Reporting of side-effects in clinical trials of psilocybin-assisted psychotherapy for psychiatric conditions: systematic review
BJPsych Open November 1, 2025 Jonathon Marinis, Sarah Clarke, Alexandre A. Guerin et al. 2 citations
Side-effects reporting in clinical trials of psilocybin-assisted psychotherapy (PAP) for psychiatric conditions is inconsistent but improving over time. A systematic review of 24 trials published between 2005 and 2024 found that only six had high-quality side-effects reporting, while nine were low and five were very low. All nine randomized controlled trials showed high risk of bias for side-effects outcomes. There was no evidence of systematic underreporting in published articles compared with trial registers, but variability in reporting hindered comparisons. The authors conclude that existing evidence has a high risk of bias and that future trials should follow best-practice guidelines, and discussions with patients should emphasize current uncertainty about PAP side-effects.