Risk of bias in dentistry-related randomized controlled trials in spanish language journals

Objectives: To assess the risk of bias (RoB) of randomized controlled trials (RCTs) published in dental journals in the Spanish language. Methods: A systematic retrospective survey was conducted of all RCTs published from 1980 to 2019 in dentistry Spanish and Latin American journals. We extracted data and performed RoB assessments using the Cochrane Risk of Bias tool. Results: 292 RCTs published in 51 journals were included. The best-rated domains were incomplete outcome data, selective reporting, and other biases. The domains assessed with higher proportions of an unclear or high risk of bias were sequence generation, allocation concealment, and blinding of outcome assessment. There is a low proportion of RCTs published in Spanish language journals. However, the number has been increasing over the years, and the low risk of bias assessment rates across domains show an increasing trend. Conclusions: A low percentage of Spanish-language dental journals issue RCTs. Our assessment of these RCTs' RoB suggests higher difficulties in the design and conduction phase than in the posterior reporting stage.

Choking, gagging and complementary feeding methods in the first year of life: a randomized clinical trial

Abstract Objective: Compare the occurrence of choking and gagging in infants subjected to three complementary feeding (CF) methods. Methods: Randomized clinical trial with mother-infant pairs, allocated according to the following methods of CF: a) Parent-Led Weaning (PLW) — group control, b) Baby-Led Introduction to SolidS (BLISS), and c) mixed (initially BLISS and if the infant presents a lack of interest or dissatisfaction, PLW), with the last two methods guided by the infant. Mothers received nutritional intervention on CF and prevention of choking and gagging according to the method at 5.5 months of age and remained in follow-up until 12 months. Frequencies of choking and gagging were collected by questionnaire at nine and 12 months. The comparison between groups was performed using the analysis of variance test (p < 0.05). Results: 130 infants were followed, and 34 (26.2%) children presented choking between six and 12 months of age, 13 (30.2%) in PLW, 10 (22.2%) BLISS, and 11 (26.2%) mixed method, no significative difference between methods (p > 0.05). The choking was caused mainly by the semi-solid/solid consistency. Moreover, 100 (80%) infants aged from six to 12 months presented gagging and their characteristics were not statistically different among groups (p > 0.05). Conclusion: Infants following a baby-led feeding method that includes advice on minimizing choking risk do not seem more likely to choke than infants following traditional feeding practice that includes advice on minimizing choking risk.

Randomized trial of the efficacy of trial-based cognitive therapy for obsessive-compulsive disorder: preliminary findings

Abstract Introduction Obsessive-compulsive disorder (OCD) is the fourth most prevalent mental disorder and is a disabling condition. OCD is associated with anatomical and functional changes in the brain, in addition to dysfunctional cognitions. The treatments of choice are selective serotonin reuptake inhibitors, cognitive-behavioral therapy (CBT), and exposure and response prevention (ERP). Trial-based cognitive therapy (TBCT) is a recent and empirically validated psychotherapy with a focus on restructuring dysfunctional negative core beliefs (CBs). The objective of this study was to evaluate the efficacy of TBCT relative to ERP for treatment of OCD. Methods A randomized, single-blind clinical trial was conducted, randomizing 26 patients for individual treatment with TBCT (n = 12) or ERP (n = 14). The groups were evaluated at baseline, at the end of 3 months (12 sessions), and at 3, 6, and 12-month follow-ups. Results Both approaches reduced the severity of symptoms with large effect sizes. These results were maintained at the 12-month follow-up assessment. Conclusion TBCT may be a valid and promising treatment for this disorder.

Analgesia preemptiva em cirurgias de implantes dentais: (i) revisão sistemática e meta-análise; (ii) ensaio clínico triplo-cego, paralelo, randomizado e controlado por placebo / Preemptive analgesia in dental implant surgery: (i) systematic review and meta analysis; (ii) triple-blind, parallel, randomized and placebo-controlled clinical trial

Não existem evidências suficientes, para recomendar um regime analgésico específico, para o controle da dor em analgesia preemptiva, após cirurgia de implante dentário. Isto sinaliza a necessidade de estudos adicionais. Esta pesquisa apresenta dois estudos com objetivos distintos: (1) avaliar a eficácia da analgesia preemptiva em cirurgias de implantes dentais por meio de uma revisão sistemática e meta-análise de ensaios clínicos randomizados. (2) avaliar e comparar por meio de um ensaio clínico randomizado (ECR), paralelo, controlado por placebo, a efetividade da analgesia preemptiva em cirurgias de implantes dentais unitários, buscando identificar dentre os analgésicos e anti-inflamatórios não esteroidais (AINES) [eterocoxibe (ETERO), ibuprofeno (IBU), nimesulida (NIME) e acetaminofeno (ACETA)], qual possui maior eficácia no alívio da dor pós-operatória e na redução do uso da medicação de resgate comparados ao uso do placebo. Esta revisão sistemática com meta-análise seguiu as diretrizes PRISMA e foi registrada no PROSPERO (CRD42020168757). Cinco estudos foram incluídos na revisão e quatro foram incorporados à meta-análise. Uma meta-análise de efeito randômico comparou a eficácia da medicação preventiva em comparação ao placebo. Para a interpretação dos resultados utlizamos a certeza da evidência usando a abordagem Grading of Recommendations, Assessment, Development and Evaluation (GRADE) e a magnitude do efeito, de acordo com as diretrizes do GRADE. Todos os estudos demonstraram que a medicação preemptiva contribuiu para uma melhora significativa da dor pós-operatória. No entanto, o desvio médio padrão (DMP) geral agrupado mostrou, que, a medicação preventiva teve um efeito pequeno em comparação com o placebo, na redução da dor (DMP: -0,43; IC: -0,71; -0,15), com baixa certeza da evidência. Essa metanálise mostrou que a magnitude do efeito foi maior seis a oito horas após a cirurgia (efeito grande), comparada ao tempo de uma a duas horas, após a cirurgia (efeito pequeno). Concluiu-se que a analgesia preventiva pode ter um efeito positivo na redução da dor em comparação ao não uso de medicação preemptiva. No entanto, as evidências são ainda insuficientes. O ECR com inserção de implante dental unitário envolveu 135 indivíduos, com média de idade de 57,1 (±11,2), de ambos os gêneros alocados em 5 grupos (ETERO, IBU, NIME, ACETA e placebo). A ocorrência, tempo e a intensidade da dor foram analisados por meio testes de teste Qui-quadrado, Exato de Fisher, ANOVA e modelos de equações de estimativas generalizadas quando adequados. Todos os medicamentos testados proporcionaram um efeito benéfico da analgesia preemptiva. Isso foi demonstrado pela redução da dor pós-operatória e do menor uso de medicação de resgaste. O grupo IBU apresentou significativamente maiores escores de dor que os outros três grupos testes (IBU>ETERO=NIME=ACETA), que foram equivalentes entre si. Apesar da ocorrência de significância estatística, do ponto de vista da relevância clínica, a diferença entre os grupos foi pequena e todos os grupos apresentaram baixos escores de dor. Assim, sugerimos que a tomada de decisão em relação à escolha do medicamento deve considerar, também, a relação de custo-benefício, efeitos adversos e características individuais dos pacientes. Em adição, estudos futuros em cirurgias implantodônticas extensas (maior número de implantes inseridos e com enxertos ósseos/gengivais) apresentando alto rigor metodológico, ainda se faz necessário. (CAEE 83534618.5.0000.5149)

