Study register · detail
Clear benefit
GRADE
Moderate
16 citations
Samplen = 15 Pat.
Durationnot specified
ControlOwn baseline measurement
EndpointModified Ashworth Scale
Blindingoffen
DesignKlinische Studie
Cannabinoidkombination
THC:CBD1:1
Routeoral
Key finding
THC-CBD spray significantly improved spasticity and pain (MAS, 9HPT, NRS, VAS each p<0.05) with neurophysiological confirmation via prolonged CSP.
Summary
n=15 secondary progressive MS patients, THC:CBD spray vs. baseline; significant improvement in Modified Ashworth Scale (p=0.001), 9-Hole Peg Test (p=0.018), NRS spasticity (p=0.001), VAS pain (p=0.005). Neurophysiologically prolonged cutaneous silent period (p=0.001).
P
PopulationAdults with secondary progressive multiple sclerosis, n=15 (11 women)
I
InterventionOromucosal THC/CBD spray (Sativex, standard dosing), applied as spray
C
ControlOwn baseline measurement (T0 vs. T1); comparison of neurophysiological parameters with 14 healthy controls
O
OutcomeSignificant improvement in spasticity (MAS p=.001, NRS p=.001) and pain (VAS p=.005) as well as prolongation of the cutaneous silent period (CSP) (p=.001) at T1 vs. T0
Confidence in the evidence
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
Open-label
Effect size
Clear benefit
Citations / year
★★★★★
Authors
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Abstract
Objectives: To investigate the action of cannabinoids on spasticity and pain in secondary progressive multiple sclerosis, by means of neurophysiological indexes.
Material And Methods: We assessed 15 patients with progressive MS (11 females) using clinical scales for spasticity and pain, as well as neurophysiological variables (H/M ratio, cutaneous silent period or CSP). Testing occurred before (T0) and during (T1) a standard treatment with an oral spray containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Neurophysiological measures at T0 were compared with those of 14 healthy controls of similar age and sex (HC). We then compared the patient results at the two time points (T1 vs T0).
Results: At T0, neurophysiological variables did not differ significantly between patients and controls. At T1, spasticity and pain scores improved, as detected by the Modified Ashworth Scale or MAS (P = .001), 9-Hole Peg Test or 9HPT (P = .018), numeric rating scale for spasticity or NRS (P = .001), and visual analogue scale for pain or VAS (P = .005). At the same time, the CSP was significantly prolonged (P = .001).
Conclusions: The THC-CBD spray improved spasticity and pain in secondary progressive MS patients. The spray prolonged CSP duration, which appears a promising tool for assessing and monitoring the analgesic effects of THC-CBD in MS.
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