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Effects of melatonin supplementation on serum oxidative stress markers and disease activity in systemic lupus erythematosus patients: A randomised, double-blind, placebo-controlled trial.

International journal of clinical practice
July 1, 2021
Mohammadmahdi Nabatian-Asl et al. (6 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effects of melatonin supplementation on oxidative stress markers and disease activity in patients with systemic lupus erythematosus (SLE).

Results Summary

Melatonin supplementation significantly reduced serum malondialdehyde (MDA), a marker of oxidative stress, but did not significantly affect total antioxidant capacity (TAC) or disease activity in SLE patients.

Population

32 female SLE patients (25 completed the trial).

Effective Dosage

10 mg/day

Duration

12 weeks

Interactions

None mentioned

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin supplementation
decrease
serum malondialdehyde (MDA)
SLE females
-
caused significant reduction
#1
melatonin supplementation
no change
serum total antioxidant capacity (TAC) level
SLE females
-
did not change significantly
#2
melatonin supplementation
no change
disease activity
SLE females
-
did not cause significant change
#3
melatonin supplementation
decrease
oxidative stress
SLE patients
-
demonstrated affirmative effects in decreasing
#4
melatonin supplementation
no change
disease activity
SLE patients
-
without any effect on
#5
Abstract

BACKGROUND: Considering pathological significance of oxidative stress in systemic lupus erythematosus (SLE), current research aimed to evaluate the effects of melatonin supplementation on oxidative stress markers and disease activity in SLE. METHOD: In this randomised double-blind, placebo-controlled trial, 32 SLE females were selected and randomly assigned into two groups to take 10 mg/day melatonin or placebo for 12 weeks. Before and after trial, serum malondialdehyde (MDA) and total antioxidant capacity (TAC) were measured and disease activity was determined by Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K). RESULTS: Twenty-five patients (13 in the melatonin and 12 in the placebo groups) completed the trial. Melatonin supplementation caused significant reduction in serum MDA compared with baseline (P = .003) and placebo group (P = .004). Serum TAC level did not change significantly in the melatonin group compared with baseline and placebo group (P > .05). Furthermore, melatonin supplementation did not cause significant change in disease activity compared to baseline and placebo group (P > .05). CONCLUSION: This study demonstrated affirmative effects of melatonin in decreasing oxidative stress in SLE patients without any effect on disease activity. Further investigations are required to affirm these primitive findings and to achieve concise conclusions.What's known Free radical damage and oxidative stress has a remarkable function in systemic lupus erythematosus (SLE) pathogenesis. Products derived from oxidative modification cascades are found in biological fluids and their redundancy has a correlation with disease activity and organ damage in SLE. Dietary supplements, which decrease oxidative stress, would be useful in managing SLE. Melatonin is a potent antioxidant and has anti-inflammatory and immunomodulatory characteristics. Limited in vitro and animal studies are available indicating desirable effects of melatonin in preventing from SLE organ damage, thereby opening a new area of investigation that can contribute to using melatonin as a therapy or co-therapy for SLE. What's new Melatonin supplementation caused significant reduction in serum MDA compared with baseline and placebo group. Serum TAC level did not change significantly in the melatonin group compared with baseline and placebo group. Furthermore, melatonin supplementation did not cause significant change in disease activity compared to baseline and placebo group.

Medical Subject Headings (MeSH)
BiomarkersDietary SupplementsDouble-Blind MethodFemaleHumansLupus Erythematosus, SystemicMelatoninOxidative Stress
Study Links
Quality Scores
Safety85
Efficacy70/10
Quality80/10
Citation Metrics
Total Citations10
Citations/Year2.5
Relative Citation Ratio1.11
NIH Percentile54%
Research Impact Scores
APT Score0.50
Weight Score2.47
Normalized Score0.78
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