OBJECTIVE: Cannabis may alleviate some symptoms associated with multiple
sclerosis (MS). This study investigated the effect of an orally administered
standardized Cannabis sativa plant extract in MS patients with poorly controlled
spasticity. METHODS: During their inpatient rehabilitation programme, 57
patients were enrolled in a prospective, randomized, double-blind,
placebo-controlled crossover study of cannabis-extract capsules standardized to
2.5 mg tetrahydrocannabinol (THC) and 0.9 mg cannabidiol (CBD) each. Patients in
group A started with a drug escalation phase from 15 to maximally 30 mg THC by 5
mg per day if well tolerated, being on active medication for 14 days before
starting placebo. Patients in group B started with placebo for seven days,
crossed to the active period (14 days) and closed with a three-day placebo
period (active drug dose escalation and placebo sham escalation as in group A).
Measures used included daily self-report of spasm frequency and symptoms,
Ashworth Scale, Rivermead Mobility Index, 10-m timed walk, nine-hole peg test,
paced auditory serial addition test (PASAT), and the digit span test. RESULTS:
In the 50 patients included into the intention-to-treat analysis set, there were
no statistically significant differences associated with active treatment
compared to placebo, but trends in favour of active treatment were seen for
spasm frequency, mobility and getting to sleep. In the 37 patients (per-protocol
set) who received at least 90% of their prescribed dose, improvements in spasm
frequency (P = 0.013) and mobility after excluding a patient who fell and
stopped walking were seen (P = 0.01). Minor adverse events were slightly more
frequent and severe during active treatment, and toxicity symptoms, which were
generally mild, were more pronounced in the active phase. CONCLUSION: A
standardized Cannabis sativa plant extract might lower spasm frequency and
increase mobility with tolerable side effects in MS patients with persistent
spasticity not responding to other drugs.
