Convalescent plasma therapy in COVID-19 patients: a non-randomized case-control study with concurrent control

Convalescent plasma therapy has shown controversial results in coronavirus disease-19 (COVID-19) patients. We performed a non-randomized case-control study with contemporaneous controls in a hospital in southern Brazil. Patients were selected for treatment with convalescent plasma by medical decision and compared with patients who did not receive plasma and were hospitalized due to COVID-19 at the same time. The outcomes of interest were intensive care unit (ICU) admission and in-hospital death. Patients that received convalescent plasma had lower in-hospital mortality than patients that did not receive plasma (relative risk (RR) 0.48; 95% confidence interval (CI) 0.29 to 0.79) and these results were consistent after changing the subset of control patients. There were no differences regarding ICU admission between groups (RR=0.80; 95%CI: 0.47 to 1.35). In this study, patients that received convalescent plasma for COVID-19 had lower in-hospital mortality, but this finding requires further confirmation given the retrospective nature of the study.

Efetividade de intervenção multicomponente na adesão e aceitabilidade à alimentação escolar: ensaio randomizado de base escolar de múltiplos braços em Sumidouro - RJ / Effectiveness of a multicomponent intervention on adherence and acceptability to school meals: a multi-arm, school-based randomized trial in Sumidouro - RJ

O Programa Nacional de Alimentação Escolar possui papel fundamental na promoção da alimentação saudável de milhões de escolares em todo o Brasil. Entretanto, pesquisas nacionais apontam baixa adesão e aceitabilidade à alimentação escolar na rede pública de ensino. Intervenções baseadas em arquitetura de escolhas e padronização de técnicas gastronômicas têm sido implementadas com o intuito de melhorar este cenário e estimular o desenvolvimento de hábitos alimentares saudáveis. Assim, o objetivo do presente estudo foi avaliar a efetividade de intervenção multicomponente na adesão e aceitabilidade à alimentação escolar. Um ensaio randomizado foi conduzido com alunos do 4o ao 9o ano de 3 escolas públicas da rede municipal de ensino da cidade de Sumidouro, Rio de Janeiro, em 2019. As escolas participantes foram alocadas aleatoriamente em três grupos: uma escola no grupo controle (sem intervenção), uma escola no grupo intervenção 1 (modificações ambientais e inclusão de sistema de autosserviço) e uma escola no grupo intervenção 2 (modificações ambientais, inclusão de sistema de autosserviço e adição de novas preparações no cardápio). A escola do grupo intervenção 1 recebeu intervenções ambientais baseadas nos princípios da arquitetura de escolhas, que consistiram em: elaboração de cartazes e displays com mensagens e imagens motivacionais para promoção de hábitos alimentares saudáveis e incentivo ao consumo da alimentação escolar; implementação de toalhas com imagens coloridas de alimentos in natura nas mesas do refeitório; alocação das frutas servidas na alimentação escolar em posição de destaque, em uma barraca de frutas; posicionamento de um banner com o cardápio das preparações diárias na entrada do refeitório; e aplicação de pegadas no chão que, de forma lúdica, direcionavam os escolares ao refeitório. Além disso, foi implementado o sistema de autosserviço, com a incorporação de um balcão térmico de distribuição de alimentos no refeitório. A escola do grupo intervenção 2 recebeu as mesmas intervenções da escola do grupo intervenção 1, com a adição da padronização de técnicas gastronômicas para alterações nas preparações culinárias que fizeram parte dos cardápios no ano letivo de 2019, além da elaboração de novas preparações a partir da identificação das percepções acerca dos motivos da não adesão à alimentação escolar relatadas em grupos focais realizados com merendeiras e escolares. A adesão à alimentação escolar (≥3 vezes na semana) foi avaliada por meio de questão inserida em questionário aplicado em três momentos (linha de base, 1o seguimento [após 5 meses de intervenção] e 2o seguimento [após 8 meses de intervenção]). Foram realizadas análises longitudinais por meio da aplicação de modelos lineares generalizados que levam em conta as medidas repetidas e os dados ausentes de desfecho dos participantes. Também foram realizadas análises do tipo piecewise, permitindo a identificação dos parâmetros no intervalo 1 (linha de base-1o seguimento) e no intervalo 2 (1o seguimento-2o seguimento). Foi observado aumento da adesão à alimentação escolar na escola intervenção 1 vs. escola controle (RR=1,20; p-valor=0,0166) e maior aumento na escola intervenção 2 vs. escola controle (RR=1,27; p-valor=0,0041). Foi possível observar também aumento da adesão na escola intervenção 1 vs. escola controle no intervalo 1 e intervalo 2 (RR=1,18; p-valor=0,0146 e RR=1,14; p-valor=0,0424, respectivamente), e maior aumento da adesão na escola intervenção 2 vs. escola controle no intervalo 1 (RR=1,22; p-valor=0,0095) e no intervalo 2 (RR=1,20; p-valor=0,0070). Não houve diferença estatisticamente significativa na variação da adesão entre as escolas intervenção 2 e 1. A aceitabilidade à alimentação escolar foi avaliada por meio da aplicação de teste de aceitabilidade referente ao cardápio servido nas escolas antes das intervenções e, aos demais cardápios, após o início das intervenções, através do uso da escala hedônica facial e verbal. Para as análises longitudinais, foram empregados modelos lineares generalizados, que levam em conta as medidas repetidas e os dados ausentes de desfecho dos participantes. Observou-se aumento significativo no índice de aceitabilidade nos grupos de preparações à base de carne bovina e doces entre os participantes da escola intervenção 1 (RR=1,36; p-valor=0,0008 e RR=3,99; p-valor=<,0001, respectivamente) e da escola intervenção 2 (RR=1,34; p-valor=0,0029 e RR=2,22; p-valor=<,0001, respectivamente), quando comparados aos da escola controle ao longo do tempo. O incremento na aceitabilidade das frutas foi maior entre os participantes da escola intervenção 2, quando comparados aos da escola intervenção 1 (RR=1,60; p-valor=0,0052). Redução da aceitabilidade de preparações à base de feijão foi observada entre escola intervenção 2 e as escolas intervenção 1 e controle (RR=0,60; p-valor=0,0003 e RR=0,57; p-valor=0,0013, respectivamente). Os resultados alcançados sugerem que intervenções multicomponentes baseadas em modificações ambientais de baixo custo e complexidade, e em modificações nos aspectos sensoriais das refeições oferecidas na alimentação escolar através da inserção de técnicas gastronômicas, podem ser efetivas para promover o aumento da adesão e aceitabilidade à alimentação escolar e, consequentemente, auxiliar na elaboração de políticas públicas voltadas à promoção da alimentação saudável.

