Europace Advance Access originally published online on February 13, 2006
Europace 2006 8(3):193-198; doi:10.1093/europace/euj041
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SYNCOPE
Fluoxetine vs. propranolol in the treatment of vasovagal syncope: a prospective, randomized, placebo-controlled study
Second Department of CardiologyOnassis Cardiac Surgery Center356 Syngrou Avenue, 17674 Athens Greece
Aims To compare the therapeutic efficacy of placebo, propranolol, and fluoxetine in patients with vasovagal syncope (VVS).
Methods and results Ninety-six consecutive patients with VVS were randomized to treatment with placebo, propranolol, or fluoxetine and followed-up for 6 months. Before and during treatment, they reported their syncopal and presyncopal episodes and graded their well-being, expressed as the general evaluation of life, general activities, and everyday activities (each scaled from 1=very good to 5=very bad). Two patients refused follow-up. Among the remaining 94, no difference between groups was observed regarding the distribution of time of vasovagal events (syncopes or presyncopes) during follow-up (log-rank test). No difference was also observed when syncopes and presyncopes were assessed separately. Eighteen patients discontinued therapy. Among the remaining 76 (‘on-treatment’ analysis), the mean time to a vasovagal episode (syncope or presyncope) was significantly longer in the fluoxetine group when compared with the two other groups (log-rank test, P<0.05). A significant difference in favour of fluoxetine was also observed regarding presyncopes. The difference between groups regarding the syncope-free period was not significant. During therapy, patients' well-being was improved (decreased) only in the fluoxetine-group (13.4±0.7 vs. 15.4±0.9 before treatment, P<0.01).
Conclusion Fluoxetine seems to be equivalent to propranolol and placebo in the treatment of VVS. However, it improves patients' well-being and might be more effective in reducing presyncopes and total vasovagal events in some patients with recurrent VVS.
Key Words: Vasovagal syncope, Neurally mediated syncope, Drugs, Nervous system, Prevention
* Corresponding author. Tel: +30 210 9493 372/9493 000; fax: +30 210 9493 373. E-mail address: elbee{at}ath.forthnet.gr
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