Comparison of the Effects of Melatonin and Oxazepam on Anxiety Levels and Sleep Quality in Patients With ST-Segment-Elevation Myocardial Infarction Following Primary Percutaneous Coronary Intervention: A Randomized Clinical Trial.

BACKGROUND: Anxiety and sleep disorders are prevalent problems in patients presenting with ST-segment-elevation myocardial infarction (STEMI). Usually, these problems are managed by benzodiazepines, which-albeit effective-could cause adverse effects and drug interaction. OBJECTIVE: This study was designed to compare the effects of melatonin and oxazepam in the management of anxiety and insomnia on patients following primary percutaneous coronary intervention (PCI) with a view to providing a safer alternative. METHODS: This study was designed as a randomized clinical trial. STEMI patients managed with primary PCI were enrolled and randomized into 2 groups through the permuted block randomization. The patients received either oxazepam (10 mg) or melatonin (3 mg) every night. Autoimmune disease or previous use of psychoactive medications was considered the exclusion criterion. Levels of anxiety and sleep quality were evaluated using the Hamilton Anxiety Rating Scale (HAM-A) and the Groningen Sleep Quality Score and compared between the groups. RESULTS: Each group contained 20 patients. Melatonin showed a significant advantage over oxazepam in improving sleep quality ( P = 0.040). Comparisons of the efficacy of both medications in lowering the anxiety levels when considering all the items of the HAM-A, including those related to cardiovascular disease, were significantly in favor of melatonin ( P = 0.019). CONCLUSIONS AND RELEVANCE: The results of this study suggest that melatonin, a drug with more favorable drug interaction and adverse effect profile, could be more effective than oxazepam in improving the sleep quality and anxiety levels of patients presenting with STEMI, and it could be considered a new alternative to benzodiazepines in this setting.

Evaluating the Potential Effect of Melatonin on the post-Cardiac Surgery Sleep Disorder.

BACKGROUND: Postoperative neurological injuries, including cognitive dysfunction, sleep disorder, delirium, and anxiety, are the important consequences of coronary artery bypass graft surgery (CABG). Evidence has shown that postoperative sleep disturbance is partly due to disturbed melatonin secretion in the perioperative period. The aim of this study was to evaluate the effect of melatonin on postoperative sleep disorder in patients undergoing CABG. METHOD: One hundred forty-five elective CABG patients participated in a randomized double-blind study during the preoperative period. The patients were randomized to receive either 3 mg of melatonin or 10 mg of Oxazepam one hour before sleep time. Each group received the medication from 3 days before surgery until the time of discharge. Sleep quality was evaluated using the Groningen Sleep Quality Score (GSQS), and the incidence of delirium was evaluated by nursing records. Sleep quality and anxiety scores were compared before and after surgery through the Wilcoxon signed-rank test. The analysis of covariance (ANCOVA) and independent t-test were used to compare the sleep and anxiety scores between the groups. P values ≤ 0.05 were considered statistically significant. RESULTS: Totally, 137 patients at a mean age of 60 years completed the study (76% male). The analysis of the data showed that sleep was significantly disturbed after surgery in both groups. The patients in the Oxazepam group demonstrated significantly higher disturbance in their mean postoperative GSQS score than did their counterparts in the melatonin group (p value < 0.001). A smaller proportion of the participants experienced delirium in the melatonin group (0.06%) than in the Oxazepam group (0.12%); however, this difference was not statistically significant. CONCLUSION: The result of the present study revealed that melatonin improved sleep in post-cardiac surgery patients more than what was observed with Oxazepam. Therefore, melatonin may be considered an effective alternative for Benzodiazepines in the management of postoperative sleep disorder.

Effect of Melatonin on Cardiac Injury after Primary Percutaneous Coronary Intervention: a Randomized Controlled Trial.

Several studies have reported that the antioxidant properties of melatonin can provide cardiac protection through scavenging of free radicals. This study sought to investigate the efficacy of melatonin on cardiac biomarkers, myocardial-specific protein high sensitive troponin-T (hs-TnT) and creatine kinase-MB (CK-MB), in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). In this randomized clinical trial, a total of 40 patients with STEMI planned to undergo pPCI were randomly assigned to two groups of receiving melatonin plus standard treatment [n=20] and control group, receiving only standard therapy [n=20]. The following parameters including hsTnT and CK-MB were assessed preoperatively (baseline) and at 6 hours after procedure. Melatonin could significantly reduce the level of CK-MB (118.2 ± 21.09 IU/L in the treated group versus 198.24 ± 20.94 IU/L in the control group; p-value = 0.01). However, there was no difference in the mean hs-TnT level between two groups (2491 ± 664 µg/L vs. 2801 ± 620 µg/L; p value = 0.73). Our results revealed that melatonin can be considered as a safe adjunctive medication to the standard regimen after pPCI for the aim of decreasing cardiovascular events. Meanwhile, this was a pilot study with a small number of patients and further studies are needed to confirm the beneficial effect of melatonin in patients with STEMI.