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OBJECTIVES: This study investigated altmetrics, citations, and field-normalized impact of dental articles reporting randomized clinical trials (RCTs) published within a one-year period. METHODS: Data were collected in 2024 from PubMed-indexed RCTs published in 2019. Dependent variables included Altmetric Attention Scores (AAS), PlumX citations, and Field-Weighted Citation Impact (FWCI). Independent variables encompassed article-, author-, and journal-related variables. Adjusted quasi-Poisson regression models were used to assess associations. Point-biserial correlation evaluated the relationship between Journal Impact Factor (JIF) and selected reporting variables. RESULTS: A total of 653 RCTs were included, with periodontology, implantology, and oral and maxillofacial surgery comprising 50.4 % of the sample. Only 28.6 % of the articles reported CONSORT use, 49.6 % pre-registered their protocol, and 68.8 % reported a sample size calculation. Most articles (63.6 %) reported no conflicts of interest, with unclear sponsorship being the most frequent (34.6 %). Regression analyses revealed significant associations for AAS, PlumX citations, and FWCI with various factors. JIF increased AAS by 17 % per unit, PlumX citations by 13 %, and FWCI by 6 %. Protocol pre-registration boosted AAS by 132 %, while mixed or no sponsorship increased PlumX citations by up to 47 %. First author H-index increased PlumX citations and FWCI by 1 % per unit, while first author continent impacted AAS, citations, and FWCI. Weak positive correlations between JIF and both protocol pre-registration and CONSORT use were observed. No significant differences were observed across different dental fields for any metric. CONCLUSION: An interplay among article-, author-, and journal-related variables collectively influenced the online attention, citations, and impact of dental RCT articles. CLINICAL SIGNIFICANCE: Understanding the factors that influence the visibility and impact of dental RCTs can guide researchers in improving the design, reporting, and dissemination of their studies, ultimately enhancing the quality and reach of dental research.

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Abstract Background 5-Fluorouracil (5-FU) is a first-line drug to treat cutaneous field cancerization (CFC). There are few clinical trials with topical colchicine (COL). Objective To evaluate the effectiveness of 0.5% COL cream versus 5% 5-FU cream in the treatment of CFC. Method This was a randomized, open, self-controlled clinical trial. Forty-five patients (90 forearms), with three to ten actinic keratoses (AK) on each forearm, used 0.5% COL cream 2×/day for seven days on one forearm, and 5% 5-FU cream 2× /day, for 21 days, on the other forearm. The dosages were defined based on previous clinical trials for each drug. Adverse effects were evaluated after 14 days and outcomes after 90 days of inclusion. The primary outcome was complete AK clearance and the secondary outcomes were: partial clearance (≥50%), reduction in AK count, assessment of the Forearm Photoaging Scale (FPS), AK Severity Score (AKSS), and adverse effects. Results After 90 days, there was complete clearance of AK in 37% (95% CI 24%-49%) and partial clearance in 85% (95% CI 76%-93%) of the forearms treated with 5-FU,versus 17% (95% CI 7%-27%) and 78% (95% CI 66%-88%) for COL (p > 0.07). There was a percentage reduction of 75% in the AK count of the forearms treated with 5-FU (95% CI 66%-83%) and 64% in those treated with COL (95% CI 55%-72%). Regarding FPS and AKSS, there was improvement in both groups, with no difference regarding FPS (p = 0.654), and 5-FU superiority for AKSS (p = 0.012). Study limitations Single-center study. Conclusions 5-FU and COL are effective for treating CFC, with neither showing superiority regarding the reduction in AK counts.

