Definition and reporting of composite outcomes are often inadequate in randomized clinical trials on pharmacological interventions for coronary artery disease.

OBJECTIVES: To estimate the frequency and critically appraise the use and reporting of composite outcomes in randomized clinical trials on pharmacological interventions for coronary artery disease. STUDY DESIGN AND SETTING: A metaresearch study. A search strategy was developed to retrieve references from MEDLINE. We considered articles, published from 1st January 2020, to December 31, 2021, reporting results of clinical primary outcomes from randomized clinical trials which assessed pharmacological interventions, used alone or in combination, for the treatment or secondary prevention (previous coronary event) of coronary artery disease. RESULTS: From the 34 included studies, 28 (82.35%) had a primary composite outcome. Thirteen unique composite primary outcomes were used with the most frequent being "cardiovascular death, myocardial infarction, stroke" (12/28, 42.86%). The term major adverse cardiac events was used for five distinct composite primary outcomes. A combination of 12 different components resulted in the 28 primary composite outcomes, with stroke being the most frequent component present in 96.43% (27/28) of the primary composite outcomes. From the included studies, 60.71% (17/28) reported the estimates for each individual component and the direction of the effect was consistent between all components and the composite outcomes in 58.82% (10/17) of them. Additionally, no included study discussed potential limitations and/or related advantages of the composite outcomes. CONCLUSION: In randomized clinical trials on pharmacological interventions for coronary artery disease, composite outcomes are frequently used, but the definition of their components is very heterogeneous. The estimate for individual components within the composite outcome is often not fully reported, which prevents a complete analysis of their adequacy for clinical practice. The term major adverse cardiac events was used inconsistently and to refer to different set of components, which can also be misleading and confusing.

Overview of Cochrane systematic review about retinal detachment / Visão geral das revisões sistemáticas Cochrane em descolamento de retina

ABSTRACT Retinal detachment (RD) is a common ophthalmic emergency that could bring permanent blindness if it is untreated or treatment is delayed. We conducted a review of Cochrane systematic reviews regarding retinal detachment interventions after a search strategy, we showed and analyzed the data narratively in Ophthalmologic Departure of Escola Paulista de Medicina-UNIFESP. As result, the group of pneumatic retinopexy was less susceptible to choroidal detachment and myopic shift as adverse events when compared with scleral buckle. Although there is no statistically significant difference in visual acuity between standard and heavy silicone oil and between C3F8 and silicone oil, the following interventions may present some benefits for RD: (a)LMWH with 5-FU versus placebo at high-risk of developing postoperative proliferative vitreoretinopathy (PVR); (b) silicone oil was favorable for macular attachment at 2 years compared to sulfur hexafluoride (SF6); (c) Retinal redetachment was reported in fewer participants in the Pars plana vitrectomy (PPV) group compared to the scleral buckling group. So, these points can be considered when choosing the technique to improve better results in cases of retinal detachment. In addition, there is still a need for studies with a prophylactic RD approach and studies with greater evidence of which surgical technique is most appropriate for each indication of RD considering the economic cost and the patient's quality of life.

RESUMO Descolamento de retina (DR) é uma emergência oftalmológica comum que pode evoluir como uma das causas de cegueira se não for tratada ou tiver o tratamento demorado. Esta é uma revisão de revisões sistemáticas da Cochrane sobre descolamento de retina, relacionada às intervenções realizadas no tratamento do DR, após uma estratégia de busca apresentamos e analisamos os dados narrativamente conduzida no departamento de oftalmologia da Escola Paulista de Medicina-UNIFESP. Como resultado, o grupo de retinopexia pneumática foi menos suscetível ao descolamento de coroide e miopização como efeito adverso em comparação ao grupo de introflexão escleral. Apesar de não ter diferença estatisticamente significante entre a acuidade visual entre o uso de óleo de silicone padrão versus pesado, nem entre C3F8 e óleo de silicone, as seguintes intervenções apresentaram benefícios para o tratamento: (a) Heparina de baixo peso molecular com 5 fluorouracil diminuíram o risco de evoluir com proliferação vítreo-retiniana; (b) Uso de silicone foi mais favorável como substituto vítreo na fixação macular em 2 anos comparado com o uso de hexafluoreto de enxofre; (c) Novo descolamento de retina foi menor em pacientes submetidos a Vitrectomia pars plana comparada ao grupo de introflexão escleral. Portanto, esses dados podem ser considerados na escolha da técnica empregada para obter melhores resultados nos casos de DR. Além disso, existe a necessidade de estudos de alto nível de evidência em busca do procedimento cirúrgico mais apropriado e profilático para DR, levando em consideração custo-benefício e qualidade de vida.

