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Clinical Uses of Melatonin: Evaluation of Human Trials
Abstract
During the last 20 years, numerous clinical trials have examined the therapeutic usefulness of melatonin in different fields of medicine. The objective of this article is to review, in depth, the science regarding clinical trials performed to date. The efficacy of melatonin has been assessed as a treatment of ocular diseases, blood diseases, gastrointestinal tract diseases, cardiovascular diseases, diabetes, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological diseases, sleep disturbances, aging and depression. Melatonin has been also used as a complementary treatment in anaesthesia, hemodialysis, in vitro fertilization and neonatal care. The conclusion of the current review is that the use of melatonin as an adjuvant therapy seems to be well founded for macular degeneration, glaucoma, protection of the gastric mucosa, irritable bowel syndrome, arterial hypertension, diabetes, side effects of chemotherapy and radiation in cancer patients or hemodialysis in patients with renal insufficiency and, especially, for sleep disorders of circadian etiology (jet lag, delayed sleep phase syndrome, sleep deterioration associated with aging, etc.) as well as in those related with neurological degenerative diseases (Alzheimer, etc.,) or Smith-Magenis syndrome. The utility of melatonin in anesthetic procedures has been also confirmed. More clinical studies are required to clarify whether, as the preliminary data suggest, melatonin is useful for treatment of fibromyalgia, chronic fatigue syndrome, infectious diseases, neoplasias or neonatal care. Preliminary data regarding the utility of melatonin in the treatment of ulcerative colitis, Crohns disease, rheumatoid arthritis are either ambiguous or negative. Although in a few cases melatonin seems to aggravate some conditions, the vast majority of studies document the very low toxicity of melatonin over a wide range of doses. Keywords: Melatonin, macular degeneration, glaucoma, gastric mucosa, irritable bowel syndrome, ulcerative colitis, Crohn's disease, rheumatoid arthritis, arterial hypertension, diabetes, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological diseases, Smith-Magenis syndrome, sleep disturbances, jet lag, shift work, aging, depression, anesthesia, hemodialysis, in vitro fertilization, neonatal care, clinical trials
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“Many in vitro experiments under different experimental conditions confirmed the good antioxidant activity of melatonin, however, levels of melatonin in certain body organs might not be high enough to exhibit antioxidant properties (Sanchez-Barcelo et al. 2010).”
From Reactive Oxygen Species, Toxicity, Oxidative Stress, and Antioxidants: Chronic Diseases and Aging (2023) · cites this paper as Sanchez-Barcelo et al. 2010
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Tan, Y.-Z., Xu, X.-Y., Dai, J.-M., Yin, Y., He, X.-T., Zhang, Y.-L., Zhu, T.-X., An, Y., Tian, B., & Chen, F.-M. (2021) · Figshare · doi:10.6084/m9.figshare.14516633
Tan, Y.-Z., Xu, X.-Y., Dai, J.-M., Yin, Y., He, X.-T., Zhang, Y.-L., Zhu, T.-X., An, Y., Tian, B., & Chen, F.-M. (2021) · Figshare · doi:10.6084/m9.figshare.14516636
Intranasal Delivery of Natural Compounds: A Promising approach for Parkinson’s Disease therapy
Jadhav, P. D., Velhal, A. B., Redasani, V. K., & Rathod, S. T. (2026) · Asian Journal of Pharmaceutical Research · doi:10.52711/2231-5691.2026.00002
Melatonin hybrids as multifunctional therapeutic agents: A comprehensive review
Damirchi, E. K., Barani, A., Hamidi, S. M., & Ebrahimzadeh, M. A. (2026) · European Journal of Medicinal Chemistry · doi:10.1016/j.ejmech.2026.119156
Metadata
- Authors
- Sanchez-Barcelo, E. J., Mediavilla, M. D., Tan, D. X., & Reiter, R. J.
- Affiliations
- Universidad de Cantabria (ES)
- ORCID
- Reiter, R.J.
- Venue
- Current Medicinal Chemistry
- Publisher
- Bentham Science Publishers Ltd.
- Published
- 2010-07-01
- Volume
- 17
- Issue
- 19
- Pages
- 2070-2095
- ISSN
- 0929-8673 (ISSN-L)
- OpenAlex
- W2121858140
- Cited by
- 301
- References
- 0
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 12 · 2023: 12 · 2022: 16 · 2021: 21 · 2020: 24 · 2019: 20 · 2018: 16 · 2017: 27 · 2016: 17 · 2015: 14 · 2014: 23 · 2013: 33 · 2012: 28
- FWCI
- 13.15
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Medicinal Chemistry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › melanin and skin pigmentation
- Keywords
- melatonin, clinical efficacy, eye diseases, macular degeneration, glaucoma, gastrointestinal diseases, irritable bowel syndrome, ulcerative colitis, Crohn's disease, rheumatoid arthritis, cardiovascular disease, hypertension, diabetes mellitus, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological disorders, Alzheimer's disease, Smith-Magenis syndrome, sleep disorders, jet lag, shift work, aging, depression, anesthesia, hemodialysis, in vitro fertilization, neonatal care, adjuvant therapy
- MeSH terms
- Cardiovascular Diseases, Clinical Trials as Topic, Communicable Diseases, Endocrine System Diseases, Eye Diseases, Gastrointestinal Diseases, Hematologic Diseases, Humans, Melatonin, Muscular Diseases, Neoplasms, Nervous System Diseases, Fatigue Syndrome, Chronic
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