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

Study
Parallel trials
Gittelman-Klein 1976
Quinn 2003
Crossover trials
Ahmann 1993
Barkley 1990
Klorman 1987
Klorman 1990
MPH (high dose)
n/N
28/41
110/206
56/82
3/19
8/48
Placebo
n/N
7/42
73/206
33/82
4/19
6/48
FIGURE 11 Relative risks of insomnia: MPH (high dose) versus placebo
Appendix 12). All of the studies examined
medium-dose MPH administered more than once
daily.
Only one of these studies evaluated MPH
treatment plus non-drug intervention using
hyperactivity as an outcome variable (Table 10). 42 In
this parallel study, the non-drug intervention was
cognitive therapy. Statistical comparisons between
the treatment arms for the (CPRS) or ACTeRs were
not clearly reported by the authors; however, mean
differences (MDs) and 95% CIs show no significant
differences between the groups.
Rating scale
The remaining two studies evaluated mediumdose
MPH plus non-drug treatment by measuring
inattention/overactivity (as one of the core
outcomes) using the IOWA Conners’ Rating Scales
(IOWA-C). 69,79 Both studies examined MPH plus a
behavioural modification intervention, and both
reported that combined treatment was better than
placebo; however, the statistical results were not
clearly presented (see Appendix 12).
Adverse events
None of the trials presented informative adverse
event data.
Summary
Only one study evaluated the effectiveness of
MPH plus a non-drug intervention compared with
placebo using hyperactivity as an outcome, 42 and
the results from these comparisons were not
significant. None of the studies evaluated CGI.
MPH high dose (>30 mg/day) plus non-drug
intervention versus placebo
Two studies evaluated high-dose (>30 mg/day)
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Health Technology Assessment 2006; Vol. 10: No. 23
RR (fixed)
95% CI
[Confidential information removed]
0.1 0.2 0.5 1 2 5 10
Favours MPH Favours placebo
4.10
1.51
1.70
0.75
1.33
RR (fixed)
95% CI
(2.02 to 8.32)
(1.20 to 1.89)
(1.25 to 2.30)
(0.19 to 2.91)
(0.50 to 3.55)
immediate-release MPH plus non-drug
intervention compared with placebo (Table 11; with
additional information presented in Appendix 12).
Both studies in this category used the IOWA-C to
evaluate inattention/overactivity. As presented in
Table 11, both examined MPH plus a behavioural
modification intervention and a placebo group.
Both reported that the MPH plus nonintervention
group differed from the placebo
group; however, direct statistical comparisons were
not clearly reported (see Appendix 12).
Adverse events
None of the trials presented informative adverse
event data.
Summary
No studies in this category examined hyperactivity
or CGI or reported informative adverse event
data.
ER-MPH low dose (20 mg/day) versus placebo
Two studies examined low-dose (≤ 20 mg/day)
extended-release MPH (ER-MPH) compared with
placebo (Table 12; with additional information
presented in Appendix 12). Both studies
examined low-dose MPH administered once daily.
Only one of these studies measured hyperactivity
as an outcome. 55 Using the Conners’ Hyperactivity
Index, this crossover study reported that low-dose
ER-MPH resulted in improved behaviour
compared with placebo, when assessed by both
parents and teachers (Table 13). The other study in
this category measured other behavioural
outcomes using scales such as the ADHD Rating
Scale IV. 92 Details from these results are presented
in Appendix 12.
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