Analysis of Cochrane Systematic Reviews about retinopathy of prematurity / Análise das Revisões Sistemáticas da Cochrane sobre retinopatia da prematuridade

ABSTRACT Background: Retinopathy of prematurity (ROP) is a vasoproliferative retinal disorder that affects extremely premature infants and is the leading cause of irreversible blindness in childhood. Objective: This study presents a review of Cochrane systematic reviews about ROP. Methods: We analyzed and summarized the results of all intervention, prevention and treatment, from Cochrane Systematic Reviews (SR) for ROP designed to the highest standard of rigor to show the current position and propose studies that are missing for decision making. Results: Eight SR were analyzed in this study, four in prophylaxis and four in treatment of ROP. The outcome 'Beneficial effect of oral beta-blockers on progression to stage 3 ROP but not to stage 2 ROP with plus disease or to stage 4 or 5 ROP was the only one that presented moderate evidence quality, all the others outcomes presented evidence quality floating from low to very low. Conclusion: There is a lack of studies showing the quality of evidence in the treatment and prevention of retinopathy of prematurity, particularly in long-term outcomes after treatment in order to assess the impact and quality of life of these patients.

RESUMO Introdução: A retinopatia da prematuridade (ROP) é um distúrbio vasoproliferativo da retina que afeta recém nascidos extremamente prematuros e é a principal causa de cegueira irreversível na infância. Objetivo: Este estudo apresenta uma revisão das revisões sistemáticas da Cochrane sobre ROP. Métodos: Analisamos e resumimos os resultados de todas as intervenções, prevenção e tratamento, das revisões sistemáticas (SR) da Cochrane para ROP, projetada com o mais alto padrão de rigor para mostrar a posição atual e propor estudos que estão faltando para a tomada de decisão. Resultados: Oito RS foram analisados neste estudo, quatro em profilaxia e quatro em tratamento de ROP. O efeito benéfico dos betabloqueadores orais na progressão para a ROP do estágio 3, mas não para a ROP da fase 2 com doença positiva ou para a ROP da fase 4 ou 5 foi o único que apresentou qualidade de evidência moderada, todos os outros resultados apresentaram qualidade de evidência flutuante de baixo a muito baixo. Conclusão: Faltam estudos demonstrando a qualidade das evidências no tratamento e prevenção da retinopatia da prematuridade, principalmente em desfechos em longo prazo após o tratamento, a fim de avaliar o impacto e a qualidade de vida desses pacientes.

What do Cochrane systematic reviews say about interventions for retinal vein occlusion / O que dizem as revisões sistemáticas da Cochrane sobre intervenções para oclusão da veia retiniana

Abstract Purpose: To summarize the evidence from Cochrane systematic reviews on interventions for Central or Branch Vein Occlusion. Methods: We included and summarized the results from Cochrane systematic reviews on interventions for both types of occlusion. The initial search retrieved was 21 reviews and four of them were selected. Results: The four systematic reviews included evaluated the effects of laser techniques and intravitreal injections of Anti-Vascular Endothelial Growth Factor (anti-VEGF) and corticosteroids on Branch and Central Retinal Vein Occlusions. Conclusions: In Branch Retinal Vein Occlusion was found some benefits in the use of grid laser when comparable to no intervention but insufficient evidence about the use of early grid laser, subthreshold laser, intravitreal triamcinolone or anti-VEGF over macular grid laser photocoagulation. In Central Retinal Vein Occlusion with Macular Edema was found insufficient evidence to determine the benefits of intravítreo steroids but ranibizumab may improve clinical and visual outcomes at six and 12 months and repeated intravitreal injection of anti-VEGF agents improved visual outcomes at six months when compared to no treatment.

