Uterine artery embolization for symptomatic uterine fibroids

Janesh K Gupta; Anju Sinha; M A Lumsden; Martha Hickey

doi:10.1002/14651858.CD005073.pub4

Embolización de la arteria uterina para los fibromas uterinos sintomáticos

Appendices

Appendix 1. MDSG search string

Keywords CONTAINS "fibroids" or "Leiomyoma" or "myoma" or "uterine fibroids" or "uterine leiomyomas" or "uterine myomas" or Title CONTAINS "fibroids" or "Leiomyoma" or "myoma" or "uterine fibroids" or "uterine leiomyomas" or "uterine myomas"

AND

Keywords CONTAINS "uterine artery embolization" or "UAE" or Title CONTAINS "uterine artery embolization" or "UAE"

Appendix 2. MEDLINE search strategy

The MEDLINE database was searched using the following subject headings and keywords:

1 exp Embolization, Therapeutic/ (23874)
2 (uter$ arter$ adj3 emboli#ation$).tw. (999)
3 UAE.tw. (1663)
4 (fibroid$ adj3 emboli#ation$).tw. (257)
5 or/1‐4 (25336)
6 exp leiomyoma/ or exp myoma/ (17581)
7 (leiomyoma$ or myoma$).tw. (13026)
8 fibro$.tw. (359782)
9 hysteromyom$.tw. (49)
10 or/6‐9 (376897)
11 5 and 10 (1409)
12 randomised controlled trial.pt. (321305)
13 controlled clinical trial.pt. (83863)
14 randomized.ab. (236535)
15 placebo.tw. (137888)
16 clinical trials as topic.sh. (159162)
17 randomly.ab. (173282)
18 trial.ti. (101540)
19 (crossover or cross‐over or cross over).tw. (52610)
20 or/12‐19 (787118)
21 exp animals/ not humans.sh. (3709121)
22 20 not 21 (726837)
23 11 and 22 (117)

Appendix 3. EMBASE search strategy

The EMBASE database was searched using the following subject headings and keywords:

1 exp Uterine Artery Embolization/ (1317)
2 (uter$ arter$ adj3 emboli#ation$).tw. (1313)
3 UAE.tw. (2164)
4 (fibroid$ adj3 emboli#ation$).tw. (371)
5 or/1‐4 (3507)
6 exp benign uterus tumor/ or exp leiomyoma/ or exp uterus myoma/ (18702)
7 (leiomyoma$ or myoma$).tw. (14385)
8 fibro$.tw. (389052)
9 hysteromyom$.tw. (78)
10 or/6‐9 (407253)
11 5 and 10 (1300)
12 Clinical Trial/ (820351)
13 Randomized Controlled Trial/ (291727)
14 exp randomization/ (54876)
15 Single Blind Procedure/ (14365)
16 Double Blind Procedure/ (101449)
17 Crossover Procedure/ (31081)
18 Placebo/ (186763)
19 Randomi?ed controlled trial$.tw. (65701)
20 Rct.tw. (7913)
21 random allocation.tw. (1060)
22 randomly allocated.tw. (15732)
23 allocated randomly.tw. (1715)
24 (allocated adj2 random).tw. (688)
25 Single blind$.tw. (11180)
26 Double blind$.tw. (118790)
27 (treble or triple) adj blind$).tw. (249)
28 placebo$.tw. (160855)
29 prospective study/ (175478)
30 or/12‐29 (1153000)
31 case study/ (13675)
32 case report.tw. (209434)
33 abstract report/ or letter/ (797863)
34 or/31‐33 (1016890)
35 30 not 34 (1119551)
36 11 and 35 (251)

Appendix 4. CENTRAL search strategy

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, 4th Quarter 2011, and again most recently on 17 April 2014. The CENTRAL database was searched using the following subject headings and keywords:

1 exp Embolization, Therapeutic/ (380)
2 (uter$ arter$ adj3 emboli#ation$).tw. (63)
3 UAE.tw. (221)
4 (fibroid$ adj3 emboli#ation$).tw. (15)
5 or/1‐4 (584)
6 exp leiomyoma/ or exp myoma/ (346)
7 (leiomyoma$ or myoma$).tw. (340)
8 fibro$.tw. (5954)
9 hysteromyom$.tw. (15)
10 or/6‐9 (6297)
11 5 and 10 (67)

Appendix 5. PsycINFO search strategy

The PsycINF0 database was searched using the following subject headings and keywords:

1 (uter$ adj3 emboli?ation$).tw. (2)
2 UAE.tw. (133)
3 (fibroid$ adj3 emboli?ation$).tw. (0)
4 or/1‐3 (135)
5 (leiomyoma$ or myoma$).tw. (28)
6 fibro$.tw. (4305)
7 hysteromyom$.tw. (2)
8 or/5‐7 (4331)
9 4 and 8 (0)

Appendix 6. CINAHL search strategy

#	Query	Results
S27	S11 AND S25	57
S26	S11 AND S25	94
S25	S12 OR S13 or S14 or S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22 OR S23 OR S24	883,706
S24	TX allocat* random*	3,869
S23	(MH "Quantitative Studies")	11,815
S22	(MH "Placebos")	8,705
S21	TX placebo*	31,365
S20	TX random* allocat*	3,869
S19	(MH "Random Assignment")	37,008
S18	TX randomi* control* trial*	71,284
S17	TX ( (singl* n1 blind) or (singl n1 mask) ) or TX ( (doubl n1 blind) or (doubl n1 mask) ) or TX ( (tripl n1 blind) or (tripl n1 mask) ) or TX ( (trebl n1 blind) or (trebl n1 mask*) )	710,423
S16	TX ( (trebl* n1 blind) or (trebl n1 mask*) )	104
S15	TX ( (trebl* n1 blind) or (trebl n1 mask*) )	0
S14	TX clinic* n1 trial*	162,339
S13	PT Clinical trial	75,742
S12	(MH "Clinical Trials+")	173,495
S11	S5 AND S10	407
S10	S6 OR S7 OR S8 OR S9	2,290
S9	TX fibroid*	820
S8	TX hysteromyom*	3
S7	TX (leiomyoma* or myoma*)	2,132
S6	(MM "Myoma")	59
S5	S1 OR S2 OR S3 OR S4	3,231
S4	TX (fibroid* N3 emboli?ation*)	132
S3	TX UAE	541
S2	TX (uter* arter* N3 emboli?ation*)	450
S1	(MM "Uterine Artery Embolization"# OR #MM "Embolization, Therapeutic"#	2,634

Appendix 7. Clinical trials registries: International Clinical Trials Registry Platform and ClinicalTrials.gov

'uterine artery embolization' AND 'fibroid*'

Clinicaltrials.gov: (22)

ICTRP: (1)

Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 3

Forest plot of comparison: 1 UAE versus surgery, outcome: 1.1 Satisfaction with treatment up to 24 months.

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Figure 4

Forest plot of comparison: 1 UAE versus surgery, outcome: 1.2 Satisfaction with treatment at 5 years.

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Figure 5

Forest plot of comparison: 1 UAE versus surgery, outcome: 1.3 Live birth.

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Figure 6

Forest plot of comparison: 1 UAE versus surgery, outcome: 1.10 Further interventions within 2 years.

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Analysis 1.1

Comparison 1 UAE versus surgery, Outcome 1 Satisfaction with treatment up to 24 months.

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Analysis 1.2

Comparison 1 UAE versus surgery, Outcome 2 Satisfaction with treatment at 5 years.

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Analysis 1.3

Comparison 1 UAE versus surgery, Outcome 3 Live birth.

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Analysis 1.4

Comparison 1 UAE versus surgery, Outcome 4 Adverse events: intraprocedural complications.

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Analysis 1.5

Comparison 1 UAE versus surgery, Outcome 5 Adverse events: Need for blood transfusion.

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Analysis 1.6

Comparison 1 UAE versus surgery, Outcome 6 Adverse events: minor postprocedural complications.

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Analysis 1.7

Comparison 1 UAE versus surgery, Outcome 7 Adverse events: major postprocedural complications within one year.

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Analysis 1.8

Comparison 1 UAE versus surgery, Outcome 8 Adverse events: later minor postprocedural complications.

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Analysis 1.9

Comparison 1 UAE versus surgery, Outcome 9 Adverse events: major postprocedural complications.

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Analysis 1.10

Comparison 1 UAE versus surgery, Outcome 10 Further interventions within 2 years.

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Analysis 1.11

Comparison 1 UAE versus surgery, Outcome 11 Further interventions within 5 years.

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Analysis 1.12

Comparison 1 UAE versus surgery, Outcome 12 Unscheduled readmission rate within 4‐6 weeks.

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Analysis 1.13

Comparison 1 UAE versus surgery, Outcome 13 Cost: duration of procedure (minutes).

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Analysis 1.14

Comparison 1 UAE versus surgery, Outcome 14 Cost: length of hospital stay (days).

