Date of Award

2023

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Abstract

OBJECTIVE: The objective of this selective EBM review is to determine whether or not “Are gonadotropin-releasing hormone antagonists effective in reducing heavy menstrual bleeding in women with uterine fibroids?”

STUDY DESIGN: Systematic review of three randomized controlled trials (RCTs) published from 2018-2021.

DATA SOURCES: The studies were found using PubMed. All resources were published in peer-reviewed journals in the English language. Each study was selected based on its relevance to the clinical question.

OUTCOME MEASURED: In each RCT, the outcome of reduction in menstrual bleeding was measured. In Schlaff et al. and Carr et al. a chemical analysis of blood loss was performed using the alkaline hematin method, while in Hoshiai et al. a pictorial blood loss assessment chart (PBAC) was used to quantify blood loss.

RESULTS: In the RCT by Schlaff et al., 84.1% of women reached the outcome goals, while only 8.7% in the placebo group achieved the endpoint goal. The study was statistically significant (p-value <0.001) with a large treatment effect based on the number needed to treat (NNT) of 2. The RCT by Carr et al. displayed statistical significance (p-value <0.001) with the intervention of elagolix when compared to the placebo group. Of the women receiving elagolix, 92% met the primary endpoint, while 27% achieved endpoint goals in the placebo group. The treatment effect was large, with a NNT of 2. The RCT, Hoshiai et al. exhibited statistical significance (p-value <0.001) with treatment with relugolix compared to placebo. The intervention group resulted in 83% of patients achieving endpoint goals, while 0% reached endpoint goals in the placebo group. There was a large treatment effect with a NNT of 2.

CONCLUSION: The three studies selected displayed statistical significance based on the presented p-values. Each study also displayed a large treatment effect based on the calculated NNT. These findings support gonadotropin-releasing hormone antagonists such as elagolix and relugolix in treatment of uterine fibroid menorrhagia. Future studies should utilize an intentionto- treat analysis and follow the effects of GnRH antagonists on long-term blood loss while combining outcome measurement types.

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