Therapeutic options for neurocardiogenic syncope: a meta-analysis of randomised trials with and without blinding
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Author(s)
Type
Journal Article
Abstract
Background: Neurocardiogenic syncope is a common condition with significant associated psychological and physical morbidity. The effectiveness of therapeutic options for neurocardiogenic syncope beyond placebo remains uncertain.
Methods: The primary endpoint was the risk ratio (RR) of spontaneously recurring syncope following any therapeutic intervention. We also examined the effect of blinding on treatment efficacy. We identified all randomised trials which evaluated the effect of any pharmacological, device-based or supportive intervention, on patients with a history of syncope. A systematic searched was conducted on Medline, Embase, PubMed databases, and Cochrane Central Register for Controlled Trials from 1950 to 25th April 2023. Event rates, their RRs and 95% CIs were calculated, and a random-effects meta-analysis was conducted for each intervention. Data analysis was performed in R using RStudio.
Results: We identified 47 eligible trials randomizing 3518 patients. Blinded trials assessing syncope recurrence were neutral for Beta-Blockers, Fludrocortisone, and conventional dual-chamber pacing but were favourable for Selective Serotonin Reuptake Inhibitors (SSRIs) (RR 0.40, 95% CI 0.26 to 0.63 p<0.001), Midodrine (RR 0.70, 95% CI 0.53 to 0.94, p=0.016) and Closed-Loop-Stimulation (CLS) pacing (RR 0.15, 95% CI 0.07 to 0.35, p < 0.001). Unblinded trials reported significant benefits for all therapy categories other than beta-blockers, and consistently showed larger benefits than blinded trials.
Conclusions :Under blinded conditions, SSRIs, midodrine, and CLS pacing significantly reduced syncope recurrence. Future trials for syncope should be blinded to avoid overestimating treatment effects.
Methods: The primary endpoint was the risk ratio (RR) of spontaneously recurring syncope following any therapeutic intervention. We also examined the effect of blinding on treatment efficacy. We identified all randomised trials which evaluated the effect of any pharmacological, device-based or supportive intervention, on patients with a history of syncope. A systematic searched was conducted on Medline, Embase, PubMed databases, and Cochrane Central Register for Controlled Trials from 1950 to 25th April 2023. Event rates, their RRs and 95% CIs were calculated, and a random-effects meta-analysis was conducted for each intervention. Data analysis was performed in R using RStudio.
Results: We identified 47 eligible trials randomizing 3518 patients. Blinded trials assessing syncope recurrence were neutral for Beta-Blockers, Fludrocortisone, and conventional dual-chamber pacing but were favourable for Selective Serotonin Reuptake Inhibitors (SSRIs) (RR 0.40, 95% CI 0.26 to 0.63 p<0.001), Midodrine (RR 0.70, 95% CI 0.53 to 0.94, p=0.016) and Closed-Loop-Stimulation (CLS) pacing (RR 0.15, 95% CI 0.07 to 0.35, p < 0.001). Unblinded trials reported significant benefits for all therapy categories other than beta-blockers, and consistently showed larger benefits than blinded trials.
Conclusions :Under blinded conditions, SSRIs, midodrine, and CLS pacing significantly reduced syncope recurrence. Future trials for syncope should be blinded to avoid overestimating treatment effects.
Date Issued
2024-06
Date Acceptance
2024-05-15
Citation
Open Heart, 2024, 11 (1)
ISSN
2053-3624
Publisher
BMJ Publishing Group
Journal / Book Title
Open Heart
Volume
11
Issue
1
Copyright Statement
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
License URL
Identifier
https://openheart.bmj.com/content/11/1/e002669
Publication Status
Published
Article Number
e002669
Date Publish Online
2024-06-18