There is insufficient evidence to recommend a specific analgesic regimen for pain management in preemptive analgesia after dental implant surgery, signaling the need for further studies. This research presents two studies with different objectives: (1) to evaluate the effectiveness of preemptive analgesia in dental implant surgeries through a systematic review and meta-analysis of randomized clinical trials. (2) to evaluate and compare, through a randomized clinical trial (RCT), parallel, controlled by placebo, the effectiveness of preemptive analgesia in single dental implant surgeries, seeking to identify among analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) [ eterocoxib (ETERO), ibuprofen (IBU), nimesulide (NIME) and acetaminophen (ACETA)], which is more effective in relieving postoperative pain and reducing the use of rescue medication compared to the use of placebo. The systematic review with meta-analysis was conducted by PRISMA guidelines and registered in PROSPERO (CRD42020168757). Five studies were included in the review and four were incorporated into the meta-analysis. A random-effect meta- analysis compared the effectiveness of preventive medication compared to placebo. The interpretation of the results followed the certainty of the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach together with the magnitude of the effect according to the GRADE guidelines. All studies demonstrated that preemptive medication contributed to a significant improvement in postoperative pain. However, the pooled overall mean standard deviation (SMD) showed that preventive medication had a small effect compared with placebo in reducing pain (SMD: -0.43; CI: -0.71; -0.15) with low certainty of evidence. Our meta-analysis showed that the magnitude of the effect was greater six to eight hours after surgery (large effect), compared to one to two hours after surgery (small effect). It was concluded that preventive analgesia can have a positive effect in reducing pain compared to not using preemptive medication, but the evidence is still insufficient. The RCT with single dental implant insertion involved 135 individuals, with a mean age of 57.1 (±11.2), of both genders allocated into 5 groups (ETERO, IBU, NIME, ACETA and placebo). The occurrence, duration and intensity of pain were analyzed using Chi- square, Fisher's Exact, ANOVA and generalized estimating equation models when appropriate. All drugs tested provided a beneficial effect of preemptive analgesia demonstrated by reduced postoperative pain and reduced use of rescue medication. The IBU group had significantly higher pain scores than the other three test groups (ETERO, NIME and ACETA), which were equivalent to each other. Despite the occurrence of statistical significance, from the point of view of clinical relevance, the difference between the groups was small and all had low pain scores. Thus, we suggest that the decision making regarding the choice of medication should also consider the cost-benefit ratio, adverse effects and individual characteristics of patients. In addition, future studies in extensive implant dentistry surgeries (greater number of implants inserted and with bone/gingival grafts) presenting high methodological rigor are still necessary. (CAEE 83534618.5.0000.5149)

Comparative evaluation of diode laser and simvastatin gel in pulpotomy of primary molars A randomized clinical trial

Background: Pulpotomy is a vital pulp therapy performed in carious pulp exposures in teeth in which the inflamed coronal pulp is removed and medicament is placed to conserve the vital root pulps. Recently, simvastatin which is a cholesterol-lowering drug has been found to be associated with the pulp regenerative potential. Aim: The aim of this parallel two-arm randomized control trial was to evaluate and compare the clinical and radiographic efficacy of diode laser (DL) and simvastatin gel (SG) in pulpotomy of carious primary molars. Methods: Hundred primary molars (in 98 children, 65 males, 33 females with age 4–8 years) requiring pulpotomy were randomized into the DL or SG group. Pulpotomy was performed as per the standardized protocol; thereafter, all teeth were restored with resin modified glass ionomer cement followed by stainless steel crowns. Follow-up evaluations were done at 3 and 12 months using clinical and radiographic criteria. Statistical analysis was done using Chi-square test at a significance level of 0.05. Results: At 12 months, out of 92 teeth available for clinical and radiographic evaluation by blinded evaluators, DL group showed clinical and radiographic success rates of 76.1% and 52.1%, while SG group showed 80.4% and 65.2% success rates, respectively. There was no statistically significant difference between the efficacy of two techniques clinically (P = 0.49) or radiographically (P = 0.30). Conclusions: Both SG and DL had similar efficacy for primary tooth pulpotomy, clinically and radiographically after 12 months. Considering its ease of application and low-cost, SG can be recommended as a potential pulpotomy medicament in primary molars.

