Abstract
BACKGROUND: The symptoms of pulmonary sarcoidosis may lead to fatigue, excessive daytime sleepiness, poor sleep quality, and a decrease in quality of life in these patients. OBJECTIVES: This study was designed to evaluate the effects of oral melatonin on sleep disorders of patients with pulmonary sarcoidosis. METHODS: A randomized, single-blinded clinical trial was conducted on patients with pulmonary sarcoidosis. Eligible patients were randomly allocated into melatonin and control groups. Patients in the melatonin group were given 3 mg melatonin one hour before bedtime for three months. Sleep quality, daytime sleepiness, fatigue status, and quality of life were assessed applying General Sleep Disturbance Scale (GSDS), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Fatigue Assessment Scale (FAS), and the Patient-Reported Outcomes Measurement Information System (PROMIS), respectively, as well as the 12-item Short Form Survey (SF-12) scores at the baseline and three months after treatment. RESULTS: There was a significant change in the GSDS (P < 0.001), PSQI (P < 0.001), ESS (P = 0.002), and FAS (P < 0.001) scores, which were decreased, compared to those of the control group. After intervention¸ global physical health and global mental health raw scores were improved comparing to the control group (P = 0.006, P = 0.02, respectively). The 12-item Short Form Survey evaluation showed that there was a significant difference between the melatonin (3.38 ± 4.61) and control (0.55 ± 7.25) groups in PCS-12 score after three months of therapy (P = 0.02). CONCLUSIONS: Our findings showed that supplemental melatonin could significantly improve sleep problems, quality of life, and excessive daytime sleepiness in sarcoidosis patients.