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J Am Coll Cardiol, 2002; 40:499-504
© 2002 by the American College of Cardiology Foundation
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CLINICAL STUDY

Vasovagal syncope: a prospective, randomized, crossover evaluation of the effect of propranolol, nadolol and placebo on syncope recurrence and patients’ well-being

Panagiota Flevari, MD*,*, Efthimios G. Livanis, MD*, George N. Theodorakis, MD*, Elias Zarvalis, MD*, Theoni Mesiskli, MD* and Dimitrios T. h Kremastinos, MD*

* Second Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece

Manuscript received October 16, 2001; revised manuscript received April 2, 2002, accepted April 30, 2002.

* Reprint requests and correspondence: Dr. Panagiota Flevari, Onassis Cardiac Surgery Center, Second Department of Cardiology, 356 Syngrou Avenue, 176 74 Athens, Greece.
elbee{at}ath.forthnet.gr

OBJECTIVES: We sought to assess the relative therapeutic efficacy of propranolol, nadolol and placebo in recurrent vasovagal syncope (VVS).

BACKGROUND: Central and peripheral mechanisms have been implicated in the pathogenesis of VVS. Propranolol, nadolol and placebo have different sites of action on central and/or peripheral mechanisms. It has not yet been clarified whether one of the aforementioned treatments is more efficient than the others in reducing clinical episodes and exerting a beneficial effect on patients’ well-being.

METHODS: We studied 30 consecutive patients with recurrent VVS and a positive head-up tilt test. All were serially and randomly assigned to propranolol, nadolol or placebo. Therapy with each drug lasted three months. On the day of drug crossover, patients reported the total number of syncopal and presyncopal attacks during the previous period. They also gave a general assessment of their quality of life, taking into account: 1) symptom recurrence; 2) drug side effects; and 3) their personal well-being during therapy (scale 0 to 4: 0 = very bad/discontinuation; 1 = bad; 2 = good; 3 = very good; 4 = excellent). At the end of the nine-month follow-up period, they reported whether they preferred a specific treatment over the others.

RESULTS: Spontaneous syncopal and presyncopal episode recurrence during each three-month follow-up period was reduced by all drugs tested (analysis of variance [ANOVA]: chi-square = 67.4, p < 0.0001 for syncopal attacks; chi-square = 60.1, p < 0.0001 for presyncopal attacks) No differences were observed in the recurrence of syncope and presyncope among the three drugs. All drugs improved the patients’ well-being (ANOVA: chi-square = 61.9, p < 0.0001).

CONCLUSIONS: Propranolol, nadolol and placebo are equally effective treatments in VVS, as demonstrated by a reduction in the recurrence of syncope and presyncope, as well as an improvement in the patients’ well-being.

Abbreviations and Acronyms
  ANOVA
  analysis of variance
  ECG
  electrocardiogram/electrocardiographic
  VVS
  vasovagal syncope




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