Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care : a pragmatic, randomised, non-inferiority clinical trial (OB12)

The trial was financed by Ministerio de Sanidad y Consumo Español through their call for independent clinical research, Orden Ministerial SAS/2377, 2010 (EC10-115, EC10-116, EC10-117, EC10-119, EC10-122); CAIBER—Spanish Clinical Research Network, Instituto de Salud Carlos III (ISCIII) (CAI08/010044); and Gerencia Asistencial de Atención Primaria de Madrid. This study is also supported by the Spanish Clinical Research Network (SCReN), funded by ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, project number PT13/0002/0007, within the National Research Program I+D+I 2013-2016 and co-funded with European Union ERDF funds (European Regional Development Fund). This project received a grant for the translation and publication of this article from the Foundation for Biomedical Research and Innovation in Primary Care (FIIBAP) Call 2017 for grants to promote research programs.Objectives To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. Design Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). Participants 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. Interventions The IM arm received 1 mg VB12 on alternate days in weeks 1–2, 1 mg/week in weeks 3–8 and 1 mg/month in weeks 9–52. The oral arm received 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. Main outcomes Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. Results The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were −0.7% (133 out of 135 vs 129 out of 130; 95% CI: −3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: −1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were −6.3% (103 out of 112 vs 115 out of 117; 95% CI: −11.9 to −0.1; p=0.025) and −6.8% (103 out of 140 vs 115 out of 143; 95% CI: −16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>−10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. Conclusions Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.Publisher PDFPeer reviewe

Utility of MRI Diffusion Techniques in the Evaluation of Tumors of the Head and Neck

cancer

Subtitling for Intercultural Communication in Foreign Language Learning/Teaching: the case of "Dhat", an Egyptian Series Subtitled in Spanish

El objetivo de este trabajo es presentar un nuevo recurso para la enseñanza del árabe como lengua extranjera. El trabajo se desarrolla dentro del marco de las actividades del proyecto E-LENGUA financiado por el programa europeo de Erasmus+. El objetivo del proyecto es desarrollar nuevos recursos y compartir buenas prácticas para la enseñanza de lenguas extranjeras aplicando las tecnologías de información y comunicación. El recurso presentado aquí consiste en la subtitulación de un conjunto de 10 capítulos de una serie egipcia contemporánea titulada, Dhat. La serie refleja la historia egipcia contemporánea desde los cincuenta hasta la revolución del 2011 a través de la vida de la protagonista, Dhat, una chica egipcia de la clase media, nacida en El Cairo. El artículo consiste en cuatro partes. La introducción presenta el marco teórico. La segunda parte explica la metodología y el alcance de la tarea planteada. La tercera parte presenta las actividades desarrolladas utilizando este recurso y su evaluación en el aula. Finalmente en la última parte se resumen las conclusiones y los futuros trabajos.The objective of this paper is to present a teaching resource for Arabic as a foreign language, developed within the context of the European project ELENGUA. E-LENGUA is funded by Erasmus+ programme and it aims at developing new resources and sharing good practices in foreign language teaching using modern information and communication technologies. The resource consists of subtitling a set of ten episodes of the Egyptian TV series, Dhat. The subtitles are in Spanish and the series depicts the evolution of the Egyptian society, from the fifties until the Egyptian Revolution in 2011 through the biography of Dhat, an Egyptian middle class girl born in the fifties in Cairo. The paper is divided into four sections. The first is an introduction covering the theoretical framework. The second presents the methodology and the scope of work. The learning activities and its evaluation are addressed in the third section. Finally, the conclusions and future work are presente

Standardization non-invasive fetal RHD and SRY determination into clinical routine using a new multiplex RT-PCR assay for fetal cell-free DNA in pregnant women plasma: Results in clinical benefits and cost saving

