Delta-9-tetrahydrocannabinol-cannabidiol in the treatment of spasticity in chronic spinal cord injury: a clinical experience
*Correspondencia: Dr. Luis-Millán González Moreno. FCAFE. Universitat de València. Gascó Oliag, 3. E-46010 Valencia.
E-mail: luis.m.gonzalez@uv.es
Introduction: Spasticity in chronic spinal cord injury is a condition that can have negative repercussions on the patient's quality of life. Its treatment is complex and sometimes the outcome is insufficient. Cannabinoids have recently been used in multiple sclerosis to successfully treat spasticity that is refractory to other therapies.
Aim: To quantify the clinical response of a group of patients with spastic chronic spinal cord injury to the orally administered drug delta-9-tetrahydrocannabinol-cannabidiol (Sativex ®) as medication for use in special situations.
Patients and methods: The research consists of a six-month observational study in patients with chronic spinal cord injuries with refractory spasticity. The variables collected were: modified Ashworth scale, Penn spasm frequency scale, Numeric Rating Scale, and Visual Analogue Scale for pain. Additionally, clinical variables and side effects of the treatment were also collected.
Results: Fifteen patients took part in this study. A significant improvement was observed on three of the scales recorded: modified Ashworth scale (z = -2.97; p = 0.003), Penn spasm frequency scale (z = -2.76; p = 0.006) and Numeric Rating Scale (z = -3.21; p = 0.001). The use of the drug was withdrawn in two patients due to side effects.
Conclusions: Sativex can be considered an alternative in patients with spasticity associated with chronic spinal cord injury for whom other therapeutic measures have been insufficient. Further studies need to be conducted before the use of this drug can be recommended and so as to define a complete profile of its long-term side effects.
Objetivo Cuantificar la respuesta clínica de un grupo de pacientes con lesión medular crónica espástica al fármaco delta-9-tetrahidrocannabinol-cannabidiol (Sativex ®), de administración oral, como medicamento de uso en situaciones especiales.
Pacientes y métodos Estudio observacional durante seis meses en lesionados medulares crónicos con espasticidad refractaria. Las variables recogidas fueron: escala modificada de Ashworth, escala de frecuencia de espasmos de Penn, Numeric Rating Scale y escala visual analógica del dolor. De forma adicional se recogieron variables clínicas y efectos secundarios del tratamiento.
Resultados Quince pacientes tomaron parte en el estudio. Se observó mejoría significativa en tres de las escalas registradas: escala de Ashworth modificada (z = 2,97; p = 0,003), escala de frecuencia de espasmos de Penn (z = 2,76; p = 0,006) y Numeric Rating Scale (z = 3,21; p = 0,001). Se suspendió el uso del fármaco en dos pacientes por efectos secundarios.
Conclusiones Sativex se muestra como una alternativa en pacientes con espasticidad asociada a lesión medular crónica, en las que otras medidas terapéuticas resultan insuficientes. Son necesarios más estudios para recomendar el uso de este fármaco y definir un perfil completo de sus efectos adversos a largo plazo.