Melatonin placebo-controlled trial

Gupta, M., Aneja, S. Kohli, K. (2005). Add-on melatonin improves sleep behavior in children with epilepsy randomized, double-blind, placebo-controlled trial. 

Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thai LJ (2003) A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer s disease. Sleep 26 893-901... 

Serfaty MA, Osborne D, Buszewicz MJ, Blizard R, Raven PW. A randomized double-blind placebo-controlled trial of treatment as usual plus exogenous slow-release melatonin (6 mg) or placebo for sleep disturbance and depressed mood. Int Clin Psychopharmacol 2010 25(3) 132-42. 

Kunz D, Mahlberg R. A two-part, doubleblind, placebo-controlled trial of exogenous melatonin in REM sleep behaviour disorder. J Sleep Res 2010 19(4) 591-6. 

KUcUkakin B, Klein M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gogenur I. No effect of melatonin on oxidative stress after laparoscopic cholecystectomy a randomized placebo-controlled trial. Acta Anaesthesiol Scand 2010 54(9) 1121-7. 

Zisapel N. Nightly treatment of primary insomnia with prolonged release melatonin for 6 months a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety. BMC Med 2010 8 51. 

Randomised trials A randomised, placebo-controlled trial of controlled-release melatonin (3 mg) for treating insomnia in children (N = 160, mean age = 6.6 years, 82% male) reported that the melatonin treatment was well tolerated with no adverse effects reported or observed and normal blood and urine analyses recorded across treatment groups [52 ]. 

A randomised, placebo-controlled trial examining the efficacy of melatonin (20 mg) in the treatment of cachexia in 73 advanced cancer patients foxmd that it did not improve appetite, weight or quality of life compared with placebo [53 ]. Despite the high dose of melatonin there was no difference befween the conditions in the prevalence or type of adverse events reported. 

A randomised, placebo-controlled trial examining the efficacy of immediate release melatonin (0.5-12 mg, depending on response) in treating sleep disorders in 146 children (aged 3-15 years) with neurodevelopmental disorders found melatonin caused mild improvements in total sleep but more marked improvement in latency to sleep and actigraphy results [54 ]. However, treatment was associated with earlier waking times. Only mild adverse events were reported and their occurrences were similar between the two groups— no formal statistical assessment of prevalence was conducfed. 

Tolerance A randomised, placebo-controlled trial examining 67 haemodialysis patients suffering subjective sleep problems found that melatonin treatment (3 mg per day) resulted in improved sleep efficiency and actual sleep time on haemodialysis days but none of these benefits remained after 12 months of treatment, suggesting melatonin may not be efficacious for treating sleep disturbances in this population in the long term [56. ... 

A randomised, placebo-controlled trial examining 3 weeks of melatonin treatment (2.5 mg) for the treatment of sleep disturbances in 16 hypertensive patients (aged 45-64 years 56% female) treated with beta-blockers found that melatonin treatment was effective at improving sleep quality with no adverse side effects, tolerance or rebound insomnia observed [57=]. 

Cortesi F, Giannotti F, Sebastiani T, Panunzi S, Valente D. Controlled-release melatonin, singly and combined with cognitive behavioural therapy, for persistent insomnia in children with autism spectrum disorders a randomized placebo-controlled trial. J Sleep Res 2012 21(6) 700-9. Epub 2012 /05/24. 

Gringras P, Gamble G, Jones A, Wiggs L, Williamson P, Sutcliffe A, et al. Melatonin for sleep problems in children with neurodevelopmental disorders randomised double masked placebo controlled trial. BMJ 2012 345. 

These results allow no firm conclusion to be drawn although, it would seem reasonable to conclude that there was no marked overall effect on seizure, neither improvement nor worsening. There is a need for large, well-designed, randomised, double-blind, placebo-controlled trial to establish the role of melatonin in either predisposing to or decreasing the likelihood of seizures. 

Del Fabbro E, Dev R, Hui D, Palmer L, Bruera E. Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia a double-blind placebo controlled trial. J Clin Oncol 2013 31(10) 1271-6. 

Wasdell MB, Jan JE, Bomben MM, Freeman RD, Rietveld WJ, Tai J, Hamilton D, Weiss MD (2008) A randomized, placebo-controUed trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities. J Pineal Res 44 57-64. 

Other studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia and fatigue in patients with cancer. However, these studies were limited by a lack of blinding and absence of placebo controls. The prime purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia. For this a randomised, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores S 4 on a 0-10 scale (10=worst appetite), and history of weight loss S 5%, was performed [45 ]. 

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