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1.
Arch Phys Med Rehabil ; 99(3): 574-583.e1, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-28803906

RESUMEN

OBJECTIVE: To assess the efficacy of viscosupplementation (hyaluronic acid [HA]) on the pain and disability caused by hip osteoarthritis, and to determine the occurrence of adverse events. DATA SOURCES: PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov database, and specific journals up to March 2017. STUDY SELECTION: Randomized controlled trials (RCTs) comparing HA with any other intra-articular injection. DATA EXTRACTION: Performed according to Cochrane/Grades of Recommendation, Assessment, Development, and Evaluation criteria. Two authors extracted data and assessed the risk of bias and quality of evidence. A random-effects meta-analysis was conducted. DATA SYNTHESIS: Eight RCTs were retrieved (n=807): 4 comparing HA to placebo; 3 to platelet-rich plasma (PRP); 3 to methylprednisolone; and 1 to mepivacaine. Some RCTs had 3 arms. There is very low evidence that HA is not superior to placebo for pain at 3 months (standardized mean difference [SMD]=-.06; 95% CI, -.38 to .25; P=.69), and high evidence that it is not superior in adverse events (risk ratio [RR]=1.21; 95% CI, .79-1.86; P=.38). There is low evidence that HA is not superior to PRP for pain at 1 month. There is very low evidence that HA is not superior to PRP for pain at 6 and 12 months (mean difference in visual analog scale [in cm]: -.05 [95% CI, -.81 to .71], 1.0 [95% CI, -1.5 to 3.50], and .81 [95% CI, -1.11 to 2.73], respectively). There is high evidence that HA is no different from methylprednisolone for pain at 1 month (SMD=.02; 95% CI, -.18 to .22; P=.85). There is low evidence that HA is no different from methylprednisolone for Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International Responders Index at 1 month (RR=.44; 95% CI, .10-1.95; P=.28). There is high evidence that HA is no different from methylprednisolone for adverse events (RR=1.21; 95% CI, .79-1.87; P=.38). CONCLUSIONS: We do not recommend viscosupplementation for hip osteoarthritis. Compared with placebo, data show scarce evidence of its efficacy up to 3 months, and suggest no difference at 6 months. However, future RCTs could present HA as an alternative to methylprednisolone for short-term symptom relief.


Asunto(s)
Artralgia/tratamiento farmacológico , Evaluación de la Discapacidad , Osteoartritis de la Cadera/tratamiento farmacológico , Viscosuplementación/estadística & datos numéricos , Adulto , Anciano , Artralgia/etiología , Femenino , Humanos , Ácido Hialurónico/administración & dosificación , Masculino , Mepivacaína/administración & dosificación , Metilprednisolona/administración & dosificación , Persona de Mediana Edad , Osteoartritis de la Cadera/complicaciones , Osteoartritis de la Cadera/fisiopatología , Dimensión del Dolor , Plasma Rico en Plaquetas , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Viscosuplementación/métodos , Viscosuplementos/administración & dosificación , Adulto Joven
2.
J Bras Pneumol ; 43(4): 302-312, 2017.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-28767773

RESUMEN

OBJECTIVE: To determine whether long-acting muscarinic antagonists (LAMAs) provide superior therapeutic effects over long-acting ß2 agonists (LABAs) for preventing COPD exacerbations. METHODS: This was a systematic review and meta-analysis of randomized clinical trials involving patients with stable, moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria, treated with a LAMA (i.e., tiotropium bromide, aclidinium, or glycopyrronium), followed for at least 12 weeks and compared with controls using a LABA in isolation or in combination with a corticosteroid. RESULTS: A total of 2,622 studies were analyzed for possible inclusion on the basis of their title and abstract; 9 studies (17,120 participants) were included in the analysis. In comparison with LABAs, LAMAs led to a greater decrease in the exacerbation rate ratio (relative risk [RR] = 0.88; 95% CI: 0.84-0.93]; a lower proportion of patients who experienced at least one exacerbation (RR = 0.90; 95% CI: 0.87-0.94; p < 0.00001); a lower risk of exacerbation-related hospitalizations (RR = 0.78; 95% CI: 0.69-0.87; p < 0.0001); and a lower number of serious adverse events (RR = 0.81; 95% CI: 0.67-0.96; p = 0.0002). The overall quality of evidence was moderate for all outcomes. CONCLUSIONS: The major findings of this systematic review and meta-analysis were that LAMAs significantly reduced the exacerbation rate (exacerbation episodes/year), as well as the number of exacerbation episodes, of hospitalizations, and of serious adverse events.


