Effectiveness of inulin intake on indicators of chronic constipation; a meta-analysis of controlled randomized clinical trials

Background: Constipation is an intestinal dysfunction. Prebiotics, such as inulin, can improve bowel function by positively influencing intestinal biota. Aim: To analyze the scientific evidence for the role of inulin in improving bowel function in patients with chronic constipation. Methods: A meta-analysis of randomized controlled clinical trials was conducted, grounded on a literature search for the period 1995-2013 (descriptors: inulin & constipation) on PubMed, ScieLo and Central Trials Register Cochrane databases. A total of 24 articles were found, 5 of them were selected for this meta-analysis, involving 252 subjects (experimental group: n = 144, control group: n = 108). The quality of the studies was assessed using the Jadad scale. Results: We found a significant overall effect of inulin on stool frequency (DEM = 0.69, 95%CI: 0.04, 1.34), stool consistency (Bristol scale) (DEM = 1.07, 95% CI: 0.70, 1.45), transit time (DEM = -0.57, 95% CI: -0.99, -0.15) and hardness of stool (RR = 0.42, 95% CI: 0.26, 0.70). Pain and bloating do not improve with inulin intake. Conclusions: inulin intake has a positive effect on bowel function.

MRI indices of functional recovery following intracerebral implantation of a human neural stem cell line in a pre-clinical model of ischaemic stroke

Stem cell therapy for ischaemic stroke is an emerging field in light of an increasing number of patients surviving with permanent disability. Several allogenic and autologous cells types are now in clinical trials with preliminary evidence of safety. Some clinical studies have reported functional improvements in some patients. After initial safety evaluation in a Phase 1 study, the conditionally immortalised human neural stem cell line CTX0E03 is currently in a Phase 2 clinical trial (PISCES-II). Previous pre-clinical studies conducted by ReNeuron Ltd, showed evidence of functional recovery in the Bilateral Asymmetry test up to 6 weeks following transplantation into rodent brain, 4 weeks after middle cerebral artery occlusion. Resting-state fMRI is increasingly used to investigate brain function in health and disease, and may also act as a predictor of recovery due to known network changes in the post-stroke recovery period. Resting-state methods have also been applied to non-human primates and rodents which have been found to have analogous resting-state networks to humans. The sensorimotor resting-state network of rodents is impaired following experimental focal ischaemia of the middle cerebral artery territory. However, the effects of stem cell implantation on brain functional networks has not previously been investigated. Prior studies assessed sensorimotor function following sub-cortical implantation of CTX0E03 cells in the rodent post-stroke brain but with no MRI assessments of functional improvements. This thesis presents research on the effect of sub-cortical implantation of CTX0E03 cells on the resting- state sensorimotor network and sensorimotor deficits in the rat following experimental stroke, using protocols based on previous work with this cell line. The work in this thesis identified functional tests of appropriate sensitivity for long-term dysfunction suitable for this laboratory, and investigated non-invasive monitoring of physiological variables required to optimize BOLD signal stability within a high-field MRI scanner. Following experimental stroke, rats demonstrated expected sensorimotor dysfunction and changes in the resting-state sensorimotor network. CTX0E03 cells did not improve post-stroke functional outcome (compared to previous studies) and with no changes in resting-state sensorimotor network activity. However, in control animals, we observed changes in functional networks due to the stereotaxic procedure. This illustrates the sensitivity of resting-state fMRI to stereotaxic procedures. We hypothesise that the damage caused by cell or vehicle implantation may have prevented functional and network recovery which has not been previously identified due to the application of different functional tests. The findings in this thesis represent one of few pre-clinical studies in resting-state fMRI network changes post-stroke and the only to date applying this technique to evaluate functional outcomes following a clinically applicable human neural stem cell treatment for ischaemic stroke. It was found that injury caused by stereotaxic injection should be taken into account when assessing the effectiveness of treatment.

Informed consent in clinical research: do patients understand what they have signed?

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.

