We evaluated the effects of repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of phantom limb pain (PLP) in landmine victims. Fifty-four patients with PLP were enrolled in a randomized, double-blinded placebo-controlled parallel group, single center trial. The intervention consisted in real or sham rTMS of M1 contralateral to the amputated leg. RTMS was given in series of 20 trains of 6s of duration (54 s inter-train, intensity 90% of Motor Threshold) at a stimulation rate of 10 Hz (1200 pulses), 20 minutes per day, during 10 days. For the control group, a sham coil was used. The administration of active rTMS induced a significantly greater reduction in pain intensity (Visual Analogue Scale scores) fifteen days after treatment when compared to sham stimulation (−53.38±53.12% vs −22.93±57.16%; mean between-group difference=30.44%, 95%CI 0.30, 60.58; p=0.03). This effect was not significant 30 days after treatment. In addition, 70.3% (19) of subjects attained a clinically significant pain reduction (>30%) in the active group compared to 40.7% (11) in the sham group fifteen days after treatment (p=0.03). The administration of 10 Hz rTMS on the contralateral primary motor cortex for 2 weeks in traumatic amputees with PLP induces significant clinical improvement in pain. Trial registry www.clinicaltrials.gov: Code Number: NCT01872481 Perspective High frequency rTMS on the contralateral primary motor cortex of traumatic amputees induces a clinically significant pain reduction up to 15 days after treatment without any major secondary effect. These results indicate that rTMS is a safe and effective therapy in patients with phantom limb pain caused by landmine explosions.
Background Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality worldwide, with a prevalence of approximately 100 million patients. There is evidence that antiplatelet agents and antihypertensive medications could reduce the risk of new vascular events in this population; however, treatment adherence is very low. An SMS text messaging intervention was recently developed based on behavior change techniques to increase adherence to pharmacological treatment among patients with a history of ASCVD. Objective This study aims to evaluate the efficacy and safety of an SMS text messaging intervention to improve adherence to cardiovascular medications in patients with ASCVD. Methods A randomized controlled clinical trial for patients with a prior diagnosis of cardiovascular events, such as acute myocardial infarction, unstable angina, cerebrovascular disease, or peripheral artery disease, in one center in Colombia was conducted. Patients randomized to the intervention arm were assigned to receive SMS text messages daily for the first 4 weeks, 5 SMS text messages on week 5, 3 SMS text messages each in weeks 6 and 7, and 1 SMS text message weekly from week 8 until week 52. In contrast, patients in the control arm received a monthly SMS text message reminding them of the next study appointment and the importance of the study, requesting information about changes in their phone number, and thanking them for participating in the study. The primary endpoint was the change in low-density lipoprotein cholesterol (LDL-C) levels, whereas the secondary endpoints were the changes in thromboxane B2 levels, heart rate, systolic and diastolic blood pressure, medication adherence, cardiac and noncardiac mortality, and hospitalization. Linear regression analyses and bivariate tests were performed. Results Of the 930 randomized patients, 805 (86.5%) completed follow-up and were analyzed for the primary endpoint. There was no evidence that the intervention changed the primary outcome (LDL-C levels; P=.41) or any of the secondary outcomes evaluated (all P>.05). There was also no evidence that the intervention was associated with adverse events. Conclusions In this study, there was no evidence that a behavior modification intervention delivered by SMS text messaging improved LDL-C levels, blood pressure levels, or adherence at 12 months. More research is needed to evaluate whether different SMS text messaging strategies, including personalized messages and different timings, are effective; future studies should include mixed methods to better understand why, for whom, and in which context (eg, health system or social environment) SMS text messaging interventions work (or not) to improve adherence in patients with ASCVD. Trial Registration ClinicalTrials.gov NCT03098186; https://clinicaltrials.gov/ct2/show/NCT03098186 International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2018-028017
INTRODUCCIÓN: Los nuevos anticoagulantes orales son el más reciente avance en anticoagulación oral. Existen suficientes estudios publicados, pero muy poca síntesis de la información. MÉTODOS: Se realizó una búsqueda sistemática de los estudios en Medline, Cochrane y Embase con los términos predefinidos. Se aplicaron los criterios de inclusión y exclusión definidos, se definieron las variables utilizadas en este estudio según el beneficio (reducción de la mortalidad y reducción del ACV) y el riesgo en la anticoagulación (sangrado intracraneal, sangrado gastrointestinal, sangrado mayor y otros sangrados). Se seleccionaron los artículos y se extrajo la información en una hoja de cálculo para análisis. RESULTADOS: Se incluyeron 24 meta-análisis y 62 subanálisis; 77 % de los meta-análisis mostraron reducción de ACV, 65 % mortalidad, 71 % reportó disminución de hemorragia intracraneal y 45 % de sangrado mayor, pero hubo aumento de sangrado gastrointestinal en el 5 4% de los estudios. En relación a los resultados de los subanálisis, 4 estudios mostraron algún dato estadísticamente significativo para apixabán, 5 para dabigatrán, 3 para edoxabán y 5 estudios para rivaroxabán. Existen diferencias en algunas variables como sexo, riesgo de ACV, resultados a 30 días, función renal; diferentes dosis (dabigatrán y edoxabán), según la edad, síntomas gastrointestinales, relación con el INR; niveles séricos del medicamento, uso de amiodarona, uso previo de warfarina; enfermedad arterial periférica, transición a warfarina; factores de riesgo de HGI y sangrado mayor para cada anticoagulante en particular. CONCLUSIONES: Los nuevos anticoagulantes orales muestran mejor perfil de seguridad y de eficacia frente a warfarina.
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