Journal Article

Pacing for neurally mediated syncope: is placebo powerless?

M. Brignole and R. Sutton

in EP Europace

Published on behalf of European Heart Rhythm Association of the European Society of Cardiology (ESC)

Volume 9, issue 1, pages 31-33
Published in print January 2007 | ISSN: 1099-5129
Published online January 2007 | e-ISSN: 1532-2092 | DOI: http://dx.doi.org/10.1093/europace/eul169
Pacing for neurally mediated syncope: is placebo powerless?

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Background After two recent controlled trials failed to prove superiority of cardiac pacing over placebo in patients affected by neurally mediated syncope, a widely accepted opinion is that cardiac pacing therapy is not very effective and that a strong placebo effect exists.

Aim To measure the effect of placebo pacing therapy.

Method and results We compared the recurrence rate of syncope during placebo vs. no treatment in controlled trials of drug or pacing therapy. Syncope recurred in 38% of 252 patients randomized to placebo pooled from five trials vs. 34% of 881 patients randomized to no treatment pooled from eight trials. The corresponding recurrence rate with active cardiac pacing was 15% in 203 patients from six trials.

Conclusions Placebo is not an effective therapy for neurally mediated syncope. Different selection criteria in patients who are candidates for cardiac pacing—for example, presence, absence, or severity of the cardioinhibitory reflex may separate positive from negative trials.

Keywords: Syncope; Neurally mediated syncope; Pacemaker therapy; Electrocardiographic monitoring; Implantable loop recorder

Journal Article.  1489 words. 

Subjects: Cardiovascular Medicine

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