Efficacy of melatonin for prolonged disorders of consciousness: a double-blind, randomized clinical trial.
Study Goal
The researchers aimed to determine whether melatonin improves outcomes in patients with prolonged disorders of consciousness (DoC), particularly unresponsive wakefulness syndrome (UWS), and explore the underlying mechanisms.
Results Summary
Melatonin significantly improved Coma Recovery Scale-Revised (CRS-R) scores in UWS patients with preserved sleep cycles after 2 weeks, though the benefits may not solely stem from sleep quality improvements.
Population
46 patients with prolonged disorders of consciousness (DoC), specifically unresponsive wakefulness syndrome (UWS).
Effective Dosage
Not specified
Duration
2-week intervention, with follow-up evaluations at 6 months post-treatment.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin | increase | CRS-R scores | patients with unresponsive wakefulness syndrome (UWS) | - | demonstrated a significant improvement | #1 |
melatonin | increase | sleep efficiency | - | - | enhance | #2 |
melatonin | increase | - | UWS patients with preserved sleep cycles | - | seems to have a better response | #3 |
BACKGROUND: Sleep is essential for the recovery of patients with disorders of consciousness (DoC). However, few approaches targeting sleep were applied. Melatonin has been shown to enhance sleep efficiency with virtually no side effects. This study explored melatonin's benefits for patients with prolonged DoC, as well as the underlying mechanisms involved. METHODS: A cohort of 46 patients with prolonged DoC were randomly assigned to either the melatonin treatment group or the placebo group. Assessments were conducted using the Coma Recovery Scale-Revised (CRS-R), electroencephalography (EEG), and polysomnography (PSG) before and after the intervention, with follow-up CRS-R evaluations performed 6 months post-treatment. RESULTS: Compared to the placebo, melatonin demonstrated a significant improvement in CRS-R scores after a 2-week period in patients with unresponsive wakefulness syndrome (UWS) (F CONCLUSIONS: Overall, melatonin intervention seems to have a better response in UWS patients with preserved sleep cycles. These positive effects may not be solely attributed to improvements in the patients' sleep quality. TRAIL REGISTRATION: ClinicalTrials.gov: NCT05285124.