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. 2016 Nov 16;2016(11):CD009178. doi: 10.1002/14651858.CD009178.pub3

Comparison 1. Melatonin versus placebo: efficacy.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 total nocturnal sleep time (minutes) 2 184 Mean Difference (IV, Fixed, 95% CI) 10.68 [‐16.22, 37.59]
1.1 melatonin (immediate‐release) 2 106 Mean Difference (IV, Fixed, 95% CI) ‐1.34 [‐37.13, 34.45]
1.2 melatonin slow‐release 1 78 Mean Difference (IV, Fixed, 95% CI) 26.30 [‐14.49, 67.09]
2 sleep efficiency 1 151 Mean Difference (IV, Fixed, 95% CI) ‐0.01 [‐0.04, 0.03]
2.1 melatonin (immediate‐release) 1 73 Mean Difference (IV, Fixed, 95% CI) ‐0.01 [‐0.06, 0.04]
2.2 melatonin slow‐release 1 78 Mean Difference (IV, Fixed, 95% CI) 0.0 [‐0.05, 0.05]
3 nocturnal time awake (minutes) 1 151 Mean Difference (IV, Fixed, 95% CI) 9.08 [‐7.51, 25.66]
3.1 melatonin (immediate‐release) 1 73 Mean Difference (IV, Fixed, 95% CI) 10.80 [‐11.90, 33.50]
3.2 melatonin slow‐release 1 78 Mean Difference (IV, Fixed, 95% CI) 7.10 [‐17.20, 31.40]
4 number of night‐time awakenings 1 33 Mean Difference (IV, Fixed, 95% CI) 6.00 [‐2.65, 14.65]
5 ratio of daytime sleep to night‐time sleep 2 184 Mean Difference (IV, Fixed, 95% CI) ‐0.13 [‐0.29, 0.03]
5.1 melatonin (immediate‐release) 2 106 Mean Difference (IV, Fixed, 95% CI) ‐0.12 [‐0.28, 0.05]
5.2 melatonin slow‐release 1 78 Mean Difference (IV, Fixed, 95% CI) ‐0.25 [‐0.78, 0.28]
6 carer‐rated sleep quality, change from baseline 2 164 Std. Mean Difference (IV, Fixed, 95% CI) 0.04 [‐0.29, 0.38]
6.1 melatonin (immediate‐release) 1 73 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.21 [‐0.71, 0.29]
6.2 melatonin slow‐release 2 91 Std. Mean Difference (IV, Fixed, 95% CI) 0.25 [‐0.19, 0.69]
7 MMSE, change from baseline 2 162 Mean Difference (IV, Fixed, 95% CI) 0.09 [‐0.85, 1.03]
7.1 melatonin (immediate‐release) 1 73 Mean Difference (IV, Fixed, 95% CI) ‐0.54 [‐1.99, 0.91]
7.2 melatonin slow‐release 2 89 Mean Difference (IV, Fixed, 95% CI) 0.54 [‐0.69, 1.76]
8 ADAS‐cog, change from baseline 2 162 Mean Difference (IV, Fixed, 95% CI) ‐1.03 [‐2.70, 0.65]
8.1 melatonin (immediate‐release) 1 73 Mean Difference (IV, Fixed, 95% CI) ‐0.43 [‐2.95, 2.09]
8.2 melatonin slow‐release 2 89 Mean Difference (IV, Fixed, 95% CI) ‐1.50 [‐3.74, 0.74]
9 ADL, change from baseline 2 162 Std. Mean Difference (IV, Fixed, 95% CI) 0.02 [‐0.32, 0.35]
9.1 melatonin (immediate‐release) 1 73 Std. Mean Difference (IV, Fixed, 95% CI) 0.08 [‐0.42, 0.57]
9.2 melatonin slow‐release 2 89 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.04 [‐0.48, 0.41]