Asunto(s)
Agonistas de Receptores Adrenérgicos beta 2/uso terapéutico , Antagonistas Muscarínicos/uso terapéutico , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Humanos , Factores de Tiempo
3.
J. bras. pneumol ; 43(4): 302-312, July-Aug. 2017. tab, graf
Artículo en Inglés | LILACS | ID: biblio-893842

RESUMEN

ABSTRACT Objective: To determine whether long-acting muscarinic antagonists (LAMAs) provide superior therapeutic effects over long-acting β2 agonists (LABAs) for preventing COPD exacerbations. Methods: This was a systematic review and meta-analysis of randomized clinical trials involving patients with stable, moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria, treated with a LAMA (i.e., tiotropium bromide, aclidinium, or glycopyrronium), followed for at least 12 weeks and compared with controls using a LABA in isolation or in combination with a corticosteroid. Results: A total of 2,622 studies were analyzed for possible inclusion on the basis of their title and abstract; 9 studies (17,120 participants) were included in the analysis. In comparison with LABAs, LAMAs led to a greater decrease in the exacerbation rate ratio (relative risk [RR] = 0.88; 95% CI: 0.84-0.93]; a lower proportion of patients who experienced at least one exacerbation (RR = 0.90; 95% CI: 0.87-0.94; p < 0.00001); a lower risk of exacerbation-related hospitalizations (RR = 0.78; 95% CI: 0.69-0.87; p < 0.0001); and a lower number of serious adverse events (RR = 0.81; 95% CI: 0.67-0.96; p = 0.0002). The overall quality of evidence was moderate for all outcomes. Conclusions: The major findings of this systematic review and meta-analysis were that LAMAs significantly reduced the exacerbation rate (exacerbation episodes/year), as well as the number of exacerbation episodes, of hospitalizations, and of serious adverse events.


RESUMO Objetivo: Determinar se long-acting muscarinic antagonists (LAMAs, antagonistas muscarínicos de longa duração) são superiores a long-acting β2 agonists (LABAs, β2-agonistas de longa duração) na prevenção de exacerbações da DPOC. Métodos: Revisão sistemática e meta-análise de ensaios clínicos controlados aleatórios com pacientes com DPOC estável, de moderada a grave, conforme os critérios da Global Initiative for Chronic Obstructive Lung Disease, tratados com LAMA (brometo de tiotrópio, aclidínio ou glicopirrônio), acompanhados durante pelo menos 12 semanas e comparados a controles que usaram LABA isoladamente ou com um corticosteroide. Resultados: Foram analisados 2.622 estudos para possível inclusão com base em seu título e resumo; 9 estudos (17.120 participantes) foram incluídos na análise. Em comparação com LABAs, LAMAs resultaram em maior diminuição da razão da taxa de exacerbações [risco relativo (RR) = 0,88; IC95%: 0,84-0,93]; menor proporção de pacientes que apresentaram pelo menos uma exacerbação (RR = 0,90; IC95%: 0,87-0,94; p < 0,00001); menor risco de hospitalizações em virtude de exacerbação da doença (RR = 0,78; IC95%: 0,69-0,87; p < 0,0001) e menor número de eventos adversos sérios (RR = 0,81; IC95%: 0,67-0,96; p = 0,0002). A qualidade geral das evidências foi moderada para todos os desfechos. Conclusões: O principal achado desta revisão sistemática e meta-análise foi que LAMAs reduziram significativamente a taxa de exacerbações (episódios de exacerbação/ano), os episódios de exacerbação, as hospitalizações e os eventos adversos sérios.


