The efficacy and safety of fluoxetine versus placebo for stroke recovery: a meta-analysis of randomized controlled trials.

Abstract

BACKGROUND:

Fluoxetine is one of the selective serotonin reuptake inhibitors that can improve motor and function recovery after a stroke. Several randomized controlled trials (RCTs) have investigated the efficacy and safety of fluoxetine compared to placebo in post-stroke recovery. However, the results are still controversial.

AIM:

This meta-analysis aimed to provide an updated analysis of the efficacy and safety of fluoxetine versus placebo in post-stroke recovery.

METHOD:

RCTs were searched from electronic databases of PubMed, Embase, Clinical Trials, and the Cochrane Central Register of Controlled Trials from inception until July 2022. Google Scholar and the reference lists of included studies were screened to identify additional studies. Outcomes were analyzed using risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI).

RESULTS:

Fourteen RCTs (6584 patients) were included. The fluoxetine group showed a significantly higher Fugl-Meyer motor scale (FMMS) score than the placebo group (MD 15.93, 95%CI 9.76-22.7, P < 0.01). No significant differences were observed in the modified Rankin Scale (mRS) (mRS ≤ 2, RR 1.00, 95%CI 0.88-1.15, P = 0.95), the Barthel index (MD 12.11, 95%CI - 0.71 to 24.92, P = 0.06), and the National Institutes of Health Stroke Scale scores (MD - 0.19, 95%CI - 0.43 to 0.04, P = 0.1) between the two groups. The fluoxetine group showed a lower rate of depression or anxiety than the placebo group (RR 0.67, 95% CI 0.49-0.92, P < 0.05). There were no significant differences between the groups regarding gastrointestinal adverse reactions (P > 0.05), drowsiness (P > 0.05) or insomnia (P > 0.05).

CONCLUSION:

Fluoxetine improved FMMS and reduced anxiety and depression. More well-designed and large sample-size RCTs are required to further analyze the efficacy of fluoxetine in post-stroke recovery.

• Authors: Jixiang Wu, Guoyong Qin
• Journal: International journal of clinical pharmacy (Int J Clin Pharm) Vol. 45 Issue 4 Pg. 839-846 (Aug 2023) ISSN: 2210-7711 [Electronic] Netherlands
• PMID: 37081168 (Publication Type: Meta-Analysis, Journal Article, Review)
• Copyright: © 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

Chemical References

• Fluoxetine
• Selective Serotonin Reuptake Inhibitors

Topics

• United States
• Humans
• Fluoxetine (therapeutic use)
• Randomized Controlled Trials as Topic
• Stroke (drug therapy)
• Selective Serotonin Reuptake Inhibitors
• Anxiety (drug therapy)