Table 1 |
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Analysis of six randomized controlled trials reporting measures of spasticity after THC-CBD treatment |
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Killestein 2002 [15] |
Wade 2003 [17] |
Zajicek 2003 [16] |
Wade 2004 [19] |
Vaney 2004 [18] |
Collin 2007 [20] |
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Design |
Crossover |
Crossover |
Parallel |
Parallel |
Crossover |
Parallel |
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Jaded score |
4 |
4 |
5 |
5 |
5 |
4 |
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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 |
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|
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Sample size |
16 |
14 |
395 (198 placebo) |
154 (77 placebo) |
57 |
184 (64 placebo) |
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Duration |
4 weeks |
4 weeks |
15 weeks |
6 weeks |
2 weeks |
6 weeks |
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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 |
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|
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Ashworth score |
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|
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Mean change |
App. -.3 |
No change |
1.24 |
-0.37 |
-2.2 |
-0.64 |
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|
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P-value |
Not significant |
>0.05 |
0.29 |
0.22 |
0.002 |
0.218 |
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VAS spasticity |
Not reported |
Not reported |
Not reported |
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|
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Mean change |
No change |
Reduced 14.9 points |
Reduced 31.2 points |
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|
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P-value |
Not significant |
<0.05 |
0.001 |
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Walk time |
Not reported |
Not reported |
Not reported |
Not reported |
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|
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Mean change |
Reduced 4% |
Reduced 2.78 (s) |
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|
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P-value |
Not reported |
0.07 |
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RMI |
Not reported |
Not reported |
Not reported |
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|
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Mean change |
Improved 0.2 |
Improved 0.4 |
Improved 0.5 |
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|
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P-value |
>0.05 |
0.21 |
0.005 |
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Self-reported rating |
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Measure |
Global impression VAS |
Numerical symptom scale |
Category rating scale |
Diary entry VAS scale |
Spasm frequency scale |
Numerical rating scale |
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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 |
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P-value |
0.02 |
<0.05 |
0.01 |
0.009 |
<0.001 |
0.048 |
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Adverse events |
41 reported, none serious |
16 reported |
12 serious reported |
4% withdrawn |
No serious reported |
4.8% withdrawn |
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RMI, Rivermead Mobility Index; VAS, Visual Analogue Scale. |
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Lakhan and Rowland BMC Neurology 2009 9:59 doi:10.1186/1471-2377-9-59 |
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