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

showed persisting significant superiority over
behavioural treatment and community care for
ADHD and oppositional–defiant symptoms at
24 months, although not as great as at 14 months.
Significant additional benefits of combined
treatment over medication management and of
behavioural treatment over community care were
not found. The groups differed significantly in
mean dose (MPH equivalents: 30.4, 37.5, 25.7 and
24.0 mg/day, respectively). 113
Summary of clinical effectiveness
data
MPH versus placebo
Studies that evaluated low-dose MPH compared
with placebo demonstrated variable results for
hyperactivity. 43,54,55,60,61,96 No differences in CGI
were reported between the groups96 (no other
studies measured this outcome). With mediumdose
MPH, the majority of studies demonstrated
that MPH was superior to placebo for
hyperactivity; 42,43,46,54,60,61,68,98 (no results were
significant in the study by Stein and colleagues91 ),
and one study reported that MPH improved CGI
compared with placebo83 (no other studies
measured this outcome). The two studies that
evaluated hyperactivity with high-dose MPH
demonstrated variable results, 43,77 although there
was evidence that high-dose MPH improved
CGI. 97 [Confidential information from one study
that evaluated the effectiveness of high-dose
MPH on CGI removed].
There was a paucity of studies that examined
MPH (any dose) plus a non-drug intervention
(e.g. cognitive therapy) compared with placebo.
Only one study reported data for hyperactivity,
and the results were not significant. 42 In addition,
very few studies examined the effectiveness of
ER-MPH compared with placebo. Of these studies,
the majority reported that ER-MPH (low, medium
or high) was superior to placebo for all outcomes
of interest (hyperactivity 55;97 and CGI 59,93,97 ).
[Confidential information from one study that
reported on CGI removed].
Again, very few studies compared MPH with a
non-drug intervention (e.g. parent training,
cognitive training and behavioural therapy).
Three studies evaluated hyperactivity, two of which
demonstrated that children receiving MPH were
significantly improved compared with children
receiving a non-drug intervention 42,53 and one
which demonstrated variable results depending on
the scale used. 65
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Health Technology Assessment 2006; Vol. 10: No. 23
A larger number of studies examined MPH in
combination with a non-drug intervention (e.g.
parent training, one-to-one reading therapy,
cognitive therapy and parent and teacher
education) compared with a non-drug intervention.
Of these, five presented reproducible results on
hyperactivity and two reported results on CGS.
Generally, combined treatment was superior to
non-drug treatment for hyperactivity 42,53,71 and
Clinical Global Impression. 51,65 In two studies,
hyperactivity was improved when assessed by
teachers, but not by parents 65,86 (in these cases the
non-drug interventions were parent training or
support and parent and teacher education).
No studies that compared ER-MPH plus non-drug
intervention with a non-drug intervention
evaluated hyperactivity or CGI.
Generally, the studies that evaluated MPH did not
adequately report on study methodology, and the
results should be interpreted with caution.
DEX versus placebo
Only two studies that compared DEX and placebo
reported reproducible data on hyperactivity. 36,45
When assessing the efficacy of medium-dose DEX,
the results for hyperactivity varied depending on the
scale used. 45 For higher dose DEX, hyperactivity
and CGI appeared to be improved with drug
treatment 36 (statistical results for hyperactivity
were not reported). Generally, this study rated well
in the quality assessement. An additional study by
Arnold and colleagues 38 evaluated DEX-TR
compared with placebo. They observed significant
improvements in hyperactivity with treatment.
However, owing to the poor reporting of some
methodological criteria, the results from this study
should be interpreted with caution.
No studies comparing DEX plus non-drug
treatment versus placebo or DEX versus non-drug
intervention, measured hyperactivity or CGI as
outcome measures. One study compared DEX in
combination with a non-drug treatment (academic
instruction and therapeutic recreation) with nondrug
treatment alone with hyperactivity as an
outcome. 62 Results were significant in favour of the
combined treatment group when assessed using
the CTRS and the Children’s Psychiatric Rating
Scale, but not when assessed using the CPRS. CGI
was not examined. In addition to evaluating
immediate release DEX, James and colleagues 62
also examined DEX-SR. In this study, combination
treatment resulted in improved behaviour
compared with non-drug treatment alone.
However, this study did not score very well in the
75