Cited by 301Circadian rhythm and melatoninSleep and Work-Related Fatiguemelanin and skin pigmentation

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Clinical Uses of Melatonin: Evaluation of Human Trials

Sanchez-Barcelo, E.J., Mediavilla, M.D., Tan, D.X., Reiter, R.J.·2010·Current Medicinal Chemistry

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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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Background
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Background
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“[65] Sánchez-Barceló EJ, Mediavilla MD, Tan D-X, Reiter”
Background
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“Melatonin has been used in various clinical fields including macular degeneration, glaucoma, coagulopathies, irritable bowel syndrome, inflammatory bowel diseases, hypertension, myocardial infarction, diabetes, rheumatoid arthritis, and other inflammatory diseases and neoplasms.(140) Melatonin's uses in many of these…”
BackgroundSelf-citation
Targeting Fatigue in Stroke Patients
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“In addition, it has been proven to be a safe, FDA-approved drug with few side effects and has since been incorporated into several human clinical trials [5].”
Background
Updated View on the Relation of the Pineal Gland to Autism Spectrum Disorders
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“However, it has been suggested that melatonin is a protective factor against cancer (43) and coronary heart disease (44).”
Background
Melatonin and Melatonergic Drugs in Clinical Practice
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“Melatonin and its analogues are currently used by millions of people around the world to prevent aging, to improve sleep performance, to ameliorate jet-lag symptoms and to treat depression [30].”
Background
Melatonin in Edible and Non-Edible Plants
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Self-citation
Circadian Variation in the Response to Experimental Endotoxemia and Modulatory Effects of Exogenous Melatonin
Alamili, M., Klein, M. F., Lykkesfeldt, J., Rosenberg, J., & Gögenür, I. (2013) · Chronobiology International · doi:10.3109/07420528.2013.808653 · Cited by 20
“…melatonin administration has been shown to have potent antioxidant and anti-inflammatory effects (Gitto et al., 2001, 2009; Reiter et al., 2000; Sánchez-Barceló et al., 2010; Srinivasan et al., 2010; Tan et al., 2007), and a beneficial effect of melatonin has also been reported in the…”
Background
Melatonin promotes survival of nonvascularized fat grafts and enhances the viability and migration of human adipose‐derived stem cells via down‐regulation of acute inflammatory cytokines
Tan, S. S. Y., Zhan, W., Poon, C. J., Han, X., Marré, D., Boodhun, S., Palmer, J. A., Mitchell, G. M., & Morrison, W. A. (2017) · Journal of Tissue Engineering and Regenerative Medicine · doi:10.1002/term.2463 · Cited by 19
Pre-treatment with melatonin decreases abamectin induced toxicity in a nocturnal insect Spodoptera litura (Lepidoptera: Noctuidae)
Subala, S. P. R. R., Esteban‐Zubero, E., Alatorre-Jiménez, M. A., et al. (2017) · Environmental Toxicology and Pharmacology · doi:10.1016/j.etap.2017.08.025 · Cited by 19
Melatonin and Neonatal Sepsis: A Promising Antioxidant Adjuvant Agent
Marseglia, L. M., Reiter, R. J., Buonocore, G., Gitto, E., & D’Angelo, G. (2017) · American Journal of Perinatology · doi:10.1055/s-0037-1604244 · Cited by 21
Self-citation
Melatonin is an appropriate candidate for breast cancer treatment: Based on known molecular mechanisms
Amin, N., Shafabakhsh, R., Reiter, R. J., & Asemi, Z. (2019) · Journal of Cellular Biochemistry · doi:10.1002/jcb.28832 · Cited by 20
“Melatonin and analogs may interact with specific receptors as well as functioning in receptor‐independent means to suppress several diseases like insomnia, epilepsy, Alzheimer's disease, migraine, depression, diabetes, obesity, alopecia, immune, cardiac disorders, and cancer.(76,77) Melatonin via its receptors and var…”
BackgroundSelf-citation
Herbal antioxidants and renal ischemic-reperfusion injury; an updated review
