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Uterine artery embolization for symptomatic uterine fibroids

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Referencias

References to studies included in this review

EMMY 2010 {published data only}

Hehenkamp WJK, Volkers NA, Birnie E, Reekers JA, Ankum WM. Pain and return to daily activities after uterine artery embolization and hysterectomy in the treatment of symptomatic uterine fibroids: Results from the randomized EMMY trial. Cardiovascular Interventional Radiology 2006;29:179‐87.
Hehenkamp WJK, Volkers NA, Birnie E, Reekers JA, Ankum WM. Symptomatic uterine fibroids: Treatment with uterine artery embolization or hysterectomy ‐ results from the randomized clinical embolization versus hysterectomy (EMMY) trial. Radiology 2008;246(3):823‐32.
Hehenkamp WJK, Volkers NA, Broekmans FJM, de Jong FH, Themmen APN, Birnie E, et al. Loss of ovarian reserve after uterine artery embolization: a randomised comparison with hysterectomy. Human Reproduction 2007;22:1996‐2005.
Hehenkamp WJK, Volkers NA, Donderwinkel PFJ, de Blok S, Birnie E, Ankum WA, et al. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): Peri‐ and postprocedural results from a randomized controlled trial. American Journal of Obstetrics and Gynecology 2005;193:1618‐29.
Volkers NA, Hehenkamp WJ, Smit P, Ankum WM, Reekers JA, Birnie E. Economic evaluation of uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids: results from the randomized EMMY trial. Journal of Vascular Interventional Radiology 2008;19:1007‐17.
Volkers NA, Hehenkamp WJK, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids: 2 years' outcome from the randomized EMMY trial. American Journal of Obstetrics and Gynecology 2007;196:519e.1‐11.
van der Kooij SM, Hehenkamp WJK, Volkers NA, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5‐year outcome from the randomized EMMY trial. American Journal of Obstetrics and Gynecology 2010;203:105.e1‐13.

FUME 2012 {published data only}

Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli A‐M. Uterine artery embolization versus myomectomy: Impact on quality of life ‐ results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) trial. Cardiovascular and Interventional Radiology 2012;35(3):530‐6.

Jun 2012 {published data only}

Jun F, Yamin L, Xinli X, Zhe L, Min Z, Bo Z, Wenli G. Uterine artery embolization versus surgery for symptomatic uterine fibroids: a randomized controlled trial and a meta‐analysis of the literature. Archives of Gynecology and Obstetrics 2012;285:1407‐13.

Mara 2008 {published data only}

Mara M, Fucikovaa Z, Maskova J, Kuzela J, Haakova L. Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial. European Journal of Obstetrics, Gynecology, and Reproductive Biology 2006;126:226‐33.
Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovascular and Interventional Radiology 2008;31:73‐85.

Pinto 2003 {published data only}

Pinto I, Chimeno P, Romo L, Haya J, De la Cal M, Bajo J. Uterine fibroids: Uterine artery embolization versus abdominal hysterectomy for treatment. A prospective randomized and controlled trial. Radiology 2003;226(2):425‐31.

REST 2011 {published data only}

Edwards RD, Moss JG, Lumsden MA, Wu O, Murray LS, Twaddle S, et al. Uterine artery embolization versus surgery for symptomatic uterine fibroids. New England Journal of Medicine 2007;356:360‐70.
Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, et al. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5 year results. British Journal of Obstetrics and Gynaecology 2011;118(8):936‐44.
Rashid S, Khaund A, Murray LS, Moss JG, Cooper K, Lyons D, et al. The effects of uterine artery embolisation and surgical treatment on ovarian function in women with uterine fibroids. British Journal of Obstetrics and Gynaecology 2010;117:985‐9.

Ruuskanen 2010 {published data only}

Ruuskanen A, Hippelainen M, Sipola P, Manninen H. Uterine artery embolisation versus hysterectomy for leiomyomas: primary and 2‐year follow‐up results of a randomised prospective clinical trial. European Radiology 2010;20(10):2524‐32.

References to studies excluded from this review

Hald 2007 {published data only}

Hald K, Kløw NE, Qvigstad E, Istre O. Laparoscopic occlusion compared with embolization of uterine vessels: a randomized controlled trial. Obstetrics and Gynecology 2007;109:20‐7.

References to ongoing studies

FEMME 2012 {published data only}

McKinnon W. Treating Fibroids with either Embolisation or Myomectomy to Measure the Effect on quality of life among women wishing to avoid hysterectomy: The FEMME study. ISRCTN registry accessed 26 November 2014.

Broder 2000

Broder MS, Kanouse DE, Mittman BS, Bernstein SJ. The appropriateness of recommendations for hysterectomy in Southern California. Obstetrics and Gynaecology 2000;95(2):199‐205.

