RESUMEN
Objetivo: valorar el uso de terapias alternativas no farmacológicas en migraña y variables relacionadas. La migraña afecta a una de cada diez personas en el mundo, con aumento creciente y mayor prevalencia entre mujeres de zonas urbanas. Aunque los tratamientos habituales son farmacológicos, se ha incrementado el uso de terapias alternativas no farmacológicas en migraña y variables relacionadas. Materiales y métodos: estudio observacional transversal mediante encuesta anónima vía web a 3.342 pacientes de países europeos sobre el uso de terapias alternativas para tratamiento de migraña. Variables de estudio: edad, género, país, tipo de localidad, nivel de estudios, ámbito rural o urbano y respuesta al tratamiento. Resultados: la utilización de terapias alternativas en migraña es un fenómeno creciente, con mayor uso en pacientes entre 41-60 años y estudios superiores. Conclusiones: en migraña se observan diferencias por edad, género, nivel cultural y país de procedencia. El uso de la medicina complementaria como alternativa terapéutica en la migraña es poco habitual y se debería indagar con mayor profundidad estableciendo relaciones que permitan apoyar al paciente afectado y priorizar las de mayor evidencia científica..(Au)
Objective: to evaluate the use of alternative non-pharmacological therapies in migraine and related variables. Migraine affects one in ten people worldwide, with a growing increase and a higher prevalence among women in urban areas. Although the usual treatments are pharmacological, the use of alternative techniques is increasing. Materials and methods: cross-sectional observational study by anonymous web survey of 3,342 patients from European countries on the use of alternative therapies. Study variables: age, gender, country, type of locality, educational level, rural or urban setting and treatment response. Results: the use of alternative therapies in migraine treatment is a growing phenomenon, with greater use in patients between 41-60 years of age and higher education. Conclusions: in Migraine, differences are observed by age, gender, cultural level and country of origin. The use of complementary medicine as an therapeutic alternative in migraine is uncommon and should be investigated in greater depth, establishing relationships that allow supporting the affected patient and prioritizing, if possible, some over others with scientific evidence..(Au)
RESUMEN
BACKGROUND: The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency. METHODS/DESIGN: The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses. DISCUSSION: The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.