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4% withdrawn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4.8% withdrawn


RMI, Rivermead Mobility Index; VAS, Visual Analogue Scale.

Lakhan and Rowland BMC Neurology 2009 9:59   doi:10.1186/1471-2377-9-59

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