Cardozo 2012

Cardozo ER. Clark AD. Banks NK. Henne MB. Stegmann BJ. Segars JH. The estimated annual cost of uterine leiomyomata in the United States. American Journal of Obstetrics & Gynecology 2012;206(3):211.e1‐9.

Coleman 2004

Coleman P. Review body for interventional procedures, Sheffield: Commissioned by the National Institute for Clinical Excellence. National Institute for Clinical Excellence2004.

Garry 2004

Garry R, Fountain J, Mason S, Hawe J, Napp V, Abbott J, et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004;328(7432):129.

Gehlbach 1993

Gehlbach DL, Sousa RC, Carpenter SE, Rock JA. Abdominal myomectomy in the treatment of infertility. International Journal of Gynaecology and Obstetrics 1993;40(1):45‐50.

Goodwin 1997

Goodwin S, Vendantham S, McLucas B, Forno A, Perella R. Preliminary experience with uterine fibroid embolization for uterine fibroids. Journal of Vascular and Interventional Radiology 1997;8:517‐26.

Greenwood 1987

Greenwood C, Glickman M, Schwartz P, Morse SS, Denny DF. Obstetric and non malignant gynecologic bleeding: Treatment with angiographic embolization radiology. Radiology 1987;164(1):155‐9.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

HOPEFUL 2007

Dutton S, Hirst A, McPherson K, Nicholson T, Maresh M. A UK multicentre retrospective cohort study comparing hysterectomy and uterine artery embolisation for the treatment of symptomatic uterine fibroids (HOPEFUL study): main results on medium‐term safety and efficacy. British Journal of Obstetrics and Gynaecology 2007;114:1340‐51.

Khaund 2008

Khaund A, Lumsden MA. Impact of fibroids on reproductive function. Best Practice & Research Clinical Obstetrics and Gynaecology 2008;22(4):749‐56.

Lepine 1997

Lepine LA, Hillis SD, Marchbanks PA, Koonin LM, Morrow B, Kicke BA, et al. Hysterectomy surveillance. United States 1980‐1983. Morbidity and Mortality Weekly Reports 1997;46 (SS‐4):1‐16.

NCHS 1998

National Centre for Health Statistics. Ambulatory and Inpatient Procedures in the United States, 1996. Hyattsville, Maryland: Public Health Service 1998; DHSS Publication No (PHS)99‐1710.

NICE 2007

National Institute for Health and Care Excellence. Heavy menstrual bleeding. http://www.nice.org.uk/guidance/cg44 (accessed 22 December 2014).

Okolo 2008

Okolo S. Incidence, aetiology and epidemiology of uterine fibroids. Best Practice & Research Clinical Obstetrics and Gynaecology 2008;22(4):571–88.

PEARL I

Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. New England Journal of Medicine 2012;366(5):409‐20.

PEARL II

Donnez J, Tomaszewski J, Vázquez F. Ulipristal acetate versus leuprolide acetate for uterine fibroids. New England Journal of Medicine 2012;366(5):421‐32.

Rahn 2011

Rahn DD, Abed H, Sung VW, Matteson KA, Rogers RG, Morrill MY, et al. Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials. J Clin Epidemiol 2011;64(3):293‐300.

Ravina 1997

Ravina JH, Bouret JM, Ciraru‐Vigneron N, Repiqurt D, Herbreteau D, Aymard A, et al. Recourse to particular arterial embolization in the treatment of some uterine leiomyoma. Bulletin de Academie Nationale de Medecine 1997;181(2):233‐43.

Spies 1999

Spies JB, Warren EH, Mathias SD, Walsh SM, Roth AR, Pentecost MJ. Uterine fibroid embolization: measurement of health‐related quality of life before and after therapy. Journal of Vascular and Interventional Radiology 1999;10(10):1293‐303.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

EMMY 2010

Methods

Study: EMMY Trial. Design: randomized controlled trial. Attending gynaecologist contacted the trial bureau by telephone, where the participant was registered and randomly assigned (1:1) to UAE or hysterectomy, using a computer‐based minimization scheme (‘balancing procedure’), and stratified for study centre. The randomisation result was recorded electronically

