RESUMEN
UNLABELLED: Topical treatments have gained popularity for general use as an adjunct to systemic drugs in neuropathic pain, but their use produces variable clinical results and local adverse events. OBJECTIVE: To evaluate the safety and analgesic effect of a formulation of liposomal capsaicin (LC) (0.025%) in patients with post herpetic neuralgia (PHN). METHOD: Patients who remained symptomatic after first-and second-line treatment were randomized to receive LC for six weeks in a placebo-controlled, crossover design study. Clinical assessment was performed at baseline, in the second, fourth and sixth week of treatment. RESULTS: Thirteen patients completed both treatment periods. Visual Analog Scale (VAS) was significantly decreased after the end of the study (p = 0.008), however the effect of treatment was not significant (p = 0.076). There was no difference on global impression of change and other pain characteristics. LC was safe and well tolerated. However, at the concentration used, its analgesic effects were marginal and not significant.
Asunto(s)
Capsaicina/administración & dosificación , Neuralgia Posherpética/tratamiento farmacológico , Fármacos del Sistema Sensorial/administración & dosificación , Anciano , Anciano de 80 o más Años , Análisis de Varianza , Estudios Cruzados , Método Doble Ciego , Femenino , Humanos , Liposomas , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Proyectos Piloto , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Escala Visual AnalógicaRESUMEN
Topical treatments have gained popularity for general use as an adjunct to systemic drugs in neuropathic pain, but their use produces variable clinical results and local adverse events. Objective To evaluate the safety and analgesic effect of a formulation of liposomal capsaicin (LC) (0.025%) in patients with post herpetic neuralgia (PHN). Method Patients who remained symptomatic after first-and second-line treatment were randomized to receive LC for six weeks in a placebo-controlled, crossover design study. Clinical assessment was performed at baseline, in the second, fourth and sixth week of treatment. Results Thirteen patients completed both treatment periods. Visual Analog Scale (VAS) was significantly decreased after the end of the study (p = 0.008), however the effect of treatment was not significant (p = 0.076). There was no difference on global impression of change and other pain characteristics. LC was safe and well tolerated. However, at the concentration used, its analgesic effects were marginal and not significant. .
Os tratamentos tópicos ganharam popularidade para uso geral como um adjuvante de medicamentos sistêmicos na dor neuropática, mas seu uso produz resultados clínicos variáveis e eventos adversos locais. Objetivo Avaliar o efeito de segurança e analgesia de uma formulação de capsaicina lipossomal (LC) (0,025%) em pacientes com neuralgia pós-herpética. Método Os pacientes que permaneceram sintomáticos após tratamento de primeira e de segunda linha foram randomizados para receber LC durante seis semanas em um estudo cruzado controlado por placebo. A avaliação clínica foi realizada no início do estudo, na segunda, quarta e sexta semana de tratamento. Resultados Treze pacientes completaram dois períodos de tratamento. Escala Visual Analógica diminuiu significativamente após o final do estudo (p = 0,008), no entanto, o efeito do tratamento não era significativo (p = 0,076). Não houve diferença na impressão global de mudança e de outras características da dor. LC foi segura e bem tolerada. No entanto, para a concentração utilizada, os seus efeitos analgésicos foram marginais e não significativos. .