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2.
Artigo em Inglês | MEDLINE | ID: mdl-32922366

RESUMO

A better understanding of the SARS-CoV-2 virus behavior and possible risk factors implicated in poor outcome has become an urgent need. We performed a systematic review in order to investigate a possible association between body weight and prognosis among patients diagnosed with COVID-19. We searched in Cochrane Library, EMBASE, MEDLINE, WHO-Global Literature on Coronavirus Disease, OpenGrey, and Medrxiv. We used the ROBINS-I tool or Cross-Sectional/Prevalence Study Quality tool from AHRQ, to evaluate the methodological quality of included studies. Nine studies (two prospective cohorts, four retrospective cohorts and three cross-sectional) were included and assessed the relationship between obesity and COVID-19 prognosis. Risk of bias of the included studies ranged from moderate to critical. Clinical and methodological heterogeneity among them precluded meta-analyses. Most of the included studies showed some degree of association to: (a) higher BMI and worse clinical presentation and (b) obesity and need of hospitalization. The results were inconsistent about the impact of obesity on mortality. Based on limited methodological quality studies, obesity seems to predict poor clinical evolution in patients with COVID-19. Further studies with appropriate prospective design are needed to reduce the uncertainty on this evidence.


Assuntos
Betacoronavirus/isolamento & purificação , Índice de Massa Corporal , Infecções por Coronavirus/mortalidade , Obesidade/fisiopatologia , Pneumonia Viral/mortalidade , Estudos de Coortes , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Humanos , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Prognóstico , Taxa de Sobrevida
3.
Rev Bras Ginecol Obstet ; 42(7): 427-435, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32736394

RESUMO

OBJECTIVE: We performed a systematic review to assess the effectiveness and safety of Tribulus terrestris to treat female sexual dysfunction (FSD). DATA SOURCES: We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov and OpenGrey databases. SELECTION OF STUDIES: We included any randomized controlled trials (RCTs) that compared T. terrestris versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs (n = 279 participants) were included. DATA COLLECTION: Data extraction was performed by two reviewers with a preestablished data collection formulary. DATA SYNTHESIS: Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTS: After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to T. terrestris had a significant increase in sexual function scores. Three months of treatment with T. terrestris showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, which means that we have very little confidence in the effect estimates, and future studies are likely to change these estimates. CONCLUSION: More RCTs are needed to support or refute the use of T. terrestris. The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process.Number of Protocol registration in PROSPERO database: CRD42019121130.

4.
Ann Palliat Med ; 9(5): 3553-3561, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32819127

RESUMO

Glioblastoma (GBM) is one of the most malignant primary intracranial neoplasms. This review aims to summarize the treatment of elderly patients with newly diagnosed GBM, with a focus on the radiation therapy (RT) approach. The available literature was reviewed, and we describe the most significant results relating to the post-operative approach of elderly GBM patients. Age limitations in randomized phase III studies have restricted the inclusion of elderly patients, and consequently, limited the generalizability of their results to this patient subset. Chronological age should not prohibit the best treatment, but instead, treatment decisions should consider patient functional status. RT showed efficacy and safety in the elderly population, without compromising quality of life. Hypofractionated RT is not inferior to standard RT. Reduction of overall RT schedule length mitigates the difficulties faced by elderly patients, improving treatment adherence. The addition of both concomitant and adjuvant temozolomide to standard RT is superior to either modality alone and should be the treatment of choice in the subset of patients with good/very good prognosis. It is reasonable to offer hypofractionated RT or temozolomide alone for poor prognosis, and best supportive care (BSC) for very poor prognosis elderly GBM patients. Although combined modality treatment is well established for the management of the good prognosis population, different RT schemes require further investigation with randomized controlled trials to determine the best regimen. A robust analysis of the molecular signatures of GBM in elderly patients might reveal opportunities for clinical protocol modifications to customize management in this group of patients.