Participants

Participants: women were enrolled from five university hospitals and 29 general hospitals. Of 349 eligible participants, 177 were randomised: 88 were allocated UAE and 89 hysterectomy. The majority of participants refusing participation did so for a strong preference for hysterectomy (58%) or for UAE (21%). After randomisation, seven women in the UAE group and 14 women in the hysterectomy group refused the allocated treatment. The mean age was 44.6 years (UAE group) and 45.4 years (hysterectomy group). Participants suffered from menorrhagia for a median of 24 months. The majority of women had multiple fibroids. Fibroid volumes were higher in the hysterectomy group. Logistic regression analysis did not reveal baseline characteristics that could predict randomisation outcome, confirming successful randomisation
Country: the Netherlands
Inclusion criteria: 1) the clinical diagnosis of uterine fibroids confirmed by ultrasonography; 2) menorrhagia (subjectively reported by the patient as increased or prolonged menstrual blood loss which caused dysfunction in daily life) was their predominant complaint, among other possibly fibroid‐related signs and symptoms; 3) they were premenopausal; and 4) they were to be scheduled for a hysterectomy
Exclusion criteria: 1) preservation of the uterus was warranted for future pregnancy; 2) renal failure (creatinine >150 mmol/L), active pelvic infection, or clotting disorders were clinically established; 3) they were allergic to contrast material; 4) uterine malignancy was suspected; 5) submucosal fibroids with 50% of their diameter within the uterine cavity or dominant pedunculated serosal fibroids were present

Interventions

Study group: after randomisation, 7 (8%) women declined UAE. UAE was successfully performed in 72 of 81 women, 5 of whom had a unilateral procedure because of single‐sided arterial blood flow to the fibroid (procedural success rate: 88.9%). The remaining 11.1% consisted of 5 women (6.2%) with a unilateral procedure (caused by technical failure on the other side) and 4 women (4.9%) with bilateral UAE failure
Control group: After randomisation, 14 (14.6%) women declined hysterectomy with 75 (85.4%) undergoing hysterectomy with 84% through an abdominal route
Duration of trial: Recruitment took place between March 2002 and February 2004 with follow‐up of 5 years reported

Outcomes

Primary endpoint: Evaluation of re‐intervention rates at 5 years: menstrual characteristics, menorrhagia, quality of life measures

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomly assigned (1:1) using a computer‐based minimization scheme

Allocation concealment (selection bias)

Low risk

Telephone randomisation

Blinding (performance bias and detection bias)
Objective outcomes

Unclear risk

No blinding, but unclear how much this would affect relatively objective outcomes (e.g. live birth, complications, re‐intervention)

Blinding (performance bias and detection bias)
Subjective outcomes

High risk

No blinding, which was likely to affect subjective outcomes (e.g. satisfaction rate, quality of life)

Incomplete outcome data (attrition bias)
All outcomes

High risk

After randomisation, 92% of randomised women were analysed in the UAE group (81/88) and 84,3% in the hysterectomy group (75/89). At 5 years, there were further dropouts: 85% in the UAE group (75/88) and 78.7% in the hysterectomy group (70/89)

Selective reporting (reporting bias)

Low risk

Protocol not available but all expected outcomes reported

Other bias

Low risk

No other potential source of bias identified

FUME 2012

Methods

Study: FUME Trial. Design: randomized controlled trial. Sealed opaque envelopes, random numbers generated by computer. Blocks of 10

Participants

Participants: 163 women were randomised: 82 were allocated UAE and 81 myomectomy. After randomisation, eight women in the UAE group who withdrew ‐ six had myomectomy, 1 had hysterectomy and one was lost to follow‐up, and eight women in the myomectomy group withdrew ‐ four had hysterectomy, two were converted to hysterectomy at time of surgery and two others lost. During follow‐up there were a further 11 lost from the UAE group and 14 lost from the myomectomy group. The mean age was 44 years (UAE group) and 43 years (hysterectomy group). The UAE group had slightly larger fibroid volumes
Country: England
Inclusion criteria: symptomatic uterine fibroids confirmed by ultrasonography > 3cm in diameter;they were seeking treatment and treatment was considered justified by the physician, they wished to preserve their uterus, and would otherwise have been offered myomectomy performed
via open abdominal surgery

Exclusion criteria included fibroids attached to the uterus by a narrow pedicle, or the whole fibroid mass being so large that it extended beyond the level of the umbilicus, or documented allergy to radiographic contrast medium, or a history of recent or ongoing pelvic inflammatory disease. Women also were excluded if they were not prepared to accept surgery as a treatment option, if they were pregnant, or if they were actively planning or trying to conceive

Interventions

Study group: UAE performed by or supervised by same experienced interventional radiologist
Control group: myomectomy without preoperative gonadotrophin releasing hormone agonists
Duration of trial: not stated

Outcomes

Primary endpoint: quality of life measures at one year using the Uterine Fibroid Symptom and Quality of Life (UFS‐QOL) questionnaire. Other endpoints: evaluation of re‐intervention rates at 2 years, complications

Notes

Fertility as an outcome was not collected as the ethics committee did not approve UAE for women who wished to conceive

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Women were randomised using the sealed opaque envelope technique, using random numbers generated by computer"

Allocation concealment (selection bias)

Low risk

"Women were randomised using the sealed opaque envelope technique, using random numbers generated by computer"

