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

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Abstract

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 I2.

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.

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Data availability

Available on request.

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Authors and Affiliations

  1. Whipps Cross Hospital, Barts Health NHS Trust, London, UK

    Neha Shah, Elizabeth Egbase & Funlayo Odejinmi

  2. Women’s Health Research Unit, Queen Mary University of London, London, UK

    Michael Sideris

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  1. Neha Shah
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  2. Elizabeth Egbase
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Contributions

NS: protocol development, data collection, quality assessment, data analysis, manuscript writing. EE: protocol development, data collection, quality assessment, manuscript editing. MS: protocol development, data analysis, manuscript editing. FO: protocol development, manuscript editing.

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Correspondence to Neha Shah.

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Shah, N., Egbase, E., Sideris, M. et al. What happens after randomised controlled trials? Uterine fibroids and ulipristal acetate: systematic review and meta-analysis of "real-world" data. Arch Gynecol Obstet 303, 1121–1130 (2021). https://doi.org/10.1007/s00404-020-05918-3

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