Table 7.12Evidence profile for botulinum toxin type A every 4 months compared with botulinum toxin type A every 12 months; lower limb; adverse events

Number of studiesNumber of participantsEffectQuality
Botulinum toxin type A every 4 monthsBotulinum toxin type A every 12 monthsRelative

(95% CI)
Absolute

(95% CI)
Proportion of children experiencing adverse effects at month 28
1 study (Kanovsky 2009)89/110 (81%)88/104 (85%)-3 fewer per 100 (from 14 fewer to 6 more)*Low
Proportion of children experiencing infection at month 28
1 study (Kanovsky 2009)17/110 (15%)18/104 (17%)-2 fewer per 100 (from 12 fewer to 8 more)*Low
Proportion of children experiencing weakness at month 28
1 study (Kanovsky 2009)15/110 (14%)15/104 (14%)-1 fewer per 100 (from 10 fewer to 9 more)*Low
Proportion of children experiencing increased cough at month 28
1 study (Kanovsky 2009)15/110 (14%)11/104 (11%)-3 more per 100 (from 6 fewer to 12 more)*Low
Proportion of children experiencing convulsions at month 28
1 study (Kanovsky 2009)6/110 (5%)14/104 (13%)-8 fewer per 100 (from 16 fewer to 0 more)*Moderate
Proportion of children developing neutralising antibodies at month 28
1 study (Kanovsky 2009)4/109 (3.7%)a1/103 (1%)a-3 more per 100*Low
Proportion of children experiencing pain at month 28
1 study (Kanovsky 2009)19/110 (17%)22/104 (21%)-4 fewer per 100*Low

CI confidence interval

*

Calculated by the NCC-WCH

a

Neutralising antibodies. Two patients were noted to have neutralising antibodies at entry to the study. A further five patients (2%) in total developed neutralising antibodies over the 2 year study period (4 monthly group = 4/110 and annual group = 1/104). In six patients the levels of antibodies were low or low–intermediate. In one patient (4 monthly group) the levels of antibodies were high although no contractures developed during the 28 month follow up and global assessments of efficacy (as subjectively assessed by physician and parent/guardian) indicated improvement

See the complete GRADE Table K.7.12 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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