Bayesian analysis of a mastitis control plan to investigate the influence of veterinary prior beliefs on clinical interpretation

The fundamental objective for health research is to determine whether changes should be made to clinical decisions. Decisions made by veterinary surgeons in the light of new research evidence are known to be influenced by their prior beliefs, especially their initial opinions about the plausibility of possible results. In this paper, clinical trial results for a bovine mastitis control plan were evaluated within a Bayesian context, to incorporate a community of prior distributions that represented a spectrum of clinical prior beliefs. The aim was to quantify the effect of veterinary surgeons’ initial viewpoints on the interpretation of the trial results. A Bayesian analysis was conducted using Markov chain Monte Carlo procedures. Stochastic models included a financial cost attributed to a change in clinical mastitis following implementation of the control plan. Prior distributions were incorporated that covered a realistic range of possible clinical viewpoints, including scepticism, enthusiasm and uncertainty. Posterior distributions revealed important differences in the financial gain that clinicians with different starting viewpoints would anticipate from the mastitis control plan, given the actual research results. For example, a severe sceptic would ascribe a probability of 0.50 for a return of <£5 per cow in an average herd that implemented the plan, whereas an enthusiast would ascribe this probability for a return of >£20 per cow. Simulations using increased trial sizes indicated that if the original study was four times as large, an initial sceptic would be more convinced about the efficacy of the control plan but would still anticipate less financial return than an initial enthusiast would anticipate after the original study. In conclusion, it is possible to estimate how clinicians’ prior beliefs influence their interpretation of research evidence. Further research on the extent to which different interpretations of evidence result in changes to clinical practice would be worthwhile.

Effect of cinnamon tea on postprandial glucose concentration

"Glycaemic control, in particular at postprandial period, has a key role in prevention of different diseases, including diabetes and cardiovascular events. Previous studies suggest that postprandial high blood glucose levels (BGL) can lead to an oxidative stress status, which is associated with metabolic alterations. Cinnamon powder has demonstrated a beneficial effect on postprandial glucose homeostasis in animals and human models. The purpose of this study is to investigate the effect of cinnamon tea (C. burmannii) on postprandial capillary blood glucose level on nondiabetic adults. Participants were given oral glucose tolerance test either with or without cinnamon tea in a randomized clinical trial. The data revealed that cinnamon tea administration slightly decreased postprandial BGL. Cinnamon tea ingestion also results in a significantly lower postprandial maximum glucose concentration and variation ofmaximum glucose concentration (p < 0.05). Chemical analysis showed that cinnamon tea has a high antioxidant capacity, whichmay be due to its polyphenol content. The present study provides evidence that cinnamon tea, obtained from C. burmannii, could be beneficial for controlling glucose metabolism in nondiabetic adults during postprandial period."

Saccharomyces Boulardii in Helicobacter Pylori Eradication in Children: A Randomized Trial From Iran

Background: Helicobacter Pylori infects around 50% of the human population and is asymptomatic in 70% of the cases. H.pylori eradication in childhood will not only result in peptic symptoms relief, but will also prevent late-term complications such as cancer. Today, probiotics are being increasingly studied in the treatment of gastrointestinal infections as an alternative or complement to antibiotics. Objectives: In this study we aimed to assess the effect of S. boulardii supplementation on H.pylori eradication among children in our region. Patients and Methods: In this randomized double-blind placebo-controlled clinical trial 28 asymptomatic primary school children with a positive H.pylori stool antigen (HpSA) exam were randomly allocated into the study group, receiving Saccharomyces Boulardii and the control group receiving placebo capsules matched by shape and size, for one month. The children were followed up weekly and were reinvestigated four to eight weeks after accomplished treatment by HpSA testing. The significance level was set at P < 0.05. Results: 24 children completed the study. The mean HpSA reduced from 0.40 ± 0.32 to 0.21 ± 0.27 in the study group, indicating a significant difference (P = 0.005). However, such difference was not observed in the control group (P = 0.89). Moreover, the HpSA titer showed a 0.019 ± 0.19 decrease in the study group whereas the same value was 0.0048 ± 0.12 for the controls, again stating a significant difference (P = 0.01). Conclusions: Saccharomyces boulardii has a positive effect on reducing the colonization of H.pylori in the human gastrointestinal system but is not capable of its eradication when used as single therapy.

