Cargando…

Placebo-Related Adverse Events in Rheumatoid Arthritis

Prospective, double-blind, randomized, placebo-controlled studies are considered to provide the highest quality of interventional evidence. This meta-analysis summarizes the frequencies of adverse events according to the Medical Dictionary for Regulatory Activities (MedDRA) in the placebo arms of 10...

Descripción completa

Detalles Bibliográficos
Autores principales: Sharma, Ratna Shree, Pallua, Johannes, Schirmer, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8869088/
https://www.ncbi.nlm.nih.gov/pubmed/35204805
http://dx.doi.org/10.3390/biom12020303
_version_ 1784656414415781888
author Sharma, Ratna Shree
Pallua, Johannes
Schirmer, Michael
author_facet Sharma, Ratna Shree
Pallua, Johannes
Schirmer, Michael
author_sort Sharma, Ratna Shree
collection PubMed
description Prospective, double-blind, randomized, placebo-controlled studies are considered to provide the highest quality of interventional evidence. This meta-analysis summarizes the frequencies of adverse events according to the Medical Dictionary for Regulatory Activities (MedDRA) in the placebo arms of 101 such studies in rheumatoid arthritis, including a total of 17,150 patients in the placebo arms and 37,819 patients in the verum arms. Placebo-treated patients reported more than one adverse event in a median of 55.0%, 65.5%, and 72.5% (compared to 72.3% in the verum arms), and a serious adverse event in 2.5%, 5.8%, and 8.6% (compared to 5.9% in the verum arms), with stable doses of corticosteroids, conventional synthetic disease-modifying antirheumatic drugs (DMARDs), and biological DMARDs as background therapies, respectively. Odds ratios were comparable between placebo and verum arms for nausea (1.00 with 95% confidence interval (CI) 0.86–1.17), for hepatobiliary disorders (1.08 with CI 0.85–1.36), for abnormal hepatic functions (1.09 with CI 0.83–1.44), and general disorders and administration site conditions (1.39 with CI 0.95–2.03). A publication bias has to be assumed for nausea (p = 0.018; Egger’s test), diarrhoea (p = 0.022), and serious infections and infestations (p = 0.009). In conclusion, patients should be aware that “adverse events” may occur even with placebo medication, independent from an additional verum medication added to the background therapy. Further studies are warranted to respect and overcome the psychological and other issues related to these placebo-related “adverse events”.
format Online
Article
Text
id pubmed-8869088
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-88690882022-02-25 Placebo-Related Adverse Events in Rheumatoid Arthritis Sharma, Ratna Shree Pallua, Johannes Schirmer, Michael Biomolecules Systematic Review Prospective, double-blind, randomized, placebo-controlled studies are considered to provide the highest quality of interventional evidence. This meta-analysis summarizes the frequencies of adverse events according to the Medical Dictionary for Regulatory Activities (MedDRA) in the placebo arms of 101 such studies in rheumatoid arthritis, including a total of 17,150 patients in the placebo arms and 37,819 patients in the verum arms. Placebo-treated patients reported more than one adverse event in a median of 55.0%, 65.5%, and 72.5% (compared to 72.3% in the verum arms), and a serious adverse event in 2.5%, 5.8%, and 8.6% (compared to 5.9% in the verum arms), with stable doses of corticosteroids, conventional synthetic disease-modifying antirheumatic drugs (DMARDs), and biological DMARDs as background therapies, respectively. Odds ratios were comparable between placebo and verum arms for nausea (1.00 with 95% confidence interval (CI) 0.86–1.17), for hepatobiliary disorders (1.08 with CI 0.85–1.36), for abnormal hepatic functions (1.09 with CI 0.83–1.44), and general disorders and administration site conditions (1.39 with CI 0.95–2.03). A publication bias has to be assumed for nausea (p = 0.018; Egger’s test), diarrhoea (p = 0.022), and serious infections and infestations (p = 0.009). In conclusion, patients should be aware that “adverse events” may occur even with placebo medication, independent from an additional verum medication added to the background therapy. Further studies are warranted to respect and overcome the psychological and other issues related to these placebo-related “adverse events”. MDPI 2022-02-14 /pmc/articles/PMC8869088/ /pubmed/35204805 http://dx.doi.org/10.3390/biom12020303 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Systematic Review
Sharma, Ratna Shree
Pallua, Johannes
Schirmer, Michael
Placebo-Related Adverse Events in Rheumatoid Arthritis
title Placebo-Related Adverse Events in Rheumatoid Arthritis
title_full Placebo-Related Adverse Events in Rheumatoid Arthritis
title_fullStr Placebo-Related Adverse Events in Rheumatoid Arthritis
title_full_unstemmed Placebo-Related Adverse Events in Rheumatoid Arthritis
title_short Placebo-Related Adverse Events in Rheumatoid Arthritis
title_sort placebo-related adverse events in rheumatoid arthritis
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8869088/
https://www.ncbi.nlm.nih.gov/pubmed/35204805
http://dx.doi.org/10.3390/biom12020303
work_keys_str_mv AT sharmaratnashree placeborelatedadverseeventsinrheumatoidarthritis
AT palluajohannes placeborelatedadverseeventsinrheumatoidarthritis
AT schirmermichael placeborelatedadverseeventsinrheumatoidarthritis