Continuous and interval aerobic sessions: effects on triglyceride concentrations / Sessões aeróbicas intervaladas e contínuas: efeitos sobre as concentrações de triglicerídeos

The regular practice of physical exercise, primarily aerobic, has been recommended as a component of the non-pharmacological treatment for dyslipidemias. However, there is a lack of studies in the literature comparing the acute effects of different aerobic exercise models (continuous and interval) on triglycerides concentrations.The purpose of the present study was to analyze the magnitude of change on triglycerides concentrations after a single session of interval and continuous exercise in persons with dyslipidemia. This study was a randomized crossover clinical trial. Fifteen volunteers performed two different aerobic sessions, a continuous and an interval session. The intensity of the continuous session was maintained between 85-90% of the heart rate at anaerobic threshold (HRAT). The interval session consisted of 9 sets of 4 minutes at 85-90%HRAT followed by one minute below 85%HRAT. Triglycerides concentrations were assessed before, immediately after and at the end of 30 minutes after all sessions. Both sessions models resulted in alterations in triglycerides concentrations immediately after exercise (p = 0.005), without difference between them (p = 0.446). Continuous session increased triglycerides concentrations by 34.9% from pre-exercise to immediately post-exercise and the interval session, by 7.9%. Thirty minutes after exercise, triglyceride concentrations showed no significant difference in relation to the pre-exercise and immediately after exercise moments in both session models. Therefore,it is concluded that aerobic exercise promotes responses in triglycerides concentrations of dyslipidemic patients, independently of the exercise method, either continuous or interval

A prática regular de exercício físico, principalmente aeróbico, tem sido recomendado como componente de tratamento não farmacológico contra as dislipidemias. No entanto, a literatura carece de estudos comparando os efeitos agudos de diferentes modelos de exercício aeróbico (contínuo e intervalado) sobre as concentrações de triglicerídeos. O objetivo do presente estudo foi analisar a magnitude de mudança sobre as concentrações de triglicerídeos após uma sessão de exercício intervalado e contínuo em pessoas com dislipidemia. Além disto, este estudo se caracteriza por ser um ensaio clínico randomizado cruzado. Nele, quinze voluntários realizaram duas sessões aeróbicas diferentes, uma sessão contínua e outra intervalada. A intensidade da sessão contínua se manteve entre 85-90% da frequência cardíaca referente ao limiar anaeróbico (HRAT). A sessão intervalada consistiu de 9 séries de quatro minutos entre 85-90% da HRAT seguidas de um minuto abaixo de 85% da HRAT. As concentrações de triglicerídeos eram verificadas antes, imediatamente após e passados 30 minutos do término de todas as sessões. Ambos os modelos de sessões resultaram em alterações das concentrações de triglicerídeos imediatamente após exercício (p = 0,005), sem diferença entre elas (p = 0,446). A sessão contínua aumentou as concentrações de triglicerídeos em 43,9% do pré-exercício para imediatamente após o exercício e a sessão intervalada aumentou em 7,93% no mesmo período. Trinta minutos após o exercício, as concentrações de triglicerídeos não apresentaram diferença significativa em relação aos momentos pré-exercício e imediatamente após o exercício em ambos os modelos de sessão. Assim, conclui-se que o exercício aeróbico promove alterações nas concentrações de triglicerídeos de pacientes dislipidêmicos, independentemente do método de exercício, se contínuo ou intervalado

Ensaio clínico randomizado: padrão ouro de desenhos experimentais - importância, vantagens, desvantagens e preconceitos / Randomized clinical trial: gold standard of experimental designs - importance, advantages, disadvantages and prejudice

Ensaios clínicos randomizados (ECR) são o padrão ouro para desenho experimental de estudo ou ensaio clínico. Apenas por meio de uma investigação do tipo ECR é possível avaliar e demonstrar a relação de causa-e-efeito entre um conjunto de variáveis independentes e dependentes. O ECR adicionou vantagens em relação aos outros modelos experimentais, principalmente devido à presença de um grupo controle. Existem várias críticas à validade interna das pesquisas em saúde, incluindo preconceitos e desvantagens que são apontadas para seu descrédito. OBJETIVO: O objetivo do presente estudo é informar características, vantagens, desvantagens e desvios deste método científico. MATERIAL E MÉTODOS: Análise crítica de método científico com base em revisão narrativa da literatura. Foi consultada a base de dados Medline por meio dos portais PubMed e Scopus, sem data de início e até julho de 2020, para extração das informações relativas aos ECR. Apenas artigos de língua inglesa foram incluídos, usando as palavras-chave "estudo randomizado controlado", "ensaio clínico randomizado", "projeto experimental" e "estudo experimental", intercaladas pelos operadores booleanos "AND ," "OR" e "NOT". Anais de conferências e resumos não foram considerados para a análise dos dados. RESULTADOS: Dos ECR selecionados, foram extraídas características, vantagens, desvantagens, importância e vantagens dos controles em pesquisa, o princípio de equilíbrio, ensaios clínicos randomizados na população pediátrica, ECR na população geriátrica, ameaças à validade interna e medidas para minimização de viéses e preconceitos em ECR. CONCLUSÃO: Tópicos relevantes dos ECR foram explicados nesta revisão que devem guiar pesquisadores clínicos.

Randomized controlled trial (RCT) is the gold standard of experimental design or clinical trial design. Only by RCT in research, the cause-and-effect relationship between a set of independent and dependent variables could be demonstrated. RCT has added advantages over other experimental designs due to the presence of the control group. The importance of control in health research trials and its advantages to be elaborated. Though various threats to internal validity in health research trials could be minimized by RCT, various biases in RCT and disadvantages add to its discredit. OBJECTIVE: The aim of the present narrative review is to brief the characteristics, advantages, disadvantages, and various biases in RCT. METHODS: This review does not follow the PRISMA statement, as it was a narrative review. Two databases, namely, Medline through PubMed and Scopus, were searched from inception to July 2020 for the information pertaining to RCTs and included in this narrative review. Only English language articles were searched with the keywords, "Randomized controlled trial," "Randomized clinical trial," "experimental design," and "experimental study." These keywords are linked together by the Boolean words, "AND," "OR" and "NOT." Conference proceedings and only abstracts were not considered for the review. RESULTS: RCTs were explained under characteristics, advantages, disadvantages, importance, and advantages of controls in research, the principle of equipoise, RCTs in the pediatric population, RCTs in the geriatric population, threats to internal validity and steps to minimize them and various biases in RCTs. CONCLUSION: The narrative presentation of RCTs under various important topics have been explained in this review.

