Prevalence of orofacial injuries in wheeled non-motor sports athletes: A systematic review and meta-analysis.

BACKGROUND/AIMS: As the popularity of sports activities grows, so do the number of sport-related injuries. Furthermore, sports that use equipment or vehicles that modify the speed of the player can present more serious injuries. The aim of this systematic review was to identify the overall prevalence of orofacial trauma in wheeled non-motor sports athletes. METHODS: The search strategy was applied in eight electronic databases (Embase, LILACS, Livivo, PEDro, PubMed, Scopus, SportDiscus, and Web of Science). Additionally, a complementary search of the gray literature (Google Scholar, OpenGrey, and ProQuest Dissertations & Theses Global), reference lists of included articles, and studies indicated by experts on the subject was done. The included articles were observational studies with sufficient data of orofacial trauma (type and anatomical site) in wheeled non-motor sport athletes, regardless of the competition level. Risk of bias was assessed by using the Joanna Briggs Institute Critical Appraisal Checklist for Studies Reporting Prevalence Data. The meta-analysis was performed using R Statistics software, and the strength of cumulative evidence was assessed by The Grading of Recommendations Assessment, Development, and Evaluation. RESULTS: From 4042 identified studies, after the removal of duplicates and phase one of selection (title and abstracts screening), 251 studies remained for phase two (full-text screening). Five articles were finally included. One study was considered to have a low risk of bias and four had a moderate risk of bias. The cumulative prevalence of orofacial injuries in wheeled non-motor sport athletes was 21.7% (CI: 8.7-34.7; I2 :97.6%) and the prevalence of dental injuries in these sports was 7.5% (CI:4.3-10.7; I2 :61.9%). The certainty in cumulative evidence was considered to be very low. CONCLUSION: About 22% of the wheeled non-motor sport athletes have suffered orofacial injuries. The most prevalent type of injury was classified as dental trauma.

Effectiveness of virtual reality in children and young adults with cerebral palsy: a systematic review of randomized controlled trial.

BACKGROUND: Cerebral palsy (CP) is one of the main causes of disability in childhood. Virtual reality (VR) has been used as a treatment option in this population, however its effectiveness is unclear. OBJECTIVE: To evaluate the effectiveness of VR in patients with CP. METHODS: We conducted electronic searches in EMBASE, MEDLINE, Cochrane library, PEDro, AMED, PsycoINFO, and LILACS databases and trial site registries such as ClinicalTrials.gov and ICTRP. We included randomized controlled trials that tested the use of VR alone or in combination with other interventions compared to more conventional rehabilitation or usual care in individuals with CP. The primary outcomes were upper and lower limb function, postural control, and balance. The secondary outcomes included global motor function, perception, cognition and spatial functions, motivation, motor learning, and adverse events. Two independent reviewers extracted and assessed included articles for risk of bias using the Cochrane risk of bias tool. We use a meta-analysis with random effect model whenever possible. We analyzed the quality of evidence using theGRADE approach. RESULTS: We included 38 trials (pooled n = 1233 participants) in this review. There is very low quality of evidence that VR plus conventional rehabilitation is better than conventional rehabilitation for upper limb function. There is also very low quality evidence that VR alone is no better than conventional rehabilitation for upper and lower limb function. No adverse events were observed among the 10 trials that provided information on this outcome. CONCLUSION: At present we have very limited to limited confidence in effect estimation for utilization of VR in this population. Future studies may change our confidence in results and effect estimates. PROTOCOL REGISTRATION: PROSPERO CRD 42018102759.

Complementary and alternative therapies for post-caesarean pain.

BACKGROUND: Pain after caesarean sections (CS) can affect the well-being of the mother and her ability with her newborn. Conventional pain-relieving strategies are often underused because of concerns about the adverse maternal and neonatal effects. Complementary alternative therapies (CAM) may offer an alternative for post-CS pain. OBJECTIVES: To assess the effects of CAM for post-caesarean pain. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, LILACS, PEDro, CAMbase, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (6 September 2019), and checked the reference lists of retrieved articles. SELECTION CRITERIA: Randomised controlled trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing CAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE. MAIN RESULTS: We included 37 studies (3076 women) which investigated eight different CAM therapies for post-CS pain relief. There is substantial heterogeneity among the trials. We downgraded the certainty of evidence due to small numbers of women participating in the trials and to risk of bias related to lack of blinding and inadequate reporting of randomisation processes. None of the trials reported pain at six weeks after discharge. Primary outcomes were pain and adverse effects, reported per intervention below. Secondary outcomes included vital signs, rescue analgesic requirement at six weeks after discharge; all of which were poorly reported, not reported, or we are uncertain as to the effect Acupuncture or acupressure We are very uncertain if acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) has any effect on pain because the quality of evidence is very low. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 130 women; 2 studies; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence). It is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) has any effect on the risk of adverse effects because the quality of evidence is very low. Aromatherapy Aromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). We are uncertain if aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia. Electromagnetic therapy Electromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence). Massage We identified six studies (651 women), five of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty. Music Music plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; participants = 115; studies = 2; I2 = 0%; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low. Reiki We are uncertain if Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women). Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence). Transcutaneous electrical nerve stimulation TENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain compared with placebo plus analgesia at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 108 women; 1 study; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence). We are uncertain if TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women). AUTHORS' CONCLUSIONS: Some CAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain. Since pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of CAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed lin this review, and use validated scales.

Toric intraocular lens versus limbal relaxing incisions for corneal astigmatism after phacoemulsification.

