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

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Clinical effectiveness
TABLE 57 MPH high dose (>30 mg/day) plus non-drug intervention versus DEX high dose (>20 mg/day) plus non-drug intervention
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered two or more times daily
Elia, 1991 51 C (3x) MPH (25–90 mg/day, b.d.) vs 6–12 9 Core: CTRS: hyperactivity;
DEX (mean 10–45 mg/day, b.d.) CPQ: hyperactivity
plus behaviour modification + diet QoL: CGI (physician); C-GAS
(11 weeks) – 48 AE: STESS (physician, parents)
C, crossover trial (number of crossovers); CGI, Clinical Global Impression; C-GAS, Children’s Global Assessment Scale;
CPQ, Conners’ Parent Questionnaire; CTRS, Conners’ Teacher Rating Scale; STESS, Subject Treatment Emergent Symptom
Scale.
TABLE 58 MPH medium dose (15–30 mg/day) plus non-drug intervention versus DEX-SR plus non-drug intervention
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered two or more times daily
Pelham, 1990 78 C (5×) MPH (20 mg/day, b.d.) vs 8.1–13.2 8 Core: no hyp; Abbreviated CTRS
DEX-SR (10 mg/day, o.d.) plus (teachers/counsellors)
behaviour modification (STP, QoL: not reported
8 weeks) – 22 AE: Side Effects Checklists
(parents/teachers/counsellors)
C, crossover trial (number of crossovers); STP, Summer Treatment Programme.
MPH high dose (>30 mg/day) plus non-drug
intervention versus DEX high dose (>20 mg/day)
plus non-drug intervention
One study evaluated high-dose (>30 mg/day)
IR-MPH compared with high-dose (>20 mg/day)
DEX (Table 57; with additional information in
Appendix 12). Although this study by Elia and
colleagues 51 examined hyperactivity and CGI as
outcomes, the results were presented in graph
form only and could not be reproduced in a table.
The authors did report that both drugs were
found to be equally efficacious.
Adverse events
No significant differences were detected in the
incidence of decreased appetite or insomnia
between treatment periods (RR = 1.12; 95% CI
0.98 to 1.28 and RR = 1.03; 95% CI 0.84 to 1.25).
No further data were reported.
Summary
One study evaluated high-dose MPH plus nondrug
intervention compared with high-dose DEX
plus non-drug intervention, 51 but no data could be
extracted for hyperactivity or CGI. The trial did
not report any differences between groups for
appetite or insomnia (the only adverse events that
were examined). This study did not score very well
in the quality assessment, and any results should
be interpreted with caution.
MPH medium dose (15–30 mg/day) plus non-drug
intervention versus DEX-SR plus non-drug
intervention
One study evaluated medium-dose (15–30 mg/day)
IR-MPH compared with DEX-SR plus non-drug
intervention (Table 58; with additional information
in Appendix 12). This study did not report any
hyperactivity or QoL outcomes. They did measure
behaviour using the Abbreviated CTRS (as
assessed by teachers and counsellors). The scores
between treatment groups were similar (see
Appendix 12).
Adverse events
No significant differences were detected in the
incidence of insomnia between DEX-SR and IR-
MPH. Occurrences of headache, stomach ache
and loss of appetite were not recorded by patients
or parents. No weight data were reported.
Summary
One study was included in this category, 78 but it
did not evaluate hyperactivity or CGI. This study