Abstract
BACKGROUND: Elagolix is an oral small molecule second-generation nonpeptide gonadotropin-releasing hormone (GnRH) antagonist drug that can quickly and reversibly inhibit female gonadotropins and ovarian sex hormones. Previous randomized controlled trials (RCTs) have evaluated the efficacy and safety of elagolix alone or in combination with add-back therapy to treat women with heavy menstrual bleeding (HMB) caused by uterine fibroids. Hence, this study sought to evaluate the safety and efficacy of elagolix alone or in combination with add-back therapy for the treatment of uterine fibroids with HMB. METHODS: The Cochrane Library, PubMed, Embase and ClinicalTrials.gov databases were searched for randomized controlled studies on the application of elagolix alone or with add-back therapy in patients with uterine fibroids and HMB from databases establishment to June 15, 2021. The outcomes reference menstrual blood loss (MBL), amenorrhea, uterine fibroid symptom quality of life (UFS-QoL), hemoglobin level, bone mineral density loss, and adverse events (AEs). The primary endpoint is MBL. Fixed/random effects models were used to calculate the risk ratio (RR)/mean difference (MD) and 95% confidence interval (CI) for each outcome. RESULTS: Two studies with four trials involving 1,217 patients were included in this meta-analysis. Compared with the placebo, when elagolix was used alone or given with additional therapy, the number of participants who satisfied the MBL was greater (MBL <80 mL and MBL was reduced by more than 50% in the last month), improved hemoglobin levels (increased by more than 2 g/dL from baseline to the final treatment month) criteria as well as triggered amenorrhea. Elagolix alone or in combination with add-back therapy improved the quality of life of patients. Compared with the elagolix treatment alone or with add-back therapy, the placebo was superior in terms of less bone mineral density change and a lower incidence of AEs. CONCLUSIONS: This study indicated that elagolix alone or in use with add-back therapy can be considered as a satisfactory treatment plan for the majority of patients who are diagnosed with uterine fibroids and HMB; however, the specific treatment plan should also consider patients' physical condition and any adverse reactions to the drug, based on existing research.