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

TABLE 30 DEX medium dose (10–20 mg/day) versus placebo
intervention group (p < 0.001 for parent and
teacher scores) (see Appendix 12).
Adverse events
Participants suffered from a significantly greater
loss of appetite in the MPH group compared with
placebo (RR = 4.33; 95% CI 1.29 to 14.54).
Differences in the incidence of headache, stomach
ache or insomnia were not detected. Data on
weight were not reported.
Summary
No studies in this category measured hyperactivity
or CGI as outcome measures. Of the four adverse
events, only loss of appetite was observed to be
significantly greater in the MPH group than in the
placebo group. This study did not score very well
in the quality assessement, and the results should
be interpreted with caution.
Health Technology Assessment 2006; Vol. 10: No. 23
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered two or more times daily
Conners, 1972 45 P DEX (20 mg/day, b.d.) – 28 6–12 8 Core: symptom checklist:
hyperactivity; parent
questionnaire: hyperactivity
QoL: CGI
AE: no specific scale reported
Gillberg, 1997 56 P DEX (17 mg/day, b.d.) – 32 6–11 15 months Core: CPRS: impulsivity/
hyperactivity; CTRS: hyperactivity
QoL: no CGI
AE: incidence of 20 adverse
events; weight
P, parallel, trial; CPRS, Conners’ Parent Rating Scale; CGI, Clinical Global Impression.
TABLE 31 Results for hyperactivity [DEX medium dose (10–20 mg/day) versus placebo]
Study Scale DEX medium dose: Placebo: p-Value
mean (SD) mean (SD) (if reported) a
6–12 years
Conners, 1972 45 Symptom checklist 6.2 (SD not reported) 13.3 (SD not reported) S – NR
(hyperactivity)
Parent questionnaire 10.6 13.4 NS
(hyperactivity)
a Note that owing to the overall poor reporting of study methodology, p-Values should be interpreted with caution.
Lower scores represent a better behavioural outcome.
NS, not significant; S – NR, significant (value not reported).
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DEX versus placebo
DEX medium dose (10–20 mg/day) versus
placebo
Two studies evaluated medium-dose
(10–20 mg/day) DEX compared with placebo
(Table 30; with additional information in
Appendix 12). In both studies, DEX was
administered twice per day and evaluated using a
parallel design.
Hyperactivity
Both studies examined hyperactivity as one of the
core outcome measures. However, Gillberg and
colleagues 56 presented their results in graph form
only, and their results could not be included in
Table 31. Conners and colleagues 45 reported a
significant difference between DEX and placebo
when using a symptom checklist, but not when
measured using the parent questionnaire.
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