Evidence map›Paper›PMID 34729549›Full record

ArticleThe Lancet regional health. Europe2022

Adverse events of active and placebo groups in SARS-CoV-2 vaccine randomized trials: A systematic review.

Martina Amanzio, Dimos D Mitsikostas, Fabio Giovannelli, Massimo Bartoli, Giuseppina Elena Cipriani, Walter A Brown

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet regional health. Europe, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
4.7field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 82 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

Martina AmanzioDepartment of Psychology, University of Turin, Via Verdi 10, 10124 Turin, Italy.
Dimos D MitsikostasFirst Department of Neurology, Aeginition Hospital, National and Kapodistrian University of Athens, 72-74 V. Sofia's Avenue, Athens 11528, Hellas, Greece.
Fabio GiovannelliSection of Psychology - Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, Via di San Salvi 12, 50135 Florence, Italy.
Massimo BartoliDepartment of Psychology, University of Turin, Via Verdi 10, 10124 Turin, Italy.
Giuseppina Elena CiprianiDepartment of Psychology, University of Turin, Via Verdi 10, 10124 Turin, Italy.
Walter A BrownDepartment of Psychiatry and Human Behavior, Brown University, 69 Brown Street Providence, RI 02912, USA.
University of Turin · ITBrown University · USNational and Kapodistrian University of Athens · GRUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor safety assessment in clinical trials, adverse events (AEs) are reported for the drug under evaluation and compared with AEs in the placebo group. Little is known about the nature of the AEs associated with clinical trials of SARS-CoV-2 vaccines and the extent to which these can be traced to nocebo effects, where negative treatment-related expectations favor their occurrence.

methodsIn our systematic review, we compared the rates of solicited AEs in the active and placebo groups of SARS-CoV-2 vaccines approved by the Western pharmaceutical regulatory agencies.We implemented a search strategy to identify trial-III studies of SARS-CoV-2 vaccines through the PubMed database. We adopted the PRISMA Statement to perform the study selection and the data collection and identified three trial: two mRNA-based (38403 participants) and one adenovirus type (6736 participants).

findingsRelative risks showed that the occurrence of AEs reported in the vaccine groups was higher compared with the placebo groups. The most frequently AEs in both groups were fatigue, headache, local pain, as injection site reactions, and myalgia. In particular, for first doses in placebo recipients, fatigue was reported in 29% and 27% in BNT162b2 and mRNA-1273 groups, respectively, and in 21% of Ad26.COV2.S participants. Headache was reported in 27% in both mRNA groups and in 24% of Ad26.COV2.S recipients. Myalgia was reported in 10% and 14% in mRNA groups (BNT162b2 and mRNA-1273, respectively) and in 13% of Ad26.COV2.S participants. Local pain was reported in 12% and 17% in mRNA groups (BNT162b2 and mRNA-1273, respectively), and in 17% of Ad26.COV2.S recipients. These AEs are more common in the younger population and in the first dose of placebo recipients of the mRNA vaccines.

interpretationOur results are in agreement with the expectancy theory of nocebo effects and suggest that the AEs associated with COVID-19 vaccines may be related to the nocebo effect.

fundingFondazione CRT - Cassa di Risparmio di Torino, IT (grant number 66346, "GAIA-MENTE" 2019).

Indexed as

adverse eventsnocebo effectplaceborandomized control trialsSARS-CoV-2 vaccines

Identifiers

PMID34729549
PMCPMC8553263
OpenAlexW3209112580

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.