BACKGROUND: Cataract is the leading cause of blindness in the world, and clinically significant astigmatism may affect up to approximately 20% of people undergoing cataract surgery. Pre-existing astigmatism in people undergoing cataract surgery may be treated, among other techniques, by placing corneal incisions near the limbus (limbal relaxing incisions or LRIs) or by toric intraocular lens (IOLs) specially designed to reduce or treat the effect of corneal astigmatism on unaided visual acuity. OBJECTIVES: To assess the effects of toric IOLs compared with LRIs in the management of astigmatism during phacoemulsification cataract surgery. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register; 2019, Issue 9); Ovid MEDLINE; Ovid Embase and four other databases. The date of the search was 27 September 2019. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing toric IOLs with LRIs during phacoemulsification cataract surgery.  DATA COLLECTION AND ANALYSIS: We used standard methods expected by Cochrane. We graded the certainty of the evidence using GRADE. Our primary outcome was the proportion of participants with postoperative residual refractive astigmatism of less than 0.50 dioptres (D) six months or more after surgery. We also collected data on mean residual refractive astigmatism. Secondary outcomes included: uncorrected distance visual acuity, vision-related quality of life, spectacle independence and adverse effects including postoperative lens rotation requiring re-alignment. To supplement the main systematic review assessing the effects of toric IOLs compared with LRIs in the management of astigmatism during phacoemulsification cataract surgery, we sought to identify economic evaluations on the subject. MAIN RESULTS: We identified 10 relevant studies including 517 people (626 eyes). These studies took place in China (three studies), UK (three), Brazil (one), India (one), Italy (one) and Spain (one). The median age of participants was 71 years. The level of corneal astigmatism specified in the inclusion criteria of these studies ranged from 0.75 D to 3 D. A variety of toric IOLs were used in these studies, in all but one study, these were monofocal. Studies used three different nomograms to determine the size and placement of the LRI. Two studies did not specify this. None of the studies were at low risk of bias in all domains, but two studies were at low risk of bias in all domains except selective outcome reporting, which was unclear. The remaining studies were at a mixture of low, unclear or high risk of bias. People receiving toric IOLs were probably more likely to achieve a postoperative residual refractive astigmatism of less than 0.5 D six months or more after surgery (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.10 to 1.78; 5 RCTs, 262 eyes). We judged this to be moderate-certainty evidence, downgrading for risk of bias. In the included studies, approximately 500 eyes per 1000 achieved postoperative astigmatism less than 0.5 D in the LRI group compared with 700 per 1000 in the toric IOLs group. There was a small difference in residual astigmatism between the two groups, favouring toric IOLs (mean difference (MD) -0.32 D, 95% CI -0.48 to -0.15 D; 10 RCTs, 620 eyes). Although all studies favoured toric IOLs, the results of individual studies were inconsistent (range of effects -0.02 D to -0.71 D; I² = 89%). We considered this to be low-certainty evidence, downgrading for risk of bias and inconsistency. People receiving a toric IOL probably have a small improvement in visual acuity at six months or more after surgery compared to people receiving LRI, but the difference is small and probably clinically insignificant (MD -0.04 logMAR, 95% CI -0.07 to -0.02; 8 RCTs, 474 eyes; moderate-certainty evidence). Low-certainty evidence from one study of 40 people suggested little difference in vision-related quality of life measured using the Visual Function Index (VF-14) (MD -3.01, 95% CI -8.56 to 2.54). Two studies reported spectacle independence and suggested that people receiving toric IOLs may be more likely to be spectacle independent (RR 1.56, 95% CI 1.14 to 2.15; 100 people; low-certainty evidence). There were no cases of lens rotation requiring surgery (very low-certainty evidence). Five studies (320 eyes) commented on a range of other adverse effects including corneal oedema, endophthalmitis and corneal ectasia. All these studies reported that there were no adverse events with the exception of one study (40 eyes) where one participant in the LRI group had a central de-epithelisation which recovered over 10 days. We found no economic studies that compared toric IOLs with LRIs. AUTHORS' CONCLUSIONS: Toric IOLs probably provide a higher chance of achieving astigmatism within 0.5 D after cataract surgery compared with LRIs. There may be a small mean difference in postoperative astigmatism, favouring toric IOLs, but this difference is likely to be clinically unimportant. There was no evidence of an important difference in postoperative visual acuity or quality of life between the techniques. Evidence on adverse effects was uncertain. The apparent shortage of relevant economic evaluations indicates that economic evidence regarding the costs and consequence of these two procedures is currently lacking.

Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain.

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.

Thoracic outlet syndrome: a narrative review. / Síndrome do desfiladeiro torácico: uma revisão narrativa.

The Thoracic Outlet Syndrome (TOS) results from compression of the brachial plexus, the subclavian artery and the subclavian vein in the thoracic outlet region. This compression may take place between the clavicle and the first rib or by a number of anatomical variations. Neurological compression is the most common form of thoracic outlet syndrome. Vascular complications occur infrequently. Arterial complications usually result from compression of the subclavian artery by a complete cervical rib. Venous complications are often related to muscle compression of the subclavian vein. The neurogenic form, previously described, is the most common, constituting more than 95% of cases, while the venous represents 2% to 3%, and the arterial, about 1%. Risk factors include biotype and individual variations such as genetics, age and gender. In Brazil, there are no data on the epidemiology of TOS. Given the suspicion of TOS, a detailed clinical evaluation is necessary, followed by complementary exams to elucidate the cause. The treatment is directed according to the etiology and the presence or absence of complications. The purpose of this study was to perform a narrative review on TOS, focusing on its etiology, pathophysiology, epidemiology, clinical evaluation, complementary exams, differential diagnoses, and treatment.

