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

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Clinical effectiveness
Summary
Only one study in this category examined
hyperactivity as an outcome. 62 In this study,
children who received DEX in combination with
academic instruction and therapeutic recreation
had better behaviour than those in the nonintervention
group when assessed using the CTRS
and the Children’s Psychiatric Rating Scale, but
not when assessed using the CPRS. No studies in
this category evaluated CGI. Owing to the poor
reporting of some methodological criteria, the
results from this study should be interpreted with
caution.
DEX high dose (>20 mg/day) plus non-drug
intervention versus non-drug intervention
One study evaluated high-dose (>20 mg/day) DEX
plus non-drug intervention compared with a nondrug
intervention (Table 40; with additional
information in Appendix 12). In this crossover
study, drug treatment was combined with a
multidisciplinary behaviour modification
programme and low monoamine diet. Although
the authors evaluated hyperactivity and CGI (with
results favouring the combined treatment group),
data were presented in graph form only and could
not be reproduced.
Adverse events
A significantly higher incidence of reduced
appetite and insomnia was detected during the
active drug phase of this trial (RR = 93.00; 95%
CI 5.90 to 1467.03 and RR = 3.00; 95% CI 1.85
to 4.87, respectively). Data on headache, stomach
ache or weight were not reported.
Summary
No studies in this category reported reproducible
data on hyperactivity or CGI. The one study in
this category reported significantly greater
incidence of loss of appetite and insomnia in the
combined treatment group.
TABLE 40 DEX high dose (>20 mg/day) plus non-drug intervention versus non-drug intervention
DEX-SR plus non-drug intervention versus nondrug
intervention
Two studies examined sustained-release DEX
(DEX-SR) plus non-drug intervention compared
with a non-drug intervention (Table 41; with
additional information in Appendix 12). In the
study by Pelham and colleagues 1990, 78
hyperactivity was not assessed, although the
authors did evaluate behaviour using the
Abbreviated CTRS. They reported that behaviour
was improved in the combined treatment group
compared with the behaviour modification group
(p < 0.050). This study also reported data on
adverse events (see below).
In addition to evaluating immediate-release DEX,
James and colleagues 62 examined DEX-SR
administered once weekly in combination with
formal academic instruction and therapeutic
recreation. Hyperactivity was improved in the
combined treatment group compared with the
non-drug treatment group when assessed using
the Children’s Psychiatric Rating Scale and the
CPRS. Statistical comparisons for the CTRS were
not reported (Table 42). This study did not
examine CGI as an outcome measure.
Adverse events
Of the two trials comparing DEX-SR and nondrug
intervention with a non-drug intervention
alone, one provided adequate data regarding the
adverse events of interest. 78 Differences in the
incidence of insomnia were not found between
treatment phases. Incidence of headache, stomach
ache or loss of appetite was not rated by patients
or parents. Neither study reported data on weight.
Summary
Of the two studies included in this category, one
evaluated hyperactivity as an outcome measure. 62
In this study, DEX-SR in combination with formal
academic instruction and therapeutic recreation
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered two or more times a day
Elia, 1991 51 C (3×) DEX (mean 10–45 mg/day, b.d.) 6–12 9 Core: CTRS: hyperactivity;
vs multidisciplinary behaviour CPQ: hyperactivity
modification programme and diet QoL: CGI (physician); C-GAS
(twice daily, 11 weeks) – 48 AE: STESS (physician, parents)
C, crossover trial (number of crossovers); C-GAS, Children’s Global Assessment Scale; CGI, Clinical Global Impression;
CPQ, Conners’ Parent Questionnaire; CTRS, Conners’ Teacher Rating Scale; STESS, Subject Treatment Emergent Symptom
Scale.