Asunto(s)
Humanos , Antagonistas Muscarínicos/uso terapéutico , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Agonistas de Receptores Adrenérgicos beta 2/uso terapéutico , Factores de Tiempo
4.
Pain Physician ; 18(3): 277-86, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26000671

RESUMEN

BACKGROUND: Transforaminal epidural steroid injections (TFESI) are widely used for the conservative treatment of radicular pain. The use of dexamethasone in TFESIs is relatively new; therefore, immediate and acute adverse effects that it may cause are not fully updated. OBJECTIVE: To evaluate immediate and acute adverse effects following TFESI with dexamethasone. STUDY DESIGN: Prospective, observational study. SETTING: A spine center affiliated with a rehabilitation hospital. METHODS: One hundred fifty consecutive patients receiving TFESI for the management of radicular and axial spinal pain at the cervical, lumbar, and sacral levels with dexamethasone using fluoroscopic guidance with digital subtraction technology were enrolled. The occurrence of adverse effects in patients in the 2-week time period following interventions was monitored through a set of questionnaires followed up by phone calls scheduled for 1 day, day 3, and day 14. Intensity and duration of side effects were recorded. RESULTS: Of the 150 patients enrolled, 31 patients (19.5%) experienced adverse effects within the first 30 minutes following the intervention. The most common adverse effects were numbness and tingling in the limb, which developed in 19 patients (11.95%) followed by perineal pruritus that occurred in 7 cases (4.4%). Patients also reported experiencing adverse effects within the 3 days following intervention; most complained of headaches, insomnia, hiccups, flushing, and increased radicular pain. No major complications were noted. LIMITATIONS: The sample size enrolled might be too small to perceive possible rare side effects related to the procedure. The 2-week follow-up period is a limitation for evaluating late side effects. CONCLUSIONS: This study offers provision to interventionalists that TFESI with dexamethasone when performed by experienced hands and with proper technique has minor self-limited transient adverse effects that can be easily managed. Patients should be made aware of these adverse effects and their management. Further larger studies are needed to validate the safe use of dexamethasone and the safety of transforaminal epidural injections.


Asunto(s)
Analgesia Epidural/métodos , Antiinflamatorios/efectos adversos , Antiinflamatorios/uso terapéutico , Dexametasona/efectos adversos , Dexametasona/uso terapéutico , Manejo del Dolor/métodos , Adulto , Anciano , Antiinflamatorios/administración & dosificación , Dexametasona/administración & dosificación , Espacio Epidural , Femenino , Fluoroscopía , Estudios de Seguimiento , Humanos , Inyecciones Epidurales/métodos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Encuestas y Cuestionarios
5.
PM R ; 7(2): 206-9, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25289843

RESUMEN

A 51-year-old man with lumbar radiculopathy underwent a right L5 transforaminal epidural steroid injection with dexamethasone. One minute after the injection, the patient experienced severe pruritus and burning, which began in the groin and then spread throughout his body. The symptoms resolved completely after 1 minute, and the patient was discharged without any complications. Although there are a small number of publications reporting perineal pruritus after intravenous administration of dexamethasone, to our knowledge there is no report of a generalized reaction to an epidural dexamethasone injection such as the one described here.


Asunto(s)
Dexametasona/efectos adversos , Glucocorticoides/efectos adversos , Prurito/inducido químicamente , Dexametasona/administración & dosificación , Glucocorticoides/administración & dosificación , Humanos , Inyecciones Epidurales , Dolor de la Región Lumbar/tratamiento farmacológico , Dolor de la Región Lumbar/etiología , Dolor de la Región Lumbar/patología , Masculino , Persona de Mediana Edad
7.
Pain Physician ; 17(1): 21-7, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24452642

