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ABSTRACT BACKGROUND: Although the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.
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Trials within cohorts （TwiCs） are design methods derived from randomized controlled trials （RCTS）. They have been widely used in chronic disease areas such as tumors and cardiovascular diseases. The basis of the TwiCs design is a prospective cohort of specific diseases. When RCTS need to be implemented， some patients meeting the inclusion and exclusion criteria are randomly sampled from the cohort to receive "trial interventions"， while the remaining patients in the cohort who meet the inclusion and exclusion criteria continue to receive conventional treatment as control groups. By comparing the efficacy differences between the intervention measures of the trial group and the control group， the efficacy of intervention measures was evaluated. Within the cohort， the same process could be repeated to carry out multiple RCTS， so as to evaluate different intervention measures or compare the efficacy of different doses or timing of interventions. Compared with classical RCTS， TwiCs make it easier to recruit patients from the cohort and have higher external validity， providing a new research paradigm for improving the efficiency and applicability of RCTS in clinical practice. However， TwiCs may also face the challenge of poor compliance of patients in the cohort. Researchers need to take effective measures to control these patients in the design and operation of TwiCs. This article focused on the methodological key points during the implementation of TwiCs， including multi-stage informed consent （patients are informed of consent at three stages： entering the cohort， entering the trial group， and after the trial）， randomization procedures （only random sampling of patients from the cohort to receive "trial interventions"）， sample size calculation， and statistical analysis methods. The article also compared the differences between TwiCs and traditional RCTS and illustrated TwiCs research design and analysis with examples， so as to provide new research ideas and methods for clinical researchers.
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Introducción: La medición de la presión arterial es uno de los procedimientos más realizados en la práctica clínica. La presente revisión narrativa pretende sintetizar los aspectos relevantes que rodearon la definición de la hipertensión arterial, el recorrido histórico del tratamiento de esta y el aporte de los estudios a la disminución de la mortalidad por enfermedad cardiovascular en el tiempo. Metodología: Revisión narrativa de la historia de la hipertensión arterial, desde el reconocimiento de la presión arterial alta como un factor asociado al riesgo cardiovascular y la evolución histórica del tratamiento hasta los hallazgos significativos del estudio SPRINT, publicado en 2015. Resultados: Hasta hace aproximadamente 50 años la hipertensión arterial era conocida como una patología esencial, es decir, esta condición no siempre fue considerada como una enfermedad. El descubrimiento de la presión sanguínea ha sido atribuido a Stephen Hales, poeta, orador y sacerdote nacido en Inglaterra. La primera medición de la presión sanguínea e incidentalmente de la presión del pulso la realizó en 1733 en animales. Se describe el origen de la presión arterial, la hipertensión arterial, el camino recorrido para el reconocimiento de esta condición como enfermedad y posteriormente su tratamiento, hasta llegar al estudio SPRINT en 2015, el cual fue contundente en demostrar el beneficio de reducir la cifra de presión arterial sistólica objetivo en una población no diabética. Conclusión: Los resultados de esta revisión narrativa exponen cómo el reconocimiento de la presión arterial alta como un factor de riesgo cardiovascular permitió el avance en la investigación científica para determinar el tratamiento y las cifras de presión arterial que favorecen la reducción de la mortalidad y morbilidad por esta causa.
Background: Blood pressure measurement is one of the most performed procedures in clinical practice. This narrative review aims to expose the relevant aspects surrounding the definition of arterial hypertension, the historical path of its treatment, and the contribution of studies to the decrease in mortality due to cardiovascular disease over time. Methodology: Narrative review of the history of arterial hypertension from recognizing high blood pressure as a factor associated with cardiovascular risk to the historical evolution of treatment up to the SPRINT study published in 2015. Results: Until about 50 years ago, arterial hypertension was known as an essential pathology; this condition was not always considered a disease. The discovery of blood pressure has been attributed to Stephen Hales, a poet, orator and priest born in England. The first measurement of blood pressure and incidentally pulse pressure was made in 1733 in animals. The origin of blood pressure, arterial hypertension, and the path travelled for recognizing this condition as a disease and later its treatment until reaching the SPRINT study in 2015, which demonstrated the benefit of reducing the target systolic blood pressure figure in a non-diabetic population. Conclusion: This narrative review demonstrates that the recognition of high blood pressure as a cardiovascular risk factor allowed progress in scientific research to determine the treatment and blood pressure figures that favor the reduction of mortality and morbidity from this cause.
