Clinical Evidence on Psilocybin and Its Representation in Media Reporting: A Systematic Review.

IMPORTANCE

Psilocybin has received increased attention as a potential therapeutic intervention, but it is unclear whether news media reporting reflects the strengths and limitations of the clinical trial evidence.

OBJECTIVE

To describe the annual counts of published clinical trials of therapeutic psilocybin and contemporaneous media articles and compare tone, efficacy, and safety messaging.

EVIDENCE REVIEW: This systematic review included English-language randomized and nonrandomized trials of psilocybin for clinical indications published from January 1, 2014, to October 10, 2024, and media articles describing its clinical use published from January 1, 2014, to April 22, 2025. Trials were found by searching Medline, Embase, PsycInfo, and the Cochrane Central Register of Controlled Trials (CENTRAL) and were characterized by design, indication, use of psychotherapy, and reporting of efficacy and safety. Media articles were found through the Factiva database and were characterized by audience, tone, indication, efficacy claim, and safety content. Data were extracted by 2 reviewers. Risk of bias for randomized clinical trials was assessed descriptively using the Cochrane Risk of Bias tool.

FINDINGS: Annual counts of both published clinical trials (n = 70) and media reports (n = 172) increased from 2018 onward. Depression was the most common clinical indication in trials (47 [67%]) and media articles (138 [80%]), while media articles frequently referenced posttraumatic stress disorder (PTSD) (74 [43%]) and anxiety (72 [42%]) as clinical indications despite absent and limited trial evidence, respectively, for these conditions. Overall, 49 trials (70%) reported benefit for the primary indication; 125 media articles (73%) made at least 1 positive efficacy claim, and 122 (71%) adopted a favorable tone. Trials typically described small sample sizes of less than 100 participants (65 trials [93%]) and methodologic limitations. Overall, 31 trials (44%) reported safety outcomes, with some (24 [34%]) documenting short-term adverse events, such as transient anxiety, nausea, or headache; long-term safety was rarely assessed (4 trials [6%]). Only 51 media articles (30%) mentioned safety; when harms were discussed, potential long-term psychological risks were sometimes noted (12 articles [7%]).

CONCLUSIONS AND RELEVANCE: In this systematic review of clinical trials and media articles, both reported positive effects of therapeutic psilocybin with similar frequency. Academic publications were more cautious and explicit about methodologic limitations, whereas media reports often presented benefits as established, extrapolated them to indications with little or no trial evidence, and provided less safety information. Clarifying these differences in emphasis may support more transparent public communication of indication-specific evidence and uncertainty as interest in psilocybin-assisted treatments grows.