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. 2016 Mar 11;2016(3):CD005563. doi: 10.1002/14651858.CD005563.pub3

Summary of findings 4. Prophylactic melatonin for preventing delirium in hospitalised non‐ICU patients.

Prophylactic melatonin for preventing delirium in hospitalised non‐ICU patients
Intervention: Prophylactic melatonin versus placebo
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of Participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Control Prophylactic melatonin
Incidence of delirium 
 CAM/DSM IV/DRS‐R‐9s
 Follow‐up: every 24 to 48 hours until discharge or 8 days 242 per 10001 128 per 1000 
 (22 to 788) RR 0.53 
 (0.09 to 3.25) 529
 (3 studies) ⊕⊝⊝⊝
 very low2,3,4  
Duration of delirium 
 Days
 Follow‐up: every 24 to 48 hours until discharge The mean duration of delirium in the control group was
2 days
The mean duration of delirium in the intervention groups was
 0 days longer 
 (0.57 shorter to 0.57 longer)   104
 (1 study) ⊕⊕⊕⊝
 moderate3  
Severity of delirium (binary severe vs. not severe) 
 Number of patients requiring greater than 3mg of haloperidol
 Follow‐up: daily until discharge 531 per 1000 457 per 1000 
 (308 to 674) RR 0.86 
 (0.58 to 1.27) 104
 (1 study) ⊕⊕⊕⊝
 moderate3  
Severity of delirium
DRS‐R‐98 score
The mean severity of delirium in the control group was
6.3 points
The mean severity of delirium in the intervention group was 4.1 points lower
(19.47 points lower to 11.27 points higher)
  6
(1 study)
⊕⊕⊝⊝
 low5  
Length of admission 
 Days The mean length of admission in the control groups ranged from
11 to 18.5 days
The mean length of admission in the intervention groups was
 0.09 days longer 
 (1.2 shorter to 1.39 longer)   500
 (2 studies) ⊕⊕⊕⊝
 moderate3  
Return to independent living ‐ not measured N/A N/A N/A   N/A  
In‐hospital mortality 
 Mortality
 Follow‐up: every 24 to 48 hours until discharge or 8 days 47 per 10001 39 per 1000 
 (17 to 88) RR 0.84 
 (0.37 to 1.88) 543
 (3 studies) ⊕⊕⊝⊝
 low6  
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.

1 The assumed risk is the risk in the control group

2 Downgraded because inconsistent results

3 Downgraded because imprecise results

4 Downgraded due to risk of bias

5 Downgraded because imprecise results and very small number of events