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Analysis 1.15

Comparison 1 UAE versus surgery, Outcome 15 Cost: resumption of normal activities (days).

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Analysis 1.16

Comparison 1 UAE versus surgery, Outcome 16 FSH levels >40 IU/L (within 2 years).

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Analysis 1.17

Comparison 1 UAE versus surgery, Outcome 17 FSH levels >10 IU/L (within 6 months).

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Analysis 1.18

Comparison 1 UAE versus surgery, Outcome 18 Fibroid recurrence within 2 years.

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Analysis 1.19

Comparison 1 UAE versus surgery, Outcome 19 Pregnancy.

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Analysis 1.20

Comparison 1 UAE versus surgery, Outcome 20 UAE versus myomectomy: Health related quality of life at one year.

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Analysis 1.21

Comparison 1 UAE versus surgery, Outcome 21 UAE versus hysterectomy or myomectomy: SF‐36 within 1 year.

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Summary of findings for the main comparison. Uterine artery embolization (UAE) compared to surgery for symptomatic uterine fibroids

UAE compared to surgery for symptomatic uterine fibroids
Population: women with symptomatic uterine fibroids Intervention: UAE Comparison: surgery
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Surgery	UAE
Satisfaction with treatment up to 24 months	861 per 1000	853 per 1000 (785 to 901)	OR 0.94 (0.59 to 1.48)	640 (6 RCTs)	⊕⊕⊕⊝ MODERATE ^1,2
Satisfaction with treatment at 5 years	876 per 1000	864 per 1000 (761 to 927)	OR 0.90 (0.45 to 1.80)	295 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Live birth ‐ UAE versus myomectomy	475 per 1000	190 per 1000 (67 to 432)	OR 0.26 (0.08 to 0.84)	66 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^3,4
Adverse events: intra‐procedural complications	63 per 1000	57 per 1000 (27 to 117)	OR 0.91 (0.42 to 1.97)	452 (4 RCTs)	⊕⊕⊝⊝ LOW^5,6,7
Adverse events: minor post‐procedural complications within one year	230 per 1000	373 per 1000 (296 to 456)	OR 1.99 (1.41 to 2.81)	735 (6 RCTs)	⊕⊕⊕⊝ MODERATE ^1,2
Adverse events: major post‐procedural complications within one year	69 per 1000	46 per 1000 (24 to 85)	OR 0.65 (0.33 to 1.26)	611 (5 RCTs)	⊕⊕⊕⊝ MODERATE ^1,5,7
Further interventions within 2 years	71 per 1000	222 per 1000 (149 to 317)	OR 3.72 (2.28 to 6.04)	732 (6 RCTs)	⊕⊕⊕⊝ MODERATE ^1,2,8
The basis for the assumed risk* is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Studies unblinded ²Two studies did not fully explain randomisation and allocation concealment, but quality not downgraded for this as their omission from analysis did not substantially change the findings ³ Wide confidence intervals compatible with substantial harm from UAE or with no effect ⁴Includes only those trial participants who wished to conceive (66/121) ⁵One study did not fully explain methods of randomisation and allocation concealment, but omission of this study did not substantially affect the findings ⁶Low event rate ⁷Wide confidence intervals compatible with substantial harm or benefit from either intervention, or with no effect ⁸Some statistical heterogeneity (I² = 45%); quality not downgraded for this as direction of effect is consistent

Summary of findings for the main comparison. Uterine artery embolization (UAE) compared to surgery for symptomatic uterine fibroids

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Comparison 1. UAE versus surgery

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Satisfaction with treatment up to 24 months Show forest plot	6	640	Odds Ratio (M‐H, Fixed, 95% CI)	0.94 [0.59, 1.48]

1.1 UAE versus hysterectomy	3	266	Odds Ratio (M‐H, Fixed, 95% CI)	0.63 [0.30, 1.32]
1.2 UAE versus hysterectomy or myomectomy	2	264	Odds Ratio (M‐H, Fixed, 95% CI)	1.29 [0.64, 2.58]
1.3 UAE versus myomectomy	1	110	Odds Ratio (M‐H, Fixed, 95% CI)	1.05 [0.33, 3.36]
2 Satisfaction with treatment at 5 years Show forest plot	2	295	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.45, 1.80]