Evaluación de las propiedades clinimétricas de la escala POSAS y su aplicación en pacientes de la Fundación del Quemado en Bogotá

•Objetivos: Se tradujo, adaptó y evaluaron las propiedades clinimétricas de la escala POSAS en pacientes con cicatrices hipertróficas (CHT) y queloides (CQ) cómo secuelas de quemadura, que fueron manejados con Z plastias en la Fundación del Quemado en Bogotá (Colombia), entre Junio de 2015 a Abril de 2016. •Métodos: Estudio de evaluación de las propiedades clinimétricas de una escala. Se hizo una traducción y adaptación transcultural siguiendo el método de traducción-retrotraducción. Se aplicó el instrumento adaptado a cincuenta y dos pacientes (n=52) antes y después de la intervención quirúrgica. Se evaluó la validez, confiabilidad, sensibilidad al cambio y la utilidad de la escala. •Resultados: Se hallaron diferencias significativas en los puntajes obtenidos del Observador y del Paciente, antes y después de la intervención quirúrgica (p<0.000); a excepción de prurito. La escala POSAS demostró ser altamente confiable para la Escala del Observador y del Paciente (α = 0.912 y 0.765). Hubo alta correlación en las evaluaciones de dos observadores para las variables ordinales de la Escala del Observador (r>0.6). La concordancia entre las evaluaciones de dos observadores para las variables categóricas de la Escala del Paciente fue buena para la evaluación antes de la intervención para pigmentación y relieve (κ>0.61). Se demostró que el instrumento es capaz de detectar cambios clínicos en el tiempo (p<0.0000), a excepción de prurito (p= 0.271). •Conclusiones: La escala POSAS demostró ser un instrumento válido, confiable y útil para evaluar la calidad de la cicatriz en pacientes con CHT y CQ cómo secuelas de quemadura.

Trastornos musculoesqueléticos en trabajadores de la industria automotriz: revisión de la literatura 2000 a 2016.

Los trastornos musculoesqueléticos (TME) tienen alta relación con la industria automotriz afectando a los trabajadores en quienes se puede encontrar varias patologías como Síndrome Del Túnel Del Carpo, Epicondilitis, Síndrome del Manguito Rotador, discopatía lumbar y lumbalgias, entre otros. Entre los factores de riesgo asociados a estos trastornos están los movimientos repetitivos, posturas inadecuadas, vibración, uso manual de herramientas, tareas físicas demandantes y el mal levantamiento de pesos. Todas estas patologías son causa de ausentismo laboral en todo el mundo, lo que conlleva a un aumento en el costo económico por incapacidades, ayudas diagnósticas y tratamientos. Se realizó una revisión de la literatura científica de artículos publicados del año 2000 a 2016 con relación a los trastornos musculoesqueléticos en la industria automotriz en las bases de datos de Pubmed, Ebsco Host, ScienceDirect y Embase. La evidencia encontrada sugiere que la patología lumbar es la que presenta mayor prevalencia en la industria, con 65% en la población Europea, 42% en Asia, Norteamérica en un 20% y en América Latina en un 46%. A pesar que en la industria automotriz predominan como fuerza laboral los hombres, se reportó que las mujeres eran las que tenían mayores factores de riesgo para desarrollar un TME y dentro de estos las posturas inadecuadas, movimientos repetitivos, sobrecarga laboral y levantamiento de pesos, sumado al tiempo de exposición que fue un común denominador en cada uno de los estudios analizados. Las conclusiones fueron que la prevalencia de TME en esta industria es elevada y esto amerita la implementación de programas de prevención más enfocados en este tema. Además no se encontró en la literatura la existencia de un método eficiente para análisis postural y de sobrecarga física, lo que habla de una necesidad urgente de realizar más investigaciones enfocadas en este tipo de población.

“Clinical and biological role of adjuvant dendritic cells vaccination in newly glioblastoma patients”

Background. Glioblastoma (GBM) is the most common primary tumor of central nervous system and it has a poor prognosis. Standard first line treatment, which includes surgery followed by adjuvant radio-chemotherapy,produces only modest benefits to survival. The interest for immunotherapy in this field derives from the development of new drugs and effective therapies as immune-check points inhibitors, adoptive T-cell approaches or dendritic cell (DC) based vaccines or a combinations of these. GBM is described as a typical “immune-deserted” cancer exhibiting a number of systemic and environmental immunosuppressive factors. Considering the role of microenvironment, and above all the lower tumor load and depletion of immunosuppressive cells in GBM, our hypothesis is that DC vaccine may induce an immune response. Main aims and study design. The main aim of this project is to study the role of immune system in GBM, including identification of potential prognostic and predictive markers of outcome and response to dendritic cell vaccine. Firstly, we performed a retrospective analysis on blood samples. Then, we analyzed the immuno-component in tissues samples of enrolled patients; and compared that with blood results. Then, the last part of the project is based on a prospective clinical trial on patients enrolled in DC-based vaccination produced at IRST Cell Factory and actually used for patients with melanoma and other tumors. The enrollment is still ongoing. Expected results. The project will i) develop an immune-panel of prognostic and predictive markers to help clinicians to improve the therapeutic strategy for GBM patients; ii) provide preliminary results on the effectiveness of immunotherapy on GBM patients.

