Effect of Melatonin Plus Zinc Supplementation on Fatigue Perception in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Antioxidants

José Luis Galmés¹  Maria-Cleofé Zaragozá¹  Irene López-Vílchez¹  Joan Carles Domingo²  Begoña Cordobilla²  Sara Maurel³  Jesús Castro-Marrero⁴  José Alegre-Martín⁵ 

[1] Clinical Research Department, Laboratorios Viñas, 08012 Barcelona, Spain;Department of Biochemistry and Molecular Biomedicine, Faculty of Biology, University of Barcelona, 08028 Barcelona, Spain;Department of Neurosciences, University of the Basque Country, 48940 Leioa, Spain;Division of Rheumatology, ME/CFS Unit, Vall d’Hebron Hospital Research Institute, 08035 Barcelona, Spain;Division of Rheumatology, ME/CFS Unit, Vall d’Hebron University Hospital, 08035 Barcelona, Spain;

关键词: chronic fatigue syndrome;    fatigue;    myalgic encephalomyelitis;    melatonin;    quality of life;    sleep quality;   

DOI  :  10.3390/antiox10071010

来源: DOAJ

【 摘 要 】

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, multisystem, and profoundly debilitating condition, probably of multifactorial etiology. No effective approved drugs are currently available for its treatment. Several studies have proposed symptomatic treatment with melatonin and zinc supplementation in chronic illnesses; however, little is known about the synergistic effect of this treatment on fatigue-related symptoms in ME/CFS. The primary endpoint of the study was to assess the effect of oral melatonin plus zinc supplementation on fatigue in ME/CFS. Secondary measures included participants’ sleep disturbances, anxiety/depression and health-related quality of life. A proof-of-concept, 16-week, randomized, placebo-controlled, double-blind trial was conducted in 50 ME/CFS patients assigned to receive either oral melatonin (1 mg) plus zinc (10 mg) supplementation (n = 24) or matching placebo (n = 26) once daily. Endpoint outcomes were evaluated at baseline, and then reassessed at 8 and 16 weeks of treatment and 4 weeks after treatment cessation, using self-reported outcome measures. The most relevant results were the significant reduction in the perception of physical fatigue in the Mel-Zinc group at the final treatment follow-up versus placebo (p < 0.05), and the significant improvement in the physical component summary at all follow-up visits in the experimental group. Urinary 6-sulfatoxymelatonin levels were significantly elevated though the treatment in experimental group vs. placebo (p < 0.0001); however, no significantly differences were observed for zinc concentration among participants. Our findings suggest that oral melatonin plus zinc supplementation for 16 weeks is safe and potentially effective in reducing fatigue and improving the quality of life in ME/CFS. This clinical study was registered on ClinicalTrials.gov (NCT03000777).

【 授权许可】

Unknown