Browsing articles by "Ángel León Valenzuela"
may
30
2013

Efectos secundarios de los AINES: Meta-análisis

Thrills, Spills and PillsSe ha publicado un meta-análisis en The Lancet con 280 ensayos de AINE versus placebo (124 513 pacientes) y 474 ensayos de un AINE versus otro AINE (229 296 pacientes) analizando los efectos secundarios de los AINES.
Como podéis ver el estudio es muy amplio y los resultados concuerdan con lo conocido en la práctica clínica habitual.

Me parece una muestra del porqué es fundamental una prescripción responsable y basada en la formación adecuada y en la actualización continua.
En unos momentos en los que el debate sobre la prescripción por no facultativos está en su máximo auge, creo que es un ejemplo que invita a la reflexión. Los AINES no coxibs son de prescripción y acceso libre en la farmacia y como podemos ver presentan unos riesgos similares a los coxibs. Tal vez se debería limitar la dosis accesible fuera de prescripción médica para evitar complicaciones mayores (tanto en dosis como en número de comprimidos), siempre me ha parecido una aberración que se puedan comprar libremente cajas de fármacos (p.ej AINES o paracetamol) que superan con creces la dosis de toxicidad, ¿tan dificil es ajustar la oferta?
Por otro lado se debería estudiar la posibilidad de implementar algún sistema de alerta en casos en los que los antecedentes personales o tratamientos añadidos puedan suponer un aumento del riesgo, sobre todo si la historia clínica completa no está accesible en el momento de la recomendación de tratamiento.
Volviendo al artículo, os dejo un resumen de los puntos clave y más abajo el abstract completo:

  • El riesgo de eventos vasculares importantes (sobre todo coronarios) se incrementó en un tercio de las personas que toman coxibs o diclofenaco a dosis altas.
  • El ibuprofeno aumenta significativamente el riesgo de eventos coronarios mayores, pero no los eventos vasculares.
  • En comparación con otros AINEs tradicionales (no coxibs), el naproxeno a dosis altas no se asoció con un mayor riesgo de eventos mayores vasculares o coronarios .
  • Todos los AINE se asociaron con un aumento en el riesgo de hospitalización por insuficiencia cardíaca y complicaciones gastrointestinales.
  • El aumento en la tasa de complicaciones GI era más bajo para los coxibs.

Interpretación de los autores:
Los riesgos vasculares del tratamiento con diclofenaco (y posiblemente, con el ibuprofeno) a dosis altas, son comparables con los de los coxibs, mientras que el naproxeno se asocia con un menor riesgo vascular que otros AINE. Aunque los AINE aumentan los riesgos vasculares y gastrointestinales, el tamaño de estos riesgos se puede predecir, lo que podría ayudar a guiar la toma de decisiones clínicas.

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Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials

Coxib and traditional NSAID Trialists’ (CNT) Collaboration†
Summary

Background
The vascular and gastrointestinal effects of non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors (coxibs) and traditional non-steroidal anti-inflammatory drugs (tNSAIDs), are not well characterised, particularly in patients at increased risk of vascular disease. We aimed to provide such information through meta-analyses of randomised trials.
Methods
We undertook meta-analyses of 280 trials of NSAIDs versus placebo (124 513 participants, 68 342 person-years) and 474 trials of one NSAID versus another NSAID (229 296 participants, 165 456 person-years). The main outcomes were major vascular events (non-fatal myocardial infarction, non-fatal stroke, or vascular death); major coronary events (non-fatal myocardial infarction or coronary death); stroke; mortality; heart failure; and upper gastrointestinal complications (perforation, obstruction, or bleed).
Findings
Major vascular events were increased by about a third by a coxib (rate ratio [RR] 1·37, 95% CI 1·14—1·66; p=0·0009) or diclofenac (1·41, 1·12—1·78; p=0·0036), chiefly due to an increase in major coronary events (coxibs 1·76, 1·31—2·37; p=0·0001; diclofenac 1·70, 1·19—2·41; p=0·0032). Ibuprofen also significantly increased major coronary events (2·22, 1·10—4·48; p=0·0253), but not major vascular events (1·44, 0·89—2·33). Compared with placebo, of 1000 patients allocated to a coxib or diclofenac for a year, three more had major vascular events, one of which was fatal. Naproxen did not significantly increase major vascular events (0·93, 0·69—1·27). Vascular death was increased significantly by coxibs (1·58, 99% CI 1·00—2·49; p=0·0103) and diclofenac (1·65, 0·95—2·85, p=0·0187), non-significantly by ibuprofen (1·90, 0·56—6·41; p=0·17), but not by naproxen (1·08, 0·48—2·47, p=0·80). The proportional effects on major vascular events were independent of baseline characteristics, including vascular risk. Heart failure risk was roughly doubled by all NSAIDs. All NSAID regimens increased upper gastrointestinal complications (coxibs 1·81, 1·17—2·81, p=0·0070; diclofenac 1·89, 1·16—3·09, p=0·0106; ibuprofen 3·97, 2·22—7·10, p<0·0001; and naproxen 4·22, 2·71—6·56, p<0·0001).
Interpretation
The vascular risks of high-dose diclofenac, and possibly ibuprofen, are comparable to coxibs, whereas high-dose naproxen is associated with less vascular risk than other NSAIDs. Although NSAIDs increase vascular and gastrointestinal risks, the size of these risks can be predicted, which could help guide clinical decision making.