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ABSTRACT Objectives: To provide an overview of low-intensity extracorporeal shockwave therapy (LIEST) for erectile dysfunction (ED), pointing out which concepts are already consolidated and which paths we still need to advance. Materials and Methods: We performed a narrative review of the literature on the role of shockwave therapies in erectile dysfunction, selecting publications in PUBMED, including only relevant clinical trials, systematic reviews and meta-analyses. Results: We found 11 studies (7 clinical trials, 3 systematic review and 1 meta-analysis) that evaluated the use of LIEST for the treatment of erectile dysfunction. One clinical trial evaluated the applicability in Peyronie's Disease and one other clinical trial evaluated the applicability after radical prostatectomy. Conclusions: The literature presents little scientific evidence but suggests good results with the use of LIEST for ED. Despite a real optimism since it is a treatment modality capable of acting on the pathophysiology of ED, we must remain cautious, until a larger volume of higher quality studies allows us to establish which patient profile, type of energy and application protocol will achieve clinically satisfactory results.
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Se considera que las revisiones sistemáticas y estudios clínicos aleatorizados (RCT) presentan el nivel de evidencia más alto. Objetivo: Realizar una revisión descriptiva de las revisiones sistemáticas y estudios clínicos controlados aleatorizados (RCT, por sus siglas en inglés) sobre la efectividad y eficacia de la homeopatía. Métodos: Los datos del reporte publicado por la Liga Medicorum Homeopathica Internationalis (LMHI) en 2014 fueron actualizados mediante una búsqueda en la base de datos PubMed. Resultados: Se localizaron 7 revisiones sistemáticas con meta-análisis, 6 de las cuales concluyeron que los efectos de la homeopatía no son compatibles con el efecto placebo; sólo una revisión sistemática llegó a la conclusión opuesta, aunque fue severamente criticado debido a sus errores metodológicos. Un total de 19 RCT fueron publicados a lo largo del periodo analizado. El 84.2% tuvo por lo menos un resultado positivo. Conclusiones: Con base en las evidencias disponibles del más alto nivel, no es posible afirmar que los efectos de la homeopatía son exclusivamente un efecto placebo. Por el contrario, se han detectado efectos específicos en varios estudios.
Systematic reviews and randomized clinical trials (RCT) are considered to have the highest level of evidence. Aim: To perform a descriptive review of systematic reviews and RCT on the effectiveness and efficacy of homeopathy. Methods: Data from the report published by Liga Medicorum Homeopathica Internationalis (LMHI) in 2014 were updated by means on a search conducted in database PubMed. Results: 7 systematic reviews with meta-analysis were located, 6 of them concluded that the effects of homeopathy are not compatible with placebo effect; only 1 systematic review arrived to the opposite conclusion, but was severely criticized due to methodological flaws. A total of 19 RCT were published along the analyzed period; 84.2% had at least one positive outcome. Conclusions: Based on the available evidences of the highest level it is not possible to assert that the effects of homeopathic are exclusively placebo effect. On the opposite, specific effects were detected in several studies.
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Basic Homeopathic Research , Treatment OutcomeABSTRACT
Background & objectives: Calcium and vitamin D, separately or in combination are usually prescribed to prevent fragility fractures in elderly population. However, there are conflicting results regarding the ideal dosage and overall efficacy obtained from randomized controlled trials (RCTs) conducted in the past. The objective of this study was to assess the fracture risk with the administration of calcium or vitamin D alone or in combination in elderly population (>60 yr). Methods: PubMed, Cochrane and Embase databases were searched to identify the studies from inception to February 2021 with keywords, ‘vitamin D’, ‘calcium’ and ‘fracture’ to identify RCTs. The trials with comparing vitamin D, calcium or combination with either no medication or placebo were included for final analyses. The data were extracted and the study quality was assessed by two reviewers. The principal outcome measure was fractures around hip joint and secondary outcomes assessed were vertebral and any other fracture. Results: Eighteen RCTs were considered for the final analysis. Neither calcium nor vitamin D supplementation was associated with risk of fractures around hip joint [risk ratio (RR) 1.56; 95% confidence interval (CI), 0.91 to 2.69, I2=28%; P=0.11]. In addition, the combined administration of calcium and vitamin D was also not associated with fractures around the hip joint in comparison to either no treatment or placebo. The incidence of vertebral (RR 0.95; 95% CI, 0.82 to 1.10, I2=0%; P=0.49) or any other fracture (RR 0.83; 95% CI 0.65 to 1.06, I2=0%; P=0.14) was not significantly associated with the administration of calcium and vitamin D either individually or in combination. Further subgroup analysis of the results did not vary with the dosage of calcium or vitamin D, dietary calcium intake sex, or serum 25-hydroxyvitamin D levels. Interpretation & conclusions: The present meta-analysis of RCTs on calcium, vitamin D or a combination of the two in comparison to no treatment or placebo did not support the routine administration protocol of calcium and vitamin D either alone or in combination to lower the risk of fractures in elderly population.
