Long-term effects of melatonin on quality of life and sleep in haemodialysis patients (Melody study): a randomized controlled trial
Version of Record online: 21 OCT 2013
© 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society
British Journal of Clinical Pharmacology
Volume 76, Issue 5, pages 668–679, November 2013
How to Cite
Russcher, M., Koch, B. C. P., Nagtegaal, J. E., van Ittersum, F. J., Pasker-de Jong, P. C. M., Hagen, E. C., van Dorp, W. T., Gabreëls, B., Wildbergh, T. X., van der Westerlaken, M. M. L., Gaillard, C. A. J. M. and ter Wee, P. M. (2013), Long-term effects of melatonin on quality of life and sleep in haemodialysis patients (Melody study): a randomized controlled trial. British Journal of Clinical Pharmacology, 76: 668–679. doi: 10.1111/bcp.12093
- Issue online: 21 OCT 2013
- Version of Record online: 21 OCT 2013
- Accepted manuscript online: 21 FEB 2013 08:29AM EST
- Manuscript Accepted: 6 FEB 2013
- Manuscript Received: 2 NOV 2012
- Dutch Kidney Foundation. Grant Number: C05.2125
- quality of life;
- sleep-wake rhythm
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.
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.
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.
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.