Blinding (performance bias and detection bias)
Objective outcomes

Unclear risk

No blinding, but unclear how much this would affect relatively objective outcomes (e.g. live birth, complications, reintervention)

Blinding (performance bias and detection bias)
Subjective outcomes

High risk

No blinding, which was likely to affect subjective outcomes (e.g. satisfaction rate, quality of life)

Incomplete outcome data (attrition bias)
All outcomes

High risk

After randomisation, 23% of randomised women excluded from analysis in the UAE group (19/82) and 27% in the myomectomy group (22/81)

Selective reporting (reporting bias)

High risk

No suggestion of selective reporting. Fertility as an outcome was not collected as the ethics committee did not approve UAE for women who wished to conceive. Findings for QoL differed according to whether change scores or end scores were used, but both were reported in the review

Other bias

High risk

There were baseline differences between the groups in QoL and although these were reported as not statistically significant, these do represent high risk

Jun 2012

Methods

Study design: randomised controlled trial. Randomisation was performed in a 1:1 ratio according to a computer‐generated schedule. The method of surgery was by open surgery in all cases

Participants

Participants: women over the age of 18 were enrolled from 1 hospital. 127 women were randomised with 63 of them undergoing embolization and 64 undergoing surgery (10 hysterectomies and 54 myomectomies)
Country: China
Inclusion criteria: women with fibroids (> 4 cm) that could be adequately visualized with the use of magnetic resonance imaging causing symptoms of menorrhagia or pelvic pain and pressure which justified surgical treatment
Exclusion criteria: contraindication to MRI, severe allergy to iodinated contrast media, recent or ongoing pelvic inflammatory disease, pregnancy and any contraindication to surgery

Interventions

Study group: 63 women were allocated to UAE and all underwent the procedure
Control group: 64 women were assigned to the surgery group (10 hysterectomies and 54 myomectomies). "The method of hysterectomy or myomectomy was not specified; the choice between these options depended on whether the patient wished to retain her uterus for fertility or other reasons." All the hysterectomies and myomectomies were performed through an abdominal incision
Duration of trial: recruitment took place between October 2006 to September 2009

Outcomes

Primary outcome measure: quality of life (36‐Item Short‐Form General Health Survey (SF‐36) and complications. The SF‐36 scores were presented at 6 month follow‐up while the complications were reported after a maximum follow‐up of 42 months. Secondary outcome measures: hospital stay, recovery time, satisfactory rate, recommending rate, pain at 24 hours and additional invasive procedures including hysterectomy or repeated embolization

Notes

Power calculation was not carried out. In the surgical group, the majority of the procedures were myomectomies but impact on fertility was not one of the outcomes of the study

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Patients were randomly assigned to study groups according to a computer‐generated schedule"

Allocation concealment (selection bias)

Unclear risk

No details provided

Blinding (performance bias and detection bias)
Objective outcomes

Unclear risk

No blinding, but unclear how much this would affect relatively objective outcomes (e.g. live birth, complications, re‐intervention)

Blinding (performance bias and detection bias)
Subjective outcomes

High risk

No blinding, which was likely to affect subjective outcomes (e.g. satisfaction rate, quality of life)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

After randomisation, 98.4% (62/63) were analysed in the UAE group and 96.9% (62/64) in the surgical group

Selective reporting (reporting bias)

Low risk

Protocol not available but all expected outcomes reported

Other bias

Unclear risk

Power calculation not carried out

Mara 2008

Methods

Study design: prospective randomised controlled trial. Randomization was performed by means of a computer‐generated random numbers. Patients with odd integers were placed into the embolization group and those with even numbers into the myomectomy group

Participants

Participants: 121 women with uterine fibroid or fibroids and unfinished reproductive plans were randomised: 58 were allocated embolization and 63 myomectomies; 120 women finished a six month follow‐up and 3 women dropped out of the trial. The mean age was 32.4 years (UAE group) and 32.0 years (myomectomy group)

Of the 121 participants, 110 were symptomatic (90.9%). 66 were nulligravidae (54.5%), 35 were sterile (28.9%; 11 in embolization and 24 in myomectomy group; P < 0.05), 18 had miscarried in the past (14.9%) and 51 had another subfertility factor other than myoma (42.1%)

Country: Czech Republic

Inclusion criteria: 1) age up to 40 years; 2) planned pregnancy; 3) ultrasound verified intramural fibroids of at least 4 cm in greatest diameter (in the case of more fibroids, the largest being at least 4 cm); 4) serum concentration of FSH under 30 IU/L (on the third day of the menstrual cycle)