2.1 UAE versus hysterectomy	1	156	Odds Ratio (M‐H, Fixed, 95% CI)	0.71 [0.29, 1.78]
2.2 UAE versus hysterectomy or myomectomy	1	139	Odds Ratio (M‐H, Fixed, 95% CI)	1.25 [0.42, 3.67]
3 Live birth Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 UAE versus myomectomy	1	66	Odds Ratio (M‐H, Fixed, 95% CI)	0.26 [0.08, 0.84]
4 Adverse events: intraprocedural complications Show forest plot	4	452	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.42, 1.97]

4.1 UAE versus hysterectomy	2	209	Odds Ratio (M‐H, Fixed, 95% CI)	1.23 [0.44, 3.44]
4.2 UAE versus myomectomy	2	243	Odds Ratio (M‐H, Fixed, 95% CI)	0.61 [0.18, 2.03]
5 Adverse events: Need for blood transfusion Show forest plot	2	277	Odds Ratio (M‐H, Fixed, 95% CI)	0.07 [0.01, 0.52]

5.1 UAE versus hysterectomy	1	156	Odds Ratio (M‐H, Fixed, 95% CI)	0.04 [0.00, 0.67]
5.2 UAE versus myomectomy	1	121	Odds Ratio (M‐H, Fixed, 95% CI)	0.21 [0.01, 4.47]
6 Adverse events: minor postprocedural complications Show forest plot	6	735	Odds Ratio (M‐H, Fixed, 95% CI)	1.99 [1.41, 2.81]

6.1 UAE versus hysterectomy	2	211	Odds Ratio (M‐H, Fixed, 95% CI)	2.12 [1.13, 3.96]
6.2 UAE versus hysterectomy or myomectomy	2	281	Odds Ratio (M‐H, Fixed, 95% CI)	2.51 [1.49, 4.23]
6.3 UAE versus myomectomy	2	243	Odds Ratio (M‐H, Fixed, 95% CI)	1.23 [0.62, 2.44]
7 Adverse events: major postprocedural complications within one year Show forest plot	5	611	Odds Ratio (M‐H, Fixed, 95% CI)	0.65 [0.33, 1.26]

7.1 UAE versus hysterectomy	2	211	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.22, 4.58]
7.2 UAE versus hysterectomy or myomectomy	1	157	Odds Ratio (M‐H, Fixed, 95% CI)	0.73 [0.30, 1.74]
7.3 UAE versus myomectomy	2	243	Odds Ratio (M‐H, Fixed, 95% CI)	0.29 [0.06, 1.50]
8 Adverse events: later minor postprocedural complications Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 UAE versus hysterectomy or myomectomy (to 5 years)	2	268	Odds Ratio (M‐H, Fixed, 95% CI)	2.93 [1.73, 4.93]
8.2 UAE versus myomectomy (1 month‐2 years)	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	1.82 [0.56, 5.94]
9 Adverse events: major postprocedural complications Show forest plot	3	388	Odds Ratio (M‐H, Fixed, 95% CI)	0.56 [0.27, 1.18]

9.1 UAE versus hysterectomy or myomectomy (to 5 years)	2	268	Odds Ratio (M‐H, Fixed, 95% CI)	0.56 [0.27, 1.18]
9.2 UAE versus myomectomy (1 month‐2 years)	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Further interventions within 2 years Show forest plot	6	732	Odds Ratio (M‐H, Fixed, 95% CI)	3.72 [2.28, 6.04]

10.1 UAE versus hysterectomy	2	209	Odds Ratio (M‐H, Fixed, 95% CI)	2.99 [1.31, 6.80]
10.2 UAE versus hysterectomy or myomectomy	2	281	Odds Ratio (M‐H, Fixed, 95% CI)	2.83 [1.29, 6.24]
10.3 UAE versus myomectomy	2	242	Odds Ratio (M‐H, Fixed, 95% CI)	6.89 [2.60, 18.27]
11 Further interventions within 5 years Show forest plot	2	289	Odds Ratio (M‐H, Fixed, 95% CI)	5.79 [2.65, 12.65]

11.1 UAE versus hysterectomy	1	145	Odds Ratio (M‐H, Fixed, 95% CI)	3.43 [1.41, 8.30]
11.2 UAE versus hysterectomy or myomectomy	1	144	Odds Ratio (M‐H, Fixed, 95% CI)	20.34 [2.68, 154.59]
12 Unscheduled readmission rate within 4‐6 weeks Show forest plot	2	278	Risk Difference (M‐H, Fixed, 95% CI)	0.14 [0.05, 0.22]