Resumo Objetivo: Resumir as evidências das revisões sistemáticas da Cochrane sobre intervenções para oclusão de veia central ou de ramo. Métodos: Incluímos e resumimos os resultados das revisões sistemáticas da Cochrane sobre intervenções para os 2 tipos de oclusão. A busca inicial recuperada foi de 21 revisões e quatro delas foram selecionadas. Resultados: As quatro revisões sistemáticas incluídas avaliaram os efeitos das técnicas de laser e injeções intravítreas do Anti-Fator de Crescimento Endotelial Vascular (anti-VEGF) e corticosteroides nas oclusões de ramos e veias retinianas centrais. Conclusões: Na oclusão de veias retinianas do ramo foram encontrados alguns benefícios no uso do laser de grade, quando comparáveis a nenhuma intervenção, mas evidências insuficientes sobre o uso precoce do laser de grade, laser sublimiar, triamcinolona intravítrea ou anti-VEGF sobre a fotocoagulação a laser de grade macular. Na oclusão da veia central da retina com edema macular, foram encontradas evidências insuficientes para determinar os benefícios dos esteroides intravítreos, mas o ranibizumabe pode melhorar os resultados clínicos e visuais em 6 e 12 meses e a injeção intravítrea repetida de agentes anti-VEGF melhorou os resultados visuais em seis meses, quando comparado ao sem tratamento.

Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist.

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.

Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist

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)

What do Cochrane systematic reviews say about interventions for age-related macular degeneration?

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.

Statins and/or fibrates for diabetic retinopathy: a systematic review and meta-analysis.

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.

Statins and/or fibrates for diabetic retinopathy: a systematic review and meta-analysis

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)

O que as revisões sistemáticas Cochrane dizem sobre o uso das 10 novas práticas de medicina integrativa incorporadas ao Sistema Único de Saúde / What systematic reviews allows the doctor to use the 10 new practices of integrated medicine to the Unified Health System

Contexto: O Ministério da Saúde do Brasil anunciou, em março de 2018, uma expansão das políticas para práticas integrativas em saúde dentro do Sistema Único de Saúde (SUS), incorporando 10 novos tipos de práticas integrativas à lista de procedimentos disponíveis no sistema público de saúde brasileiro. Objetivo: Identificar, sintetizar e avaliar criticamente evidências de revisões sistemáticas Cochrane sobre as novas práticas de medicina integrativa inseridas no SUS. Métodos: Revisão de revisões sistemáticas conduzida pela Disciplina de Medicina Baseada em Evidências, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp), sobre as seguintes intervenções: apiterapia, aromaterapia, bioenergética, constelação familiar, terapia de florais, cromoterapia, geoterapia, hipnoterapia, imposição de mãos e ozonioterapia. Resultados: Foram incluídas 16 revisões sistemáticas: 4 sobre apiterapia, 4 sobre aromaterapia, 6 sobre hipnoterapia e 2 sobre ozonioterapia. Não foram encontradas revisões sistemáticas Cochrane referentes aos temas bioenergética, constelação familiar, cromoterapia, geoterapia, terapia de florais ou imposição de mãos. A única evidência de alta qualidade encontrada nessas revisões foi sobre o potencial benefício da apiterapia, especificamente para o uso de curativos de mel para cura parcial de feridas por queimadura, para redução de tosse entre crianças com tosse aguda e para prevenção de reações alérgicas a picadas de insetos. Conclusão: Exceto por alguns usos específicos da apiterapia (mel para lesões por queimadura e para tosse aguda e do veneno de abelhas para reações alérgicas às picadas de insetos), o uso das 10 práticas integrativas recentemente incorporadas ao SUS não é embasado por evidências de revisões sistemáticas Cochrane.

