Summary of findings 1. Fluoxetine versus control at end of treatment, for stroke recovery, using data from high quality trials only.
| Fluoxetine 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: fluoxetine versus control at end of treatment *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 | Fluoxetine versus control at end of treatment | |||||
| Disability (primary analysis) | SMD 0.0 (‐0.05, 0.05) | 5436 (5 studies) | ⊕⊕⊕⊕ High | ‐ | ||
| Independent on modified Rankin score (mRS 0 to 2) (primary analysis) | Study population | RR 0.98
(0.93 to 1.03) |
5926 (5 studies) | ⊕⊕⊕⊕ High | ‐ | |
| 1541/2971 (i.e. 52 per hundred) | 1498/2955 (i.e. 51 per hundred) |
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| Neurological deficit score | SMD ‐0.39 (95% CI (‐1.12 to 0.33) | 30 participants, one study | ⊕⊕⊝⊝ Lowa |
This is a small effect (based on the 'rule‐of‐thumb' method for interpreting SMD) | ||
| Depression (continuous data) | SMD ‐0.14 (‐0.19 to ‐0.08) | 5356 (4 studies) | ⊕⊕⊕⊕ High | This is a small effect (based on the 'rule‐of‐thumb' method for interpreting SMD) | ||
| Death | Study population | RR 1.01 (0.82 to 1.24) | 6090 (6 studies) | ⊕⊕⊕⊝ Moderate | ‐ | |
| 168/3029 (i.e. 55 per thousand) | 170/3061 (i.e. 56 per thousand) |
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| Number of seizures | Study population | RR 1.40 (1.00 to 1.98) | 6080 (6 studies) | ⊕⊕⊕⊝ Moderatec |
‐ | |
| 54/3024 (i.e. 18 per thousand) | 76/3056 (i.e. 25 per thousand) | |||||
| Bone fractures | Study population | RR 2.35 (1.62 to 3.41) | 6080 (6 studies) | ⊕⊕⊕ ⊕ High | ‐ | |
| 40/3024 (i.e. 13 per thousand) |
93/3056 (i.e. 30 per thousand) |
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| *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. | ||||||
aNeurological deficit from only one trial of 30 people so we have downgraded for imprecision (GRADE 2013).
bDeath downgraded for imprecision.
cSeizures downgraded for imprecision.
Note that because we included only the low risk of bias studies in our review, none of the evidence was downgraded because of study quality.
A range of different outcome scales were used for disability (including Barthel Index and daily activities subscale of the Stroke Impact Scale), and depression (including emotional role function of the Stroke Impact Scale).