APPENDICES. A systematic review and economic model of the ...

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Appendix 13
Study characteristics Results Validity
Inclusion criteria
Fair
Reference
Rapport and Moffitt, 2002 114
Search strategy
Fair
Validity assessment
Poor
Adverse events
Weight:
8/11 studies investigating effects on weight found significant differences in expected levels of weight
gain, less comparable weight gain between treated and untreated children, between placebo and
active medication conditions or between baseline and active medication. However, one of these
studies consequently found no difference between groups at 2-year follow-up
Objective
To review three classes (height/weight,
cardiovascular and somatic complaints)
of treatment-emergent symptoms
(side-effects) associated with MPH
therapy for children with ADHD
Study details
Good
Reviewers’ comments
A ‘vote counting’ method of
synthesis is used in this review;
degree of effect is not given
Height:
4/10 studies reported significant reductions in expected levels of height gain, less comparable height
gain relative to control children, lower height percentile under active medication contrasted with
baseline and greater expected gains in height percentiles at 2-year follow-up in children discontinued
from medication during summer months. In two of these studies, initial differences were no longer
significant at longer term follow-up assessments
Intervention
Studies assessing MPH treatment
Cardiovascular effects:
7/14 studies detected significant effects of MPH on heart rate between placebo and active drug
conditions or between high- vs low-dose conditions. One further study found that initial differences
were not sustained over time
Population
Studies examining children described
as hyperactive (pre-1980) or meeting
DSM criteria for ADHD (post-1980)
5/10 studies reported elevated systolic blood pressure compared with placebo or baseline. 6/10
studies reported elevated diastolic blood pressure compared with placebo or baseline
Included studies
10 longitudinal studies
22 RCTs
2 CCTs
Somatic complaints:
8/12 studies reported significantly more complaints under MPH conditions. Loss of appetite, sleep
disturbances, dizziness, headaches and stomach aches were the most common complaints reported.
4/12 studies reported a greater number of complaints under placebo conditions, whereas 2/12
detected no differences between treatment arms
Authors’ conclusions
The more easily quantifiable side-effects (e.g. blood pressure, heart rate, height/weight) are mostly
transient, dose dependent, easily rectified with dosage adjustments and considered minor from a
clinical perspective considering the breadth and level of improvement in behaviour and cognitive
functioning observed in most children. Previously reported somatic complaints associated with
psychostimulant therapy may reflect symptoms occurring prior to initiation of treatment and require
additional study