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

Quality assessmentSummary of findings
No. of patientsEffectQuality
No. of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsBaclofenPlaceboRelative

(95% CI)
Absolute
Improvement of spasticity (by 1 level of Ashworth scale) at day 28 of treatment
1 study (Milla 1977)randomised trialsserious1no serious inconsistencyno serious indirectnessserious 2none9/2032/204RR 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)randomised trialsserious1no serious inconsistencyno serious indirectnessserious5none5/2060/206RR 11 (0.65 to 186.62)*-Low
Reduced muscle tone (Ashworth scale) reported by investigators
1 study (McKinlay 1980)randomised trialsserious7no serious inconsistencyno serious indirectnessserious2none---8-Low
Reduced muscle tone or better movement reported by physiotherapist
1 study (McKinlay 1980)randomised trialsserious6no serious inconsistencyno serious indirectnessno serious imprecisionnone14/2095/209RR 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)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious10none15111512-4.4 lower13Moderate

CI confidence interval, RR relative risk

*

Calculated by the NCC-WCH

1

No washout period, allocation concealment unclear

2

Total number of events less than 300, the 95% confidence interval is wide

3

Reported Sign test p<0.001

4

Reported Sign test p=0.25. The 2 patients who improved received placebo before baclofen

5

Total number of events less than 300, the 95% confidence interval includes no effect and is wide

6

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

7

Allocation concealment unclear

8

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

9

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

10

Total population less than 400, the 95% confidence interval includes no effect and is wide

11

Baseline Mean Tardieu score 20.9 (15.7 to 26.2). Final score 25.6 (19.4 – 25.8)

12

Baseline Mean Tardieu score 20.9 (15.7 to 26.2). Final score 27.1 (21.0 - 33.3)

13

No significant treatment, carry over or period effects found. Reported in paper as mean change = -4.4 (-10.8 to 2.0)

Calculated by the NCC-WCH

No washout period, allocation concealment unclear

Total number of events less than 300, the 95% confidence interval is wide

Reported Sign test p<0.001

Reported Sign test p=0.25. The 2 patients who improved received placebo before baclofen

Total number of events less than 300, the 95% confidence interval includes no effect and is wide

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

Allocation concealment unclear

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

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

Total population less than 400, the 95% confidence interval includes no effect and is wide

Baseline Mean Tardieu score 20.9 (15.7 to 26.2). Final score 25.6 (19.4 – 25.8)

Baseline Mean Tardieu score 20.9 (15.7 to 26.2). Final score 27.1 (21.0 - 33.3)

No significant treatment, carry over or period effects found. Reported in paper as mean change = -4.4 (-10.8 to 2.0)

From: Appendix K, GRADE tables

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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