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RATIONALE & OBJECTIVE: Almost 80% of individuals with chronic kidney disease (CKD) reside in low- and middle-income countries (LMICs) and are potentially underrepresented in randomized controlled clinical trials (RCTs). We assessed the global distribution of RCTs comparing pharmacological treatments for CKD over the past 2 decades, as well as the magnitude and evolution of participation by LMICs. STUDY DESIGN: Systematic review. SETTING & STUDY POPULATIONS: RCTs evaluating pharmacological interventions in adults with CKD. SELECTION CRITERIA FOR STUDIES: RCTs published between 2003-2023 and indexed in MEDLINE. DATA EXTRACTION: Each trial was reviewed and extracted independently by 2 investigators with disagreements settled by consensus or a third reviewer. ANALYTICAL APPROACH: RCT participation of World Bank-defined income groups and geographic regions were described, and the representation indices (RI) according to RCT participants and estimated CKD prevalences were calculated. RCTs were also categorized as global, regional, or national in scope. RESULTS: Among 7,760 identified studies, we included 1,366 RCTs conducted in 84 countries with 301,158 participants. National, regional, and global RCTs represented 85.4%, 3.5%, and 11.1% of studies, respectively. LMICs were included in 34.7% of RCTs. No RCTs included participants from low-income countries, and lower-middle-income countries participated in 13.2%. Of participants from RCTs with available information, 25.4% (n=64,843 of 255,237) were from LMICs. According to the RI, 6 LMICs were overrepresented (>1.25), 7 were adequately represented (0.75-1.25), and 26 were underrepresented (<0.75). Most global CKD RCTs (80.2%) included LMICs; however, LMIC participants constituted only 32.9% of the global trial population. We observed a positive trend in LMIC inclusion over time, rising from 22.9% (n=71of 310) in 2003-2007 to 45.5% (n=140of 308) in 2018-2023. LIMITATIONS: The use of an income-group dichotomy, exclusion of nonrandomized studies of intervention, and studies identified in 1 database. CONCLUSIONS: Despite an increase in participation over the past 2 decades, individuals with CKD from LMICs remain significantly underrepresented in RCTs. These findings suggest that increased efforts are warranted to increase LMIC representation in pharmacological CKD RCTs. PLAIN-LANGUAGE SUMMARY: Chronic kidney disease (CKD) substantially affects people from low- and middle-income countries (LMICs). However, the participation of these countries in randomized controlled trials (RCTs) remains uncertain. To assess the global distribution and representation of these countries in kidney disease research, we reviewed 1,366 CKD drug RCTs published from 2003-2023, conducted in 84 countries involving more than 300,000 participants. LMICs were included in approximately a third of these studies, with their participants making up approximately one-quarter of the total; lower-middle-income countries were poorly represented, and low-income countries were absent. LMICs constituted a third of participants in multinational RCTs. Most LMICs were underrepresented relative to the prevalence of CKD. We observed an increasing inclusion of LMICs, particularly in the last decade. Nonetheless, individuals with CKD from LMICs remain underrepresented in drug RCTs, suggesting that increased efforts are warranted to include representation of these populations in these studies.

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The objective was to compare the color match and color stability behavior of single- and multi-shade resin-based composites (RBCs) used for direct restorations. This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized clinical trials evaluating the shade performance of single-shade RBCs in direct restorations were included. A search of the scientific literature was performed in five databases (April 2024). The meta-analysis was performed using RevMan 5.4, calculating the risk difference (RD) and 95% confidence interval (CI) of the dichotomous outcome using a random effects model. Bias was assessed using the RoB 2.0 tool, and certainty of evidence was assessed using the GRADEpro tool. Four studies were selected, with 263 restorations analyzed. The results showed comparable performance between single-shade RBCs and multi-shade RBCs in terms of color match and color stability over 12 months. Three studies had a low risk of bias with all expected results, and one study had some concerns. The certainty of evidence for color stability was considered low for all follow-up periods due to the small number of events and sample size. According to the United States Public Health Service Evaluation (USPHS) and the World Dental Federation (FDI), there is comparable clinical color performance between single-shade and multi-shade RBCs over 12 months.

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BACKGROUND: The vegan diet (VEGD) has gained popularity in recent years for ecological and ethical reasons, as well as for its health benefits. In addition to the type of diet, the resistance training program (RTP) plays a fundamental role as one of the main natural anabolic stimuli to increase musculoskeletal mass and reduce fat mass. METHODS: The study was a 16-week non-randomized controlled clinical trial consisting of three RTP sessions per week. The sample included 70 Chilean individuals, aged between 18 and 59 years, who had been following a VEGD or omnivorous diet (OMND) for the past 6 months. Four groups were established: Vegan Diet Resistance Training Program (VEGD-RTP), Vegan Diet Control (VEGD-C), Omnivorous Diet Resistance Training Program (OMND-RTP), and Omnivorous Diet Control (OMND-C). RESULTS: The sample consisted of 47 women and 23 men, with a mean age of 30.1 (±8.6) years. A reduction of 1.20% in the percentage of fat mass (%FM) was observed in the VEGD-RTP group (r = 0.554, p = 0.016), as well as a reduction of 0.70 kg in kilograms of fat mass (KFM) (r = 0.480, p = 0.036). The OMND-RTP group decreased %FM by 0.90% (r = 0.210, p = 0.432) and KFM by 0.50 kg (r = 0.109, p = 0.683). CONCLUSIONS: RTP combined with VEGD or OMND significantly reduced the percentage of fat mass, although its effect was more significant in the VEGD-RTP participants.

