Information regarding the epidemiology of spasticity in patients with multiple sclerosis (MS) in Spain is limited. This cross-sectional survey-based study was undertaken to evaluate the symptoms, severity and consequences of MS-related spasticity (MSS) and to estimate the prevalence of MSS overall and according to the degree of severity (mild/moderate/severe). Adult MS patients (n = 8463) from the two main Spanish MS patients' associations were asked to complete a web-based questionnaire. Two thousand six hundred twenty seven responses were received, of which 2029 were valid for analysis. Two thirds were for women. The mean age of respondents was 40.2 years and the mean MS duration was 8.7 years. MSS was reported by 65.7% of respondents with 40% of these rating it as moderate/severe. MS patients with spasticity experienced more symptoms (including greater difficulty walking), consumed more healthcare resources (including care and rehabilitation sessions), and had a higher degree of disability than patients without spasticity. There was a significant correlation between increasing severity of spasticity and worsening of symptoms. Only 42.4% of patients with moderate spasticity and 52.6% of patients with severe spasticity were currently receiving antispasticity medication compared with 69% and 79%, respectively, reported in a similar survey-based study from the United States; this is likely to reflect regional variations in practice. Early and effective treatment of MSS is important to minimise the consequences of spasticity-related symptoms on patients' quality of life and the economic burden on healthcare systems. In appropriate patients, antispastic treatment, including pharmacotherapy and physiotherapy/rehabilitation, may provide such benefits.
People with multiple sclerosis may present with a wide range of disease symptoms during the evolution of the disease; among these, spasticity can have a marked impact on their well-being and quality of life. Symptom control, including spasticity, remains a key management strategy to improve the patient's well-being and functional status. However, available drug therapies for spasticity sometimes have limited benefit and they are often associated with poor tolerability. Sativex is a 1:1 mix of 9-delta-tetrahydrocannabinol and cannabidiol extracted from cloned Cannabis sativa chemovars, which is available as an oromucosal spray. Clinical experience with Sativex in patients with multiple sclerosis is accumulating steadily. Results from randomized, controlled trials have reported a reduction in the severity of symptoms associated with spasticity, leading to a better ability to perform daily activities and an improved perception of patients and their carers regarding functional status when Sativex was added to the current treatment regimen. Adverse events such as dizziness, diarrhea, fatigue, nausea, headache and somnolence occur quite frequently with Sativex, but they are generally of mild-to-moderate intensity and their incidence can be markedly reduced by gradual 'uptitration'. In summary, initial well-controlled studies with Sativex oromucosal spray administered as an add-on to usual therapy have produced promising results and highlight encouraging avenues for future research.
The results confirm an association between spasticity severity and QoL in patients with MS. The correlation between 0-10 NRS scores and QoL was stronger than that between modified Ashworth scale scores and QoL.
Despite the proven efficacy of Sativex(®) (9-delta-tetrahydrocannabinol plus cannabidiol) oromucosal spray in reducing spasticity symptoms in multiple sclerosis (MS), little is known about the neurophysiological correlates of such effects. The aim of the study was to investigate the effects of Sativex on neurophysiological measures of spasticity (H/M ratio) and corticospinal excitability in patients with progressive MS. This was a randomized, double-blind, placebo-controlled, crossover study. Consecutive subjects with progressive MS and lower limb spasticity referred to our center were randomized to 4 weeks' treatment (including 2 weeks' titration) with Sativex or placebo, with crossover after a 2-week washout. Clinical and neurophysiological measures (H/M ratio and cortical excitability) of spasticity were assessed. The H/M ratio was the primary outcome, with sample size calculation of 40 patients. Of 44 recruited patients, 34 were analyzed due to 6 drop-outs and 4 exclusions, which lowered the power of the study to show differences between treatments. Neurophysiological measures did not differ significantly according to treatment and did not correlate significantly with clinical response. Response on the modified Ashworth scale (at least 20 % improvement) was significantly more frequent after Sativex than placebo (50 vs 23.5 %; p = 0.041; McNemar). Side effects did not differ significantly according to treatment. Our findings confirm the clinical benefit of Sativex on MS spasticity. The lack of corresponding changes in corticospinal excitability and on the monosynaptic component, of the stretch reflex, although in a limited sample size, points to the involvement of other spinal and supraspinal mechanisms in the physiopathology of spasticity in progressive MS.
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