Comparación entre uso y no uso de antibióticos profilácticos en pancreatitis aguda grave: ensayo clínico aleatorizado: reporte preliminar / Comparison between use and non-use of prophylactic antibiotics in severe acute pancreatitis: randomized clinical trial: preliminary report

Resumen Introducción: La pancreatitis aguda es una enfermedad frecuente en el país, con una tasa de mortalidad de 10%-30%. La administración profiláctica de antibióticos ha sido parte del tratamiento de pancreatitis aguda grave (PAG), por la teórica prevención de complicaciones infecciosas y reducción de mortalidad. Sin embargo, la evidencia científica disponible es controversial. Objetivo: Demostrar que los antibióticos profilácticos no disminuyen las complicaciones locales y/o sistémicas, requerimiento de Unidad de Paciente Crítico (UPC), ni mortalidad en PAG. Definimos PAG como APACHE II ≥ 8 o PCR ≥ 150 o falla multiorgánica. Material y Método: Ensayo clínico aleatorizado, con aleatorización simple mediante tabla electrónica (uso o no uso de antibióticos profilácticos) de pacientes con PAG. En el grupo que usó antibióticos profilácticos se utilizó ciprofloxacino y metronidazol por 7 días. El resto del manejo no tuvo variación. Resultados: n = 71, dos grupos aleatorizados; Grupo 1 (n = 35), sin uso de antibióticos profilácticos, y grupo 2 (n = 36) con uso de profilaxis antibiótica. 12 pacientes (16%) requirieron UPC; 6 pacientes del grupo 1, y 6 del grupo 2 (p = 0,957). Siete pacientes (9,8%) tuvieron algún tipo de complicación, 3 en el grupo 1 y 4 en el grupo 2 (p = 0,516). El promedio de estancia hospitalaria fue 18,2 ± 9,5 días en el grupo 1, y 22,6 ± 29.2 días en el grupo 2 (p = 0,495). Mortalidad: 1 paciente (1,41%) en el grupo 2 (p = 0,493). Conclusión: En este reporte preliminar, el uso de antibióticos profilácticos en PAG no mostró reducir las complicaciones, necesidad de cama en UPC, ni la mortalidad.

Introduction: Acute pancreatitis is a common disease in the country, with a mortality rate of 10%-30%. The prophylactic administration of antibiotics has been part of the treatment of severe acute pancreatitis (SAP), due to the theoretical prevention of infectious complications and mortality reduction. However, the available scientific evidence is controversial. Objective: To demonstrate that prophylactic antibiotics do not reduce local and/or systemic complications, critical patient unit (CPU) requirement, or mortality in SAP. We define SAP as APACHE II ≥ 8 or PCR ≥ 150° or multiorgan failure. Material and Method: Randomized clinical trial, with simple randomization by electronic table (use or non-use of prophylactic antibiotics) of patients with SAP. In the group that used prophylactic antibiotics, ciprofloxacin and metronidazole were used for 7 days. Results: n = 71, two randomized groups; Group 1 (n = 35), without the use of prophylactic antibiotics, and group 2 (n = 36) with the use of antibiotic prophylaxis. 12 patients (16%) required CPU; 6 patients from group 1, and 6 from group 2 (p = 0.957). Seven patients (9.8%) had some type of complication, 3 in group 1 and 4 in group 2 (p = 0.516). The average hospital stay was 18.2 ± 9.5 days in group 1, and 22.6 ± 29.2 days in group 2 (p = 0.495). Mortality: 1 patient (1.41%) in group 2 (p = 0.493). Conclusion: In this preliminary report, the use of prophylactic antibiotics in SAP was not shown to reduce complications, need for bed in CPU, or mortality.

Association of BDNF, HTR2A, TPH1, SLC6A4, and COMT polymorphisms with tDCS and escitalopram efficacy: ancillary analysis of a double-blind, placebo-controlled trial

Objective: We investigated whether single nucleotide polymorphisms (SNPs) associated with neuroplasticity and activity of monoamine neurotransmitters, such as the brain-derived neurotrophic factor (BDNF, rs6265), the serotonin transporter (SLC6A4, rs25531), the tryptophan hydroxylase 1 (TPH1, rs1800532), the 5-hydroxytryptamine receptor 2A (HTR2A, rs6311, rs6313, rs7997012), and the catechol-O-methyltransferase (COMT, rs4680) genes, are associated with efficacy of transcranial direct current stimulation (tDCS) in major depression. Methods: Data from the Escitalopram vs. Electrical Current Therapy for Treating Depression Clinical Study (ELECT-TDCS) were used. Participants were antidepressant-free at baseline and presented with an acute, moderate-to-severe unipolar depressive episode. They were randomized to receive escitalopram/tDCS-sham (n=75), tDCS/placebo-pill (n=75), or placebo-pill/sham-tDCS (n=45). General linear models assessed the interaction between treatment group and allele-wise carriers. Additional analyses were performed for each group and each genotype separately. Results: Pairwise group comparisons (tDCS vs. placebo, tDCS vs. escitalopram, and escitalopram vs. placebo) did not identify alleles associated with depression improvement. In addition, exploratory analyses also did not identify any SNP unequivocally associated with improvement of depression in any treatment group. Conclusion: Larger, combined datasets are necessary to identify candidate genes for tDCS response.

Effectiveness of magnesium sulfate compared to rocuronium for rapid sequence tracheal intubation in adults: clinical randomized trial / Efetividade do sulfato de magnésio comparado ao rocurônio para intubação em sequência rápida em adultos: ensaio clínico randomizado

Abstract Introduction and objectives: Magnesium sulphate has been used in anesthesia because it has relevant clinical features such as: analgesia, autonomic response control and muscle relaxation. Using the agent to establish adequate conditions for tracheal intubation remains controversial. The aim of the study was to compare the effectiveness of magnesium sulfate and rocuronium for rapid sequence tracheal intubation in adults. Methods: Double blind, randomized, unicentric, prospective study assessed 68 patients, ASA 1 or 2, over 18 years, scheduled for appendectomy under general anesthesia. Patients were divided into two groups. GM patients received 50 mg.kg-1magnesium sulfate and GR patients, 1 mg.kg-1 rocuronium immediately before anesthesia induction. Arterial Blood Pressure (BP) and Heart Rate (HR) were measured in both groups at five times related to the administration of the drugs studied. The primary variable was the clinical status of tracheal intubation. Trial Registry: RBR-4xr92k. Results: GM was associated with no significant hemodynamic parameter change after injection. GM showed 85% (29/34) poor intubation clinical status, 15% (5/34) good, and 0% excellent (< 0.0001). Conclusion: Magnesium sulfate did not provide adequate clinical status when compared to rocuronium at a dose of 50 mg.kg-1 for rapid sequence intubation in adult patients.

