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

easily rectified with dosage adjustments. They also
highlighted the need for further research into
somatic complaints, which may be associated with
the disorder itself rather than the initiation of
treatment. Appendix 13 presents the results of this
review in more detail.
Tertiary sources
The BNF 29 details the following as possible
physical side-effects resulting from the
administration of MPH: tremor, rash, pruritus,
urticaria, fever, arthralgia, alopecia, exfoliative
dermatitis, erythema multiforme,
thrombocytopenic purpura, thrombocytopenia,
leucopoenia, dizziness, headache, gastrointestinal
symptoms, anorexia, urinary disorders, dry mouth,
sweating, convulsions, tachycardia, anginal pain,
palpitations, increased blood pressure and visual
disturbances. Rare cases of liver damage, muscle
cramps and cerebral arteritis have been noted. In
addition, cardiomyopathy has been reported with
chronic use. Choreoathetoid movements, tics and
Tourette syndrome have also been reported in
predisposed individuals. Growth retardation in
children has further been noted. Behavioural
adverse effects listed include sleep disturbances,
insomnia, depression, confusion, restlessness,
irritability and excitability, nervousness, night
terrors and euphoria. Some individuals have
presented with drug dependence and tolerance or
psychosis.
DEX versus placebo
Primary studies
Two studies comparing DEX with placebo
adequately reported adverse events data of interest
to our review. One study examining medium-dose
DEX reported no difference in adverse events
between treatment groups; 56 the other study
examining high-dose DEX reported a greater
incidence of loss of appetite, but detected no
further differences. 58
Adverse events data were not adequately reported
in the one study comparing a time-release form of
DEX with placebo.
No studies comparing combined DEX and
behavioural treatment with placebo reported
adequate adverse events data.
No adequate data were reported for studies
comparing DEX alone with a non-drug
intervention.
One study examining high-dose DEX combined
with a non-drug intervention compared with a
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Health Technology Assessment 2006; Vol. 10: No. 23
non-drug intervention alone reported adverse
events data: significantly decreased appetite and
increased insomnia were observed in the
combined treatment group. 51
One study comparing an extended-release form of
DEX combined with a non-drug intervention with
a non-drug intervention alone reported no
differences in the incidence of insomnia between
treatment phases. 78 No further adverse events data
of interest were reported.
Systematic reviews
No SR examining the adverse event profile of
DEX was identified.
Tertiary sources
The BNF 29 details the following as possible
physical side-effects resulting from the
administration of DEX: tremor, dizziness,
headache, gastrointestinal symptoms, dry mouth,
anorexia, sweating, convulsions, tachycardia,
anginal pain, palpitations, increased blood
pressure and visual disturbances. In addition,
cardiomyopathy has been reported with chronic
use. Choreoathetoid movements, tics and Tourette
syndrome have also been reported in predisposed
individuals. Growth retardation in children has
further been noted. Behavioural adverse effects
listed include insomnia, restlessness, irritability
and excitability, nervousness, night terrors and
euphoria. Some individuals have presented with
drug dependence and tolerance or psychosis.
ATX versus placebo
Primary studies
Studies in this category presented evidence that
ATX (all doses) results in significantly reduced
appetite compared with placebo, but does not
impact the incidence of headache, stomach ache
or insomnia. 63,73–75,89,94 In the one trial that
reported weight data, ATX appeared to have an
adverse effect on children’s weight gain. 73
Systematic reviews
No SR examining the adverse event profile of
atomoxetine hydrochloride was identified.
Tertiary sources
The BNF 29 cites the following as physical sideeffects
associated with the administration of ATX:
anorexia, dry mouth, nausea, vomiting, abdominal
pain, constipation, dyspepsia, flatulence,
palpitations, tachycardia, increased blood
pressure, postural hypotension, hot flushes,
dizziness, headache, fatigue, lethargy, tremor,
rigors, urinary retention, mydriasis, conjunctivitis,
77