5.
Rev Bras Ter Intensiva ; 32(2): 166-196, 2020 06.
Artigo em Inglês, Português | MEDLINE | ID: mdl-32667444

RESUMO

INTRODUCTION: Different therapies are currently used, considered, or proposed for the treatment of COVID-19; for many of those therapies, no appropriate assessment of effectiveness and safety was performed. This document aims to provide scientifically available evidence-based information in a transparent interpretation, to subsidize decisions related to the pharmacological therapy of COVID-19 in Brazil. METHODS: A group of 27 experts and methodologists integrated a task-force formed by professionals from the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB), the Brazilian Society of Infectious Diseases (Sociedad Brasileira de Infectologia - SBI) and the Brazilian Society of Pulmonology and Tisiology (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT). Rapid systematic reviews, updated on April 28, 2020, were conducted. The assessment of the quality of evidence and the development of recommendations followed the GRADE system. The recommendations were written on May 5, 8, and 13, 2020. RESULTS: Eleven recommendations were issued based on low or very-low level evidence. We do not recommend the routine use of hydroxychloroquine, chloroquine, azithromycin, lopinavir/ritonavir, corticosteroids, or tocilizumab for the treatment of COVID-19. Prophylactic heparin should be used in hospitalized patients, however, no anticoagulation should be provided for patients without a specific clinical indication. Antibiotics and oseltamivir should only be considered for patients with suspected bacterial or influenza coinfection, respectively. CONCLUSION: So far no pharmacological intervention was proven effective and safe to warrant its use in the routine treatment of COVID-19 patients; therefore such patients should ideally be treated in the context of clinical trials. The recommendations herein provided will be revised continuously aiming to capture newly generated evidence.


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Humanos , Pandemias
7.
Clin Rehabil ; 34(6): 713-722, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32204620

RESUMO

OBJECTIVE: The purpose of this study was to determine the benefits and harms of low-level laser therapy for Achilles tendinopathy. DATA SOURCES: Search strategies were conducted (from inception to February 2020) in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Literatura Latino Americana em Ciências da Saúde e do Caribe (LILACS), Physiotherapy Evidence Database (PEDro), SPORTDiscus, ClinicalTrials.gov, World Health Organization (WHO)-ICTRP and OpenGrey databases, to retrieve all randomized controlled trials that compared laser therapy with inactive/active interventions. REVIEW METHODS: This study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The risk of bias was assessed using the Cochrane Risk of bias table. Meta-analyses were performed on dependence of homogeneity, otherwise results were reported narratively. The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: Four trials (119 participants) were analyzed. Laser therapy associated to eccentric exercises when compared to eccentric exercises and sham had very low to low certainty of evidence in pain and function assessment. Despite one trial favored laser therapy at two months (mean difference (MD) -2.55, 95% confidence interval (95% CI) -3.87 to -1.23), the CIs did not include important differences between groups at 3 and 13 months. The function assessment showed an improvement favoring the placebo group at one month (MD 9.19, 95% CI -16.16 to -2.23) and non-significant difference between groups at 3 and 13 months. Adverse events were poorly reported but restricted to minor events related to the exercises. CONCLUSION: The certainty of evidence was low to very low, and the results are insufficient to support the routine use laser therapy for Achilles tendinopathy.

