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An Overview of Nocebo Adverse Events in Clinical Trials
Martina Amanzio1, Giuseppina Elena Cipriani2
1Department of Psychology, University of Turin, Via Verdi 10, Turin 10124, Italy.
Neurologic Clinics
|November 13, 2025
Summary
The nocebo effect negatively impacts clinical trials and patient care by increasing adverse events and drop-out rates. Understanding psychological factors and improving communication are key to mitigating these negative outcomes.
Area of Science:
- Clinical Psychology
- Medical Research Methodology
Background:
- The nocebo effect, a negative outcome influenced by negative expectations, significantly impacts clinical trials and patient care.
- It contributes to increased adverse event reporting, higher patient dropout rates, and biased assessments of treatment efficacy.
Purpose of the Study:
- To review findings on the nocebo effect across various disease areas.
- To emphasize the role of psychological factors in treatment outcomes.
- To highlight strategies for minimizing nocebo reactions.
Main Methods:
- This study is a review of existing literature and findings from different disease areas.
- It synthesizes information on the impact of psychological factors on treatment outcomes.
Main Results:
- Psychological factors play a crucial role in treatment outcomes related to the nocebo effect.
- Effective communication and patient awareness are vital for managing nocebo responses.
Conclusions:
- Minimizing nocebo effects is critical for improving patient adherence and the validity of clinical trials.
- Addressing nocebo side effects is essential for optimizing patient care and treatment success.
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