What do Cochrane systematic reviews say about interventions for age-related macular degeneration?

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.

What do Cochrane systematic reviews say about new practices on integrative medicine?

BACKGROUND: This study identified and summarized all Cochrane systematic reviews (SRs) on the effects of ten integrative practices that were recently added to the Brazilian public healthcare system (SUS). 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 SRs on the following interventions were identified, summarized and critically assessed: apitherapy, aromatherapy, bioenergetics, family constellation, flower therapy, chromotherapy, geotherapy, hypnotherapy, hand imposition or ozone therapy. RESULTS: We included a total of 16 SRs: 4 on apitherapy, 4 on aromatherapy, 6 on hypnotherapy and 2 on ozone therapy. No Cochrane SR was found regarding bioenergetics, family constellation, chromotherapy, clay therapy, flower therapy or hand imposition. The only high-quality evidence was in relation to the potential benefit of apitherapy, specifically regarding some benefits from honey dressings for partial healing of burn wounds, for reduction of coughing among children with acute coughs and for preventing allergic reactions to insect stings. CONCLUSION: Except for some specific uses of apitherapy (honey for burn wounds and for acute coughs and bee venom for allergic reactions to insect stings), the use of ten integrative practices that have recently been incorporated into SUS does not seem to be supported by evidence from Cochrane SRs.

What do Cochrane systematic reviews say about new practices on integrative medicine?

ABSTRACT BACKGROUND: This study identified and summarized all Cochrane systematic reviews (SRs) on the effects of ten integrative practices that were recently added to the Brazilian public healthcare system (SUS). 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 SRs on the following interventions were identified, summarized and critically assessed: apitherapy, aromatherapy, bioenergetics, family constellation, flower therapy, chromotherapy, geotherapy, hypnotherapy, hand imposition or ozone therapy. RESULTS: We included a total of 16 SRs: 4 on apitherapy, 4 on aromatherapy, 6 on hypnotherapy and 2 on ozone therapy. No Cochrane SR was found regarding bioenergetics, family constellation, chromotherapy, clay therapy, flower therapy or hand imposition. The only high-quality evidence was in relation to the potential benefit of apitherapy, specifically regarding some benefits from honey dressings for partial healing of burn wounds, for reduction of coughing among children with acute coughs and for preventing allergic reactions to insect stings. CONCLUSION: Except for some specific uses of apitherapy (honey for burn wounds and for acute coughs and bee venom for allergic reactions to insect stings), the use of ten integrative practices that have recently been incorporated into SUS does not seem to be supported by evidence from Cochrane SRs.

What do Cochrane systematic reviews say about diabetic retinopathy?

CONTEXT AND OBJECTIVE:: Diabetic retinopathy is a disease caused by increased permeability of retinal vessels. Its incidence and prevalence have been increasing due to urbanization, greater life expectancy and the habits of modern life. Its onset is insidious and it may lead to blindness in 75% of individuals who have been diabetic for more than 20 years. The aim here was to evaluate the evidence from Cochrane systematic reviews on interventions relating to diabetic retinopathy. DESIGN AND SETTING:: Review of systematic reviews, conducted at Cochrane Brazil. METHODS:: We included Cochrane systematic reviews on interventions relating to diabetic retinopathy. Two researchers evaluated the inclusion criteria, summarized the reviews and presented the results narratively. RESULTS:: Ten reviews met the inclusion criteria. They showed some evidence of benefits from: (a) photocoagulation for diabetic retinopathy; (b) strict glucose and pressure control for postponing the onset of retinopathy; (c) antiangiogenic drugs for macular edema (high-quality evidence); (d) anti-vascular endothelial growth factor agents for proliferative diabetic retinopathy (very low to low-quality evidence); and (e) intravitreal injection or surgical implantation for treating persistent or refractory macular edema. However, blood pressure control seems to have no benefit after the onset of retinopathy. CONCLUSION:: Only a few options are likely to be effective for treating diabetic retinopathy. These include photocoagulation and anti-vascular endothelial growth factor agents. Strict glucose and pressure control seem to postpone the onset of retinopathy. For macular edema, antiangiogenic drugs, intravitreal injection and surgical implantation seem to have some benefit.

