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

Study Intervention Participants Outcomes
Core symptoms
Not reported
Reference
Gittelman-Klein et al.,
1976 57
Co-existent problems
Not reported
Source
AHRQ Report
Educational performance
Not reported
Setting
USA
Psychological function
Not reported
Arm 1
MPH
Fixed dose for first 4 weeks to a maximum
dosage of 60 mg/day unless noticeable sideeffects
occurred; MPH twice daily (a.m., lunch)
and placebo once daily (night)
Mean dosages (at 12 weeks) 1.66 mg/kg/day
(0.83–3.08 mg/kg/day)
(Individual administering medication not
reported)
Design
Parallel trial
Depression or anxiety
Not reported
Inclusion criteria
1. 6–12 years old
2. Attending school
3. Free of neurological disease, such as epilepsy,
hemiparesis, cerebral palsy, microcephaly
4. Non-psychotic
5. WISC IQ of ≥ 80 and a sub-IQ of ≥ 85
6. A parent or responsible adult willing to come for
weekly visits
7. Home telephone
8. Family fluent in English
9. No previous history of psychopharmacological
treatment (more than a daily dose of 5 mg DEX or
10 mg MPH for a 2-month period).
Quality of life
Not reported
Adverse events
Side-effects standardised form: severity and
consistency
Arm 2
Thioridazine hydrochloride
Fixed dose for first 4 weeks to a maximum
dosage of 300 mg/day unless noticeable sideeffects
occurred; placebo twice daily (a.m.,
lunch) and thioridazine hydrochloride once daily
(night)
Mean dosage 4.54 mg/kg/day
(0.99–14.38 mg/kg/day)
(Individual administering medication not
reported)
Duration
Drug treatment
periods: 12 weeks each;
placebo treatment
period: 4 weeks
Additional outcomes
Not reported
Diagnostic criteria
DSM-II
CTRS, Home Hyperactivity Scale (parents), Test
Behaviour Scale (psychologists, psychiatrists) were
used for diagnosis
Purpose
To evaluate the relative
efficacy of a stimulant
and a phenothiazine in
the treatment of
hyperkinetic children
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Health Technology Assessment 2006; Vol. 10: No. 23
Number
Total randomised = 166 (male = 140/155)
Arm 1 = 41
Arm 2 = 41
Arm 3 = 42
Arm 4 = 42
Total withdrawals = 11
Arm 1 = 2
Arm 2 = 5
Arm 3 = 3
Arm 4 = 1
Reasons for withdrawals:
Arm 1: 1/2 dropped out owing to poor family
motivation; 1/2 dropped out owing to sleep
difficulties
Arm 2: 2/5 had extreme drowsiness, 1/5 had
nosebleeds, 1/5 parents dissatisfied with lack of
improvement, 1/5 did not follow prescription and
stopped attending appointments
Arm 3
MPH and thioridazine hydrochloride
Fixed dose for first 4 weeks to a maximum
dosage of 60 mg/day and 300 mg/day,
respectively, unless noticeable side-effects
occurred; dosages to be equal for each drug;
MPH twice daily (a.m., lunch) and thioridazine
hydrochloride once daily (night)
Mean dosage 1.59 mg/kg/day MPH
(25–60 mg/day) and 3.94 mg/kg/day thioridazine
hydrochloride (25–300 mg/day)
(Individual administering medication not
reported)
Arm 4
Placebo
Three times daily (a.m., lunch, night)
(Individual administering medication not
reported)
continued
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