Abstract

Background: A few clinical trials have suggested that selective serotonin reuptake inhibitors (SSRI’s) enhance motor recovery after stroke but no study has been done in haemorhagic stroke patients. We therefore aimed to investigate whether fluoxetine, an SSRI would enhance motor recovery in patients of haemorrrhagic stroke. Methods: Patients who had haemorrhagic stroke with hemiplegia or hemiparesis and were aged between 18 years and 80 years were included in this double-blind, placebo-controlled trial. Patients were randomly assigned, in a 1:1 ratio to fluoxetine (20 mg/d, orally) or placebo for 3 months starting 5-10 days after the onset of stroke. All patients also had routine physiotherapy. The primary outcome measure was the change on the FMMS between day 0 and day 90 after the start of the study drug. Results: A total of 89 patients were assigned to fluoxetine (n=45) or placebo (n=44), group, and 84 were finally included in the analysis (42 vs 42) after 5 patients lost to follow up. Mean FMMS score improved significantly greater at day 90 in the fluoxetine group (mean 35.64 points) than in the placebo group (23.60 points; p =0.001). Conclusion: Use of fluoxetine in patients of haemorrhagic stroke in early post stroke period added to physiotherapy increased recovery in motor deficits at 3 months.

Highlights

  • Keeping in view the above evidence suggesting a role of serotonergic drugs in stroke rehabilitation, we aimed to test whether a 3-month treatment with fluoxetine would enhance motor recovery in patients of haemorrhagic stroke

  • A total of 84 patients were analyzed for study variables

  • The two groups were well balanced in terms of baseline and demographic characteristics and stroke severity

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Summary

Introduction

It is the second commonest cause of death and fourth leading cause of disability worldwide. Stroke affects about 16 million people for the first time and causes about 5.7 million deaths [1]. 12.6 million people have moderate to severe disability following stroke and of this, 8.9 million are from low and middle income countries. Clinical trials on role of pharmacotherapy in functional recovery after stroke have mainly involved three classes of drugs; noradrenergic agonists, serotonergic agonists and the dopamine agonists. A few clinical trials have suggested that selective serotonin reuptake inhibitors (SSRI’s) enhance motor recovery after stroke but no study has been done in haemorhagic stroke patients. We aimed to investigate whether fluoxetine, an SSRI would enhance motor recovery in patients of haemorrrhagic stroke

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