Abstract
Objectives: The nocebo phenomenon refers to adverse side effects that are brought on by placebos. Experimental studies showed that gender plays a role in the nocebo response. This study aims to analyse the clinical relevance of gender effects in the context of clinical trials on antidepressants with depressive patients as well as anxiety patients.
Methods: Data from a recent meta-analysis on antidepressants (k =143; n= 12.742) are reanalysed to investigate the hypothesized moderating influence of gender on reported nocebo effects.
Results: Studies with a high percentage of male patients (>66.6%) reported higher nocebo rates in 4 out of a total of 11 symptom categories. After controlling for diagnosis, gender effects became more pronounced. In patients with depressive disorders, rates where significantly higher for male participants in 9 out of 11 symptoms (e. g., dizziness: odds ratio (OR) 10.5; con-fidence interval (CI) 6.2 – 18.0; p < 0.001). Opposite effects where found in studies with patients with anxiety disorders. Here, 8 out of 11 symptoms where reported more often in studies with a higher percentage of female patients (e. g., dizziness: OR 0.3; CI 0.2 – 0.6; p < 0.001).
Conclusions: In clinical studies, female and male patients have a different risk of developing adverse side effects when taking antidepressant-placebos. These gender effects are related to diagnoses and need to be taken into account during the planning of clinical trials.
Get full access to this article
View all access options for this article.