12.1 UAE versus hysterectomy	1	157	Risk Difference (M‐H, Fixed, 95% CI)	0.23 [0.09, 0.38]
12.2 UAE versus myomectomy	1	121	Risk Difference (M‐H, Fixed, 95% CI)	0.02 [‐0.04, 0.07]
13 Cost: duration of procedure (minutes) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

13.1 UAE versus hysterectomy	1	156	Mean Difference (IV, Fixed, 95% CI)	‐16.40 [‐26.04, ‐6.76]
13.2 UAE versus myomectomy	1	121	Mean Difference (IV, Fixed, 95% CI)	‐49.7 [‐58.76, ‐40.64]
14 Cost: length of hospital stay (days) Show forest plot	7		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

14.1 UAE versus hysterectomy	3		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.2 UAE versus hysterectomy or myomectomy	2		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.3 UAE versus myomectomy	2		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
15 Cost: resumption of normal activities (days) Show forest plot	5		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

15.1 UAE versus hysterectomy	2	188	Mean Difference (IV, Fixed, 95% CI)	‐22.85 [‐27.30, ‐18.40]
15.2 UAE versus hysterectomy or myomectomy	2	220	Mean Difference (IV, Fixed, 95% CI)	‐13.68 [‐16.05, ‐11.30]
15.3 UAE versus myomectomy	1	121	Mean Difference (IV, Fixed, 95% CI)	‐10.20 [‐13.60, ‐6.80]
16 FSH levels >40 IU/L (within 2 years) Show forest plot	2	297	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.53, 1.94]

16.1 UAE versus hysterectomy	1	153	Odds Ratio (M‐H, Fixed, 95% CI)	0.70 [0.32, 1.54]
16.2 UAE versus hysterectomy or myomectomy	1	144	Odds Ratio (M‐H, Fixed, 95% CI)	2.35 [0.64, 8.68]
17 FSH levels >10 IU/L (within 6 months) Show forest plot	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	4.8 [0.97, 23.64]

17.1 UAE versus myomectomy	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	4.8 [0.97, 23.64]
18 Fibroid recurrence within 2 years Show forest plot	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	1.32 [0.38, 4.57]

18.1 UAE versus myomectomy	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	1.32 [0.38, 4.57]
19 Pregnancy Show forest plot	1	66	Odds Ratio (M‐H, Fixed, 95% CI)	0.29 [0.10, 0.85]

19.1 UAE versus myomectomy	1	66	Odds Ratio (M‐H, Fixed, 95% CI)	0.29 [0.10, 0.85]
20 UAE versus myomectomy: Health related quality of life at one year Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

20.1 USF‐QOL end scores	1	122	Mean Difference (IV, Fixed, 95% CI)	‐13.40 [‐21.41, ‐5.39]
20.2 USF‐QOL change scores	1	122	Mean Difference (IV, Fixed, 95% CI)	‐7.60 [‐17.55, 2.35]
21 UAE versus hysterectomy or myomectomy: SF‐36 within 1 year Show forest plot	2	1405	Mean Difference (IV, Fixed, 95% CI)	9.14 [8.04, 10.23]

21.1 Physical function	2	281	Mean Difference (IV, Fixed, 95% CI)	7.77 [5.83, 9.70]
21.2 Social function	2	281	Mean Difference (IV, Fixed, 95% CI)	6.14 [2.71, 9.58]
21.3 Mental Health	2	281	Mean Difference (IV, Fixed, 95% CI)	12.00 [9.50, 14.50]
21.4 Emotional role	2	281	Mean Difference (IV, Fixed, 95% CI)	10.28 [7.96, 12.60]
21.5 Vitality	2	281	Mean Difference (IV, Fixed, 95% CI)	8.75 [6.09, 11.41]

Comparison 1. UAE versus surgery

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Embolización de la arteria uterina para los fibromas uterinos sintomáticos

Appendices

Appendix 1. MDSG search string

Appendix 2. MEDLINE search strategy

Appendix 3. EMBASE search strategy

Appendix 4. CENTRAL search strategy

Appendix 5. PsycINFO search strategy

Appendix 6. CINAHL search strategy

Appendix 7. Clinical trials registries: International Clinical Trials Registry Platform and ClinicalTrials.gov

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Appendices

Appendix 1. MDSG search string

Appendix 2. MEDLINE search strategy

Appendix 3. EMBASE search strategy

Appendix 4. CENTRAL search strategy

Appendix 5. PsycINFO search strategy

Appendix 6. CINAHL search strategy

Appendix 7. Clinical trials registries: International Clinical Trials Registry Platform and ClinicalTrials.gov

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