الملخص
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.
الملخص
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.
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.
الملخص
La eficacia de una nueva intervención se establece generalmente a través de ensayos clínicos (EC) con asignación aleatoria (AA). Sin embargo, entre otros tantos desafíos metodológicos, el especificar la hipótesis de un EC con AA, sigue siendo un problema complejo de resolver para los investigadores clínicos. En este manuscrito discutimos las características de tres variantes de los EC con AA: EC de superioridad (ECS), EC de no-inferioridad (ECNI), y EC de equivalencia (ECE). Estos tres tipos de EC tienen supuestos diferentes sobre los efectos de una intervención, por lo que plantear hipótesis y definir objetivos requiere conocer algunos supuestos subyacentes a estos EC, incluso hasta elementos relacionados con la estimación del tamaño de muestra para cada cual. El objetivo de este manuscrito fue describir las diferencias metodológicas entre ECS, ECNI y ECE.
Efficacy and effectivity of new interventions are generally established through randomized clinical trials (RCTs). However, among many other methodological challenges, specifying the hypothesis of a RCT remains complex problem for clinical researchers. In this manuscript we discuss the characteristics of three variants of RCTs: superiority RCT (SRCT), non-inferiority RCT (NIRCT), and equivalence RCT (ERCT). These three types of RCT have different assumptions about the effects of an intervention, so setting hypotheses and defining objectives requires knowing some assumptions underlying these RCTs, including elements related to the estimation of the sample size for each one. The aim of this manuscript was to describe methodological differences between SRCT, NIRCT and ERCT.
الموضوعات
Clinical Trials as Topic , Research Design , Non-Randomized Controlled Trials as Topic , Equivalence Trials as Topicالملخص
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.
الملخص
Objective To strengthen nursing awareness and attention,and improve the quality of medication and nursing care,Meta-analysis was used to evaluate the occurrence of sodium-glucose transporter 2 inhibitor related ketoacidosis.Methods Relevant randomized controlled trials were searched in 6 databases,such as CNKI,PubMed,Embase,and the Clinical trial platform,and the literature was screened based on inclusion and exclusion criteria.The search time was from the establishment of databases to January 2023.Revman 5.4.1 was used for quality evaluation and Meta-analysis.Results 24 randomized controlled trials were included.The Meta-analysis results showed that sodium-glucose transporter 2 inhibitors increased the incidence of ketoacidosis(RR=2.52,95％CI[1.82,3.49],P＜0.001).Subgroup analysis showed that the sodium-glucose transporter 2 inhibitors increased the incidence of ketoacidosis in patients with type 2 diabetes(RR=2.42,95％CI[1.70,3.43],P＜0.001),cardiovascular disease(RR=2.32,95％CI[1.59,3.39],P＜0.001),and chronic kidney disease(RR=2.82,95％CI[1.73,4.58],P＜0.001).Cargliflozin(RR=3.21,95％CI[1.43,7.18],P=0.005),Daggliflozin(RR=2.73,95％CI[1.51,4.93],P＜0.001),and Sogliflozin(RR=1.92,95％CI[1.06,3.50],P=0.030)increased the incidence of ketoacidosis,while Engliflozin(RR=1.80,95％CI[0.79,4.11],P=0.160)did not have a significant effect.When the eGFR of patients≤60(mUmin/1.73m2)(RR=2.74,95％CI[1.63,4.60],P＜0.001),the duration of medication≤ 12 month(RR=3.31,95％CI[1.79,6.12],P＜0.001),or the duration of medication＞12 month(RR=2.19,95％CI[1.23,3.91],P=0.008),the sodium-glucose transporter 2 inhibitors increased the occurrence of ketoacidosis.Conclusion For patients receiving sodium-glucose transporter 2 inhibitors treatment regardless of whether they are complicated with diabetes,especially those with heart and kidney diseases,in the early and middle stages of medication,with eGFR ≤60 ml/(min·1.73m2),and those with other susceptibility factors,we should strengthen the observation of patients'medication,optimize medication care,and early identify and intervene in the occurrence of ketoacidosis.