Introduction: Among negative RhD mothers it is essential to know the fetal RhD status in order to avoid the possibility of hemolytic disease of the newborn. In this regard, the detection of fetal DNA in maternal plasma might become a new diagnostic tool. In the current study, we have evaluated the standardization of a Multiplex-PCR targeted towards two exons of the RHD and one SRY gene to monitor RhD negative women. The current study addresses questions concerning feasibility and applicability of this approach into the clinical practice.Materials and methods: Both single and multiplex real-time PCRs targeting RHD exons 5 and 7 and SRY were applied for the detection of fetal-specific RHD sequences and sex in maternal plasma. A large cohort of 2127 women was studied between 10 and 28. weeks of pregnancy. 134 of them were used for single TaqMan PCR studies and 1993 were evaluated using Multiplex TaqMan PCR studies. All of them were serologically typed as RhD negative according to Spanish guidelines. Single and multiplex real-time PCR results were compared with postnatal serology and sex identification.Results: There was a 100% concordance between results obtained with single and multiplex real-time PCR assays. At present, 1012 of the 1993 pregnant women studied gave birth and the results of RHD status obtained with the multiplex TaqMan PCR assay were confirmed postpartum by serological methods showing that sensitivity, specificity, and accuracy of the multiplex assay were 100, 98.6, and 99.3%, respectively. This procedure improved the speed of the assay, avoided over-treatment among RhD negative pregnant women bearing RhD negative fetus, and reduced the requirements for clinical and biological monitoring, resulting in a clinical benefit and cost saving.Conclusions: The routine determination of fetal RHD status and SRY in maternal plasma, using multiplex real-time PCR, is feasible. The use of multiplex real-time PCR allows improving the response of the laboratory, saving time and reagent costs, opening the door to a complete automatization of the process. © 2011 Elsevier B.V.This work was supported by grants from the Instituto de Salud Carlos III (Red RETICEF RD06/00130001 and Evaluación de Tecnologías Sanitarias, P107/90175).Peer Reviewe

Volatile composition of Carignan noir wines from ungrafted and grafted onto País (Vitis vinifera L.) grapevines from ten wine-growing sites in Maule Valley, Chile

[Background] Carignan noir is one of the minor and ancient varieties from the Chilean wine scenario that has had a resurgence as a result of to its rediscovered oenological potential when cultivated under the conditions of the interior dryland area. Under these growing conditions Carignan noir wines stand out as fruit driven and fresh compared to those originating from other growing areas. On the other hand, it is well known that wine aroma composition depends mainly on variety, viticultural management and winemaking. Thus, the present study aimed to investigate the volatile composition of wines from Carignan noir grapes originating from ungrafted and grafted onto País grapevines, in ten sites of the Maule Valley (Chile) during two consecutive vintages. [Results] Higher alcohols were the most abundant volatile compounds, whereas ethyl esters and ß‐damascenone were the most odoriferous compounds according to their odorant activity value. The dominant factor in Carignan noir wine volatile composition was season, whereas rootstock did not have a significant effect in differentiating the wines. In terms of climate, cold nights during the month prior to harvest correlated with higher linalool, α‐terpineol and trans‐3‐hexen‐1‐ol content. The biologically effective degree‐days index was inversely correlated with isoamyl acetate and 2‐phenylethyl acetate content. Huglin's heliothermal and the average mean temperature of the warmest month indices were inversely correlated with ethyl vanillate, ethyl hexanoate and ethyl octanoate content. [Conclusion] Site climate conditions were related to the accumulation of certain wine volatile compounds. This information may be useful for devising new Carignan noir vineyard management strategies when aiming to improve wine quality or adjust site selection approaches to maximize grape/wine volatile composition according to wine style.This work was funded by FIC BIP 30.345.677‐0 Gobierno Regional del Maule‐Chile, Vigno (Vignadores de Carignan), Wines of Chile, Viña Casas Patronales, Cooperativa Loncomilla and INIA‐Gobierno de La Rioja. GG‐G is grateful for the financial support given by CONICYT, BCH/Doctorado‐72170532. TG‐C and EPP‐Á thank MINECO for their contracts.Peer reviewe