCLUSIONS: This study showed trend of better and faster response of the signs and symptoms of the patients treated with ganciclovir compared with the control group, but with no statistical significant. These results need to be confirmed by additional studies, with more patients and longer follow-up. Clinical Trails.gov: NCT01349452
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    Validity of Qualis database as a predictor of evidence hierarchy and risk of bias in randomized controlled trials: a case study in dentistry
    (Faculdade de Medicina / USP, 2011-01-01) Ferreira, Christiane Alves [UNIFESP]; Loureiro, Carlos Alfredo Salles [UNIFESP]; Saconato, Humberto [UNIFESP]; Atallah, Álvaro Nagib [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    OBJECTIVE: To evaluate the validity of the Qualis database in identifying the levels of scientific evidence and the quality of randomized controlled trials indexed in the Lilacs database. METHODS: We selected 40 open-access journals and performed a page-by-page hand search, to identify published articles according to the type of study during a period of six years. Classification of studies was performed by independent reviewers assessed for their reliability. Randomized controlled trials were identified for separate evaluation of risk of bias using four dimensions: generation of allocation sequence, allocation concealment, blinding, and incomplete outcome data. The Qualis classification was considered to be the outcome variable. The statistical tests used included Kappa, Spearman's correlation, Kendall-tau and ordinal regressions. RESULTS: Studies with low levels of scientific evidence received similar Qualis classifications when compared to studies with high levels of evidence. In addition, randomized controlled trials with a high risk of bias for the generation of allocation sequences and allocation concealment were more likely to be published in journals with higher Qualis levels. DISCUSSION: The hierarchy level of the scientific evidence as classified by type of research design, as well as by the validity of studies according to the bias control level, was not correlated or associated with Qualis stratification. CONCLUSION: Qualis classifications for journals are not an approximate or indirect predictor of the validity of randomized controlled trials published in these journals and are therefore not a legitimate or appropriate indicator of the validity of randomized controlled trials.