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@#Cardiac surgery presents specific challenges in conducting randomized controlled trials (RCTs). The American Heart Association made a scientific statement of methodological standards, with the purpose to review key concepts and standards in design, implementation, and analysis of cardiac surgery RCTs, and to provide recommendations. Recommendations include an evaluation of the suitability of the research question, clinical equipoise, feasibility of enrolling a representative patient cohort, impact of practice variations on the effect of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and adequate deliverability of the trial interventions should be ensured. Every effort must be made to keep a high completeness of follow-up. Trial design and analytic techniques must be tailored to the specific research question and trial setting. In this paper, the authors made an interpretation of this scientific statement based on their practical experience.
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Resumo Fundamento: Revisões sistemáticas anteriores não identificaram benefício do uso da hidroxicloroquina ou da cloroquina em pacientes com COVID-19 não hospitalizados. Após a publicação dessas revisões, os resultados do COPE, o maior ensaio clínico randomizado até hoje, tornaram-se disponíveis. Objetivos: Conduzir uma revisão sistemática e metanálise de ensaios clínicos randomizados (ECRs) para sintetizar as evidências sobre a eficácia e a segurança da hidroxicloroquina e da cloroquina em pacientes com COVID-19 não hospitalizados em comparação a controle ou tratamento padrão. Métodos: As buscas foram conduzidas nos bancos de dados PubMed, Embase, The Cochrane Library e ClinicalTrials.gov, e complementadas por busca manual. Foram realizadas metanálises diretas e avaliações de risco de viés e certeza da evidência, incluindo análise do tamanho ótimo da informação (OIS, optimal information size). Um nível de significância de 0,05 foi adotado na metanálise. PROSPERO: CRD42021265427. Resultados: Oito ECRs com 3219 participantes foram incluídos. As taxas de internação por COVID-19 e de eventos adversos não foram significativamente diferentes entre hidroxicloroquina (5,6% e 5,1%) e controle (7,4% e 20,4%) [risco relativo (RR) 0,77, intervalo de confiança 95% (IC95%), 0,57-1,04, I2: 0%; RR 1,78, IC95% 0,90; 3,52, I2: 93%, respectivamente)]. O OIS (7880) não foi alcançado para hospitalização por COVID-19, independentemente da simulação para a taxa de evento e redução do RR estimados. Conclusão: A evidência de muito baixa qualidade indicou falta de benefício com hidroxicloroquina em prevenir internações por COVID-19. Apesar de ser a revisão sistemática com o maior número de participantes incluídos, o OIS, considerando a resposta à infecção anterior à vacinação, não foi atingido.
Abstract Background: Previous systematic reviews have identified no benefit of hydroxychloroquine and chloroquine in non-hospitalized COVID-19 patients. After publication of these reviews, the results of COPE, the largest randomized trial conducted to date, became available. Objectives: To conduct a systematic review and meta-analyses of randomized clinical trials (RCTs) to synthesize the evidence on the efficacy and safety of hydroxychloroquine and chloroquine for non-hospitalized COVID-19 patients compared to placebo or standard of care. Methods: Searches were conducted in PubMed, Embase, The Cochrane Library, and ClinicalTrials.gov complemented by manual search. Pairwise meta-analyses, risk of bias, and evidence certainty assessments were conducted, including optimal information size analysis (OIS). A level of significance of 0.05 was adopted in the meta-analysis. PROSPERO: CRD42021265427. Results: Eight RCTs with 3,219 participants were included. COVID-19 hospitalization and any adverse events rates were not significantly different between hydroxychloroquine (5.6% and 35.1%) and control (7.4% and 20.4%) (risk ratio, RR, 0.77, 95% confidence interval, CI, 0.57-1.04, I2: 0%; RR 1.78, 95%-CI 0.90; 3.52, I2: 93%, respectively). The OIS (7,880) was not reached for COVID-19 hospitalization, independently of the simulation for anticipated event rate and RR reduction estimate. Conclusion: Evidence of very low certainty showed lack of benefit with hydroxychloroquine in preventing COVID-19 hospitalizations. Despite being the systematic review with the largest number of participants included, the OIS, considering pre-vaccination response to infection, has not yet been reached.