Resumo Justificativa e objetivos: O sulfato de magnésio vem sendo utilizado em anestesia por apresentar características relevantes à prática clínica como: analgesia, controle dos reflexos autonômicos e relaxamento muscular. A utilização deste agente para garantir condições adequadas para a intubação traqueal permanece controverso. O objetivo deste trabalho é determinar a efetividade do sulfato de magnésio comparado ao rocurônio para intubação orotraqueal em sequência rápida em pacientes adultos. Métodos: Este estudo duplamente encoberto, aleatorizado, unicêntrico e prospectivo avaliou 68 pacientes, ASA 1 ou 2, maiores de 18 anos, escalados para cirurgias de apendicectomia sob anestesia geral. Foram alocados em dois grupos, o GM recebeu 50 mg.kg-1 de sulfato de magnésio e o GR, 1 mg.kg-1 de rocurônio imediatamente antes da indução anestésica. Os valores de Pressão Arterial (PA) e Frequência Cardíaca (FC) foram aferidos nos dois grupos em cinco momentos relacionados com a administração dos fármacos do estudo. A variável primária foi condição clínica da intubação. Registro: RBR-4xr92k. Resultados: O GM não apresentou alteração significativa dos parâmetros hemodinâmicos após infusão. O GM apresentou 85% (29/34) de condição pobre, 15% (5/34) condição clínica boa e 0% condição clínica excelente (< 0,0001). Conclusão: O sulfato de magnésio não propiciou condições clínicas aceitáveis quando comparado ao rocurônio para intubação orotraqueal em sequência rápida em pacientes adultos quando utilizada a dose de 50 mg.kg-1.

Effect of vitamin D3 supplementation on 25 OHD plasma levels in the presence of VDR gene polymorphisms / Efecto de la suplementación con vitamina D3 en los niveles plasmáticos de 25 OHD, en presencia de polimorfismos del gen VDR

The objective of this review was to investigate the effect of vitamin D3 supplementation on serum 25-hydroxyvitamin D concentration in individuals with single-nucleotide polymorphisms in the vitamin D receptor gene. The research was conducted on 241 articles found in the PubMed, Scopus, Science Direct, and Cochrane Library databases between November and December 2018. After article screening, three randomized double-blind placebo-controlled clinical trials were identified as eligible for this review. Participants were Australian, Brazilian, and Chinese individuals, who ingested doses of vitamin D3 ranging from 2000 IU to a megadose of 200,000 IU. The presence of the BB/Bb genotype of the BsmI polymorphism and the FokI G allele caused an increase in the serum concentrations of vitamin D after supplementation. Nonetheless, the few studies on this subject are not unanimous in their results. It is possible that differences among populations, sample sizes, doses, and time of supplementation have an impact on data and outcomes.

El objetivo de esta revisión fue investigar el efecto de la suplementación con vitamina D3 sobre la concentración sérica de 25-hidroxivitamina D en individuos con los polimorfismos de un solo nucleótido en el gen del receptor de la vitamina D. La investigación se realizó en 241 artículos encontrados en las bases de datos PubMed, Scopus, Science Direct y Cochrane Library entre noviembre y diciembre de 2018. Después de la selección del artículo, se identificaron tres ensayos clínicos aleatorios, controlados con placebo, doble ciego, como elegibles para esta revisión. Los participantes fueron australianos, brasileños y chinos, quienes ingirieron dosis de vitamina D3 que iban desde las 2000 UI hasta una megadosis de 200,000 UI. La presencia del genotipo BB / Bb del polimorfismo BsmI y el alelo FokI G causó un aumento en las concentraciones séricas de vitamina D después de la suplementación. No obstante, los pocos estudios sobre este tema no son unánimes en sus resultados. Es posible que las diferencias entre poblaciones, tamaños de muestra, dosis y tiempo de suplementación tengan un impacto en los datos y resultados de la investigación.

Efficacy and Safety of Guilingji Capsules () for Treating Mild-to-Moderate Cognitive Impairment: Study Protocol for A Randomized, Double-Blind, Positive-Controlled, Multicenter and Noninferiority Trial / 中国结合医学杂志

BACKGROUND@#The incidence of cognitive impairment (CI) is gradually increasing, which has attracted more attention from medical researchers worldwide. Definitive mechanisms of pathogenesis remain elusive, and there are few medications that have been proven effective for CI. The utilization of Chinese herbal medicine has shown positive therapeutic effects for a broad spectrum of diseases, including CI.@*OBJECTIVE@#The purpose of this study is to evaluate the safety and efficacy of Guilingji Capsules (GLJC, ) in treating mild-to-moderate CI with Shen (Kidney) and marrow deficiency syndrome.@*METHODS@#This is a randomized, double-blind, positive-controlled, multicenter clinical trial with a noninferiority design that included 348 participants randomly divided into an experimental arm and an active comparator arm. Individuals in the experimental arm (174 cases) took 0.6 g of GLJC once a day and 19.2 mg of Gingko biloba extract mimetic 3 times a day. Individuals in the active comparator arm (174 cases) took 0.6 g of GLJC mimetic once a day and 19.2 mg of Gingko biloba extract in tablet form 3 times a day. The intervention period included two sessions over 24 weeks. The primary outcome be the effectiveness of GLJC on cognitive improvement after 24 weeks of treatment, which was defined as an increase in the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) Scale. The secondary outcomes were improvement in independence, daily living ability, and Chinese medicine (CM) syndrome, which were measured with the Alzheimer's disease Rating Scale-Cognitive Project (ADAS-Cog), Clinical Dementia Rating (CDR) Total Score, Activities of Daily Living (ADL) Total Score and the Chinese Medicine Symptom Scale (CM-SS), respectively. Serum acetylcholine, acetylcholinesterase, bax and bcl-2 were monitored to explore the mechanism of GLJC on CI. In addition, safety measures, including vital signs, electrocardiography, laboratory indicators (full blood count, kidney and liver function tests, routine urine test and routine stool test) and adverse events, were also recorded.@*DISCUSSION@#The purpose of this trial is to evaluate the efficacy and safety of GLJC in patients with mild-to-moderate CI with kidney and marrow deficiency syndrome. If successful, the results would provide a viable treatment for patients with mild-to-moderate CI. (Clinical Trials.gov. ID: NCT03647384. Registered on 23 August 2018).