A Síndrome do Desfiladeiro Torácico (SDT) é causada pela compressão do plexo braquial, artéria subclávia e veia subclávia na região do desfiladeiro torácico. Estas estruturas podem ser comprimidas entre a clavícula e a primeira costela ou por um número de variações anatômicas. A compressão neurológica é a forma mais comum da síndrome do desfiladeiro torácico. Complicações vasculares ocorrem com pouca frequência. Complicações arteriais geralmente resultam da compressão da artéria subclávia por costela cervical completa. As complicações venosas estão muitas vezes relacionadas à compressão muscular da veia subclávia. A forma neurogênica, anteriormente descrita, é a mais comum, constituindo mais de 95% dos casos. Já a forma venosa representa 2% a 3% e, a arterial, cerca de 1% dos casos. Fatores de risco incluem biótipo e variações individuais, como genética, idade e sexo. No Brasil, não há dados acerca da epidemiologia da SDT. Diante da suspeita de SDT é necessária uma avaliação clínica detalhada, seguida de exames complementares para elucidação da causa. O tratamento é direcionado de acordo com a etiologia e a presença ou não de complicações. A proposta do presente trabalho foi realizar uma revisão narrativa sobre a SDT, versando sobre sua etiologia, fisiopatologia, epidemiologia, avaliação clínica, exames complementares, diagnósticos diferenciais e tratamento.

Barriers to outpatient education for medical students: a narrative review.

OBJECTIVES: This study surveys medical education literature published over the last 25 years (1993-2018) to identify the factors scholars consider deleterious to outpatient teaching for medical students. METHODS: This study conducts a review of medical education literature published between 1993 and 2018 using Medline, Lilacs, Ibecs, Cochrane Library, and Scielo databases. The following search terms were utilized: "Education, Medical, Undergraduate" AND "Ambulatory Care" AND "Teaching/methods" OR "Clinical Clerkship" OR "Preceptorship." This study focuses on papers describing deleterious factors for outpatient teaching with medical students and analyzes their results, discussions, and conclusions sections. RESULTS: Of the 363 articles obtained, this study selected 33 for analysis. These papers identify numerous factors as barriers to outpatient education. For didactic purposes, these factors are categorized into four barrier groups: environment-institution, academic staff, students, and patients. Academic staff-related teaching barrier was the most frequently mentioned obstacle. Intense care schedule with little teaching time was considered the most common and relevant barrier to outpatient medical education, followed by inappropriate teaching environment and inadequate supervision model. CONCLUSIONS: There is a lack of recent literature on studies focusing on barriers to effective outpatient medical education. Factors identified as harmful to outpatient education have been pointed out by course directors, academic staff, and students in the literature. However, many of these factors remain overlooked by educators, who can use these factors to modify their academic activities for more effective results.

Percepção de Alunos de Curso de Graduação em Medicina sobre o Team-Based Learning (TBL) / Undergraduate Medical Students' Views on Team-Based Learning (TBL)

RESUMO O Team-Based Learning (TBL) é uma estratégia educacional baseada em aprendizagem ativa que se tornou uma proposta pedagógica alternativa importante no contexto dos métodos de ensino utilizados em educação médica. A proposta do presente trabalho foi avaliar a percepção dos alunos sobre o uso da metodologia TBL em curso de graduação em Medicina e analisar os diferentes aspectos da aplicação desse método de ensino em relação à forma tradicional de ensino utilizada na maior parte dos cursos de Medicina no País. Foi aplicado um questionário específico aos alunos com oito questões e respostas dicotomizadas (escala de Likert com cinco itens). Durante o mês de junho de 2017, alunos do curso de graduação em Medicina (quarto e sétimo períodos) foram submetidos a várias sessões de ensino com o método TBL na Universidade Municipal de São Caetano do Sul (USCS) com os temas sepse, trauma, leucemia, câncer colorretal e câncer de pulmão. A amostra foi calculada em 193 participantes, considerando uma precisão relativa de 10% e um nível de significância de 5% para uma estimativa de 70% de respostas positivas (concordo e concordo firmemente) para a afirmação "Esse TBL teve um impacto positivo no meu aprendizado". A análise foi realizada com cálculo de estatística descritiva e das frequências relativas e absolutas de respostas com intervalo de confiança de 95% para cada ponto estimado. A utilização do método foi percebida como favorável nos aspectos de preferência (em relação à aula expositiva tradicional), motivação, satisfação e aprendizado. O TBL se destacou como um método pedagógico excelente para a aprendizagem em alunos do curso de Medicina. Uma das vantagens foi a capacidade de desenvolver habilidades em raciocínio clínico e a possibilidade de construir o conhecimento com sua utilização prática. O método ativo apareceu, dessa forma, como uma importante alternativa de metodologia se comparada ao método tradicional.

ABSTRACT Team-Based Learning (TBL) is an educational strategy based on active learning which has become an important alternative pedagogical proposal in the context of teaching methods used in medical education. The aim of this study was to evaluate students' perceptions about the use of the TBL methodology in Medical School and to analyze the different aspects of the application of this teaching method. A specific questionnaire was applied to the students with 8 questions and dichotomized answers (Likert scale with 5 items). During the month of June 2017 second and fourth year undergraduate medical students underwent several sessions of teaching with the TBL method at the Municipal University of São Caetano do Sul (USCS) with focus on the following themes: sepsis; trauma; leukemia; colorectal cancer; and lung cancer. The sample was calculated on 193 participants considering a relative precision of 10% and a statistical significance of 5% for an estimate of 70% of positive responses (strongly agree and agree) to the statement "This TBL had a positive impact on my learning". The analysis was performed with descriptive statistics and the relative and absolute frequencies of responses with a 95% confidence interval for each estimated point. The use of the method was perceived as positive in aspects of preference (regarding the traditional expository class), motivation, satisfaction and learning. TBL stood out as an excellent pedagogical method for learning among medical students. One of the advantages was the ability to develop skills in clinical reasoning and the possibility of building knowledge with its practical use. The active method was thus found to be an important methodological alternative when compared to the traditional method.

Effectiveness of different accelerated partial breast irradiation techniques for the treatment of breast cancer patients: Systematic review using indirect comparisons of randomized clinical trials.

