Table 6.4Evidence profile for oral baclofen compared with placebo in children with spasticity of different severities; tone assessment

Number of studiesNumber of participantsEffectQuality
BaclofenPlaceboRelative

(95% CI)
Absolute

(95% CI)
Improvement of spasticity (by 1 level of Ashworth scale) at day 28 of treatment
1 study (Milla 1977)9/20a2/20bRR 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)5/20c0/20cRR 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)14/20e5/20eRR 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)15f15g-4.4 lowerhModerate

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)

See the complete GRADE Table K.6.4 which accompanies this abbreviated version.

From: 6, Oral drugs

Cover of Spasticity in Children and Young People with Non-Progressive Brain Disorders
Spasticity in Children and Young People with Non-Progressive Brain Disorders: Management of Spasticity and Co-Existing Motor Disorders and Their Early Musculoskeletal Complications.
NICE Clinical Guidelines, No. 145.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2012 Jul.
Copyright © 2012, National Collaborating Centre for Women's and Children's Health.

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