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According to systematic reviews, a short-term treatment of aquatic physiotherapy, mind-body therapies and exergame improve quality of life of people with parkinsonism. But few studies examined the group physiotherapy effects on quality of life of people with parkinsonism. Objective: We aimed to investigate the short-term effects of group physiotherapy protocols on the quality of life of people with Parkinson's disease or secondary parkinsonism. Methods: This is a quasi-experimental study, a controlled, non-randomized, unmasked trial, with consecutive arms for one group and parallel to another, with 15 participants with parkinsonism. They were organized in 3 groups: OG-E1wI (n = 9), observed group treated with group physiotherapy once a week; EG-C (n = 6), in the control phase without treatment, concomitant with OG-E1wI; EG-2wI (n = 6), the same subjects as EG-C, they were treated with group physiotherapy twice a week, in a posterior consecutive phase. The PDQ-39 scale was used to assess Quality of Life. Results: The mean differences between OG-E1wI and EG-C and between EG-2wI and EG-C in the various domains of PDQ-39 were not statistically significant. Conclusion: A group physiotherapy protocols performed once or twice a week may not be enough to improve quality of life for people with parkinsonism. The literature suggests that group physiotherapy protocols performed three to five times a week improve quality of life in a short period
Contexto: Revisões sistemáticas sugerem que fisioterapia aquática, terapias corporais complementares e exergame aumentam a qualidade de vida da pessoa com parkinsonismo em tratamento de curto prazo. Porém, os efeitos da fisioterapia em grupo na qualidade de vida da pessoa com parkinsonismo são pouco estudados. Objetivo: Investigar os efeitos em curto prazo de protocolos de fisioterapia grupal sobre a Qualidade de Vida de pessoas com doença de Parkinson e parkinsonismo secundário. Métodos: Estudo quasi-experimental, ensaio controlado não randomizado, sem mascaramento, com braços consecutivos para um grupo e paralelo para outro, com 15 participantes com parkinsonismo. Os participantes foram organizados em 3 grupos: OG-E1wI (n= 9), intervenção de fisioterapia em grupo uma vez por semana; EG-C (n= 6), em fase controle sem tratamento, concomitante ao OG-E1wI; EG-2wI (n=6), os mesmos sujeitos do EG-C, em fase consecutiva com intervenção de fisioterapia em grupo, duas vezes por semana. A escala PDQ-39 foi utilizada para avaliar a Qualidade de Vida. Resultados: As diferenças médias entre OG-E1wI e EG-C e entre EG-2wI e EG-C nos vários domínios da PDQ-39 não são estatisticamente significativas. Conclusão: Protocolos de fisioterapia em grupo com frequência de uma ou duas vezes por semana podem não ser suficiente para promover ganhos na qualidade de vida de pessoas com parkinsonismo. A literatura sugere que protocolos de fisioterapia em grupo feitos três a cinco vezes por semana obtêm ganho de qualidade de vida em um período de curto prazo
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Humans , Male , Female , Middle Aged , Aged , Physical Therapy Modalities , Parkinsonian Disorders , Parkinsonian Disorders/rehabilitation , Aquatic Therapy , ExergamingABSTRACT
Aim: to evaluate the clinical efficacy of an acetaminophen analgesic by comparing its prescription in fixed versus ondemand schedules after periodontal surgery. The hypothesis of the study was that the fixed regimen would be more effective than the on-demand regimen for postoperative analgesics following periodontal surgery. Methods: An open randomized clinical trial was conducted. The 68 patients who needed total flap surgery to restore supracrestal tissue attachment or surgical treatment of periodontitis were randomized". Visual Analogue Scale was used to assess pain. The fixed group (n = 34) received 500 mg of acetaminophen every 4 hours for 2 days. The on-demand group (n = 34) was instructed to use the acetaminophen "as needed," at intervals of no less than 4 hours between doses. Ibuprofen was the rescue medication for both groups. Pain scores and medication use were recorded 2, 6, 12, 24 and 48 hours after the surgical procedure. The study was registered at the Brazilian Registry of Clinical Trials under RBR-7wv259. Results: The two groups did not differ in relation to the frequency or the intensity of pain in a 48-hour period (n=20 in the fixed group, and n=22 in the on-demand group), or even in the intention-to-treat (n=34 in each group). Individuals who experienced moderate to severe pain used rescue medication more frequently in both groups. No adverse events were reported. Conclusion: Both regimens were effective in controlling postoperative pain after periodontal surgery
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Humans , Male , Female , Pain, Postoperative , Periodontal Diseases , Acetaminophen/therapeutic useABSTRACT
ABSTRACT We assessed the effects of anti-inflammatory treatment after selective laser trabeculoplasty through a systematic search of the MEDLINE, COCHRANE, and ClinicalTrials.gov. The outcome measures were intraocular pressure, anterior chamber inflammation, and discomfort. Evidence synthesis was performed using fixed effects or random-effects model according to the heterogeneity of the included studies. Heterogeneity was assessed using Q-statistic and I2. For an overall estimate of continuous outcomes, the mean differences and their 95% confidence intervals were applied, while odds ratios and their 95% confidence intervals were applied for dichotomous outcomes. Six studies were included in all. No significant difference was noted in the patients for intraocular pressure and discomfort when treated with anti-inflammatory drops. However, the patients showed benefit from reduced anterior chamber inflammation in the first postoperative week [FE OR=0.43, 95% CI=(0.19, 0.95), PQ=0.97, I2=0%], with no significant difference between the outcomes of non-steroidal anti-inflammatory drugs and steroids [FE OR=0.75, 95% CI=(0.20, 2.82), PQ=0.37, I2=0%]. Anti-inflammatory drops reduce anterior chamber inflammation after selective laser trabeculoplasty but showed no effect on the intraocular pressure.