AIM: This systematic review was conducted to compare the effectiveness of different accelerated partial breast irradiation (APBI) techniques for the treatment of breast cancer patients. BACKGROUND: Numerous (APBI) techniques are available for clinical practice. METHODS AND MATERIALS: Systematic review of randomized controlled trials of APBI versus whole breast irradiation (WBI). The data from APBI studies were extracted for the analyses. Indirect comparisons were used to compare different APBI techniques. RESULTS: Ten studies fulfilled the inclusion criteria. A total of 4343 patients were included, most of them with tumor stage T1-T2 and N0. Regarding APBI techniques, six trials used external beam radiation therapy; one intraoperative electrons; one intraoperative low-energy photons; one brachytherapy; and one external beam radiation therapy or brachytherapy. The indirect comparisons related to 5-years local control and 5-years overall survival were not significantly different between APBI techniques. CONCLUSIONS: Based on indirect comparisons, no differences in clinical outcomes were observed among diverse APBI techniques in published clinical trials that formally compared WBI to APBI. However wide confidence intervals and high risk of inconsistency precluded a sound conclusion. Further head-to-head clinical trials comparing different APBI techniques are required to confirm our findings. Studies comparing different techniques using individual participant data and/or real-life data from population-based studies/registries could also provide more robust results.

Non-invasive positive pressure ventilation for prevention of complications after pulmonary resection in lung cancer patients.

BACKGROUND: Pulmonary complications are often seen during the postoperative period following lung resection for patients with lung cancer. Some situations such as intubation, a long stay in the intensive care unit, the high cost of antibiotics and mortality may be avoided with the prevention of postoperative pulmonary complications. Non-invasive positive pressure ventilation (NIPPV) is widely used in hospitals, and is thought to reduce the number of pulmonary complications and mortality after this type of surgery. Therefore, a systematic review is needed to critically assess the benefits and harms of NIPPV for patients undergoing lung resection. This is an update of a Cochrane review first published in 2015. OBJECTIVES: To assess the effectiveness and safety of NIPPV for preventing complications in patients following pulmonary resection for lung cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS and PEDro until 21 December 2018, to identify potentially eligible trials. We did not use any date or language restrictions in the electronic searches. We searched the reference lists of relevant papers and contacted experts in the field for information about additional published and unpublished studies. We also searched the Register of Controlled Trials (www.controlled-trials.com) and ClinicalTrials.gov (clinicaltrials.gov) to identify ongoing studies. SELECTION CRITERIA: We considered randomised or quasi-randomised clinical trials that compared NIPPV in the immediate postoperative period after pulmonary resection with no intervention or conventional respiratory therapy. DATA COLLECTION AND ANALYSIS: Two authors collected data and assessed trial risk of bias. Where possible, we pooled data from the individual studies using a fixed-effect model (quantitative synthesis), but where this was not possible we tabulated or presented the data in the main text (qualitative synthesis). Where substantial heterogeneity existed, we applied a random-effects model. MAIN RESULTS: Of the 190 references retrieved from the searches, 7 randomised clinical trials (RCTs) (1 identified with the new search) and 1 quasi-randomised trial fulfilled the eligibility criteria for this review, including a total of 486 patients. Five studies described quantitative measures of pulmonary complications, with pooled data showing no difference between NIPPV compared with no intervention (RR 1.03; 95% CI 0.72 to 1.47). Three studies reported intubation rates and there was no significant difference between the intervention and control groups (RR 0.55; 95% CI 0.25 to 1.20). Five studies reported measures of mortality on completion of the intervention period. There was no statistical difference between the groups for this outcome (RR 0.60; 95% CI 0.24 to 1.53). Similar results were observed in the subgroup analysis considering ventilatory mode (bi-level versus continuous positive airway pressure (CPAP). No study evaluated the postoperative use of antibiotics. Two studies reported the length of intensive care unit stay and there was no significant difference between the intervention and control groups (MD -0.75; 95% CI -3.93 to 2.43). Four studies reported the length of hospital stay and there was no significant difference between the intervention and control groups (MD -0.12; 95% CI -6.15 to 5.90). None of the studies described any complications related to NIPPV. Of the seven included studies, four studies were considered as 'low risk of bias' in all domains, two studies were considered 'high risk of bias' for the allocation concealment domain, and one of these was also considered 'high risk of bias' for random sequence generation. One other study was considered 'high risk of bias' for including participants with more severe disease. The new study identified could not be included in the meta-analysis as its intervention differed from the other studies (use of pre and postoperative NIPPV in the same population). AUTHORS' CONCLUSIONS: This review demonstrated that there was no additional benefit of using NIPPV in the postoperative period after pulmonary resection for all outcomes analysed (pulmonary complications, rate of intubation, mortality, postoperative consumption of antibiotics, length of intensive care unit stay, length of hospital stay and adverse effects related to NIPPV). However, the quality of evidence is 'very low', 'low' and 'moderate' since there were few studies, with small sample size and low frequency of outcomes. New well-designed and well-conducted randomised trials are needed to answer the questions of this review with greater certainty.

Short-acting insulin analogues versus regular human insulin on postprandial glucose and hypoglycemia in type 1 diabetes mellitus: a systematic review and meta-analysis.