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Composição Corporal , Dieta Vegana , Treinamento Resistido , Humanos , Feminino , Adulto , Masculino , Treinamento Resistido/métodos , Adulto Jovem , Pessoa de Meia-Idade , Adolescente , Chile , Dieta

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PURPOSE: This two-arm parallel randomized controlled trial aimed to evaluate and compare periodontal changes due to rapid maxillary expansion (RME) using tooth-bone-borne and tooth-borne devices in growing patients via clinical examinations and cone-beam computed tomography (CBCT). MATERIALS AND METHODS: Forty-two eligible patients (aged 11-14 years; transverse maxillary deficiency, posterior crossbite) were screened and divided into two groups based on the treatment received (randomization was performed using computer-generated numeric sequences): hybrid hyrax tooth-bone-borne group (TBB) and hyrax tooth-borne group (TB). The primary outcome was the change in cortical bone thickness (by CBCT). In addition, the clinical attachment level (CAL), gingival recession, and bleeding were assessed. Both examinations were performed before and 3 months after the activation phase. Intergroup comparisons were performed using analysis of covariance (ANCOVA; P < 0.05). RESULTS: Twenty-one patients (12 girls and 9 boys; mean initial age, 13.3 years) were included in the TBB group and 21 (5 girls and 16 boys; mean initial age, 13.2 years) were included in the TB group. The TB group exhibited a decrease in buccal bone thickness in the first premolars and first molars at all three evaluated levels. Specifically, tooth 14 at 3 mm from the enamel-cement junction showed a significant width reduction (0.7 mm; p < 0.001), accompanied by a notable increase in palatal cortical thickness at 6 mm of enamel-cement junction (1.13 mm; p < 0.001). CONCLUSIONS: RME resulted in buccal bone thickness reduction at the first premolar with hyrax treatment. In the molar region, both devices resulted in cortical bone alterations that were less pronounced in the TBB group.

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BACKGROUND: The purpose of this study was to review and summarize the association between preoperative magnetic resonance imaging (MRI) and surgical outcomes in women with newly diagnosed invasive breast cancer from published randomized controlled trials (RCT). MATERIALS AND METHODS: Two independent researchers conducted a systematic review through a comprehensive search of electronic databases, including PubMed, Medline, Embase, Ovid, Cochrane Library, and Web of Science. If there was disagreement between the two reviewers, a third reviewer assessed the manuscript to determine whether it should be included for data extraction. The quality of the papers was assessed using the risk of bias tool, and the evidence was analyzed using GRADE. Meta-analyses using a fixed-effects model were used to estimate the pooled risk ratio (RR) and 95% confidence interval (CI). RESULTS: Initially, 21 studies were identified, 15 of which were observational comparative studies. A total of five RCTs were included, and they suggested that preoperative MRI significantly reduced the rate of immediate breast-conserving surgery and increased the risk for mastectomy. CONCLUSIONS: From the RCT perspective, preoperative MRI for newly diagnosed invasive breast cancer did not improve surgical outcomes and may increase the risk of mastectomy.

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Neoplasias da Mama , Imageamento por Ressonância Magnética , Cuidados Pré-Operatórios , Humanos , Neoplasias da Mama/cirurgia , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/patologia , Feminino , Imageamento por Ressonância Magnética/métodos , Prognóstico , Mastectomia , Ensaios Clínicos Controlados Aleatórios como Assunto , Tomada de Decisão Clínica , Mastectomia Segmentar/métodos

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INTRODUCTION AND HYPOTHESIS: Transcranial direct current stimulation (tDCS) can enhance muscle function in healthy individuals. However, it is unknown if tDCS associated with pelvic floor muscle training (PFMT) can improve pelvic floor muscle function (PFMF) in healthy women. The aim of this study was to investigate the acute effect of a single session of tDCS in PFMF compared with sham-tDCS in healthy women. METHODS: A double-blind, cross-over, randomized clinical trial was conducted with healthy, nulliparous and sexually active women. PFMF was assessed by bidigital palpation (PERFECT scale) and intravaginal pressure by a manometer (Peritron™). Participants randomly underwent two tDCS sessions (active and sham) 7 days apart. The electrode was positioned equal for both protocols, the anode electrode in the supplementary motor area (M1) and the cathode electrode in the right supraorbital frontal cortex (Fp2). The current was applied for 20 min at 2 mA in active stimulation and for 30 s in sham-tDCS. The tDCS applications were associated with verbal instructions to PFMT in a seated position. After each tDCS session PFMF was reevaluated. RESULTS: Twenty young healthy women (aged 23.4 ± 1.7 years; body mass index 21.7 ± 2.2 kg/m2) were included. No difference was observed in power, endurance, and intravaginal pressure of PFMF (p > 0.05). The number of sustained contractions improved from 3.0 (2.0-3.5) to 4.0 (3.0-5.0) after active-tDCS (p = 0.0004) and was superior to sham-tDCS (p = 0.01). CONCLUSION: The number of sustained contractions of PFM improved immediately after a single active-tDCS session, with a difference compared with the post-intervention result of sham-tDCS in healthy young women.