The National School Feeding Program plays a key role in promoting healthy eating for millions of schoolchildren throughout Brazil. However, national surveys indicate low adherence and acceptability to school meals in the public school system. Interventions based on choices architecture and standardization of gastronomic techniques have been implemented aiming to improve this scenario and encourage the development of healthy eating habits. Thus, the objective of this study was to evaluate the effectiveness of a multicomponent intervention in adherence and acceptability to school meals. A randomized trial was conducted with students from 4th to 9th grade from 3 public schools of Sumidouro, a city located in Rio de Janeiro, in 2019. The participating schools were randomly allocated into three groups: one school in the control group (no intervention), another school in the intervention group 1 (environmental modifications and addition of a self-service system) and other one in the intervention group 2 (environmental modifications, addition of a self-service system and inclusion of new dishes in the menu). The school from the intervention group 1 received environmental interventions based on the principles of choices architecture, which consisted of: creation of posters and displays with motivational messages and images to promote healthy eating habits and encourage the consumption of school meals; implementation of tablecloth with colorful images of fresh food on the cafeteria tables; allocation of fruits in a prominent position, in a fruit stand; placement of a banner with the daily menu at the cafeteria's entrance; and application of footprints on the floor that, in a playful way, directed students to the cafeteria. Moreover, a self-service system was implemented through the addition of a thermal food distribution counter in the cafeteria. The school from intervention group 2 received the same interventions as the school from intervention group 1, plus the standardization of gastronomic techniques for changes in the dishes that were part of the menus in 2019, and also the creation of new ones, based on the perceptions about the reasons for non-adherence to school meals reported in focus groups carried out with lunch ladies and schoolchildren. Adherence to school meals (≥3 times a week) was assessed through a question inserted in a questionnaire applied at three different moments (baseline, 1st follow-up [after 5 months of intervention] and 2nd follow-up [after 8 months of intervention]). Longitudinal analyzes were performed through the application of generalized linear models that take into account repeated measures and missing participant outcome data. Piecewise analyzes were also performed, allowing the identification of parameters in interval 1 (baseline - 1st follow-up) and in interval 2 (1st follow-up - 2nd follow-up). An increase in adherence to school meals was observed in the intervention school 1 vs. control school (RR=1.20; p-value=0.0166) and greater increase in intervention school 2 vs. control school (RR=1.27; p-value=0.0041). It was also observed an increase in adherence in the intervention school 1 vs. control school in interval 1 and interval 2 (RR=1.18; p-value=0.0146 and RR=1.14; p-value=0.0424, respectively), and greater increase in adherence in intervention school 2 vs. control school in interval 1 (RR=1.22; p-value=0.0095) and in interval 2 (RR=1.20; p-value=0.0070). There was no statistically significant difference in the variation of adherence between intervention 2 and 1 schools. The acceptability of school meals was evaluated by applying an acceptability test referring to the menu served in schools before the interventions and, to the other menus, after the beginning of the interventions, through the use of facial and verbal hedonic scale. For the longitudinal analyses, generalized linear models were used, taking into account repeated measures and missing outcome data from the participants. There was a significant increase in the acceptability index in the groups of preparations based on meat and sweets among participants in the intervention school 1 (RR=1.36; p-value=0.0008 and RR=3.99; p- value=<.0001, respectively) and intervention school 2 (RR=1.34; p-value=0.0029 and RR=2.22; p-value=<.0001, respectively), when compared to the control school over time. The increase in fruit acceptability was greater among participants in the intervention school 2, when compared to those in the intervention school 1 (RR=1.60; p-value=0.0052). Reduction in the acceptability of bean-based preparations was observed between intervention 2 school and intervention 1 and control schools (RR=0.60; p-value=0.0003 and RR=0.57; p-value=0.0013, respectively). The results suggest that multicomponent interventions based on low cost and complexity environmental modifications, and also on changes in the sensory aspects of meals offered at school through the use of gastronomic techniques, can be effective in increasing adherence and acceptability to school meals, assisting in the creation of public policies aimed at promoting healthy eating.