INTRODUCTION: Strict glucose control using multiple doses of insulin is the standard treatment for type 1 diabetes mellitus (T1DM), but increased risk of hypoglycemia is a frequent drawback. Regular insulin in multiple doses is important for achieving strict glycemic control for T1DM, but short-acting insulin analogues may be better in reducing hypoglycemia and postprandial glucose levels. OBJECTIVE: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the effects of short-acting insulin analogues vs regular human insulin on hypoglycemia and postprandial glucose in patients with T1DM. METHODS: Searches were run on the electronic databases MEDLINE, Cochrane-CENTRAL, EMBASE, ClinicalTrials.gov, LILACS, and DARE for RCTs published until August 2017. To be included in the study, the RCTs had to cover a minimum period of 4 weeks and had to assess the effects of short-acting insulin analogues vs regular human insulin on hypoglycemia and postprandial glucose levels in patients with T1DM. Two independent reviewers extracted the data and assessed the quality of the selected studies. The primary outcomes analyzed were hypoglycemia (total episodes, nocturnal hypoglycemia, and severe hypoglycemia) and postprandial glucose (at all times, after breakfast, after lunch, and after dinner). Glycated hemoglobin (HbA1c) levels and quality of life were considered secondary outcomes. The risk of bias of each RCT was assessed using the Cochrane Collaboration Risk of Bias table, while the quality of evidence for each outcome was assessed using the GRADEpro software. The pooled mean difference in the number of hypoglycemic episodes and postprandial glucose between short-acting insulin analogues vs. regular human insulin was calculated using the random-effects model. RESULTS: Of the 2897 articles retrieved, 22 (6235 patients) were included. Short-acting insulin analogues were associated with a decrease in total hypoglycemic episodes (risk rate 0.93, 95% CI 0.87-0.99; 6235 patients; I2 = 81%), nocturnal hypoglycemia (risk rate 0.55, 95% CI 0.40-0.76, 1995 patients, I2 = 84%), and severe hypoglycemia (risk rate 0.68, 95% CI 0.60-0.77; 5945 patients, I2 = 0%); and with lower postprandial glucose levels (mean difference/MD - 19.44 mg/dL; 95% CI - 21.49 to - 17.39; 5031 patients, I2 = 69%) and lower HbA1c (MD - 0,13%; IC 95% - 0.16 to - 0.10; 5204 patients; I2 = 73%) levels. CONCLUSIONS: Short-acting insulin analogues are superior to regular human insulin in T1DM patients for the following outcomes: total hypoglycemic episodes, nocturnal hypoglycemia, severe hypoglycemia, postprandial glucose, and HbA1c.

Síndrome do desfiladeiro torácico: uma revisão narrativa / Thoracic outlet syndrome: a narrative review

RESUMO A Síndrome do Desfiladeiro Torácico (SDT) é causada pela compressão do plexo braquial, artéria subclávia e veia subclávia na região do desfiladeiro torácico. Estas estruturas podem ser comprimidas entre a clavícula e a primeira costela ou por um número de variações anatômicas. A compressão neurológica é a forma mais comum da síndrome do desfiladeiro torácico. Complicações vasculares ocorrem com pouca frequência. Complicações arteriais geralmente resultam da compressão da artéria subclávia por costela cervical completa. As complicações venosas estão muitas vezes relacionadas à compressão muscular da veia subclávia. A forma neurogênica, anteriormente descrita, é a mais comum, constituindo mais de 95% dos casos. Já a forma venosa representa 2% a 3% e, a arterial, cerca de 1% dos casos. Fatores de risco incluem biótipo e variações individuais, como genética, idade e sexo. No Brasil, não há dados acerca da epidemiologia da SDT. Diante da suspeita de SDT é necessária uma avaliação clínica detalhada, seguida de exames complementares para elucidação da causa. O tratamento é direcionado de acordo com a etiologia e a presença ou não de complicações. A proposta do presente trabalho foi realizar uma revisão narrativa sobre a SDT, versando sobre sua etiologia, fisiopatologia, epidemiologia, avaliação clínica, exames complementares, diagnósticos diferenciais e tratamento.

ABSTRACT The Thoracic Outlet Syndrome (TOS) results from compression of the brachial plexus, the subclavian artery and the subclavian vein in the thoracic outlet region. This compression may take place between the clavicle and the first rib or by a number of anatomical variations. Neurological compression is the most common form of thoracic outlet syndrome. Vascular complications occur infrequently. Arterial complications usually result from compression of the subclavian artery by a complete cervical rib. Venous complications are often related to muscle compression of the subclavian vein. The neurogenic form, previously described, is the most common, constituting more than 95% of cases, while the venous represents 2% to 3%, and the arterial, about 1%. Risk factors include biotype and individual variations such as genetics, age and gender. In Brazil, there are no data on the epidemiology of TOS. Given the suspicion of TOS, a detailed clinical evaluation is necessary, followed by complementary exams to elucidate the cause. The treatment is directed according to the etiology and the presence or absence of complications. The purpose of this study was to perform a narrative review on TOS, focusing on its etiology, pathophysiology, epidemiology, clinical evaluation, complementary exams, differential diagnoses, and treatment.

Effectiveness and safety of carbohydrate counting in the management of adult patients with type 1 diabetes mellitus: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to evaluate the effectiveness and safety of carbohydrate counting (CHOC) in the treatment of adult patients with type 1 diabetes mellitus (DM1). MATERIALS AND METHODS: We performed a systematic review of randomized studies that compared CHOC with general dietary advice in adult patients with DM1. The primary outcomes were changes in glycated hemoglobin (HbA1c), quality of life, and episodes of severe hypoglycemia. We searched the following electronic databases: Embase, PubMed, Lilacs, and the Cochrane Central Register of Controlled Trials. The quality of evidence was analyzed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: A total of 3,190 articles were identified, and two reviewers independently screened the titles and abstracts. From the 15 potentially eligible studies, five were included, and 10 were excluded because of the lack of randomization or different control/intervention groups. Meta-analysis showed that the final HbA1c was significantly lower in the CHOC group than in the control group (mean difference, random, 95% CI: -0.49 (-0.85, -0.13), p = 0.006). The meta-analysis of severe hypoglycemia and quality of life did not show any significant differences between the groups. According to the GRADE, the quality of evidence for severe hypoglycemia, quality of life, and change in HbA1c was low, very low, and moderate, respectively. CONCLUSION: The meta-analysis showed evidence favoring the use of CHOC in the management of DM1. However, this benefit was limited to final HbA1c, which was significantly lower in the CHOC than in the control group.

