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Bhattacharya S, Middleton LJ, Tsourapas A, et al.; the International Heavy Menstrual Bleeding Individual Patient Data Meta-analysis Collaborative Group. Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis. Southampton (UK): NIHR Journals Library; 2011 Apr. (Health Technology Assessment, No. 15.19.)

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Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis.

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Appendix 8Pooled results for Mirena versus second-generation endometrial destruction

Appendix 8.1. Quality of life and clinical outcomes

Time pointTrials (no.)WMD (95% CI)aOR (95%CI)bp-valueHetero (p)/I2 (%)
Proportion amenorrhoea6 months2 (107)1.76 (0.42 to 7.34)0.40.5/0
12 months3 (127)2.43 (0.61 to 9.67)0.20.02/82
2 years1 (39)5.99 (1.43 to 25.1)0.01
Proportion with heavy bleeding6 months3 (162)4.30 (1.76 to 10.6)0.0010.6/0
12 months4 (200)1.54 (0.56 to 4.24)0.40.02/75
2 years1 (39)13.0 (2.00 to 84.2)0.007
Bleeding score (change)6 months4 (169)10 (−37 to 57)0.70.2/29
12 months4 (168)−35 (−75 to 5)0.090.3/26
2 years1 (39)117 (−113 to 347)0.7
Proportion dysmenorrhoea6 months1 (83)0.78 (0.33 to 1.85)0.6
12 months1 (48)0.77 (0.25 to 2.43)0.7
2 years1 (83)0.97 (0.31 to 3.05)1.0
SF-36 general health (absolute)12 months3 (147)3.7 (−2.7 to 10.1)0.30.006/81
SF-36 physical function (absolute)3 (146)−0.9 (−6.9 to 5.0)0.80.6/0
SF-36 role physical (absolute)3 (147)−9.6 (−20.5 to 1.3)0.080.1/56
SF-36 role emotional (absolute)3 (147)5.7 (−5.4 to 16.8)0.30.02/75
SF-36 mental health (absolute)3 (146)−0.8 (−6.7 to 5.1)0.80.02/73
SF-36 social function (absolute)3 (147)2.3 (−3.6 to 8.2)0.40.06/65
SF-36 vitality (absolute)3 (146)0.01 (−5.9 to 6.1)1.00.3/7
SF-36 pain (absolute)3 (147)1.1 (−6.6 to 8.9)0.81.0/0
SF-36 general health (absolute)2 years1 (49)1.7 (−10.3 to 13.7)0.8
SF-36 physical function (absolute)1 (50)−1.2 (−8.0 to 5.6)0.7
SF-36 role physical (absolute)1 (50)8.2 (−4.9 to 21.3)0.2
SF-36 role emotional (absolute)1 (50)−1.0 (−16.4 to 14.4)0.9
SF-36 mental health (absolute)1 (49)−0.4 (−8.9 to 8.1)0.9
SF-36 social function (absolute)1 (50)2.2 (−7.0 to 11.4)0.6
SF-36 vitality (absolute)1 (49)1.8 (−8.6 to 12.2)0.7
SF-36 pain (absolute)1 (50)8.7 (−2.3 to 19.7)0.1
SF-36 general health (change)12 months2 (81)1.9 (−6.5 to 10.4)0.70.1/59
SF-36 physical function (change)2 (81)−0.5 (−10.1 to 9.2)0.90.5/0
SF-36 role physical (change)2 (82)−7.0 (−28.9 to 14.9)0.50.8/0
SF-36 role emotional (change)2 (82)1.8 (−18.5 to 22.1)0.90.04/75
SF-36 mental health (change)2 (81)−2.1 (−9.6 to 5.4)0.60.03/78
SF-36 social function (change)2 (82)−1.9 (−10.9 to 7.1)0.70.2/49
SF-36 vitality (change)2 (80)−2.0 (−12.2 to 8.2)0.70.7/0
SF-36 pain (change)2 (82)−8.0 (−20.0 to 3.9)0.20.6/0
SF-36 general health (change)2 years1 (49)−4.1 (−14.0 to 5.8)0.4
SF-36 physical function (change)1 (50)−4.4 (−14.9 to 6.1)0.4
SF-36 role physical (change)1 (50)−1.1 (−28.4 to 26.2)0.9
SF-36 role emotional (change)1 (50)2.0 (−23.3 to 27.3)0.9
SF-36 mental health (change)1 (49)−5.7 (−14.2 to 2.8)0.2
SF-36 social function (change)1 (50)−4.9 (−17.6 to 7.8)0.5
SF-36 vitality (change)1 (49)−9.6 (−20.4 to 1.2)0.08
SF-36 pain (change)1 (50)1.3 (−17.8 to 15.2)0.9
Hysterectomy after EA/Mirena6 months1 (50)1.79 (0.40 to 8.01)0.5
12 months2 (105)0.22 (0.05 to 1.04)0.060.9/0
2 years2 (146)0.86 (0.33 to 0.21)0.80.2/41
TrialsFrequency
Discontinued Mirena6 months13/42 (7%)
12 months318/96 (19%)
2 years221/75 (28%)
EA after Mirena12 months13/18 (17%)
2 years14/42 (10%)
6 months13/25 (12%)
Hysterectomy after Mirena12 months26/54 (11%)
2 years211/75 (15%)
TrialsFrequency (second-generation: max. 157; Mirena: max. 158)OR (95% CI)bp-valueHetero (p)/I2 (%)
Periprocedure complications
Uterine perforation (second-generation, Mirena)50; 0
Cervical laceration (second-generation, Mirena)50; 0
Anaesthesia problems (second-generation)50
Excessive bleeding (second-generation)50
Fluid overload (second-generation)50
Visceral damage (second-generation)50
Procedure abandoned (second-generation)50
Converted to hysterectomy (second-generation)50
Failed to insert (Mirena)50
Further complications (< 1 month)
Urinary tract infection (second-generation)50
Deep-vein thrombosis (second-generation)50
Further bleeding (second-generation)50
Sepsis (second-generation)50
Pyrexia (second-generation)50
Endometriosis (second-generation)50
Haematomata (second-generation)50
Abdominal pain (second-generation)50
Foul discharge (second-generation)50
Visceral damage (second-generation)50
Infection (Mirena)50
Expelled/migrated (Mirena)55
Removed before 3 months (MIrena)54
a

< 0 favours second-generation EA, > 0 favours Mirena.

b

< 1 favours second-generation EA, > 1 favours Mirena.

© 2011, Crown Copyright.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK99737

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