Evaluation of efficacy of an ayurvedic mouthwash on dental plaque and gingivitis: a double blinded parallel randomized controlled study

Introduction: Due to inherent limitations of chlorhexidine, search for an effective and potentially safe anti-plaque agent has led to emergence of alternative products. Aim: To evaluate and compare the effects of Oral Pal Plus mouth rinse and chlorhexidine on dental plaque and gingivitis. Materials and Methods: The present study was randomized parallel group controlled trial. A group of 90 healthy subjects in the age group of 18-21 yrs received complete supragingival scaling at baseline and study variables viz, Plaque index and Gingival index were recorded. Subjects were then randomly divided into three groups (30 in each group) and were randomly intervened with three different mouthwashes. ie, Chlorhexidine, Oral Pal Plus and normal saline. Variables were again recorded on the 7th day 14th day after use of mouthwashes and data obtained was subjected to statistical analysis. Results: There was statistically significant reduction in plaque and gingival scores from baseline to 14 days in both the groups A & B. Conclusion: Chlorhexidine (0.2%) and Oral Pal Plus mouthwash showed significantly reduction in plaque scores and gingival scores whereas no improvement was seen in Group C using normal saline over 14 days. (AU)

Comparison between calcium hydroxide mixtures and mineral trioxide aggregate in primary teeth pulpotomy: a randomized controlled trial

Abstract Objectives: To evaluate the effect of calcium hydroxide (CH) associated with two different vehicles as a capping material for pulp tissue in primary molars, compared with mineral trioxide aggregate (MTA). Methodology: Forty-five primary mandibular molars with dental caries were treated by conventional pulpotomy using one of the following materials: MTA only (MTA group), CH with saline (CH+saline group) and CH with polyethylene glycol (CH+PEG group) (15 teeth/group). Clinical and periapical radiographic examinations of the pulpotomized teeth were performed 3, 6, and 12 months after treatment. Data were tested by chi-squared analysis and a multiple comparison post-test. Results: The MTA group showed both clinical and radiographic treatment success in 14/14 teeth (100%), at all follow-up appointments. By clinical evaluation, no teeth in the CH+saline and CH+PEG groups had signs of mobility, fistula, swelling or inflammation of the surrounding gingival tissue. However, in the CH+saline group, radiographic analysis detected internal resorption in up to 9/15 teeth (67%), and inter-radicular bone resorption and furcation radiolucency in up to 5/15 teeth (36%), from 3 to 12 months of follow-up. In the CH+PEG group, 2/11 teeth (18%) had internal resorption and 1/11 teeth (9%) presented bone resorption and furcation radiolucency at all follow-up appointments. Conclusion: CH with PEG performed better than CH with saline as capping material for pulpotomy of primary teeth. However, both combinations yielded clinical and radiographic results inferior to those of MTA alone.

Evaluation of local intra-pleural application of tranexamic acid on postoperative blood loss in lung decortication surgery, a prospective, randomized, double-blind, placebo-controlled study

Background: During decortication surgery, fibrous peel over the lung was removed to allow expansion of the lung and therefore, wide raw area was created with surface oozing. The phenomenon of fibrinolysis usually activated after such procedure, resulting in increasing the postoperative bleeding. Tranexamic acid is one of antifibrinolytic therapies that could be used topically and to targets directly the source of bleeding and reducing the local activation of the fibrinolytic process and consequently reducing the postoperative bleeding. Patients and Methods: A total of 70 patients underwent lung decortication surgery in Cardiothoracic Surgery Department at Tanta University Hospital from January 2015 to May 2017. Patients were randomly allocated into two groups, Group I (35 patients) receiving 3 g of tranexamic acid in 100 ml of saline solution and Group II (35 patients) receiving 100 ml of saline solution as placebo. At the end of the operation and before closing the chest, in both groups, drug or placebo solution was distributed locally all over the pleural cavity. Comparison between the groups was done regarding the amount of postoperative bleeding, postoperative hemoglobin in the first 24 and 48 h postoperatively, blood transfusion, Intensive Care Unit (ICU) stay, and hospital stay. Results: Both groups were comparable regarding demographic and surgical data. Group I patients had the significantly lesser amount of postoperative blood loss than Group II during the first postoperative 48 h, and hence, the need of postoperative blood transfusion was significantly lower in Group I with better postoperative hemoglobin level than Group II. However, there was no difference in overall ICU and hospital stay. Conclusion: The local intrapleural use of tranexamic acid after decortication surgery of the lung is safe and significantly reduces the amount of postoperative blood loss and in consequence reduces the amount of postoperative blood transfusion.

