JAMA Netw Open

Meta-analysis evaluates safety profile of therapeutic doses of psilocybin

April 17, 2024

In this meta-analysis of 6 randomized, double-blind clinical trials with 528 patients, headaches, nausea, anxiety, dizziness, and fluctuations in BP occurred significantly more frequently with psilocybin vs. comparators. However, psilocybin use wasn't associated with risk of paranoia or transient thought disorder.

Psilocybin has been studied in the treatment of depression and anxiety disorders, but clinical studies have mainly focused on efficacy, with systematic reviews showing favorable results. This is the first systematic review and meta-analysis to focus primarily on safety.

Study results:

• Researchers screened randomized, double-blind clinical trials that reported adverse effects of psilocybin in patients treated for depression and anxiety.
• The primary outcome was considered as the adverse effects of psilocybin at high and moderate (ie, therapeutic) dose regimens and compared with placebo, low-dose psilocybin, or other comparators in the treatment of depression and/or anxiety.
• Six studies met inclusion criteria with a total sample of 528 participants (approximately 51% female; median age 39.8 years).
• Seven adverse effects were reported in multiple studies and included in the analysis.
• Among these, headache (relative risk [RR], 1.99; 95% confidence interval [CI], 1.06-3.74), nausea (RR, 8.85; 95% CI, 5.68-13.79), anxiety (RR, 2.27; 95% CI, 1.11-4.64), dizziness (RR, 5.81; 95% CI, 1.02-33.03), and elevated BP (RR, 2.29; 95% CI, 1.15- 4.53) were statistically significant.
• No association was found between psilocybin use and risk of paranoia and transient thought disorder.

Source:

Yerubandi A, et al. (2024, April 1). JAMA Netw Open. Acute Adverse Effects of Therapeutic Doses of Psilocybin: A Systematic Review and Meta-Analysis. https://pubmed.ncbi.nlm.nih.gov/38598236/