Wednesday, December 5, 2018

Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial

So it seems antidepression meds do not increase motor recovery. Ask your doctor to analyze all sets of research to determine which way to go. Well, fuck, the Rankin scale has nothing objective in it at all except for 6 - death. Using the Rankin scale is stupid, it has very limited discriminatory power and is not objective. 

Common antidepressant can help stroke patients improve movement and coordination Sept. 2015 

 

Antidepressants may help people recover from stroke even if they are not depressed Jan. 2013

 

 

Effects of fluoxetine(SSRI) on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial

Open AccessPublished:December 05, 2018DOI:https://doi.org/10.1016/S0140-6736(18)32823-X
Open access funded by Department of Health UK

Summary

Background

Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.

Methods

FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.

Findings

Between Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.

Interpretation

Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.

Funding

UK Stroke Association and NIHR Health Technology Assessment Programme.

Introduction

Each year, stroke affects around 9 million people worldwide for the first time and results in long-term disability for around 6·5 million people.
Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), is used to treat depression and emotional lability after stroke. Many clinical and preclinical studies have suggested that SSRIs might improve outcomes after stroke through a range of mechanisms, which include enhancing neuroplasticity and promoting neurogenesis. In 2011, the results of the FLAME (FLuoxetine for motor recovery After acute ischaeMic strokE) trial indicated that fluoxetine enhanced motor recovery.
In this double-blind, placebo-controlled, multicentre trial, 118 patients with ischaemic stroke and unilateral motor weakness, and a median National Institutes of Health Stroke Scale (NIHSS) score of 13, were randomly allocated between 5 and 10 days after stroke onset to receive fluoxetine 20 mg daily or placebo for 3 months. At day 90, the improvement from baseline in the Fugl-Meyer motor score was significantly greater in the fluoxetine group than in the placebo group. Additionally, the proportion of patients who were independent in daily living (with a modified Rankin Scale [mRS] score of 0–2) was significantly higher in the fluoxetine group than in the placebo group (26% vs 9%, p=0·015). More participants were free from depression at 3 months in the fluoxetine group than in the placebo group (93% vs 71%; p=0·002). A subsequent Cochrane systematic review
of SSRIs for stroke recovery identified 52 randomised controlled trials of SSRIs versus controls (in 4060 patients), but no others tested the effect of fluoxetine on functional outcomes measured with the mRS. The findings of the Cochrane review suggested that SSRIs might reduce post-stroke disability, although this estimate was based on a meta-analysis done across various measures of function and greater effects were seen if studies with increased risk of bias were retained and patients with depression were included. Although promising, data from the FLAME trial and the Cochrane review were not sufficiently compelling to alter stroke treatment guidelines or to alleviate concerns that any possible benefits might be offset by serious adverse reactions.


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