El propósito de este estudio es determinar si el cannabis vaporizado es eficaz como analgésico
para el tratamiento de la neuropatía diabética dolorosa.
There is emerging evidence that the cannabinoids are effective in neuropathic pain. A randomized, double-blinded, placebo controlled crossover design methodology was conducted in sixteen patients with painful diabetic peripheral neuropathy (7 women, 9 men). Subjects participated in four sessions where they were exposed to placebo, low (1% tetrahydrocannabinol, THC), medium (4% THC), or high (7% THC) dose of cannabis. Baseline spontaneous pain, evoked pain and cognitive testing were performed. Subjects were then administered aerosolized cannabis or placebo and the pain intensity and subjective highness score was measured at 5, 15, 30, 45, 60 minutes and then every 30 minutes for an additional 3 hours. Cognitive testing was performed at 5 and 30 minutes and then every 30 minutes for an additional 3 hours. Area under the spontaneous pain versus time curve was the primary endpoint. Overall effect of cannabis dose on spontaneous pain was significant (p=0.029) with only the high dose reaching significance (p=0.013). There was an overall difference in mean lowest achieved spontaneous pain score between groups (0.044) with the high dose achieving the lowest mean pain score (p=0.017). There was a trend for significant effects of the cannabis on evoked pain. Overall effects for brush (p=0.085) and pin prick (p=0.199) pain trended toward significance with the high dose most effective (brush p=0.057, pin prick p=0.144). There was a dose dependent increase in the subjective highness score reported after cannabis exposure which persisted into the late time course. There was a significant difference in two of the three neuropsychological tests (Paced Auditory Serial Addition Test, p=0.005; Trail Making Test B, p=0.049; Trail Making Test A, p=0.362). These results are consistent with evidence in other neuropathic pain syndromes and suggest additional research is warranted.
Un estudio aleatorizado, doble ciego, controlado con placebo estudio cruzado se llevó a cabo en 16 pacientes con neuropatía periférica diabética dolorosa para evaluar la eficacia y la tolerabilidad de cannabis inhalado a corto plazo. En un diseño cruzado, cada participante fue expuesta a 4 sesiones de dosificación individuales de placebo o baja (1% tetrahidrocannabinol [THC]), medio (4% THC), o alto (7% de THC) dosis de cannabis. Dolor espontáneo de línea de base, evocó el dolor y las pruebas cognitivas se realizaron. Los sujetos fueron administrados cannabis en forma de aerosol o placebo y la intensidad del dolor y "alteza" subjetiva puntaje se midió a los 5, 15, 30, 45 y 60 minutos y luego cada 30 minutos durante 3 horas. Las pruebas cognitivas se realizó a los 5 y 30 minutos y luego cada 30 minutos durante 3 horas. El análisis primario comparó las diferencias en el dolor espontáneo en el tiempo entre las dosis utilizando modelos de efectos mixtos lineales. Hubo una diferencia significativa en las puntuaciones de dolor espontáneo entre las dosis (P <0,001). Comparaciones específicas significativos fueron placebo frente baja, media, y las dosis altas (P = 0,031, 0,04 y <0,001, respectivamente) y alta frente a dosis bajas y medias (ambos p <0,001). No hubo un efecto significativo de la dosis alta en el cepillo de espuma y von Frey evocó el dolor (ambos p <0,001). Hubo un efecto significativo negativo (rendimiento deteriorado) de la alta dosis en 2 de las 3 pruebas neuropsicológicas (a ritmo auditiva Prueba Adición de serie, Trail Making Test Parte B.
PERSPECTIVA: Este pequeño y de corta duración, controlado con placebo de cannabis inhalado demostró una reducción dependiente de la dosis en el dolor neuropatía periférica diabética en pacientes con dolor refractario al tratamiento. Esto agrega evidencia preliminar para apoyar nuevas investigaciones sobre la eficacia de los cannabinoides en el dolor neuropático.
There is emerging evidence that inhaled cannabis is effective in the treatment of neuropathic pain. However, few studies have looked at the correlation between THC plasma concentration and pain relief. A randomized, double-blinded, placebo controlled crossover study was conducted in sixteen patients with painful diabetic peripheral neuropathy. Subjects participated in four sessions where they were exposed to placebo, low (1% tetrahydrocannabinol, THC), medium (4% THC), or high (7% THC) dose of cannabis. Subjects were administered aerosolized cannabis or placebo and the spontaneous and evoked (von frey and stroking) pain intensity was measured and a blood sample for plasma THC levels were taken at 5, 15, 30, 45, 60minutes and then every 30 minutes for an additional 3 hours. Analysis was done for both the administered dose and peak plasma concentrations. Within each dose level, subjects were divided into those with peak plasma concentration < 15 ng/ml or>15 ng/ml. There was a significant dose dependent reduction in both spontaneous and evoked pain with the highest dose being most effective. Evoked pain showed the tightest correlation and was used to analyze THC concentration and pain reduction. There was a significant correlation between pain reduction between 5- 15 ng/ml (p=0.0319) which was lost at>15 ng/ml THC (p=0.9111). There appears to be a therapeutic window for the analgesic effects of THC and patients should be counseled that more is not better.
El propósito de este estudio es determinar si el cannabis vaporizado es eficaz como analgésico para el tratamiento de la neuropatía diabética dolorosa.