RESUMO O objetivo deste estudo é avaliar os efeitos do tratamento anti-inflamatório após a trabeculoplastia seletiva a laser. Uma busca sistemática foi feita no MEDLINE, COCHRANE e ClinicalTrials.gov. As medidas de resultado foram pressão intraocular, inflamação da câmara anterior e desconforto. A síntese de evidência foi realizada utilizando-se modelo de efeitos fixos ou efeitos aleatórios, de acordo com a heterogeneidade dos estudos incluídos. A heterogeneidade foi avaliada utilizando-se Q-statistic e I². Para uma estimativa global dos resultados contínuos, foram usadas diferenças médias e seus intervalos de confiança de 95% enquanto para resultados dicótomos, usou-se odds ratios e seus intervalos de confiança de 95%. Seis estudos foram incluídos. Nenhuma diferença significativa foi encontrada em pacientes tratados com gotas anti-inflamatórias em termos de pressão intraocular e desconforto. No entanto, eles se beneficiaram da redução da inflamação da câmara anterior na primeira semana pós-operatória [FE OR=0,43, IC 95% = (0,19, 0,95), PQ=0,97, I2=0%], sem diferença significativa entre anti-inflamatórios não esteroidais e esteroidais [FE OR=0,75, IC 95% = (0,20, 2,82), PQ=0,37, I2=0%]. Gotas anti-inflamatórias reduzem a inflamação da câmara anterior após trabeculoplastia seletiva a laser, não afetando a pressão intraocular.
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ABSTRACT Objectives: Describe the frequency and types of outcomes in randomized clinical trials (RCT) of intervention for distal radius fractures, analyze how confusing outcome presentations can lead to misinterpretations, and suggest strategies to improve the reader's understanding of the decision-making process. Methods: A retrospective study was conducted through a systematized search on the PubMed® database in the last 10 years, in which only intervention RCT was included for distal radius fractures, and outcomes were analyzed. Results: Of the primary outcomes analyzed in the 75 selected articles, 46.6% were classified as clinical outcomes, 20% as surrogate, 30.6% as composite, 1.3% as complex scales, and 1.3% as safety outcomes. 34.7% of the articles did not report adverse events. Conclusion: The presentation of outcomes with little clinical relevance represented more than half of the sample (53.4%) - such studies can harm the reader since they confuse the interpretation of scientific evidence; the Core Outcome Measures in Effectiveness Trials (COMET) initiative could help health professionals in understanding and selecting the most appropriate therapeutic interventions for patients. Level of Evidence III; Retrospective comparative study .
RESUMO Objetivos: Descrever a frequência e os tipos de desfechos em ensaios clínicos randomizados (RCT) de intervenção para fraturas distais do rádio, analisar como apresentações confusas de desfechos podem levar a interpretações equivocadas e sugerir estratégias para melhorar a compreensão do leitor sobre o processo de tomada de decisão. Métodos: Foi realizado estudo retrospectivo mediante busca sistematizada na base de dados PubMed® nos últimos 10 anos, na qual foram incluídos apenas RCT de intervenção para fraturas do segmento distal do rádio, cujos desfechos foram analisados. Resultados: Dos desfechos primários analisados nos 75 artigos selecionados, 46,6% foram classificados como desfechos clínicos, 20% como substitutos, 30,6% como compostos, 1,3% como escalas complexas e em 1,3% como desfechos de segurança. 34,7% dos artigos não reportaram eventos adversos. Conclusão: A apresentação de desfechos com pouca relevância clínica representou mais da metade da amostra (53,4%) - tais estudos podem prejudicar o leitor, uma vez que confundem a interpretação das evidências científicas; a iniciativa Core Outcome Measures in Effectiveness Trials (COMET) auxilia os profissionais de saúde na compreensão e seleção das intervenções terapêuticas mais adequadas para os pacientes. Nível de Evidência III; Estudo retrospectivo comparativo .
