Investigation of melatonin effect on the outcome of moderate and severe diffuse axonal injury (DAI) - A randomized, placebo-controlled clinical trial

Abstract

Objective The efficacy of melatonin in improving diffuse axonal injury has not been evaluated. This study investigated the melatonin effect on moderate and severe diffuse axonal injury outcomes. Methods This was a randomized clinical trial. The case group (N = 35) received 3mg of oral melatonin, and the control group (N = 35) received Placebo. extended-Glasgow Outcome Scale (e-GOS) and Functional Independence Measure (FIM) scores at baseline, 1 month, 3 months, and 6 months after injury were defined as primary outcomes, and Glasgow Coma Scale (GCS) at baseline, 24 hours, 48 hours, 1 week, 2week until discharge defined as secondary outcomes. Results A total of 70 patients were enrolled and were randomly allocated into the intervention (n = 35) and placebo (n = 35) groups. The results showed that there was no statistically significant difference between melatonin and placebo in GOS (P > 0.05) and FIM (P > 0.05) at 3 months and 6 months after hospitalization but the mean E-GOS (P = 0.001) and FIM (P = 0.001) at the first month was significantly higher in the melatonin group. Conclusions The use of melatonin as a low-cost and safe medicine complementary treatment in people with DAI can accelerates functional recovery.