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Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information()()

BACKGROUND: Patients trying life-preserving agents such as beta-blockers may be discouraged by listings of harmful effects provided in good faith by doctors, drug information sheets, and media. We systematically review the world experience of side-effect information in blinded, placebo-controlled be...

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Autores principales: Barron, Anthony J., Zaman, Nabeela, Cole, Graham D., Wensel, Roland, Okonko, Darlington O., Francis, Darrel P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3819624/
https://www.ncbi.nlm.nih.gov/pubmed/23796325
http://dx.doi.org/10.1016/j.ijcard.2013.05.068
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author Barron, Anthony J.
Zaman, Nabeela
Cole, Graham D.
Wensel, Roland
Okonko, Darlington O.
Francis, Darrel P.
author_facet Barron, Anthony J.
Zaman, Nabeela
Cole, Graham D.
Wensel, Roland
Okonko, Darlington O.
Francis, Darrel P.
author_sort Barron, Anthony J.
collection PubMed
description BACKGROUND: Patients trying life-preserving agents such as beta-blockers may be discouraged by listings of harmful effects provided in good faith by doctors, drug information sheets, and media. We systematically review the world experience of side-effect information in blinded, placebo-controlled beta-blockade in heart failure. We present information for a physician advising a patient experiencing an unwanted symptom and suspecting the drug. METHODS: We searched Medline for double-blinded randomized trials of beta-blocker versus placebo in heart failure reporting side-effects. We calculated, per 100 patients reporting the symptom on beta-blockade, how many would have experienced it on placebo: the “proportion of symptoms non-pharmacological”. RESULTS: 28 of the 33 classically-described side-effects are not significantly more common on beta-blockers than placebo. Of the 100 patients developing dizziness on beta-blockers, 81 (95% CI 73–89) would have developed it on placebo. For diarrhoea this proportion is 82/100 (70–95), and hyperglycaemia 83/100 (68–98). For only two side-effects is this under half (i.e. predominantly due to beta-blocker): bradycardia (33/100, CI 21–44) and intermittent claudication (41/100, 2–81). At least 6 so-called side-effects are less common on beta-blocker than placebo, including depression (reduced by 35%, p < 0.01) and insomnia (by 27%, p = 0.01). CONCLUSIONS: Clinicians might reconsider whether it is scientifically and ethically correct to warn a patient that a drug might cause them a certain side-effect, when randomized controlled trials show no significant increase, or indeed a significant reduction. A better informed consultation could, in patients taking beta-blockers, alleviate suffering. In patients who might otherwise not take the drug, it might prevent deaths.
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spelling pubmed-38196242013-11-07 Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information()() Barron, Anthony J. Zaman, Nabeela Cole, Graham D. Wensel, Roland Okonko, Darlington O. Francis, Darrel P. Int J Cardiol Article BACKGROUND: Patients trying life-preserving agents such as beta-blockers may be discouraged by listings of harmful effects provided in good faith by doctors, drug information sheets, and media. We systematically review the world experience of side-effect information in blinded, placebo-controlled beta-blockade in heart failure. We present information for a physician advising a patient experiencing an unwanted symptom and suspecting the drug. METHODS: We searched Medline for double-blinded randomized trials of beta-blocker versus placebo in heart failure reporting side-effects. We calculated, per 100 patients reporting the symptom on beta-blockade, how many would have experienced it on placebo: the “proportion of symptoms non-pharmacological”. RESULTS: 28 of the 33 classically-described side-effects are not significantly more common on beta-blockers than placebo. Of the 100 patients developing dizziness on beta-blockers, 81 (95% CI 73–89) would have developed it on placebo. For diarrhoea this proportion is 82/100 (70–95), and hyperglycaemia 83/100 (68–98). For only two side-effects is this under half (i.e. predominantly due to beta-blocker): bradycardia (33/100, CI 21–44) and intermittent claudication (41/100, 2–81). At least 6 so-called side-effects are less common on beta-blocker than placebo, including depression (reduced by 35%, p < 0.01) and insomnia (by 27%, p = 0.01). CONCLUSIONS: Clinicians might reconsider whether it is scientifically and ethically correct to warn a patient that a drug might cause them a certain side-effect, when randomized controlled trials show no significant increase, or indeed a significant reduction. A better informed consultation could, in patients taking beta-blockers, alleviate suffering. In patients who might otherwise not take the drug, it might prevent deaths. Elsevier 2013-10-09 /pmc/articles/PMC3819624/ /pubmed/23796325 http://dx.doi.org/10.1016/j.ijcard.2013.05.068 Text en © 2013 The Authors https://creativecommons.org/licenses/by-nc-sa/3.0/ Open Access under CC BY-NC-SA 3.0 (https://creativecommons.org/licenses/by-nc-sa/3.0/) license
spellingShingle Article
Barron, Anthony J.
Zaman, Nabeela
Cole, Graham D.
Wensel, Roland
Okonko, Darlington O.
Francis, Darrel P.
Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information()()
title Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information()()
title_full Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information()()
title_fullStr Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information()()
title_full_unstemmed Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information()()
title_short Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information()()
title_sort systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: recommendations for patient information()()
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3819624/
https://www.ncbi.nlm.nih.gov/pubmed/23796325
http://dx.doi.org/10.1016/j.ijcard.2013.05.068
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