Syncope: recurrent vasovagal: paroxetine reduced recurrent episodes

Clinical bottom line (level 1b)

  1. Patients with recurrent vasovagal syncope resistant to or intolerant of standard medication who took paroxetine compared with placebo were less likely to have recurrent syncopal episodes (NNT = 3 at 2 years) .
Di Girolamo et al: Journal of the American College of Cardiology 1999; 33 (5): 1227-1230
Expires November 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, Italy

68 patients (aged mean 45, 62% female) with recurrent vasovagal syncope resistant to or intolerant of traditional drug therapy, and a positive nitrate-potentiated tilt-table test.

Excluded if
  • major endogenous depression or panic disorder
  • cause of syncope found on extensive testing (history and physical examination, CT or MRI of brain, carotid sinus massage and blood pressure determination, 12-lead ECG, chest X-ray, routine laboratory tests, 2-D echocardiography, 24-hour Holter monitoring and exercise stress testing)


    • Control Group: (n = 34, 34 analysed): placebo
    Experimental Group: (n = 34, 34 analysed): paroxetine 20 mg daily

    100% followed for 25 months
    Outcome notes:
    • adverse effects : headache, transient sexual dysfunction, nausea and diarrhoea

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    recurrent syncope 2 years 18
    (52.9%)    		 6
    (17.7%)    		 67%
    (26% to 85%)    		 35.3%
    (14.2% to 56.4%)    		 3
    (2 to 7)
    adverse effects 2 years 1
    (2.94%)    		 3
    (8.82%)    		 -200%
    (-2600% to 67%)    		 -5.88%
    (-17;0% to 5;22%)    		 -17
    (NNT = 19 to infinity;
    NNH = 6 to infinity)

    Comments

    1. In rare patients where these management strategies are unsuccessful, consideration has to be given to pharmacological therapy. However, long-term prophylactic therapy should not be advised, since vasovagal syncope is a self-limited, non-life-threatening condition.
    2. The study is too small to show any difference between the two groups for adverse effects.
    3. Patients on paroxetine compared with placebo had a mean of 6 fewer episodes of syncope per year.

    Citation

    1. Di Girolamo E, Di Iorio C, Sabatini P, et al: effects of paroxetine hydrochloride, a selective serotonin reuptake inhibitor, on refractory vasovagal syncope: a randomized double-blind placebo-controlled study. Journal of the American College of Cardiology 1999; 33 (5): 1227-1230
    Search Terms: ?
    Contributor: Chris Ball and Clare Wotton, November 1999
    Reviewer: Wouter Wieling

    Clinical Question.
    Patient recurrent vasovagal syncope resistant to other medication
    Intervention or Exposure paroxetine
    Comparison placebo
    Outcome recurrent syncope