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. 2016 Oct 12;2016(10):CD008536. doi: 10.1002/14651858.CD008536.pub3

Comparison 1. Tibolone versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Vasomotor symptoms 7 1657 Std. Mean Difference (Fixed, 95% CI) ‐0.99 [‐1.10, ‐0.89]
1.1 Tibolone 0.625 mg/d 1 158 Std. Mean Difference (Fixed, 95% CI) ‐0.05 [‐0.46, 0.36]
1.2 Tibolone 1.25 mg/day 3 414 Std. Mean Difference (Fixed, 95% CI) ‐0.83 [‐1.06, ‐0.60]
1.3 Tibolone 2.5 mg/day 7 920 Std. Mean Difference (Fixed, 95% CI) ‐1.16 [‐1.30, ‐1.03]
1.4 Tibolone 5 mg/day 1 165 Std. Mean Difference (Fixed, 95% CI) ‐0.84 [‐1.25, ‐0.43]
2 Unscheduled bleeding 9 7814 Odds Ratio (M‐H, Random, 95% CI) 2.79 [2.10, 3.70]
2.1 Tibolone, 2.5 mg/day 8 4186 Odds Ratio (M‐H, Random, 95% CI) 2.58 [1.89, 3.52]
2.2 Tibolone, 1.25 mg/day 3 3628 Odds Ratio (M‐H, Random, 95% CI) 3.63 [2.37, 5.55]
3 Endometrial cancer 9   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
3.1 Tibolone, all doses 9 8504 Odds Ratio (M‐H, Random, 95% CI) 2.04 [0.79, 5.24]
4 Breast cancer; women without previous breast cancer 4   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
4.1 Tibolone, all doses 4 5500 Odds Ratio (M‐H, Random, 95% CI) 0.52 [0.21, 1.25]
5 Breast cancer; women with previous breast cancer 2   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
5.1 Tibolone, 2.5 mg/day 2 3165 Odds Ratio (M‐H, Random, 95% CI) 1.50 [1.21, 1.85]
6 Venous thromboembolic events (clinical evaluation) 5 9176 Odds Ratio (M‐H, Random, 95% CI) 0.85 [0.37, 1.97]
6.1 Tibolone (all doses) 5 9176 Odds Ratio (M‐H, Random, 95% CI) 0.85 [0.37, 1.97]
7 Cardiovascular events 4   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
7.1 Tibolone, all doses 4 8401 Odds Ratio (M‐H, Random, 95% CI) 1.38 [0.84, 2.27]
8 Cerebrovascular events; women's mean age over 60 years 4   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
8.1 Tibolone (all doses) 4 7930 Odds Ratio (M‐H, Random, 95% CI) 1.74 [0.99, 3.04]
9 Mortality from any cause 4 8242 Odds Ratio (M‐H, Random, 95% CI) 1.06 [0.79, 1.41]
9.1 Tibolone, 2.5 mg/day 3 3736 Odds Ratio (M‐H, Random, 95% CI) 0.94 [0.32, 2.73]
9.2 Tibolone, 1.25 mg/day 1 4506 Odds Ratio (M‐H, Random, 95% CI) 0.93 [0.54, 1.59]
10 Insomnia 3 3432 Std. Mean Difference (Fixed, 95% CI) ‐0.19 [‐0.38, ‐0.00]
10.1 Tibolone, 2.5 mg/day 3 3432 Std. Mean Difference (Fixed, 95% CI) ‐0.19 [‐0.38, ‐0.00]
11 Vaginal dryness and painful sexual intercourse 3 3348 Std. Mean Difference (Fixed, 95% CI) ‐0.66 [‐0.90, ‐0.43]
11.1 Tibolone, 1.25mg/day 1 62 Std. Mean Difference (Fixed, 95% CI) ‐1.78 [‐2.43, ‐1.13]
11.2 Tibolone, 2.5 mg/day 3 3286 Std. Mean Difference (Fixed, 95% CI) ‐0.49 [‐0.75, ‐0.24]
12 Vaginal infections 2 7639 Odds Ratio (M‐H, Random, 95% CI) 2.50 [1.24, 5.06]
12.1 Tibolone, 2.5 mg/day 1 3133 Odds Ratio (M‐H, Random, 95% CI) 1.73 [1.17, 2.55]
12.2 Tibolone, 1.25 mg/day 1 4506 Odds Ratio (M‐H, Random, 95% CI) 3.54 [2.61, 4.81]
13 Urinary tract infections 1   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
13.1 Tibolone, 2.5 mg/day 1 3133 Odds Ratio (M‐H, Random, 95% CI) 0.70 [0.46, 1.06]
14 Endometrial hyperplasia 4   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
14.1 Tibolone, all doses 4 4518 Odds Ratio (M‐H, Random, 95% CI) 1.20 [0.23, 6.25]
15 Sensitivity Analysis ‐ Vasomotor symptoms without trials with high risk of attrition bias 4   Std. Mean Difference (Fixed, 95% CI) ‐0.61 [‐0.73, ‐0.49]
15.1 Tibolone 0.625 mg/day 1   Std. Mean Difference (Fixed, 95% CI) ‐0.05 [‐0.46, 0.36]
15.2 Tibolone 1.25 mg/day 2   Std. Mean Difference (Fixed, 95% CI) ‐0.62 [‐0.86, ‐0.38]
15.3 Tibolone 2.5 mg/day 4   Std. Mean Difference (Fixed, 95% CI) ‐0.65 [‐0.80, ‐0.50]
15.4 Tibolone 5 mg/day 1   Std. Mean Difference (Fixed, 95% CI) ‐0.84 [‐1.25, ‐0.43]