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

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Clinical effectiveness
(in favour of the MPH group) when assessed
by teachers and non-significant when assessed by
parents. One study reported results for CGI 51
and one measured Clinical Global Improvement. 65
Both studies reported that children receiving
MPH in addition to a behavioural modification
programme, or parent and teacher education,
showed improvement compared with
children receiving only non-drug treatments.
Regarding adverse events, no differences
were observed between treatment groups for
headache or stomach ache. One study reported
a higher incidence of loss of appetite and
insomnia in the MPH group, whereas the other
two did not. However, these studies did not
score very well in the quality assessment,
and any results should be interpreted with
caution.
ER-MPH low dose (20 mg/day) plus non-drug
intervention versus non-drug intervention
Two studies evaluated low-dose (≤ 20 mg/day)
ER-MPH plus non-drug intervention compared
with a non-drug intervention (Table 28; with
additional information in Appendix 12). 77,78 Both
studies were crossover trials conducted by Pelham
and colleagues that examined the effectiveness of
ER-MPH in association with a behaviour
modification programme. Neither reported
hyperactivity as a core outcome measure, but both
measured behaviour using the Abbreviated
Conners’ Rating Scale as measured by teachers
(and counsellors). Only one significant result was
reported: Pelham and colleagues 78 found
behaviour was improved in children receiving ER-
MPH plus behaviour modification in comparison
with children receiving only behaviour
modification (p < 0.05) when assessed by
counsellors.
Adverse events
Neither study displayed significant differences
between treatments in the incidence of insomnia.
Data regarding other adverse events or weight
were not adequately reported to be included in the
analysis.
Summary
No studies in this category measured hyperactivity
or CGI as outcome measures. Only data on
insomnia could be evaluated, and no differences
were observed between treatment groups. These
studies did not score very well in the quality
assessment, and the results should be interpreted
with caution.
ER-MPH medium dose (20–40 mg/day) plus nondrug
intervention versus non-drug intervention
Only one study evaluated medium-dose
(20–40 mg/day) extended-release MPH plus nondrug
intervention compared with a non-drug
intervention (Table 29; with additional information
in Appendix 12). In this crossover trial, the nondrug
intervention involved a behavioural
programme incorporating parent training, teacher
consultation and a point system. 82 One of the main
outcomes examined was inattention/overactivity as
measured using the IOWA-C. Behaviour was
significantly improved in the combined treatment
group compared with the non-drug intervention
group when assessed by teachers, parents and
counsellors (see Appendix 12).
Although Pelham and colleagues 82 did not
examine CGI, they did measure global
effectiveness (as assessed by parents and teachers).
They observed that consistently higher
percentages of children rated better in the
combined treatment compared with the non-
TABLE 29 ER-MPH medium dose (20–40 mg/day) plus non-drug intervention versus non-drug intervention
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered once daily
Pelham, 2001 82 C (3×) OROS MPH (Concerta) (18, 36 6–12 3 Core: no hyp; IOWA-C
or 54 mg/day, o.d.) vs parent (inattention/overactivity) (teacher,
training, teacher consultation and parent, counsellor)
point systems (3 weeks) – 70 QoL: no CGI; global effectiveness
(parent/teacher)
AE: questions regarding adverse
events, sleep quality, appetite,
and tics (parents) plus
spontaneous reporting
C, crossover trial (number of crossovers); CGI, Clinical Global Impression.