A study involving 230 patients with multiple sclerosis (MS) who had not sufficiently responded to previous medications were treated with Sativex® (nabiximols) as an add-on treatment. The drug effectively reduced spasticity in the majority of those involved in the study. Sativex® is a medication that was formulated by GW Pharmaceuticals and is proprietary mix of cannabinoids and non-cannabinoid components that primarily includes tetrahydrocannabinol (THC) and cannabidiol (CBD). The medication has been approved for use in treating seizure disorders, spasticity, and other symptoms associated with MS throughout Europe.
The study, which was published in BMC Neurology, took place in Belgium and relied on self-reports from patients that occurred at baseline, and then after 4, 8, and/or 12 weeks of treatment. Some patients reported outcomes 6 (n = 180) and 12 months (n = 113) after continued treatment, as well. Spasticity was measured using the 0-10 spasticity Numerical Rating Scale. Mean spasticity scores declined from 8.1 (±1.08) at baseline to 5.2 (±1.82), 4.6 (±1.69), and 4.1 (±1.78) after 4, 8, and 12 weeks, respectively. Patients who reported continued use after 6 and 12 months reported sustained effects with mean spasticity scores of 4.3 (±1.77) and 4.0 (±1.92), respectively.
After 4 weeks of treatment, 168 of 230 (73%) of patients reported a minimally clinically important difference (MCID) in symptoms (defined as a greater than 20% improvement in NRS score), while approximately 50% (116) reported a clinically important difference (CID) in symptoms (defined as a greater than 30% improvement in NRS score). This level of improvement was sustained in 89% of patients through week 8 of the treatment. Of the 52 patients who reported MCID but not CID at 4 weeks, 34 reported CID at week 8. Of the remaining 18, 11 progressed to CID at week 12. 9 patients who had reported neither NCID nor CID at 4 weeks reported CID at week 8 and another 7 reported CID at week 12. In total, 171 (74%) of patients reported CID at week 12.
Quality of life scores saw significant improvement, as well, and were measured using the visual analog scale (VAS) component of the EuroQol five-dimensional (EQ-5D) instrument (EQ VAS). Possible scores range from 0-100, with 0 being the worst possible health and 100 being the best. Patient scores rose from 39 at baseline to 52, 57, and 59 after 4, 8, and 12 weeks, respectively. Scores continued to improve at 6- and 12-month follow-ups, where mean EQ VAS scores were 61 and 64, respectively.
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