RESUMEN

BACKGROUND: Transforaminal epidural steroid injections (TFESI) are a mainstay in the treatment of spine pain. Though this commonly performed procedure is generally felt to be safe, devastating complications following inadvertent intra-arterial injections of particulate steroid have been reported. The use of digital subtraction angiography (DSA) has been suggested as a means of detecting intra-arterial needle placements prior to medication injection. OBJECTIVE: To examine the efficacy of DSA in detecting intra-arterial needle placements during TFESI. STUDY DESIGN: Prospective cohort study evaluating the impact of DSA on detecting intra-arterial needle placements during TFESI. METHODS: We enrolled 150 consecutive patients presenting to a university-affiliated spine center with discogenic and/or radicular symptoms affecting the cervical, lumbar, and sacral regions. For each injection, prior to imaging with DSA, traditional methods for vascular penetration detection were employed, including the identification of blood in the needle hub (flash), negative aspiration of blood prior to injection, and live fluoroscopic injection of contrast. Once these tests were performed and negative for signs of intra-arterial needle placement, DSA imaging was utilized prior to medication administration for identification of vascular flow. RESULTS: A total number of 222 TFESI were performed, 41 injections at the cervical levels (18.47%), 113 at the lumbar levels (50.9%), and 68 at the sacral levels (30.36%). Flash was observed in 13 injections performed (5.85% of the total number of injections): one (0.45%) in the cervical, 2 (0.9%) in the lumbar, and 10 (4.5%) in the sacral levels. In 11 TFESI blood aspiration was obtained (4.95% of all injections): 3 (1.3%) in cervical, 4 (1.8%) in lumbar, and 4 (1.8%) in sacral injections. Live fluoroscopy during contrast injection detected 46 (20.72%) intravascular flow patterns: 7 (3.1%) cervical, 17 (7.6%) lumbar, and 22 (9.9%) sacral. DSA identified an additional 5 intravascular injections after all previous steps had resulted in negative vascular penetration signs, which accounted for 2.25% of all injections. LIMITATIONS: This is a prospective, single-center study with a relatively small number of patients and no control group. CONCLUSION: DSA detected additional 5.26% intravascular needle placements following traditional methods. Our findings also support other studies that conclude TFESI are generally a safe procedure. We recommend that special attention should be paid to the sacral injections as vascular penetration was statistically higher than at other levels.


Asunto(s)
Dolor de Espalda/tratamiento farmacológico , Inyecciones Epidurales , Radiculopatía/tratamiento farmacológico , Esteroides/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Angiografía de Substracción Digital , Dolor de Espalda/diagnóstico por imagen , Estudios de Cohortes , Femenino , Fluoroscopía , Humanos , Región Lumbosacra , Masculino , Persona de Mediana Edad , Radiculopatía/diagnóstico por imagen , Adulto Joven
8.
Pain Physician ; 17(1): E45-60, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24452657

RESUMEN

BACKGROUND: Low back pain with or without radiculopathy is an important cause of disability and economic expenditure. However, many patients are not meeting optimal pain control through existing treatments. Recent studies have linked nerve growth factor (NGF) and the pathophysiology of persistent pain. Anti-NGF could be an alternative drug treatment for low back pain. OBJECTIVE: Systematically review the efficacy and safety of anti-NGF in the treatment of low back pain. METHODS: A systematic review of the literature with no language, date or publication status restriction, using Medline, EMBASE, Cochrane Library, and the clinicaltrials.gov database. Additional literature was retrieved by conferring with experts in the field or reviewing bibliographies and annals of meetings and congresses. Search terms included "monoclonal antibodies," "nerve growth factor," "anti-ngf," "fulranumab," "tanezumab," "sciatica," "back pain," and "spine." STUDY DESIGN: Inclusion criteria were observational studies with safety as an outcome and randomized or nonrandomized controlled trials studying the efficacy and/or the safety of anti-NGF drugs on low back pain. Exclusion criteria included patients with autoimmune conditions or osteoporosis. Studies were assessed independently by 2 authors regarding inclusion/exclusion criteria, risk of bias, clinical relevance, and quality of evidence (GRADE approach). RESULTS: 1,168 studies were retrieved. After excluding duplicates and applying the inclusion/exclusion criteria, 4 RCTs remained (n = 2,109): 2 for tanezumab, one for REGN475, and one for fulranumab. Only the tanezumab studies showed any significant difference over placebo (n = 1,563) for both pain relief and functional improvement. CONCLUSIONS: There is very low evidence that systemically administered anti-NGF therapy has a small positive effect compared to placebo for both pain relief (standarized mean difference [SMD] = -0.29, 95% confidence interval [CI] -0.58 to 0.00) and functional improvement (SMD = -0.21, 95%CI -0.37 to -0.05 ) of low back pain. There was low evidence of adverse effects (AEs) compared to placebo and low evidence of neurological AEs than placebo (relative risk = 1.93, 95%CI 1.41 to 2.64).Tanezumab, as a specific anti-NGF treatment, showed low evidence of a small to moderate effect for pain relief of low back pain (SMD = -0.44, 95%CI -0.81 to -0.07); and low evidence of a small effect for functional improvement (SMD = -0.26, 95%CI -0.40 to -0.12) with systemic administration, although not clinically significant. Tanezumab and anti-NGFs overall had, respectively, moderate and low evidence of overall AEs and serious AEs and a higher risk of developing neurological AEs when compared with placebo. Although anti-NGF, specifically tanezumab, showed a low-to-moderate effect on pain relief and functional improvement, it cannot be recommended for low back pain treatment. Without more research on the pathophysiology of anti-NGFs and adverse effects, its use is not safe in the overall population. However, as corroborated by the US Food and Drug Administration, this meta-analysis underscores a role for greater insight into anti-NGF therapy for painful conditions that are refractory to current drugs, such as oncologic pain, chronic pancreatitis, and phantom-limb pain. Given the pathophysiology of axial pain involving inflammatory mediators and the adverse effects of systemic anti-NGF use, consideration of local therapies may warrant further exploration.


