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

Quality assessmentSummary of findings
No. of patientsEffectQuality
No. of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsBotulinum toxin A (BoNT-A)/Occupational therapyOccupational therapy only all outcomesRelative (95% CI)Absolute
Adverse effects
1 study (Hoare 2010)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious1none----1Low
1 study (Olesch 2010)randomised trialsserious1no serious inconsistencyno serious indirectnessserious2none1111--2Low

CI confidence interval


95% confidence interval not calculable. No adverse effects were reported in 2 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 six months in Russo 2007. Three of these events involved hospitalisation for seizures in known epileptic children, and one child had 3 hospitalisations for medical reasons. Excessive weakness in the injected limb (reported as a minor adverse effect) was reported in 5 children and was prolonged in 2 children. In the Wallen 2007 RCT, there were 5 adverse events reported in the BoNT and therapy group and four adverse events in the therapy only group


Three adverse events were reported in BoNT/occupational therapy group of the Olesch 2010 trial - One child with a maculopapular rash (immunological test to consider if response to BoNT inconclusive), one child with 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

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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