may
26
2013

Gestión de la fatiga en Esclerosis Múltiple y Terapia conductual en Afasia

1) Terapia de “gestión de la fatiga” en Esclerosis Múltiple: Revisión sistemática A corto plazo, la terapia de “gestión de la fatiga” puede ser más eficaz que la no intervención en la reducción del impacto de la fatiga y en la mejora de 3 escalas de calidad de vida (rol físico, función social y salud mental) en pacientes fatigados con EM. Se necesitan más ECA que también estudian los resultados a largo plazo.

Hecho en falta un seguimiento a largo plazo para ver las consecuencias de la terapia y comparación con otras medidas farmacológicas y no farmacológicas.

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Arch Phys Med Rehabil. 2013 Feb 8. pii: S0003-9993(13)00112-3. doi: 10.1016/j.apmr.2013.01.025. [Epub ahead of print]
Effectiveness of Energy Conservation Treatment in Reducing Fatigue in Multiple Sclerosis: A Systematic Review and Meta-Analysis.
Blikman LJ, Huisstede BM, Kooijmans H, Stam HJ, Bussmann JB, van Meeteren J.
Source
Department of Rehabilitation Medicine and Physical Therapy, Erasmus MC University Medical Center, Rotterdam, The Netherlands. Electronic address: l.blikman@erasmusmc.nl.
Abstract
OBJECTIVES:
To systematically review the effects of energy conservation management (ECM) treatment for fatigue in multiple sclerosis (MS), and to study the effect of ECM treatment on restrictions in participation and quality of life (QoL).
DATA SOURCES:
PubMed, CINAHL, Embase, and Web of Knowledge were searched to identify relevant randomized controlled trials (RCTs) and controlled clinical trials.
STUDY SELECTION:
To select potential studies, 2 reviewers independently applied the inclusion criteria.
DATA EXTRACTION:
Two reviewers independently extracted data and assessed the methodologic quality of the studies included. If meta-analysis was not possible, qualitative best-evidence synthesis was used to summarize the results.
DATA SYNTHESIS:
The searches identified 532 studies, 6 of which were included. The studies compared the short-term effects of ECM treatment and control treatment on fatigue and QoL; 1 study reported short-term and midterm effects on participation, but found no evidence for effectiveness. Meta-analyses (2 RCTs, N=350) showed that ECM treatment was more effective than no treatment in improving subscale scores of the (1) Fatigue Impact Scale: cognitive (mean difference [MD]=-2.91; 95% confidence interval [CI], -4.32 to -1.50), physical (MD=-2.99; 95% CI, -4.47 to -1.52), and psychosocial (MD=-6.05; 95% CI, -8.72 to -3.37); and (2) QoL: role physical (MD=17.26; 95% CI, 9.69-24.84), social function (MD=6.91; 95% CI, 1.32-12.49), and mental health (MD=5.55; 95% CI, 2.27-8.83). Limited or no evidence was found for the effectiveness of ECM treatment on the other outcomes in the short-term or midterm. None of the studies reported long-term results.
CONCLUSIONS:
The systematic review results provide evidence that in the short-term, ECM treatment can be more effective than no treatment (waiting controls) in reducing the impact of fatigue and in improving 3 QoL scales-role physical, social function, and mental health-in fatigued patients with MS. More RCTs that also study long-term results are needed.

