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. 2020 Jun 12;2020(6):CD002126. doi: 10.1002/14651858.CD002126.pub4

Comparison 2. LNG‐IUS versus any other medical treatment.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
2.1 Mean menstrual blood loss at end of study 2   Mean Difference (IV, Random, 95% CI) Totals not selected
2.1.1 Alkaline haematin method (mL) 2   Mean Difference (IV, Random, 95% CI) Totals not selected
2.1.2 PBAC score 2   Mean Difference (IV, Random, 95% CI) Totals not selected
2.2 Percentage reduction in blood loss at end of study (from baseline) 3   Mean Difference (IV, Random, 95% CI) Subtotals only
2.2.1 Alkaline haematin method 2 170 Mean Difference (IV, Random, 95% CI) 66.91 [42.61, 91.20]
2.2.2 PBAC score 3 335 Mean Difference (IV, Random, 95% CI) 55.05 [27.83, 82.28]
2.3 Menstrual blood loss by alkaline haematin ‐ descriptive results 3   Other data No numeric data
2.4 PBAC scores for menstrual blood loss ‐ descriptive results 1   Other data No numeric data
2.5 Percentage change in MBL (from baseline to end of study) 2   Other data No numeric data
2.6 Improvement in HMB 1 35 Risk Ratio (M‐H, Fixed, 95% CI) 11.05 [0.67, 182.23]
2.6.1 Amenorrhoea greater than 3 months 1 35 Risk Ratio (M‐H, Fixed, 95% CI) 11.05 [0.67, 182.23]
2.7 Total menstrual fluid loss ‐ descriptive results 1   Other data No numeric data
2.8 Proportion of women satisfied with treatment up to one year follow up 3 141 Risk Ratio (M‐H, Fixed, 95% CI) 1.28 [1.01, 1.63]
2.9 Quality of life (good or excellent) 2 170 Risk Ratio (M‐H, Fixed, 95% CI) 1.20 [0.72, 2.00]
2.10 Quality of life (unhealthy days and lost days) 2   Mean Difference (IV, Fixed, 95% CI) Subtotals only
2.10.1 Unhealthy days in past month (physical) 2 170 Mean Difference (IV, Fixed, 95% CI) ‐1.40 [‐2.17, ‐0.63]
2.10.2 Unhealthy days in past month (mental) 2 170 Mean Difference (IV, Fixed, 95% CI) 1.44 [0.61, 2.27]
2.10.3 Activity limitation in past month (lost days) 2 170 Mean Difference (IV, Fixed, 95% CI) ‐5.07 [‐5.79, ‐4.35]
2.11 Quality of life scores (between group difference in SF36 and EQ5D over 2 years) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
2.11.1 Overall MMAS 1   Mean Difference (IV, Fixed, 95% CI) 13.40 [9.89, 16.91]
2.11.2 SF36: physical functioning 1   Mean Difference (IV, Fixed, 95% CI) 2.70 [‐0.00, 5.40]
2.11.3 SF36: physical role 1   Mean Difference (IV, Fixed, 95% CI) 5.90 [2.65, 9.15]
2.11.4 SF 36: Emotional role 1   Mean Difference (IV, Fixed, 95% CI) 4.60 [1.25, 7.95]
2.11.5 SF 36: Social functioning 1   Mean Difference (IV, Fixed, 95% CI) 5.10 [2.04, 8.16]
2.11.6 SF 36: Mental health 1   Mean Difference (IV, Fixed, 95% CI) 1.50 [‐0.95, 3.95]
2.11.7 SF 36: Energy and vitality 1   Mean Difference (IV, Fixed, 95% CI) 5.30 [2.46, 8.14]
2.11.8 SF 36: Pain 1   Mean Difference (IV, Fixed, 95% CI) 7.80 [4.55, 11.05]
2.11.9 SF 36: Perception of general health 1   Mean Difference (IV, Fixed, 95% CI) 2.90 [0.06, 5.74]
2.11.10 EQ5D descriptive 1   Mean Difference (IV, Fixed, 95% CI) 0.01 [‐0.02, 0.04]
2.11.11 EQ5D visual analogue scale 1   Mean Difference (IV, Fixed, 95% CI) 2.00 [‐0.55, 4.55]
2.11.12 over 2 years 0   Mean Difference (IV, Fixed, 95% CI) Not estimable
2.12 Quality of life scores (between group difference in SF36 and EQ5D over 5 years) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
2.12.1 Overall MMAS 1   Mean Difference (IV, Fixed, 95% CI) 3.90 [‐0.60, 8.40]
