Summary of findings for the main comparison. SSRI versus control at end of treatment, by SSRI for stroke recovery.
| SSRI versus control at end of treatment, by SSRI, for stroke recovery* | ||||||
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Patient or population: people with stroke recovery
Settings: hospital
Intervention: SSRI versus control at end of treatment, by SSRI * Summary of Findings table based on studies with low risk of bias. | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | SSRI versus control at end of treatment, by SSRI | |||||
| Disability (primary analysis) | The mean disability (primary analysis) in the intervention groups was 0.01 standard deviations lower (0.09 lower to 0.06 higher) | 2829 (2 studies) | ⊕⊕⊕⊝ moderatea | Outcomes: Stroke Impact Scale (SIS) score at 6 months (FOCUS Trial Collaboration 2018); Barthel Index (BI) score on day 90 (Marquez Romero 2013) | ||
| Independent on modified Rankin score (mRS 0 to 2) (primary analysis) | Study population | RR 1.00 (0.91 to 1.09) | 3249 (3 studies) | ⊕⊕⊕⊝ moderateb,c | ‐ | |
| 367 per 1000 | 367 per 1000 (334 to 400) |
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| Neurological deficit score | The mean neurological deficit score in the intervention groups was 0.3 standard deviations lower (0.63 lower to 0.04 higher) | 142 (2 studies) | ⊕⊕⊕⊝ moderated |
Outcomes: Fugl‐Meyer Assessment (FMA) score on day 90 (Marquez Romero 2013); National Institutes of Health Stroke Scale (NIHSS) score on day 90 (Chollet 2011) | ||
| Depression (continuous data) | The mean depression (continuous data) in the intervention groups was 0.11 standard deviations lower (0.19 to 0.04 lower) | 2861 (2 studies) | ⊕⊕⊕⊝ moderatee | Outcomes Mental Health Inventory 5 (MHI‐5) score at 6 months (FOCUS Trial Collaboration 2018); Montgomery‐Åsberg Depression Rating Scale (MADRS) score on day 90 (Chollet 2011) | ||
| Death | Study population | RR 0.99 (0.79 to 1.25) | 3254 (3 studies) | ⊕⊕⊕⊕ high | ‐ | |
| 80 per 1000 | 80 per 1000 (64 to 101) | |||||
| Number of seizures | Study population | RR 1.47 (0.99 to 2.18) | 3275 (3 studies) | ⊕⊕⊕⊝ moderatef | ‐ | |
| 24 per 1000 | 36 per 1000 (24 to 53) | |||||
| Gastrointestinal side effects | Study population | RR 2.19 (1.00 to 4.76) | 148 (2 studies) | ⊕⊕⊕⊝ moderateg | ‐ | |
| 107 per 1000 | 234 per 1000 (107 to 508) | |||||
| *The basis for the assumed risk (e.g. the mean control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; SMD: standardised mean difference | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
aDisability is outcome is reported as a standardised mean difference. The sample size is large (> 400) and the 95% CI overlaps no effect and therefore we have downgraded for imprecision.(GRADE 2013). bHeterogeneity may be due to clinical variation ‐ Chollet 2011 and Marquez Romero 2013 give 20 mg fluoxetine for 90 days and FOCUS Trial Collaboration 2018 gives 20 mg for 180 days; methodological differences (when the outcomes are measured) ‐ Chollet 2011 and Marquez Romero 2013 measure at 90 days and FOCUS Trial Collaboration 2018 measures at 180 days; or population differences ‐ Chollet 2011 recruited participants only with ischaemic stroke with motor deficits, Marquez Romero 2013 recruited only participants with haemorrhagic stroke and FOCUS Trial Collaboration 2018 recruited all pathological subtypes. The trials were performed in different countries where other factors such as the amount of therapy might influence outcome. These are plausible explanations for the observed heterogeneity and we have therefore we have not downgraded the evidence (Schünemann 2017). cThe optimal information size criterion (FOCUS Trial Collaboration 2018) has been met and the 95% CI overlaps no effect; we have therefore downgraded for imprecision (GRADE 2013). dNeurological deficit outcomes reported as a SMD. Sample size is < 400 and we have therefore downgraded for imprecision (GRADE 2013). eStudies used different measures of depression. This variability in study design may have contributed to variability in intervention effects. fThe sample size is large (> 2000) but the 95% CI overlaps no effect; we have therefore downgraded for imprecision (GRADE 2013). gStudies are small with too few events and wide CIs; we have therefore downgraded for imprecision (Schünemann 2017).