Statins and Fibrates for Diabetic Retinopathy: Protocol for a Systematic Review.

BACKGROUND: Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus, and more than 75% of patients who have had diabetes for more than 20 years will have some degree of DR. This disease is highly destructive to self-esteem and puts a high burden on public health and pension systems due to the effects that it has on people of working age. The current mainstay of treatment is laser photocoagulation, which causes impairment of vision and discomfort to patients. Thus, finding a systemic drug that could act on all microcirculation and prevent direct manipulation of the eyes would be highly desirable. OBJECTIVE: To assess the efficacy and safety of the drugs in the statin and/or fibrate groups for the prevention and treatment of DR. METHODS: In this systematic review, we will select randomized controlled trials of fibrates or statins used for the treatment or prevention of DR. Our search strategy will include free text terms and controlled vocabulary (eg, MeSH, Emtree) for, "diabetic retinopathy", "statins", "fibrates", "hypolipidemic agents", and for drugs from both groups. Databases that will be used include Medical Literature Analysis and Retrieval System/PubMed, Embase, Cochrane Central Register of Controlled Trials, Latin American and Caribbean Center on Health Sciences Information, Clinicaltrials.gov, World Health Organization International Clinical Trials Registry Platform, and OpenGrey, and we will not have language or date limits. Two review authors will independently select eligible studies and assess the risk of bias using the Cochrane Collaboration's tool. We will report structured summaries of the included studies and, if possible, conduct meta-analyses. RESULTS: This is a protocol for a systematic review, therefore results are not available. We registered a short version of this protocol before progressing in the review and we are currently in the process of selecting the studies for inclusion. CONCLUSIONS: Intensive glucose control and lowering blood pressure and lipids are mechanisms that protect macrocirculation in diabetic patients. Both macrovascular and microvascular events in diabetic patients appear to have a common pathway, starting with endothelial injury. Thus, prevention and treatment of microvascular events may benefit from the same interventions. In the review for which we have written this protocol, we will assess whether the use of lipid-lowering oral drugs of the statin and/or fibrate groups may prevent and/or retard progression of DR, with the added benefit of preserving visual acuity. TRIAL REGISTRATION: PROSPERO CRD42016029746.

What do Cochrane systematic reviews say about diabetic retinopathy? / O que as revisões sistemáticas da Cochrane dizem sobre retinopatia diabética?

ABSTRACT CONTEXT AND OBJECTIVE: Diabetic retinopathy is a disease caused by increased permeability of retinal vessels. Its incidence and prevalence have been increasing due to urbanization, greater life expectancy and the habits of modern life. Its onset is insidious and it may lead to blindness in 75% of individuals who have been diabetic for more than 20 years. The aim here was to evaluate the evidence from Cochrane systematic reviews on interventions relating to diabetic retinopathy. DESIGN AND SETTING: Review of systematic reviews, conducted at Cochrane Brazil. METHODS: We included Cochrane systematic reviews on interventions relating to diabetic retinopathy. Two researchers evaluated the inclusion criteria, summarized the reviews and presented the results narratively. RESULTS: Ten reviews met the inclusion criteria. They showed some evidence of benefits from: (a) photocoagulation for diabetic retinopathy; (b) strict glucose and pressure control for postponing the onset of retinopathy; (c) antiangiogenic drugs for macular edema (high-quality evidence); (d) anti-vascular endothelial growth factor agents for proliferative diabetic retinopathy (very low to low-quality evidence); and (e) intravitreal injection or surgical implantation for treating persistent or refractory macular edema. However, blood pressure control seems to have no benefit after the onset of retinopathy. CONCLUSION: Only a few options are likely to be effective for treating diabetic retinopathy. These include photocoagulation and anti-vascular endothelial growth factor agents. Strict glucose and pressure control seem to postpone the onset of retinopathy. For macular edema, antiangiogenic drugs, intravitreal injection and surgical implantation seem to have some benefit.

