DISCUSSION
bleeding, fibroids, fibroid, two‐thirds
BLEEDING, FIBROID, HEAVY MENSTRUAL BLEEDING, UTERINE FIBROIDS, COMPLICATION, FIBROIDS, OVARIAN FAILURE
While both procedures improved participant‐reported health‐related QOL scores, women assigned to the myomectomy group reported higher scores than those in the UAE group. The menstrual bleeding scores appeared similar in both groups. The overall complication rates for both procedures were low. The need for additional treatments was higher in the UAE group, and length of hospital stay was shorter in the UAE group. There were no consistent differences between the groups in biomarkers of ovarian reserve, and too few pregnancies in the present study to conclude the effect of the procedures on fertility.The doubling of the UFS‐QOL score from baseline to each time point shows that both treatments are effective, with some additional benefit accrued from myomectomy equating to a small to moderate standardized treatment benefit at 2 years.There were substantially more surgical re‐interventions in the UAE group within 2 years of follow‐up, possibly reflecting the higher residual impact on QOL observed in the UAE group and the marginal patient‐reported preference for myomectomy.Similar large improvements in UFS‐QOL scores have been reported after various fibroid treatments,Previous randomized trials that measured FSH, and used varying thresholds for ovarian failure, also found no evidence of harm from UAE over short and longer time frames.The present study is the largest ever randomized clinical trial to report on the treatment of symptomatic fibroids by UAE and any surgery. The robust study design ensures internal validity, enabling the results to be interpreted with confidence. In addition, the other measures reported above reflect the aspects of the condition of most importance to women.The techniques used for both myomectomy and UAE were determined by the fibroid presentation and the preference of the operating clinician. This enabled a diverse range of fibroid diagnoses to be included in the study. There was an 81% response rate for the primary outcome.There were a substantial number of women who were not recruited due to their preference for a particular treatment option, and the expectations of treatment benefit were not captured before randomization. All participants were analyzed in the groups to which they were allocated and the per‐protocol analysis gave a treatment effect very similar to the ITT population analysis, suggesting little impact of non‐adherence to the allocation.The two procedures have considerably different recovery periods, which may be reflected in the first outcome measures reported by participants at 6 months. The mean duration from randomization to the procedure was approximately 13 weeks in both groups, and the primary outcome was to compare QOL at 2 years postoperatively as a realistic time point.The present trial did not select patients based on their pregnancy intentions. The generalizability of the findings is increased by the inclusion of multiple centers, gynecological surgeons, and interventional radiologists. This allowed for the evaluation of the impact of both interventions without confounding by individual variance in clinical practice and skill, although nearly two‐thirds of participants were recruited from just three hospitals.Some blood samples were not analyzed as FSH and luteinizing hormone were not obtained within 5 days of the start of the last menstrual period. Despite randomization, there was a small difference in the age of participants between the two groups, prompting a post‐hoc adjusted analysis of the ovarian reserve markers.The data from the present study showed that myomectomy was cost‐effective in the UK healthcare settingUAE is now an established treatment for symptomatic fibroids but is mainly used in high‐income countries. The uptake in low‐income countries has been slow.The present study can form a solid evidence base in LMIC settings to support the studies arising from the regions themselves.In conclusion, both UAE and myomectomy are effective treatments for improving the QOL of women with symptomatic uterine fibroids. They both decrease the incidence of heavy menstrual bleeding equally. Neither treatment impacted significantly on measures of ovarian reserve.Myomectomy and UAE are both established procedures within the repertoire of many gynecologists and interventional radiologists, respectively, and the training of junior doctors should continue to include these procedures. Services should continue to offer both procedures to women where both are potential options. Women should be provided with the evidence generated by the FEMME trial to enable them to make a fully informed decision regarding their fibroid treatment.