Nocebo Effect in patients with Adverse Drug Reactions: The Role of Emotion Regulation

Mara Donatella Fiaschi, Susanna Voltolini, Patrizia Velotti, Fabiola Bizzi


Patients who have experienced adverse drug reactions (ADRs) can show some psychological problems both pre-existing than consequently the reactions. Anxiety, depression, somatization, as well as a minor capability of expressing emotions, have been demonstrated in some of these subjects. Nevertheless, a negative expectation toward a new drug administration related to some nocebo reactions can complicate the evaluation of these patients. This study aims to investigate the link between the nocebo effect and emotional functioning in ADRs patients to better understanding the psychological mechanisms involved in this phenomenon. Therefore, patients who have manifested or not (non responders) a nocebo reaction following the administration of an inert substance (placebo) have been compared. One hundred twenty patients (N = 30 with nocebo reactions; N = 90 non responders) completed the Difficulties in Emotion Regulation Scale, Emotion Regulation Questionnaire, and Toronto Alexithymia Scale-20. ADRs patients with nocebo reactions showed: 1) higher level of Cognitive Reappraisal than non responders; 2) associations between higher level of emotion dysregulation and not immediate drug reactions; 3) associations between higher level of alexithymia, Expressive Suppression and more frequent access to healthcare services; 4) alexithymia and Expressive Suppression as predictors of more frequent access to healthcare services, evident in 35% of the sample. The clarification of some psychological mechanisms involved in the nocebo effect is a basic prerequisite to better understand and manage these patients.


Adverse drug reactions; Nocebo effect; Emotion dysregulation; Emotion regulation strategies; Alexithymia.

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