Exclusion criteria: 1) type 0 and type 1 submucous myomas and subserous myomas; 2) size of largest fibroid greater than 12 cm in greatest diameter on ultrasound or a uterus greater than the 4th month of pregnancy on palpation; 3) previous surgical or medical treatment; 4) suspected uterine sarcoma; 5) significant illness that would contraindicate pregnancy; 6) lack of consent

Interventions

Study group: Bilateral UAE

Control group: After randomisation, 63 women underwent myomectomy, (42 laparoscopic, 21 open). The type and route of access were left at the discretion of the attending gynaecologist

Outcomes

  • Early post‐operative complications during the first 30 days

  • Symptomatic effectiveness

  • Post‐procedural follicle stimulating hormone levels

  • Late complications after 30 days of the procedure

  • Reproductive outcome following both procedures

Notes

40 women after myomectomy and 26 women after UAE have tried to conceive

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Patients marked with odd integers were placed into the E group (embolization) and patients given even numbers by the computer were located into the Mgroup (myomectomy). In other words, a random number has been generated a new for every new patient; none of the researchers could therefore either know or predict the next number (there was no pre‐created list of numbers)."

Allocation concealment (selection bias)

Low risk

"Patients marked with odd integers were placed into the E group (embolization) and patients given even numbers by the computer were located into theMgroup (myomectomy). In other words, a random number has been generated anew for every new patient; none of the researchers could therefore either know or predict the next number (there was no pre‐created list of numbers)."

Blinding (performance bias and detection bias)
Objective outcomes

Unclear risk

No blinding, but unclear how much this would affect relatively objective outcomes (e.g. live birth, complications, re‐intervention)

Blinding (performance bias and detection bias)
Subjective outcomes

High risk

No blinding, which was likely to affect subjective outcomes (e.g. satisfaction rate, quality of life)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

After randomisation, 100% (58/58) were analysed in the UAE group and 98.4% (6263) in the myomectomy group. At 12 months there were 2 further dropouts in the UAE group giving a follow‐up rate of 96.6%

Selective reporting (reporting bias)

Low risk

Protocol not available but all expected outcomes reported

Other bias

Low risk

No other potential source of bias identified

Pinto 2003

Methods

Study design: randomized, parallel, controlled clinical trial. Method of randomisation: Zelen design which is random allocation prior to seeking consent. The randomisation was stratified 2:1 in favour of UAE and generated by computer sealed number envelopes

Participants

Participants: women aged 35 to 57 years. 57 women were randomised. 38 women to study group who were told of UAE and hysterectomy. 19 women to control group who were informed of hysterectomy only
Country: Spain
Inclusion criteria: women with bleeding uterine fibroids who were candidates for hysterectomy
Exclusion criteria: wish to retain fertility; fibroids larger than 10 cm in diameter, any contraindication to surgery; sensitivity to iodine‐based contrast material

Interventions

Study group: 38 women informed of the study and offered the option of undergoing hysterectomy or UAE. 37 women elected to undergo UAE and one hysterectomy
Control group: 19 women were assigned to the hysterectomy group. 16 women underwent hysterectomy and 3 underwent UAE
Duration of trial: Recruitment took place between April 1999 to June 2001 with intended 2 years of follow‐up

Outcomes

Evaluation of efficiency: total length of hospital stay after UAE and hysterectomy
Evaluation of safety: complications resulting from both the procedures
Evaluation of effectiveness: cessation of bleeding after UAE

Notes

The analysis is different for different outcomes. The length of hospital stay in the two study arms were compared on an intent‐to‐treat basis. However, due to the participants electing different treatments to those they were allocated to, effectiveness and safety were evaluated on the basis of the actual treatment received (treatment received analysis) and hence, this was excluded from the analysis

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The random patient assignments were generated by computer and kept in sealed, numbered envelopes"

Allocation concealment (selection bias)

Low risk

"The random patient assignments were generated by computer and kept in sealed, numbered envelopes"

Blinding (performance bias and detection bias)
Objective outcomes

Unclear risk

No blinding, but unclear how much this would affect relatively objective outcomes (e.g. live birth, complications, re‐intervention)

Blinding (performance bias and detection bias)
Subjective outcomes

High risk

No blinding, which was likely to affect subjective outcomes (e.g. satisfaction rate, quality of life)

Incomplete outcome data (attrition bias)
All outcomes

High risk

The analysis is different for different outcomes. Per protocol analysis used

Selective reporting (reporting bias)

Low risk

Protocol not available but all expected outcomes reported

Other bias

Low risk

No other potential source of bias identified

REST 2011

Methods

Study design: randomised controlled trial. Randomisation was performed by means of a computer‐generated schedule (permuted blocks). This was stratified by centre and women were randomly assigned (2:1) to UAE or surgery (hysterectomy or myomectomy). The method of surgery was not specified