9.
Cochrane Database Syst Rev ; 1: CD009256, 2020 01 13.
Artigo em Inglês | MEDLINE | ID: mdl-31930743

RESUMO

BACKGROUND: Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death in both sexes worldwide. Approximately 50% of those diagnosed with lung cancer will have locally advanced or metastatic disease and will be treated in a palliative setting. Platinum-based combination chemotherapy has benefits in terms of survival and symptom control when compared with best supportive care. OBJECTIVES: To assess the effectiveness and safety of carboplatin-based chemotherapy when compared with cisplatin-based chemotherapy, both in combination with a third-generation drug, in people with advanced non-small cell lung cancer (NSCLC). To compare quality of life in people with advanced NSCLC receiving chemotherapy with cisplatin and carboplatin combined with a third-generation drug. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 13 January 2019), MEDLINE (via PubMed) (1966 to 13 January 2019), and Embase (via Ovid) (1974 to 13 January 2019). In addition, we handsearched the proceedings of the American Society of Clinical Oncology Meetings (January 1990 to September 2018) and reference lists from relevant resources. SELECTION CRITERIA: Randomised clinical trials (RCTs) comparing regimens with carboplatin or cisplatin combined with a third-generation drug in people with locally advanced or metastatic NSCLC. We accepted any regimen and number of cycles that included these drugs, since there is no widely accepted standard regimen. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the search results, and a third review author resolved any disagreements. The primary outcomes were overall survival and health-related quality of life. The secondary outcomes were one-year survival rate, objective response rate and toxicity. MAIN RESULTS: In this updated review, we located one additional RCT, for a total of 11 included RCTs (5088 participants, 4046 of whom were available for meta-analysis). There was no difference in overall survival (hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.82 to 1.20; 10 RCTs; 2515 participants; high-quality evidence); one-year survival rate (risk ratio (RR) 0.98, 95% CI 0.89 to 1.08; I2 = 17%; 4004 participants; all 11 RCTs; high-quality evidence); or response rate (RR 0.89, 95% CI 0.79 to 1.00; I2 = 12%; all 11 RCTs; 4020 participants; high-quality evidence). A subgroup analysis comparing carboplatin with different doses of cisplatin found an overall survival benefit in favour of carboplatin-based regimens when compared to cisplatin at lower doses (40 to 80 mg/m2) (HR 1.15, 95% CI 1.03 to 1.28; 6 RCTs; 2508 participants), although there was no overall survival benefit when carboplatin-based chemotherapy was compared to cisplatin at higher doses (80 to 100 mg/m2) (HR 0.93, 95% CI 0.83 to 1.04; I2 = 0%; 4 RCTs; 1823 participants). Carboplatin caused more thrombocytopenia (RR 2.46, 95% CI 1.49 to 4.04; I2 = 68%; 10 RCTs; 3670 participants) and was associated with more neurotoxicity (RR 1.42, 95% CI 0.91 to 2.23; I2 = 0%, 5 RCTs; 1489 participants), although we believe this last finding is probably related to a confounding factor (higher dose of paclitaxel in the carboplatin-containing treatment arm of a large study included in the analysis). There was no statistically significant difference in renal toxicity (RR 0.52, 95% CI 0.19 to 1.45; I2 = 3%; 3 RCTs; 1272 participants); alopecia (RR 1.11, 95% CI 0.73 to 1.68; I2 = 0%; 2 RCTs; 300 participants); anaemia (RR 1.37, 95% CI 0.79 to 2.38; I2 = 77%; 10 RCTs; 3857 participants); and neutropenia (RR 1.18, 95% CI 0.85 to 1.63; I2 = 94%; 10 RCTs; 3857 participants) between cisplatin-based chemotherapy and carboplatin-based chemotherapy regimens. Two RCTs performed a health-related quality of life analysis; however, as they used different methods of measurement we were unable to perform a meta-analysis. One RCT reported comparative health-related quality of life data between cisplatin and carboplatin-containing arms but found no significant differences in global indices of quality of life, including global health status or functional scales. In this Cochrane review, we found that the quality of evidence was high for overall survival, one-year survival rate and response rate but moderate quality evidence for the other outcomes measured. AUTHORS' CONCLUSIONS: Advanced NSCL patients treated with carboplatin or cisplatin doublet with third-generation chemotherapy drugs showed equivalent overall survival, one-year survival, and response rate. Regarding adverse events, carboplatin caused more thrombocytopenia, and cisplatin caused more nausea/vomiting. Therefore, in this palliative therapeutic intent, the choice of the platin compound should take into account the expected toxicity profile, patient's comorbidities and preferences.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Antineoplásicos/uso terapêutico , Carboplatina/uso terapêutico , Cisplatino/uso terapêutico , Feminino , Humanos , Masculino , Náusea/induzido quimicamente , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Taxa de Sobrevida , Resultado do Tratamento , Vômito/induzido quimicamente
11.
Cochrane Database Syst Rev ; 12: CD011927, 2019 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-31830313