Asunto(s)
Anticuerpos/uso terapéutico , Dolor de la Región Lumbar/tratamiento farmacológico , Factor de Crecimiento Nervioso/antagonistas & inhibidores , Radiculopatía/tratamiento farmacológico , Bases de Datos Factuales/estadística & datos numéricos , Humanos , Factor de Crecimiento Nervioso/inmunología
9.
Pain Physician ; 17(1): E27-44, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24452656

RESUMEN

BACKGROUND: Low back pain, with or without radiculopathy, is an important cause of disability and economic expenditure. However, many patients are not achieving optimal pain control with existing medications. Tumor necrosis factor antagonists (anti-TNFα) could be an alternative drug treatment. OBJECTIVES: Systematic review the efficacy and safety of anti-TNFα in the treatment of low back pain with or without radiculopathy. STUDY DESIGN: Inclusion criteria were observational studies with safety as an outcome, and randomized or nonrandomized controlled trial (RCT) studies on efficacy and/or safety of anti-TNFα drugs on low back pain. Exclusion criteria included patients with auto-immune conditions or osteoporosis. RESULTS: Studies were assessed independently by 2 authors regarding inclusion/exclusion criteria, risk of bias, clinical relevance, quality, and strength of evidence (GRADE approach). Of the 1,179 studies retrieved, all duplicates were excluded and then the inclusion/exclusion criteria was applied. One observational study (n = 143) and 11 RCTs remained (n = 539): 8 for etanercept (n = 304), one for adalimumab (n = 61), one for adalimumab and etanercept (n = 60), one for infliximab (n = 40) and one for REN-1654 (n = 74). Only 3 etanercept and 2 adalimumab studies showed statistically significant pain relief when compared to placebo. There was no difference in the overall incidence of adverse effects when comparing anti-TNF-α and placebo. LIMITATIONS: Despite the statistically significant effect, this meta-analysis has important limitations, such as high heterogeneity and high use of outcome imputation. CONCLUSIONS: There is low evidence that epidural etanercept has a low-to-moderate effect size when compared to placebo for pain due to discogenic lumbar radiculopathy (5 studies, n=185), with a standardized mean difference = -0.43 (95% confidence interval [CI] -0.84 to -0.02).There is moderate evidence that epidural etanercept does not have a higher adverse effects incidence rate when compared to placebo for discogenic lumbar radiculopathy (5 studies, n = 185) with a relative risk (RR) = 0.84 (95% CI 0.53 to 1.34).There is moderate evidence that anti-TNFα does not have a higher adverse effects incidence rate when compared to placebo for low back pain (10 studies, n= 343) with an RR = 0.93 (95% CI 0.56 to 1.55).We strongly suggest that anti-TNFα continue to be studied in experimental settings for the treatment of low back pain. We cannot currently recommend this therapy in clinical practice. New research could shed some light on the efficacy of anti-TNFα and change this recommendation in the future.


