Researchers of a study revealed that half of the patients receiving a placebo in clinical trials for systemic psoriasis therapies reported adverse events (AEs), which may be explained by nocebo effects—a phenomenon where negative expectations of treatment lead to the reporting of side effects. The systemic review and meta-analysis investigated placebo-controlled clinical trials to assess the incidence of AEs in patients treated with either biologic or non-biologic psoriasis therapies compared with those given placebo. This high occurrence of AEs among placebo recipients underscores the importance of considering nocebo effects in both the design of randomized controlled trials (RCTs) and the clinical evaluation of treatment side effects.
The study encompassed data from 103 RCTs involving over 30,000 patients, finding that 49.8% of placebo recipients reported AEs compared with 57.1% of those receiving active treatment, with a risk difference of 6.7%. These findings highlight the need for heightened awareness of nocebo effects in clinical trials and patient care, particularly in how clinicians communicate with patients about potential side effects.
Reference: Steinzor P. Half of Patients With Psoriasis Receiving Placebo in Clinical Trials Report Adverse Events. Dermatology Times. Published April 19, 2024. Accesses April 30,2024. https://www.dermatologytimes.com/view/half-of-patients-with-psoriasis-receiving-placebo-in-clinical-trials-report-adverse-events