As interest in classic psychedelics such as LSD, psilocybin, DMT, and 5-MeO-DMT grows within clinical and research settings, it is crucial to understand their safety profiles.   

A comprehensive systematic review and meta-analysis, published in Scientific Reports, delves into the nature, frequency, and severity of adverse events (AEs) reported in studies involving these substances. Here’s an in-depth look at the key findings and their implications.

Overview

The primary objective of the study was to evaluate the adverse events associated with classic psychedelics in controlled environments. Researchers analyzed data from 3504 participants across 114 studies to assess both serious adverse events (SAEs) and nonserious adverse events (NSAEs) that required medical or psychiatric intervention. This review aimed to provide clarity on the safety of these substances and highlight any potential risks.

Key Findings:

1. Serious Adverse Events (SAEs)

   • Frequency: The study found that SAEs were reported in approximately 4% of participants with preexisting neuropsychiatric disorders. Notably, no SAEs were reported among healthy participants.
   • Types of SAEs: SAEs included exacerbations of preexisting conditions such as worsening depression, suicidal behavior, psychotic episodes, and convulsive seizures. This indicates that individuals with preexisting mental health conditions may be more vulnerable to severe adverse effects.
   • Reporting and Detection Issues: The study noted potential issues with underdetection and incomplete reporting of SAEs. This could mean that the true incidence of severe adverse effects might be higher than reported.

2. Nonserious Adverse Events (NSAEs)

   • Frequency and Types: NSAEs requiring medical intervention were relatively rare. Common NSAEs included headaches, nausea, anxiety, and paranoia. These effects were generally transient and manageable.
   • No Reports of Extreme Outcomes: The study did not find any reports of deaths by suicide, persistent psychotic disorders, or hallucinogen persisting perception disorder (HPPD) in contemporary research settings. This contrasts with some of the more severe outcomes reported in nonclinical or recreational contexts.

3. Quality of Adverse Event Reporting

   • Variability: There was significant variability in the quality of AE monitoring and reporting across studies. Of 68 studies published since 2005, only 16 (23.5%) described systematic approaches to AE assessment, and only 20 (29.4%) reported all AEs comprehensively.
   • Implications for Research: Inconsistent AE reporting underscores the need for standardized methodologies in monitoring and documenting adverse effects. Improved pharmacovigilance practices are essential to accurately assess the risks associated with psychedelic substances.

4. Meta-Analysis Results

   • Common Adverse Events: Meta-analyses of common AEs, such as headaches, anxiety, nausea, fatigue, and dizziness, showed similar prevalence rates for psilocybin and LSD. This helps establish a baseline for expected adverse effects and their management.

Conclusion

The systematic review and meta-analysis provide a nuanced understanding of the safety profile of classic psychedelics. While these substances are generally well-tolerated in clinical and research settings, the presence of SAEs, particularly among those with preexisting conditions, highlights the need for careful monitoring and personalized approaches to treatment.

Ongoing research and improved pharmacovigilance are crucial to understanding the complete risk-benefit profile of classic psychedelics. Enhanced reporting practices and systematic AE assessments will contribute to safer and more effective use of these substances in clinical settings.

For a comprehensive exploration of the study, access the full article here.

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This blog is based on the meta-analysis (التحليل التلوي, メタアナリシス, 元分析, Μεταανάλυση) titled "Adverse Events in Studies of Classic Psychedelics: A Systematic Review and Meta-Analysis." Read the full article here.