RESUMO

BACKGROUND: Chronic neck pain is a highly prevalent condition, affecting 10% to 24% of the general population. Transcutaneous electrical nerve stimulation (TENS) is the noninvasive, transcutaneous use of electrical stimulation to produce analgesia. It is a simple, low-cost and safe intervention used in clinical practice as an adjunct treatment for painful musculoskeletal conditions that have a considerable impact on daily activities, such as chronic neck pain. This review is a split from a Cochrane Review on electrotherapy for neck pain, published in 2013, and focuses specifically on TENS for chronic neck pain. OBJECTIVES: To evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) (alone or in association with other interventions) compared with sham and other clinical interventions for the treatment of chronic neck pain. SEARCH METHODS: We searched Cochrane Back and Neck Trials Register, CENTRAL, MEDLINE, Embase, five other databases and two trials registers to 9 November 2018. We also screened the reference lists of relevant studies to identify additional trials. There were no language, source, or publication date restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) involving adults (≥ 18 years of age) with chronic neck pain (lasting > 12 weeks) that compared TENS alone or in combination with other treatments versus active or inactive treatments. The primary outcomes were pain, disability and adverse events. DATA COLLECTION AND ANALYSIS: Two independent review authors selected the trials, extracted data and assessed the risk of bias of included studies. A third review author was consulted in case of disagreements. We used the Cochrane 'Risk of bias' tool (adapted by Cochrane Back and Neck), to assess the risk of bias of individual trials and GRADE to assess the certainty of evidence. We used risk ratios (RRs) to measure treatment effects for dichotomous outcomes, and mean differences (MDs) for continuous outcomes, with their respective 95% confidence intervals (CIs). MAIN RESULTS: We included seven RCTs with a total of 651 participants, mean age 31.7 to 55.5 years, conducted in three different countries (Turkey, Jordan and China). The length of follow-up ranged from one week to six months. Most RCTs used continuous TENS, with a frequency of 60 Hz to 100 Hz, pulse width of 40 µs to 250 µs and tolerable intensity, described as a tingling sensation without contraction, in daily sessions lasting 20 to 60 minutes. Due to heterogeneity in interventions and outcomes, we did not pool individual study data into meta-analyses. Overall, we judged most studies as being at low risk for selection bias and high risk for performance and detection bias. Based on the GRADE approach, there was very low-certainty evidence from two trials about the effects of conventional TENS when compared to sham TENS at short-term (up to 3 months after treatment) follow-up, on pain (assessed by the Visual Analogue Scale (VAS)) (MD -0.10, 95% CI -0.97 to 0.77) and the percentage of participants presenting improvement of pain (RR 1.57, 95% CI 0.84 to 2.92). None of the included studies reported on disability or adverse events. AUTHORS' CONCLUSIONS: This review found very low-certainty evidence of a difference between TENS compared to sham TENS on reducing neck pain; therefore, we are unsure about the effect estimate. At present, there is insufficient evidence regarding the use of TENS in patients with chronic neck pain. Additional well-designed, -conducted and -reported RCTs are needed to reach robust conclusions.


