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

34
Clinical effectiveness
Study
Parallel trials
Gittelman-Klein 1976
Quinn 2003
Wolraich 2001
Crossover trials
Ahmann 1993
Barkley 1990
Klorman 1987
Klorman 1990
MPH (high dose)
n/N
22/41
20/107
132/206
46/82
2/19
14/48
studies included participants spanning a wide age
range: 5–13 and 5–15 years, respectively.
One parallel and two crossover trials detected a
significantly higher incidence of insomnia in the
treatment groups, with the greatest RR in the
parallel study (4.10) compared with RRs of 1.51
and 1.70 in the crossover trials (Figure 11).
[Confidential information removed].
Placebo
n/N
1/42
12/99
54/206
12/82
6/19
3/48
FIGURE 9 Relative risks of loss of appetite: MPH (high dose) versus placebo
Study
Parallel trials
Gittelman-Klein 1976
Quinn 2003
Wolraich 2001
Crossover trials
Ahmann 1993
Barkley 1990
Klorman 1987
Klorman 1990
MPH (high dose)
n/N
2/41
6/107
74/206
29/82
1/19
4/48
Placebo
n/N
1/42
1/99
35/206
15/82
1/19
2/48
FIGURE 10 Relative risks of stomach ache: MPH (high dose) versus placebo
Summary
Only two studies reported detailed data on
hyperactivity and there was variability in the
results. The one non-confidential study that
reported data on CGI reported improved
behaviour in the high-dose MPH group compared
with placebo [Confidential information removed].
Adverse event data showed that high-dose MPH
seems to be associated with higher incidences of
RR (fixed)
95% CI
[Confidential information removed]
0.1 0.2 0.5 1 2 5 10
Favours MPH Favours placebo
RR (fixed)
95% CI
[Confidential information removed]
0.1 0.2 0.5 1 2 5 10
Favours MPH Favours placebo
22.54
1.54
2.44
3.83
0.33
4.67
2.05
5.55
2.11
1.93
1.00
2.00
headaches, loss of appetite, stomach ache and
insomnia, although not all differences were
significant. Most of these studies did not score
very well in the quality assessment and their
results should be interpreted with caution.
[Confidential information removed].
RR (fixed)
95% CI
(3.18 to 159.56)
(0.80 to 2.99)
(1.90 to 3.14)
(2.20 to 6.69)
(0.08 to 1.45)
(1.43 to 15.20)
RR (fixed)
95% CI
(0.19 to 21.73)
(0.68 to 45.30)
(1.49 to 3.01)
(1.12 to 3.33)
(0.07 to 14.85)
(0.38 to 10.41)
MPH low dose (≤15 mg/day) plus non-drug
intervention versus placebo
No studies reported on low-dose (≤15 mg/day)
immediate-release MPH plus a non-drug
intervention versus placebo.
MPH medium dose (15–30 mg/day) plus non-drug
intervention versus placebo
Three studies examined medium-dose
(15–30 mg/day) immediate-release MPH plus nondrug
intervention compared with placebo (Table 9;
with additional information presented in