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

STP. 77,78 Neither examined hyperactivity or
CGI as core outcomes. Behaviour was assessed
using the teacher-rated Abbreviated CTRS,
and both studies reported no significant
differences between the treatment groups (see
Appendix 12).
Adverse events
Both trials reported on the incidence of insomnia;
neither detected significant differences between
treatments. Pelham and colleagues 77 reported
the incidence of anorexia; however, no
significant differences were found between
treatments. No further data of interest were
reported.
Summary
No studies in this category evaluated hyperactivity
or CGI as outcomes. Two studies did report some
Health Technology Assessment 2006; Vol. 10: No. 23
TABLE 51 IR-MPH medium dose (15–30 mg/day) plus non-drug intervention versus ER-MPH low dose (≤ 20 mg/day) plus non-drug
intervention
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered twice daily
Pelham, 1987 77 C (3×) MPH (20 mg/day, b.d.) vs 6.5–11 7 Core: no hyp; Abbreviated CTRS
sustained-release MPH (Slow (teacher)
Release Ritalin, SR-20) (20 mg/day, QoL: not reported
o.d.) plus behaviour modification AE: Side Effects Checklists
(STP, 7 weeks) – 13 (parents, teachers, counsellors)
Pelham, 1990 78 C (5×) MPH (20 mg/day, b.d.) vs 8.1–13.2 8 Core: no hyp; Abbreviated CTRS
sustained-release MPH (Slow (teachers/counsellors)
Release Ritalin, SR-20) (20 mg/day, QoL: not reported
o.d.) plus behaviour modification AE: Side Effects Checklists
(STP, 8 weeks) – 22 (parents, teachers, counsellors)
C, crossover trial (number of crossovers); STP, Summer Treatment Programme.
TABLE 52 MPH high dose (>40 mg/day) plus non-drug intervention versus ER-MPH medium dose (20–40 mg/day) plus non-drug
intervention
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered twice or more daily
Pelham, 2001 82 C (3×) MPH (15, 30 or 45 mg/day, t.d.s.) 6–12 3 Core: no hyp; IOWA-C:
vs OROS MPH (Concerta) inattention/overactivity (teacher
(18, 36 or 54 mg/day, o.d.) plus and parent)
parent training, teacher QoL: no CGI; global effectiveness
consultation and point systems (parent and teacher)
(3 weeks) – 70 AE: questions regarding adverse
events, sleep quality, appetite,
and tics (parents); spontaneous
reports of adverse events
C, crossover trial (number of crossovers); CGI, Clinical Global Impression.
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adverse event data, and found no difference in
insomnia or anorexia.
IR-MPH high dose (>40 mg/day) plus non-drug
intervention versus ER-MPH medium dose
(20–40 mg/day) plus non-drug intervention
One crossover study evaluated high-dose
(>40 mg/day) IR-MPH plus non-drug intervention
compared with medium-dose (20–40 mg/day)
ER-MPH plus non-drug intervention (Table 52;
with additional information in Appendix 12).
The non-drug intervention involved a behavioural
programme incorporating parent training, teacher
consultation and a point system. This study by
Pelham and colleagues 82 did not evaluate
hyperactivity or CGI, but did assess a number of
other core outcomes. For some outcomes, ER-
MPH was superior to IR-MPH (see Appendix 12),
but this was not the case when inattention/
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