Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Russcher M

PROVIDER: S-EPMC3853526 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Russcher Marije M Koch Birgit C P BC Nagtegaal J Elsbeth JE van Ittersum Frans J FJ Pasker-de Jong Pieternel C M PC Hagen E Chris EC van Dorp Wim Th WT Gabreëls Bas B Wildbergh Thierry X TX van der Westerlaken Monique M L MM Gaillard Carlo A J M CA Ter Wee Piet M PM

British journal of clinical pharmacology 20131101 5

<h4>Aim</h4>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.<h4>Methods</h4>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 qu ...[more]

PMID: 23432361

Similar Datasets

Project description:ObjectiveTo evaluate the effects of a home-based respiratory muscle training programme (inspiratory [IMT] or inspiratory/expiratory muscles [RMT]) supervised by telerehabilitation on quality of life and exercise tolerance in individuals with long-term post-COVID-19 symptoms. The secondary objective was to evaluate the effects of these programmes on respiratory muscle function, physical and lung function, and psychological state.Methods88 individuals with long-term symptoms of fatigue and dyspnoea after COVID-19 diagnosis were randomly (1:1 ratio) assigned to IMT, IMTsham, RMT or RMTsham groups for an 8-week intervention (40min/day, 6 times/week). Primary outcomes were quality of life (EuroQol-5D questionnaire) and exercise tolerance (Ruffier test). Secondary outcomes were respiratory muscle function (inspiratory/expiratory muscle strength; inspiratory muscle endurance), physical function (lower and upper limb strength [1-min Sit-to-Stand and handgrip force]), lung function (forced spirometry), and psychological status (anxiety/depression levels and post-traumatic stress disorder). All outcomes were measured pre-, intermediate- (4th week), and post-intervention.ResultsAt post-intervention, there was a statistically significant and large (d>0.90) improvement in quality of life, but not in exercise tolerance, in the RMT group compared with the RMTsham group. Both of the real training groups produced a statistically significant and large increase in inspiratory muscle strength and endurance (d≥0.80) and in lower limb muscle strength (d≥0.77) compared with the 2 sham groups. Expiratory muscle strength and peak expiratory flow showed a statistically significant and large (d≥0.87) increase in the RMT group compared with the other 3 groups.ConclusionOnly an 8-week supervised home-based RMT programme was effective in improving quality of life, but not exercise tolerance, in individuals with long-term post-COVID-19 symptoms. In addition, IMT and RMT programmes were effective in improving respiratory muscle function and lower limb muscle strength, but had no impact on lung function and psychological status.

Project description:IntroductionThis study aims to assess the quality of life (QoL) in patients who have undergone decompressive craniectomy (DC) for any pathology that has caused life-threatening intracranial hypertension. Similarly, it aims to evaluate QoL perceived by caregivers or external informants. In addition to that, the last purpose is to determine which clinical or therapeutic factors could correlate with a better QoL.MethodsA single-center cross-sectional study was designed. All patients over 18 years old who underwent a supratentorial DC at our department due to intracranial hypertension of any etiology, from January 2015 to December 2021, were retrospectively selected. Patients with incomplete follow-up (under 1 year from the event or those who died) or who declined to participate in the study were excluded. QoL was assessed with SF-36 and CAVIDACE scales. The correlation between clinical and therapeutic variables and SF-36 subscales was studied with Spearman's correlation and the Mann-Whitney U-test.ResultsA total of 55 consecutive patients were recruited: 22 patients had died, three were missed for follow-up, and 15 declined to participate, thus 15 subjects were finally included. The mean follow-up was 47 months (IQR 21.5-67.5). A significant reduction in the "role physical" and "role emotional" subscales of SF-36 was observed compared with the general population. According to caregivers, a significant reduction was assigned to the "physical wellbeing" and "rights" domains. The "physical functioning" score was poorer in women, older patients, those with dominant hemisphere disease, those who required tracheostomy, and those with poor outcomes in the modified Rankin scale. A strong correlation was found between the QoL index at the CAVIDACE scale and the SF-36 subscales "physical functioning" and "role physical".ConclusionMost patients and caregivers reported acceptable QoL after DC due to a life-threatening disease. A significant reduction in SF- 36 subscales scores "role limitation due to physical problems" and "role limitation due to emotional problems" was referred by patients. According to caregivers' QoL perception, only 25% of the survey's participants showed low scores in the QoL index of the CAVIDACE scale. Only 26.7% of the patients showed mood disorders.

Project description:There are limited long-term randomized controlled trials of growth hormone (GH) supplementation to adult height and few published reports of the health-related quality of life (HRQOL) following treatment. The present follow-up study of young adults from a long-term controlled trial of GH treatment in patients with Turner syndrome (TS) yielded data to examine whether GH supplementation resulted in a higher HRQOL (either due to taller stature or from the knowledge that active treatment and not placebo had been received) or alternatively a lower HRQOL (due to medicalization from years of injections).The original trial randomized 154 Canadian girls with TS aged 7-13 years from 13 centres to receive either long-term GH injections at the pharmacologic dose of 0.3 mg/kg/week or to receive no injections; estrogen prescription for induction of puberty was standardized. Patients were eligible for the follow-up study if they were at least 16 years old at the time of follow-up. The instrument used to study HRQOL was the SF-36, summarized into physical and mental component scales (PCS and MCS); higher scores indicate better HRQOL.Thirty-four of the 48 eligible participants (71%) consented to participate; data were missing for one patient. Both groups (GH and no treatment) had normal HRQOL at this post-treatment assessment. The GH group had a (mean ± SD) PCS score of 56 ± 5; the untreated group 58 ± 4; mean score for 16-24 year old females in the general population 53.5 ± 6.9. The GH group had a mean MCS score of 52 ± 6; the untreated group 49 ± 13; mean score for 16-24 year old females in the general population 49.6 ± 9.8. Secondary analyses showed no relationship between HRQOL and height.We found no benefit or adverse effect on HRQOL either from receiving or not receiving growth hormone injections in a long-term randomized controlled trial, confirming larger observational studies. We suggest that it remains ethically acceptable as well as necessary to maintain a long-term untreated control group to estimate the effects of pharmacological agents to manipulate adult height. Young adult women with TS have normal HRQOL suggesting that they adjust well to their challenges in life.ClinicalTrials.gov Identifier NCT00191113.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets