RESUMEN
This review focuses on contact dermatitis as an adverse effect of a selection of topically used herbal medicinal products for which the European Medicines Agency has completed an evaluation up to the end of November 2013 and for which a Community herbal monograph - now (since 2015)() called a European Union herbal monograph - has been produced. Part 3: Mentha × piperita L.-Solanum dulcamara L.
Asunto(s)
Dermatitis por Contacto/etiología , Mentha piperita/efectos adversos , Fitoterapia/efectos adversos , Preparaciones de Plantas/efectos adversos , Rosmarinus/efectos adversos , Salvia officinalis/efectos adversos , Europa (Continente) , Humanos , Oenothera biennis/efectos adversos , Pimpinella/efectos adversos , Quercus/efectos adversos , Ruscus/efectos adversos , Solanum/efectos adversosRESUMEN
OBJECTIVE: This randomised, double-blind, parallel group phase II/III study with adaptive two-stage design and interim analysis compared the efficacy and tolerability of spray (containing a Salvia officinalis fluid extract) against placebo in the treatment of patients with acute viral pharyngitis. - STUDY PARTICIPANTS: in two study parts, a total of 286 patients with subjective and objective evidence of pharyngitis were randomized. In the first study part 122 patients were enrolled. In the second study part 164 patients were included. The treatment duration per patient was 3 days, including one baseline visit and one final visit. - MAIN OUTCOME MEASURES: Area under Curve for change of throat pain intensity (spontaneous pain), documented every 15 minutes within the first 2 hours after the first application as compared to baseline using a visual analog scale (VAS 100 mm). - RESULTS: Following the interim analyses of the first study part the 15 % spray containing 140 microl sage extract per dose was the most promising preparation for the second study part (main study) whereas for the 30% and the 5% preparation results made superiority over placebo unlikely in the final analysis. Overall, the 15 % spray was significantly superior to placebo for the primary efficacy variable with regard to a reduction of the throat pain intensity score. Only minor side effects such as dry pharynx or burning of mild intensity were seen. - CONCLUSIONS: The efficacy and tolerability profile of a 15 % sage spray indicated that this preparation provides a convenient and safe treatment for patients with acute pharyngitis. A symptomatic relief occurred within the first two hours after first administration and was statistically significantly superior to placebo.
Asunto(s)
Dolor/tratamiento farmacológico , Faringitis/tratamiento farmacológico , Fitoterapia , Extractos Vegetales/administración & dosificación , Extractos Vegetales/uso terapéutico , Proyectos de Investigación , Salvia officinalis/química , Enfermedad Aguda , Administración Oral , Adolescente , Adulto , Anciano , Analgésicos/administración & dosificación , Analgésicos/efectos adversos , Analgésicos/uso terapéutico , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Humanos , Persona de Mediana Edad , Dolor/complicaciones , Dimensión del Dolor/efectos de los fármacos , Faringitis/complicaciones , Placebos , Extractos Vegetales/efectos adversos , Plantas Medicinales/efectos adversos , Plantas Medicinales/química , Salvia officinalis/efectos adversosAsunto(s)
Cosméticos/efectos adversos , Dermatitis Alérgica por Contacto/etiología , Enfermedades de los Labios/etiología , Extractos Vegetales/efectos adversos , Salvia officinalis/efectos adversos , Anciano de 80 o más Años , Cosméticos/química , Femenino , Humanos , Pruebas del Parche , Salvia officinalis/químicaRESUMEN
Many cultures have developed folk herbal remedies to treat symptoms of mental illness. An evidence-based view is now being developed for some of these so-called alternative herbal treatments. This article discusses clinically relevant scientific information on medicinal extracts of 4 herbs: saffron, passionflower, valerian, and sage.