National Collaborating Centre for Women's and Children's Health

Spasticity in children and young people with non-progressive brain disorders
Oral baclofen versus placebo or no treatment
All three studies identified for inclusion (McKinlay 1980; Milla 1977; Scheinberg 2006) reported
reduction of spasticity.
Table 6.4 Evidence profile for oral baclofen compared with placebo in children with spasticity of different
severities; tone assessment
Number of
studies
Number of participants Effect Quality
Baclofen Placebo Relative
Absolute
(95% CI)
(95% CI)
Improvement of spasticity (by 1 level of Ashworth scale) at day 28 of treatment
1 study (Milla
1977)
9/20 a 2/20 b RR 4.50 (1.11 to
18.27)*
35 more per 100
(from 1 more to
173 more)*
Low
Improvement of spasticity (by more than 1 level of Ashworth scale) at day 28 of treatment
1 study (Milla
1977)
5/20 c 0/20 c RR 11 (0.65 to
186.62)*
- Low
Reduced muscle tone (Ashworth scale) reported by investigators
1 study
(McKinlay
1980)
- - - d - Low
Reduced muscle tone or better movement reported by physiotherapist
1 study
(McKinlay
1980)
14/20 e 5/20 e RR 2.8 (1.26 to
6.22)*
45 more per 100
(from 6 more to
130 more)*
Moderate
Mean Tardieu scale score at week 12 of treatment (better indicated by lower values)
1 study
(Scheinberg
2006)
15 f 15 g - 4.4 lower h Moderate
CI confidence interval, P probability, RR relative risk
* Calculated by the NCC-WCH
a Reported Sign test P < 0.001
b Reported Sign test P = 0.25. The two patients who improved received placebo before baclofen
c Significance level was not reported. Using data from the first period only and analysing as a parallel trial, (3/10 in baclofen
group versus 0/10 placebo group improved) relative risk (RR) = 7.00 (0.41 to 120.16) P = 0.18
d Data not presented. Statement in report: “No significant changes between baclofen and placebo were observed in muscle
tone”. The assessment period for this observation was not reported
e Reduced muscle tone or better movement was reported by physiotherapists in 14 children taking baclofen (70%), five
children taking placebo (25%), P = 0.064 reported, method used not reported. One child showed no change throughout. N=20
f Baseline Mean Tardieu score 20.9 (15.7 to 26.2). Final score 25.6 (19.4–25.8)
g Baseline Mean Tardieu score 20.9 (15.7 to 26.2). Final score 27.1 (21.0–33.3)
h No significant treatment, carry over or period effects found. Reported in paper as mean change = -4.4 (-10.8 to 2.0)
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