Assuntos
Dor Crônica/terapia , Cervicalgia/terapia , Estimulação Elétrica Nervosa Transcutânea/métodos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
12.
Säo Paulo med. j ; 137(6): 530-542, Nov.-Dec. 2019. tab
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1094518

RESUMO

ABSTRACT BACKGROUND: Age-related macular degeneration (AMD) is the third largest cause of blindness worldwide, accounting for 8.7% of all cases. A considerable number of preventive or therapeutic interventions have been used for AMD. OBJECTIVE: This study presents a critical view of the interventions that have been assessed through Cochrane systematic reviews. DESIGN AND SETTING: Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: Review of Cochrane systematic reviews about interventions for AMD. RESULTS: The 18 systematic reviews included assessed the effects of surgical techniques, laser/photo/radiotherapy, intravitreal injections, systemic drugs and phytotherapy/vitamins/supplements. CONCLUSION: The Cochrane systematic reviews found evidence that use of bevacizumab, ranibizumab, pegaptanib, laser photocoagulation, photodynamic therapy and multivitamin compounds may present some benefits for treating AMD. There was insufficient evidence for supporting the use of macular translocation, submacular surgery, steroid implantation, radiotherapy, intravitreal aflibercept, interferon alfa, statins or omega-3 fatty acids for treating AMD; or the use of multivitamin antioxidant vitamins or mineral supplementation for preventing AMD. Future randomized controlled trials are imperative to reduce the uncertainty in several clinical questions regarding AMD.

13.
Trials ; 20(1): 729, 2019 Dec 16.
Artigo em Inglês | MEDLINE | ID: mdl-31842982

RESUMO

BACKGROUND: A considerable amount of randomized controlled trials (RCTs) have been published on statins and/or fibrates for diabetic retinopathy, a clinical condition associated with high social and economic burden. Adherence to the CONSORT statement items is imperative to ensure transparency and reproducibility in clinical research. The aim of this study is to assess the reporting quality and the adherence to CONSORT of RCTs assessing statins and/or fibrates for diabetic retinopathy. METHODS: We conducted a critical appraisal study at Discipline of Evidence-based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). A sensitive literature search was performed to identify all relevant RCTs, with no time or language limits. Two authors independently evaluated the reporting quality of the selected RCTs using the CONSORT statement as a standard. RESULTS: Thirteen reports of RCTs were included in this study. The adherence of the reports to CONSORT items ranged from 24% to 68%. The median score was 11 (interquartile range (IQR) 8 to 13). When analyzed separately, the methods sections of the reports had a median of three items (IQR 2 to 4) judged adherent to the methods items of CONSORT (items 3 to 12). The most underreported items were those related to trial design, title and abstract, allocation concealment, implementation of the randomization sequence, and blinding. Other important items, such as the one related to the description of the inclusion criteria, also had low adherence. CONCLUSIONS: The overall adherence to the CONSORT checklist items was poor, especially in the items related to the methods section. RCT reports on statins and/or fibrates for diabetic retinopathy must be optimized to avoid reporting biases and to improve transparency and reproducibility.


Assuntos
Lista de Checagem/normas , Confiabilidade dos Dados , Retinopatia Diabética/tratamento farmacológico , Ácidos Fíbricos/uso terapêutico , Fidelidade a Diretrizes/normas , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Retinopatia Diabética/diagnóstico , Ácidos Fíbricos/efeitos adversos , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Resultado do Tratamento
14.
Trials ; 20(1): 729-735, dez., 2019. tab., graf.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1049617

RESUMO

BACKGROUND: A considerable amount of randomized controlled trials (RCTs) have been published on statins and/or fibrates for diabetic retinopathy, a clinical condition associated with high social and economic burden. Adherence to the CONSORT statement items is imperative to ensure transparency and reproducibility in clinical research. The aim of this study is to assess the reporting quality and the adherence to CONSORT of RCTs assessing statins and/or fibrates for diabetic retinopathy. METHODS: We conducted a critical appraisal study at Discipline of Evidence-based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). A sensitive literature search was performed to identify all relevant RCTs, with no time or language limits. Two authors independently evaluated the reporting quality of the selected RCTs using the CONSORT statement as a standard. RESULTS: Thirteen reports of RCTs were included in this study. The adherence of the reports to CONSORT items ranged from 24% to 68%. The median score was 11 (interquartile range (IQR) 8 to 13). When analyzed separately, the methods sections of the reports had a median of three items (IQR 2 to 4) judged adherent to the methods items of CONSORT (items 3 to 12). The most underreported items were those related to trial design, title and abstract, allocation concealment, implementation of the randomization sequence, and blinding. Other important items, such as the one related to the description of the inclusion criteria, also had low adherence. CONCLUSIONS: The overall adherence to the CONSORT checklist items was poor, especially in the items related to the methods section. RCT reports on statins and/or fibrates for diabetic retinopathy must be optimized to avoid reporting biases and to improve transparency and reproducibility. (AU)


