A recent study found that saffron had similar efficacy at both 14-mg and 28-mg doses, increasing melatonin levels but not cortisol.
Investigators concluded that saffron extract (affron; Gencor) had sleep-enhancing effects when taken by adults with unsatisfactory sleep over a period of 28 days. Saffron supplementation improved outcome measures, namely sleep quality ratings, mood ratings after awakening, Insomnia Symptom Questionnaire (ISQ) score, and ISQ-insomnia classifications, when compared to placebo.
The 3-arm, parallel group, randomized, double-blind, placebo-controlled trial enrolled a total of 120 patients between the ages of 18 and 70 reporting unsatisfactory sleep. Patients were randomized into placebo (n = 40) or treatment groups, the latter groups receiving either 14-mg doses (n = 40) or 28-mg doses (n = 40) of standardized saffron extract. Included participants had a regular bedtime between 9 PM and 12 AM, with a body mass index between 20 and 35.
When taking either dose of saffron extract 1 hour before bedtime, investigators saw greater improvement in patients’ sleep-related measures, namely the primary outcome of change in Pittsburgh Sleep Diary (PSD) sleep quality ratings from baseline to week 4, as the between-group difference in change was statistically significant (P = .023) when compared to placebo. When comparing the 14-mg and 28-mg saffron groups, the results were not statistically significant (P = .949).
“The results of this study are consistent with those identified in a previous study on saffron. In this previous trial, saffron was administered at a dose of 14 mg twice daily for 28 days, which contrasts with the current study where supplementation was administered once daily, 1 hour before bed,” corresponding author Adrian L. Lopresti, PhD, managing director, Clinical Research Australia, and adjunct senior lecturer, College of Science, Health, Engineering and Education, Murdoch University, Western Australia, et al wrote. “Together, these results suggest that supplementation once or twice daily at total daily doses of either 14 or 28 mg may be effective in improving sleep quality in adults with self-reported poor sleep.”
Evaluating salivary hormones, investigators found that concentrations of melatonin were significantly different in the saffron groups compared to the placebo (P = .021). From baseline to day 28, concentration levels increased in combined saffron groups significantly (P = .036) while not significantly changing within the placebo (P = .526), 14-mg saffron group (P = .128) and 28-mg saffron group (P = .268). There was no significant decrease in cortisol concentrations in the saffron groups compared to the placebo group, despite statistically significant decreases in the combined saffron groups (P = .040) and the 28-mg saffron group (P = .032).
Investigators further evaluated the Restorative Sleep Questionnaire–Weekly Version (RSQ-W), ISQ scores, and the remaining PSD factors using a multivariate analysis, finding no significant difference reflected in the change for overall scores (F16,186 = 1.33; P = .183) among the 3 groups. When conducting a univariate analysis, there was a statistically significant difference in change in PSD mood ratings when comparing the 3 groups (F2,99 = 4.49; P = .014), as well as a change in ISQ scores (F2,99 = 3.18; P = .046).
Nonsignificant differences were found between all 3 groups for the Profile of Mood States (POMS-A) scores (F14,188 = 0.53; P = .915). When evaluating ISQ insomnia classification, significant differences were observed between the combined saffron groups and the placebo group (P = .041), with insomnia classifications decreasing in all 3 groups (placebo, 6%; 14-mg saffron group, 22%; 28-mg saffron group, 26%).
Investigators found no difference between combined saffron groups and the placebo group in changes in self-reported alertness after wakening, total sleep time, time to sleep onset, number of awakenings after sleep onset, and restorative sleep. Additionally, considering quality of life and its association with excessive sleepiness, investigators found no significant differences when measuring with the Functional Outcomes of Sleep Questionnaire.
Within the placebo and saffron 14-mg groups, 82.5% of participants reported no adverse effects (AEs) and 87.5% of participants in the saffron 28-mg group reported no AEs. Every 7 days, participants completed an online questionnaire to screen for AEs associated with treatment. The study was limited due to several factors, including its ability to be generalized, as females with a mean age of 52 years accounted for 70% of participants, meaning they were likely peri- or post-menopausal. Additionally social media advertisements for recruitment may have created a bias. Additional research is necessitated to investigate the efficacy of saffron supplementation over a longer duration using objective sleep measures.