Asunto(s)
Anticuerpos/uso terapéutico , Inmunoglobulina G/uso terapéutico , Dolor de la Región Lumbar/tratamiento farmacológico , Radiculopatía/tratamiento farmacológico , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Factor de Necrosis Tumoral alfa/inmunología , Ensayos Clínicos como Asunto , Bases de Datos Factuales/estadística & datos numéricos , Etanercept , Humanos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores
10.
Int J Neuropsychopharmacol ; 14(8): 1133-45, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21320389

RESUMEN

Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation that has been intensively investigated in clinical and cognitive neuroscience. Although the general impression is that tDCS is a safe technique with mild and transient adverse effects (AEs), human data on safety and tolerability are largely provided from single-session studies in healthy volunteers. In addition the frequency of AEs and its relationship with clinical variables is unknown. With the aim of assessing tDCS safety in different conditions and study designs, we performed a systematic review and meta-analysis of tDCS clinical trials. We assessed Medline and other databases and reference lists from retrieved articles, searching for articles from 1998 (first trial with contemporary tDCS parameters) to August 2010. Animal studies, review articles and studies assessing other neuromodulatory techniques were excluded. According to our eligibility criteria, 209 studies (from 172 articles) were identified. One hundred and seventeen studies (56%) mentioned AEs in the report. Of these studies, 74 (63%) reported at least one AE and only eight studies quantified AEs systematically. In the subsample reporting AEs, the most common were, for active vs. sham tDCS group, itching (39.3% vs. 32.9%, p>0.05), tingling (22.2% vs. 18.3%, p>0.05), headache (14.8% vs. 16.2%, p>0.05), burning sensation (8.7% vs. 10%, p>0.05) and discomfort (10.4% vs. 13.4%, p>0.05). Meta-analytical techniques could be applied in only eight studies for itching, but no definite results could be obtained due to between-study heterogeneity and low number of studies. Our results suggested that some AEs such as itching and tingling were more frequent in the tDCS active group, although this was not statistically significant. Although results suggest that tDCS is associated with mild AEs only, we identified a selective reporting bias for reporting, assessing and publishing AEs of tDCS that hinders further conclusions. Based on our findings, we propose a revised adverse effects questionnaire to be applied in tDCS studies in order to improve systematic reporting of tDCS-related AEs.


Asunto(s)
Terapia por Estimulación Eléctrica/efectos adversos , Sesgo , Recolección de Datos , Estimulación Encefálica Profunda/efectos adversos , Estimulación Encefálica Profunda/métodos , Terapia por Estimulación Eléctrica/métodos , Femenino , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Cráneo , Encuestas y Cuestionarios
11.
Arch Phys Med Rehabil ; 92(2): 306-15, 2011 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-21272730

RESUMEN

OBJECTIVE: To assess systematically the reporting of sample size calculation in randomized controlled trials (RCTs) in 5 leading journals in the field of physical medicine and rehabilitation (PM&R). DATA SOURCES: The data source was full reports of RCTs in 5 leading PM&R journals (Journal of Rehabilitation Medicine, Archives of Physical Medicine and Rehabilitation, American Journal of Physical Medicine and Rehabilitation, Clinical Rehabilitation, and Disability and Rehabilitation) between January and December of 1998 and 2008. Articles were identified in Medline. STUDY SELECTION: A total of 111 articles met our inclusion criteria, which include RCTs of human studies in the 5 selected journals. DATA EXTRACTION: Sample size calculation reporting and trial characteristics were collected for each trial by independent investigators. DATA SYNTHESIS: In 2008, 57.3% of articles reported sample size calculation as compared with only 3.4% in 1998. The parameters that were commonly used were a power of 80% and alpha of 5%. Articles often failed to report effect size or effect estimates for sample size calculation. Studies reporting sample size calculation were more likely to describe the main outcome and to have a sample size greater than 50 subjects. The study outcome (positive vs negative) was not associated with the likelihood of sample size reporting. Trial characteristics of the 2 periods (1998 vs 2008) were similar except that in 1998 there were more negative studies compared with 2008. CONCLUSIONS: Although sample size calculation reporting has improved dramatically in 10 years and is comparable with other fields in medicine, it is still not adequate given current publication guidelines.


Asunto(s)
Medicina Física y Rehabilitación , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Tamaño de la Muestra , Bibliometría , Humanos , Publicaciones Periódicas como Asunto
12.
Rev Assoc Med Bras (1992) ; 56(4): 458-61, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-20835644