Efficacy And Safety Of Intravitreal Bevacizumab In Eyes With Neovascular Glaucoma Undergoing Ahmed Glaucoma Valve Implantation: 2-year Follow-up.

To evaluate the efficacy and safety of intravitreal bevacizumab (IVB) in eyes with neovascular glaucoma (NVG) undergoing Ahmed glaucoma valve (AGV) implantation. This was a multicentre, prospective, randomized clinical trial that enrolled 40 patients with uncontrolled neovascular glaucoma that had undergone panretinal photocoagulation and required glaucoma drainage device implantation. Patients were randomized to receive IVB (1.25 mg) or not during Ahmed valve implant surgery. Injections were administered intra-operatively, and 4 and 8 weeks after surgery. After a mean follow-up of 2.25 ± 0.67 years (range 1.5-3 years), both groups showed a significant decrease in IOP (p < 0.05). There was no difference in IOP between groups except at the 18-month interval, when IOP in IVB group was significantly lower (14.57 ± 1.72 mmHg vs. 18.37 ± 1.06 mmHg - p = 0.0002). There was no difference in survival success rates between groups. At 24 months, there was a trend to patients treated with IVB using less antiglaucoma medications than the control group (p = 0.0648). Complete regression of rubeosis iridis was significantly more frequent in the IVB group (80%) than in the control group (25%) (p = 0.0015). Intravitreal bevacizumab may lead to regression of new vessels both in the iris and in the anterior chamber angle in patients with neovascular glaucoma undergoing Ahmed glaucoma valve implantation. There is a trend to slightly lower IOPs and number of medications with IVB use during AGV implantation for neovascular glaucoma.

Análise de custo-efetividade de métodos preventivos para superfície oclusal de acordo com o risco de cárie: resultados de um ensaio clínico controlado

This study presents the results of a cost-effectiveness analysis in a controlled clinical trial on the effectiveness of a modified glass ionomer resin sealant ( Vitremer, 3M ESPE) and the application of fluoride varnish (Duraphat, Colgate) on occlusal surfaces of first permanent molars in children 6-8 years of age (N = 268), according to caries risk (high versus low). Children were examined semiannually by the same calibrated dentist for 24 months after allocation in six groups: high and low risk controls (oral health education every three months); high and low risk with varnish (oral health education every three months + varnish biannually); and high and low risk with sealant (oral health education every three months + a single application of sealant). Economic analysis showed that sealing permanent first molars of high-risk schoolchildren showed a C/E ratio of US$ 119.80 per saved occlusal surface and an incremental C/E ratio of US$ 108.36 per additional saved occlusal surface. The study concluded that sealing permanent first molars of high-risk schoolchildren was the most cost-effective intervention.

Masticatory afficiency in denture wearers with bilateral balanced occlusion and canine guidance

The maintenance of masticatory function is especially important for patients wearing complete dentures due to their limitations. Thus, the bilateral balanced occlusal concept is used to achieve greater masticatory efficiency. However, a critical review of the literature reveals that there is not sufficient scientific evidence to support bilateral balanced occlusion as the most appropriate occlusal concept in complete dentures. Therefore, the aim of this study was to evaluate the masticatory efficiency in complete dentures wearers with bilateral balanced occlusion and canine guidance. A double-blinded controlled crossover clinical trial was conducted. The sample was composed by 24 edentulous patients who wore sets of complete dentures with both occlusal concepts during equal periods of 3 months. Objective data were collected through the masticatory efficiency test performed by the colorimetric method with the beads, in which capsules of a synthetic material enclosing fuchsine-containing granules were used. Subjective data were recorded by patient's ratings of their chewing function. No significant statistical difference was found for masticatory efficiency (p=0.095) between the two occlusal concepts studied. The results suggest that bilateral balanced occlusion does not improve the masticatory efficiency in complete denture wearers.

