RESUMEN
INTRODUCTION: Preliminary studies have suggested that balneotherapy (BT) is an effective and well-tolerated treatment for generalized anxiety disorder (GAD) and psychotropic medication withdrawal syndrome. We carried out a study in 4 spa resorts to assess the efficacy of BT in GAD. METHOD: We compared BT to paroxetine in terms of efficacy and safety in a randomized multicentre study lasting 8 weeks. Patients meeting the diagnostic criteria of GAD (DSM-IV) were recruited. Assessments were conducted using the Hamilton Rating Scale for Anxiety (HAM-A) and other scales, by a specifically trained and independent physician. The primary outcome measure was the change in the total HAM-A score between baseline and week 8. RESULTS: A total of 237 outpatients were enrolled in four centres; 117 were assigned randomly to BT and 120 to paroxetine. The mean change in HAM-A scores showed an improvement in both groups with a significant advantage of BT compared to paroxetine (-12.0 vs -8.7; p<0.001). Remission and sustained response rates were also significantly higher in the BT group (respectively 19% vs 7% and 51% vs 28%). CONCLUSION: BT is an interesting way of treating GAD. Due to its safety profile it could also be tested in resistant forms of generalized anxiety and in patients who do not tolerate or are reluctant to use pharmacotherapies.
Asunto(s)
Trastornos de Ansiedad/terapia , Balneología , Paroxetina/uso terapéutico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Adulto , Anciano , Balneología/métodos , Balneología/normas , Femenino , Francia , Humanos , Masculino , Persona de Mediana Edad , Paroxetina/efectos adversos , Paroxetina/normas , Escalas de Valoración Psiquiátrica , Inhibidores Selectivos de la Recaptación de Serotonina/efectos adversos , Inhibidores Selectivos de la Recaptación de Serotonina/normas , Resultado del TratamientoAsunto(s)
Antidepresivos de Segunda Generación/normas , Composición de Medicamentos/normas , Metformina/normas , Paroxetina/normas , Tiazoles/normas , Antidepresivos de Segunda Generación/química , Combinación de Medicamentos , Control de Medicamentos y Narcóticos , Metformina/química , Paroxetina/química , Tiazoles/químicaAsunto(s)
Antidepresivos de Segunda Generación/antagonistas & inhibidores , Antidepresivos de Segunda Generación/uso terapéutico , Interpretación Estadística de Datos , Industria Farmacéutica , Paroxetina/antagonistas & inhibidores , Paroxetina/uso terapéutico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Adolescente , Antidepresivos de Segunda Generación/normas , Niño , Protección a la Infancia , Ensayos Clínicos como Asunto , Depresión/tratamiento farmacológico , Industria Farmacéutica/normas , Humanos , América del Norte , Paroxetina/normas , Inhibidores Selectivos de la Recaptación de Serotonina/normas , Recursos HumanosRESUMEN
Venlafaxine, oxydesmethylvenlafaxine and an internal standard (paroxetine) were extracted from plasma by a solid-phase extraction technique. Chromatography was performed using isocratic reversed-phase high-performance liquid chromatography (HPLC) with coulometric endpoint detection. The standard curves were linear over the range 0-200 ng/ml for both venlafaxine and oxydesmethylvenlafaxine in plasma. The mean inter- and intra-assay coefficients of variation over the range of the standard curves were less than 10%. The absolute recovery averaged 74% for venlafaxine and 67% for oxydesmethylvenlafaxine. The sensitivity was 0.5 ng for both the analytes. Plasma profiles of the analytes following oral administration of venlafaxine, are presented.