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did report that there were no significant
differences between treatments in the incidence of
insomnia (other adverse events of interest were
not examined). This study 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 DEX-SR plus non-drug
intervention
One study evaluated low-dose (≤ 20 mg/day) ER-
MPH compared with DEX-SR plus non-drug
intervention (Table 59; with additional information
in Appendix 12). As presented above, this study
did not report any hyperactivity or QoL outcomes.
The scores between treatment groups were similar
when assessed using the Abbreviated CTRS (see
Appendix 12).
Adverse events
No significant differences were detected in the
incidence of insomnia between DEX-SR and ER-
MPH. Occurrences of headache, stomach ache
and loss of appetite were not recorded by patients
or parents. No weight data were reported.
Health Technology Assessment 2006; Vol. 10: No. 23
TABLE 59 ER-MPH low dose (≤ 20 mg/day) plus non-drug intervention versus DEX-SR plus non-drug intervention
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered once daily
Pelham, 1990 78 C (5×) Sustained-release MPH (Slow 8.1–13.2 8 Core: no hyp; Abbreviated CTRS
Release Ritalin, SR-20) (20 mg/day, (teachers/counsellors)
o.d.) vs DEX-SR (10 mg/day, o.d.) QoL: not reported
plus behaviour modification (STP, AE: Side Effects Checklists
8 weeks) – 22 (parents/teachers/counsellors)
C, crossover trial (number of crossovers); STP, Summer Treatment Programme.
TABLE 60 MPH high dose (>30 mg/day) versus ATX high dose (≥ 1.5 mg/kg/day)
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered twice daily
Kratochvil, P MPH (31.3 mg/day 1–3×) vs ATX 7–15 10 Core: ADHD-RS-IV–Parent
2002 70 (max. 2.0 mg/kg/day, b.d.) – 228 Version (investigator administered
and scored):
hyperactivity/impulsivity;
CPRS-R: hyperactivity
QoL: CGI
AE: open-ended questions;
weight
CPRS-R, Conners’ Parent Rating Scale – Revised; CGI, Clinical Global Impression; P, parallel trial.
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Summary
As above, one study was included in this
category, 78 but it did not evaluate hyperactivity or
CGI. This study reported that there were no
significant differences between treatments in the
incidence of insomnia (other adverse events of
interest were not examined). This study did not
score very well in the quality assessment, and any
results should be interpreted with caution.
MPH versus ATX
MPH high dose (>30 mg/day) versus ATX high
dose (≥1.5 mg/kg/day)
One study evaluated high-dose (>30 mg/day) IR-
MPH compared with high-dose (≥1.5 mg/kg/day)
ATX (Table 60; with additional information in
Appendix 12).
In this parallel study by Kratochvil and colleagues, 70
hyperactivity was measured using two scales. No
differences were reported between the treatment
groups using either scale (Table 61). This study also
reported on CGI – Severity. Again, no difference was
reported in children in the MPH group compared
with children in the DEX group (p = 0.663).
71