A randomized trial on the efficacy of telephone interviews on the quality of life in patients with chronic Keshan disease / 中华地方病学杂志

Objective To evaluate the efficacy of telephone interviews on the quality of life of patients with chronic Keshan disease.Methods Totally 120 cases of chronic Keshan disease patients with chronic heart failure and NYHA classification of Ⅱ-Ⅳ were enrolled among the 181 patients with chronic Keshan disease,which confirmed by case search in Heshui County and Zhengning County in Qingyang City,Gansu Province in 2015,general demographic and clinical data were collected.According to the principle of random number table grouping,these 120 patients were randomly divided into a intervention group (n =60) and a control group (n =60).Both groups were given the conventional therapy and encouraged to inquiry or given regular outpatient medical follow-up.The patients in the intervention group received telephone interviews regularly for 6 months,with a interview frequency once a week in the first month,once every two weeks in the second and third months and once a month in the fourth,the fifth and the sixth months,with about 15 to 20 minutes interviews each time.Meanwhile there was no telephone interviews in the control group.At the begining of study,and after 3 months and 6 months of study,quality of life scores were scored according to the Minnesota Heart Insufficiency Scale (MLHFQ).The scores included total quality of life,physical field scores,emotional field scores,and other field scores.The lower the score,the higher the quality of life.Results After 3 months of telephone interviews,the emotional domain score of the intervention group (10.16 ± 4.58) was lower than that of the control group (13.10 ± 5.37,P ＜ 0.05).After 6 months of telephone interviews,the patients in the intervention group (35.60 ± 16.07,6.67 ± 4.01,13.16 ± 4.13) had significantly better quality of life than those in the control group (57.19 ± 14.97,12.43 ± 5.29,18.94 ± 6.68),with lower total points of life quality,emotion area and other area scores.The differences between the two groups were statistically significant (P ＜ 0.05).Conclusions Telephone interviews may promote the quality of life for patients with chronic Keshan disease.It is an effective way in enhancing the ability of chronic Keshan disease management.

Resultados de la electrólisis percutánea intratisular en el dolor en el hombro: infraespinoso, un ensayo controlado aleatorio / Résultats de l'Électrolyse Percutanée Intra-tissulaire contre la douleur de l'épaule: Muscle sous-épineux. Une étude contrôlée et randomisée / Results of the Electrolysis Percutaneous Intratissue in the shoulder pain: infraspinatus, A Randomized Controlled Trial

Background: The Electrolysis Percutaneous Intratissue (EPI®) is a novel technique that provokes a local inflammatory process, allowing the phagocytises and affected tissue to repair. Objectives: The work is aimed to: a) verify the effectiveness of the EPI® when there is shoulder pain, b) locate where the EPI® should be applied, c) and find the possible interaction between the trigger points and the tendon pain. Design: Randomized controlled trial. Setting: Institute of Physiotherapy and Sports. Method: A double randomized experimental longitudinal study was conducted on four groups of 10 people aged 34-47 years with pain in the shoulder. In the first study there were three intervention groups and a control group. In the second study, the group with the best results in the first study served as a control group. Measurements: The variables measured were the perceived pain and the restriction for abduction, internal and external rotation. Results: Although the three intervention groups improved respect to the control group when the EPI® was applied, the results show that the EPI® is more effective when it is applied in all detected trigger points and to tendon pain. Conclusions: The EPI® is more effective if applied in the infraspinatus muscle and the tendon than applied only to one of the two structures, when both structures have pain. Limitations: The study could have tested the involvement of different structures and its related biomechanical implications. It could have also considered more variables(AU)

Introducción: la electrólisis percutánea intratisular (EPI®) es una novedosa técnica que provoca un proceso inflamatorio local, que permite la fagocitosis y la reparación del tejido afectado. Objetivos: verificar la efectividad de la EPI® cuando hay dolor del hombro, b) localizar dónde debería ser aplicada la EPI® y C) y determinar la interacción entre los posibles puntos de activación y el dolor del tendón. Diseño: estudio controlado aleatorio. Ubicación: Instituto de Fisioterapia y el Deporte. Método: se realizó un estudio longitudinal experimental aleatorizado doble en cuatro grupos de 10 personas con edades entre 34-47 años que sufrían dolor en el hombro. En el primer estudio hubo tres grupos de intervención y un grupo de control. En el segundo estudio, el grupo que tuvo mejores resultados en el primer estudio sirvió como grupo de control. Mediciones: las variables que se midieron fueron dolor percibido y la restricción de la abducción, rotación interna y rotación externa. Resultados: aunque los tres grupos de intervención mejoraron respecto al grupo de control cuando se aplicó la EPI®, los resultados muestran que la EPI® es más eficaz cuando se aplica en todos los puntos de activación detectados y donde hay dolor en los tendones. Conclusiones: la EPI® es más eficaz si se aplica en el músculo infraespinoso y el tendón que si se aplica solo a una de las dos estructuras, cuando ambas presentan dolor. Limitaciones: el estudio podría haber probado la participación de diferentes estructuras y sus implicaciones biomecánicas relacionadas. Podría también haber tenido en cuenta más variables(AU)