الملخص
Objective:To evaluate the efficacy of electroacupuncture(EA)in enhancing the recovery of gastrointestinal function after laparoscopic cholecystectomy(LC). Methods:Randomized controlled trials(RCTs)of EA treatment in the postoperative period of patients undergoing LC were searched.Studies were obtained from Excerpta Medica Database(EMBASE),PubMed,Cochrane Library,Wanfang Academic Journal Full-text Database(Wanfang),China National Knowledge Infrastructure(CNKI),China Biology Medicine Disc(CBM),and Chongqing VIP Database(CQVIP)from inception to December 10th,2022.RevMan 5.4.1 was used to perform the meta-analysis.The Cochrane tool was used to assess the risk of bias.Mean difference(MD)and confidence interval(CI)were used for statistical descriptions. Results:A total of 7 studies were included in the meta-analysis.The meta-analysis found that the EA group had a shorter time to the first flatus[P<0.001,MD=-5.32,95%CI(-6.42,-4.21)],bowel movement recovery[P<0.001,MD=-6.22,95%CI(-8.11,-4.34)],and the first defecation(P<0.001,MD=-11.08,95%CI(-15.78,-6.39)]than the control group. Conclusion:EA treatments can promote the recovery of gastrointestinal function after LC.
الملخص
【Objective】 To systematically evaluate the effects of various rehabilitation therapies, including hydrotherapy, rehabilitation robot, core stability training (CST), whole-body vibration training (WBV), repetitive transcranial magnetic stimulation (rTMS), sling exercise training (SET), task-oriented training (TOT) and virtual reality (VR), on motor dysfunction in children with spastic cerebral palsy, so as to provide a reference for the scientific selection of rehabilitation programs for children. 【Methods】 Randomized controlled trials (RCTs) of the 8 rehabilitation therapies in the treatment of motor dysfunction in children with spastic cerebral palsy were searched from various databases, including PubMed, The Cochrane Library, Web of Science, EmBase, CNKI, CBM, VIP, and WanFang Database, from database inception to December 2022. Two researchers independently conducted literature screening, data extraction, and literature quality evaluation. Network Meta-analysis was performed using ADDIS 1.16.6 software, and Stata 16.0 software was used for graphic representation. 【Results】 A total of 43 RCTs involving 2 722 children with spastic cerebral palsy were included in the analysis. The results of the network Meta-analysis indicated that WBV had the most significant effect in improving the GMFM-88 score (MD=18.56, 95%CI: 34.91 - 2.45, P<0.05). Rehabilitation robot had the most significant effect in improving dimensions D (MD=6.30, 95%CI: 8.44 - 4.41, P<0.05) and E (MD=10.03, 95%CI: 15.03 - 4.84, P<0.05) of the GMFM-88 score. Additionally, hydrotherapy showed the most significant effect in improving the BBS score (MD=11.24, 95%CI: 22.26 - 0.20, P<0.05). 【Conclusions】 For children with spastic cerebral palsy, WBV is the most effective rehabilitation therapy to improve gross motor function, rehabilitation robot is the most effective therapy for improving standing and walking function, and hydrotherapy is the most effective therapy for improving balance.
الملخص
ObjectiveTo systematically collect， analyze， and evaluate the randomized controlled trials （RCT） of Chinese patent medicine combined with western medicine in the treatment of hypertension， map the evidence， and provide reference for the future clinical research and formulation of guidelines and policies. MethodThe relevant articles were retrieved from China Biology Medicine disc， China National Knowledge Infrastructure （CNKI）， VIP， Wanfang Data， PubMed， Embase， and Cochrane Library with the time interval from inception to December 31， 2022. The RCT of Chinese patent medicines combined with western medicine in the treatment of hypertension were included. The research characteristics and methodological quality were analyzed and evaluated. ResultA total of 330 RCTs of treating hypertension with Chinese patent medicines combined with Western medicine were included in this study， all of which were published in Chinese. These RCTs involved 88 Chinese patent medicines and 37 788 patients， and 46% of RCT had the sample size ≥100 patients. Eighty-seven percent of RCT showed the study period within 3 months. All the interventions in the RCTs were Chinese patent medicine + western medicine vs western medicine. Among the evaluation indicators， blood pressure， response rate， TCM syndrome score， endothelial cell function， and safety were mainly concerned. In terms of methodological quality， most articles did not mention the generation of random sequences， allocation concealment， or blinding method. The blinding evaluation of outcomes showed low risks of bias， and there was insufficient information to judge whether there was selective bias or other bias. ConclusionThere were many Chinese patent medicines used in combination with western medicine in the treatment of hypertension， and they were mainly taken orally. The existing RCT had problems such as small sample size， unclear clinical value positioning， imperfect design failing to reflect the value of Chinese patent medicines， unreasonable measurement indicators， and non-standard measurement methods. Future research should solve the above problems， improve the research quality， value， and authenticity， and enhance the reliability and extension of evidence.