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Abstract Background Gout is a common inflammatory arthritis caused by increased serum uric acid levels. Untreated or insufficiently treated gout can lead to deposition of monosodium urate crystals in joints, cartilage, and kidneys. Although Tongfengding capsules, a Chinese patent medicine, have long been used to treat gout, their effects and safety have not been reviewed systematically. This study evaluated its efficacy and safety for gout in adults. Methods Randomized controlled trials involving Tongfengding capsule for gout in adults were searched from PubMed, EMBASE, Cochrane Central Register of Controlled Trials, CBM, CNKI, and VIP databases, and analyzed using the Cochrane Handbook criteria. The primary outcome measures were the total effective rate. The secondary outcome measures including the blood uric acid (BUA), 24-h urinary total protein (24-h UTP), blood urea nitrogen (BUN), interleukin (IL)-6, IL-8, tumor necrosis factor-alpha (TNF-α) and adverse effects. The risk of bias was evaluated in all included studies. RevMan ver. 5.3.5 and GRADE profiler was used for data analysis and assessing the quality of evidence, respectively. Results Six studies (n = 607 Chinese participants) were included. Tongfengding capsules plus conventional treatment significantly increased the total effective rate (RR 1.21, 95% CI 1.11-1.33), while reducing the BUA (MD − 66.05 μmol/L, 95% CI − 81.26 to − 50.84), 24-h UTP (MD − 0.83 g/24 h, 95% CI − 0.96 to − 0.70), BUN (MD − 0.90 mmol/L, 95% CI − 1.60 to − 0.20), IL-6 (MD − 6.99 ng/L, 95% CI − 13.22 to − 0.75), IL-8 (MD − 12.17 ng/L, 95% CI − 18.07 to − 6.27), TNF-α (MD − 8.50 ng/L, 95% CI − 15.50 to − 1.51), and adverse effects (RR 0.21, 95% CI 0.04-0.95). Conclusion Tongfengding capsules plus conventional treatment is safe and beneficial for adults with gout compared with conventional treatment.
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ABSTRACT Dexmedetomidine has been subjected to an extensive evaluation for its' role in the prevention of postoperative delirium following cardiac surgery. In striking contrast to the preexisting meta-analysis supporting postoperative delirium-reduction with dexmedetomidine, few recently concluded multicentric large scale randomized controlled trials suggest otherwise. This article aims to present a nuanced perspective of the evolving controversy by attempting to decode the apparent incongruences in the literature accumulating off-late, which is particularly pertinent amidst an ever-escalating heterogeneity in the current research ecosystem.
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Different anti-infecthe drugs have been proposedfor the treatment ofpatients with COVID-19. We carried out a network meta-analysis to assess their relath'e efficacy and safety. Methods: We searched relevant databases for all randomized controlled trials that reported the efficacy and or safety ofany anti-infective drugs published up to April 30, 2022 for different outcomes. We did both painvise and network meta-analysis with 95% confidence intervals using afixed-effect model. We assessed studies for quality of evidence using an extension of the standard Grading ofRecommendations, Assessment, Development and Evaluation approach considering PSubject(s)
Humans
, Randomized Controlled Trial
, COVID-19
, COVID-19 Drug Treatment
, Community Networks
, Network Meta-Analysis
, Systematic Reviews as Topic
, SARS-CoV-2
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Objective:To systematically assess the efficacy and safety of acupuncture therapy for essential hypertension.Methods:A computerized literature search of the Chinese National Knowledge Infrastructure(CNKI),Chongqing VIP Database(CQVIP),Wanfang Academic Journal Full-text Database(Wanfang),China Biology Medicine Disc(CBM),PubMed,Excerpta Medica Database(EMBASE),and Cochrane Library was conducted to retrieve randomized controlled clinical trials on acupuncture as the main intervention for the treatment of essential hypertension published from the inception of the database to 30 January 2021.The risk-of-bias assessment was carried out for each included study according to the Cochrane Handbook.Data analysis was performed using Review Manager 5.4.1 and Stata 15.0.Results:After the screening,46 randomized controlled trials involving a total of 3 859 subjects were included.Primary outcomes included changes in the diastolic blood pressure after intervention[eight studies showed that the acupuncture plus antihypertensive drug group was better