Nocebo responses in randomized controlled trials of COVID-19 vaccines
DC Field | Value | Language |
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dc.contributor.author | Lee, Young Ho | - |
dc.contributor.author | Song, Gwan Gyu | - |
dc.date.accessioned | 2022-02-11T11:41:03Z | - |
dc.date.available | 2022-02-11T11:41:03Z | - |
dc.date.created | 2022-01-19 | - |
dc.date.issued | 2022-01 | - |
dc.identifier.issn | 0946-1965 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/135333 | - |
dc.description.abstract | Objective: The aim of this study was to evaluate the frequency and magnitude of nocebo responses in COVID-19 vaccine trials. Materials and methods: We performed a meta-analysis of adverse effects (AEs), severe adverse effects (SAEs), withdrawal due to AEs, death, and immune-mediated SAEs observed in randomized controlled trials (RCTs) of COVID-19 vaccines. Results: Four RCTs with a total of 119,110 participants (65,254 from the vaccine group and 53,856 from the placebo group) were considered. The pooled estimate of AEs in the placebo and vaccine groups was 16.4% (95% confidence interval (CI), 9.1 - 27.7%) and 25.3% (95% CI, 22.7 - 28.1%), respectively. The pooled SAE rate in the placebo and vaccine groups was 0.7% (95% CI, 0.5 - 1.0%) and 0.6% (95% CI, 0.4 - 0.9%), respectively. The pooled estimate of participants who withdrew from treatment due to AEs in the placebo and vaccine groups was 0.3% (95% CI, 0.1 - 1.0%) and 0.2% (95% CI, 0.1 - 0.5%), respectively. The pooled death rate in the placebo and vaccine groups was 0.02% (95% CI, 0.01 - 0.04%) and 0.01% (95% CI, 0.01 - 0.03%), respectively. The pooled estimate of immune-mediated SAEs in the placebo and vaccine groups was 0.01% (95% CI, 0.01 - 0.04%) and 0.02% (95% CI, 0.01 - 0.05%), respectively. There were no differences observed in the pooled risk of AEs, SAEs, withdrawal due to AEs, death, and immune-mediated SAEs between placebo and vaccine groups. Conclusion: The frequency and magnitude of nocebo responses were 16.4% and 0.3%, respectively. Therefore, the incidence of nocebo responses was high, but their magnitude was low in COVID-19 vaccine trials. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | DUSTRI-VERLAG DR KARL FEISTLE | - |
dc.subject | SYSTEMIC-LUPUS-ERYTHEMATOSUS | - |
dc.subject | RHEUMATOID-ARTHRITIS | - |
dc.subject | DISEASE-ACTIVITY | - |
dc.subject | METAANALYSIS | - |
dc.title | Nocebo responses in randomized controlled trials of COVID-19 vaccines | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Lee, Young Ho | - |
dc.identifier.doi | 10.5414/CP204028 | - |
dc.identifier.scopusid | 2-s2.0-85123878851 | - |
dc.identifier.wosid | 000734278700002 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, v.60, no.1, pp.5 - 12 | - |
dc.relation.isPartOf | INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS | - |
dc.citation.title | INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS | - |
dc.citation.volume | 60 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 5 | - |
dc.citation.endPage | 12 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | SYSTEMIC-LUPUS-ERYTHEMATOSUS | - |
dc.subject.keywordPlus | RHEUMATOID-ARTHRITIS | - |
dc.subject.keywordPlus | DISEASE-ACTIVITY | - |
dc.subject.keywordPlus | METAANALYSIS | - |
dc.subject.keywordAuthor | nocebo | - |
dc.subject.keywordAuthor | COVID-19 vaccine | - |
dc.subject.keywordAuthor | & | - |
dc.subject.keywordAuthor | nbsp | - |
dc.subject.keywordAuthor | RCT | - |
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