Assuntos
Ensaios Clínicos como Assunto , Viés de Publicação , Inibidores de Hidroximetilglutaril-CoA Redutases , Retinopatia Diabética , Hipolipemiantes
15.
Diabetol Metab Syndr ; 11: 92, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31719846

RESUMO

Evidence from observational studies have found a relationship between serum cholesterol and diabetic retinopathy (DR). Apart of the assumption that cholesterolemic control has benefits for patients with diabetes with or without retinopathy, the effects of lipid-lowering drugs have not been properly mapped and critically assessed so far. The objective of this study was to evaluate the effects of statins and/or fibrates on prevention and progression of DR. We conducted a Systematic review of randomized controlled trials (RCTs) following the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. GRADE approach was used to summarize the certainty of the evidence. Eight RCTs that fulfilled our eligibility criteria were included, assessing the effects of fibrates (n = 4), statins (n = 3) and fibrate plus statins (n = 1) for therapy (n = 8) or prevention (n = 4) of DR. Overall, the main concern regarding risk of bias assessment was due to incomplete outcome data because high rate of losses in five RCTs. Furthermore, the risk of reporting bias was rated unclear due the lack of previously published protocol in seven RCTs. Fibrates seemed to be associated with a 45% risk reduction of macular edema incidence (Relative Risk 0.55, 95% confidence interval of 0.38 to 0.81, 1309 participants, 2 RCTs, I2 = 0%, low certainty of the evidence). The certainty of evidence for other outcomes was also very low or low, and we are uncertain regarding the effects of fibrates for DR. Overall, adverse events seemed to be similar between fibrate and placebo, but again based on the width of the confidence intervals, an important increase of adverse events cannot be rule out. The combination statin/fibrate did not seem to have benefit for visual acuity but is likely that further studies can modify this estimate since the current evidence is limited. Adverse events and quality of life were not measured or reported. Concluding, this study found eight RCTs, with limited methodological quality, that assessed the effects of fibrates and/or statins for DR. Based on these findings, we are uncertain about the effects of statins for DR. Fibrates seemed to reduce the incidence of macular edema (low certainty evidence) without increase adverse events (low to very low certainty evidence). Number of Protocol registration PROSPERO CRD42016029746.

16.
Diabetol. metab. syndr ; 00: 01-14, Nov. 2019. tabela, gráfico
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1025136

RESUMO

Abstract Evidence from observational studies have found a relationship between serum cholesterol and diabetic retinopathy (DR). Apart of the assumption that cholesterolemic control has benefits for patients with diabetes with or without retinopathy, the effects of lipid-lowering drugs have not been properly mapped and critically assessed so far. The objective of this study was to evaluate the effects of statins and/or fibrates on prevention and progression of DR. We conducted a Systematic review of randomized controlled trials (RCTs) following the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. GRADE approach was used to summarize the certainty of the evidence. Eight RCTs that fulfilled our eligibility criteria were included, assessing the effects of fibrates (n = 4), statins (n = 3) and fibrate plus statins (n = 1) for therapy (n = 8) or prevention (n = 4) of DR. Overall, the main concern regarding risk of bias assessment was due to incomplete outcome data because high rate of losses in five RCTs. Furthermore, the risk of reporting bias was rated unclear due the lack of previously published protocol in seven RCTs. Fibrates seemed to be associated with a 45% risk reduction of macular edema incidence (Relative Risk 0.55, 95% confidence interval of 0.38 to 0.81, 1309 participants, 2 RCTs, I2 = 0%, low certainty of the evidence). The certainty of evidence for other outcomes was also very low or low, and we are uncertain regarding the effects of fibrates for DR. Overall, adverse events seemed to be similar between fibrate and placebo, but again based on the width of the confidence intervals, an important increase of adverse events cannot be rule out. The combination statin/fibrate did not seem to have benefit for visual acuity but is likely that further studies can modify this estimate since the current evidence is limited. Adverse events and quality of life were not measured or reported. Concluding, this study found eight RCTs, with limited methodological quality, that assessed the effects of fibrates and/or statins for DR. Based on these findings, we are uncertain about the effects of statins for DR. Fibrates seemed to reduce the incidence of macular edema (low certainty evidence) without increase adverse events (low to very low certainty evidence). Number of Protocol registration PROSPERO CRD42016029746. (AU)


