Table 7.8Evidence profile for botulinum toxin type A and physical therapy compared with physical therapy alone; upper limb; adverse events

Number of studiesNumber of participantsEffectQuality
Botulinum toxin type A and occupational therapyOccupational therapy onlyRelative

(95% CI)
Absolute

(95% CI)
Adverse effects
1 study (Hoare 2010)----aLow
1 study (Olesch 2010)1111--bLow

CI confidence interval

a

95% confidence interval not calculable. No adverse effects were reported in two studies (Greaves 2005: Speth 2005). No major adverse events reported in Boyd 2004 although three children were noted to have decreased extension of the index finger that resolved by 6 weeks. There were 31 adverse events reported by 15 participants and no between-group difference in Lowe 2006. There were 29 adverse events reported by 20 participants over 6 months in Russo 2007. Three of these events involved hospitalisation for seizures in known epileptic children, and one child had three hospitalisations for medical reasons. Excessive weakness in the injected limb (reported as a minor adverse effect) was reported in five children and was prolonged in two children. In the Wallen 2007 RCT, there were five adverse events reported in the BoNT and therapy group and four adverse events in the therapy only group

b

Three adverse events were reported in BoNT/occupational therapy group of the Olesch 2010 trial. One child had a maculopapular rash (immunological test to consider if response to BoNT inconclusive) and one child had weakness in index finger after BoNT administration into adductor pollicis. Both these adverse events resolved spontaneously and the children continued with treatment. One child with prolonged weakness in the finger flexors did not receive any further BoNT injections at this site, but completed the study with respect to other muscle groups

See the complete GRADE Table K.7.8 which accompanies this abbreviated version.

From: 7, Botulinum toxin

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.
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