Introduction: L'Électrolyse Percutanée Intra-tissulaire (EPI®) est une nouvelle technique qui produit une réaction inflammatoire locale permettant la régénération tissulaire du tendon, ligament, muscle, etc. Objectifs: Le but de ce travail est de, a) confirmer l'effectivité de l'EPI® lorsqu'il y a une douleur au niveau de l'épaule, b) localiser la région sur laquelle l'EPI® doit être appliqué, et c) trouver la possible interaction entre les points de stimulation et la douleur tendineuse. Dessin: Une étude contrôlée et randomisée. Lieu: Institut de physiothérapie et de sports. Méthode: Une étude randomisée, expérimentale et longitudinale de quatre groupes de 10 personnes, âgées de 34 - 47 ans et atteintes d'une douleur au niveau de l'épaule, a été réalisée. Dans la première étude, il y a eu trois groupes expérimentaux et un groupe témoin. Dans la deuxième étude, le groupe ayant les meilleurs résultats dans la première étude a servi de groupe témoin. Évaluations: Parmi les variables analysées, on peut trouver la perception de la douleur et la limitation de l'adduction et de la rotation interne et externe. Résultats: Quoique les trois groupes expérimentaux ont éprouvé une amélioration vis-à-vis le groupe témoin après l'application de l'EPI®, les résultats ont montré que cette technique est plus effective si elle est appliquée sur tous les points de stimulation détectés et contre la douleur tendineuse. Conclusions: L'EPI® est plus effective si elle est appliquée sur le muscle sous-épineux et les tendons que sur une seule de ces deux structures, quand toutes les deux sont douloureuses. Limitations: L'étude pouvait avoir examiné les différentes structures compromises et leurs implications biomécaniques associées. Elle pouvait avoir aussi considéré beaucoup plus de variables(AU)

Influência do tratamento periodontal na função endotelial da doença cardiovascular / The influence of periodontal treatment in the endothelial function of cardiovascular disease ­ a systematic review

Objetivo: diversos estudos epidemiológicos vêm estudando a associação entre doença periodontal e doença cardiovascular, defendendo a ideia de que a DP seria um fator de risco para a doença cardiovascular. A doença periodontal é uma inflamação crônica que está associada ao aumento de marcadores inflamatórios sistemicamente e interferência na função endotelial. Vale ressaltar que a inflamação e a função endotelial têm um importante papel na patogênese da aterosclerose. Material e métodos: pouca informação existe a respeito da influência do tratamento periodontal na doença cardiovascular, sendo assim, este trabalho consiste em uma revisão de literatura, através da busca no MedLine/Pubmed de ensaios clínicos randomizados que estudem a influência do tratamento periodontal nos marcadores da doença cardiovascular. Resultados: através deste trabalho, foi possível concluir que o tratamento periodontal parece exercer influência na melhora dos níveis séricos dos marcadores cardiovasculares. Conclusão: mais estudos são necessários para comprovar a real relação.

Objective: several epidemiological studies have investigated the association between periodontal disease and cardiovascular disease, defending the idea that the DP would be a risk factor for cardiovascular disease. Periodontal disease is a chronic inflammation which is associated with inflammatory markers increasing and systemically interference in endothelial function. It is noteworthy that inflammation and endothelial function play an important role in the pathogenesis of atherosclerosis. Material and methods: little information exists about the influence of periodontal treatment in cardiovascular disease; therefore this study consists of a randomized clinical trial literature review to study the influence of periodontal treatment on markers of cardiovascular disease, through search in MedLine/Pubmed. Results: through this work it was possible to conclude that the periodontal treatment looks to influence the improvement of the serious levels of the cardiovascular markets. Conclusion: more studies are necessary to verify the real relationship between them.

Glutamina: su papel en el paciente crítico / Glutamine: the role in critically ill patients

La glutamina es un aminoácido condicionalmente esencial considerado actualmente como un importante fármaco-nutriente. Niveles plasmáticos bajos de glutamina han demostrado comportarse como un factor independiente de mortalidad en el paciente crítico, y su adición al soporte nutricional ha probado disminuir las complicaciones infecciosas, la mortalidad y la estancia hospitalaria. En los últimos años han aparecido nuevos estudios que indicanla necesidad de individualizar la vía de acceso y la dosis y el período de suplementación para determinados grupos de pacientes candidatos a la suplementación con glutamina, y por otra parte, a tenor de los resultados, es aconsejable evitarla en situaciones deshock hipovolémico inestable, fallo multiorgánico o insu¬ciência renal no sometida a técnicas de depuración.

Glutamine is a conditionally essential aminoacid which is nowadays considered an important pharmaco nutrient. Low serum levels of glutamine have proven to be an independent predictor of mortality in the critically ill patient. Supplementation with glutamine as a part of a nutritional therapy has demonstrated to reduce infectious complications, length of stay in hospital and mortality. Recent new published data show the need to individualize the route, dose, length of supplementation for determined groups of candidate patients to glutamine administration. On the other hand, according to results, glutamine is not recommended in case of unstable hypovolemic shock, multiorgan faillure, or renal failure not subjected to depuration techniques.