Preoperative imaging of the inferior alveolar nerve canal by cone-beam computed tomography and 1-year neurosensory recovery following mandibular setback through bilateral sagittal split ramus osteotomy: a randomized clinical trial

OBJECTIVES: One of the most common complications of bilateral sagittal split ramus osteotomy (BSSRO) is neurosensory impairment of the inferior alveolar nerve (IAN). Accurate preoperative determination of the position of the IAN canal within the mandible using cone-beam computed tomography (CBCT) is recommended to prevent IAN dysfunction during BSSRO and facilitate neurosensory improvement after BSSRO.MATERIALS AND METHODS: This randomized clinical trial consisted of 86 surgical sites in 43 patients (30 females and 13 males), including 21 cases (42 sides) and 22 controls (44 sides). Panoramic and lateral cephalographs were obtained from all patients. In the experimental group, CBCT was also performed from both sides of the ramus and mandibular body. Neurosensory function of the IAN was subjectively assessed using a 5-point scale preoperatively and 7 days, 1 month, 3 months, 6 months, and 12 months post-surgery. Data were analyzed using Fisher's test, Spearman's test, t-test, linear mixed-model regression, and repeated-measures ANCOVA (α=0.05, 0.01).RESULTS: Mean sensory scores in the control group were 1.57, 2.61, 3.34, 3.73, and 4.20 over one year and were 1.69, 3.00, 3.60, 4.19, and 4.48 in the CBCT group. Significant effects were detected for CBCT intervention (P=0.002) and jaw side (P=0.003) but not for age (P=0.617) or displacement extent (P=0.122).CONCLUSION: Preoperative use of CBCT may help surgeons to practice more conservative surgery. Neurosensory deficits might heal faster on the right side.

Can Current Recommendations on Sun Exposure Sufficiently Increase Serum Vitamin D Level?: One-Month Randomized Clinical Trial

BACKGROUND: Lack of sunlight exposure is the primary reason for the worldwide epidemic of vitamin D deficiency. Although recommended sunlight exposure guidelines exist, there is no evidence regarding whether current guidelines are optimal for increasing vitamin D levels among individuals with vitamin D deficiency.METHODS: Sixty Korean adults aged 20–49 years with serum 25-hydroxyvitamin D (25[OH]D) levels of < 20 ng/mL were randomly assigned to three groups: sunlight exposure (n = 20), vitamin D supplementation groups (n = 20), and daily living (n = 20) for 1 month. The sunlight exposure group had sunlight exposure on 20% to 30% of their body surface areas for 30–60 minutes per day, 3 times a week during the summer season. Vitamin D supplementation was prescribed with 800 IU/day of vitamin D. The serum levels of 25(OH)D were measured at baseline and at 1-month follow-up examinations.RESULTS: The largest change in serum 25(OH)D was observed among the vitamin D supplementation group (+3.5 ng/mL, P < 0.001). The sunlight exposure group showed a slight increase in serum 25(OH)D level, but the absolute increase was less than one-third that of the vitamin D supplementation group (+0.9 ng/mL, P = 0.043). Only two participants in the sunlight exposure reached serum concentrations of 25(OH)D ≥ 20 ng/mL at follow-up. The daily living group showed no difference in vitamin D levels (−0.7 ng/mL, P = 0.516).CONCLUSION: Sunlight exposure was not sufficient to overcome vitamin D insufficiency or deficiency in the current study subjects. Effectiveness of current sunlight exposure guidelines among various populations should be reassessed in larger clinical studies.TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0002671

Emotion regulation as the mediator of reductions in anxiety and depression in the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders: double-blind randomized clinical trial / Regulação emocional como mediadora de reduções em ansiedade e depressão no Protocolo Unificado para o tratamento transdiagnóstico de transtornos psicológicos: ensaio clínico randomizado duplo-cego

Abstract Objective: An important subject in evaluation of the efficacy of treatments is to examine how the intervention is effective and to identify the consequences of that treatment. In this regard, the current study investigates the role of emotion regulation as the mediator of the treatment outcomes of therapy using the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders. Method: This article describes a double-blind randomized clinical trial. A sample of 26 individuals was selected based on cut-off scores for the Beck Depression Inventory and Beck Anxiety Inventory and their final diagnoses were confirmed with the Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV). The sample was randomly divided into two groups: control and treatment (13 patients each). The treatment group received 20 one-hour UP sessions. The Beck Depression Inventory, the Beck Anxiety Inventory, and the Difficulties in Emotion Regulation Scale were administered at two stages, pre-treatment and post-treatment. Results: The UP reduced anxiety and depression in patients through improvement in emotion regulation. Furthermore, the results showed that the difficulty engaging in goal-directed behavior and non-acceptance of emotional response subscales were capable of predicting 62% of variance in anxiety scores. In turn, two subscales, difficulty engaging in goal-directed behavior and lack of emotional clarity, predicted 72% of variance in depression scores. Conclusion: Emotion regulation can be considered as a potential mediating factor and as predictive of outcomes of transdiagnostic treatment based on the UP. Clinical trial registration: Iranian Registry of Clinical Trials, IRCT2017072335245N1.