Effectiveness and safety of carbohydrate counting in the management of adult patients with type 1 diabetes mellitus: a systematic review and meta-analysis

Abstract Objective: This study aimed to evaluate the effectiveness and safety of carbohydrate counting (CHOC) in the treatment of adult patients with type 1 diabetes mellitus (DM1). Materials and methods: We performed a systematic review of randomized studies that compared CHOC with general dietary advice in adult patients with DM1. The primary outcomes were changes in glycated hemoglobin (HbA1c), quality of life, and episodes of severe hypoglycemia. We searched the following electronic databases: Embase, PubMed, Lilacs, and the Cochrane Central Register of Controlled Trials. The quality of evidence was analyzed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: A total of 3,190 articles were identified, and two reviewers independently screened the titles and abstracts. From the 15 potentially eligible studies, five were included, and 10 were excluded because of the lack of randomization or different control/intervention groups. Meta-analysis showed that the final HbA1c was significantly lower in the CHOC group than in the control group (mean difference, random, 95% CI: −0.49 (-0.85, −0.13), p = 0.006). The meta-analysis of severe hypoglycemia and quality of life did not show any significant differences between the groups. According to the GRADE, the quality of evidence for severe hypoglycemia, quality of life, and change in HbA1c was low, very low, and moderate, respectively. Conclusion: The meta-analysis showed evidence favoring the use of CHOC in the management of DM1. However, this benefit was limited to final HbA1c, which was significantly lower in the CHOC than in the control group.

Physical Activity Interventions in Faith-Based Organizations: A Systematic Review.

OBJECTIVE: To review and assess the effectiveness of physical activity interventions delivered in faith-based organizations. DATA SOURCE: We searched the Cochrane Library, DoPHER, EMBASE, LILACS, MEDLINE, PsycINFO, WHO ICTRP, and Clinicaltrials.gov databases until January 2016, without restriction of language or publication date. STUDY INCLUSION AND EXCLUSION CRITERIA: Randomized and nonrandomized controlled trials investigating physical activity interventions for adults delivered in faith-based organizations. DATA EXTRACTION: Two independent reviewers extracted data and assessed study methodological quality. DATA SYNTHESIS: We used relative risk and mean difference with 95% confidence interval to estimate the effect of the interventions on measures of physical activity, physical fitness, and health. RESULTS: The review included 18 studies. Study participants were predominantly female, and the majority of trials were conducted in the United States. Study heterogeneity did not allow us to conduct meta-analyses. Although interventions delivered in faith-based organizations increased physical activity and positively influenced measures of health and fitness in participants, the quality of the evidence was very low. CONCLUSION: Faith-based organizations are promising settings to promote physical activity, consequently addressing health disparities. However, high-quality randomized clinical trials are needed to adequately assess the effectiveness of interventions delivered in faith-based organizations.

Neuromuscular electrical stimulation (NMES) for patellofemoral pain syndrome.

BACKGROUND: Patellofemoral pain syndrome, now generally referred to as patellofemoral pain (PFP), is one of the most common orthopaedic disorders, characterised by pain in the anterior or retropatellar knee region. Neuromuscular electrical stimulation (NMES) has been proposed generally as a complementary treatment, associated with other interventions such as exercise, or as a single treatment to increase muscle force, reduce knee pain, and improve function. OBJECTIVES: To assess the effects (benefits and harms) of neuromuscular electrical stimulation for people with patellofemoral pain. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PEDro, CINAHL, SPORTDiscus, AMED, LILACS, trial registers, conference abstracts, and reference lists. We carried out the search in May 2017. SELECTION CRITERIA: We included randomised controlled clinical trials that evaluated the use of NMES for people with PFP. DATA COLLECTION AND ANALYSIS: Two review authors independently performed the process of study selection, data extraction, and 'Risk of bias' assessment in duplicate. The primary outcomes were knee pain, knee function, and adverse events. The timing of outcome measurements was up to three months (short term), three to 12 months (medium term), and 12 months and above from trial entry (long term). We calculated risk ratios for dichotomous data and mean differences or standardised mean differences for continuous data. Where appropriate, we pooled data using the fixed-effect model. MAIN RESULTS: We included eight randomised clinical trials, reporting results for 345 participants with PFP. The mean ages of trial populations ranged from 25 to 43 years, and the majority (53% to 100%) of participants were female. There was a wide duration of symptoms, with the minimum duration of symptoms for trial inclusion ranging from one to six months. In addition to the study inclusion criteria, studies varied widely in the characteristics of the NMES and its application, and associated co-interventions. We assessed all trials as at high risk of bias in at least one domain, particularly blinding and incomplete outcome data. The results of a laboratory-based trial reporting knee pain immediately after a single 15-minute session of NMES are not reported here as these are of questionable clinical relevance. The seven remaining trials provided evidence for three comparisons. We assessed the overall quality of the evidence, using GRADE, for all primary outcomes for all comparisons as very low, thus we are very unsure of the findings.Four studies compared NMES plus exercise versus exercise alone. Patellar taping was applied as well as exercise to all participants of one study, and patellar taping and ice were also applied in another study. Each trial tested a different multiple-session NMES programme. Pooled data from three studies (118 participants) provided very low-quality evidence that NMES is associated with reduced pain at the end of treatment (ranging from 3 to 12 weeks): mean difference -1.63, 95% confidence interval (CI) -2.23 to -1.02; visual analogue scale (VAS) 0 to 10; higher scores = worse pain. However, this result may not be clinically relevant since the minimal clinically important difference for VAS during activities (1.5 to 2.0, out of 10 points) lies within the 95% CI. We found very low-quality evidence from pooled data from two trials of little effect of NMES on knee function, as measured by two knee function rating systems. We found inconclusive and very low-quality evidence from one trial (29 participants) of little effect of NMES on pain and function at one-year follow-up. None of the four trials reported on adverse effects of treatment.One study (94 participants) compared NMES, applied four hours per day on a daily basis for four weeks, with two types of exercises (isometric and isokinetic). The study did not report on knee pain or adverse events. The study provided very low-quality evidence of no important difference between the two groups in knee function at the end of the four-week treatment. Of note is the potentially onerous NMES schedule in this study, which does not correspond to that typically used in clinical practice.Two studies compared different types of NMES. Simultaneously delivered high-low frequencies NMES was compared with sequentially delivered high-low frequencies NMES in one trial (14 participants) and with fixed frequency NMES in the second trial (64 participants). The studies provided very low-quality evidence of no important differences at the end of the six-week treatment programme between the simultaneous frequencies NMES and the two other NMES programmes in overall knee pain, knee function, or in quadriceps fatigue (an adverse event). AUTHORS' CONCLUSIONS: This review found insufficient and inconclusive evidence from randomised controlled trials to inform on the role of NMES for treating people with PFP in current clinical practice. The very low-quality evidence available means that we are uncertain whether or not a multiple-session programme of NMES combined with exercise over several weeks versus exercise alone results in clinically important differences in knee pain and function at the end of the treatment period or at one year. There were no data on adverse effects such as muscle fatigue and discomfort. High-quality randomised clinical trials are needed to inform on the use of NMES for people with PFP. However, professional and stakeholder consensus is required on prioritisation of the research questions for interventions for treating people with PFP, including on the NMES treatment protocol for trials testing NMES.

