title: Long-term effects of melatonin on quality of life and sleep in haemodialysis patients (Melody study): a randomized controlled trial.
abstract: OBJECTIVE
  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.
authors: Department of Hospital Pharmacy, Meander Medical Centre, Amersfoort, the Netherlands.
authors: Marije
authors: M
authors: Russcher
authors: Birgit C P
authors: BC
authors: Koch
authors: J Elsbeth
authors: JE
authors: Nagtegaal
authors: Frans J
authors: FJ
authors: van Ittersum
authors: Pieternel C M
authors: PC
authors: Pasker-de Jong
authors: E Chris
authors: EC
authors: Hagen
authors: Wim Th
authors: WT
authors: van Dorp
authors: Bas
authors: B
authors: Gabreëls
authors: Thierry X
authors: TX
authors: Wildbergh
authors: Monique M L
authors: MM
authors: van der Westerlaken
authors: Carlo A J M
authors: CA
authors: Gaillard
authors: Piet M
authors: PM
authors: Ter Wee
mesh_terms: D056044:Actigraphy; D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage / Q000627:therapeutic use; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008550:Melatonin / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D006435:Renal Dialysis; D012463:Saliva / Q000737:chemistry; D012890:Sleep / Q000187:drug effects; D020178:Sleep Disorders, Circadian Rhythm / Q000188:drug therapy* / Q000209:etiology; D013997:Time Factors
chemical_list: D000975:Antioxidants; D008550:Melatonin
keywords: actigraphy; haemodialysis; melatonin; quality of life; sleep-wake rhythm