الملخص
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.
الملخص
Abstract Objective: This study aimed to systematically evaluate the efficacy and safety of Endoscopic Ultrasonography (EUS) for the treatment of pancreatic cancer. Methods: The PubMed, Embase, Web of Science, and Google Scholar databases were searched from the inception of the databases to June 2022. RevMan 5.3.0 software was utilized for data analysis. In total, 13 self-descriptive studies, which enrolled 382 patients, were finally included. Results It was revealed that EUS for the treatment of pancreatic cancer exhibited a lower incidence of adverse reactions (Relative Risk Ration [RR = 0.23], 95 % Confidence interval [95 % CI 0.23-0.23]), a higher success rate (RR = 0.90, 95 % CI 0.90-0.90), and a low failure rate (RR = 0.06, 95 % CI 0.06-0.06). Moreover, EUS-guided Celiac Plexus Neurolysis (EUS-CPN) not only significantly relieved pancreatic cancer patients' pain (RR = 0.83, 95 % CI 0.83-0.83), but also significantly eliminated pain in some patients (RR = 0.09, 95 % CI 0.09-0.09). The effects of EUS on pancreatic cancer treatment were satisfactory, and few adverse reactions were found. Conclusion: Owing to the restricted sample size in this meta-analysis, primarily consisting of descriptive studies, it was imperative to conduct more rigorously designed, multi-center, long-term follow-up, larger sample, and Randomized Controlled Trials (RCTs) to validate the findings.
الملخص
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.
الموضوعات
Humans , Narration , Heart Disease Risk Factors , History , Hypertension , Therapeutics , Review Literature as Topic , Randomized Controlled Trials as Topic , Multicenter Studies as Topic , Treatment Outcomeالملخص
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.
الملخص
Background: The current therapies for schizophrenia are targeted at reducing the severity of symptoms and they do not cure the disease. The research in this field is going on for many years. The present study was designed to access the current status of interventional studies conducted in schizophrenia based on studies registered in the CTRI. Methods: Interventional studies for schizophrenia registered on CTRI from 2007 to May 2022 were reviewed and analysed, using the keyword “schizophrenia”. Parameters such as number of studies, year wise distribution of the studies registered, status of the studies at the time of analysis, types of study designs, randomization, blinding, geographical distribution, type of intervention. Results: Out of 42952 studies registered with CTRI from 2007 to May 2022, 323 studies exclusively involved schizophrenia which accounts for only 0.75% of the total studies. 206 were interventional studies. Among the interventional studies 188 were randomized and 87 were blinded. Of all the interventional studies 141(68.4%) involved pharmacological interventions (Allopathy), 53 (25.7%) were non drug interventions, the rest were AYUSH. Of the 141 studies involving pharmacological interventions 28 were comparative studies with active control, 23 were addon studies, 14 were single arm efficacy and safety studies and 76 were BA/BE studies. Conclusions: The study showed a rise in schizophrenia interventional study registries in the last 5 years. However, it highlighted the need to conduct more comparative studies with active control or efficacy and safety studies rather than BA/BE studies, in order to propose better alternatives to the existing therapy.
الملخص
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.
الموضوعات
Basic Homeopathic Research , Treatment Outcomeالملخص
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.
الملخص
@#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.
