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

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Clinical effectiveness
Study
Michelson 2001
Spencer 2002
Weiss 2004
ATX (high dose)
n/N
10/85
28/129
24/101
Adverse events
Of the six trials comparing a high dose of ATX
with placebo, five presented data informative to
the analysis of adverse events. Adverse events
results were combined in the trials reported by
Spencer and colleagues. 89 No significant
differences in the incidence of headache, 73,89
stomach ache 73,89 or insomnia 73 were found.
Participants in the ATX treatment groups
displayed a significantly greater loss of appetite in
two trials (Figure 18).
A detrimental effect of a high dose of ATX on
mean change in weight was observed in all four
trials (Figure 19).
Summary
High-dose ATX improved hyperactivity/impulsivity
and QoL (as measured by CGI) compared with
placebo. No significant differences in the
incidence of headache, stomach ache or insomnia
were observed between groups, although children
in the ATX had greater loss of appetite in two of
the trials. The studies by Michelson and
colleagues 73 and Spencer and colleagues 89 rated
well in the quality assessement, hence their results
are likely to be reliable. The other studies did not
score as well, and their results should be
interpreted with caution.
ATX versus non-drug intervention
No studies evaluated ATX compared with nondrug
intervention.
Placebo
n/N
4/84
9/124
2/52
FIGURE 18 Relative risks of loss of appetite: ATX (high dose) versus placebo
Study
Michelson 2001
Michelson 2004
Spencer 2002
Weiss 2004
RR (fixed)
95% CI
0.1 0.2 0.5 1 2 5 10
Favours ATX Favours placebo
2.47
2.99
6.18
RR (fixed)
95% CI
(0.81 to 7.57)
(1.47 to 6.08)
(1.52 to 25.13)
ATX (high dose) Placebo
WMD (fixed)
WMD (fixed)
N Mean (SD) N Mean (SD) 95% CI
95% CI
81 –0.50 (1.70) 83 1.70 (1.60)
–2.20 (–2.71 to –1.69)
292 1.20 (2.40) 124 3.30 (3.60)
–2.10 (–2.79 to –1.41)
127 –0.50 (1.40) 122 1.40 (1.40)
–1.90 (–2.25 to –1.55)
101 –0.67 (1.21) 52 1.21 (1.38)
–1.88 (–2.32 to –1.44)
–10 –5 0 5 10
Favours placebo Favours ATX
FIGURE 19 Differences between mean weight change: ATX (high dose) versus placebo
IR-MPH versus ER-MPH
IR-MPH low dose (≤ 15 mg/day) versus ER-MPH
low dose (≤ 20 mg/day)
One study evaluated low-dose (≤ 15 mg/day)
immediate-release MPH (IR-MPH) compared with
low-dose (≤ 20 mg/day) extended-release MPH
(ER-MPH) (Table 47; with additional information
in Appendix 12). This study by Fitzpatrick and
colleagues 55 examined hyperactivity using two
different scales as assessed by both parents and
teachers, and reported no significant differences
between IR-MPH and ER-MPH (Table 48).
This study did not evaluate CGI, but did
present comment ratings by parents and teachers
(see Appendix 12). Generally, the authors
found no differences between the MPH
conditions.
Adverse events
No significant differences in the incidence of
headache, loss of appetite, stomach ache or
insomnia were detected between treatments. Data
on weight were not adequately reported.
Summary
The one study included in this category reported
no differences between low-dose IR-MPH and
low-dose ER-MPH for hyperactivity or any
adverse events. 55 This study did not report on
CGI. The quality of reporting for some aspects
of study methodology was poor for this study,
hence the results should be interpreted with
caution.