Acute Adverse Effects of Therapeutic Doses of Psilocybin: A Systematic Review and Meta-Analysis.

Autor:	Yerubandi A; Department of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens., Thomas JE; Department of Clinical and Administrative Sciences, Larkin University, Miami, Florida., Bhuiya NMMA; Department of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens., Harrington C; Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, Florida., Villa Zapata L; Department of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens., Caballero J; Department of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2024 Apr 01; Vol. 7 (4), pp. e245960. Date of Electronic Publication: 2024 Apr 01.
DOI:	10.1001/jamanetworkopen.2024.5960
Abstrakt:	Importance: Psilocybin has been studied in the treatment of depression and anxiety disorders. Clinical studies have mainly focused on efficacy, with systematic reviews showing favorable efficacy; however, none have primarily focused on psilocybin safety. Objective: To evaluate the acute adverse effects of psilocybin at therapeutic doses in the treatment of depression and anxiety. Data Sources: MEDLINE via PubMed, Web of Science, and ClinicalTrials.gov were searched for publications available between 1966 and November 30, 2023. Study Selection: Randomized, double-blind clinical trials that reported adverse effects of psilocybin in patients treated for depression and anxiety were screened. Data Extraction and Synthesis: Data were independently extracted by 2 authors and verified by 2 additional authors following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. The inverse variance method with the Hartung-Knapp adjustment for the random-effects model was used, with a continuity correction of 0.5 for studies with 0 cell frequencies. Sensitivity analysis was conducted by sequentially removing 1 study at a time to assess the robustness of the results. Main Outcomes and Measures: 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 comparator in the treatment of depression and/or anxiety. Results: Six studies met the inclusion criteria with a total sample of 528 participants (approximately 51% female; median age 39.8 years; IQR, 39.8-41.2). Seven adverse effects were reported in multiple studies and included in the analysis. Among these, headache (relative risk [RR], 1.99; 95% 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 blood pressure (RR, 2.29; 95% CI, 1.15- 4.53) were statistically significant. Psilocybin use was not associated with risk of paranoia and transient thought disorder. Conclusions and Relevance: In this meta-analysis, the acute adverse effect profile of therapeutic single-dose psilocybin appeared to be tolerable and resolved within 48 hours. However, future studies need to more actively evaluate the appropriate management of adverse effects.
Databáze:	MEDLINE
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