Participants

Participants: women over the age of 18 were enrolled from 27 hospitals. 157 women were randomised with 106 of them undergoing embolization and 51 undergoing surgery
Country: United Kingdom
Inclusion criteria: women with fibroids (> 2 cm) that could be adequately visualized with the use of magnetic resonance imaging causing symptoms of menorrhagia or pelvic pain and pressure which justified surgical treatment
Exclusion criteria: contraindication to MRI, severe allergy to iodinated contrast media, subserosal pedunculated fibroids, recent or ongoing pelvic inflammatory disease and any contraindication to surgery

Interventions

Study group: 106 women were allocated to UAE. 101 of these underwent the procedure with technical failure encountered in three
Control group: 51 women were assigned to the surgery group (43 hysterectomies and 8 myomectomies). "The method of hysterectomy or myomectomy was not specified; the choice between these options depended on whether the patient wished to retain her uterus for fertility or other reasons." 48 of these underwent surgery with one technical failure necessitating conversion of a myomectomy to a hysterectomy. One patient underwent embolization and two were not treated. All the hysterectomies and myomectomies were performed through an abdominal incision
Duration of trial: recruitment took place between November 2000 to May 2004 with long‐term follow‐up of 5 years

Outcomes

Primary outcome measure: quality of life (36‐Item Short‐Form General Health Survey (SF‐36). Secondary outcome measures: time until resumption of usual activities (we have used the data for when women started driving their car as a resumption to normal activities), satisfaction score, pain score at 24 hours, any complications and treatment failure. Ovarian failure has also been reported at 1 year. Pregnancy outcomes were reported at 5 year follow‐up. The study was not set up or powered to assess this outcome and there were only 8 myomectomies in the surgical group of 51 women

Notes

The original target of 200 women was reduced to 150 because of difficulties in recruitment which reduced the power to 80%. The data were presented in median and inter‐quartile ranges as the milestone data were very skewed. After contacting the authors they released the mean and standard deviations of the data on the understanding that these data are included in this review with this caveat.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomly assigned (2:1) using a computer‐generated schedule

Allocation concealment (selection bias)

Low risk

Remote telephone randomisation

Blinding (performance bias and detection bias)
Objective outcomes

Unclear risk

No blinding, but unclear how much this would affect relatively objective outcomes (e.g. live birth, complications, re‐intervention)

Blinding (performance bias and detection bias)
Subjective outcomes

High risk

No blinding, which was likely to affect subjective outcomes (e.g. satisfaction rate, quality of life)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

After randomisation, 89.6% (95/106) were analysed in the UAE group and 88.2% (45/51) in the surgical group

Selective reporting (reporting bias)

Low risk

Protocol not available but all expected outcomes reported

Other bias

Low risk

No other potential source of bias identified

Ruuskanen 2010

Methods

Single‐centre, prospective, randomised trial. Enrolled and assigned eligible participants to UAE or hysterectomy using sealed envelopes (1:1 ratio). Recruitment and randomisation were performed at the same gynaecology outpatient clinic visit

Participants

Of 137 eligible women, 57 (41.6%) were randomised (UAE, N = 27; hysterectomy, N = 30). All Caucasians, were recruited to the prospective follow‐up study between 2002 and 2007

Inclusion criteria were women's subjective symptoms, which had to be severe enough to warrant consideration of hysterectomy, and only women agreeing to hysterectomy, if necessary, were included in the study

Exclusion criteria were suspected genital tract malignancy, adnexal pathological features (suspected tumour or sactosalpinx), acute pelvic inflammatory disease, fertility preservation, uterovaginal prolapse requiring treatment, previous reactions to contrast media, renal impairment, and leiomyomas suitable for hysteroscopic myomectomy (single leiomyoma over 50% in the cavum uteri and 5 cm or less in size)

Interventions

Embolisation procedure: shortly after selective catheterization of both uterine arteries from right femoral artery access, embolization was performed with calibrated microsphere particles (550–700 μm; EmboSphere; BioSphere Medical, Louvres, France) until near‐stasis was observed in the ascending segment of the uterine artery. In tortuous, small or spastic uterine arteries, catheterization was performed with a 2.1‐ French microcatheter to ensure free‐flow embolization. An Angio‐Seal closure device was routinely used. The same interventional radiologist performed all interventions (HM, with 2 years’ experience in UAE at the beginning of the trial). After the intervention, women were observed in a recovery room for 4–6 h, after which they were transferred to the gynaecology ward for further care

Hysterectomy: the type of hysterectomy and route of access were not standardised and left to the discretion of the attending gynaecologist, in order to maintain the protocol as close to that of daily practice as possible. Hysterectomy was performed as an abdominal hysterectomy, vaginal hysterectomy or laparoscopic‐assisted hysterectomy. General anaesthesia was used in all operations

Outcomes

The primary endpoint was improvement of symptoms; secondary endpoints were procedural characteristics, major complications, time to discharge from hospital, length of sick leave, re‐interventions required, and satisfaction with treatment at 2 year follow‐up.

