Feizabadi Faezeh, Abedini Atefeh, Salamzadeh Jamshid, Barati Saghar, Dastan Farzaneh
Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Pharm Res. 2023 Feb 12;21(1):e132168. doi: 10.5812/ijpr-132168. eCollection 2022 Dec.
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.
This study was designed to evaluate the effects of oral melatonin on sleep disorders of patients with pulmonary sarcoidosis.
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.
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).
Our findings showed that supplemental melatonin could significantly improve sleep problems, quality of life, and excessive daytime sleepiness in sarcoidosis patients.
肺结节病的症状可能导致这些患者出现疲劳、日间过度嗜睡、睡眠质量差以及生活质量下降。
本研究旨在评估口服褪黑素对肺结节病患者睡眠障碍的影响。
对肺结节病患者进行了一项随机、单盲临床试验。符合条件的患者被随机分为褪黑素组和对照组。褪黑素组患者在睡前1小时服用3毫克褪黑素，持续三个月。分别应用一般睡眠障碍量表（GSDS）、匹兹堡睡眠质量指数（PSQI）、爱泼华嗜睡量表（ESS）、疲劳评估量表（FAS）和患者报告结局测量信息系统（PROMIS）评估睡眠质量、日间嗜睡、疲劳状态和生活质量，以及在基线和治疗三个月后进行12项简短健康调查（SF - 12）评分。
与对照组相比，GSDS（P < 0.001）、PSQI（P < 0.001）、ESS（P = 0.002）和FAS（P < 0.001）评分有显著变化，且均降低。干预后，与对照组相比，总体身体健康和总体心理健康原始评分有所改善（分别为P = 0.006，P = 0.02）。12项简短健康调查评估显示，治疗三个月后，褪黑素组（3.38 ± 4.61）和对照组（0.55 ± 7.25）在PCS - 12评分上有显著差异（P = 0.02）。
我们的研究结果表明，补充褪黑素可以显著改善结节病患者的睡眠问题、生活质量和日间过度嗜睡。
