Objective
To
determine whether fluoxetine, at any dose, given within the first year
after stroke to patients who did not have to have mood disorders at
randomization reduced disability, dependency, neurological deficits and
fatigue; improved motor function, mood, and cognition at the end of
treatment and follow-up, with the same number or fewer adverse effects.
Methods
Searches
(from 2012) in July 2018 included databases, trials registers,
reference lists, and contact with experts. Co-primary outcomes were
dependence and disability. Dichotomous data were synthesized using risk
ratios (RR) and continuous data using standardized mean differences
(SMD). Quality was appraised using Cochrane risk of bias methods.
Sensitivity analyses explored influence of study quality.
Results
The
searches identified 3414 references of which 499 full texts were
assessed for eligibility. Six new completed RCTs (n = 3710) were
eligible, and were added to the seven trials identified in a 2012
Cochrane review (total: 13 trials, n = 4145). There was no difference in
the proportion independent (3 trials, n = 3249, 36.6% fluoxetine vs.
36.7% control; RR 1.00, 95% confidence interval 0.91 to 1.09, p = 0.99, I
2 = 78%) nor in disability (7 trials n = 3404, SMD 0.05, −0.02 to 0.12 p = 0.15, I
2 = 81%)
at end of treatment. Fluoxetine was associated with better neurological
scores and less depression. Among the four (n = 3283) high-quality
RCTs, the only difference between groups was lower depression scores
with fluoxetine.
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