Table 16:
Comparative Effectiveness Trials of Hysterectomy and Uterine-Preserving Fibroid Treatments
| Author, Year | Country | Study Design | Centres, Subjects | Study Outcomes |
|---|---|---|---|---|
| UAE versus hysterectomy | ||||
| Volkers N et al, 2006, 2007 (129;130) | Netherlands (EMMY trial) | Multicentre, non-inferiority RCT | 28 sites, 170 women (88 UAE, 89 hysterectomy) | Comparison of the 2-year efficacy outcomes |
| Pinto I et al, 2003 (128) | Spain, Madrid | RCT (Zelen consent): randomized to group 1 (informed choice of UAE or hysterectomy) or group 2 (assigned hysterectomy) | 1 site, 57 women (38 in group 1, 19 in group 2) | Comparison of the effectiveness of UAE for management of bleeding secondary to uterine fibroids with an additional focus on hospital stay and safety |
| Edwards R et al, 2007 (132) | United Kingdom (REST trial) | 2:1 pragmatic RCT (for surgical intervention) | 27 sites, 157 women (106 UAE, 51 surgery: myomectomy or hysterectomy) | Clinical outcomes and HRQOL at 1 year |
| Moss J et al, 2011 (127) | United Kingdom (REST trial) | 2:1 pragmatic RCT (for surgical intervention) | 27 sites, 157 women (106 UAE, 51 surgery: myomectomy or hysterectomy) | 5-year clinical and economic outcomes |
| Ananthakrishnan G et al, 2013 (131) | United Kingdom (REST trial) | 2:1 pragmatic RCT (for surgical intervention) | 27 sites, 157 women (106 UAE, 51 surgery: myomectomy or hysterectomy) | Relationship of imaging to clinical outcomes and need for reintervention |
| Spies J et al, 2010 (24) | United States | Prospective non-randomized comparative cohort study comparing 3 uterine fibroid interventions and a control group | 329 women either undergoing hysterectomy (n = 106), myomectomy (n = 61), or UAE (n = 107) recruited from 4 sites and 130 control subjects from 5 sites | Comparison of the longitudinal changes in symptoms and HRQOL in those undergoing uterine fibroid interventions with those in a control population |
| UAE versus myomectomy | ||||
| Mara M et al, 2008 (135) | Czeck Republic | RCT | 1 site, 121 women (58 UAE, 63 myomectomy) | Evaluation of midterm clinical and first reproductive outcomes |
| Manyonda I et al, (REST trial) 2012 (134;135) | United Kingdom, (FUME trial) London | RCT | 1 site, 163 women (82 UAE, 81 myomectomy) | HRQOL, measured as UFS-QOL score at 1-year was the primary outcome measure |
| Goodwin S et al, 2006 (136) | United States | Parallel contemporary prospective cohort study, assignment by physician and patient | 6 US sites, 163 women (149 UAE, 60 myomectomy) | Comparison of adverse events, recovery, clinical outcomes, and HRQOL at 6-months (both groups) and at 1-year (UAE only) |
| MRgHIFU versus hysterectomy | ||||
| Taran F et al, 2009 (133) | International study (United States, Israel, United Kingdom, Germany) | Prospective comparative cohort study with contemporaneous controls | 14 medical centers: 7 sites, 109 women for MRgHIFU; and7 separate sites, 83 women abdominal hysterectomy | Incidence of significant clinical complications and adverse events and HRQOL at 6 months |
| USgHIFU versus myomectomy | ||||
| Wang X et al, 2013 (59) | China | RCT | 1 site, 120 women (60 USgHIFU, 60 abdominal myomectomy) | Impact of treatments on immune function was the primary outcome, adverse reactions and complications were also compared |
| Wang X et al, 2013 (58) | China | RCT | 1 site, 100 premenopausal women (55 USgHIFU, 55 abdominal myomectomy) | Impact of treatments on sexual function (BISF-W); hospital stay, recovery time and complications; adverse reactions were also compared |
| Wang F et al, 2014 (56) | China | Prospective comparative cohort study | 1 site, 130 premenopausal women (83 USgHIFU, 39 laparoscopic myomectomy) | Impact of treatments on HRQOL at 1-year follow-up |
| MRgHIFU versus UAE | ||||
| Froeling V et al, 2013 (126;137) | Germany | Prospective comparative cohort study | 1 site; among women equally eligible for UAE or MRgHIFU, 30 in UAE group and 50 in MRgHIFU group | Comparison of the reintervention rate and midterm changes in symptom severity and HRQOL |
| Bouwsma E et al, 2011 (117) | United States | RCT (protocol stage, due in 2014) | 2 sites, 220 planned to randomize to MRgHIFU or UAE and a control group | Outcomes to include recovery, complications, symptom relief and fibroid reduction, reinterventions and impact on reproductive function, as well as an economic analysis with 3-year follow-up |
| USgHIFU versus radiofrequency ablation | ||||
| Meng X et al, 2010 (52) | China | RCT | 1 site, 100 premenopausal women randomized to USgHIFU (n = 50) or radiofrequency ablation (n = 50) | Comparison of ablation rates, and complications |
Abbreviations: BISF-W, Brief Index of Sexual Functioning for Women; HRQOL, health-related quality of life; MRgHIFU, magnetic resonance-guided high-intensity focused ultrasound; RCT, randomized controlled trial; UAE, uterine artery embolization; UFS-QOL, Uterine Fibroid Symptom and Quality of Life questionnaire; USgHIFU, ultrasound-guided high-intensity focused ultrasound.