 

Afasia

2) Una de los problemas añadidos en el trabajo con pacientes con afasia tras un ictus es la alteración de la esfera emocional. La identificación y el tratamiento precoz de los trastornos depresivos es fundamental en el ictus, ahondando en el tema se ha publicado un ECA que concluye que la terapia conductual puede mejorar el estado de animo de los pacientes con afasia.

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Clin Rehabil. 2013 May;27(5):398-408. doi: 10.1177/0269215512462227. Epub 2012 Oct 11.
Communication and Low Mood (CALM): a randomized controlled trial of behavioural therapy for stroke patients with aphasia.
Thomas SA, Walker MF, Macniven JA, Haworth H, Lincoln NB.
Source
1University of Nottingham, Nottingham, UK.
Abstract
Objective: The aim was to evaluate behavioural therapy as a treatment for low mood in people with aphasia. Design: A randomized controlled trial comparing behavioural therapy plus usual care with a usual care control. Potential participants with aphasia after stroke were screened for the presence of low mood. Those who met the criteria and gave consent were randomly allocated. Setting: Participants were recruited from hospital wards, community rehabilitation, speech and language therapy services and stroke groups. Subjects: Of 511 people with aphasia identified, 105 had low mood and were recruited. Interventions: Behavioural therapy was offered for up to three months. Outcomes were assessed three and six months after random allocation. Main measures: Stroke Aphasic Depression Questionnaire, Visual Analog Mood Scales ‘sad’ item, and Visual Analogue Self-Esteem Scale. Results: Participants were aged 29 to 94 years (mean 67.0, SD 13.5) and 66 (63%) were men. Regression analysis showed that at three months, when baseline values and communication impairment were controlled for, group allocation was a significant predictor of the Stroke Aphasic Depression Questionnaire (P < 0.05), visual analogue ‘sad’ (P = 0.03), and Visual Analogue Self-Esteem Scale (P < 0.01). At six months, group alone was a significant predictor of the Stroke Aphasic Depression Questionnaire (P < 0.05), and remained significant when baseline values were controlled for (P = 0.02). Mean Stroke Aphasic Depression Questionnaire 10-item hospital version scores decreased from baseline to six months by six points in the intervention group as compared with an increase of 1.9 points in the control group. Conclusions: Behavioural therapy seemed to improve the mood of people with aphasia.

may
12
2013

Manejo no farmacológico la espasticidad en la Esclerosis Múltiple y Neuroestimulación en Parkinson

En ésta entrada de domingo os dejo dos artículos relacionados con la Neurorrehabilitación.  Simplemente os dejo un pequeño comentario y a continuación podéis os he añadido directamente el abstract y la referencia del artículo.

1) Se ha publicado una actualización de la Cochrane sobre las intervenciones no farmacológicas en la espasticidad en pacientes con Esclerosis Múltiple. Se han encontrado pruebas de baja calidad a favor de la terapia física en conjunción con otras intervenciones (p.ej toxina botulínica) y a favor de la estimulación magnética y terapia electromagnética.

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Amatya B, Khan F, La Mantia L, Demetrios M, Wade DT.
Non pharmacological interventions for spasticity in multiple sclerosis.
Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD009974. DOI: 10.1002/14651858.CD009974.pub2.BackgroundSpasticity is commonly experienced by people with multiple sclerosis (MS), and it contributes to overall disability in this population. A wide range of non pharmacological interventions are used in isolation or with pharmacological agents to treat spasticity in MS. Evidence for their effectiveness is yet to be determined.

Objectives

To assess the effectiveness of various non pharmacological interventions for the treatment of spasticity in adults with MS.

Search methods

A literature search was performed using the Specialised Register of the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Review Group on using the Cochrane MS Group Trials Register which among other sources, contains CENTRAL, Medline, EMBASE, CINAHL, LILACS, PEDRO in June 2012. Manual searching in the relevant journals and screening of the reference lists of identified studies and reviews were carried out. Abstracts published in proceedings of conferences were also scrutinised.

