Long-term effects of melatonin on quality of life and sleep in haemodialysis patients (Melody study): a randomized controlled trial

M Russcher, Birgit Koch, JE Nagtegaal, FJ van Ittersum, PCM Pasker-de Jong, EC Hagen, WT van Dorp, B Gabreels, TX Wildbergh, MML van der Westerlaken, CAJM Gaillard, PM ter Wee

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Abstract

AimThe disturbed circadian rhythm in haemodialysis patients results in perturbed sleep. Short term melatonin supplementation has alleviated these sleep problems. Our aim was to investigate the effects of long-term melatonin supplementation on quality of life and sleep. MethodsIn this randomized double-blind placebo-controlled trial haemodialysis patients suffering from subjective sleep problems received melatonin 3mg day(-1)vs. placebo during 12 months. The primary endpoint quality of life parameter vitality' was measured with Medical Outcomes Study Short Form-36. Secondary outcomes were improvement of three sleep parameters measured by actigraphy and nighttime salivary melatonin concentrations. ResultsSixty-seven patients were randomized. Forty-two patients completed the trial. With melatonin, no beneficial effect on vitality was seen. Other quality of life parameters showed both advantageous and disadvantageous effects of melatonin. Considering sleep, at 3 months sleep efficiency and actual sleep time had improved with melatonin compared with placebo on haemodialysis days (difference 7.6%, 95% CI 0.77, 14.4 and 49min, 95% CI 2.1, 95.9, respectively). At 12 months none of the sleep par ConclusionsThe high drop-out rate limits the strength of our conclusions. However, although a previous study reported beneficial short term effects of melatonin on sleep in haemodialysis patients, in this long-term study the positive effects disappeared during follow up (6-12 months). Also the quality of life parameter, vitality, did not improve. Efforts should be made to elucidate the mechanism responsible for the loss of effect with chronic use.
Original languageUndefined/Unknown
Pages (from-to)668-679
Number of pages12
JournalBritish Journal of Clinical Pharmacology
Volume76
Issue number5
DOIs
Publication statusPublished - 2013

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