Resumo Objetivo: É importante, na avaliação da eficácia de tratamentos, examinar como a intervenção tem efeito e identificar suas consequências. O presente estudo investiga o papel da regulação emocional enquanto mediadora de desfechos do tratamento que emprega o Protocolo Unificado (PU) para o tratamento transdiagnóstico de transtornos psicológicos. Método: Este artigo descreve um ensaio clínico randomizado duplo-cego. Uma amostra de 26 indivíduos foi selecionada com base em escores pré-estabelecidos para o Inventário de Depressão de Beck e o Inventário de Ansiedade de Beck, e seus diagnósticos finais foram confirmados utilizando o instrumento Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV). A amostra foi dividida aleatoriamente em dois grupos: controle e tratamento (13 pacientes em cada). O grupo tratamento recebeu 20 sessões de PU de 1 hora cada. O Inventário de Depressão de Beck, Inventário de Ansiedade de Beck Beck e Escala de Dificuldades de Regulação Emocional foram administrados em duas etapas, antes e depois do tratamento. Resultados: O PU reduziu a ansiedade e a depressão em pacientes, ao melhorar a regulação emocional. Além disso, os resultados mostraram que as subescalas dificuldade de se engajar em comportamentos orientados por objetivos e não aceitação de resposta emocional responderam por 62% da variância nos escores de ansiedade. Nos escores de depressão, duas subescalas, dificuldade de se engajar em comportamentos orientados por objetivos e falta de claridade emocional, explicaram 72% da variância. Conclusão: A regulação emocional pode ser considerada o principal fator mediador e também preditora de desfechos do tratamento transdiagnóstico baseado no PU. Registro do ensaio clínico: Iranian Registry of Clinical Trials, IRCT2017072335245N1.

Crossover studies of pediatric dental sedation are inappropriate

Abstract Crossover studies continue to be published in spite of warnings about their inherent risks in relation to behavioral outcomes. This study took the opportunity of access to secondary data analysis in order to demonstrate the impact of a crossover design on the outcomes of randomized clinical trials aimed at the behavior of children during dental treatment. We evaluated the effect of the sequence of sedative administration, the sedative and the participant's age on the behavior of children undergoing two sequential dental visits. Eighteen uncooperative healthy young children were equally randomly assigned to: (G1) 1.0 mg/kg oral midazolam (first session) and oral placebo (second session); (G2) oral placebo (first) and 1.0 mg/kg oral midazolam (second). One trained observer assessed children's behavior. Data were analyzed by three-way mixed ANOVA. Both midazolam [mean(SD); 71.7%(16.5)] and placebo [48.6%(33.1)] produced more struggling behavior when they were administered in the first session compared to the second one (p=0.001). For the placebo, children aged 2-3 years exhibited more struggling behavior [G1 54.9%(36.2); G2 80.5%(8.3)] than those aged 4-5 years (p=0.04). Also, the reduction of percentage of struggling behavior was higher in G1 for older children (76.2%) and in G2 for younger children (32.9%). There were significant interactions between drug and sequence of administration, and between drug and age. The results of our study confirm the conventional wisdom that crossover study design is inappropriate to evaluate children's behavior/anxiety related-dental treatment under sedation and the results of crossover studies of dental sedation should be treated with extreme caution.

Resumo Pouco se sabe sobre o impacto de um delineamento cruzado nos desfechos de ensaios clínicos randomizados voltados ao comportamento de crianças durante tratamento odontológico. Este estudo objetivou avaliar o efeito da sequência de administração do sedativo, da droga em si e da idade dos participantes no comportamento de crianças que receberam duas consultas odontológicas consecutivas. Dezoito crianças saudáveis não colaboradoras, 2-5 anos de idade, foram randomizadas em dois grupos: G1 - 1,0 mg/kg midazolam oral (primeira sessão) e placebo oral (segunda sessão); G2 - placebo (primeira) e 1,0 mg/kg midazolam oral (segunda). Um observador treinado avaliou o comportamento infantil. Os dados foram analisados por ANOVA de três fatores (alfa=0,05). Midazolam [média(DP); 71,7%(16,5)] e placebo [48,6%(33,1)] resultaram em mais comportamento não cooperativo quando administrados na primeira sessão comparado com a segunda (p=0,001). Com o uso do placebo, crianças de 2-3 anos de idade exibiram mais comportamento não cooperativo [G1 54,9%(36,2); G2 80,5%(8,3)] que as de 4-5 anos de idade (p=0,04). Além disso, a porcentagem de redução do comportamento não cooperativo foi maior em crianças mais velhas em G1 (76,2%) e em crianças mais novas em G2 (32,9%). Considerando a avaliação do comportamento infantil sob sedação, a primeira sessão odontológica influenciou a segunda visita. Os resultados deste estudo confirmam a especulação de que o delineamento cruzado é inadequado para avaliar o comportamento odontológico relacionado à ansiedade/comportamento infantil; os resultados dos ensaios cruzados de sedação odontológica devem ser tratados com extrema cautela.

Tutorial for performing systematic review and meta-analysis with interventional anesthesia studies / Tutorial para execução de revisões sistemáticas e metanálises com estudos de intervenção em anestesia

Abstract Background and objective: The systematic review of randomized clinical trials is crucial to assess the safety and effectiveness of intermediate procedures. The objective of this article is to present a tutorial for the planning and execution of systematic review and meta-analysis of randomized clinical trial studies. Method: The systematic literature review is the type of research that organizes, criticizes, and integrates available evidence published in the health field. Systematization leads to less bias, however, the quality of systematic reviews may not always be perceived due to the way it is described in the articles. The information disclosed in the articles is not always free of bias. The steps for carrying out a systematic review include design, protocol registration, implementation, mathematical analysis of results, and dissemination. PRISMA statement has improved the quality of systematic review reports by providing a list of items to be described, and this article emphasizes the key steps for performing a systematic review of interventions. Conclusion: The evidence generated through a systematic review can provide the clinician with greater confidence in decision making at the moment of clinical practice and optimize the benefits to his patients, serving as a tool to assist managers in making decisions regarding the implementation of new strategies for the health of the population.

Resumo Justificativa e objetivo: A revisão sistemática de ensaios clínicos randomizados é crucial para avaliar a segurança e a efetividade das intervenções médicas. O objetivo deste artigo é apresentar um tutorial para o planejamento e execução de revisões sistemáticas e metanálises de estudos de ensaios clínicos randomizados. Método: A revisão sistemática da literatura é o tipo de pesquisa que organiza, critica e integra as evidências disponíveis publicadas na áera da saúde. A sistematização leva a menos vieses, entretanto a qualidade das revisões sistemáticas nem sempre pode ser percebida devido à forma como têm sido descritas nos artigos. A informação divulgada nos artigos nem sempre está livre de vieses. Os passos para a revisão sistemática incluem o delineamento, o registro do protocolo, a execução, a análise matemática dos resultados e a divulgação. O PRISMA statement melhorou a qualidade dos relatos das revisões sistemáticas, pois fornece uma lista de itens a serem descritos, e este artigo enfatiza os principais passos para a execução de uma revisão sistemática de intervenção. Conclusão: A evidência gerada por meio de uma revisão sistemática pode propiciar ao médico maior confiança na tomada de decisões no momento da prática clínica, aprimorar os benefícios aos seus pacientes e servir como ferramenta para auxiliar os gestores na tomada de decisões quanto à implantação de novas estratégias em prol da saúde da população.