Changing core beliefs with trial-based cognitive therapy may improve quality of life in social phobia: a randomized study

Objective: To determine whether there are differences in quality of life (QoL) improvement after treatment with the trial-based thought record (TBTR) versus conventional cognitive therapy (CCT) in patients with social anxiety disorder (SAD). Method: A randomized trial comparing TBTR with a set of CCT techniques, which included the standard 7-column dysfunctional thought record (DTR) and the positive data log (PDL) in patients with SAD, generalized type. Results: Repeated measures analysis of variance (ANOVA) revealed a significant time effect in the general health, vitality, social functioning, and mental health domains of the Short Form 36. It also indicated significant treatment effects on the bodily pain, social functioning, role-emotional, and mental health domains, with higher scores in the TBTR group. One-way analysis of covariance (ANCOVA), using pretreatment values as covariates, showed that TBTR was associated with significantly better QoL post-treatment (bodily pain, social functioning and role-emotional) and at follow-up (role-emotional). A significant treatment effect on the role-emotional domain at 12-month follow-up denoted a sustained effect of TBTR relative to CCT. Conclusion: This study provided preliminary evidence that TBTR is at least as effective as CCT in improving several domains of QoL in SAD, specifically when the standard 7-column DTR and the PDL are used. .

Effectiveness on the education and food safety programs among senior primary students in 2 counties from west China-a cluster randomized trial / 中华流行病学杂志

Objective To evaluate the effectiveness of nutrition and food safety educational programs on primary students from grade 4 to 6 in impoverished areas of Western China,under a school-based cluster-randomized trial.Methods Twelve primary schools were selected from 2 impoverished counties in West China and assigned to intervention or control groups,randomly,with 6 schools in each group.Self-rating knowledge,attitude and practice questionnaires were used at both baseline and final stages.Textbooks and supportive materials were designed according to the characteristics of baseline data.All students in the intervention group were treated with targeted nutrition and food safety lectures of 0.5 hour per week for 2 semesters.Generalized linear mixedeffects model was applied to fit the random effects on individual and clusters as well as to fit the fixed effect of the programs.Results Three hundred seventy-eight students from grade 4 to 6 were randomly selected at the baseline study and the differences of scores on knowledge,attitude and practice between the 2 groups were statistically insignificant (P＞0.05).No cluster was lost during the trial.In the final investigation,478 students were randomly selected at the individual level.Scores on knowledge,attitude and practice among students in the intervention group were significantly higher,when comparing to the control group (P＜0.01).At the cluster level,more schools in the intervention group showed significant changes on knowledge and practice,yet the change in attitude was less obvious.Data from the mixed-effects model demonstrated that the program served as an influential factor on scores related to knowledge after the intervention (P=0.015) but did not affect the scores on related attitude or practice (P＞0.05).Conclusion Lectures seemed to have improved the cognition of nutrition and food safety among primary students from grade 4 to 6.However,long-term observation and larger sample size were needed to evaluate the changes on attitude and practice among the students.

A randomized trial of 24 versus 48 weeks of peginterferon a-2a plus ribavirin in Egyptian patients with hepatitis C virus genotype 4 and rapid viral response.

Background and aim: Little data is available regarding the 24-week therapy with pegylated interferon and ribavirin in Egyptian patients with hepatitis C virus (HCV) genotype 4 infection. We aimed to investigate the efficacy of 24-week versus 48-week peginterferon a-2a plus ribavirin therapy in patients with HCV genotype 4 infection with with rapid virological response. Methods: This trial included 102 patients with HCV genotype 4 infection and low viral load. They were treated with peginterferon a-2a (180 μg/week) plus ribavirin. Patients (87/102) with a rapid virological response were randomized for a total treatment duration of 24 weeks (group A: 43) or 48 weeks (group B:44). Virological responses (EVR: early virological response, EOTR: end of treatment response, and SVR: sustained virological response) were assessed for each group. Results: In group A, EVR was achieved in 37/43 (84%) patients, while EOTR was achieved in 34/43 (79%) patients and SVR in 30/43 (70%) patients. In group B, on the other hand EVR was achieved in 38/44 (84%) patients, while EOTR was achieved in 35/44 (80%) patients and SVR in 32/44 (73%) patients. No significant difference in SVR rates was observed between the two groups. The rate of adverse events was higher in group B, with lower adherence rates than group A. Conclusions: In patients with chronic HCV genotype 4 infection with rapid virological response and low viral loads, a 24-week peginterferon a-2a plus ribavirin therapy is as effective as a 48-week therapy with lower rate of adverse events.

A Randomized, Open-Label, Multicenter Trial of Topical Tacrolimus for the Treatment of Pruritis in Patients with Atopic Dermatitis

BACKGROUND: Pruritis caused by atopic dermatitis (AD) is not always well controlled by topical corticosteroid therapy, but use of tacrolimus often helps to soothe such intractable pruritis in clinical settings. OBJECTIVE: To determine the anti-pruritic efficacy of topical tacrolimus in treating AD in induction and maintenance therapy. METHODS: Prior to the study, patients were randomly allocated into two groups, induction therapy followed by tacrolimus monotherapy maintenance, and induction therapy followed by emollient-only maintenance. In the induction therapy, the patients were allowed to use topical tacrolimus and emollients in addition to a low dose (<10 g/week) of topical steroids. Patients showing relief from pruritis were allowed to proceed to maintenance therapy. Recurrence of pruritis in maintenance therapy was examined as a major endpoint. RESULTS: Two-thirds of patients (44/68; 64.7%) showed relief from pruritis after induction therapy. Pruritis recurred in 23.8% (5/21) of the tacrolimus monotherapy group and in 100% (21/21) of the emollient group during maintenance period, a difference that was statistically significant. CONCLUSION: Use of topical tacrolimus is effective in controlling pruritis of AD compared to emollient.

