The sham effect of invasive interventions in chronic coronary syndromes: a systematic review and meta-analysis

© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, p...

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Published in:BMC cardiovascular disorders 2022-05, Vol.22 (1), p.223-223, Article 223
Main Authors: Palma, Catarina, Antunes David, Cláudio Virgílio, Fernandes, Ricardo, Pinto, Fausto J., Costa, João, Ferreira, Joaquim J, Caldeira, Daniel
Format: Article
Language:English
Subjects:
Angina
Angina pectoris
Bias
Cardiac stress tests
Cardiovascular disease
Care and treatment
Chronic coronary syndromes
Clinical trials
Confidence intervals
Coronary vessels
Data collection
Evaluation
Heart diseases
Heart failure
Intervention
Invasive treatment
Meta-analysis
Patients
Placebo effect
Quality of life
Sensitivity analysis
Sham effect
Sham procedure
Software reviews
Systematic review
Therapeutics, Experimental
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Summary:© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Background: Some patients with chronic coronary syndromes undergo invasive procedures but the efficacy of such interventions remains to be robustly established by randomised sham-controlled trials (RCTs). Purpose: To determine the sham effect in patients with chronic coronary syndromes enrolled in RCTs by performing a systematic review and meta-analysis. Methods: In April 2022, we performed a literature search for published patient-blind RCTs (CENTRAL, MEDLINE®, PsycINFO, and reference lists) with sham procedures, reporting the pre-post effects in the invasive sham arm among patients with Canadian cardiovascular society (CCS) angina or angina equivalents. Results: 16 RCTs were included with 546 patients in the sham arm. Pooled results showed that sham interventions were associated with: improvement of 7% (95% CI 2-11%; I2 = 0%) in exercise time; decrease of 0.78 (95% CI - 1.10 to - 0.47; I2 = 75%) in CCS angina class; decrease of 53% (95% CI 24-71%; I2 = 96%) and 25% (95% CI 20-29%; I2 = 0%) in anginal episodes and nitroglycerine (NTG) use, respectively. Pooled results also showed an improvement in the physical functioning, angina frequency, treatment satisfaction, and disease perception domains of the Seattle Angina Questionnaire (SAQ). Conclusion: Sham interventions in patients with chronic coronary syndromes were associated with a significant decrease in anginal episodes, NTG use, and CCS
ISSN:1471-2261
1471-2261
DOI:10.1186/s12872-022-02658-x