O estresse em mães de prematuros: ensaio clínico sobre atividade educativa / Educative activity and maternal stress of premature infant: controlled trial / El estrés en madres de prematuros: ensayo clínico sobre actividad educativa

Decorrente de eventos estressores na hospitalização, mães de recém-nascidos prematuros tornam-se vulneráveis para desenvolver a competência parental saudável. Objetivou-se comparar o nível de estresse de mães de recém-nascidos prematuros na hospitalização e após a alta hospitalar correlacionando-os aos níveis detectados na análise do conhecimento materno sobre os cuidados com o prematuro. Ensaio clínico randomizado, com mães de recém-nascidos prematuros hospitalizados em Unidade de Terapia Intensiva Neonatal, divididas em: Grupo de Intervenção-GI (atividades educativas) e Grupo Controle-GC (rotina). Mensurou-se o estresse materno pela Escala de Estresse Parental:UTIN (hospitalização) e Índice de Estresse Parental (após a alta hospitalar). Níveis de estresse do GI diminuíram 2,68 vezes em relação ao GC após a alta, contudo sem significância estatística quanto ao conhecimento materno entre os grupos. Para prevenir o estresse após a alta, em mães de prematuros, deve-se empoderá-las para cuidarem do filho

Mothers of preterm infants suffer stressful events during the hospitalization, making them vulnerable for not developing healthy parental competence. This study aimed to compare the stress level of mothers of preterm infants at hospital admission and after discharge, correlating them with the levels detected in the analysis of maternal knowledge about premature infants' care. This was a randomized clinical trial. Mothers of premature infants hospitalized in Neonatal Intensive Care Unit were divided in Intervention Group-IG (educative activities) and Control Group-CG (routine). Stress levels were measured by Parental Stress Scale:NICU (hospitalization) and Parental Stress Index (after hospital discharge). The stress levels of mothers that participated in IG decreased 2.68 times compared to CG after discharge; however, there was no statistical significance in the knowledge between the groups. Preventing stress after discharge in mothers of preterm infant requires empowering them to take care of their children

A raíz de acontecimientos estresantes en la hospitalización, las madres de recién nacidos prematuros se vuelven vulnerables para desarrollar la competencia parental saludable. Se objetivó comparar el nivel de estrés de madres de recién nacidos prematuros en la hospitalización y después del alta hospitalaria correlacionándolos a los niveles detectados en el análisis del conocimiento materno sobre los cuidados con el prematuro. En el estudio clínico aleatorizado, con madres de recién nacidos prematuros hospitalizados en Unidad de Terapia Intensiva Neonatal, divididas en: Grupo de Intervención-GI (actividades educativas) y Grupo Control-GC (rutina). Se midió el estrés materno por la Escala de estrés parental: UTIN (hospitalización) e índice de estrés parental (después del alta hospitalaria). Los niveles de estrés del GI disminuyeron 2,68 veces en relación con el GC después del alta, pero sin significancia estadística en cuanto al conocimiento materno entre los grupos. Para prevenir el estrés después del alta, en madres de prematuros, se deben empoderarlas para cuidar del hijo

Pain and quality of life in human t-cell lymphotropic virus type 1-associated myelopathy or tropical spastic paraparesis after home-based exercise protocol: a randomized clinical trial

Abstract INTRODUCTION: Human T-cell lymphotropic virus type 1-associated myelopathy or tropical spastic paraparesis (HAM/TSP) causes, among other abnormalities, chronic pain that may impair quality of life (QOL). Home protocols can help those who have difficulty attending rehabilitation centers. This study aimed to evaluate the impact of a home-based exercise protocol on pain and QOL in people with HAM/TSP. METHODS: A randomized clinical trial of people with HAM/TSP (World Health Organization criteria) classified as probable or definite. The supervised group (SG) underwent training for 12 weeks and continued the protocol at home for another 12 weeks; the unsupervised group (UG) performed the same protocol at home without physical therapist supervision for 24 weeks; and the control group (CG) maintained the usual care. QOL was assessed by the Short Form-36 health survey and the pain condition by the Brief Pain Inventory (BPI). The Chi-square, analysis of variance, Kruskal-Wallis, and Friedman tests (5% alpha) were used for the analyses. The intention-to-treat method was adopted in case of follow-up losses. Record number RBR-849jyv/UTN: U1111-1176-2858. RESULTS: Of 56 participants, 49 completed the protocol. Mean pain was moderately reduced (>30%) in the UG and CG and mildly reduced (20%) in the SG. Loss in the vitality score of QOL in the CG was noted. CONCLUSIONS: The protocol generated mild and moderate pain relief and reduced losses in the functional QOL in the treatment groups.

Meta-Analysis of the Efficacy and Safety of Uninterrupted NOACs in Patients Undergoing Atrial Fibrillation Catheter Ablation / 中国药学杂志

OBJECTIVE: To systematically assess the efficacy and safety of uninterrupted novel oral anticoagulation (NOAC) in patients undergoing atrial fibrillation catheter ablation. METHODS: Databases including multiple databases were searched electronically for randomized controlled trial (RCT) of NOAC in patients undergoing atrial fibrillation catheter ablation up to October, 2018. Two reviewers independently screened literatures according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of the included studies. Then Meta-analysis was performed using Rev Man 5.3 software. RESULTS: A total of 5 RCTs involving 1 843 patients were included. Experimental group including apixaban, rivaroxaban and dabigatran; control group using warfarin. Efficacy outcome including stroke and transient ischemic attack (TIA); safety outcome was major bleeding. RESULTS were as followsthere was no significant difference between experimental group and control group in efficacy outcome; the safety of the experimental group was significantly superior to that of the control group. CONCLUSION: Compared with warfarin, uninterrupted NOACs during percutaneous atrial fibrillation catheter ablation could reduce the risk of major bleeding and would not increase the incident of stroke and TIA.