Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.
Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.
Clin Neurol Neurosurg. 2020 Aug;195:105878. doi: 10.1016/j.clineuro.2020.105878. Epub 2020 May 1.
This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.
本研究旨在评估褪黑素补充对帕金森病（PD）患者临床和代谢特征的影响。
这是一项随机、双盲、安慰剂对照的临床试验，纳入了 60 名 PD 患者。参与者被随机分为两组，分别服用 10mg 褪黑素（2 粒褪黑素胶囊，每粒 5mg）（n=30）或安慰剂（n=30），每天睡前 1 小时服用，持续 12 周。
褪黑素补充治疗可显著降低帕金森病统一评定量表（UPDRS）第一部分评分（β-2.33；95%置信区间，-3.57，-1.09；P<0.001）、匹兹堡睡眠质量指数（PSQI）（β-1.82；95%置信区间，-3.36，-0.27；P=0.02）、贝克抑郁量表（BDI）（β-3.32；95%置信区间，-5.23，-1.41；P=0.001）和贝克焦虑量表（BAI）（β-2.22；95%置信区间，-3.84，-0.60；P=0.008）评分。与安慰剂治疗相比，褪黑素补充治疗可显著降低血清高敏 C 反应蛋白（hs-CRP）（β-0.94mg/L；95%置信区间，-1.55，-0.32；P=0.003），并显著提高血浆总抗氧化能力（TAC）（β 108.09mmol/L；95%置信区间，78.21，137.97；P<0.001）和总谷胱甘肽（GSH）水平（β 77.08μmol/L；95%置信区间，44.29，109.86；P<0.001）。此外，褪黑素补充治疗可显著降低血清胰岛素水平（β-1.79μIU/mL；95%置信区间，-3.12，-0.46；P=0.009）、稳态模型评估胰岛素抵抗指数（HOMA-IR）（β-0.47；95%置信区间，-0.80，-0.13；P=0.007）、总胆固醇（β-13.16mg/dL；95%置信区间，-25.14，-1.17；P=0.03）和 LDL 胆固醇（β-10.44mg/dL；95%置信区间，-20.55，-0.34；P=0.04）水平。
总的来说，PD 患者补充褪黑素 12 周对 UPDRS 第一部分评分、PSQI、BDI、BAI、hs-CRP、TAC、GSH、胰岛素水平、HOMA-IR、总胆固醇、LDL 胆固醇以及 TNF-α、PPAR-γ和 LDLR 的基因表达有有益影响，但对其他代谢特征没有影响。