الملخص
OBJECTIVE@#To analyze the report status of outcomes and measurement instruments of randomized controlled trials (RCTs) of acupuncture for post-stroke dysphagia, so as to provide a basis for designing clinical trials and developing the core outcome set in acupuncture for post-stroke dysphagia.@*METHODS@#RCTs of acupuncture for post-stroke dysphagia were searched in databases i.e. CNKI, SinoMed, Wanfang, PubMed, EMbase, Web of Science and clinical trial registries i.e. ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR), from January 1st, 2012 to October 30th, 2021. By literature screening and data extraction, outcomes and measurement instruments were summarized and analyzed.@*RESULTS@#A total of 172 trials (including 165 RCTs and 7 ongoing trials registrations) were included, involving 91 outcomes. The outcomes could be classified into 7 domains according to functional attributes, namely clinical manifestation, physical and chemical examination, quality of life, TCM symptoms/syndromes, long-term prognosis, safety assessment and economic evaluation. It was found that there were various measurements instruments with large differences, inconsistent measurement time point and without discriminatively reporting primary or secondary outcomes.@*CONCLUSION@#The status quo of outcomes and measurement instruments of RCTs of acupuncture for post-stroke dysphagia is not conducive to the summary and comparison of each trial's results. Thus, it is suggested to develop a core outcome set for acupuncture for post-stroke dysphagia to improve the normative and research quality of their clinical trial design.
الموضوعات
Humans , Deglutition Disorders/therapy , Randomized Controlled Trials as Topic , Acupuncture Therapy , Databases, Factual , Physical Examination , Stroke/complicationsالملخص
Objective:To compare the effects of intensive and standard blood pressure control on the outcomes of patients with acute ischemic stroke in the anterior circulation who have successfully recanalized after endovascular therapy (EVT).Methods:A multicenter, open-label, blinded-endpoint, randomized controlled design was used. Patients with anterior circulation stroke received EVT and successfully recanalized in Nanjing First Hospital, Nanjing Medical University and several branch hospitals from July 2020 to October 2022 were prospectively included. They were randomly divided into the intensive blood pressure control group (target systolic blood pressure [SBP] 100-120 mmHg) or the standard blood pressure control group (target SBP 121-140 mmHg). The blood pressure of both groups needs to achieve the target within 1 h and maintain for 72 h. The primary outcome endpoint was outcome at 90 d, and the good outcome was defined as a score of 0-2 on the modified Rankin Scale. Secondary outcome endpoints included early neurological improvement, symptomatic intracranial hemorrhage (sICH) within 24 h, and death and serious adverse events within 90 d.Results:A total of 120 patients were included, including 63 in the intensive blood pressure control group and 57 in the standard blood pressure control group. There was no statistically significant difference in baseline characteristics between the two groups. The SBP at 72 h after procedure was 122.7±8.1 mmHg in the intensive blood pressure control group and 130.2±7.4 mmHg in the standard blood pressure control group, respectively. There were no significantly differences in the good outcome rate (54.0% vs. 54.4%; χ2=0.002, P=0.963), the early neurological improvement rate (45.2% vs. 34.5%; χ2=1.367, P=0.242), the incidence of sICH (6.3% vs. 3.5%; P=0.682), mortality (7.9% vs. 14.0%; χ2=1.152, P=0.283) and the incidence of serious adverse events (12.7% vs. 15.8%; χ2=0.235, P=0.628) at 90 d between the intensive blood pressure control group and the standard blood pressure control group. Conclusion:In patients with anterior circulation stroke and successful revascularization of EVT, early intensive blood pressure control don’t improve clinical outcomes and reduce the incidence of sICH.