RETRACTED: Ivabradine as adjuvant treatment for chronic heart failure.

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted at the request of editors as it is contains multiple serious errors in the data of its primary end-point that make its conclusions unreliable. For example, in Figure 4, the cardiovascular death rates cited from Fox 2008 and Swedberg 2010 are incorrect. K. Fox, et al. Lancet, 372 (2008), pp. 807­816; K. Swedberg et al. Lancet, 376 (2010), pp. 875­885.

Chewing gum for enhancing early recovery of bowel function after caesarean section.

BACKGROUND: Caesarean sections (CS) are the most frequent major surgery in the world. A transient impairment of bowel motility is expected after CS. Although this usually resolves spontaneously within a few days, it can cause considerable discomfort, require symptomatic medication and delay hospital discharge, thus increasing costs. Chewing gum in the immediate postoperative period is a simple intervention that may be effective in enhancing recovery of bowel function in other types of abdominal surgeries. OBJECTIVES: To assess the effects of chewing gum to reduce the duration of postoperative ileus and to enhance postoperative recovery after a CS. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (20 June 2016), LILACs (20 June 2016), ClinicalTrials.gov (20 June 2016), WHO International Clinical Trials Registry Platform (ICTRP) (20 June 2016) and the reference lists of retrieved studies. SELECTION CRITERIA: All randomised controlled trials comparing chewing gum versus usual care, for women in the first 24 hours after a CS. We included studies published in abstract form only.Quasi-randomised, cross-over or cluster-randomised trials were not eligible for inclusion in this review. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the studies for inclusion, extracted data and assessed the risk of bias following standard Cochrane methods. We present dichotomous outcome results as risk ratio (RR) with 95% confidence intervals (CI) and continuous outcome results as mean differences (MD) and 95% CI. We pooled the results of similar studies using a random-effects model in case of important heterogeneity. We used the GRADE approach to assess the overall quality of evidence. MAIN RESULTS: We included 17 randomised trials (3149 participants) conducted in nine different countries. Seven studies (1325 women) recruited exclusively women undergoing elective CS and five studies (833 women) only included women having a primary CS. Ten studies (1731 women) used conventional feeding protocols (nil by mouth until the return of intestinal function). The gum-chewing regimen varied among studies, in relation to its initiation (immediately after CS, up to 12 hours later), duration of each session (from 15 to 60 minutes) and number of sessions per day (three to more than six). All the studies were classified as having a high risk of bias due to the nature of the intervention, women could not be blinded and most of the outcomes were self-reported.Primary outcomes of this review: for the women that chewed gum, the time to passage of first flatus was seven hours shorter than those women in the 'usual care' control group (MD -7.09 hours, 95% CI -9.27 to -4.91 hours; 2399 women; 13 studies; random-effects Tau² = 14.63, I² = 95%, very low-quality evidence). This effect was consistent in all subgroup analyses (primary and repeat CS, time spent chewing gum per day, early and conventional feeding protocols, elective and non-elective CS and time after CS when gum-chewing was initiated). The rate of ileus was on average over 60% lower in the chewing-gum group compared to the control (RR 0.39, 95% CI 0.19 to 0.80; 1139 participants; four studies; I² = 39%, low-quality evidence). Tolerance to gum-chewing appeared to be high. Three women in one study complained about the chewing gum (but no further information was provided) and none of the studies reported adverse effects (eight studies, 925 women, low-quality evidence).Secondary outcomes of this review: the time to passage of faeces occurred on average nine hours earlier in the intervention group (MD -9.22 hours, 95% CI -11.49 to -6.95 hours; 2016 participants; 11 studies; random-effects Tau² = 12.53, I² = 93%, very low-quality evidence). The average duration of hospital stay was shorter in the intervention compared to the control group (MD -0.36 days, 95% CI -0.53 to -0.18 days; 1489 participants; seven studies; random-effects Tau² = 0.04, I² = 92%). The first intestinal sounds were heard earlier in the intervention than in the control group (MD -4.56 hours, 95% CI -6.18 to -2.93 hours; 1729 participants; nine studies; random-effects Tau² = 5.41, I² = 96%). None of the studies assessed women's satisfaction in relation to having to chew gum. The need for analgesia or antiemetic agents did not differ between the intervention and control groups (average RR 0.50, 95% CI 0.12 to 2.13; 726 participants; three studies; random-effects Tau² = 0.79, I² = 69%). AUTHORS' CONCLUSIONS: This review found 17 randomised controlled trials (involving 3149 women). We downgraded the quality of the evidence for time to first passage of flatus and of faeces and for adverse effects/intolerance to gum chewing because of the high risk of bias of the studies (due to lack of blinding and self-report). For time to first flatus and faeces, we downgraded the quality of the evidence further because of the high heterogeneity in these meta-analyses and the potential for publication bias based on the visual inspection of the funnel plots. The quality of the evidence for adverse effects/tolerance to gum chewing and for ileus was downgraded because of the small number of events. The quality of the evidence for ileus was further downgraded due to the unclear risk of bias for the assessors evaluating this outcome.The available evidence suggests that gum chewing in the immediate postoperative period after a CS is a well tolerated intervention that enhances early recovery of bowel function. However the overall quality of the evidence is very low to low.Further research is necessary to establish the optimal regimen of gum-chewing (initiation, number and duration of sessions per day) to enhance bowel function recovery and to assess potential adverse effects of and women's satisfaction with this intervention. New studies also need to assess the compliance of the participants to the recommended gum-chewing instructions. Future large, well designed and conducted studies, with better methodological and reporting quality, will help to inform future updates of this review and enhance the body of evidence for this intervention.