than the antihypertensive drug monotherapy group[mean difference(MD)=1.45,95%confidence interval(CI)(0.48,2.43),P=0.004,fixed effects model;I2=39%]and changes in the systolic blood pressure after intervention{11 studies showed that the acupuncture plus antihypertensive drug group was better than the antihypertensive drug monotherapy group[MD=8.60,95%CI(7.12,10.07),P<0.00001,fixed effects model;I2=26%]}.The secondary outcome was antihypertensive efficacy,12 studies of acupuncture monotherapy group[risk ratio(RR)=1.20,95%CI(1.12,1.28),P<0.00001,fixed effects model;I2=36%]and 15 studies of acupuncture combined with antihypertensive drug group[RR=1.27,95%CI(1.20,1.34),P<0.00001,fixed effects model;I2=6%]showed better results than the antihypertensive drug monotherapy group in antihypertensive efficacy.In terms of the adverse events,four studies showed that the acupuncture monotherapy group had fewer adverse events than the antihypertensive drug monotherapy group[RR=0.10,95%CI(0.04,0.25),P<0.00001,fixed effects model;I2=0%].Conclusion:Acupuncture combined with antihypertensive drugs is superior to antihypertensive drugs alone in reducing blood pressure,and acupuncture therapy is effective and safe for the treatment of essential hypertension with fewer side effects.However,there is still a lack of high-quality multicenter randomized double-blinded controlled trials in this field.Rigorous large-sample clinical trials are needed to validate these findings.
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Background: A randomized controlled trial (RCT) is the most valued method for evaluating the drug safety and its efficacy. However, due to incomplete reporting, RCTs may not be a reliable source of information and can lead to false interpretation of outcome. Aim and Objective: The aim of this study was to analyze the completeness in reporting of RCTs published in the Indian medical journals (IMJs) according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and to analyze, if there was a variation in the completeness between registered and unregistered trials. Materials and Methods: This was a cross-sectional study conducted in the Department of Pharmacology, Bangalore Medical College and Research Institute. The clinical trials published by the IMJs between January 2020 and August 2021 were accessed online, and its full text versions published were downloaded. Completeness in reporting of the RCTs with respect to different CONSORT checklist domains was recorded. The impact of trial registration and CONSORT endorsement on the completeness of reporting RCTs according to CONSORT checklist was determined. Descriptive statistics was used to assess and summarize the data. Results: The overall completeness of reporting was 82.4%, better than the previous years. Major areas of reporting deficiencies were in the title and abstract, result, and registration domains. Registered trials reported better than unregistered. Conclusions: Endorsement of CONSORT in the journal had no difference in reporting. Although the quality of reporting RCTs in the IMJs has improved, it remains unsatisfactory. Completeness of trial reporting could be improvised by strict implementation of CONSORT guidelines.
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Introduction The prevalence of inclusion of randomized controlled trials published in Latin American journals has not been evaluated yet. This study explores the extent to which randomized trials published in Latin American medical journals are cited and used in systematic reviews. Methods We did a descriptive observational study on randomized trials published in MEDLINE-indexed Latin American journals from 2010 to 2015. The primary outcome was the inclusion of these trials in systematic reviews. The secondary outcome was the total number of citations each trial received, as reported by Google Scholar. Results Twenty-nine journals were selected. After searching these journals, we found 135 trials that fulfilled the inclusion criteria accounting for 2% of all research articles published in these journals. Of these, 55 (41%) were included in 202 systematic reviews. Of the nine most-cited randomized trials by systematic reviews and meta-analyses, only two were published in Spanish. Nine received zero citations by any article type. Most had small sample sizes. Conclusions The overall impact of randomized controlled trials published in Latin American journals is low. Little funding, language bias and small sample sizes may explain the low inclusion in systematic reviews and meta-analyses.