The following symptoms were recorded: duration and severity of menstrual flow (no periods, mild, moderate, severe; with moderate or severe indicating menorrhagia), dysmenorrhoea, pressure symptoms of the bladder, bowel, or back, increased urinary frequency, urinary stress incontinence, and non‐menstrual related lower abdominal pain. Menstrual flow was recorded severe when it prevented everyday activities, caused anaemia, and extra large pads or tampons (change every 1 to 2 h) were needed. Complete blood count, ferritin, haematocrit, follicle‐stimulating hormone and estrogen levels were ordered

Notes

Power calculation not carried out. Sample size is small. Attempts to randomise more women in a reasonable time failed because of difficulties in recruitment, and recruitment was stopped after 5 years

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient details reported, states "The same gynaecologist discussed treatment options with the patient and enrolled and assigned eligible participants to UAE or hysterectomy using sealed envelopes (1:1 ratio)."

Allocation concealment (selection bias)

Unclear risk

Insufficient details reported, states "The same gynaecologist discussed treatment options with the patient and enrolled and assigned eligible participants to UAE or hysterectomy using sealed envelopes (1:1 ratio)."

Blinding (performance bias and detection bias)
Objective outcomes

Unclear risk

Carried out in same gynaecology outpatient clinic

Blinding (performance bias and detection bias)
Subjective outcomes

High risk

No blinding, which was likely to affect subjective outcomes (e.g. satisfaction rate, quality of life)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

After randomisation, 96.35 (26/27) were analysed in the UAE group and 96.7% (29/30) in the hysterectomy group. One patient from the UAE group withdrew consent for follow‐up 1 day after UAE, and one patient from the hysterectomy group died from cerebral infarct 13 months after the hysterectomy

Selective reporting (reporting bias)

Low risk

Protocol not available but all expected outcomes reported

Other bias

Unclear risk

Power calculation not carried out

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Hald 2007

Compared two similar methods of uterine artery occlusion i.e. laparoscopic bilateral occlusion of uterine arteries versus uterine artery embolization

Characteristics of ongoing studies [ordered by study ID]

FEMME 2012

Trial name or title

Treating Fibroids with either Embolisation or Myomectomy to Measure the Effect on quality of life among women wishing to avoid hysterectomy: The FEMME study

Methods

Multicentre randomised trial comparing myomectomy to UAE. Follow‐up at 6 weeks, 6 months, 12 months, 2 and 4 years

Participants

216 women to be randomised

Inclusion criteria: all criteria must be met. Women with symptomatic fibroids who do not wish to have a hysterectomy; Women with symptomatic fibroids who would ordinarily be offered a myomectomy; Women must be considered suitable for either treatment (myomectomy or embolisation); Clinical team uncertain as to which treatment is indicated; Written informed consent

Exclusion criteria: refusal to accept hysterectomy, even as a result of an intra‐operative complication; recent or ongoing pelvic inflammatory disease; significant adenomyosis, as identified by TVUS or CEMRI. Concurrent adenomyosis where fibroids are believed to the predominant cause of symptoms will be eligible; Positive pregnancy test; Refusal to accept surgery or embolisation as treatment option; Postmenopausal, as defined as greater than one year since previous menstrual period; Suspected malignancy; Women aged under 18 years old; Unable to provide informed consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity (Scotland) Act 2000); A non‐English speaker where translation or interpretation facilities are insufficient to guarantee informed consent; A previous myomectomy via a laparotomy or a previous embolization

Interventions

Myomectomy or UAE

Outcomes

Primary: quality of life (UFS‐QOL).

Secondary: effect on menstrual bleeding, pregnancy outcomes, need for further treatment and adverse events, ovarian function and reserve

Starting date

March 2012 to October 2014

Contact information

Dr William McKinnon

[email protected]

Tel: +44 (0) 121 414 8335

http://www.birmingham.ac.uk/femme

Notes

ISRCTN: 70772394. Registry accessed 26 November 2014.

Funder is NIHR.

Data and analyses

Open in table viewer
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]

Analysis 1.1

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

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

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]

Analysis 1.2

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

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

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

Analysis 1.3

Comparison 1 UAE versus surgery, Outcome 3 Live birth.

Comparison 1 UAE versus surgery, Outcome 3 Live birth.

