Selective Serotonin Reuptake Inhibitors for Stroke Recovery

Abstract

Background<br/>Stroke is a major cause of adult disability. The 2012 Cochrane Review of SSRIs for stroke recovery demonstrated positive effects on recovery. We updated this review in 2019 because a large trial of fluoxetine for stroke recovery (Fluoxetine or Control Under Supervision, FOCUS) was published in December 2018. <br/>Objectives<br/>To determine if SSRIs are more effective than placebo or usual care at improving outcomes in people less than 12 months post‐stroke, and to determine associations with adverse effects. <br/>Search methods<br/>We searched several electronic databases up to July 2018, trials registers and grey literature. <br/>Selection criteria<br/>We selected all randomized controlled trials (RCTs) of any SSRI treatment versus no usual care or placebo recruiting patients who had had a stroke in the previous year. Trials had to collect data on at least one of our primary (disability score or independence) or secondary outcomes (impairments, depression, anxiety, quality of life, fatigue, healthcare cost, death, adverse events and leaving the trial early). <br/>Data collection and analysis<br/>Two review authors independently extracted data and assessed risk of bias. We calculated standardised mean differences (SMDs), and risk ratios (RRs) as appropriate. We restricted the primary analysis to studies at low risk of bias. <br/>Main results<br/>We identified a total of 63 eligible trials recruiting 9168 participants. About half the trials required participants to have depression to enter the trial. The duration, drug, and dose varied between trials. Meta‐analysis of the three trials at low risk of bias found no effect of SSRI on disability score (SMD −0.01; 95% CI −0.09 to 0.06; P = 0.75; 2 studies, 2829 participants) or independence (RR 1.00; 95% CI 0.91 to 1.09; P = 0.99; 3 studies, 3249 participants) (see Figure). We downgraded both these outcomes for imprecision. <br/><br/>Figure: Forest plot of the outcome independence; comparing SSRIs with usual care or placebo. CI indicates confidence interval.<br/>SSRIs reduced the depression scores but increased gastrointestinal side effects. When all trials were included irrespective of risk of bias, SSRIs reduced disability scores but not dependence. <br/><br/>Authors' conclusions and implication<br/>There is no reliable evidence that SSRIs should be used routinely to promote recovery after stroke. <br/>

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