Assuntos
Metanálise , Inibidores de Hidroximetilglutaril-CoA Redutases , Retinopatia Diabética , Ácidos Fíbricos
17.
Cochrane Database Syst Rev ; 10: CD012936, 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31637711

RESUMO

BACKGROUND: People with multiple sclerosis (MS) have complex symptoms and different types of needs. These demands include how to manage the burden of physical disability as well as how to organise daily life, restructure social roles in the family and at work, preserve personal identity and community roles, keep self-sufficiency in personal care, and how to be part of an integrated care network. Palliative care teams are trained to keep open full and competent lines of communication about symptoms and disease progression, advanced care planning, and end-of-life issues and wishes. Teams create a treatment plan for the total management of symptoms, supporting people and families on decision-making. Despite advances in research and the existence of many interventions to reduce disease activity or to slow the progression of MS, this condition remains a life-limiting disease with symptoms that impact negatively the lives of people with it and their families. OBJECTIVES: To assess the effects (benefits and harms) of palliative care interventions compared to usual care for people with any form of multiple sclerosis: relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), and progressive-relapsing MS (PRMS) We also aimed to compare the effects of different palliative care interventions. SEARCH METHODS: On 31 October 2018, we conducted a literature search in the specialised register of the Cochrane MS and Rare Diseases of the Central Nervous System Review Group, which contains trials from CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Clinical trials.gov and the World Health Organization International Clinical Trials Registry Platform. We also searched PsycINFO, PEDro and Opengrey. We also handsearched relevant journals and screened the reference lists of published reviews. We contacted researchers in palliative care and multiple sclerosis. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster randomised trials were eligible for inclusion, as well as the first phase of cross-over trials. We included studies that compared palliative care interventions versus usual care. We also included studies that compared palliative care interventions versus another type of palliative interventions. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. We summarised key results and certainty of evidence in a 'Summary of Finding' table that reported outcomes at six or more months of post-intervention. MAIN RESULTS: Three studies (146 participants) met our selection criteria. Two studies compared multidisciplinary, fast-track palliative care versus multidisciplinary standard care while on a waiting-list control, and one study compared a multidisciplinary palliative approach versus multidisciplinary standard care at different time points (12, 16, and 24 weeks). Two were RCTs with parallel design (total 94 participants) and one was a cross-over design (52 participants). The three studies assessed palliative care as a home-based intervention. One of the three studies included participants with 'neurodegenerative diseases', with MS people being a subset of the randomised population. We assessed the risk of bias of included studies using Cochrane's 'Risk of Bias' tool.We found no evidence of differences between intervention and control groups in long-time follow-up (> six months post-intervention) for the following outcomes: mean change in health-related quality of life (SEIQoL - higher scores mean better quality of life; MD 4.80, 95% CI -12.32 to 21.92; participants = 62; studies = 1; very low-certainty evidence), serious adverse events (RR 0.97, 95% CI 0.44 to 2.12; participants = 76; studies = 1, 22 events, low-certainty evidence) and hospital admission (RR 0.78, 95% CI 0.24 to 2.52; participants = 76; studies = 1, 10 events, low-certainty evidence).The three included studies did not assess the following outcomes at long term follow-up (> six months post intervention): fatigue, anxiety, depression, disability, cognitive function, relapse-free survival, and sustained progression-free survival.We did not find any trial that compared different types of palliative care with each other. AUTHORS' CONCLUSIONS: Based on the findings of the RCTs included in this review, we are uncertain whether palliative care interventions are beneficial for people with MS. There is low- or very low-certainty evidence regarding the difference between palliative care interventions versus usual care for long-term health-related quality of life, adverse events, and hospital admission in patients with MS. For intermediate-term follow-up, we are also uncertain about the effects of palliative care for the outcomes: health-related quality of life (measured by different assessments: SEIQoL or MSIS), disability, anxiety, and depression.