Community-based Health Workers Achieve High Coverage in Neonatal Intervention Trials: A Case Study from Sylhet, Bangladesh.

A large proportion of four million neonatal deaths occur each year during the first 24 hours of life. Research is particularly needed to determine the efficacy of interventions during the first 24 hours. Large cadres of community-based workers are required in newborn-care research both to deliver these interventions in a standardized manner in the home and to measure the outcomes of the study. In a large-scale community-based efficacy trial of chlorhexidine for cleansing the cord in north-eastern rural Bangladesh, a two-tiered system of community-based workers was established to deliver a package of essential maternal and newborn-care interventions and one of three umbilical cord-care regimens. At any given time, the trial employed approximately 133 community health workers—each responsible for 4-5 village health workers and a population of approximately 4,000. Over the entire trial period, 29,760 neonates were enrolled, and 87% of them received the intervention (their assigned cord-care regimen) within 24 hours of birth. Approaches to recruitment, training, and supervision in the study are described. Key lessons included the importance of supportive processes for community-based workers, including a strong training and field supervisory system, community acceptance of the study, consideration of the setting, study objectives, and human resources available.

The impact of ICT on adolescents' perceptions and consumption of substances

This paper reports the results of a three-month randomized controlled trial toestimate the impact of an Internet and mobile telephone short messageservice (SMS) intervention on adolescents’ information about substances and rates of consumption. A low percentage of participants logged on to the Web platform, but most participants were reached through e-mails and SMS. It is found that the intervention was able to affect awareness that certain substances are drugs, but no significant changes in consumption habits were found.

Quality Assessment of Non-Randomized Studies in the Korean Journal of Family Medicine / 가정의학회지

BACKGROUND: Since the Korean Journal of Family Medicine (KJFM) started publishing in 1980, randomized controlled trials (RCTs) and non-randomized controlled studies (NRSs) consistently have increased in quality and quantity. Although there have been several studies on the quality assessment of RCTs in Korea, there has been no study on quality assessment of NRSs. Thus, this study evaluated NRS in the KJFM to assess the quantity and quality. METHODS: Upon extracting NRSs for assessing the intervention effects from all the articles published in the KJFM from 1980 to 2006, assessments were made on methodological index for non-randomized studies (MINORS). Also, the analysis were made upon the proportion of NRSs within original articles according to two categories (comparative study, noncomparative study). The mean scores by research methods and years, and total scores and mean scores of yearly research methods were analyzed. RESULTS: A total of 34 trials on NRSs were selected. In 1980s, 0.65% of the total selected original articles, in 1990s, 1.54%, and in 2000s 5.11% were NRSs. According to the research designs, the mean scores of MINORS were before and after study 8.5, interrupted Time Series 9.7 (out of 16), controlled before and after 13.5, quasi randomized trial 12.6, and non randomized trial 13 (out of 24). Before and after design was the most frequently used (55.9%). CONCLUSION: Although NRSs consistently increased in quantity, the assessed mean scores were low and most articles used before and after design. Thus, there should be studied using appropriate research methods in the future.

Effects of purified herbal extract of Salvia miltiorrhiza on lipid profile in hyperlipidemic patients / 老年心脏病学杂志（英文版）

Background and Objective Hyperlipidemia is one of the most potent and best substantiated risk factors for coronary heart disease (CHD). Purified Salvia miltiorrhiza extract (PSME) had been shown to have hypolipidemic effect in animal experiments. This study aimed to evaluate its iipids modulating effects in hyperlipidemic patients. Methods In this single-blind, placebo controlled study, lipid profiles of 80 hyperlipidemic patients were checked at same conditions. They were divided into two equal groups randomly (each composing of 40 patients). They were given PSME tablet (800 mg) three times per day, or placebo tablet. All patients were put on NCEP type Ⅱ diet and six weeks later, lipid profiles were checked. Results In PSME group, total cholesterol decreased by 27.32 mg/dl (12.3% reduction), LDL-cholesterol decreased by 23.13 mg/dl (16.8% reduction) and HDL-cholesterol increased by 9.06 mg/dl (11.1%), all were statistically significant. Although triglyceride dropped by 12.12 mg/dl (5.1%) but this was not significant statistically (P=-0.34). There were no significant changes oflipids levels in the placebo group. Conclusions PSME has significant favorable effect on total cholesterol, LDL-cholesterol, and HDL-cholesterol and may be a potential agent for the treatment ofatherogenic dyslipidemia.

