Trial reportBritish journal of clinical pharmacology2013
Long-term effects of melatonin on quality of life and sleep in haemodialysis patients (Melody study): a randomized controlled trial.
Trial report in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- Pooled it
- Interventions for improving sleep quality in people with chronic kidney disease.The Cochrane database of systematic reviews · 2019Pooled it
- The effect of oral melatonin on the quality of life, sleep and blood pressure of hemodialysis patients: a randomized clinical trial.BMC nephrology · 2025Trial
- Melatonin ingestion before intradialytic exercise improves immune responses in hemodialysis patients.International urology and nephrology · 2021Trial
- Circadian Influences on Chronic Kidney Disease Progression: Molecular Signaling Pathways of Melatonin and Their Therapeutic Potential.Pharmaceuticals (Basel, Switzerland) · 2026Review
- The role of sleep disorders in the risk for CKD and CKD progression.Clinical kidney journal · 2026Review
- Synergistic effects of intradialytic concurrent training and melatonin supplementation on immune cell adaptations in hemodialysis patients.Frontiers in pharmacology · 2026Article
- Treatment of insomnia, restless legs, cramps, and pain associated with chronic kidney disease: results from a multinational survey of kidney supportive care practice.BMC nephrology · 2025Article
- The Synergistic Effect of Intradialytic Concurrent Training and Melatonin Supplementation on Oxidative Stress and Inflammation in Hemodialysis Patients: A Double-Blind Randomized Controlled Trial.Antioxidants (Basel, Switzerland) · 2024Article
- A scoping review of over-the-counter products for depression, anxiety and insomnia in older people.BMC complementary medicine and therapies · 2024Article
- Study of the Effects of Melatonin on Sleep Disorders in Pulmonary Sarcoidosis Patients.Iranian journal of pharmaceutical research : IJPR · 2022Article
- Circadian clocks of the kidney: function, mechanism, and regulation.Physiological reviews · 2022Review
- Improvement of sleep and melatonin in children with autism spectrum disorder after β-1,3/1,6-glucan consumption: An open-label prospective pilot clinical study.Brain and behavior · 2022Article
- Use of Melatonin and/on Ramelteon for the Treatment of Insomnia in Older Adults: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2022Review
- Insomnia and Poor Sleep in CKD: A Systematic Review and Meta-analysis.Kidney medicine · 2022Article
- Effects of Melatonin on Salivary Levels of Cortisol and Sleep Quality of Hemodialysis Patients: A Randomized Clinical Trial.Iranian journal of psychiatry · 2021Article
- Efficacy and Safety of Melatonin as an Adjunctive Therapy on Clinical, Biochemical, and Quality of Life in Patients with Ulcerative Colitis.Iranian journal of pharmaceutical research : IJPR · 2021Article
- A Comparative Study on the Use of Alprazolam and Melatonin for Sleep Disturbances in Hemodialysis Patients.Cureus · 2020Article
- Association of Insomnia in Patients with Chronic Kidney Disease on Maintenance Hemodialysis.Cureus · 2020Article
- Prescribing in renal supportive care.Australian prescriber · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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 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.
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 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.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.