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. 2017 Nov 15;2017(11):CD000547. doi: 10.1002/14651858.CD000547.pub2

Comparison 6. SPRM versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Reduction in uterine volume     Other data No numeric data
2 Reduction in fibroid volume     Other data No numeric data
3 Haemoglobin (g/dL) 2 173 Mean Difference (IV, Random, 95% CI) 0.93 [0.52, 1.35]
4 Reduction in menstrual bleeding (PBAC < 75) 1   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
4.1 Ulipristal acetate 5 mg 1 143 Odds Ratio (M‐H, Random, 95% CI) 41.41 [15.26, 112.38]
4.2 Ulipristal acetate 10 mg 1 146 Odds Ratio (M‐H, Random, 95% CI) 78.83 [24.02, 258.74]
5 Change in menstrual blood loss from baseline to treatment end 1 22 Mean Difference (IV, Random, 95% CI) ‐166.9 [‐277.60, ‐56.20]
6 Serious adverse events 3   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
6.1 Breast cancer 1 241 Odds Ratio (M‐H, Random, 95% CI) 0.08 [0.00, 2.04]
6.2 Uterine haemorrhage 2 274 Odds Ratio (M‐H, Random, 95% CI) 0.24 [0.00, 12.70]
6.3 Ovarian haemorrhage 1 241 Odds Ratio (M‐H, Random, 95% CI) 0.76 [0.03, 18.84]
6.4 Fibroid protruding through cervix 1 241 Odds Ratio (M‐H, Random, 95% CI) 0.08 [0.00, 2.04]
6.5 Menometrorrhagia 1 241 Odds Ratio (M‐H, Random, 95% CI) 0.08 [0.00, 2.04]
6.6 Hyperplasia 2 263 Odds Ratio (M‐H, Random, 95% CI) 0.38 [0.02, 8.38]
7 Other adverse events 3   Odds Ratio (M‐H, Random, 95% CI) Subtotals only
7.1 Headache 3 304 Odds Ratio (M‐H, Random, 95% CI) 0.78 [0.14, 4.30]
7.2 Breast pain or tenderness 2 274 Odds Ratio (M‐H, Random, 95% CI) 1.76 [0.26, 11.70]
7.3 Abdominal pain 3 304 Odds Ratio (M‐H, Random, 95% CI) 1.71 [0.36, 8.12]
7.4 Pyrexia 1 241 Odds Ratio (M‐H, Random, 95% CI) 0.61 [0.12, 3.25]
7.5 Hypercholesterolaemia 1 241 Odds Ratio (M‐H, Random, 95% CI) 1.25 [0.14, 10.96]
7.6 Hypothyroidism 1 241 Odds Ratio (M‐H, Random, 95% CI) 3.36 [0.19, 60.73]
7.7 Constipation 2 274 Odds Ratio (M‐H, Random, 95% CI) 0.60 [0.13, 2.79]
7.8 Hypertriglyceridaemia 1 241 Odds Ratio (M‐H, Random, 95% CI) 0.99 [0.11, 9.11]
7.9 Influenza 1 241 Odds Ratio (M‐H, Random, 95% CI) 0.99 [0.11, 9.11]
7.10 Dizziness 1 241 Odds Ratio (M‐H, Random, 95% CI) 2.30 [0.12, 43.52]
7.11 Nasopharyngitis 2 274 Odds Ratio (M‐H, Random, 95% CI) 0.45 [0.09, 2.31]
7.12 Dysmenorrhoea 1 241 Odds Ratio (M‐H, Random, 95% CI) 0.05 [0.00, 1.02]
7.13 Bladder pressure 1 30 Odds Ratio (M‐H, Random, 95% CI) 0.33 [0.03, 3.64]
7.14 Micturition problem 2 63 Odds Ratio (M‐H, Random, 95% CI) 1.91 [0.28, 13.23]
7.15 Lower back pain 2 63 Odds Ratio (M‐H, Random, 95% CI) 1.33 [0.29, 6.15]
7.16 Proctodynia 1 30 Odds Ratio (M‐H, Random, 95% CI) 3.67 [0.14, 97.49]
7.17 Coital pain 1 30 Odds Ratio (M‐H, Random, 95% CI) 6.6 [0.29, 150.07]
7.18 Hot flushes 1 30 Odds Ratio (M‐H, Random, 95% CI) 25.24 [1.27, 503.38]
7.19 Nausea 2 63 Odds Ratio (M‐H, Random, 95% CI) 1.97 [0.46, 8.46]
7.20 Vomiting 1 30 Odds Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.21 Diarrhoea 2 63 Odds Ratio (M‐H, Random, 95% CI) 3.62 [0.39, 33.89]
7.22 Change of mood 1 30 Odds Ratio (M‐H, Random, 95% CI) 15.00 [1.54, 146.54]
7.23 Lowered libido 1 30 Odds Ratio (M‐H, Random, 95% CI) 6.0 [0.58, 61.84]
7.24 Weakness 1 30 Odds Ratio (M‐H, Random, 95% CI) 2.8 [0.43, 18.38]
7.25 Fatigue 1 30 Odds Ratio (M‐H, Random, 95% CI) 1.73 [0.31, 9.57]
7.26 Dental pain 1 33 Odds Ratio (M‐H, Random, 95% CI) 1.35 [0.12, 14.82]
7.27 Vaginal infections 1 33 Odds Ratio (M‐H, Random, 95% CI) 2.44 [0.11, 55.56]
7.28 Vaginal discharge 1 33 Odds Ratio (M‐H, Random, 95% CI) 1.35 [0.12, 14.82]
8 Quality of life (Uterine Fibroid Symptoms and QoL questionnaire)     Other data No numeric data