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

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Clinical effectiveness
quality assessment, and the results should be
interpreted with caution.
ATX versus placebo
Generally, there was consistent evidence that ATX
was superior to placebo for hyperactivity and
CGI. 63,73–75,89 No studies compared ATX with nondrug
treatment. Two of these studies were deemed
to be of good quality (based on the reporting of
the study methodology) and their results are likely
to be reliable. 73,89 [Confidential information from
one study that examined hyperactivity and CGI
removed].
IR-MPH versus ER-MPH
Of the studies that evaluated IR-MPH compared
with ER-MPH, no differences were reported for
hyperactivity 55,97 or CGI. 97 However, these two
studies scored poorly in the quality assessment,
and the results should be interpreted with caution.
[Confidential information from two studies that
reported on CGI removed].
MPH versus DEX
The results of comparisons between MPH and
DEX were variable. One study reported that MPH
(medium dose) was superior to DEX (low dose)
when assessed using Conners’ teacher-rated scales,
but not for Conners’ parent-rated scales. 50
Another study observed no differences between
MPH (medium dose) and DEX (medium dose) for
hyperactivity. 37 CGI was not assessed in either
study. The study that evaluated medium-dose
MPH compared with medium-dose DEX rated
well in the quality assessment, whereas the other
did not score very well, and any results should be
interpreted with caution.
MPH versus ATX
Very few studies compared MPH and ATX. One
reported no difference between the two drugs for
hyperactivity or CGI. 70 This study did not
adequately report study methodology, and the
results should be interpreted with caution.
[Confidential information from one study that
evaluated ER-MPH with ATX on hyperactivity
and CGI removed].
ATX versus DEX
No studies compared ATX versus DEX.
Summary of adverse events data
MPH versus placebo
Primary studies
Amongst studies that compared low-dose MPH
with placebo, no differences in adverse events were
detected between the treatment groups. 55,60
However, amongst studies that compared mediumor
high-dose MPH with placebo, there was
evidence that treatment was associated with higher
incidences of headaches, loss of appetite, stomach
ache and insomnia compared with
placebo. 35,39,44,46,57,60,66–68,83,91,95 [Confidential
information from one study that examined
adverse events removed].
None of the studies examining MPH (any dose)
combined with a non-drug intervention compared
with placebo presented adverse events data
informative to our analysis.
Of the studies comparing ER-MPH (any dose) with
placebo, treatment was associated with decreased
appetite and increased insomnia amongst
participants. 32,55,59,92,97 [Confidential information
from one study that examined adverse events
removed].
None of the studies comparing MPH (any dose)
alone with a non-drug intervention reported
adequate data on adverse events.
Amongst the trials comparing MPH in
combination with a non-drug intervention with a
non-drug intervention alone, the majority did not
report differences in adverse events between
treatment groups. 51,77,78,80–82,88
Of the studies comparing ER-MPH plus non-drug
intervention with a non-drug intervention alone,
the medium-dose study reported that loss of
appetite was significantly greater in the combined
treatment group. 82
Systematic reviews
Only one SR met the inclusion criteria for our
analysis of adverse events; 114 this reported on
studies assessing MPH treatment. The majority of
the included studies that examined weight
detected differences between treatment arms or
baseline and active drug conditions. Fewer studies
found effects on height, and some initial
differences were no longer significant at long-term
follow-up. Approximately half of the studies
evaluating heart rate or blood pressure detected
differences between treatment arms or baseline
and active drug conditions. Loss of appetite, sleep
disturbances, dizziness, headaches and stomach
aches were the most commonly reported somatic
complaints. The authors concluded that adverse
events related to growth and cardiovascular
outcomes were predominantly transient in nature,