Asgharpour, M., Tolouian, A. C., Bhaskar, L. V., Tolouian, R., & Massoudi, N. (2020) · Journal of Nephropharmacology · doi:10.34172/npj.2021.03 · Cited by 19
“Melatonin plays a major role in several pathological conditions; including cardiovascular diseases, neurodegenerative diseases, metabolic syndrome, infection and others (36).”
Background
Multiple interactions between melatonin and non‐coding RNAs in cancer biology
Maleki, M., Khelghati, N., Alemi, F., Younesi, S., Asemi, Z., Abolhasan, R., Bazdar, M., Kafil, H. S., & Yousefi, B. (2021) · Chemical Biology & Drug Design · doi:10.1111/cbdd.13849 · Cited by 18
Melatonin reduces changes to small intestinal microvasculature during systemic inflammation
Lansink, M. O., Patyk, V., de GROOT, H., & Effenberger‐Neidnicht, K. (2016) · Journal of Surgical Research · doi:10.1016/j.jss.2016.11.055 · Cited by 18
The Effect of Melatonin on Plasma Markers of Inflammation and on Expression of Nuclear Factor-Kappa Beta in Acetic Acid-Induced Colitis in the Rat
Sayyed, H., Jaumdally, R. J., Idriss, N. K., Sers, D. A. E., & Blann, A. D. (2013) · Digestive Diseases and Sciences · doi:10.1007/s10620-013-2811-x · Cited by 17
“Several groups have used melatonin to treat this disease and others in our own species [28–31].”
Melatonin as a Therapeutic Resource for Inflammatory Visual Diseases
Aranda, M. L., Fleitas, M. F. G., Diéguez, H. H., Iaquinandi, A., Sande, P. H., Dorfman, D., & Rosenstein, R. E. (2017) · Current Neuropharmacology · doi:10.2174/1570159x15666170113122120 · Cited by 17
“Thus, melatonin, a safe compound for human use even at high doses [149, 150], could constitute a potential therapy for primary ON.”
Beneficial Effects of Exogenous Melatonin in Acute Staphylococcus aureus and Escherichia coli Infection-Induced Inflammation and Associated Behavioral Response in Mice After Exposure to Short Photoperiod
Bishayi, B., Adhikary, R., Nandi, A., & Sultana, S. (2016) · Inflammation · doi:10.1007/s10753-016-0445-9 · Cited by 18
“Melatonin is generally anti-inflammatory and immunoenhancing in most laboratory animal species [14].”
The Influence of Melatonin on Immune System and Cancer
Vinther, A. G. (2015) · International Journal of Cancer and Clinical Research · doi:10.23937/2378-3419/2/4/1024 · Cited by 22
“When it comes to melatonin and autoimmune diseases, the results are few and contradictory [6,22].”
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Potentiating the Benefits of Melatonin through Chemical Functionalization: Possible Impact on Multifactorial Neurodegenerative Disorders
Galano, A., Guzmán‐López, E. G., & Reiter, R. J. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms222111584 · Cited by 16
Self-citation
The importance of melatonin in the regulation of metabolism, eating behavior, sleep, and the prospects for the use of melatonin drugs for obesity treatment
Tsvetkova, E. S., Romantsova, T. I., Poluektov, M. G., Евгеньевна, Р. Г., Glinkina, I. V., & Fadeev, V. V. (2021) · Obesity and metabolism · doi:10.14341/omet12279 · Cited by 17
The Prospective Application of Melatonin in Treating Epigenetic Dysfunctional Diseases
Monayo, S. M., & Liu, X. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.867500 · Cited by 16
Atopy and autoimmune thyroid diseases: melatonin can be useful?
D’Angelo, G., Marseglia, L. M., Manti, S., Colavita, L., Cuppari, C., Impellizzeri, P., Arena, S., Arrigo, T., Salpietro, C. D., & Gitto, E. (2016) · The Italian Journal of Pediatrics/Italian journal of pediatrics · doi:10.1186/s13052-016-0305-0 · Cited by 16
Adreno–melatonin receptor complexes control ion homeostasis and intraocular pressure ‐ their disruption contributes to hypertensive glaucoma
Alkozi, H. A., Navarro, G., Aguinaga, D., Reyes‐Resina, I., Sánchez-Navés, J., de Lara, M. J. P., Franco, R., & Pintor, J. J. (2020) · British Journal of Pharmacology · doi:10.1111/bph.14971 · Cited by 16
Adverse events in long-term studies of exogenous melatonin
Besag, F., & Vasey, M. J. (2022) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2022.2160444 · Cited by 15
“Studies have investigated the therapeutic potential of melatonin for diverse health outcomes [5,6].”
Background
Programmed cell death and melatonin: A comprehensive review
