Evidence regarding the effect of melatonin supplementation on depression symptoms is mixed, with some studies indicating potential benefits while others report no significant effects.
55 Background: Breast cancer patients frequently experience a cluster of debilitating symptoms, including sleep disturbances, depression, and cancer-related fatigue, which persist during and after treatment. Melatonin, an endogenous hormone regulating circadian rhythms with antioxidant properties, has been proposed as a supportive therapy. However, clinical trials have yielded inconsistent findings regarding its symptomatic benefits. This meta-analysis aims to evaluate the efficacy of melatonin compared to placebo in improving sleep quality, depressive symptoms, and fatigue in breast cancer patients. Methods: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted. Eligible studies compared oral melatonin supplementation with placebo in patients with breast cancer. Primary outcomes included sleep quality (measured by the Pittsburgh Sleep Quality Index [PSQI]), depression, and fatigue. Data were pooled using a random-effects model in Review Manager (RevMan) due to anticipated heterogeneity. Effect sizes were reported as Mean Differences (MD) for sleep quality and Standardized Mean Differences (SMD) for depression and fatigue, with 95% Confidence Intervals (CI). Heterogeneity was quantified using the I 2 statistic. Results: Seven RCTs involving a total of 568 patients were included in the pooled analysis. For sleep quality, analysis of three trials (N=186) showed no statistically significant improvement with melatonin compared to placebo (MD -9.13; 95% CI -23.87 to 5.62; P = 0.22), with extreme heterogeneity (I 2 = 99%). Regarding depressive symptoms (five trials, N=337), the pooled analysis indicated a trend towards reduction that did not reach statistical significance (SMD -0.42; 95% CI -0.96 to 0.12; P = 0.13), accompanied by high heterogeneity (I 2 = 83%). Similarly, no significant reduction in fatigue scores was observed across four trials (N=435) (SMD -0.21; 95% CI -0.91 to 0.50; P = 0.57), with substantial heterogeneity (I 2 = 92%). Conclusions: Current aggregated evidence does not support a significant therapeutic benefit of melatonin supplementation for improving sleep quality, depression, or fatigue in breast cancer patients. The analysis is limited by high heterogeneity, likely driven by variations in dosing, treatment duration, and baseline symptom severity. While individual studies suggest potential benefits, routine clinical use cannot be recommended based on current pooled data. Further standardized, large-scale trials are required to identify specific subgroups that may benefit.
<h4>Objective</h4>This study evaluated the impact of melatonin supplementation on bone mineral density (BMD), sleep quality, menopausal symptoms, mood, sexual function, serum insulin levels, and body mass index in menopausal women.<h4>Evidence review</h4>A systematic literature review and meta-analysis were conducted using PubMed/MEDLINE, Embase, and Web of Science (2015-2024), following PRISMA guidelines. The risk of bias was assessed with the Cochrane tool.<h4>Findings</h4>Analysis of 7 groups (497 participants) indicated that melatonin may increase bone mineral density (BMD), particularly in the femoral neck, based on two randomized controlled trials (RCTs). However, high heterogeneity prevented pooled statistical analysis. No significant improvements were observed in sleep quality, menopausal symptoms, anxiety, depression, sexual function, BMI, or insulin levels. Side effects were similar across groups.<h4>Conclusion</h4>Available evidence suggests that melatonin-containing supplements may be associated with improved BMD in menopausal women, but the independent effect of melatonin and an optimal dose remain unclear due to heterogeneity in interventions and the prevalent use of combination therapies. For other outcomes (sleep, menopausal symptoms, mood, sexual function, BMI, and insulin), the evidence is currently inconclusive. Further large-scale RCTs are needed to confirm these findings.
s, therapeutic doses or an optimal serum levels are yet to be determined.
A recent systematic review ( 87 ) included eight randomized double-blind controlled trials using exogenous melatonin as an augmentation strategy in major depression, bipolar disorder or seasonal affective disorder in comparison with placebo. The dosage of exogenous melatonin ranged from 0.125 to 10 mg. Among the three studies that evaluated melatonin in the context of depression, one showed that melatonin improved subjective sleep quality but not depressive symptoms [( 88 ), using 5–10 mg slow release melatonin], the second showed no effect [( 89 ), using 6 mg] and the third compared the use of 3 mg slow-release melatonin plus 15 mg buspirone vs. 15 mg buspirone and placebo, showing a significant antidepressant effect of the melatonin combination ( 90 ). Of the four studies using melatonin for SAD, one ( 91 ) showed significant antidepressant effect (using 0.125 mg twice daily), while the other three did not show significant effects ( 92 – 94 ). Another systematic review ( 95 ) pooled results of clinical trials testing the prophylactic or therapeutic effect of melatonin for depression in adults, including comorbid conditions. Among the three studies that tested prophylactic melatonin, one study with older adults with sleep complaints showed lower depressive scores after supplementation with 5 mg melatonin at bedtime. Two other studies were in individuals with irritable bowel syndrome and found no antidepressant effect of 3 mg melatonin. Of the studies testing melatonin as a treatment for depression, one showed a decrease in depressive scores in individuals with Delayed Sleep Phase Syndrome treated with melatonin 5 mg between 19:00 and 21:00; the other six found no significant antidepressant effects. Adverse effects reported in these studies include mild sleepiness, headache, poor sleep, vivid dreams, daytime sleepiness, and fuzzy feeling.
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BACKGROUND Pineal gland cysts are believed to alter the production and release of melatonin, which can impact the sleep/wake cycle and gastrointestinal motility. The optimal management and treatment strategies for benign symptomatic pineal gland cysts are not yet fully determined. CASE REPORT This case report explores the effects of therapeutic melatonin supplementation on gastrointestinal (GI) motility and hypersomnolence in a 59-year-old woman with a benign pineal gland cyst. Melatonin was initiated and titrated based on response to 30 mg nightly. The patient experienced significant improvements in bowel movement regularity (improving from 1 every 5-7 days to daily) and hypersomnolence (reduction in number and dosage of stimulant medications and adverse effects) with this high-dose melatonin supplementation. Mood improvements in anxiety and depressive symptoms were also observed, with anxiety (GAD-7) scores experiencing a clinically significant decrease from the severe to moderate range. Amantadine and sertraline were used in conjunction with melatonin. This case highlights the potential broader implications and benefits of high-dose melatonin use in patients with symptomatic benign pineal gland cysts. CONCLUSIONS Treatment with high-dose melatonin was associated with improvements in hypersomnolence and GI motility. The report is limited by being a single case with lack of a control group, and use of concurrent medications. Larger, controlled studies are needed to further explore the mechanisms involved in the relationships between melatonin, GI functioning, and sleep dysregulation.
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