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

• Published in: British journal of clinical pharmacology Vol. 76; no. 5; pp. 668 - 679
• Main Authors: Russcher, Marije, Koch, Birgit C. P., Nagtegaal, J. Elsbeth, Ittersum, Frans J., Pasker‐de Jong, Pieternel C. M., Hagen, E. Chris, Dorp, Wim Th, Gabreëls, Bas, Wildbergh, Thierry X., Westerlaken, Monique M. L., Gaillard, Carlo A. J. M., ter Wee, Piet M.
• Format: Journal Article
• Language: English
• Published: England Blackwell Science Inc 01.11.2013
• Subjects: Actigraphy; Aged; Antioxidants - administration & dosage; Antioxidants - therapeutic use; Clinical Trials; Dietary Supplements; Double-Blind Method; Female; Follow-Up Studies; haemodialysis; Humans; Male; melatonin; Melatonin - administration & dosage; Melatonin - therapeutic use; Middle Aged; Quality of Life; Renal Dialysis; Saliva - chemistry; Sleep - drug effects; Sleep Disorders, Circadian Rhythm - drug therapy; Sleep Disorders, Circadian Rhythm - etiology; sleep‐wake rhythm; Time Factors; sleep-wake rhythm; haemodialysis; actigraphy; melatonin; quality of life
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/bcp.12093

Aim The 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. Methods In this randomized double‐blind placebo‐controlled trial haemodialysis patients suffering from subjective sleep problems received melatonin 3 mg 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. Results Sixty‐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 49 min, 95% CI 2.1, 95.9, respectively). At 12 months none of the sleep parameters differed significantly from placebo. Melatonin salivary concentrations at 6 months had significantly increased in the melatonin group compared with the placebo group. Conclusions The 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.