PMID- 33682603 OWN - NLM STAT- MEDLINE DCOM- 20210510 LR - 20210510 IS - 1751-2441 (Electronic) IS - 1751-2433 (Linking) VI - 14 IP - 4 DP - 2021 Apr TI - How do nocebo effects in placebo groups of randomized controlled trials provide a possible explicative framework for the COVID-19 pandemic? PG - 439-444 LID - 10.1080/17512433.2021.1900728 [doi] AB - Introduction: Randomized clinical trials (RCTs) are useful to study the role of individual and contextual factors in which therapies vs placebos are administered and to provide an important perspective for understanding the phenomenon of nocebo-related risks.Areas covered: The results of nocebo effects in RCT placebo groups, measured in terms of adverse events (AEs) and dropouts, will be presented as an explicative framework for the COVID-19 pandemic. Currently, SARS-CoV-2 vaccines are the only RCTs routinely conducted during the pandemic. Information about efficacy and safety of different vaccines represents a fertile ground for nocebo phenomena. Individual and contextual factors will be emphasized in order to understand the presence of a refusal of immunization associated with a specific vaccine considered less effective and safe. Critical aspects and some guidelines will be presented in order to counteract the nocebo effects and to improve adherence to drug treatments and the vaccination campaign.Expert opinion: The nocebo effect could explain the presence of strong resistance in European countries to immunization with a vaccine perceived as less effective, compared to others. Increased awareness of the nocebo effect would be relevant as it could lead to a greater participation in the vaccination campaign and in protecting individuals against SARS-CoV-2 infection. FAU - Amanzio, Martina AU - Amanzio M AUID- ORCID: 0000-0002-2504-032X AD - Department of Psychology, University of Turin, Turin, Italy. FAU - Cipriani, Giuseppina Elena AU - Cipriani GE AUID- ORCID: 0000-0002-8427-9293 AD - Department of Psychology, University of Turin, Turin, Italy. FAU - Bartoli, Massimo AU - Bartoli M AUID- ORCID: 0000-0002-8950-3602 AD - Department of Psychology, University of Turin, Turin, Italy. LA - eng PT - Journal Article DEP - 20210312 PL - England TA - Expert Rev Clin Pharmacol JT - Expert review of clinical pharmacology JID - 101278296 RN - 0 (COVID-19 Vaccines) SB - IM MH - COVID-19/*prevention & control MH - COVID-19 Vaccines/*administration & dosage/adverse effects MH - Europe MH - Humans MH - Medication Adherence MH - *Nocebo Effect MH - Patient Dropouts MH - Practice Guidelines as Topic MH - Randomized Controlled Trials as Topic/*methods MH - Vaccination Refusal/statistics & numerical data OTO - NOTNLM OT - Adverse events OT - COVID-19 OT - aging OT - nocebo effect OT - randomized clinical trials EDAT- 2021/03/09 06:00 MHDA- 2021/05/11 06:00 CRDT- 2021/03/08 08:42 PHST- 2021/03/09 06:00 [pubmed] PHST- 2021/05/11 06:00 [medline] PHST- 2021/03/08 08:42 [entrez] AID - 10.1080/17512433.2021.1900728 [doi] PST - ppublish SO - Expert Rev Clin Pharmacol. 2021 Apr;14(4):439-444. doi: 10.1080/17512433.2021.1900728. Epub 2021 Mar 12.