Han · Phytotherapy research : PTR 2024 · systematic review and meta-analysis of randomized controlled trials · n=46 studies

New horizons for the study of saffron (Crocus sativus L.) and its active ingredients in the management of neurological and psychiatric disorders: A systematic review of clinical evidence and mechanisms.

Level 1 - systematic review of randomized trials

Systematic review and meta-analysis of randomized controlled trials

PubMed 38424688 · doi:10.1002/ptr.8110 · record verified 2026-08-26

What was done

This systematic review and meta-analysis evaluated the efficacy of saffron (Crocus sativus) or its active extracts in neurological and psychiatric conditions. Researchers searched PubMed/Medline, Web of Science, and ClinicalTrials.gov through June 2023 for randomized controlled trials (RCTs). Studies evaluated healthy participants or patients with neurological and psychiatric disorders (cognition, depression, anxiety, sleep disorders, ADHD, and OCD) receiving saffron alone or alongside conventional pharmacotherapy over durations of 4 to 48 weeks. Risk of bias was evaluated using Cochrane tools, and pooled effect sizes were calculated using fixed- or random-effects models following PRISMA guidelines.

What was found

Across 46 enrolled RCTs, saffron was more effective than placebo for depression with a pooled effect size of -4.26 (95% CI: -5.76 to -2.77), anxiety with an effect size of -3.75 (95% CI: -5.83 to -1.67), and sleep disorders with an effect size of -1.91 (95% CI: -2.88 to -0.93). Saffron also improved cognition over placebo, though specific numerical effect sizes were not reported in the abstract. Saffron was described as non-inferior to standard pharmaceuticals for cognitive disorders, depression, anxiety, ADHD, and OCD, with favorable tolerability and few adverse effects.

Why it matters

This review aggregates randomized trial data indicating that saffron may serve as an effective, well-tolerated alternative or adjunct to conventional psychotropic medications for mood, sleep, and cognitive conditions.

Limits

The total number of human participants across the 46 trials was not reported in the abstract. Specific extract preparations, standardized dosages, and numeric values for cognitive outcomes or non-inferiority comparisons against active pharmaceutical controls were omitted from the abstract. Heterogeneity across diverse clinical conditions was not detailed.

Cited by