Selection criteria

Randomised controlled trials (RCTs) that reported non pharmacological intervention/s for treatment of spasticity in adults with MS and compared them with some form of control intervention (such as sham/placebo interventions or lower level or different types of intervention, minimal intervention, waiting list controls or no treatment; interventions given in different settings), were included.

Data collection and analysis

Three review authors independently selected the studies, extracted data and assessed the methodological quality of the studies using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) tool for best-evidence synthesis. A meta-analysis was not possible due to methodological, clinical and statistical heterogeneity of included studies.

Main results

Nine RCTs (N = 341 participants, 301 included in analyses) investigated various types and intensities of non pharmacological interventions for treating spasticity in adults with MS. These interventions included: physical activity programmes (such as physiotherapy, structured exercise programme, sports climbing); transcranial magnetic stimulation (Intermittent Theta Burst Stimulation (iTBS), Repetitive Transcranial Magnetic Stimulation (rTMS)); electromagnetic therapy (pulsed electromagnetic therapy; magnetic pulsing device), Transcutaneous Electrical Nerve Stimulation (TENS); and Whole Body Vibration (WBV). All studies scored ‘low’ on the methodological quality assessment implying high risk of bias.

There is ‘low level’ evidence for physical activity programmes used in isolation or in combination with other interventions (pharmacological or non pharmacological), and for repetitive magnetic stimulation (iTBS/rTMS) with or without adjuvant exercise therapy in improving spasticity in adults with MS. No evidence of benefit exists to support the use of TENS, sports climbing and vibration therapy for treating spasticity in this population.

Authors’ conclusions

There is ‘low level’ evidence for non pharmacological interventions such as physical activities given in conjunction with other interventions, and for magnetic stimulation and electromagnetic therapies for beneficial effects on spasticity outcomes in people with MS. A wide range of non pharmacological interventions are used for the treatment of spasticity in MS, but more robust trials are needed to build evidence about these interventions.

Neuroestimulación en Parkinson
2)
La Neuroestimulación subtalácmica en Pacientes con Parkinson y alteraciones motoras precoces fue superior al tratamiento médico con respecto a la discapacidad motora, actividades de la vida diaria, las complicaciones inducidas por levodopa, y el tiempo con buena movilidad y sin discinesia.

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Neurostimulation for Parkinson’s Disease with Early Motor Complications
W.M.M. Schuepbach, J. Rau, K. Knudsen, J. Volkmann, P. Krack, L. Timmermann, T.D. Hälbig, H. Hesekamp, S.M. Navarro, N. Meier, D. Falk, M. Mehdorn, S. Paschen, M. Maarouf, M.T. Barbe, G.R. Fink, A. Kupsch, D. Gruber, G.-H. Schneider, E. Seigneuret, A. Kistner, P. Chaynes, F. Ory-Magne, C. Brefel Courbon, J. Vesper, A. Schnitzler, L. Wojtecki, J.-L. Houeto, B. Bataille, D. Maltête, P. Damier, S. Raoul, F. Sixel-Doering, D. Hellwig, A. Gharabaghi, R. Krüger, M.O. Pinsker, F. Amtage, J.-M. Régis, T. Witjas, S. Thobois, P. Mertens, M. Kloss, A. Hartmann, W.H. Oertel, B. Post, H. Speelman, Y. Agid, C. Schade-Brittinger, and G. Deuschl for the EARLYSTIM Study Group
N Engl J Med 2013; 368:610-622February 14, 2013DOI: 10.1056/NEJMoa1205158

BACKGROUND
Subthalamic stimulation reduces motor disability and improves quality of life in patients with advanced Parkinson’s disease who have severe levodopa-induced motor complications. We hypothesized that neurostimulation would be beneficial at an earlier stage of Parkinson’s disease.

METHODS
In this 2-year trial, we randomly assigned 251 patients with Parkinson’s disease and early motor complications (mean age, 52 years; mean duration of disease, 7.5 years) to undergo neurostimulation plus medical therapy or medical therapy alone. The primary end point was quality of life, as assessed with the use of the Parkinson’s Disease Questionnaire (PDQ-39) summary index (with scores ranging from 0 to 100 and higher scores indicating worse function). Major secondary outcomes included parkinsonian motor disability, activities of daily living, levodopa-induced motor complications (as assessed with the use of the Unified Parkinson’s Disease Rating Scale, parts III, II, and IV, respectively), and time with good mobility and no dyskinesia.