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Estudos Cross-Over , Diafragma da Pelve , Estimulação Transcraniana por Corrente Contínua , Humanos , Feminino , Diafragma da Pelve/fisiologia , Método Duplo-Cego , Adulto Jovem , Estimulação Transcraniana por Corrente Contínua/métodos , Adulto , Voluntários Saudáveis , Contração Muscular/fisiologia

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BACKGROUND: Premature loss of primary teeth presents a significant challenge in oral health, with conflicting views on using space maintainers. AIM: To assess mandibular arch space changes associated with premature lower primary molar (PM) loss with or without a space maintainer. DESIGN: A randomized clinical trial with children (6-9 years old) with premature loss of a lower PM divided into two groups: control group (CG), without a space maintainer, and intervention group (IG), with a space maintainer. Dental casts were measured at baseline, 3 months, and 6 months. Linear distance; intercanine width and length; and arch width, length, and perimeter were measured. ANOVA and t-test were applied (p = .05). RESULTS: Twenty-six patients (mean: 7.3 years; standard deviation [SD]: 0.92) were included: 14 in CG and 12 in IG. CG had a greater space loss (-0.9 mm; SD: 0.45) than IG (-0.4 mm; SD: 0.61) at 3 months (p < .05). No difference between the groups was observed after 6 months (p = .610). CG decreases space at 6 months, especially with the first permanent molars without intercuspation (-2 mm; SD: 0.71; p = .007). CONCLUSION: Premature lower PM loss resulted in reduced arch space loss after 6 months, regardless of a space maintainer use. CG showed more loss of space when the first permanent molars lacked intercuspal relationship.

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INTRODUCTION: Impairments in bottom-up perceptual processing have been associated to the age-related cognitive decline. Digital cognitive training focusing on bottom-up and/or top-down processes have been studied as a tool to remediate age-related cognitive decline. However, the most effective training type and order of application remain unclear. METHODS: One hundred and fifteen older adults were randomly assigned to 40 h of bottom-up then top-down or top-down then bottom-up digital cognitive training or an active control group. We evaluated cognition at baseline, after 20 h and 40 h of training and at follow-up using a mixed-model analysis. RESULTS: Global cognition improved, for the top-down group, after 20 h of training (p = 0.04; d = 0.7) and for all three groups after 40 h. The improvement in global cognition remained five months after the bottom-up/ top-down training (p = 0.009; d = 4.0). There were also improvements in the recall cognitive domain, after 20 h of training, for the bottom-up group and, after 40 h, for all three groups. Gains were observed in verbal fluency after 40 h of training for both therapeutic groups. Processing speed was significantly slower, after 20 h of training, for the control and bottom-up groups and, after 40 h, only for the control group. Emotion recognition improved, after 20 h, for the control group as compared to the therapeutic groups. CONCLUSIONS: These results indicate that the bottom-up/top-down training has the most endurable effects, which reveals the importance of the order of application of the exercises for gains in cognition in older adults.

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Cognição , Disfunção Cognitiva , Humanos , Masculino , Feminino , Idoso , Disfunção Cognitiva/terapia , Cognição/fisiologia , Terapia Cognitivo-Comportamental/métodos , Testes Neuropsicológicos , Idoso de 80 Anos ou mais , Treino Cognitivo

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INTRODUCTION: Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery. METHODS AND ANALYSES: This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways. ETHICS AND DISSEMINATION: This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798.

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Cirurgia Bariátrica , Dor Crônica , Terapia com Luz de Baixa Intensidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Método Duplo-Cego , Dor Crônica/etiologia , Dor Crônica/terapia , Terapia com Luz de Baixa Intensidade/métodos , Obesidade/complicações , Qualidade de Vida , Articulação do Joelho , Medição da Dor , Adulto , Artralgia/etiologia , Artralgia/terapia

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BACKGROUND: Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. AIM: The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. METHODS: From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. OUTCOMES: The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. RESULTS: Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group. CLINICAL IMPLICATIONS: Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. STRENGTHS & LIMITATIONS: The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. CONCLUSION: After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment.

