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Randomized Controlled Trial
. 2020 Jun 15;16(6):937-947.
doi: 10.5664/jcsm.8376.

Effects of saffron on sleep quality in healthy adults with self-reported poor sleep: a randomized, double-blind, placebo-controlled trial

Adrian L Lopresti  1   2 , Stephen J Smith  1   2 , Alexandra P Metse  1 , Peter D Drummond  1
Affiliations
Free PMC article
Randomized Controlled Trial

Effects of saffron on sleep quality in healthy adults with self-reported poor sleep: a randomized, double-blind, placebo-controlled trial

Adrian L Lopresti et al. J Clin Sleep Med. .
Free PMC article

Abstract

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 standardized saffron extract (affron).

Methods: This was a 28-day, parallel-group, double-blind, randomized controlled trial. Sixty-three healthy adults aged 18-70 with self-reported sleep problems were recruited and randomized to receive either saffron extract (affron; 14 mg twice daily) or a placebo. Outcome measures included the Insomnia Severity Index (ISI; primary outcome measure) collected at baseline and days 7, 14, 21, and 28 and the Restorative Sleep Questionnaire (RSQ) and the 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.

Conclusions: 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.

Clinical trial registration: Registry: Australian New Zealand Clinical Trials Registry; Name: Effects of Saffron on Sleep Quality in Healthy Adults with Self-Reported Unsatisfactory Sleep; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377781; Identifier: ACTRN12619000863134.

Keywords: herbal; insomnia; saffron; sleep.

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Conflict of interest statement

All authors have seen and approved the manuscript. This study was funded by Pharmactive Biotech Products SL. Pharmactive Biotech Products was not involved in the design of the research, analysis of data, or in the writing of the report. The authors report no conflicts of interest.

Figures

Figure 1
Figure 1. Systematic illustration of the study design.
DASS-21 = Depression, Anxiety, Stress Scale–21; DBAS = Dysfunctional Beliefs Associated with Sleep Questionnaire; ISI = Insomnia Severity Index; PSD = Pittsburgh Sleep Diary; RSQ = Restorative Sleep Questionnaire.
Figure 2
Figure 2. Change in Insomnia Severity Index scores (error bars depict SEs).
See this image and copyright information in PMC

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