Análise dos efeitos da cinesioterapia e da hidrocinesioterapia sobre a qualidade de vida de pacientes com fibromialgia: um ensaio clínico randomizado

OBJETIVO: Verificar e comparar os efeitos da hidrocinesioterapia e da cinesioterapia na qualidade de vida de pacientes portadoras de fibromialgia. MATERIAIS E MÉTODOS: Foi realizado um ensaio clínico randomizado, cego, para os avaliadores. Para avaliar a qualidade de vida, utilizou-se o questionário genérico SF-36 a fim de analisar os aspectos físicos e psicológicos em 24 pacientes do sexo feminino, portadoras de fibromialgia, com idade de 30 a 55 anos, alocadas aleatoriamente em dois grupos: hidrocinesioterapia e cinesioterapia. Durante um período de 23 semanas, as pacientes foram submetidas a alongamentos e exercícios aeróbios de baixa intensidade com duração de uma hora cada sessão (em ambos os grupos). RESULTADOS: Observou-se melhora estatisticamente significante (p < 0,05) na maior parte dos aspectos abordados pelo SF-36 em ambos os grupos. CONCLUSÃO: A hidrocinesioterapia promoveu um relaxamento muscular favorável para a melhora da qualidade de vida, porém, não foi o fator principal para amenizar os efeitos da patologia, uma vez que a cinesioterapia também proporcionou efeitos benéficos para a promoção do bem-estar dessas pacientes. Portanto, os alongamentos e os exercícios aeróbios de baixa intensidade empregados em ambos os protocolos são os prováveis responsáveis pelos efeitos benéficos observados nas duas modalidades terapêuticas analisadas.

Influência da proteína de soja e dos exercícios com pesos sobre o gasto energético de repouso de mulheres na pós-menopausa

OBJETIVO: Analisar a influência da ingestão alimentar de proteína da soja e dos exercícios com pesos sobre o gasto energético de repouso (GER) de mulheres na pós-menopausa. MÉTODOS: Ensaio clínico, 16 semanas, envolvendo 60 mulheres, 59 (7) anos, distribuídas em quatro grupos: G1 (proteína da soja e exercício), G2 (placebo e exercício), G3 (proteína da soja e sem exercício) e G4 (placebo e sem exercício). A proteína da soja e o placebo (maltodextrina) foram distribuídos, aleatoriamente, sob a forma de pó, na porção de 25 gramas/dia. Foram 10 exercícios com pesos, realizados em três sessões semanais, com 3 séries de 8-12 repetições cada, carga de 60 por cento-80 por cento de uma repetição máxima (RM). O GER foi calculado a partir do O2 e CO2, obtidos por calorimetria indireta (Quinton-QMC®), durante 30 minutos, sob temperatura e umidade controladas. Na análise estatística foi utilizada ANOVA, teste T de Student e regressão múltipla, por meio do software Stata 9.2, α<0,05. RESULTADOS: As mulheres apresentaram homogeneidade em todas as variáveis do estudo. Houve aumento, significante, do GER (p<0,05) no G1 (158 kcal/dia) e G2 (110 kcal/dia), correspondente a 17 por cento e 9 por cento, respectivamente, enquanto, o G4, diminuição em 4 por cento (p<0,05). CONCLUSÃO: Exercícios com pesos são determinantes para o aumento do gasto energético de repouso, de mulheres na pós-menopausa, podendo ser potencializado pela ingestão de proteína da soja

Consumption of a flaxseed-rich food is not more effective than a placebo in alleviating the climacteric symptoms of postmenopausal women

Our objective in this work was to test the effects of daily intake of bread produced with partially defatted ground flaxseed on the climacteric symptoms and endometrial thickness of postmenopausal women. A double-blind, placebo-controlled, randomized clinical trial was performed with 38 women who had been postmenopausal for 1–10 y and consumed 2 slices of bread containing 25 g of flaxseed (46 mg lignans) or wheat bran (<1 mg lignans; control) every day for 12 consecutive weeks. The outcome variables were the daily number of hot flashes, the Kupperman Menopausal Index (KMI), and endometrial thickness. The plasma lipid profile (total cholesterol and HDL, LDL, and VLDL cholesterol fractions and triglycerides) and the hormones estradiol, follicle-stimulating hormone, thyroid-stimulating hormone, and free thyroxine also were measured. Food intake was evaluated by means of 2 24-h recalls, before and after the treatment. Twenty patients in the study group and 18 in the control group completed the study. The general characteristics did not differ between the 2 groups at the start of the study. Both had significant, but similar, reductions in hot flashes and KMI after 3 mo of treatment. Moreover, endometrial thickness was not affected in either group. Our findings clearly show that although flaxseed is safe, its consumption at this level (46 mg lignans/d) is no more effective than placebo for reducing hot flashes and KMI