Introducción La prevalencia de la inclusión de ensayos controlados aleatorizados publicados en revistas latinoamericanas aún no ha sido evaluada. Este estudio tiene como objetivo explorar el grado en que los ensayos aleatorizados publicados en revistas médicas latinoamericanas son citados y utilizados en revisiones sistemáticas. Métodos Se realizó un estudio observacional descriptivo sobre los ensayos aleatorizados publicados en revistas latinoamericanas indexadas en MEDLINE entre 2010 y 2015. El resultado primario fue la inclusión de estos ensayos en revisiones sistemáticas. El resultado secundario fue el número total de citas que recibió cada ensayo según lo informado por Google Scholar. Resultados Se seleccionaron 29 revistas. Después de buscar en estas revistas, se encontraron 135 ensayos que cumplían los criterios de inclusión, lo que representa el 2% de todos los artículos de investigación publicados en estas revistas. De estos, 55 (41%) fueron incluidos por 202 revisiones sistemáticas. De los nueve ensayos aleatorios más citados por las revisiones sistemáticas y los metaanálisis, sólo dos fueron publicados en español. Nueve recibieron cero citas por cualquier tipo de artículo. La mayoría tenían tamaños muestrales pequeños. Conclusiones El impacto de los ensayos controlados aleatorios publicados en revistas latinoamericanas es bajo. La escasa financiación, el sesgo lingüístico y el pequeño tamaño muestral pueden explicar la escasa inclusión en las revisiones sistemáticas y los metaanálisis.
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This study systematically and comprehensively sorted out the application status of Chinese patent medicines for the treatment of constipation in the clinic， to provide scientific evidence for future research directions and clinical drug use in this field. Based on the method of scoping review， the Chinese patent medicines for the treatment of constipation were retrieved from three drug lists to obtain the medicines that needed to be evaluated. A comprehensive and systematic search was carried out on the included studies on the treatment of constipation by Chinese patent medicines through eight Chinese and English databases， and the included studies were integrated and analyzed. The results were displayed in combination with charts. Thirty-four Chinese patent medicines and 118 studies were included in this study. According to the efficacies， Chinese patent medicines were divided into 4 categories， namely eliminating accumulation， purging fire， promoting Qi， and moistening bowels， involving 125 Chinese medicines. The overall attention of constipation research is on the rise. Marenwan （granules or soft capsules） gained the highest attention， with 42 studies， followed by Qirong Runchang oral liquid， with 21 studies， and Biantong tablets （capsules）， with 19 studies. There are 10 studies on Congrong Tongbian oral liquid. Seventeen Chinese patent medicines had no corresponding clinical research. There were 8 study design types， and all drugs were mainly randomized controlled trials except Danggui Longhui pill. Among the intervention types， the comparison between Chinese patent medicines and western medicines was the most. The highest outcome indicators were efficacy， safety evaluation， and main symptoms or scores， and there was a lack of a unified core outcome indicator set. There were few studies on adverse reactions and the economy. Only 11.86% of the studies were funded. Clinically， Chinese patent medicines are widely used in the treatment of constipation， and the amount of related research shows an increasing trend. However， some Chinese patent medicines lack corresponding clinical evidence， and the published research has problems such as unrigorous design， ununified criteria for efficacy evaluation， lack of comprehensive evidence studies， and insufficient funds. It is hoped that more investment will be made in this field in the future， and more attention will be paid to drugs with relatively blank research and constipation syndromes with few treatments. Comprehensive evidence studies such as systematic reviews should be carried out actively. And the study design should be standardized to provide reliable evidence for the treatment of constipation with Chinese patent medicines.
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Abstract This systematic review evaluated the efficacy of applying Contingency Management (CM) to Alcohol Use Disorder. We followed the PRISMA recommendation and consulted the following databases: Cochrane Library, MEDLINE Complete, PsycINFO and Pubmed. A total of eight randomized controlled trials were included in this review, all of them with good methodological quality. In seven of these, CM was more efficacious in promoting continuous abstinence. Both trials that evaluated treatment retention found statistically significant results favorable to CM. On two of the three trials presenting follow-up results, CM was more efficacious in promoting abstinence. The large-scale application of CM can promote substantial public health improvements and should be encouraged.
Resumo Esta revisão sistemática avaliou a eficácia do Manejo de Contingência (MC) no tratamento do Transtorno por Uso de Álcool. Para isso, foi utilizada a recomendação PRISMA e consultadas as bases de dados: Cochrane Library, MEDLINE Complete, PsycINFO e Pubmed. Foram incluídos oito ensaios clínicos randomizados nesta revisão. Em sete, o MC foi mais eficaz em promover abstinência continuada. Dos dois que avaliaram a retenção no tratamento, ambos encontraram resultados estatisticamente favoráveis ao MC. Dos três que apresentaram resultados de avaliação de seguimento, em dois o MC foi mais eficaz em promover abstinência. Todos apresentaram boa qualidade metodológica. A aplicação do MC em larga escala pode promover melhorias substanciais para a saúde pública e deve ser encorajada.