2.12.2 SF 36 Physical functioning 1   Mean Difference (IV, Fixed, 95% CI) 1.60 [‐2.70, 5.90]
2.12.3 SF36: Physical role 1   Mean Difference (IV, Fixed, 95% CI) 2.70 [‐2.10, 7.50]
2.12.4 SF 36: Emotional role 1   Mean Difference (IV, Fixed, 95% CI) ‐2.00 [‐6.80, 2.80]
2.12.5 SF36 Social functioning 1   Mean Difference (IV, Fixed, 95% CI) 2.20 [‐2.50, 6.90]
2.12.6 SF 36 Mental health 1   Mean Difference (IV, Fixed, 95% CI) ‐1.60 [‐5.20, 2.00]
2.12.7 SF 36 Energy/vitality 1   Mean Difference (IV, Fixed, 95% CI) 2.80 [‐1.20, 6.80]
2.12.8 SF 36 Pain 1   Mean Difference (IV, Fixed, 95% CI) 3.70 [‐1.30, 8.70]
2.12.9 SF 36 General health perception 1   Mean Difference (IV, Fixed, 95% CI) 4.70 [0.60, 8.80]
2.12.10 EQ‐5D Descriptive system 1   Mean Difference (IV, Fixed, 95% CI) ‐0.02 [‐0.06, 0.02]
2.12.11 EQ‐5D VAS 1   Mean Difference (IV, Fixed, 95% CI) 0.60 [‐3.20, 4.40]
2.13 Quality of life (menorrhagia severity score) 1   Other data No numeric data
2.14 Quality of Life (WHO QoL‐Bref TR) 1 320 Mean Difference (IV, Fixed, 95% CI) ‐0.18 [‐2.55, 2.19]
2.14.1 Physical domain 1 64 Mean Difference (IV, Fixed, 95% CI) ‐0.38 [‐6.04, 5.28]
2.14.2 Psychological domain 1 64 Mean Difference (IV, Fixed, 95% CI) 0.56 [‐5.18, 6.30]
2.14.3 Social domain 1 64 Mean Difference (IV, Fixed, 95% CI) ‐0.02 [‐7.10, 7.06]
2.14.4 Environmental 1 64 Mean Difference (IV, Fixed, 95% CI) ‐0.43 [‐4.93, 4.07]
2.14.5 Environmental‐TR 1 64 Mean Difference (IV, Fixed, 95% CI) ‐0.32 [‐4.92, 4.28]
2.15 Proportion of women with serious adverse events 1 571 Risk Ratio (M‐H, Fixed, 95% CI) 0.91 [0.63, 1.30]
2.16 Individual adverse events 6   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
2.16.1 Pelvic pain 4 823 Risk Ratio (M‐H, Fixed, 95% CI) 2.22 [0.94, 5.23]
2.16.2 Mood swings 1 31 Risk Ratio (M‐H, Fixed, 95% CI) 1.08 [0.60, 1.95]
2.16.3 Intermenstrual bleeding and menstrual irregularity 2 70 Risk Ratio (M‐H, Fixed, 95% CI) 0.98 [0.53, 1.82]
2.16.4 Breast tenderness 3 244 Risk Ratio (M‐H, Fixed, 95% CI) 2.85 [1.29, 6.29]
2.16.5 Nausea 1 51 Risk Ratio (M‐H, Fixed, 95% CI) 0.52 [0.10, 2.59]
2.16.6 Diarrhoea 1 51 Risk Ratio (M‐H, Fixed, 95% CI) 0.26 [0.03, 2.17]
2.16.7 Upper respiratory infection 2 213 Risk Ratio (M‐H, Fixed, 95% CI) 1.73 [0.67, 4.44]
2.16.8 Ovarian cysts 3 784 Risk Ratio (M‐H, Fixed, 95% CI) 3.28 [1.31, 8.21]
2.16.9 Headache 4 823 Risk Ratio (M‐H, Fixed, 95% CI) 1.20 [0.75, 1.93]
2.16.10 Vaginitis 1 162 Risk Ratio (M‐H, Fixed, 95% CI) 3.08 [0.86, 10.95]
2.16.11 Acne 1 162 Risk Ratio (M‐H, Fixed, 95% CI) 1.02 [0.31, 3.41]
2.16.12 Hypertension 1 162 Risk Ratio (M‐H, Fixed, 95% CI) 5.12 [0.61, 42.90]
2.16.13 Sinusitis 1 162 Risk Ratio (M‐H, Fixed, 95% CI) 1.71 [0.42, 6.91]
2.16.14 Fatigue 1 162 Risk Ratio (M‐H, Fixed, 95% CI) 2.05 [0.39, 10.88]
2.16.15 Urinary tract infection 1 162 Risk Ratio (M‐H, Fixed, 95% CI) 2.05 [0.53, 7.92]
2.16.16 Increased weight 1 162 Risk Ratio (M‐H, Fixed, 95% CI) 0.82 [0.23, 2.94]
2.16.17 Lower abdominal pain 2 201 Risk Ratio (M‐H, Fixed, 95% CI) 0.42 [0.13, 1.44]
2.16.18 Any adverse events 2 101 Risk Ratio (M‐H, Fixed, 95% CI) 1.13 [0.85, 1.48]
2.17 Withdrawal from treatment 4   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
2.17.1 For adverse events 4 819 Risk Ratio (M‐H, Fixed, 95% CI) 1.07 [0.74, 1.54]
2.17.2 For any reason 1 571 Risk Ratio (M‐H, Fixed, 95% CI) 0.49 [0.39, 0.60]
2.18 Treatment failure (PBAC > 100 at end of treatment or requirement for alternative treatment ) 6 535 Risk Ratio (M‐H, Fixed, 95% CI) 0.34 [0.26, 0.44]