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Terapia por Exercício , Diafragma da Pelve , Vagina , Humanos , Feminino , Diafragma da Pelve/fisiopatologia , Pessoa de Meia-Idade , Vagina/fisiopatologia , Estudos Prospectivos , Terapia por Exercício/métodos , Adulto , Disfunções Sexuais Fisiológicas/terapia , Prolapso de Órgão Pélvico/terapia , Incontinência Urinária/terapia , Incontinência Urinária/fisiopatologia , Resultado do Tratamento

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Several randomized controlled trials (RCTs) have investigated the potential benefits of green tea on the inflammatory process in metabolic syndrome (MetS). However, the results are inconclusive and inconsistent. In the present study, we performed a literature review and meta-analysis to evaluate the effect of green tea supplementation on inflammatory markers [e.g., tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and interleukin-6 (IL-6)] among patients with MetS and related disorders. We systematically searched for relevant publications up to March 2022 in the PubMed, Scopus, Web of Science, and SciELO databases. The review was registered with PROSPERO (CRD42022320345). Mean differences with 95% confidence intervals were pooled on the basis of the random effects model to compare the effects of green tea with placebo. We used meta-regression and subgroup analyses to determine the cause of heterogeneity and performed study quality assessment using the Grading of Recommendations Assessment, Development, and Evaluation method. We assessed publication bias using funnel plots and Egger's tests. Out of the total 15 RCTs that were included in this systematic review, 12 were chosen for the meta-analysis. The results revealed that green tea significantly decreased TNF-α levels but did not affect CRP and IL-6 levels. Subgroup analysis showed that green tea supplementation in studies lasting ≤8 weeks significantly increased CRP levels. Furthermore, meta-regression analysis demonstrated a significant association between increasing IL-6 concentration and treatment duration. According to our meta-analysis, green tea was shown to considerably lower circulating TNF-α levels. To confirm these findings, carefully planned trials are required.

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Abstract Objective To compare the functional outcomes of anterior cruciate ligament (ACL) reconstruction with hamstring autograft (HA) through the all-inside (AI) technique with adjustable-loop cortical Endobutton (Smith & Nephew, Watford, Hertfordshire, England) on the sides of the femur and tibia and through the outside-in (OI) technique using an interference screw on the tibial side and a cortical Endobutton on the femoral side. Materials and Methods The present is a double-blinded randomized controlled trial (RCT) of 44 patients undergoing arthroscopic ACL reconstruction from February 2019 to February 2022 in a tertiary care hospital. As per computer-based randomization, the patients were distributed into two groups: the AI and OI groups. Both groups were evaluated for 12 months using the Visual Analog Scale (VAS), the Lysholm Knee Scoring Scale, and part I (pain score) and part II (function score) of the Knee Society Score (KSS). Results On postoperative day 2,the VAS score was significantly higher in the OI group (p = 0.0001), but insignificant (p = 0.807) at 6 weeks. At 3, 6, and 12 months of follow-up, the score on the Lysholm Knee Scoring Scale was significantly higher (p = 0.001) in the AI group. At 6 months, both parts of the KSS showed a significant difference, with the AI group presenting a better outcome (p = 0.04). However, at 12 months, the AI group presented a better score on part I of the KSS, but no differences were observed regarding part II. Conclusion In a follow-up of 12 months, the patients submitted to the AI technique presented better outcome scores and pain relief than those submitted to the OI technique.

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Resumo Objetivo Comparar os resultados funcionais da reconstrução do ligamento cruzado anterior (LCA) com autoenxerto de isquiotibiais pela técnica all-inside (AI) com Endobutton (Smith & Nephew, Watford, Hertfordshire, Inglaterra) cortical de alça ajustável nos lados do fêmur e da tíbia e pela técnica outside-in (OI) com parafuso de interferência no lado tibial e Endobutton cortical no lado femoral. Métodos Trata-se de um ensaio clínico controlado, randomizado e duplo-cego com 44 pacientes submetidos à reconstrução artroscópica do LCA de fevereiro de 2019 a fevereiro de 2022 em um hospital de cuidados terciários. De acordo com a randomização por computador, os pacientes foram distribuídos em dois grupos: AI e OI. Ambos os grupos foram avaliados durante 12 meses pela Escala Visual Analógica (EVA), a Escala de Pontuação do Joelho de Lysholm e pela parte I (pontuação de dor) e a parte II (pontuação de função) da escala Knee Society Score (KSS). Resultados No segundo dia de pós-operatório, a pontuação média na EVA foi significativamente maior no grupo OI (p = 0,0001), mas insignificante (p 0,807) às 6 semanas. Aos 3, 6 e 12 meses de acompanhamento, a pontuação na Escala de Lysholm (p = 0,001) foi significativamente maior no grupo AI. Aos 6 meses, ambas as partes da KSS apresentam uma diferença significativa, com o grupo AI apresentando um desfecho melhor (p = 0,04). No entanto, aos 12 meses, o grupo AI apresentou uma pontuação melhor na parte I da KSS, mas não foram observadas diferenças na parte II. Conclusão Em um acompanhamento de 12 meses, os pacientes submetidos à técnica AI apresentaram melhores pontuações de desfecho e alívio da dor do que aqueles submetidos à técnica OI.

