Table 1 Analysis of six randomized controlled trials reporting measures of spasticity after THC-CBD treatment
Killestein 2002 [15] | Wade 2003 [17] | Zajicek 2003 [16] | Wade 2004 [19] | Vaney 2004 [18] | Collin 2007 [20] | |
|---|---|---|---|---|---|---|
Design | Crossover | Crossover | Parallel | Parallel | Crossover | Parallel |
Jaded score | 4 | 4 | 5 | 5 | 5 | 4 |
Study objective | Small study to compare effects of THC and THC-CBD | Pilot study to explore benefits for neurogenic symptoms | Large study to compare effects of THC and THC-CBD | Benefits over a range of symptoms | Effects on spasm frequency | Effects on spasticity |
Sample size | 16 | 14 | 395 (198 placebo) | 154 (77 placebo) | 57 | 184 (64 placebo) |
Duration | 4 weeks | 4 weeks | 15 weeks | 6 weeks | 2 weeks | 6 weeks |
Intervention | THC-CBD <10 mg daily | THC-CBD 2.5-120 mg daily | THC-CBD <25 mg daily | THC-CBD <120 mg daily | THC-CBD <30 mg daily | THC-CBD >25 mg daily |
Ashworth score | ||||||
Mean change | App. -.3 | No change | 1.24 | -0.37 | -2.2 | -0.64 |
P-value | Not significant | >0.05 | 0.29 | 0.22 | 0.002 | 0.218 |
VAS spasticity | Not reported | Not reported | Not reported | |||
Mean change | No change | Reduced 14.9 points | Reduced 31.2 points | |||
P-value | Not significant | <0.05 | 0.001 | |||
Walk time | Not reported | Not reported | Not reported | Not reported | ||
Mean change | Reduced 4% | Reduced 2.78 (s) | ||||
P-value | Not reported | 0.07 | ||||
RMI | Not reported | Not reported | Not reported | |||
Mean change | Improved 0.2 | Improved 0.4 | Improved 0.5 | |||
P-value | >0.05 | 0.21 | 0.005 | |||
Self-reported rating | ||||||
Measure | Global impression VAS | Numerical symptom scale | Category rating scale | Diary entry VAS scale | Spasm frequency scale | Numerical rating scale |
Mean change | Worsened | Frequency reduced 1.9; severity reduced 2.1 | 52% treated reported improvement | Frequency score reduced 21.41; severity reduced 21.67 | Reduced 0.4 | Reduced 1.18 |
P-value | 0.02 | <0.05 | 0.01 | 0.009 | <0.001 | 0.048 |
Adverse events | 41 reported, none serious | 16 reported | 12 serious reported | 4% withdrawn | No serious reported | 4.8% withdrawn |