RESULTS
For the primary outcome of quality of life, the mean score for the neurostimulation group improved by 7.8 points, and that for the medical-therapy group worsened by 0.2 points (between-group difference in mean change from baseline to 2 years, 8.0 points; P=0.002). Neurostimulation was superior to medical therapy with respect to motor disability (P<0.001), activities of daily living (P<0.001), levodopa-induced motor complications (P<0.001), and time with good mobility and no dyskinesia (P=0.01). Serious adverse events occurred in 54.8% of the patients in the neurostimulation group and in 44.1% of those in the medical-therapy group. Serious adverse events related to surgical implantation or the neurostimulation device occurred in 17.7% of patients. An expert panel confirmed that medical therapy was consistent with practice guidelines for 96.8% of the patients in the neurostimulation group and for 94.5% of those in the medical-therapy group.

CONCLUSIONS
Subthalamic stimulation was superior to medical therapy in patients with Parkinson’s disease and early motor complications. (Funded by the German Ministry of Research and others; EARLYSTIM ClinicalTrials.gov number, NCT00354133.)

may
1
2013

¿Qué tratamientos son eficaces para el tratamiento del síndrome de dolor regional complejo en los adultos?

Síndrome de dolor regional complejoSe ha publicado una revisión de la Cochrane sobre la evidencia actual de distintas intervenciones terapéuticas en el Síndrome de dolor regional complejo.
Se basa en 6 revisiones Cochrane y 13 no Cochrane que incluyeron una amplia gama de tratamientos (fármacos, Rehabilitación, Cirugía, terapias alternativas…) en la mayoría de los casos, los artículos se basaban en estudios de baja calidad.
En forma de resumen:

  • El uso ketamina iv puede reducir eficazmente el dolor, aunque también se asocia con una aumento de efectos secundarios.
  • Bifosfonatos, la calcitonina y los programas imaginería motora graduada pueden ser eficaces en el SDRC (en general), y que la terapia del espejo puede ser eficaz en SDRC tras ictus. (baja calidad)
  • La fisioterapia y la terapia ocupacional no dieron lugar a beneficios clínicamente importantes en el seguimiento a un año. (baja calidad)
  • El bloqueo de los nervios simpáticos con anestesia local, no es eficaz. (baja calidad)
  • Hay pruebas de calidad moderada de que el bloqueo regional intravenoso con guanetidina no es eficaz y puede estar asociada con complicaciones.

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Background:
There is currently no strong consensus regarding the optimal management of complex regional pain syndrome although a multitude of interventions have been described and are commonly used.

Objectives:
To summarise the evidence from Cochrane and non-Cochrane systematic reviews of the effectiveness of any therapeutic intervention used to reduce pain, disability or both in adults with complex regional pain syndrome (CRPS).

Main results:
We included six Cochrane reviews and 13 non-Cochrane systematic reviews. Cochrane reviews demonstrated better methodological quality than non-Cochrane reviews. Trials were typically small and the quality variable.

There is moderate quality evidence that intravenous regional blockade with guanethidine is not effective in CRPS and that the procedure appears to be associated with the risk of significant adverse events.

There is low quality evidence that bisphosphonates, calcitonin or a daily course of intravenous ketamine may be effective for pain when compared with placebo; graded motor imagery may be effective for pain and function when compared with usual care; and that mirror therapy may be effective for pain in post-stroke CRPS compared with a ‘covered mirror’ control. This evidence should be interpreted with caution. There is low quality evidence that local anaesthetic sympathetic blockade is not effective. Low quality evidence suggests that physiotherapy or occupational therapy are associated with small positive effects that are unlikely to be clinically important at one year follow up when compared with a social work passive attention control.

For a wide range of other interventions, there is either no evidence or very low quality evidence available from which no conclusions should be drawn.

Authors’ conclusions:
There is a critical lack of high quality evidence for the effectiveness of most therapies for CRPS. Until further larger trials are undertaken, formulating an evidence-based approach to managing CRPS will remain difficult.

This record should be cited as: O’Connell NE, Wand BM, McAuley J, Marston L, Moseley GL. Interventions for treating pain and disability in adults with complex regional pain syndrome. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD009416. DOI: 10.1002/14651858.CD009416.pub2
Assessed as up to date: March 1, 2013

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