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OBJECTIVE: To determine in the long term whether supervised physiotherapy is more effective than a home exercise program for functional improvement and pain relief in patients with distal radius fracture (DRF). DESIGN: Randomized controlled trial. SETTING: Rehabilitation hospital. PARTICIPANTS: A total of 74 patients older than 60 years with extra-articular DRF were randomly allocated into two groups. INTERVENTIONS: The experimental group received 6 weeks of supervised physiotherapy (n = 37) and the control group received 6 weeks of home exercise program (n = 37). MAIN OUTCOME MEASURES: The primary outcome was wrist/hand function assessed using the Patient-Rated Wrist Evaluation (PRWE) questionnaire; secondary outcomes were the pain visual analogue scale (VAS), grip strength and wrist flexion-extension active range of motion. RESULTS: All patients completed the trial. For the primary outcome, at 6-weeks and 1-year follow-up, the PRWE questionnaire showed a mean difference between groups of 18.6 (95% CI 12.8 to 24.3) and 18.5 points (95% CI 12.7 to 24.2) respectively, these differences are clinically important. Conversely, at 2-year follow-up this effect decreases to 3.3 points (95% CI -2.4 to 9.0). For secondary outcomes, at 6-weeks and 1-year follow-up, in all measurements the effect size range from medium to large. Conversely, at 2-year follow-up only grip strength showed large effect size in favor of supervised physiotherapy, the rest of outcomes did not show difference between groups. CONCLUSION: At the 6-week and 1-year follow-up, supervised physiotherapy was more effective for functional improvement and pain relief compared with a home exercise program in patients older than 60 years with extra-articular DRF. However, this effect decreases over time, at the 2-year follow-up, only grip strength showed a difference in favor of supervised physiotherapy. TRIAL REGISTRATION: Brazilian registry of clinical trials UTN no. U1111- 1249-2492. Registered 17 March 2020. CONTRIBUTION OF THE PAPER.

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Terapia por Exercício , Força da Mão , Modalidades de Fisioterapia , Fraturas do Rádio , Amplitude de Movimento Articular , Humanos , Masculino , Feminino , Idoso , Fraturas do Rádio/reabilitação , Terapia por Exercício/métodos , Pessoa de Meia-Idade , Seguimentos , Medição da Dor , Serviços de Assistência Domiciliar , Fraturas do Punho

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INTRODUCTION: New therapies for resistant hypertension (RH), including renal denervation (RDN), have been studied. AIM: Access the safety and effectiveness of radiofrequency-based RDN vs pharmacological treatment for RH. METHODS: A thorough literature search was conducted across PubMed, EMBASE, and the Cochrane databases, focusing on studies that compared the effects of radiofrequency-based RDN versus pharmacological treatment for RH. Treatment effects for binary and continuous endpoints were pooled and used, respectively, odds-ratio (OR) and mean differences (MD) with 95% confidence intervals (CI) to analyze continuous outcomes. RESULTS: In the 10 included studies, involving 1.182 patients, 682 received radiofrequency-based RDN. The follow-up period ranged from 6 to 84 months. Analysis revealed that the RDN group had a significant reduction in office systolic blood pressure (BP) (MD - 9.5 mmHg; 95% CI - 16.81 to - 2.29; P = 0.01), office diastolic BP (MD - 5.1 mmHg; 95% CI - 8.42 to - 2.80; P < 0.001), 24 h systolic BP (MD - 4.8 mmHg; 95% CI - 7.26 to - 2.42; P < 0.001). For 24 h diastolic BP RDN did not have a significant reduction (MD - 2.3 mmHg; 95% CI - 4.19 to - 0.52; P = 0.012). The heterogeneity between the studies was high, visible in the funnel and Baujat plots. The OR was non-significant for non-serious adverse events, but also clinically significant for hypertensive crises and strokes for the RDN group. CONCLUSIONS: While the pharmacological regimen of 3 or more anti-hypertensive, including a diuretic, still be the first-line option for RH treatment, our results support that radiofrequency-based RDN is superior in reducing global BP and is safe.

