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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.)

Appendix 7Pooled results for Mirena versus first-generation endometrial ablation

Appendix 7.1. Clinical outcome and quality of life

Time pointTrials (no.)WMD (95% CI)aOR (95%CI)bp-valueHetero (p)/I2 (%)
Proportion amenorrhoea12 months3 (177)0.84 (0.43 to 1.63)0.60.3/11
2 years1 (44)0.68 (0.19 to 2.45)0.6
3 years1 (41)0.68 (0.19 to 2.38)0.5
Proportion with heavy bleeding12 months2 (125)1.13 (0.33 to 3.86)0.90.3/0
3 years1 (41)1.84 (0.29 to 11.7)0.5
Bleeding score (change)6 months1 (68)−28 (−57 to 1.4)0.06
12 months3 (168)−39 (−66 to −12)0.0040.6/0
2 years1 (44)41 (−189 to 271)0.7
3 years1 (41)37 (−202 to 276)0.8
SF-36 general health (absolute)12 months1 (62)−6.2 (−14.6 to 2.2)0.2
SF-36 physical function (absolute)1 (62)−1.2 (−12.7 to 10.3)0.8
SF-36 role physical (absolute)1 (62)−1.7 (−19.0 to 15.6)0.9
SF-36 role emotional (absolute)1 (62)−11.1 (−29.1 to 6.9)0.2
SF-36 mental health (absolute)1 (62)0.5 (−9.2 to 10.2)0.9
SF-36 social function (absolute)1 (62)0.1 (−11.5 to 11.7)1.0
SF-36 vitality (absolute)1 (62)1.5 (−7.3 to 10.3)0.7
SF-36 pain (absolute)1 (62)−11.4 (−24.2 to 1.4)0.08
Hysterectomy after EA/Mirena12 months1 (70)7.39 (0.15 to 372)0.3
TrialsFrequency
Discontinued Mirena12 months312/95 (13%)
2 years18/30 (27%)
3 years19/30 (30%)
EA after Mirena12 months14/30 (13%)
Hysterectomy after Mirena12 months10/35 (0%)
TrialsFrequency (first-generation: max. 95; Mirena: max. 95)OR (95% CI)bp-valueHetero (p)/I2 (%)
Periprocedure complications
Uterine perforation (first-generation, Mirena)50; 0
Cervical laceration (first-generation, Mirena)50; 0
Anaesthesia problems (first-generation)50
Excessive bleeding (first-generation)50
Fluid overload (first-generation)50
Visceral damage (first-generation)50
Procedure abandoned (first-generation)50
Converted to hysterectomy (first-generation)50
Failed to insert (Mirena)50
Further complications (< 1 month)
Urinary tract infection (first-generation)50
Deep-vein thrombosis (first-generation)50
Further bleeding (first-generation)57
Sepsis (first-generation)50
Pyrexia (first-generation)50
Endometriosis (first-generation)52
Haematomata (first-generation)53
Abdominal pain (first-generation)54
Foul discharge (first-generation)50
Visceral damage (first-generation)50
Infection (Mirena)50
Expelled/migrated (Mirena)52
Removed before 3 months (Mirena)54
a

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

b

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

Appendix 7.2. First- and second-generation endometrial ablation versus Mirena

Proportion with amenorrhoea < 12 months

Proportion with amenorrhoea – 12 months

Proportion with amenorrhoea – 2 years

Proportion with amenorrhoea – 3 years

Proportion with heavy bleeding – < 12 months

Proportion with heavy bleeding – 12 months

Proportion with heavy bleeding – 2 years

Proportion with heavy bleeding – 3 years

Bleeding/pictorial blood loss assessment chart scores (change from baseline) – < 12 months

Bleeding/pictorial blood loss assessment chart scores (change from baseline) – 12 months

Bleeding/pictorial blood loss assessment chart scores (change from baseline) – 2 years

Bleeding/pictorial blood loss assessment chart scores (change from baseline) – 3 years

Proportion with dysmenorrhoea – < 12 months

Proportion with dysmenorrhoea – 12 months

Proportion with dysmenorrhoea – 2 years

SF-36 general health (absolute values) – 12 months

SF-36 physical function (absolute values) – 12 months

SF-36 mental health (absolute values) – 12 months

SF-36 vitality (absolute values) – 12 months

SF-36 physical role limitation (absolute values) – 12 months

SF-36 emotional role limitation (absolute values) – 12 months

SF-36 social function (absolute values) – 12 months

SF-36 bodily pain (absolute values) – 12 months

SF-36 general health (absolute values) – 2 years

SF-36 physical function (absolute values) – 2 years

SF-36 mental health (absolute values) – 2 years

SF-36 vitality (absolute values) – 2 years

SF-36 physical role limitation (absolute values) – 2 years

SF-36 emotional role limitation (absolute values) – 2 years

SF-36 social function (absolute values) – 2 years

SF-36 bodily pain (absolute values) – 2 years

SF-36 general health (change from baseline) – 12 months

SF-36 physical function (change from baseline) – 12 months

SF-36 mental health (change from baseline) – 12 months

SF-36 vitality (change from baseline) – 12 months

SF-36 physical role limitation (change from baseline) – 12 months

SF-36 bodily pain (change from baseline) – 12 months

SF-36 social function (change from baseline) – 12 months

SF-36 emotional role limitation (change from baseline) – 12 months

SF-36 general health (change from baseline) – 2 years

SF-36 physical function (change from baseline) – 2 years

SF-36 mental health (change from baseline) – 2 years

SF-36 vitality (change from baseline) – 2 years

SF-36 physical role limitation (change from baseline) – 2 years

SF-36 bodily pain (change from baseline) – 2 years

SF-36 social function (change from baseline) – 2 years

SF-36 emotional role limitation (change from baseline) – 2 years

Proportion requiring endometrial ablation – 12 months

Proportion requiring endometrial ablation – 2 years

Proportion requiring hysterectomy – < 12 months

Proportion requiring hysterectomy – 12 months

Proportion requiring hysterectomy – 2 years

Proportion discontinuing Mirena – < 12 months

Proportion discontinuing Mirena –12 months

Proportion discontinuing Mirena – 2 years

Proportion discontinuing Mirena – 3 years

Patients with adverse events – periprocedure (uterine perforation)

Patients with adverse events – periprocedure (cervical laceration)

Patients with adverse events – periprocedure (anaesthesia problems)

Patients with adverse events – periprocedure (excessive bleeding)

Patients with adverse events – periprocedure (fluid overload)

Patients with adverse events – periprocedure (excessive visceral damage)

Patients with adverse events – periprocedure (procedure abandoned)

Patients with adverse events – periprocedure (procedure converted to hysterectomy)

Patients with adverse events – periprocedure (failed insert)

Patients with adverse events – postoperatively (urinary tract infection)

Patients with adverse events – postoperatively (deep-vein thrombosis)

Patients with adverse events – postoperatively (further bleeding)

Patients with adverse events – postoperatively (sepsis)

Patients with adverse events – postoperatively (pyrexia)

Patients with adverse events – postoperatively (endometriosis)

Patients with adverse events – postoperatively (haematometra)

Patients with adverse events – postoperatively (abdominal pain)

Patients with adverse events – postoperatively (foul discharge)

Patients with adverse events – postoperatively (visceral damage)

Patients with adverse events – postoperatively (infection)

Patients with adverse events – postoperatively (migrated coil)

Patients with adverse events – postoperatively (removed < 3 months)

© 2011, Crown Copyright.

Included under terms of UK Non-commercial Government License.

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

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