18.
Value Health Reg Issues ; 20: 172-179, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31622803

RESUMO

OBJECTIVES: To report on the translation procedures and psychometric properties of the DISCERN tool in Brazilian Portuguese. METHODS: Three people translated the DISCERN from English into Brazilian Portuguese. A committee of experts and community representatives evaluated the quality of the 3 versions in 2 online voting rounds. Two native speakers back-translated the questionnaire into English. We compared these versions to the original DISCERN and made small adjustments. The final Brazilian Portuguese version of DISCERN was tested twice by journalism students to evaluate the quality of a text about smoking cessation treatments. We evaluated participants' health literacy with the Short Assessment of Health Literacy for Portuguese-Speaking Adults (SAHL-PA) tool, assessed the internal consistency of the translated questionnaire with the Cronbach test, and measured its reproducibility with the intraclass correlation coefficient (ICC). We then investigated the relationship between DISCERN and SAHL-PA scores and demographic variables. RESULTS: The participants (n = 126) had no difficulty in using the questionnaire. Cronbach's alpha was 0.865 (95% confidence interval [CI], 0.826-0.898), and the ICC between the 2 evaluations was 0.845 (CI 0.717-0.912). The mean health literacy of the participants was adequate. There was no correlation between the DISCERN score and the SAHL-PA score, age, or sex (P > .05). CONCLUSIONS: The Brazilian Portuguese version of the DISCERN questionnaire has excellent internal consistency and good reproducibility. The evaluators' ages, sex, and health literacy did not interfere with the score resulting from the evaluation of the quality of the text.

19.
J Pain ; 2019 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-31513934

RESUMO

This systematic review investigated the effectiveness and safety of botulinum toxin type A (BTX-A) for painful temporomandibular disorders. We searched for randomized controlled trials (RCTs) in 10 databases, from inception to February 12, 2019 (MEDLINE, EMBASE, CENTRAL, LILACS, BBO, Web of Science, Scopus, ClinicalTrials.gov, WHO and OpenGrey). We included 12 RCTs that compared BTX-A versus inactive or active interventions. BTX-A was slightly more effective than placebo for pain reduction at 1 month: mean difference -1.74 points (0-10 scale), 95% confidence interval -2.94 to -.54, 3 RCTs, 60 participants, I-square (I2) = 0%. However, there were no significant differences at 3 and 6 months. BTX-A was similar to no treatment for pain reduction at 3 and 6 months. BTX-A was more effective than conventional treatment and low-level laser therapy for pain reduction at 1, 6, and 12 months, but less effective than facial manipulation for pain reduction at 3 months. BTX-A was not associated with a significant increase in the risk of adverse events. The quality of the evidence was low, and results are insufficient to support the use of BTX-A for painful temporomandibular disorders. High-quality RCTs are needed to increase confidence in effect estimates. PERSPECTIVE: BTX-A for painful temporomandibular disorders appears to be well tolerated. For pain reduction, BTX-A is slightly more effective than placebo only at 1 month; conventional treatment and low-level laser at 1, 6, and 12 months. Low-quality evidence limits the applicability of these findings and precludes recommendations for practice.

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