Assuntos

Anti-Hipertensivos , Pressão Sanguínea , Ablação por Cateter , Resistência a Medicamentos , Hipertensão , Rim , Simpatectomia , Humanos , Resultado do Tratamento , Hipertensão/fisiopatologia , Hipertensão/cirurgia , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Pressão Sanguínea/efeitos dos fármacos , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Ablação por Cateter/efeitos adversos , Rim/inervação , Pessoa de Meia-Idade , Simpatectomia/efeitos adversos , Simpatectomia/métodos , Feminino , Masculino , Idoso , Fatores de Risco , Artéria Renal/inervação , Artéria Renal/cirurgia , Fatores de Tempo , Adulto

RESUMO

INTRODUCTION: This study reports the evaluation of the short-term effects of the Strengthening Families Program (SFP 10-14), adapted as Famílias Fortes (Strong Families) in Brazil, on preventing adolescent drug use and improving parenting behaviors. METHODS: A two-arm, parallel cluster randomized controlled trial was conducted in 60 Social Assistance Reference Centers (SARC) from 12 Brazilian municipalities. In each city, the SARC were randomly assigned to the intervention or control group. A total of 805 families participated in the study, each contributing data from one parent or legal guardian and one adolescent totaling 1,610 participants. Data collection occurred before intervention implementation and 6 months after baseline collection. Data were analyzed using multilevel mixed-effects modeling with repeated measures in two different paradigms: Intention to Treat (ITT) and Per protocol (PP). The study was registered in the Brazilian Ministry of Health Register of Clinical Trials (REBEC), under protocol no. RBR-5hz9g6z. RESULTS: Considering the ITT paradigm, the program reduced the chance of parents and legal guardians being classified as negligent by 60% (95%CI 0.21; 0.78), increased the use of nonviolent discipline by caregivers (Coef 0.33, 95%CI 0.01; 0.64) and decreased the chance of adults exposing adolescents to their drunken episodes by 80% (95%CI 0.06; 0.54). No program effects were observed on outcomes related to adolescent drug use. Similar results were found for the PP paradigm. CONCLUSION: The positive effects on family outcomes suggest preventive potential of the program among the Brazilian population. Long-term evaluations are necessary to verify if the program can also achieve the drug use reduction goals not observed in the short term.

RESUMO

CONTEXT: The global prevalence of type 2 diabetes mellitus (DM2) has been rising significantly over the years. Recent studies have shown beneficial effects of cinnamon on metabolic biomarkers. OBJECTIVE: The objective of this review was to assess the effect of cinnamon supplementation on metabolic biomarkers in patients with DM2. DATA SOURCES: The Pubmed/MEDLINE, Cochrane CENTRAL, and Embase databases were searched up to November 10, 2022. DATA EXTRACTION: A systematic search was performed for randomized controlled trials (RCTs) evaluating the effect of cinnamon supplementation on metabolic biomarkers, in adults and the elderly with DM2, and comparing the data for a cinnamon intervention group with that for a placebo group or a control group. The main exclusion criteria were studies (1) with other types of diabetes (ie, gestational diabetes or type 1 diabetes), (2) without cinnamon consumption, (3) that did not evaluate metabolic biomarkers, or (4) in vitro and animal studies. Two researchers independently screened 924 records, evaluated full-text studies, extracted data, and appraised their quality. A third researcher was consulted to resolve any discrepancies. The data were pooled using random-effects models and expressed as the weighted mean difference (WMD) with 95% CI. Heterogeneity was assessed using Cochran's Q test and quantified using I2 statistics. Risk of bias was assessed using the Joanna Briggs Institute (JBI) instrument. Sensitivity analysis and the GRADE system were used to assess the robustness and certainty of the findings. DATA ANALYSIS: In total, 28 RCTs with a duration ranging from 30 to 120 days and a total enrollment of 3054 patients with DM2 were included. Participants consuming cinnamon showed a significant reduction in fasting blood glucose (FBG) (WMD: -15.26 mg/dL; 95% CI: -22.23 to -8.30; I2 = 88%), postprandial glucose (WMD: -39.22 mg/dL; 95% CI: -63.90 to -14.55; I2 = 100%), HbA1c (WMD: -0.56 mg/dL; 95% CI: -0.99 to -0.13; I2 = 94%), and HOMA-IR (WMD = -0.76, 95% CI: -1.13 to -0.39; I2 = 22%) compared with the control group. An intervention of cinnamon in capsule form reduced FBG (WMD:-18.43 mg/dL, 95% CI: -26.32 to -10.53; I2 = 89%), postprandial glucose (WMD: -44.83 mg/dL, 95% CI: -70.67 to -18.99; I2 = 100%), HbA1c (WMD: -0.56 mg/dL, 95% CI: -1.02 to -0.09; I2 = 94%), total cholesterol (WMD: -13.39 mg/dL; 95% CI: -24.71 to -2.07; I2 = 96%), LDL-C (WMD: -6.49 mg/dL, 95% CI: -12.69 to -0.29; I2 = 92%), and triglycerides (WND: -19.75 mg/dL; 95% CI, -33.71 to -5.80; I2 = 88%). Both doses (≤2 g/day and >2 g/day) reduced FBG and postprandial glucose. Only cinnamon doses of ≤2 g/day reduced HbA1c (WMD: -0.68 mg/dL, 95% CI: -1.16 to -0.1; I2 = 92%), HOMA-IR (WMD: -0.94 mg/dL; 95% CI: -1.21 to -0.67; I2 = 0%), and BMI (WMD: -1.18 kg/m2; 95% CI: -1.97 to -0.39; I2 = 0%). CONCLUSION: The data suggest that cinnamon improves the glycemic and lipid profile and reduces the BMI, particularly in DM2 patients who receive cinnamon supplementation in capsule form and at a dose of ≤2 g/day. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42022370332.