RESUMO CONTEXTO: A retinopatia diabética é uma doença causada pelo aumento da permeabilidade dos vasos da retina. Sua incidência e prevalência vêm aumentando devido à urbanização, maior expectativa de vida e hábitos de vida modernos. Seu início é insidioso e pode levar à cegueira em 75% dos pacientes diabéticos com mais de 20 anos de doença. O objetivo foi avaliar a evidência das revisões sistemáticas Cochrane sobre intervenções para retinopatia diabética. TIPO DE ESTUDO E LOCAL: Revisão de revisões sistemáticas conduzida no Centro Cochrane do Brasil. MÉTODOS: Nós incluímos revisões sistemáticas Cochrane sobre intervenções para retinopatia diabética. Dois pesquisadores avaliaram os critérios de inclusão, resumiram as revisões e apresentaram os resultados narrativamente. RESULTADOS: Dez revisões preencheram os critérios de inclusão e mostraram benefícios com: (a) fotocoagulação para retinopatia diabética; (b) controle rigoroso da glicose e da pressão para adiar o início da retinopatia; (c) fármacos antiangiogênicos para edema macular (evidência de alta qualidade); (d) agentes antifator de crescimento do endotélio vascular para retinopatia diabética proliferativa (evidência de qualidade muito baixa a baixa); (e) injeção intravítrea ou implante cirúrgico para o tratamento do edema macular persistente ou refratário. No entanto, o controle da pressão arterial parece não ter benefício após o início da retinopatia. CONCLUSÃO: Existem poucas opções provavelmente efetivas para o tratamento da retinopatia diabética. Estas incluem fotocoagulação e agentes antifator de crescimento do endotélio vascular. O controle rigoroso da glicose e da pressão parecem adiar o início da retinopatia. Para o edema macular, fármacos antiangiogênicos, injeção intravítrea e implante cirúrgico parecem ter algum benefício.

Statins and Fibrates for Diabetic Retinopathy: Protocol for a Systematic Review

BACKGROUND:Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus, and more than 75% of patients who have had diabetes for more than 20 years will have some degree of DR. This disease is highly destructive to self-esteem and puts a high burden on public health and pension systems due to the effects that it has on people of working age. The current mainstay of treatment is laser photocoagulation, which causes impairment of vision and discomfort to patients. Thus, finding a systemic drug that could act on all microcirculation and prevent direct manipulation of the eyes would be highly desirable.OBJECTIVE:To assess the efficacy and safety of the drugs in the statin and/or fibrate groups for the prevention and treatment of DR.METHODS:In this systematic review, we will select randomized controlled trials of fibrates or statins used for the treatment or prevention of DR. Our search strategy will include free text terms and controlled vocabulary (eg, MeSH, Emtree) for, "diabetic retinopathy", "statins", "fibrates", "hypolipidemic agents", and for drugs from both groups. Databases that will be used include Medical Literature Analysis and Retrieval System/PubMed, Embase, Cochrane Central Register of Controlled Trials, Latin American and Caribbean Center on Health Sciences Information, Clinicaltrials.gov, World Health Organization International Clinical Trials Registry Platform, and OpenGrey, and we will not have language or date limits. Two review authors will independently select eligible studies and assess the risk of bias using the Cochrane Collaboration's tool. We will report structured summaries of the included studies and, if possible, conduct meta-analyses.