Summary of findings for the main comparison. Melatonin compared to placebo for sleep disturbances in dementia.
| Melatonin compared to placebo for sleep disturbances in dementia | ||||||
| Patient or population: sleep disturbances in dementia Setting: community and long‐term care facilities Intervention: melatonin Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with melatonin | |||||
| Total nocturnal sleep time assessed with: actigraphy follow‐up: range 8 weeks to 10 weeks | The mean total nocturnal sleep time across placebo groups was 397 minutes | The total nocturnal sleep time was, on average, 10.68 minutes higher across the melatonin groups (16.22 lower to 37.59 higher) | ‐ | 184 (2 RCTs) | ⊕⊕⊝⊝ LOW 1, 2 | |
| Nocturnal time awake after sleep onset assessed with: actigraphy follow‐up: 8 weeks | The mean nocturnal time awake after sleep onset in the placebo group was 156 minutes | The nocturnal time awake after sleep onset was, on average, 9.08 minutes higher in the melatonin group (7.51 lower to 25.66 higher) | ‐ | 151 (1 RCT) | ⊕⊕⊝⊝ LOW 1, 2 | |
| Number of nocturnal awakenings assessed with: actigraphy follow‐up: 10 weeks | The mean number of nocturnal awakenings in the placebo group was 34 | The number of nocturnal awakenings was, on average, 6 fewer in the melatonin group (2.65 more to 14.65 fewer) | ‐ | 33 (1 RCT) | ⊕⊕⊝⊝ LOW 1, 2 | |
| Ratio of daytime to night‐time sleep assessed with: actigraphy follow‐up: range 8 weeks to 10 weeks | The mean ratio of daytime to night‐time sleep across placebo groups was 0.72 | The ratio of daytime to night‐time sleep was, on average, 0.13 lower across the melatonin groups (0.29 lower to 0.03 higher) | ‐ | 184 (2 RCTs) | ⊕⊕⊝⊝ LOW 1, 2 | |
| Reporting at least one adverse event assessed with: spontaneous patient/carer report follow‐up: 8 weeks | Assumed risk for the placebo group was 70 per 100 |
Comparative risk for the melatonin group was 75 per 100 (60 to 93) |
RR 1.07 (0.86 to 1.33) | 151 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 | |
| Cognitive function assessed with: MMSE, change from baseline. Scale from: 0 (worse) to 30 follow‐up: range 8 weeks to 24 weeks | The mean MMSE score across the placebo groups was 14.3 | The MMSE score was, on average, 0.09 points higher across the melatonin groups (0.85 lower to 1.03 higher) | ‐ | 162 (2 RCTs) | ⊕⊕⊝⊝ LOW 2 3 4 | Minimum clinically important difference is uncertain but has been estimated at 1.4 points in moderate to severe AD (Howard 2011). |
| Caregiver burden ‐ not measured | Not measured | ‐ | ‐ | ‐ | ||
| *The risk in the intervention group (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; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 95% CI includes no effect and a difference likely to be of clinical importance.
2 Small number of participants.
3 One study had high risk of bias but result not downgraded because it contributed very few participants.
4 High level of heterogeneity