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TABLE 47 IR-MPH low-dose (≤ 15 mg/day) versus ER-MPH low dose (≤ 20 mg/day)
IR-MPH high dose (>30 mg/day) versus
ER-MPH medium dose (20–40 mg/day)
Three studies evaluated high-dose (>30 mg/day)
IR-MPH compared with medium-dose
(20–40 mg/day) ER-MPH (Table 49; with additional
information in Appendix 12). Only one of these
studies reported data on hyperactivity (Table 50).
In this study by Wolraich and colleagues, 97 no
significant differences were reported between the
two MPH treatment groups.
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Quality of life
All three studies examined CGI. In the study by
Wolraich and colleagues, 97 the percentages of
those ‘much or very much improved’ were very
similar between treatment groups (IR-MPH 47.2%
vs ER-MPH 46.7%).
Health Technology Assessment 2006; Vol. 10: No. 23
Study Design Intervention – N Age Duration Core outcomes
(years) (weeks)
Administered twice daily
Fitzpatrick, C (4×) MPH (10–15 mg/day, b.d.) vs 6.9–11.5 8 Core: Conners’ Hyperactivity
1992 55 sustained-release MPH (Slow Index (parents/teacher); TOTS:
Release Ritalin, SR-20) (20 mg/day, hyperactivity (parents and
o.d.) – 19 teachers)
QoL: no CGI; comments ratings
(parent/teacher)
AE: STESS (parents); weight
C, crossover trial (number of crossovers); CGI, Clinical Global Impression; STESS, Subject’s Treatment Emergent Symptom
Scale; TOTs, Loney’s Time on Task Scale.
TABLE 48 Results for hyperactivity [IR-MPH low dose (≤ 15 mg/day) versus ER-MPH low dose (≤ 20 mg/day)]
Study Scale IR-MPH low dose: ER-MPH low dose: p-Value
mean (SD) mean (SD) (if reported) a
6–11 years
Fitzpatrick, 1992 55 (? Mean, ? SD) (? Mean, ? SD)
Conners’ Hyperactivity Index
(parents)
0.96 (0.50) 0.98 (0.72) NS
Conners’ Hyperactivity Index (teacher) 0.73 (0.65) 0.77 (0.63) NS
Mean (SD) Mean (SD)
TOTS (hyperactivity) (parents) 0.20 (0.31) 0.22 (0.50) NS
TOTS (hyperactivity) (teachers) 0.16 (0.44) 0.12 (0.51) NS
a Note that owing to poor reporting for some aspects of the study methodology, p-Values should be interpreted with
caution.
Lower scores represent a better behavioural outcome.
NS, not significant; TOTS, Loney’s Time on Task Scale.
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[Commercial information removed].
Adverse events
In the trial by Wolraich and colleagues, 97
participants assigned to the extended release form
of MPH suffered from a significantly higher
incidence of headache (Figure 20).
In the trial by Wolraich and colleagues, 97 no
significant differences were observed with regard
to loss of appetite or stomach ache. Data on
insomnia or weight were not reported in this trial.
[Confidential information removed].
Summary
One study in this category assessed hyperactivity
with no significant differences reported between
high-dose IR-MPH and medium-dose
ER-MPH. 97 All three studies evaluated CGI; the
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