Melatonin in the Management of Mood and Sleep Problems Induced by Androgen Deprivation Therapy in Prostate Cancer Patients: A Randomized Double-blinded, Placebo-controlled Clinical Trial
Abstract
Background Androgen deprivation therapy (ADT) has been considered as a mainstay of treatment for advanced prostate cancer. Considering ADT for cancer patients is accompanied with many side effects, such as behavioral and neurologic side effects that adversely affect the quality of life. Objectives This study aimed to evaluate the effects of melatonin administration on sleep problems and mood changes induced by ADT in prostate cancer patients. Methods The randomized, double-blind, placebo-controlled trial was designed in the oncology-hematology outpatient clinic of Omid Hospital, Isfahan, Iran. After screening by the hospital anxiety and depression scale (HADS), patients were divided into either an intervention group receiving 6 mg melatonin daily for four weeks or an identical placebo. After that, patients were evaluated by the Pittsburgh sleep quality index (PSQI), the Hamilton Anxiety Rating Scale (HAM-A), and Beck Depression Inventory (BDI) questionnaires at baseline and after 4-week follow-ups. Results Forty-three patients, including 21 and 22 patients in melatonin and placebo groups, respectively completed follow-ups period. Melatonin administration significantly improved PSQI scores in four domains of sleep quality, sleep latency, sleep efficacy, and daytime dysfunction. After 4-week melatonin supplementation, the severity of depression and anxiety assessed by BDI and HAM-A questionnaires, respectively, decreased non-statistically significant in both melatonin and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 21 participants or records.
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