Recovery in stroke patients treated with fluoxetine versus placebo: A pooled analysis of 7,165 patients
Abstract Purpose We conducted this study to build clear evidence regarding the outcomes of recovery in stroke patients treated with fluoxetine versus placebo. Methods Seventeen randomized clinical trials were identified by searching PubMed, Cochrane, Scopus, and Web of Science until June 2021. Results Fluoxetine enhances the National Institutes of Health Stroke Scale (NIHSS) score [MD -0.67, 95% CI (-1.19 to -0.15), P = 0.01] and the Fugl-Meyer Motor Scale (FMMS) score [MD 17.36, 95% CI (12.12 to 22.61), P <0.00001] at three months follow up. However, the NIHSS score showed no significant difference between the two groups at two weeks [MD -0.32 ,95% CI (-0.72 to 0.07), p=0.11] or at six months [MD -0.17 ,95% CI (-0.47 to 0.14), p=0.29]. Fluoxetine and placebo-treated patients had the same overall impact on FMMS scores at one month [MD 7.77, 95% CI (-10.57 to 26.11), P = 0.41]. The fluoxetine had a higher risk of broken bone (RR = 2.30, 95% CI [1.59, 3.32], p < 0.001) and hyponatremia (RR = 2.12, 95% CI [1.19, 3.76], p= 0.01) with lower risk of new depression (RR = 0.72, 95% CI [0.61, 0.84], p< 0.001) in comparison to placebo. Conclusion The efficacy of fluoxetine on the NIHSS and FMMS is likely to take time to emerge and is expected to be transient. The BI score did not differ between the fluoxetine and placebo groups. The use of fluoxetine increased the incidence of hyponatremia and bone fractures while decreasing the risk of new-onset depression.