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]

Analysis 1.4

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

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

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]

Analysis 1.5

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

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

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]

Analysis 1.6

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

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

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]

Analysis 1.7

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

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

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

Analysis 1.8

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

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

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]

Analysis 1.9

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

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

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]

Analysis 1.10

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

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

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]

Analysis 1.11

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

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

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]

Analysis 1.12

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

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

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

Analysis 1.13

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

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

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

Analysis 1.14

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

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

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

Analysis 1.15

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

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

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]

Analysis 1.16

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

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

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]

Analysis 1.17

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

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

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]

Analysis 1.18

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

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

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]

Analysis 1.19

Comparison 1 UAE versus surgery, Outcome 19 Pregnancy.

Comparison 1 UAE versus surgery, Outcome 19 Pregnancy.

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

Analysis 1.20

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

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

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]

Analysis 1.21

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

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

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]

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

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

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

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

Forest plot of comparison: 1 UAE versus surgery, outcome: 1.1 Satisfaction with treatment up to 24 months.
Figuras y tablas -
Figure 3

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

Forest plot of comparison: 1 UAE versus surgery, outcome: 1.2 Satisfaction with treatment at 5 years.
Figuras y tablas -
Figure 4

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

Forest plot of comparison: 1 UAE versus surgery, outcome: 1.3 Live birth.
Figuras y tablas -
Figure 5

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

Forest plot of comparison: 1 UAE versus surgery, outcome: 1.10 Further interventions within 2 years.
Figuras y tablas -
Figure 6

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

Comparison 1 UAE versus surgery, Outcome 1 Satisfaction with treatment up to 24 months.
Figuras y tablas -
Analysis 1.1

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

Comparison 1 UAE versus surgery, Outcome 2 Satisfaction with treatment at 5 years.
Figuras y tablas -
Analysis 1.2

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

Comparison 1 UAE versus surgery, Outcome 3 Live birth.
Figuras y tablas -
Analysis 1.3

Comparison 1 UAE versus surgery, Outcome 3 Live birth.

Comparison 1 UAE versus surgery, Outcome 4 Adverse events: intraprocedural complications.
Figuras y tablas -
Analysis 1.4

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

Comparison 1 UAE versus surgery, Outcome 5 Adverse events: Need for blood transfusion.
Figuras y tablas -
Analysis 1.5

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

Comparison 1 UAE versus surgery, Outcome 6 Adverse events: minor postprocedural complications.
Figuras y tablas -
Analysis 1.6

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

Comparison 1 UAE versus surgery, Outcome 7 Adverse events: major postprocedural complications within one year.
Figuras y tablas -
Analysis 1.7

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

Comparison 1 UAE versus surgery, Outcome 8 Adverse events: later minor postprocedural complications.
Figuras y tablas -
Analysis 1.8

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

Comparison 1 UAE versus surgery, Outcome 9 Adverse events: major postprocedural complications.
Figuras y tablas -
Analysis 1.9

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

Comparison 1 UAE versus surgery, Outcome 10 Further interventions within 2 years.
Figuras y tablas -
Analysis 1.10

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

Comparison 1 UAE versus surgery, Outcome 11 Further interventions within 5 years.
Figuras y tablas -
Analysis 1.11

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

Comparison 1 UAE versus surgery, Outcome 12 Unscheduled readmission rate within 4‐6 weeks.
Figuras y tablas -
Analysis 1.12

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

Comparison 1 UAE versus surgery, Outcome 13 Cost: duration of procedure (minutes).
Figuras y tablas -
Analysis 1.13

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

Comparison 1 UAE versus surgery, Outcome 14 Cost: length of hospital stay (days).
Figuras y tablas -
Analysis 1.14

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

Comparison 1 UAE versus surgery, Outcome 15 Cost: resumption of normal activities (days).
Figuras y tablas -
Analysis 1.15

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

Comparison 1 UAE versus surgery, Outcome 16 FSH levels >40 IU/L (within 2 years).
Figuras y tablas -
Analysis 1.16

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

Comparison 1 UAE versus surgery, Outcome 17 FSH levels >10 IU/L (within 6 months).
Figuras y tablas -
Analysis 1.17

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

Comparison 1 UAE versus surgery, Outcome 18 Fibroid recurrence within 2 years.
Figuras y tablas -
Analysis 1.18

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

Comparison 1 UAE versus surgery, Outcome 19 Pregnancy.
Figuras y tablas -
Analysis 1.19

Comparison 1 UAE versus surgery, Outcome 19 Pregnancy.

Comparison 1 UAE versus surgery, Outcome 20 UAE versus myomectomy: Health related quality of life at one year.
Figuras y tablas -
Analysis 1.20

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

Comparison 1 UAE versus surgery, Outcome 21 UAE versus hysterectomy or myomectomy: SF‐36 within 1 year.
Figuras y tablas -
Analysis 1.21

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

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)

⊕⊕⊝⊝
LOW5,6,7

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

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

Figuras y tablas -
Comparison 1. UAE versus surgery