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

M Amanzio, DD Mitsikostas, F Giovannelli… - The Lancet Regional …, 2022 - thelancet.com
Background For 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 …

[HTML][HTML] Really just a little prick? A meta-analysis on adverse events in placebo control groups of seasonal influenza vaccination RCTs

FL Bender, W Rief, M Wilhelm - Vaccine, 2023 - Elsevier
Abstract Background The Corona pandemic and ongoing mass vaccinations raise the
question of the nocebo mechanisms involved. Since immunization is usually administered to …

Nocebo and placebo effects and their implications in psychotherapy

W Rief, M Wilhelm - Psychotherapy and Psychosomatics, 2024 - karger.com
In most fields of medicine, placebo groups achieve substantial improvements, even though
the patients do not receive any treatments with active ingredients. Improvements in placebo …

Multidisciplinary management of the nocebo effect in biosimilar-treated IBD patients: results of a workshop from the NOCE-BIO consensus group

F D'amico, L Pouillon, M Argollo, A Hart… - Digestive and Liver …, 2020 - Elsevier
The high cost of biological drugs for patients with inflammatory bowel disease (IBD)
considerably impacts on health-care budgets. Since the patent of biological products …

Unethical informed consent caused by overlooking poorly measured nocebo effects

J Howick - Journal of Medical Ethics, 2021 - jme.bmj.com
Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a
negative outcome) has been almost ignored. Epistemic and ethical confusions related to its …

The effect of positively framing side-effect risk in two different formats on side-effect expectations, informed consent and credibility: a randomised trial of 16-to 75-year …

RK Webster, GJ Rubin - Drug Safety, 2020 - Springer
Introduction Reframing side-effect information in patient information leaflets (PILs) in terms of
those who remain side-effect–free may reduce negative expectations and side-effects …

Can positive expectations help to improve the learning of risk literacy? A cluster-randomized study in undergraduate medical students

S Benson, K Schmidt, J Kleine-Borgmann… - BMC Medical …, 2022 - Springer
Background Risk literacy, ie, the ability to calculate and apply risk parameters, represents a
key competence for risk communication and medical decision making. However, risk literacy …

The unintended consequences of adverse event information on medicines' risks and label content

G Furlan, D Power - Pharmaceutical Medicine, 2020 - Springer
Patients and prescribers need to be aware of adverse drug events to minimize the risk of
their occurrence and the severity with which they appear. However, numerous studies show …