Polyunsaturated fatty acid supplementation for drug-resistant epilepsy.

BACKGROUND: An estimated 1% to 3% of all individuals will receive a diagnosis of epilepsy during their lives, which corresponds to approximately 50 million affected people worldwide. The real prevalence is possibly higher because epilepsy is underreported in developing countries. Although most will achieve adequate control of their disease though the use of medication, approximately 25% to 30% of all those with epilepsy are refractory to pharmacological treatment and will continue to have seizures despite the use of two or more agents in adequate dosages. Over the last decade, researchers have tested the use of polyunsaturated fatty acid (PUFA) supplements for the treatment of refractory epilepsy, with inconsistent results. There have also been some concerns about the use of omega-3 PUFA compounds because they reduce platelet aggregation and could, in theory, cause bleeding. OBJECTIVES: To assess the effectiveness and tolerability of omega-3 polyunsaturated fatty acids (eicosapentaenoic acid-EPA and docosahexanoic acid-DHA) in the control of seizures in people with refractory epilepsy. SEARCH METHODS: We searched the Cochrane Epilepsy Group Specialised Register (from inception up to November 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, issue 11), MEDLINE (1948 to November 2015), EMBASE (1980 to November 2015), SCOPUS (1823 to November 2015); LILACS (Literatura Latino-Americana e do Caribe de Informação em Ciências da Saúde) (1982 to November 2015); ClinicalTrials.gov; World Health Organization (WHO) International Clinical Trials Registry Platform (November 2015). No language restrictions were imposed. We contacted study authors for additional and unpublished information and screened the reference lists of retrieved citations for potentially eligible studies not identified through the electronic search. SELECTION CRITERIA: All randomised and quasi-randomised studies using PUFAs for the treatment of drug-resistant epilepsy. DATA COLLECTION AND ANALYSIS: Two review authors were involved in study selection, data extraction and quality assessment of the included trials. The following outcomes were assessed: seizure freedom, seizure reduction, improvement in quality of life, potential adverse effects, gastrointestinal effects, drop-out rates and changes in plasma lipid profile. Primary analyses were by intention to treat. MAIN RESULTS: Eight studies were identified as potentially relevant; three fulfilled the selection criteria and were included in the review. Two placebo-controlled, double blind trials involving adult participants were conducted in developed countries, while one placebo-controlled, single blind trial involving children was conducted in a developing country (Egypt). Bromfield 2008 randomised 27 American adults to receive 2.2 g/day of omega-3 PUFAs (EPA:DHA in a 3:2 ratio) or placebo. Yuen 2005 randomised 58 people in the UK to approximately 1.7 g/day omega-3 PUFAs (1g EPA and 0.7g DHA) or placebo. Reda 2015 randomised 70 Egyptian children to receive 3 ml/day of 1200 mg fish oil (providing 0.24 g DHA and 0.36 g EPA) or placebo. The three studies recruited a total of 155 subjects (85 adults and 70 children); 78 of them (43 adults and 35 children) were randomised to PUFAs and 77 (42 adults and 35 children) to placebo. All participants were followed for up to 12 weeks. Seizure freedom was reported by only one study, with a high risk of bias, involving exclusively children. The risk estimate for this outcome was significantly higher in the children receiving PUFA compared to the control group (risk ratio (RR) 20.00, 95% confidence interval (CI) 2.84 to 140.99, 1 study, 70 children). Similarly, PUFA supplementation was associated with a significant difference in the proportion of children with at least 50% reduction in seizure frequency (RR 33.00 95% CI 4.77 to 228.15, 1 study with a high risk of bias, 70 children). However, this effect was not observed when the data from two studies including adult participants were pooled (RR 0.57, 95% CI 0.19 to 1.75, I² 0%, 2 studies, 78 participants, low-quality evidence). One of our three primary outcomes (adverse effects related to bleeding) was not assessed in any of the studies included in this review. There were no significant differences between the PUFA and control groups in relation to gastrointestinal effects (RR 0.78, 95% CI 0.32 to 1.89, 2 studies, 85 participants, low-quality evidence).Supplementation with PUFA did not produce significant differences in mean frequency of seizures, quality of life or other side effects. AUTHORS' CONCLUSIONS: In view of the limited number of studies and small sample sizes, there is not enough evidence to support the use of PUFA supplementation in people with refractory epilepsy. More trials are needed to assess the benefits of PUFA supplementation in the treatment of drug-resistant epilepsy.