Rafiyan, M., Reiter, R. J., Manesh, S. M. R., Asemi, R., Sharifi, M., Mohammadi, S., Mansournia, M. A., & Asemi, Z. (2024) · Functional & Integrative Genomics · doi:10.1007/s10142-024-01454-4 · Cited by 14
“One of the critical aspects of melatonin is its long-term effects as the data about these effects are limited but current researches suggested that it could be well tolerated (Sánchez-Barceló et al. 2010; Menczel Schrire et al. 2022).”
Self-citation
Melatonin; from pineal gland to healthy foods
Korkmaz, A., Reiter, R. J., Tan, D. X., et al. (2011) · Spatula DD · doi:10.5455/spatula.20110113080358 · Cited by 14
“The data in reference to efficacy of melatonin on a variety of diseases and conditions are not only derived from experimental studies but most of them are also clinically well founded [4].”
Self-citation
Historical and cultural aspects of the pineal gland: comparison between the theories provided by Spiritism in the 1940s and the current scientific evidence.
Lucchetti, G., Daher, J. C., Iandoli, D., Gonçalves, J. P. B., & Lucchetti, A. L. G. (2013) · PubMed · Cited by 13
The Variable Nature of Vitamin C—Does It Help When Dealing with Coronavirus?
Grudlewska‐Buda, K., Wiktorczyk-Kapischke, N., Budzyńska, A., Kwiecińska-Piróg, J., Przekwas, J., Kijewska, A., Sabiniarz, D., Gospodarek-Komkowska, E., & Skowron, K. (2022) · Antioxidants · doi:10.3390/antiox11071247 · Cited by 13
Melatonin Improves Vasogenic Edema via Inhibition to Water Channel Aquaporin-4 (AQP4) and Metalloproteinase-9 (MMP-9) Following Permanent Focal Cerebral Ischemia
Lee, A., Tai, S., Huang, S., et al. (2024) · Biomedicines · doi:10.3390/biomedicines12102184 · Cited by 13
“While melatonin shows promise for treating ischemic stroke patients who present outside the thrombolytic window, additional clinical trials are necessary to establish its efficacy and safety [39].”
Background
Effectiveness of melatonin for sleep impairment post paediatric acquired brain injury: Evidence from a systematic review
Keegan, L.-J., Reed-Berendt, R., Neilly, E., Morrall, M. C. H. J., & Murdoch‐Eaton, D. G. (2013) · Developmental Neurorehabilitation · doi:10.3109/17518423.2012.741147 · Cited by 13
Melatonin and its Relationships with Diabetes and Obesity: A Literature Review
Ramirez, A. V. G., Filho, D. R., & de Sá, L. B. P. C. (2020) · Current Diabetes Reviews · doi:10.2174/1573399816666200727102357 · Cited by 13
Low melatonin as a contributor to SARS-CoV-2 disease
Pandi-Perumal, S. R., Cardinali, D. P., Reiter, R. J., & Brown, G. M. (2020) · Melatonin Research · doi:10.32794/mr11250079 · Cited by 13
Self-citation
PK-PD based optimal dose and time for orally administered supra-pharmacological dose of melatonin to prevent radiation induced mortality in mice
Choudhary, S., Kumar, A., Saha, N., et al. (2019) · Life Sciences · doi:10.1016/j.lfs.2019.01.007 · Cited by 12
Impact of Melatonin and Branched-Chain Amino Acids Cosupplementation on Quality of Life, Fatigue, and Nutritional Status in Cachectic Heart Failure Patients: A Randomized Controlled Trial
Vayghan, H. J., Moludi, J., Saleh‐Ghadimi, S., Enamzadeh, E., Seyed-Mohammadzad, M., & Alizadeh, M. (2019) · American Journal of Lifestyle Medicine · doi:10.1177/1559827619874044 · Cited by 12
“Along with the therapeutic usefulness of melatonin seen in numerous clinical trials, very low toxicity of melatonin was reported over an extensive range of doses.(53) Furthermore, melatonin safety has been established in doses that noticeably exceed those that were used in cardiovascular diseases.”
Background
Inflammatory Bowel Disease
Parian, A. M., Mullin, G. E., Langhorst, J., & Brown, A. C. (2017) · Elsevier eBooks · doi:10.1016/b978-0-323-35868-2.00050-5 · Cited by 15
Melatonin Administered before or after a Cytotoxic Drug Increases Mammary Cancer Stabilization Rates in HER2/Neu Mice
Панченко, А. В., Тындык, М. Л., Maydin, M. A., et al. (2020) · Chemotherapy · doi:10.1159/000509238 · Cited by 12

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)
DOI: 10.2174/092986710791233689
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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Clinical Uses of Melatonin: Evaluation of Human Trials

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