The impact of framed side effect information on nocebo effect

Abstract

This study examined the impact of framed side effect information on nocebo effect and anxiety levels. In this randomized, controlled study design participants (N=180) healthy volunteers completed a short demographic survey, the Q-No Questionnaire, and the Beck Anxiety Inventory. Participants were randomized to read a positive Patient Information Leaflet (PIL) or standard PIL or none PIL of analgesic. After reading the PIL, participants completed for second time the Beck Anxiety Inventory. Side effects of analgesic were assessed a month later through the report of symptoms in a diary. More participants who read the standard PIL reported symptoms (N=28, 47.5%) compared to participants who read the positive PIL (N=23, 38.3%). Moreover, participants with higher scores in Q-No (nocebo) were more likely to experience symptoms than those with lower scores (No Nocebo) (OR = 7.47, 95% CI: 3.78-14.79). There is a difference in the increase of anxiety levels in participants with high scores in Q-No between the three groups. The highest average increase of anxiety was in the standard framed group (6.00±4.27), while the positive framed follows (5.13± 3.42) and finally the control group (3.20±2.74). Results indicate that positive framed PIL reduced the likelihood of participants to attribute side effects to the treatment. Further research is needed in a patient population and in preventive treatment.