Efficacy of a Saffron-Based (Crocus sativus L.) Herbal Supplement on Sleep Disturbances in Pulmonary Sarcoidosis: A Randomized Single-Blind Controlled Trial.

Abstract

Background: Sleep disturbances in pulmonary sarcoidosis increase fatigue and reduce quality of life; however, standard anti-inflammatory treatments provide limited benefit. Saffron (Crocus sativus L., family Iridaceae), which has anti-inflammatory and neuromodulatory properties, may improve sleep, although its effects in this population have not been studied.

Objectives: This study evaluated whether 60 days of saffron supplementation (30 mg twice daily) improves sleep quality, reduces daytime sleepiness and fatigue, and enhances quality of life in patients with pulmonary sarcoidosis.

Methods: In this single-blind randomized controlled trial, 76 adults with pulmonary sarcoidosis, confirmed according to the American Thoracic Society/European Respiratory Society/World Association of Sarcoidosis and Other Granulomatous Disorders criteria, and Pittsburgh Sleep Quality Index (PSQI) scores ≥ 5 were assigned to groups using permuted block randomization (block size, 4). Allocation concealment was ensured using opaque, sealed, sequentially numbered envelopes. Participants were randomly allocated to receive either saffron (30 mg twice daily) plus sleep-hygiene counseling or counseling alone for 60 days. Sleep quality, daytime sleepiness, fatigue, and quality of life were assessed at baseline and day 60 using the PSQI, General Sleep Disturbance Scale (GSDS), Epworth Sleepiness Scale (ESS), Fatigue Assessment Scale (FAS), Patient-Reported Outcomes Measurement Information System (PROMIS)-fatigue, and 12-item Short Form Health Survey (SF-12).

Results: Of the 76 participants enrolled, 72 completed the study (36 per group). Compared with the control group, saffron supplementation significantly improved PSQI (adjusted mean difference [MD], -2.21), GSDS (adjusted MD, -14.60), ESS (adjusted MD, -2.46), FAS (adjusted MD, -4.58), and the PROMIS global physical health score (adjusted MD, 1.65) (all P < 0.001). Significant improvements were also observed in the SF-12 physical (P = 0.03) and mental (P = 0.003) component scores. No serious adverse events occurred.

Conclusions: Adjunctive saffron supplementation significantly improved sleep quality, reduced daytime sleepiness and fatigue, and enhanced quality of life in patients with pulmonary sarcoidosis. Larger, placebo-controlled studies are warranted to confirm these findings.