Source: J Clin Sleep Med. 2020 Feb 14.
Study objectives: Herbal medicines are frequently used by adults with sleep difficulties. However, evidence of their efficacy is limited. Therefore, the goal of this study was to examine the sleep-enhancing effects of a standardised saffron extract (affron).
Methods: This was a 28-day, parallel-group, double-blind, randomised controlled trial. Sixty-three healthy adults aged 18 to 70 with self-reported sleep problems were recruited and randomised to receive either saffron extract (affron, 14mg twice daily) or a placebo. Outcome measures included the Insomnia Severity Index (ISI) (primary outcome measure) collected at baseline, days 7, 14, 21, and 28; Restorative Sleep Questionnaire (RSQ) and Pittsburgh Sleep Diary (PSD) collected on days -1, 0, 3, 7, 14, 27, and 28.
Results: Based on data collected from 55 participants, saffron was associated with greater improvements in ISI total score (p=.017), RSQ total score (p=.029), and PSD sleep quality ratings (p=.014) than the placebo. Saffron intake was well-tolerated with no reported adverse effects.
Saffron intake was associated with improvements in sleep quality in adults with self-reported sleep complaints. Further studies using larger samples sizes, treatment periods, objective outcome measures, and volunteers with varying demographic and psychographic characteristics are required to replicate and extend these findings.