الملخص
Objective:To evaluate the efficacy and safety of Tuina(Chinese therapeutic massage)in the treatment of functional dyspepsia(FD)in children and adults. Methods:Related articles in PubMed,Excerpta Medica Database(EMBASE),Cochrane Library,Web of Science,China Biology Medicine Disc(CBM),Wanfang Academic Journal Full-text Database(Wanfang),China National Knowledge Infrastructure(CNKI),and Chongqing VIP Database(CQVIP)were collected.The retrieval time was from each database's start to March 2022.Two researchers independently screened the literature,extracted the data,and evaluated the risk of bias in the included studies.A meta-analysis was then performed using the RevMan 5.4 software. Results:A total of 19 clinical trials were included,9 of which encompassed studies on adults while 10 were on children with FD,comprising a total of 1961 patients.The findings of the meta-analysis showed that the effective rate of FD in children and adults treated with Tuina was significantly higher than that in the control group[risk ratio(RR)=1.15,95%confidence interval(CI)(1.09,1.21),P<0.001],[RR=1.13,95%CI(1.06,1.21),P<0.001].In addition,the effective rate of FD in children and adults treated with Tuina combined with other treatments was significantly higher than that in the control group[RR=1.14,95%CI(1.07,1.21),P<0.001],[RR=1.12,95%CI(1.02,1.24),P=0.02].In terms of single symptoms,Tuina improved epigastric burning sensation score in adults[standardized mean difference(SMD)=-0.41;95%CI(-0.79,-0.02);Z=2.08;P=0.04]compared with that of the Western medicine group.Compared with children treated with oral Chinese medications(CM)or Chinese patent medicine(CPM),children with FD demonstrated lower scores of epigastric pain[SMD=-0.38,95%CI(-0.56,-0.19);Z=3.96;P<0.001],postprandial fullness[SMD=-0.30,95%CI(-0.50,-0.10);Z=2.88;P=0.004],and early satiety[SMD=-0.26,95%CI(-0.47,-0.06);Z=2.54;P=0.01]after receiving Tuina combined with CM or CPM treatment.No adverse events were reported in the Tuina treatment group,and the follow-up indicated that the symptom scores in the Tuina group improved. Conclusion:Compared with the control group,both Tuina and Tuina combined with other treatments are shown to have better effective rates,lower incidence of adverse events,and better follow-up outcomes.The study results suggest that Tuina may be a clinically viable complementary therapy.However,due to limitations in the number and quality of the included studies,the above conclusions should be verified by further high-quality studies.
الملخص
Objective:To assess the efficacy and safety of acupuncture compound anesthesia(ACA)for traditional thyroidectomy. Methods:Randomized controlled trials(RCTs)studying the use of ACA for traditional thyroidectomy were retrieved from PubMed,Excerpta Medica Database(EMBASE),Cochrane Library,Web of Science,China National Knowledge Infrastructure(CNKI),Chongqing VIP Database(CQVIP),Wanfang Academic Journal Full-text Database(Wanfang),and China Biology Medicine Disc(CBM)from inception to September 30,2021.Two investigators independently extracted data and assessed the risk of bias and quality of the studies.Anesthesia effectiveness was the primary outcome,while the secondary outcomes included various pain scales,vital signs,analgesic consumption,and adverse events.Review Manager 5.3 was used for meta-analysis.Weighted mean difference(WMD),standardized mean difference(SMD),and confidence interval(CI)were used for statistical descriptions. Results:A total of 16 papers were included,involving 1228 patients.Meta-analysis showed that anesthesia effectiveness was significantly improved after adding acupuncture as an adjunct[SMD=0.62,95%CI(0.40,0.83),P<0.0001,I2=36%].Besides,ACA can also moderate vital signs and reduce the feeling of pain[SMD=-1.61,95%CI(-2.61,-0.61),P<0.00001,I2=95%],analgesic consumption,and adverse events.Subgroup analysis of the electroacupuncture(EA)group further revealed that the effectiveness of low-frequency EA[WMD=0.43,95%CI(0.30,0.55),P<0.00001,I2=15%]and the entire operative stimulation of EA[WMD=0.55,95%CI(0.33,0.77),P<0.00001,I2=0%]was significantly better than high-frequency EA and short-time stimulation of EA during the operation.Further,no significant difference existed between conventional analgesia and acupuncture analgesia. Conclusion:ACA is beneficial to traditional thyroidectomy regarding efficacy and safety when acupuncture is applied as an adjunct.However,additional high-quality studies with larger sample sizes are needed to verify the findings.