Ventilação não-invasiva no edema agudo de pulmão cardiogênico: [revisão] / Noninvasive ventilation in acute cardiogenic pulmonary edema: [review]

O uso da continuous positive airway pressure (CPAP) no tratamento do edema agudo de pulmão (EAP) cardiogênico tem sido estudado por alguns autores. Recentemente, a utilização da ventilação não-invasiva com dois níveis de pressão (BiPAP) vem sendo estudada nessa situação clínica; entretanto, os resultados são controversos. Dessa forma, foi realizado, através do MEDLINE, um levantamento dos ensaios clínicos randomizados publicados em língua inglesa que analisaram a utilização do BiPAP em pacientes com EAP cardiogênico, obtendo-se um total de 11 trabalhos. O BiPAP mostrou-se útil no manuseio do EAP, apresentando benefícios similares à CPAP. Nos pacientes hipercápnicos, o BiPAP surge como uma importante estratégia de suporte ventilatório não-invasivo. Porém, faz-se necessário um estudo com grande número de pacientes para esclarecer certas dúvidas ainda persistentes.

The use of continuous positive airway pressure (CPAP) in the treatment of acute cardiogenic pulmonary edema (CPE) has been studied by some authors. Recently, the use of bi-level positive airway pressure (BiPAP) has been studied in this clinical situation, although the results have been controversial. We searched MEDLINE in order to find randomized trials published in English that analyzed the use of BiPAP in patients with CPE. Eleven trials were found. BiPAP was useful in the management of CPE, showing similar benefits to those of CPAP. In hypercapnic patients, BiPAP appears to be an important strategy of noninvasive ventilatory support. However, large trials are necessary to clarify certain doubts that still remain.

Controlled randomized trial on therapeutic effects of Biqi Capsule and VitB combined with FENG'S manipulation(FSM) on lubar intervertebral disc protrusion mainly with paresthesia of skin / 中华中医药杂志

Objective:To evaluate the therapeutic effects of capsule of Biqi Capsule and VitB on lubar intervertebral disc protrusion(LIDP).Methods:78 Patients with LIDP were divided randomly into 2 groups:treatment and control group.39 Patients in treatment group were treated with Biqi Capsule and FENG's bone-setting manipulation,39 patients in control group were treated with vitamine B and FENG's bone-setting manipulation.All patients were followed up for 1 month after treatment for 2 weeks and therapeutic effects were evaluated.Results:In treatment group,24 patients were cured,6 patients had remarkable effects,5 effective,4 ineffective.In control group,the data were 16,8,8,7 correspondly.The therapeutic effects in treatment group were obviously better than those of control group(P

Preliminary Results of the Prospective Randomized Phase III Trial on the Induction Chemotherapy in the Concurrent Chemoradiotherapy for the Locally Advanced Non-small Cell Lung Cancer

PURPOSE: To investigate the role of induction chemotherapy in relation to the treatment results and toxicities of concurrent chemoradiotherapy (CCRT) for locally advanced non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: Patients with unresectable and pathologically confirmed Stage III NSCLC were eligible. According to the stage and pathological subgroup, the patients were randomized into two arms. Arm A received two cycles of the induction chemotherapy composed of gemcitabine, 1,000 mg/m2 (D1 and D8), and cisplatin, 70 mg/m2 (D1), followed by CCRT with weekly paclitaxel, 50 mg/m2, and cisplatin, 20 mg/m2. Arm B received immediate CCRT without the induction chemotherapy. A daily 2.2 Gy radiation dose was delivered to the isodose line covering the planned target volume, which was defined as the gross tumor volume plus a 1.0 cm margin from the planning CT, using a 3-D conformal radiation therapy technique. RESULTS: Between May 2003 and 2004, 63 patients were enrolled. Forty four patients (Arm A 23, Arm B 21) were evaluable, with follow-up periods exceeded 1 month after the end of the assigned treatment. The median follow-up periods were 6 and 7 months for Arms A and B, respectively. The patients' characteristics, including gender, age, weight loss, performance status, pulmonary function and stage, were well balanced between the two arms. The median largest tumor diameters were 4.8 cm (3.0~15 cm) and 5.0 cm (2.5~10 cm) for Arms A and B, respectively. The one-year survival rates were 58 and 63% for Arms A and B respectively, which showed no statistical significance (p=0.6667). The compliance of the induction chemotherapy was 96% (22/23 patients), and those of the CCRT were 86% for both arms (18/21 patients). The response rate of the induction chemotherapy was 64% (14/22 patients) and those of the CCRT were 83 (15/18 patients) and 89% (16/18 patients) for Arms A and B, respectively, which showed no statistical significance (p=0.630). In the 23 patients of Arm A, 8 (35%) suffered grade 3~4 neutropenia during the induction chemotherapy and 1 expired due to sepsis. CCRT caused grade 3~4 neutropenia in 6 and 1 patients of Arms A (29%) and B (5%), respectively, showing statistical significance (p=0.038). Grade 3~4 radiation pneumonitis developed in 2 and patients from Arms A (10%) and B (5%), respectively, (p=0.464) and grade 3~4 acute esophagitis developed in 7 (Arm A) and 5 patients (Arm B) (p=0.495). CONCLUSION: Both treatment schemes showed acceptable treatment compliance and toxicities. However, the induction chemotherapy resulted in a higher incidence of severe neutropenia. The treatment outcomes, as yet, have shown no statistical significance. To evaluate the role of induction chemotherapy on the survival prolongation in CCRT for locally advanced NSCLC, more patients and a longer follow-up are mandatory