What happens after randomised controlled trials? Uterine fibroids and ulipristal acetate: systematic review and meta-analysis of real-world data

Purpose Real-world data incorporates studies performed outside of controlled environments, allowing for a better understanding of the effects of treatment in routine clinical practice. We, therefore, performed a systematic review to summarise available real-world studies reporting on the use of ulipristal acetate (UPA) for management of uterine fibroids. Methods We designed a prospective protocol according to PRISMA guidelines and registered it with PROSPERO (ID: CRD42019151393). We searched all major databases for relevant citations until 20th September 2019. Our screen included studies for risk of bias using an adapted structured quality assessment tool. Random-effects meta-analysis was used to calculate proportion estimates for each outcome including 95% confidence interval. Reported heterogeneity was assessed using I-2. Results Initial search yielded 755 studies and 13 were included in the final synthesis. Administration of UPA resulted in reduction in the size of fibroids in 56.5% of women, improved menorrhagia in 83% of women, improved perception of pain in 80.1% of women and lead to an improvement in global symptom scores in 85.2% of women. Mean reduction in surgical blood loss and surgical time with use of UPA was 59.85 ml and 12.47 min, respectively. Qualitative analysis suggested that there was no difference in overall surgical experience for patients treated with UPA compared to those without pre-treatment. Conclusions Our findings are consistent with previously reported data that UPA is an acceptable management option for women with fibroids. However, it provides limited benefits when used as a pre-operative adjunct, in terms of blood loss and surgical time.

Automated summary

This study conducted a systematic review on the use of ulipristal acetate (UPA) for managing uterine fibroids in real-world studies. The findings suggest that UPA can reduce fibroid size, improve menorrhagia and pain perception, and enhance global symptom scores. However, limited benefits were observed when UPA was used as a pre-operative adjunct in terms of reducing blood loss and surgical time.