RESUMEN

OBJECTIVE: Since being introduced as an elective discipline (non-obligatory) in the second semester of 2002, acupuncture has been taught in the University of São Paulo School of Medicine. We conducted this study to verify interest and acceptance among under graduate medical students and to discern a positive influence contributing to improving their skills. METHODS: The study was conducted from 2002 to 2007 using descriptive statistical methods. RESULTS: The average number of students who concluded the discipline is 24.9 students per semester with an average number of medical students per semester of 87.5 (28% of all medical students in the 7th and 8th semesters). After a semester of basic training in acupuncture, only eight students per group are promoted (after selection) to the Medical Academic League of Acupuncture which lasts for two years. Every semester, all eight vacancies are filled. Among the students who concluded the course, 98% described course quality as good or very good, 85% considered themselves at least partially able to use acupuncture and 79% stated that the course influenced them in their medical education. CONCLUSION: There is a genuine interest to learn acupuncture, almost 30% of all students volunteer for a brief training in acupuncture while some of them choose additional training of two years due to the importance of acupuncture as part of professional skills. Results indicate that acupuncture should be included as an elective discipline for medical students.


Asunto(s)
Acupuntura/educación , Educación de Pregrado en Medicina , Facultades de Medicina , Brasil , Curriculum , Humanos , Estudiantes de Medicina , Encuestas y Cuestionarios
13.
Rev. Assoc. Med. Bras. (1992) ; 56(4): 458-461, 2010. tab
Artículo en Inglés | LILACS | ID: lil-557327

RESUMEN

OBJECTIVE: Since being introduced as an elective discipline (non-obligatory) in the second semester of 2002, acupuncture has been taught in the University of São Paulo School of Medicine. We conducted this study to verify interest and acceptance among under graduate medical students and to discern a positive influence contributing to improveing their skills. METHODS: The study was conducted from 2002 to 2007 using descriptive statistical methods. RESULTS: The average number of students who concluded the discipline is 24.9 students per semester with an average number of medical students per semester of 87.5 (28 percent of all medical students in the 7th and 8th semesters). After a semester of basic training in acupuncture, only eight students per group are promoted (after selection) to the Medical Academic League of Acupuncture which lasts for two years. Every semester, all eight vacancies are filled. Among the students who concluded the course, 98 percent described course quality as good or very good, 85 percent considered themselves at least partially able to use acupuncture and 79 percent stated that the course influenced them in their medical education. CONCLUSION: There is a genuine interest to learn acupuncture, almost 30 percent of all students volunteer for a brief training in acupuncture while some of them choose additional training of two years indue to the importance of acupuncture as part of professional skills. Results indicate that acupuncture should be included as an elective discipline for medical students.


OBJETIVO: Após ter sido introduzida como disciplina eletiva (não obrigatória) no segundo semestre de 2002, a acupuntura tem sido ensinada na Faculdade de Medicina da Universidade de São Paulo (FMUSP) desde então. Esse estudo foi realizado com o intuito de verificar o interesse e a aceitação da acupuntura entre os estudantes de medicina da FMUSP e se, de alguma forma, ela poderia influenciá-los positivamente, contribuindo para melhorar as suas competências. MÉTODOS: O estudo foi conduzido durante o período de 2002 a 2007, utilizando-se métodos de estatística descritiva. RESULTADOS: A média de todos os estudantes que concluíram a disciplina foi de 24,9 alunos por semestre, sendo que a média de estudantes de medicina por semestre é de 87,5 (28 por cento de todos os estudantes de medicina nos 7º e 8º semestres). Após o primeiro semestre de formação básica em acupuntura, apenas oito alunos por grupo são promovidos (após seleção) para a Liga Médica Acadêmica de Acupuntura, que tem a duração de dois anos. Em todos os semestres, as oito vagas são preenchidas. Entre os estudantes que concluíram o curso, 98 por cento consideraram-no de boa ou muito boa qualidade, 85 por cento consideravam-se parcialmente capazes para empregar a acupuntura e 79 por cento consideraram que o curso contribuiu para a sua educação médica. CONCLUSÃO: Existe um real interesse para a aprendizagem da acupuntura, pois em torno de 30 por cento de todos os alunos quiseram passar por um breve treinamento em acupuntura, alguns deles optando por uma formação de dois anos em reconhecimento à importância da acupuntura como parte da capacitação profissional. Os resultados sugerem que a acupuntura deve ser incluída como uma disciplina eletiva para alunos de medicina.


Asunto(s)
Humanos , Acupuntura/educación , Educación de Pregrado en Medicina , Facultades de Medicina , Brasil , Curriculum , Estudiantes de Medicina , Encuestas y Cuestionarios
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