RESUMO

Cardiovascular disease (CVD) is the primary cause of death and disability worldwide. Although age-standardized CVD mortality rates decreased globally by 14.5% between 2006 and 2016, the burden of CVD remains disproportionately higher in low- and middle-income countries compared to high-income countries. Even though proven, effective approaches based on multiple-drug intake aimed at the prevention and treatment of CVD are currently available, poor adherence, early discontinuation of treatment, and suboptimal daily execution of the prescribed therapeutic regimes give rise to shortfalls in drug exposure, leading to high variability in the responses to the prescribed medications. Wald and Law, in their landmark paper published in BMJ 2003, hypothesized that the use of a fixed-dose combination of statins, ß-blockers, angiotensin receptor blockers, angiotensin-converting enzyme inhibitors, and aspirin (classic Polypill composition) may increase adherence and decrease CVD by up to 80% when prescribed as primary prevention or in substitution of traditional protocols. Since then, many clinical trials have tested this hypothesis, with comparable results. This review aims to describe the available clinical trials performed to assess the impact of fixed-dose combinations on adherence, cost-effectiveness, and the risk factors critical to the onset of CVD.

RESUMO

BACKGROUND: There is general agreement that sexuality is a central aspect of human development; it is key in sexual health and reproductive education during adolescence. However, in spite of the existing interventions on this topic and the evidence generated, the inclusion of a gender focus in sexuality is relatively recent and there is little evidence available, thus structured and corroborated interventions with a gender-transforming perspective in sexuality are required. METHODS: We will use a mixed method experimental design with a parallel cluster-randomized trial (GRTs) that will evaluate the effectiveness of a comprehensive gender-transformative intervention of sexual education (ENFOCATE -Focus-on-), which will be complemented with qualitative studies to understand the implementation process. The participants will be 609 10th and 11th-grade students. The randomization will be by grade, and the data will be collected at three moments (pre-intervention, post-intervention, and a 3-month follow-up). DISCUSSION: Comprehensive, gender-focused, and culturally pertinent interventions in sexuality are needed for adolescents of countries with high, middle, and low incomes. These produce better results in terms of sexual health, and including a gender-transformative focus contributes to equity in health. Focus-on is unique since it uses a comprehensive gender-transformative intervention in sexual education that will allow putting into practice a program based both on international evidence and that which arises from the object population. It also uses a culturally-sensitive focus, since it is designed based on the characteristics of the object population; it will allow adapting some activities to the needs of the context in which it is developed. TRIAL REGISTRATION: The study was prospectively registered on June 6, 2023, at ClinicalTrials.gov ID: NCT05896540. Protocol version number 1.0. May 22, 2023.

Assuntos

Ensaios Clínicos Controlados Aleatórios como Assunto , Serviços de Saúde Escolar , Educação Sexual , Saúde Sexual , Humanos , Adolescente , Educação Sexual/métodos , Feminino , Masculino , Comportamento do Adolescente , Comportamento Sexual , Fatores Sexuais , Conhecimentos, Atitudes e Prática em Saúde , Fatores de Tempo